Category Archives: Medical Devices

How AI is redefining content creation in pharma — And why humans are still the drivers of trust

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In an era where speed, efficiency, and personalization have become imperatives, Artificial Intelligence (AI) — particularly machine learning, AI algorithms, and generative AI — is revolutionizing how the pharmaceutical industry approaches content creation. From automating reference linking to generating first drafts, AI is making content smarter, faster, and more scalable.

Yet, amidst this digital acceleration, one thing remains clear that human expertise is still the foundation of trust in healthcare communication.

At recent industry events and conferences, thought leaders echoed a common sentiment: AI is a catalyst, not a replacement. The most impactful pharma content today is born from a powerful synergy between AI and human intelligence, particularly when applied across disciplines such as data analysis, pharmacovigilance, clinical trials, and drug development.

 

The power of AI in pharma content creation

AI has significantly shortened the timeline of content development. By automating routine tasks like data architecture, extraction, summarization, and even modular content creation, AI enables teams to focus on higher-value activities. Some of the key advantages include:

  • Speed and efficiency: Drafting scientific summaries, creating modular content blocks, and auto-tagging assets for reuse — AI can perform these tasks in minutes, which previously took days.
  • Compliance and consistency: AI can cross-reference regulatory guidelines and validate claims faster, ensuring fewer errors and a higher level of consistency across materials.
  • Personalization at scale: Machine learning and AI algorithms help in tailoring content to specific audiences, ensuring that messaging is relevant, targeted, and timely – particularly in fields like personalized medicine and patient care.

The impact is undeniable. Pharma companies are no longer just creating more content — they are creating better content, delivered at the right time, to the right audience.

Why humans remain at the heart of trusted communications

Yet, even as AI transforms the operational side of content creation, human oversight remains indispensable for several reasons:

  1. Contextual accuracy and nuance

Medical communication is not just about relaying information — it’s about conveying it with precision, empathy, and context. AI can process data, but only humans can interpret complex medical nuances, drug discovery insights, and cultural considerations that shape the right narrative.

  1. Ethical and regulatory oversight

In the field of regulatory pharmalike pharmacovigilance and clinical trials, accuracy and ethics are non-negotiable. While AI can check references, it cannot assure about the ethical gray areas – a responsibility that remains with human experts.

  1. Building emotional connection

Trust in healthcare communications is deeply emotional. Physicians, patients, and stakeholders seek authenticity and human connection – something machines like large language models cannot replicate. Skilled writers infuse compassion, clarity, and credibility into every piece of content, building the trust that AI alone cannot establish.

  1. Innovation and strategic thinking

AI can optimize existing processes but cannot create disruptive strategies. Human creativity is still essential in commercial areas like customer engagement, content marketing, and long-term drug development strategies.

The future is Human + Machine, Not Human vs Machine

The future of pharma content creation lies in collaboration, not competition. AI — whether used in pharma AI tools, generative AI, or data analysis pipelines — should be seen as a powerful tool that augments human potential. When medical writers, regulatory experts, and creative strategists partner with AI, the result is content that is faster, smarter, and — most importantly — trusted.

At Turacoz, we believe that technology is only as powerful as the people who wield it. By combining the scalability of AI with the critical thinking, empathy, and expertise of humans, we help our clients craft communications that build lasting trust with healthcare professionals and patients alike.

Final thoughts

AI is redefining the way content is created in pharma, making processes smarter, faster, and more scalable — especially with advancements in AI algorithms, data architecture, and personalized medicine. But even the most sophisticated AI cannot replace the human touch that drives trust, credibility, and connection in healthcare communications.

As we embrace this exciting new era, the winning formula is clear: leverage the best of AI innovation, anchored by the irreplaceable value of human expertise.

Ready to elevate your content strategy with the perfect blend of human insight and AI innovation? Connect with Turacoz today.

World Thalassemia Day 2025: Giving a Voice to the Global Patient Community

Medical Devices, Medical Writing, , , , , , , , , , , , , ,

Every 8 May, World Thalassemia Day shines an international spotlight on the millions of people living with this inherited genetic disorder. The 2025 theme – “Together for Thalassaemia: Uniting Communities, Prioritising Patients” – captures the day’s core mission: to centre the patient, safeguard their rights, and ensure they are heard in every conversation about diagnosis, care, and cure.

Why patient voices matter

Thalassemia is more than severe anaemia or the frequent blood transfusions keep patient alive. It also means coping with fatigue, recurrent infections, painful splenomegaly, and the anxiety of waiting for a suitable bone marrow transplant. When patients share these everyday realities, they transform abstract epidemiology into human stories that resonate with policy‑makers, clinicians, and the public. Listening to patient experiences helps researchers design therapies that protect quality of life, not just haemoglobin levels, and reminds health systems that compassionate, patient‑centred care is a clinical imperative, not a luxury.

Awareness breeds early detection – and equity

World Thalassemia Day is the year’s biggest megaphone for public awareness. Broad campaigns that explain the difference between alpha and beta thalassemia, the role of genetic mutations, and the importance of early genetic counselling empower families to seek screening before the birth of an affected child. Awareness also normalises lifelong treatment – from iron‑chelation to emerging gene therapies – helping communities overcome stigma and misinformation. Crucially, it spotlights the wide gap in access to care between well‑resourced urban centres and low‑income regions where health inequalities still dictate life expectancy.

Patient advocacy: From individual struggle to collective power

Grass‑roots organisations turn individual stories into collective action. Their advocacy has expanded newborn screening programmes, secured government subsidies for transfusion supplies, and pressured insurers to cover expensive iron‑chelators. By partnering with scientific bodies, advocates elevate patient priorities on the global research agenda – accelerating healthcare innovation such as CRISPR‑based gene editing. This year’s theme urges deeper community engagement so local groups in Africa, South‑East Asia, and the Middle East can exchange strategies and unite around shared goals.

Public health policies that put patients first

No amount of patient courage can replace political will. World Thalassemia Day provides a rallying point for drafting evidence‑based public health and healthcare policies that guarantee timely transfusions, safe blood donation networks, and affordable chelation therapy. Advocates are calling for national guidelines that enshrine healthcare equality, fund specialised thalassemia centres, and subsidise cutting‑edge cures so that ability to pay never determines access to quality healthcare. Governments are also urged to adopt preventive measures—premarital carrier testing, public education on consanguinity risks, and school‑based disease prevention programmes—to curb the financial and emotional burden on future generations.

  • Donate blood – A single unit sustains a child with thalassemia for weeks.
  • Champion prevention – Encourage friends to seek carrier testing and pre‑marital genetic counselling.
  • Amplify stories – Share patient videos or blog posts on social media to shift the narrative from statistics to lived reality.
  • Support research funds – Philanthropy accelerates clinical trials for curative therapies and less invasive treatments.
  • Engage politicians – Write to representatives about the need for robust, patient‑friendly thalassemia legislation.

Looking ahead

World Thalassemia Day is more than a date on the calendar; it is a movement that refuses to let patients be passive recipients of care. By elevating their voices, the global community can drive healthcare access, reduce the financial burden of lifelong therapy, and ultimately fulfil the promise that no child will be barred from a healthy future because of an inherited blood disorder.

On this 8 May, Turacoz calls for the community support, systemic change, and truly person‑centred care reverberates far beyond a single day—until every patient, everywhere, is not just surviving, but thriving.

 

Health Journalism: Combating Misinformation with Accuracy

Medical Devices, Medical Publishing, Medical Writing,

By Turacoz Healthcare Solutions | World Liver Day 2025

In a world where social media dominates wellness discussions, liver health is a popular topic — albeit not always a well-informed one. From miracle cures to detox diets, the liver is the focus of myriad health claims with little scientific basis. On this World Liver Day, we highlight the vital role of health journalism in separating fact from fiction and delivering accurate, science-based information.

Emergence of Misinformation about Liver Health

Digital media have opened health information to everyone—but with such openness comes an influx of unfiltered information. Wellness bloggers, often with little to no medical training, tout liver ‘cleanses’ and ‘superfoods’ without accountability. These messages, though alluring, can mislead consumers, undermine patient education campaigns, and jeopardize liver health.

False information not only causes confusion but also can delay treatment and accurate diagnosis. With early treatment being essential in conditions such as non-alcoholic fatty liver disease (NAFLD), hepatitis, and cirrhosis, patients are at a loss if discussion centers around misinformation.

The Role of Health Journalism in Public Health

Evidence-based health journalism acts as a link between health practitioners and the general population. Accurate, accessible, and understandable health reporting translates complex medical jargon into clear messages, enhancing health literacy and supporting informed decision-making.

Medical writers and journalists have an obligation to:

  • Confirm information from evidence-based sources like peer-reviewed journals and clinical practice guidelines.
  • Work with specialists such as hepatologists, nutritionists, and scientists.
  • Employ health information management systems to track, interpret, and share accurate data.

Fact-checking in the Social Media era

With misinformation traveling at lightning speed on the internet, fact-checking now forms a bedrock of trustworthy health communication. Using health information technology like automated content verification systems and AI-based surveillance, medical communicators can quickly address misleading claims and disseminate accurate content to the masses.

Agencies, along with journalists, should also predict patterns. Tracking social media discussions enables them to correct misleading reports in a timely fashion and present scientifically correct counter-information.

Empowering Patients Through Education

Correct health information not only educates, it empowers. Liver health education should be centered in useful, actionable information: comprehending liver function, identifying risks, adopting evidence-based dietary practices, and recognizing warning signs that necessitate medical care.

By ensuring that educational resources are synchronized with national health goals and governmental standards, medical communicators contribute effectively to national campaigns promoting liver health.

A Partnership with Health Professionals

Effective health journalism does not exist in a vacuum. It is developed in close collaboration with health professionals, patient advocacy organizations, and public health organizations. Such collaborations help guarantee that information is up to date, applicable, and consistent with clinical best practices.

The way forward

Combating misinformation on matters related to the liver necessitates a multifaceted approach:

In Conclusion

Being a trusted medical communications agency, Turacoz is of the opinion that science-based, accessible, and honest communication is central to improved health outcomes. On this World Liver Day, we reaffirm our values of truth, science, and service—because timely information is a matter of saving people’s lives.

 

Patient Voices Matter: How Patient-reported Outcomes Are Redefining Market Access

Medical Devices, Medical Publishing, Medical Writing,

The healthcare industry is experiencing a paradigm shift as patient voices take center stage in drug development and approval processes. While clinical trial data continues to be the cornerstone of drug development and approval, patient-reported outcomes (PROs) are emerging as the gold standard for demonstrating real-world value, particularly when it comes to market access approvals offering valuable insights into the patient experience and treatment impact. As healthcare systems worldwide shift toward value-based care, PROs are getting more and more widely used in clinical trials and approval processes. For example, the proportion of industry-sponsored oncology trials including PROs assessments rose from 26% (2007–2013) to 75% (2014–2018).1 This increased integration of PROs into clinical trials and regulatory submissions reflects a growing acknowledgment of their value in evaluating therapies from the patient’s perspective.

The Evolution of Healthcare Metrics

Historically, drug approvals focused primarily on “hard” clinical endpoints, while these metrics remain important, they tell only part of the story, and do not completely capture the picture of quality of life (QoL) or daily functioning. PROs that reflect the patient’s direct perspective on their symptoms, functional status, and overall well-being capture this crucial dimension that clinical data alone cannot measure complementing the traditional clinical outcomes. This holistic view of treatment effects is particularly important for chronic and debilitating conditions, where symptom burden and QoL are critical determinants of treatment success.2,3

Regulatory Recognition

Regulatory bodies worldwide have recognized this gap and are increasingly demanding PRO data as part of approval submissions:

  • The U.S. Food and Drug Administration (FDA)1 has established Patient-Focused Drug Development (PFDD) to encourages patient participation in R&D decision-making process with an aim to develop a drug which better meets the patients’ needs. PROs were included in FDA’s 53% of medical device authorizations.4
  • The EMA’s regulatory guidance explicitly recommends PROs inclusion for many therapeutic areas. For example, 78.1% of oncology approvals by EMA included PROs.5
  • Health technology assessment (HTA) bodies and reimbursement agencies are leveraging PROs to evaluate the value of treatments in real-world settings. This trend is supported by studies showing that PROs can identify low-value care and inform cost-effectiveness analyses, thereby optimizing resource allocation in healthcare systems.6 

The increasing integration of PROs into regulatory submissions underlines their significance in demonstrating treatment benefits from a patient perspective.

The Market Access Imperative

For pharmaceutical companies PRO data is becoming essential for market access success. Here’s why:

Differentiation in Crowded Markets

PRO data can help to distinguish therapies, especially in oncology post-progression scenarios. A study has indicated that positive PRO data such as superior symptom relief, improved physical functioning support continued therapy at the physician’s discretion upon regulatory approval, even in progressive disease.7

Pricing and Reimbursement Leverage

The U.S. healthcare system is shifting from fee-for-service to value-based payment models to enhance patient care quality and control costs. Under the 2015 Medicare Access and Children’s Health Insurance Program Reauthorization Act, providers will be assessed on quality and cost efficiency, affecting their reimbursement rates. PROs play a key role in this transition by offering insights into patient preferences, experiences, and perceptions of benefits and risks. These insights inform pricing, reimbursement, and benefit-risk assessments, ensuring treatments align with patient values. PROs also influence health technology assessments by evaluating the impact of medical technologies on quality of life, guiding more equitable pricing decisions based on what patients value.8,9

Formulary Placement and Treatment Guidelines

Clinical practice guidelines are giving greater weight to PROs evidence when making recommendations. For example, European Society for Medical Oncology (ESMO) recommends symptom monitoring using patient-reported outcome measures (PROMs) for patients with stage IIIB/IV lung cancer who have completed initial or maintenance treatment. Additionally, it also recommends PROMs in survivorship care of patients after treatment of cancer, to improve communication and identify late toxicities, symptoms or functional impairment warranting supportive care.10

Beyond regulatory initiatives, incorporating PROs can increase the “value” of your therapeutic from a payor perspective, ultimately helping formulary placement.11

Advances in Digital Data Collection Have Made Collecting PROs Easy

The advent of digital health technologies has facilitated the collection and analysis of PROs, making them more accessible and actionable. Electronic patient-reported outcome measures (ePROMs) enable real-time data capture, reducing barriers to implementation and improving the quality of PRO data.6,12  For example, digital platforms are being used to collect PROs in large-scale studies, such as the PROMchronic study in Germany, which aims to evaluate the effectiveness of ePROMs in improving care for patients with chronic diseases like diabetes and asthma.6 Additionally, AI and machine learning help analyze PRO data to identify patterns and insights.

Challenges and Opportunities

Despite their growing importance, the use of PROs in market access approvals is not without challenges. Issues such as the lack of standardization, variability in data quality, and the need for robust methodologies remain. However, ongoing research and policy initiatives are addressing these challenges, with a focus on developing validated instruments, improving data collection practices, and integrating PROs into regulatory frameworks.13,14

For example, the European Medicines Agency (EMA) has emphasized the need for harmonization of PRO measures to facilitate their use in drug development and regulatory decision-making. Similarly, initiatives like the Innovative Medicines Initiative (IMI) PREFER project are working to establish best practices for incorporating patient preferences into regulatory evaluations.14,15

The Future of PROs in Market Access

The future of PROs in market access approvals is promising, with ongoing advancements in technology, policy, and methodology. As regulators and payers increasingly recognize the value of patient-centered data, PROs are likely to become even more integral to healthcare decision-making. Their ability to capture the patient’s perspective, complement traditional outcomes, and support real-world evidence makes them indispensable in the era of value-based healthcare.16

Conclusion

In conclusion, PROs are becoming the gold standard for market access approvals because they provide a patient-centered perspective, complement traditional clinical outcomes, and support regulatory and reimbursement decisions with real-world evidence. As healthcare systems continue to evolve, the integration of PROs into decision-making processes will remain a cornerstone of value-based, patient-centered care.

References

  1. Cao K, et al. From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments. Drug Des Devel Ther. 2024;18:5759-5771.
  2. Bonsel JM, et al. The use of patient-reported outcome measures to improve patient-related outcomes – a systematic review. Health Qual Life Outcomes. 2024;22(1):101.
  3. Jeyaraman N, et al. Voices that matter: The impact of patient-reported outcome measures on clinical decision-making. World J Methodol.2025; 15(2):98066.
  4. Matts ST, et al. Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations. J Patient Rep Outcomes. 2022;6(1):38.
  5. Teixeira MM, et al. A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020. Front Med (Lausanne). 2022;9:968272.
  6. Nikkhah J, et al. Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol. JMIR Res Protoc. 2024;13:e56487.
  7. Brogan AP, et al. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples. J Manag Care Spec Pharm. 2017;23(2):125-134.
  8. Chachoua L, et al. Use of Patient Preference Information in Benefit-Risk Assessment, Health Technology Assessment, and Pricing and Reimbursement Decisions: A Systematic Literature Review of Attempts and Initiatives. Front Med (Lausanne). 2020;7:543046.
  9. Squitieri L, Bozic KJ, and Pusic AL. The Role of Patient-Reported Outcome Measures in Value-Based Payment Reform. Value Health. 2017;20(6):834-836.
  10. Di Maio M, et al. The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline. Ann Oncol. 2022;33(9):878-892.
  11. Oderda G, et al. Payer perceptions on the use of patient-reported outcomes in oncology decision making. J Manag Care Spec Pharm. 2022;28(2):188-195.
  12. Joeris A, et al. Real-world patient data: Can they support decision making and patient engagement?. Injury. 2023;54 Suppl 3:S51-S56.
  13. Almeida D, et al. Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU. Front Med (Lausanne). 2024;11:1408636.
  14. Janssens R, et al. How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action. Front Pharmacol. 2023;14:1192770.
  15. Ciani O, et al. Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017-2022. Neurol Sci. 2023;44(8):2933-2937.
  16. Adeghe EP, Okolo CA, and Ojeyinka OT. The influence of patient-reported outcome measures on healthcare delivery: A review of methodologies and applications. OARJBP. 2024;10(2):013-21.

The Role of AI & Machine Learning in Real-World Evidence Generation

Medical Devices, Medical Publishing, Medical Writing,

In the evolving era of healthcare, data is the foundation of informed decision-making. With the rise of Artificial Intelligence (AI) and Machine Learning (ML), real-world evidence (RWE) generation is undergoing a revolutionary transformation. AI-driven analytics empower researchers and healthcare professionals (HCPs) to extract meaningful insights from vast and complex datasets which ultimately improve patient outcomes and optimize treatment strategies.

The power of RWE in healthcare

AI and ML are playing a pivotal role in bridging the gap between controlled clinical trials and real-world clinical practices by enabling seamless synthesis and interpretation of diverse datasets. These technologies help in aligning clinical evidence with real-world treatment patterns and outcomes, making the data more applicable and impactful for regulatory documentation. Through automated data extraction, natural language processing, and real-time analytics, AI supports the creation of timely and compliant regulatory submissions that reflect real-world treatment efficacy and safety. In publication planning, ML can identify emerging data trends and prioritize high-impact topics, while AI-driven tools streamline manuscript generation and literature analysis. Additionally, in Health Economics and Outcomes Research (HEOR), AI enhances model precision by incorporating dynamic, real-world variables—leading to more robust cost-effectiveness and budget impact assessments that resonate with payers and policymakers.

How AI & ML transform RWE generation

  1. Data integration & processing

Healthcare data is often fragmented across multiple systems, making integration a major challenge. AI-driven algorithms efficiently harmonize disparate datasets, standardizing information from diverse sources such as:

  • EHRs: AI extracts relevant clinical information while maintaining patient privacy.
  • Wearable & sensor data: Continuous monitoring devices provide real-time insights into patient health trends.
  • Medical imaging & genomic data: AI enhances pattern recognition, enabling precision medicine approaches.
  1. Predictive analytics for better decision-making

ML models analyze historical patient data to predict outcomes, identify disease progression, and assess treatment efficacy. For example:

  • Early disease detection: AI models detect anomalies in imaging scans or lab results, enabling early intervention.
  • Treatment optimization: By analyzing patient responses to therapies, ML suggests tailored treatment plans, reducing trial-and-error approaches.
  • Risk stratification: AI helps classify patients based on risk factors, aiding in proactive disease management.
  1. Enhancing clinical trials & drug development

AI and ML streamline clinical research by:

  • Patient recruitment: Identifying eligible participants through automated data analysis.
  • Synthetic control arms: Using AI-generated patient models to simulate control groups, reducing the need for large trial populations.
  • Real-time monitoring: AI continuously tracks patient responses, adjusting protocols dynamically for optimal results.
  1. Improving pharmacovigilance & safety monitoring

Post-market drug surveillance benefits from AI’s ability to detect adverse events from vast datasets, including:

  • Social media & patient forums: AI scans digital discussions for emerging side effect patterns.
  • EHRs & claims data: Identifies unexpected adverse reactions across large patient populations.
  • Natural Language Processing (NLP): Extracts insights from unstructured physician notes and reports.

Real-world impact of AI & ML in RWE generation

AI-driven RWE applications are already making tangible improvements in healthcare:

  • Personalized medicine: AI enables the development of individualized treatment plans based on genetic, environmental, and lifestyle factors.
  • Chronic disease management: ML models predict disease exacerbations, prompting timely interventions.
  • Health policy & public health initiatives: AI-driven RWE informs regulatory decisions, optimizing healthcare resource allocation.

Challenges & Solutions in AI-Powered RWE Generation

Challenge Solution
Data privacy & security Implementing robust encryption and federated learning techniques.
Bias & algorithm transparency Ensuring diverse datasets and conducting regular audits to reduce biases.
Regulatory compliance Aligning AI applications with global data governance frameworks.
Interpretability of AI models Developing explainable AI (XAI) methods for better clinical adoption.

 

The future of AI in RWE

As AI and ML continue to advance, their role in RWE generation will expand, fostering

  • More efficient drug approvals: Regulatory bodies increasingly rely on AI-enhanced RWE to accelerate decision-making.
  • Improved patient-centric care: AI-powered insights enable more holistic, tailored treatment plans.
  • Greater integration with wearable tech: Continuous patient monitoring enhances real-time evidence collection.

Turacoz remain committed to scientific integrity, clear communication, and regulatory compliance. Our AI-enhanced approach to RWE documentation ensures that valuable real-world insights are effectively translated into actionable information for all stakeholders.

By combining medical writing expertise with advanced AI and ML capabilities, we help our clients transform complex real-world data into compelling evidence narratives that advance medical knowledge, support regulatory decisions, and ultimately improve patient care.

Are Real-World Studies Reliable? Addressing Bias & Data Quality Issues

Medical Devices, Medical Publishing, Medical Writing,

In an era where healthcare decisions are increasingly driven by data, real-world evidence (RWE) has become a crucial tool for assessing treatment effectiveness beyond controlled medical trials. Real-world data (RWD) provides insights into how medical interventions perform across diverse patient populations in routine practice. However, concerns regarding bias, data integrity, and regulatory compliance raise an important question: How reliable are real-world studies?

The Growing Importance of RWE

Unlike traditional clinical trials, which follow strict protocols and eligibility criteria, real-world studies rely on data from electronic health records (EHRs), insurance claims, patient registries, and even wearable devices. This shift allows researchers, policymakers, and healthcare professionals to evaluate the long-term safety, cost-effectiveness, and impact of treatments in real-world settings.

Medical affairs teams use RWE to support health economics research, inform market access strategies, and guide regulatory decision-making. However, ensuring the credibility of findings requires a proactive approach to addressing biases and enhancing data quality.

Common Biases in Real-world Studies

Real-world studies are vulnerable to multiple forms of bias, which can compromise their reliability:

  • Selection bias: Since real-world studies do not employ randomized patient selection, certain demographic or clinical groups may be overrepresented or underrepresented, leading to skewed results.
  • Confounding variables: Unlike randomized controlled trials (RCTs), real-world studies often lack mechanisms to isolate variables, making it difficult to establish causality.
  • Reporting bias: Incomplete or inconsistent data entry in electronic health records and insurance claims databases can introduce errors that affect study conclusions.
  • Publication bias: Studies with favorable outcomes are more likely to be published, creating an incomplete picture of a treatment’s true effectiveness.

Mitigating Bias in RWE

Several methodologies can help mitigate bias in RWE studies:

  1. Propensity score matching (PSM): This statistical technique matches patients with similar baseline characteristics to reduce confounding.
  2. Inverse probability weighting (IPW): A weighting method that adjusts for imbalances in patient characteristics, improving comparability.
  3. Sensitivity analyses: Conducting multiple analyses with different assumptions helps assess the robustness of findings.
  4. Use of linked datasets: Combining multiple data sources (e.g., EHRs, registries, and claims data) can improve data completeness and reduce missingness-related biases1.

Ensuring Data Quality in Real-world Studies

Improving the reliability of RWE requires stringent methodologies and advanced analytical tools. Strategies to enhance data quality include:

  • Systematic literature reviews: Conducting thorough literature reviews ensures that RWE studies incorporate all relevant data, reducing the risk of biased conclusions2.
  • Artificial intelligence in healthcare: AI-driven analytics can identify patterns, clean datasets, and account for missing variables, leading to more reliable insights3.
  • Standardized data collection: Implementing structured reporting systems across healthcare institutions ensures greater consistency and completeness in real-world data4.
  • Regulatory compliance: Adhering to guidelines set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) ensures that real-world studies meet rigorous scientific and ethical standards5.

The Role of Regulatory Compliance in RWE Reliability

To incorporate RWE into clinical decision-making, regulatory bodies have introduced stringent data governance frameworks. Ensuring compliance with Good Clinical Practice (GCP) and other regulations mitigates the risks associated with incomplete or biased data.

  • The FDA’s Real-World Evidence Framework establishes standards for assessing RWD quality, study design, and applicability in regulatory submissions6.
  • The EMA emphasizes transparency and reproducibility in RWE submissions, ensuring that studies meet the highest scientific standards7.

For example, the FDA approved Palbociclib (Ibrance) for male breast cancer based on RWE from claims and EHR data rather than traditional clinical trials8. This case highlights how high-quality RWE can inform regulatory decisions when RCTs are impractical.

Future Outlook: Combining RWE with Clinical Trials

While RCTs remain the gold standard for evaluating treatment efficacy, RWE plays a complementary role by providing insights into long-term safety, patient adherence, and economic impact. Integrating real-world data with traditional research methodologies can create a more comprehensive understanding of healthcare interventions.

Advancements in AI-driven analytics, real-time data integration, and digital health monitoring are improving the accuracy of RWE studies. Organizations are increasingly leveraging these technologies to refine data accuracy and eliminate bias9. By embracing the best practices in systematic literature review, regulatory compliance, and data validation, real-world studies can offer valuable insights that drive evidence-based healthcare decisions.

The Path Forward

RWE is a powerful tool in modern healthcare, but its reliability depends on addressing biases and ensuring data integrity. Implementing standardized methodologies, leveraging artificial intelligence, and adhering to regulatory standards can help unlock the full potential of real-world studies and effectively disseminate findings across the healthcare ecosystem.

References

  1. Schneeweiss S. Learning from big health care data. N Engl J Med. 2014;370(23):2161-3.
  2. Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies. BMJ 2021;372:m4856.
  3. Rajkomar A, Dean J, Kohane I. Machine learning in medicine. N Engl J Med. 2019;380(14):1347-58.
  4. FDA. Real-world evidence: what is it and what can it tell us? [Internet]. 2023 [cited Feb 27, 2025]. Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
  5. European Medicines Agency. Real-world evidence in regulatory decision-making [Internet]. 2022 [cited Feb 27, 2025]. Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/real-world-evidence
  6. US FDA. Framework for FDA’s real-world evidence program [Internet]. 2018 [cited Feb 27, 2025]. Available from: https://www.fda.gov/media/120060/download
  7. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) [Internet]. 2021 [cited Feb 27, 2025]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices_en.pdf
  8. US FDA. FDA approves Ibrance for male breast cancer based on real-world evidence [Internet]. 2019 [cited Feb 27, 2025]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-ibrance-male-breast-cancer-based-real-world-evidence
  9. Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and regulatory decision making: where are we now? Clin Pharmacol Ther. 2018;104(5):822-9.

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The Role of Medical Science Liaisons in Educating Physicians on Colorectal Cancer Advances

Medical Devices, Medical Publishing, Medical Writing,

Colorectal cancer (CRC) is the third most commonly diagnosed form of cancer globally and is the second most common cancer-related cause of death worldwide.1,2 This makes CRC a major public health issue due to the great economic burden it places on countries. There is significant progress in screening, diagnosis, and therapy for CRC at present; however, prognosis is poor, and there are challenges.2 With rapid advancements in treatment, staying updated on new therapeutic developments is crucial. Medical Science Liaisons (MSLs) play a vital role in bridging the gap between pharmaceutical companies and healthcare professionals (HCPs) by providing scientific expertise, facilitating medical education, and ensuring the exchange of accurate, up-to-date clinical data and therapeutic guidelines.3

The growing importance of MSLs in oncology

MSLs are highly trained scientific professionals, often with advanced degrees in medicine, pharmacy, or life sciences, and are key members of the medical Affairs teams of pharmaceutical companies.3 They serve as a critical link between the pharmaceutical industry and the medical community, aiding in informed decision-making, fostering collaborations, and enhancing patient care.4

In oncology, where the treatment landscape evolves rapidly, MSLs play a key role in equipping physicians with the knowledge necessary to optimize patient care.

How MSLs keep physicians updated on CRC research

Colorectal cancer treatment has witnessed major advancements in recent years, including targeted therapies, immunotherapies, precision medicine and biomarker-based treatment, antibody-drug conjugate therapy, and novel chemotherapy.5 MSLs ensure that physicians stay informed on these innovations in the following ways:

  1. Providing clinical insights

MSLs interpret and communicate complex clinical trial data, helping physicians understand the latest scientific breakthroughs and how new therapies compare with existing treatments in terms of efficacy, safety, and patient outcomes.6 Thus, MSLs serve as a bridge between the industry and HCPs or key opinion leaders (KOLs), facilitating a two-way exchange of scientific and clinical information. By keeping KOLs informed about the latest industry developments, MSLs help save their valuable time.4

  1. Explaining mechanisms of action

With the rise of precision medicine, understanding the molecular mechanisms of novel drugs is crucial. MSLs educate physicians on how therapies, such as immune checkpoint inhibitors, monoclonal antibodies, and combination regimen, work at a molecular level.

  1. Navigating treatment guidelines

Organizations like the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) frequently update treatment guidelines. MSLs assist physicians in integrating these changes into clinical practice, ensuring adherence to the most recent guidelines.

  1. Facilitating real-world data insights

Beyond clinical trials, real-world evidence plays a crucial role in assessing long-term treatment effectiveness and improving medical treatment.7 MSLs provide valuable insights into patient responses, adverse event management, and emerging real-world trends.

How MSLs bridge research and clinical practice

One of the major challenges in oncology is translating scientific research into practical, patient-centered care. MSLs address this challenge by:

  1. Conducting peer-to-peer educational programs

MSLs organize advisory boards, roundtable discussions, and one-on-one meetings with KOLs to discuss recent advancements in the therapeutic area and their implications for clinical practice.  MSLs gather insights from KOLs and help in guiding research and product development for pharmaceutical and biotechnology companies.

  1. Facilitating clinical trials

Oncologists often collaborate with pharmaceutical companies to enroll patients in clinical trials. MSLs help identify suitable studies, clarify eligibility criteria, and provide trial-related updates to oncologists.

  1. Providing medical education resources

From whitepapers to webinars, MSLs curate educational content tailored to the needs of oncologists, ensuring they have access to reliable and relevant information.

  1. Fostering multidisciplinary collaboration in CRC treatment

Colorectal cancer management requires a multidisciplinary approach, involving medical specialists such as medical oncologists, surgical oncologists, radiologists, gastroenterologists, radiation oncologists, and pathologists.8 MSLs play a crucial role in fostering collaboration among these specialties by:

  • Encouraging interdisciplinary discussions on treatment sequencing and combination strategies.
  • Addressing concerns related to emerging therapies, such as side effect management and patient selection criteria.
  • Ensuring consistent communication between pharmaceutical companies and medical institutions to align treatment advancements with real-world patient needs.

Call to action: Recognizing the impact of MSLs in oncology

The Colorectal Cancer Awareness Month serves as a timely reminder to recognize and appreciate the invaluable contributions of MSLs in the fight against CRC. Turacoz proudly acknowledges and values the critical role MSLs play in advancing care and driving impact in the battle against CRC. Their expertise not only advances physician education but also enhances patient outcomes by ensuring that the latest medical innovations are seamlessly integrated into clinical practice.

By championing the role of MSLs, we can bridge the gap between research and real-world care, ensuring every patient with CRC receives the best treatment possible.

 

References

  1. Klimeck L, Heisser T, Hoffmeister M, et al. Colorectal cancer: A health and economic problem. Best Practice & Research Clinical Gastroenterology. 2023 Oct 1;66:101839.
  2. Fadlallah H, El Masri J, Fakhereddine H, et al. Colorectal cancer: Recent advances in management and treatment. World journal of clinical oncology. 2024 Sep 24;15(9):1136.
  3. Chen J, Burns G, Kelly C, Vanderhoef D, Johnson J. Medical Science Liaisons: A Guide for Advanced Practice Registered Nurses. The Journal for Nurse Practitioners. 2024 Nov 1;20(10):105211.
  4. García García C, Riosalido Montero M, Sastre V, González del Castillo A, Matesanz Marín A. The medical science liaison role in Spain: Opinion of the commercial department personnel. Therapeutic Innovation & Regulatory Science. 2023 Sep;57(5):1030-9.
  5. Alese OB, Wu C, Chapin WJ, et al. Update on emerging therapies for advanced colorectal cancer. American Society of Clinical Oncology Educational Book. 2023 May;43:e389574.
  6. Theron P, Britland M, Holder D, Ikeda Y, Rewers RF, Tiku A. Promoting best practices for medical science liaisons position statement from the APPA, IFAPP, MAPS and MSLS. Therapeutic Innovation & Regulatory Science. 2021 Nov;55:1139-44.
  7. Moss B, Goodall EA, Maravic Z, et al. Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions. Future Oncology. 2023 Aug 1;19(26):1811-23.
  8. Sievers CK, Kratz JD, Zurbriggen LD, et al. The multidisciplinary management of colorectal cancer: present and future paradigms. Clinics in colon and rectal surgery. 2016 Sep;29(03):232-8.

Are randomized clinical trials enough: Why regulatory bodies are demanding more real-world evidence?

Medical Devices, Medical Publishing, Medical Writing,

Real-world evidence (RWE) has emerged as a critical complement to randomized clinical trials (RCTs) in healthcare regulatory decision-making. While RCTs remain the gold standard to assess an intervention and the efficacy of an intervention and are irreplaceable when testing the effect of new treatments, they often face limitations in terms of generalizability, cost, and timeliness. Derived from real-world data (RWD), RWE offers valuable insights into the effectiveness, safety, and economic impact of healthcare interventions in everyday clinical settings. It has become an essential part of integrated evidence generation, creating a continuous flow of information from the premarket to post-market approval decisions. By providing a meaningful clinical context, RWE bridges the gap between evidence of efficacy and effectiveness, enriching the decision-making process.

Although RWE has been used for years to support post-marketing approval and drug safety, the 21st Century Cures Act, enacted in December 2016, accelerated the use of RWE for regulatory submission.1 The act, designed to speed up medical product development and deliver innovations to patients more efficiently, has led to an increase in the use of RWE.2 For example, between 2017 and 2019, only 13% of evaluated oncology submissions to the FDA included RWE to support efficacy, compared to 70% from 2019 to 2021 using RWE to support efficacy and/or safety.1

The Role of Real-World Evidence in Regulatory Decision-Making

  1. Complementing RCTs

RCTs are highly controlled studies that provide robust evidence of efficacy and safety but are often limited by their strict inclusion and exclusion criteria, which may not reflect real-world patient populations. On the other hand, RWE captures data from diverse real-world settings, including patients with comorbidities, rare diseases, and those taking multiple medications, thereby enhancing the generalizability of the findings. Additionally, the RWE allows for the assessment of intervention values, considering both clinical and economic implications. Understanding real-world costs and outcomes is essential for optimizing resource allocation and ensuring the greatest value to patients and society.3,4

  1. Addressing Evidence Gaps

RWE is particularly valuable in addressing questions that RCTs cannot answer or do not answer. For example, RWE can provide long-term safety and effectiveness data, information on drug interactions, assess treatment outcomes in rare diseases, and evaluate the impact of medications in paediatric or geriatric populations.5,6 Additionally, RWE can inform decisions on drug labelling, post-marketing surveillance, and reimbursement.7

  1. Regulatory Applications

Regulatory bodies such as the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Health Canada have increasingly recognized the value of RWE in regulatory decision-making. In North America, both the FDA and Health Canada have created frameworks to integrate RWE into the regulatory process for premarket and post-market activities. The FDA’s 2018 framework emphasizes using RWE to modify drug labels and evaluate effectiveness, whereas Health Canada encourages its use for special populations and rare diseases. In Europe, the EMA has set out strategies, including the “Regulatory Science to 2025” document and Adaptive Pathways, to incorporate RWE throughout the drug lifecycle, with a focus on harmonizing data access and analysis within the EU. In Asia, countries such as China, Japan, and Taiwan, have developed specific guidelines for the use of RWE in drug development. China’s National Medical Products Administration (NMPA) emphasizes its use for rare diseases and label expansions, while Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is working to refine methods for ensuring the reliability of registry data.8

Examples of RWE Improving Decision-Making

  1. COVID-19 Vaccine Deployment

During the COVID-19 pandemic, RWE was crucial in speeding up vaccine deployment by assessing vaccine effectiveness (VE) in real-world settings and complementing clinical trial data. Studies conducted in Denmark and Israel have provided valuable insights into VE against emerging variants and the effectiveness of booster doses. RWE also helped refine vaccination strategies and dosing regimens, offering evidence that RCTs couldn’t deliver on time. It supported safety monitoring and vaccine adaptation to new variants, enabling regulatory bodies to adjust dosing, guide on target populations, and optimize vaccine strategies for rapid decision-making.9

  1. Rare Disease Medicine Approvals

In the context of rare diseases, the RWE has been instrumental in broadening the indicated population for orphan drugs. A study analysing engagements with the EMA found that submissions, including RWE, resulted in a broader indicated population than those relying solely on RCT evidence. This highlights the potential of RWE to expand treatment access for rare diseases.10

  1. Medical Cannabis

RWE has also been used to support the approval of medical cannabis, where RCT evidence is often limited due to the challenges of studying whole-plant medicines. RWE studies, incorporating patient-reported outcomes, have demonstrated the positive impact of medical cannabis on patients’ lives, providing a broader evidence base for regulatory decisions.11

Challenges and Limitations of RWE

While RWE offers significant advantages, it also has limitations. Key challenges include concerns about data quality, potential biases, and lack of standardization in data collection and analysis. Additionally, RWE studies may lack the rigor of RCTs, and their findings may be influenced by confounding factors.4,6 To address these challenges, regulatory bodies stress the need for fit-for-purpose data, ensuring transparent study designs, and applying robust analytical methods.12

The Future of RWE in Regulatory Decision-Making

The integration of RWE into regulatory decision-making is expected to grow as methodologies improve and data quality is enhanced. Emerging trends, such as the use of artificial intelligence in healthcare and patient-generated data, offer new opportunities for leveraging RWE.4,13 Additionally, hybrid trial designs that combine elements of RCTs and RWE are being explored to generate evidence that is both robust and generalizable.14

Conclusion

Real-world evidence has become an indispensable tool for healthcare regulatory bodies, complementing the strengths of RCTs and addressing their limitations. By providing insights into real-world effectiveness, safety, and health economics impact, RWE has improved decision-making in areas where RCT data is insufficient. As methodologies evolve and data quality improves, the role of RWE in regulatory decision-making is expected to expand, offering new opportunities for advancing public health.

Turacoz specializes in leveraging RWE to support regulatory submissions, market access strategies, and healthcare decision-making. With expertise in data analytics, evidence synthesis, and regulatory compliance, we help pharmaceutical, and healthcare organizations integrate RWE into their product development and approval processes. From designing fit-for-purpose RWE studies to ensuring alignment with global regulatory frameworks, our tailored solutions empower clients to generate high-quality, actionable insights. By partnering with us, companies can enhance their evidence-generation strategies, optimize resource allocation, and accelerate patient access to innovative treatments.

References:

  1. Wilson BE, Booth CM. Real-world data: bridging the gap between clinical trials and practice. EClinicalMedicine. 2024;78:102915.
  2. Real-World Evidence. Available at: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence#:~:text=The%2021st%20Century%20Cures%20Act,drug%20post%2Dapproval%20study%20requirements. Last accessed: March 2025.
  3. Hernandez RK, Critchlow CW, Dreyer N, et al. Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence. Clin Pharmacol Ther. Published online January 14, 2025.
  4. Bhatia N. Harnessing real-world evidence in pharmacoeconomics: A comprehensive review. Open Health. 2024:5(1).
  5. Prilla S, Groeneveld S, Pacurariu A, et al. Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases. Clin Pharmacol Ther. 2024;116(5):1188-1197.
  6. Bakker E, Plueschke K, Jonker CJ, et al. Contribution of Real-World Evidence in European Medicines Agency’s Regulatory Decision Making. Clin Pharmacol Ther. 2023;113(1):135-151.
  7. Pulini AA, Caetano GM, Clautiaux H, et al. Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation. Ther Innov Regul Sci. 2021;55(1):228-238.
  8. Burns L, Roux NL, Kalesnik-Orszulak R, et al. Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World. Clin Ther. 2022;44(3):420-437.
  9. Bollaerts K, Wyndham-Thomas C, Miller E, et al. The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report. Biologicals. 2024;85:101750.
  10. Jandhyala R. The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency. Pharm. Policy Pract. 2022:15.
  11. Schlag AK, Zafar RR, Lynskey MT, et al. The value of real world evidence: The case of medical cannabis. Front Psychiatry. 2022;13:1027159.
  12. Dreyer NA, Hall M, Christian JB. Modernizing Regulatory Evidence with Trials and Real-World Studies. Ther Innov Regul Sci. 2020;54(5):1112-1115.
  13. Dagenais S, Russo L, Madsen A, et al. Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design. Clin Pharmacol Ther. 2022;111(1):77-89.
  14. Andre EB, Reynolds R, Caubel P, et al. Trial designs using real-world data: The changing landscape of the regulatory approval process. Pharmacoepidemiol Drug Saf. 2020;29(10):1201-1212.

 

Why Ongoing Education for Healthcare Professionals is Crucial

Medical Devices, Medical Publishing, Medical Writing,

Healthcare is a constantly evolving field, where innovation, research, and technology shape patient care and outcomes. Ongoing education isn’t just a professional requirement – it’s a commitment to delivering the highest standard of care. Continuing Medical Education (CME) plays a vital role in ensuring that healthcare professionals (HCPs) remain informed, adaptable, and prepared to meet the dynamic needs of their patients and communities. Additionally, AI in medical education is transforming how HCPs learn and apply knowledge in real-time clinical settings.

When HCPs engage in continuous learning, they stay informed, adaptable, and prepared to meet the dynamic needs of their patients and communities.

KEY REASONS ONGOING EDUCATION BENEFITS HEALTHCARE

Enhanced patient outcomes
The updated knowledge and skills help to provide better diagnoses, treatments, and patient care strategies.

Studies show that HCPs who engage with the continuous education

  • Reduce medical errors by 30%1
  • Improve patient recovery rates by 20%2

Updated with medical advancements
New drug therapies, innovative treatment protocols, and emerging medical technologies help to shape modern healthcare. Ongoing education ensures

  • Adoption of the latest clinical guidelines3
  • Prescription of evidence-based treatments4
  • Enhanced patient safety through updated protocols1

Compliance with evolving regulations and guidelines
Healthcare policies and best practices change frequently. Staying informed ensures compliance, reduces liability and improves the quality of care. For example, updated infection control guidelines have been crucial in managing global health crises like COVID-19.5

Professional growth and career advancement
Continuous education opens doors to career progression, specialization opportunities, and leadership roles. HCPs who pursue further training are 25% more likely to attain senior positions.² With advancements in technology-driven medical education, professionals can access flexible training that enhances their qualifications and career prospects.

Adapting to technological innovations
From AI-powered diagnostics to robotic-assisted surgeries, technology is revolutionizing healthcare. HCPs who receive ongoing education in digital health can

  • Increase diagnostic accuracy
  • Optimize workflow efficiency

Enhance patient engagement through telemedicine

REAL-WORLD IMPACT OF ONGOING EDUCATION IN HEALTHCARE

  • Reducing hospital readmissions – HCPs trained in post-discharge care strategies lower readmission rates by 15%.5
  • Improving emergency response – Advanced training in emergency care boosts survival rates for critical cases by 40%.5
  • Strengthening public health initiatives – Continuous education enables HCPs to drive better vaccination campaigns, disease prevention, and health promotion efforts.
  • Better interdisciplinary collaboration – Education fosters stronger teamwork among doctors, nurses, and specialists, improving overall healthcare efficiency.

CHALLENGES TO CONTINUOUS EDUCATION & SOLUTIONS

THE PATH FORWARD: A CALL TO ACTION

Investing in ongoing education for healthcare professionals is an investment in better healthcare for all. Supporting continuous learning opportunities ensures that providers

  • Deliver the highest quality care
  • Stay ahead of medical advancements
  • Contribute to improved patient outcomes worldwide

Healthcare never stands still—neither should learning. What step will you take today to stay ahead?

Turacoz is committed to empowering healthcare professionals (HCPs) by providing specialized training on the integration of Artificial Intelligence (AI) in medical education. Our programs are designed to help HCPs leverage AI-driven tools for enhanced learning, clinical decision-making, and patient management. Through interactive workshops, case-based discussions, and hands-on training, we equip professionals with the knowledge to utilize AI-powered diagnostics, predictive analytics, and personalized learning platforms effectively. By bridging the gap between technology and healthcare education, Turacoz ensures that HCPs stay ahead in the evolving medical landscape, improving both educational outcomes and patient care.

References:

  1. World Health Organization. Global patient safety action plan 2021–2030. Available from: https://www.who.int/publications/i/item/9789240032705
  2. National Institutes of Health. The impact of continuing education on professional growth. Available from: https://www.nih.gov/research-training/training-opportunities
  3. World Health Organization. Global guidelines and implementation strategies for clinical practice. Available from: https://www.who.int/publications/guidelines
  4. Agency for Healthcare Research and Quality (AHRQ). Evidence-based practice centers (EPCs) [Internet]. Rockville (MD): AHRQ. Available from: https://www.ahrq.gov/research/findings/evidence-based-reports/index.html

Centers for Disease Control and Prevention. Strategies to reduce hospital readmissions. Available from: https://www.cdc.gov/healthcare/quality/reduction-of-hospital-readmissions.html

Pharma’s Shift to Patient-Centric Models: How Listening to Patients Drives Better Health Outcomes

Medical Devices, Medical Publishing, Medical Writing,

The pharmaceutical industry is undergoing a significant transformation. In the past, the focus was primarily on research, development, and approval processes driven by science and regulations. However, today’s landscape is evolving to prioritize what truly matters — delivering effective, affordable treatments to patients faster. For instance, in 2020, the rapid development and approval of COVID-19 vaccines in less than a year showed the power of collaboration, new technologies, and streamlined processes, setting a new precedent for how the industry can respond to urgent health crises.

The shift to patient-centricity is one of the most profound changes to impact the industry in recent years. As patients take on more responsibility for their own healthcare, their voices are becoming more influential in shaping the direction of pharmaceutical development and treatment options.

Why is Patient-Centric approach is so Important?

Patients are no longer passive recipients of care. Patients today are well-informed, actively involved in their healthcare decisions, and expect both healthcare providers and pharmaceutical companies to listen to their needs. This shift is not only about improving the patient’s experience but also about ensuring better outcomes in drug development, clinical trials, and treatment efficacy.

As we look ahead, here are a few key reasons why patient-centric models are crucial for the future of pharma:

  1. Improved Patient Health Outcomes
    Evidence shows that patient-centered care significantly improves clinical outcomes. A study on adolescents with diabetes highlights that key element—improved patient-provider communication, providing symptom information, and addressing concerns—are linked to better psychosocial health outcomes. The findings reveal a strong correlation (r ≥ 0.3) between these factors and improved patient-reported outcomes. This reinforces that prioritizing patients’ preferences and needs enhances treatment effectiveness and overall health results (Vasanwala et al 2022). By integrating patient feedback into the drug development process, pharmaceutical companies can design treatments that are more aligned with patients’ real-world needs. Whether it’s reducing side effects, improving drug delivery methods, or ensuring easier access to medications, listening to patients is key to developing effective therapies that work in practice — not just in theory.
  1. Enhanced Patient Engagement
    A recent study on patient’s beliefs about medicine and adherence shows that patients who perceive higher levels of people-centered care (PCC) are more likely to adhere to prescribed medications. Each point increase in PCC corresponds to a 7% higher chance of adherence, underscoring how active patient engagement and listening to their needs and beliefs about treatment can lead to better health outcomes. Patients who are actively engaged in their treatment are more likely to adhere to prescribed therapies, leading to better health outcomes. By involving patients in their care journey, pharmaceutical companies can enhance engagement, trust, and overall satisfaction. This shift is not just about providing a product but about offering a comprehensive healthcare solution that fits into a patient’s life (Dilles et al 2023).
  2. Bridging the Gap in Clinical Trials
    Historically, clinical trials have had limited diversity and were often not fully representative of the populations that would ultimately use the drugs. By adopting patient-centric approaches, companies can ensure that trials are more inclusive, ensuring a broader range of patient experiences, which leads to more relevant and effective treatments.
  3. Building Trust Through Transparency
    Recent advances in patient engagement show improved health outcomes across prevention and chronic disease management. Addressing health literacy and ensuring clear, actionable information is key. Gaps remain in effectively engaging patients, especially in decision-making and self-management. Future efforts should integrate patient feedback from wearables, improve information navigation, and involve patients in designing healthcare systems, policies, and research to make patient engagement a cultural norm for better health outcomes. Patients today want to know how treatments are being developed, the risks involved, and how their data is being used. Pharma companies that communicate openly with patients build trust, foster long-term relationships and ensure better patient cooperation and compliance.

How Medical Communications Agencies Support Patient-Centric Models

While the shift to patient-centricity is a broad industry-wide movement, medical communications agencies play a critical role in ensuring that pharma companies effectively implement these models. Here’s how they contribute to the patient-centric process:

  1. Bridging the Communication Gap
    Medical communications agencies can facilitate clear, effective communication between pharmaceutical companies and patients. Through the creation of educational materials, online platforms, and patient-facing content, agencies ensure that patients are fully informed about treatments, potential side effects, and clinical trial options. This transparency helps build trust and encourages patient engagement.
  2. Developing Patient-Centered Content
    Agencies specializing in medical communications create content that resonates with patients, ensuring that it’s not only scientifically accurate but also accessible and empathetic. Whether through print, digital channels, or social media, agencies ensure that the content speaks directly to patients’ concerns, empowering them with information that helps them make informed decisions about their treatment options.
  3. Facilitating Patient Advocacy Partnerships
    Medical communications agencies often collaborate with patient advocacy groups to ensure that patients’ voices are heard in the development process. Agencies help to amplify the concerns and needs of patient communities, ensuring that pharma companies are aware of the specific issues patients face. This collaboration leads to more inclusive and responsive drug development strategies.
  4. Enhancing Patient Engagement Strategies
    Agencies help design and execute strategies for sustained patient engagement, whether through digital tools, community forums, or targeted campaigns. By utilizing real-time patient feedback, agencies ensure that pharma companies are continually improving their patient-centric approaches and creating solutions that meet evolving patient needs.
  5. Optimizing Clinical Trial Recruitment
    Medical communications agencies can assist pharmaceutical companies in reaching out to a diverse patient population for clinical trials. They help design recruitment campaigns that are tailored to various patient groups, ensuring that trials reflect the diverse populations that will eventually benefit from the drugs. Moreover, agencies provide ongoing support to patients throughout the trial process, increasing retention and improving overall success rates.

The Road Ahead: A Patient-First Future

The transition to a patient-centric model in the pharmaceutical industry is not just a trend — it’s a necessity. As the demand for more personalized, effective, and accessible healthcare continues to grow, pharma companies must keep patients at the forefront of their strategies.

By truly listening to patients and involving them in every step of the journey, from drug discovery to post-market support, pharmaceutical companies can help create a future where treatments are not only more effective but also more aligned with the needs of the people they are designed to help.

Ultimately, a patient-first approach doesn’t just lead to better outcomes — it leads to a healthier, more informed world. As industry continues to evolve, embracing patient-centric models will be the key to transforming lives and advancing healthcare for generations to come.

References:

  1. Vasanwala, R., Lim, A., Soo Ting, L., Pei Kwee, L., Yuen Ching, H., & Xiang Feng, T. (2022). The impact of patient-centered care on health outcomes in adolescents living with diabetes. Patient Experience Journal, 9(1), 46–53. https://doi.org/10.35680/2372-0247.1619
  2. Dilles, T., Mortelmans, L., Loots, E., Sabbe, K., Feyen, H., Wauters, M., Haegdorens, F., & De Baetselier, E. (2023). People-centered care and patients’ beliefs about medicines and adherence: A cross-sectional study. Heliyon, 9(5), e15795. https://doi.org/10.1016/j.heliyon.2023.e15795

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AI-Driven Insights: Discovering New Research Opportunities in Medical Science

HR, Medical Devices, Medical Writing, ,

In the evolving medical research field, identifying unexplored areas and novel opportunities is crucial for advancing scientific knowledge and improving patient outcomes. Effective, traditional methods of literature review and gap analysis can often be time-consuming and prone to human error. This is where artificial intelligence (AI) – a transformative technology- plays a key role in revolutionizing how researchers identify gaps in the literature and uncover new avenues for investigation. This blog explores the role of AI in medical research, specifically how it can analyze existing literature to identify research gaps and suggest new opportunities.

Role of AI in Medical Research

Artificial intelligence, with its capacity to process vast amounts of data quickly and accurately, offers a powerful tool for researchers. AI technologies, such as machine learning (ML) and natural language processing (NLP), can scan and analyze thousands of research papers, clinical trials, and medical records, providing insights that would be impossible to achieve manually.

One of the primary applications of AI in medical research is in literature mining. Systematic literature reviews (SLRs) and meta-analyses, in particular, are critical for synthesizing existing knowledge. However, conducting an SLR manually can take several months to over a year, requiring researchers to sift through thousands of articles to identify relevant studies. This laborious process often involves multiple rounds of selection and data extraction. With AI tools like Covidence, Rayyan, Easy SLR, and Robot Reviewer, this timeline can be drastically reduced, as AI automates the initial stages of searching, screening, and extracting data from large datasets, making the process more efficient.

Moreover, AI can assist in meta-analyses by automating the extraction of relevant data from studies, calculating effect sizes, and synthesizing findings. This automation not only accelerates the research process but also enhances the accuracy and reproducibility of the results.

AI in Identifying Research Gaps

The identification of research gaps is a critical step in the scientific process. A research gap represents an area within a field where little or no information is available, indicating a need for further study. Traditionally, identifying these gaps required extensive literature review, expert consultation, and a deep understanding of the field. However, AI offers a more efficient and systematic approach.

  1. Automated Literature Review

AI-powered tools can perform comprehensive literature reviews in a fraction of the time it would take a human researcher. By scanning thousands of publications, AI can identify under-researched areas, highlight inconsistencies in findings, and pinpoint topics that have not been adequately explored. For example, AI algorithms can map the frequency and distribution of certain keywords or concepts across publications, revealing topics that are either overrepresented or underrepresented in the literature.

While AI can efficiently analyze vast amounts of data, it is essential to maintain a human-in-the-loop approach. Human researchers are crucial in ensuring the correctness and relevance of the AI-generated insights. AI may identify a potential gap based on patterns in the data, but human expertise is necessary to evaluate whether the gap is genuinely significant and to provide the necessary clinical or scientific context. A human in the loop ensures that biases, misinterpretations, or irrelevant results are filtered out, improving the overall accuracy and validity of the findings.

  1. Trend Analysis

AI can track trends in research by analyzing the publication dates, authorship patterns, and citation networks of scientific papers. This analysis can reveal emerging areas of interest, shifts in research focus, and the lifecycle of topics. By understanding these trends, researchers can identify when a field is reaching saturation and where new questions are beginning to emerge.

  1. Sentiment Analysis

NLP techniques enable AI to perform sentiment analysis on research articles, identifying the tone and sentiment expressed in the literature. By analyzing the positive, negative, or neutral language used in studies, AI can detect areas of controversy, skepticism, or confidence within a field. This information can guide researchers toward topics that require further investigation or areas where there is a lack of consensus.

  1. Predictive Analytics

AI’s predictive capabilities can forecast future research trends based on historical data. By analyzing past and present research outputs, AI can predict which areas are likely to gain attention in the future and where potential research gaps may arise. This foresight allows researchers to position themselves at the forefront of emerging fields, contributing to innovative studies that address anticipated knowledge gaps.

AI in Suggesting New Research Opportunities

Beyond identifying existing research gaps, AI has the potential to suggest new research opportunities. By integrating data from multiple sources, AI can uncover connections and correlations that may not be immediately apparent, leading to the generation of novel hypotheses and research questions.

  1. Cross-Disciplinary Research

AI can facilitate cross-disciplinary research by identifying intersections between different fields of study. For example, by analyzing literature from both oncology and immunology, AI might identify a potential link between cancer treatment and immune response that has not been fully explored. These cross-disciplinary insights can lead to innovative research that bridges gaps between traditionally separate fields.

Read More: Predictive Analytics in Medical Research: The Role of AI

  1. Data-Driven Hypotheses

AI’s ability to analyze large datasets enables the generation of data-driven hypotheses. By examining patterns and correlations within clinical data, patient records, and genetic information, AI can suggest new avenues for research that are grounded in empirical evidence. These hypotheses can then be tested in clinical trials or experimental studies, potentially leading to breakthroughs in medical science.

  1. Real-World Data Integration

AI can integrate real-world data, such as electronic health records (EHRs), wearable device data, and social media activity, into the research process. By analyzing this data, AI can identify patterns and trends that may not be visible in traditional clinical studies. This real-world evidence can highlight gaps in current medical knowledge and suggest new research opportunities that are more aligned with the needs and experiences of patients.

Challenges and Considerations

While AI offers significant advantages in identifying research gaps and opportunities, it is not without its challenges. The quality of AI-driven insights depends on the quality of the data it analyzes. Incomplete or biased datasets can lead to incorrect conclusions and missed opportunities. Therefore, it is crucial for researchers to ensure that the data fed into AI algorithms is comprehensive, diverse, and representative of the broader population.

AI algorithms may generate insights based on patterns in the data, but these insights require human interpretation and validation. Human researchers bring critical thinking, domain expertise, and the ability to assess the broader scientific context that AI lacks. Additionally, AI systems may sometimes generate false positives or overlook subtle nuances that are crucial in the interpretation of research gaps and opportunities.

Monitoring AI systems and ensuring proper checks and balances are in place is vital for the integrity of the research process. AI can suggest promising avenues of research, but human researchers must critically evaluate and refine these suggestions to ensure that they align with scientific goals and ethical standards.

AI is transforming the way researchers identify gaps in the medical literature and uncover new opportunities for investigation. By automating literature reviews, analyzing trends, and generating data-driven hypotheses, AI enables researchers to focus on the most promising areas of study and contribute to the advancement of medical science. However, the successful integration of AI into the research process requires careful consideration of data quality and a collaborative approach that leverages the strengths of both AI and human expertise.

As AI continues to evolve, its role in medical research will likely expand, offering even more sophisticated tools for identifying research gaps and suggesting new opportunities. For researchers and medical communication professionals, embracing AI’s potential is key to staying at the forefront of scientific discovery and innovation.

Medical Writing: A Promising Career for Freshers and Professionals Alike

Medical Devices, Medical Publishing, Medical Writing, Publication Writing, Regulatory Writing, Scientific Writing

Medical writing is an exciting and rapidly growing field that blends the expertise of healthcare professionals with the creativity of communicators. As the medical and pharmaceutical industries continue to expand globally, the demand for skilled medical writers is skyrocketing. For freshers entering this dynamic profession, medical writing offers a unique opportunity to combine scientific knowledge with strong writing skills to create impactful content that educates, informs, and influences healthcare professionals, patients, and the general public.

In this blog, we will explore why medical writing is an excellent career option, the essential skills required to succeed in this field, and how enrolling in a specialized course can provide a solid foundation for a successful career in medical writing.

The Growing Demand for Medical Writers

The healthcare industry is vast and multifaceted, encompassing pharmaceuticals, medical devices, diagnostics, health services, and more. As new drugs, therapies, and technologies are developed, there is an increasing need for clear and accurate communication between researchers, healthcare providers, regulatory authorities, and patients. Medical writers play a crucial role in this communication by producing a wide range of documents, including clinical trial reports, regulatory submissions, promotional content, scientific publications, and patient education materials.

The demand for medical writers has surged in recent years, driven by factors such as:

  • Expanding Research and Development: As more pharmaceutical companies invest in research and development, there is a greater need for writers who can document clinical trials, draft regulatory submissions, and communicate scientific data effectively.
  • Increasing Regulatory Requirements: Regulatory authorities such as the FDA and EMA require detailed documentation for the approval of new drugs and medical devices. Medical writers help ensure that these documents meet regulatory standards.
  • Rising Importance of Healthcare Communication: Clear and accurate communication is essential for educating healthcare professionals and patients about new treatments, medical devices, and health practices. Medical writers are instrumental in crafting this communication.
  • Emerging Digital Health Technologies: The rise of digital health, telemedicine, and artificial intelligence (AI) in healthcare has created new opportunities for medical writers to work on cutting-edge technologies and innovations.

Read More: Revolutionizing Medical Writing with AI and Automation

The Role of Medical Writers

Medical writers wear many hats and can work in various niches depending on their interests and expertise. Here are some of the common types of medical writers:

  • Regulatory Writers: These writers focus on creating documents required by regulatory authorities for the approval of drugs, biologics, and medical devices. This includes clinical study reports, investigator brochures, and regulatory submission documents.
  • Scientific Writers: These professionals specialize in writing research papers, review articles, and conference abstracts for publication in scientific journals. Their goal is to communicate complex scientific data clearly and concisely.
  • Medico-Marketing Writers: In this role, medical writers produce promotional materials such as brochures, websites, and presentations aimed at healthcare professionals and patients. They must balance scientific accuracy with persuasive messaging.
  • Patient Education Writers: These writers create materials that help patients understand their medical conditions, treatment options, and health management strategies. Their work is critical in promoting patient engagement and adherence to treatment plans.
  • Health Communication Writers: These writers develop content for public health campaigns, awareness programs, and social media. They focus on making health information accessible and understandable to the general public.

Essential Skills for Medical Writers

While a background in life sciences or healthcare is often beneficial, it is not the only requirement for becoming a successful medical writer. Here are some key skills that are essential for a career in medical writing:

  • Strong Writing Skills: Medical writers must be able to communicate complex scientific concepts clearly and concisely. They need to adapt their writing style to suit different audiences, from regulatory authorities to patients.
  • Attention to Detail: Accuracy is paramount in medical writing. Even small errors in a document can have significant consequences, especially in regulatory submissions or scientific publications.
  • Critical Thinking: Medical writers need to critically analyze scientific data and research findings to produce accurate and reliable content. They must also ensure their writing is evidence-based and supported by credible sources.
  • Project Management: Medical writers often work on multiple projects simultaneously, each with its own deadlines and requirements. Strong organizational and time management skills are crucial for meeting deadlines and producing high-quality work.
  • Collaboration and Communication: Medical writers frequently collaborate with researchers, clinicians, regulatory professionals, and other stakeholders. Effective communication and teamwork are essential for producing accurate and coherent documents.

The Importance of Specialized Medical Writing Courses

While some medical writers enter the field with a degree in life sciences or healthcare, specialized medical writing courses can provide a significant advantage, particularly for freshers and those transitioning from other fields. These courses offer structured learning, hands-on experience, and a comprehensive understanding of the different aspects of medical writing.

Here is why a specialized course can be the key to launching a successful career in medical writing:

  • Comprehensive Knowledge: A well-structured course provides a solid foundation in medical writing, covering essential topics such as clinical research, regulatory writing, scientific publications services, and ethical considerations. It helps freshers gain a deep understanding of the healthcare industry and the specific requirements of different types of medical writing.
  • Practical Experience: Many courses include practical assignments and projects that allow students to apply their knowledge in real-world scenarios. This hands-on experience is invaluable for developing the skills needed to produce high-quality medical writing.
  • Understanding of Regulatory Requirements: One of the most challenging aspects of medical writing is navigating the complex regulatory landscape. Specialized courses provide detailed guidance on regulatory requirements, helping writers produce documents that meet the standards of agencies like the FDA, EMA, and other regulatory bodies.
  • Introduction to AI in Medical Writing: The integration of AI in medical writing is a game-changer. AI tools can streamline the writing process, analyze large datasets, and even assist in regulatory submissions. A specialized course that explores the role of AI in medical writing can give freshers a competitive edge by equipping them with knowledge of cutting-edge technologies that are shaping the future of the field.
  • Mentorship and Networking Opportunities: Many medical writing courses are taught by experienced professionals who have worked in the industry for years. Their insights and mentorship can provide valuable guidance as students navigate their careers. Additionally, these courses often offer networking opportunities, allowing students to connect with peers and industry experts.
  • Portfolio Development: A course can help students build a portfolio of writing samples that demonstrate their skills and expertise. Having a strong portfolio is essential for securing job opportunities in medical writing.
  • Career Support and Guidance: Many courses offer career support, including resume writing, interview preparation, and job placement assistance. This support can be especially helpful for freshers looking to break into the industry.

Conclusion

Medical writing is a rewarding and versatile career that offers opportunities across various domains, from regulatory writing to health communication. For freshers entering the field, a specialized medical writing course can provide the knowledge, skills, and confidence needed to succeed in this dynamic profession.

As the healthcare industry continues to evolve, the demand for skilled medical writers will only increase. By enrolling in a comprehensive medical writing course, freshers can position themselves at the forefront of this exciting field, equipped with the expertise and tools to make a meaningful impact on healthcare communication.

 

Journal Submission Process: Tips for Researchers

Medical Devices, Medical Writing,

The journey from completing a research project to seeing your work published in a reputable journal can be daunting. The submission process involves several critical steps: selecting the right journal, preparing a manuscript, and handling revisions and rejections. This guide offers practical advice to help researchers effectively navigate this process.

Selecting the Right Journal

Choosing the right journal is a crucial step. A well-chosen journal increases the chances of acceptance and ensures your work reaches the appropriate audience.

Understand Research Niche

  • Identify the Audience: Consider who would benefit most from the research findings. Is the work highly specialized or general? Identifying the audience will help narrow down the list of potential journals. For example, if the research is on a niche topic within oncology, it might look for journals that specialize in cancer research rather than general medical journals.
  • Journal Scope: Review the aims and scope of potential journals to ensure the manuscript aligns with their focus. Many journals outline their scope on their website, detailing the types of articles they are interested in. This can save time and effort by ensuring that the work is suitable for the journal before submission.
  • Read Past Issues: Familiarize with the type of research published in the journal. This helps gauge whether the work fits their editorial style and content. Reading past issues also gives insight into the topics and methodologies that the journal prioritizes.

Assess Journal Quality and Impact

  • Impact Factor: While not the sole indicator of quality, the impact factor can give an idea of the journal’s reach and influence. However, it is important to balance the desire for a high-impact publication with the suitability of the journal for specific research.
  • Reputation: Look at the editorial board and the journal’s reputation within the field. High-quality journals often have renowned experts as editors, which can lend credibility to published work.
  • Indexing: Ensure the journal is indexed in major databases like PubMed, Scopus, or Web of Science. Indexing in these databases increases the visibility and accessibility of research.

Practical Considerations

  • Open Access Subscription-Based: Decide whether to make the article freely accessible (open access) or to accept it being behind a paywall. Open access can increase the reach of the research but often involves higher publication fees.
  • Publication Time: Some journals have longer review and publication times. Consider how quickly the work needs to be published, especially if the research is time-sensitive or if there are deadlines for career progression.
  • Publication Charges: Be aware of submission or publication fees, especially for open-access journals. Consider these costs during the decision-making process.

Preparing the Manuscript

A well-prepared manuscript can significantly increase the chances of acceptance. Here are key steps to ensure the manuscript is polished and ready for submission.

Follow Journal Guidelines

  • Author Instructions: Each journal has specific guidelines for formatting, structure, and submission. Adhere to these meticulously to avoid desk rejection. These guidelines often include details on word count, figure and table formats, and referencing style.
  • Referencing Style: Use the correct citation style as required by the journal. Consistency in referencing is crucial, as incorrect citations can be a red flag for reviewers.

Writing Tips

  • Clear and Concise: Write clearly and concisely. Avoid jargon and ensure the manuscript is easy to understand. Clarity is the key to effective communication, especially when conveying complex research findings.
  • Logical Structure: Organize the manuscript logically, with a clear introduction, methods, results, and discussion. Each section should flow naturally into the next, guiding the reader through the research process.
  • Strong Abstract: Craft a compelling abstract. It should summarize the study’s key points and entice readers to delve deeper. A well-written abstract can capture the attention of reviewers and readers.
  • Figures and Tables: Use figures and tables to present data effectively. Ensure they are well-designed and complement the text. Visual aids can help clarify complex data and make the findings more accessible.

Peer Review and Editing

  • Internal Review: Have colleagues review the manuscript before submission. Fresh eyes can catch errors and provide valuable feedback. Internal reviews can also provide insights into the clarity and impact of the manuscript.
  • Professional Editing: Consider professional editing services, especially if English is not your first language. A polished manuscript stands a better chance during the review process. Professional editors can help refine the writing, ensuring it meets the high standards of academic publishing.

Handling Revisions and Rejections

Receiving feedback from reviewers is an integral part of the submission process. Knowing how to handle revisions and rejections can turn setbacks into opportunities for improvement.

Revisions

  • Respond Promptly: Address reviewers’ comments promptly and thoroughly. Delays can slow down the publication process. Timely responses demonstrate the commitment to the publication process and respect for the reviewers’ time.
  • Be Detailed: In response to reviewers, address each comment individually. Provide clear explanations of the changes made. Detailed responses demonstrate thoughtful consideration of feedback and appropriate adjustments.
  • Be Respectful: Maintaining a respectful tone, even in disagreement with a reviewer’s comment, is important. Diplomacy can smooth the review process. If a comment appears to be based on a misunderstanding, providing a polite clarification supported by evidence is advisable.

Rejections

  • Never Take it Personally: Rejection is part of the process. Even top researchers face rejection. Use it as a learning experience. Remember that rejection is often not a reflection of the quality of work but may be due to fit or other factors beyond control.
  • Review Feedback: Carefully review the feedback provided. It can offer insights into how to improve the manuscript. Constructive criticism can help identify weaknesses and areas for enhancement.
  • Revise and Resubmit: Use the feedback to revise the manuscript. You can then resubmit to the same journal or consider a different, more suitable journal. Persistence and willingness to improve are key to eventual success.
  • Persistence Pays Off: Persistence is key. Keep refining work and submitting it until it finds a home. Many successful researchers have stories of multiple rejections before achieving publication.

Navigating the journal submission process requires careful planning, attention to detail, and resilience. Selecting the right journal, meticulously preparing the manuscript, and handling revisions and rejections with professionalism, can improve the chances of seeing research published. Each step is a learning opportunity that brings researchers closer to contributing valuable knowledge to the field.

Additional Tips

  • Networking: Attend conferences and engage with fellow researchers. Networking can provide insights into journal reputations and submission tips.
  • Stay Updated: Keep abreast of trends and changes in the field. This includes new journals, changes in editorial boards, and evolving publication standards.
  • Keep Records: Maintain detailed records of the submissions, including dates, responses, and feedback. This can help track the progress and manage multiple submissions.

Publishing the research is a significant achievement that requires dedication and strategic planning. By following these tips and remaining committed to the process, can navigate the journal submission process successfully and contribute meaningful advancements to the field.

The journal submission process can be both challenging and rewarding. At Turacoz Healthcare Solutions, we support through every stage of academic publishing, with a range of services designed to enhance the quality and impact of research work. Our expertise extends beyond journal publication to include manuscript refinement, revision handling, and guidance on journal selection. We also offer additional support for book writing, thesis development, and chapter authoring. Partner with us to advance research and ensure it reaches its full potential. For more information, visit www.turacoz.com to explore how we can help achieve your academic goals.

AI-Powered Content Lab Management: Boosting Productivity and Quality

Medical Devices, Medical Publishing

In the dynamic field of medical communication, managing a content lab effectively is crucial to ensure the delivery of high-quality and timely outputs. As the demands for precise, accurate, and compliant medical documentation increase, so does the need for efficiency in handling these tasks. Enter Artificial Intelligence (AI) – a transformative technology revolutionizing content lab management by automating repetitive tasks and improving workflow efficiency. At Turacoz, we understand the growing need to integrate and accept AI in the workflow whilst ensuring no data is compromised.

Role of AI in Content Lab Management

AI, with its capabilities in machine learning, natural language processing (NLP), and data analytics, offers a myriad of solutions to the challenges faced by content labs. It can automate routine tasks, streamline workflows, and enhance the accuracy and quality of medical content. Here’s how AI-powered solutions are making a significant impact:

  1. Automating Repetitive Tasks

Repetitive tasks such as data entry, document formatting, and reference management are time-consuming and prone to human error. AI can automate these tasks, save valuable time for medical writers and editors to focus on more complex activities.

  • Data Entry and Extraction: AI algorithms can automatically extract relevant data from clinical trial reports, research papers, and regulatory documents, and input it into predefined templates. This not only speeds up the process but also reduces the risk of errors.
  • Document Formatting: Formatting documents according to specific guidelines can be tedious. AI tools can automate this process, ensuring that all documents adhere to the required standards and are consistent in style and structure.
  • Reference Management: AI-powered reference management tools can automatically generate, format, and update citations and bibliographies, ensuring accuracy and compliance with journal or regulatory requirements.
  1. Enhancing Workflow Efficiency

AI can significantly enhance workflow efficiency by streamlining processes and improving collaboration among team members. This is achieved through intelligent task management, real-time collaboration tools, and predictive analytics.

  • Intelligent Task Management: AI-driven project management tools can allocate tasks based on team members’ expertise, workload, and deadlines. They can also prioritize tasks and set reminders, ensuring that projects stay on track and deadlines are met.
  • Real-Time Collaboration: AI-powered platforms enable seamless real-time collaboration among team members, regardless of their geographical location. These platforms can facilitate document sharing, version control, and instant feedback, improving the overall efficiency of the content creation process.
  • Predictive Analytics: By analyzing historical data, AI can predict potential bottlenecks and suggest proactive measures to mitigate them. This helps in anticipating challenges and optimizing workflows to ensure smooth project execution.
  • Improving Quality and Accuracy

Quality and accuracy are paramount in medical communication. AI can enhance these aspects through advanced proofreading, content generation, and compliance checks.

  • Advanced Proofreading: AI-powered proofreading tools can detect grammatical errors, spelling mistakes, and inconsistencies in medical terminology. They can also suggest improvements in sentence structure and readability, ensuring that the content is clear, concise, and error-free.
  • Content Generation: AI algorithms, particularly those based on NLP, can generate initial drafts of medical documents such as clinical trial reports, patient information leaflets, and regulatory submissions. These drafts can then be reviewed and refined by human experts, significantly reducing the time and effort required to create high-quality content.
  • Compliance Checks: Ensuring compliance with regulatory guidelines and industry standards is critical in medical communication. AI tools can automatically check documents for compliance with specific guidelines, flagging any deviations and suggesting corrections. This reduces the risk of non-compliance and ensures that all documents meet the necessary standards.

Human Intervention: The critical component

While AI offers numerous benefits, human intervention remains crucial in AI-powered content lab management. AI can handle many aspects of data processing and initial content creation, but human oversight is essential for ensuring the accuracy, relevance, and quality of the output. Medical writers and editors bring expertise and critical thinking that AI cannot replicate. They review and refine AI-generated content, provide context-specific insights, and make judgment calls that require a deep understanding of the subject matter. This collaborative approach, where AI handles the heavy lifting and humans add the finishing touches, ensures that the final product is both technically sound and contextually appropriate.

Case Studies: AI in Action

Case Study 1: Streamlining Clinical Trial Reporting

A global pharmaceutical company implemented an AI-powered solution to streamline its clinical trial reporting process. The AI tool extracted data from clinical trial databases and automatically populated predefined templates for clinical study reports. This reduced the time required to generate these reports by 50%, allowing the company to accelerate its drug development timelines and bring new treatments to market faster.

Case Study 2: Enhancing Quality Control

A medical communication agency adopted an AI-driven proofreading tool to enhance the quality control of its publications. The tool identified and corrected errors in grammar, punctuation, and medical terminology, ensuring that all documents were of the highest quality. As a result, the agency saw a significant reduction in rework and an increase in client satisfaction.

Case Study 3: Improving Regulatory Submissions

A biotech firm leveraged AI for regulatory writing and compliance checks. The AI system reviewed regulatory documents for adherence to guidelines and flagged any non-compliant sections. This automated review process not only ensured compliance but also reduced the review time by 40%, allowing the firm to expedite its regulatory submissions.

The Future of AI in Content Lab Management

The integration of AI in content lab management is still in its early stages, but its potential is immense. As AI technology continues to evolve, we can expect even more advanced solutions that will further optimize workflows, enhance quality, and drive productivity.

  1. Emerging Trends:
    • AI-Powered Content Personalization: AI will enable more personalized content creation, tailoring information to the specific needs and preferences of different audiences, such as healthcare professionals, patients, and regulatory authorities.
    • Integration with Other Technologies: The combination of AI with other technologies like blockchain and the Internet of Things (IoT) will enhance data security, traceability, and real-time data sharing, further improving content lab management.
    • Continuous Learning and Improvement: AI systems will continuously learn from new data and user feedback, becoming more accurate and efficient over time. This will lead to continuous improvement in the quality and efficiency of medical communication.
  2. Challenges and Considerations

While the benefits of AI are clear, there are also challenges and considerations to keep in mind:

  • Data Privacy and Security: Handling sensitive medical data requires strict adherence to data privacy and security regulations. Ensuring that AI systems comply with these regulations is crucial.
  • Human Oversight: Despite the capabilities of AI, human oversight is essential to ensure the accuracy and relevance of AI-generated content. Collaboration between AI and human experts will be key to achieving the best results.
  • Ethical Considerations: The use of AI in medical communication raises ethical questions about transparency, accountability, and bias. It is important to address these issues to maintain trust and integrity in medical communication.

AI-powered content lab management is transforming the field of medical communication by automating repetitive tasks, enhancing workflow efficiency, and improving quality and accuracy. By leveraging AI, medical communication companies can boost productivity, ensure high-quality outputs, and meet the increasing demands of the industry. As AI technology continues to advance, its integration into content lab management will become even more impactful, driving innovation and excellence in medical communication.

The Evolution of Academic Publishing: From Print to Digital

Medical Devices, Medical Publishing, Medical Writing

For centuries, the world of academic publishing was dominated by the printed word. Scholarly journals, monographs, and textbooks were carefully typeset, printed on paper, and distributed through a network of publishers, libraries, and bookstores. However, the rise of the Internet and digital technologies has ushered in a seismic shift in the creation, sharing, and preservation of academic knowledge. The transition from traditional print to digital formats has brought significant changes and opportunities for scholarly publishing.

  1. Traditional Print Era
  • Historical Context
    The origins of academic publishing were traced back to the 17th century, with the establishment of some of the first scientific journals, such as “Philosophical Transactions of the Royal Society” in 1665. For centuries, the print media has been the primary vehicle for the dissemination of scholarly work. Journals, often affiliated with academic societies, were revered to be the cornerstone of academic communication.
  • The Role of Print Journals

Print journals play a crucial role in shaping the field of academics:

  1. Validation and Peer Review: Print journals establish a rigorous peer-review process, ensuring the credibility and quality of published research.
  2. Archival Value: Physical copies of journals provided a tangible archival record that future scholars could access and reference.
  3. Limited Accessibility: Access to print journals was often restricted to those affiliated with institutions that could afford costly subscriptions, limiting the reach of academic knowledge.

2. Digital Revolution

Emergence of Digital Formats

The seeds of the digital revolution in academic publishing were planted in the late 20th century with the advent of electronic databases and online repositories. Initiatives such as JSTOR and Elsevier’s ScienceDirect have begun digitizing academic journals, making them accessible to researchers and students through institutional subscriptions. This initial foray into digital publishing provided a glimpse into the potential for wider dissemination of scholarly work and more efficient information retrieval.

As the Internet became more ubiquitous and bandwidth increased, publishers started experimenting with online journals and e-books. These early digital formats offered several advantages over their print counterparts, including lower production and distribution costs, faster publication cycles, and the ability to incorporate multimedia elements.

Benefits of Digital Publishing

The shift to digital formats brought a plethora of benefits:

  1. Accessibility and Reach: Digital publishing democratized access to academic research. Scholars, students, and practitioners worldwide can access journals without geographic and financial constraints of print subscriptions.
  2. Speed and Efficiency: The digital medium significantly reduced the time lag between submission, peer review, and publication. This accelerated the dissemination of new findings and fostered timely academic dialogue.
  3. Interactivity and Multimedia: Digital platforms allowed the inclusion of interactive elements, such as hyperlinks, videos, and datasets, enhancing the depth and engagement of scholarly articles.
  4. Searchability and Discoverability: Advanced search functions and indexing made it easier for researchers to find relevant literature, boosting the visibility and impact of published work.
  5. Environmental Impact: Reducing the need for physical copies helped decrease the environmental footprint of academic publishing.

3. Open Access Movement

One of the most significant developments in the digital era of academic publishing is the emergence of the open access (OA) movement. Driven by the belief that scholarly research should be freely available, OA initiatives aim to remove barriers in accessing and sharing academic content.

OA publishing models typically fall into two categories: gold open access, where authors or their institutions pay article processing charges to make their work openly available immediately upon publication, and green open access, where authors self-archive their works in institutional or subject-specific repositories after an embargo period.

Prominent OA publishers like the Public Library of Science (PLOS) and BioMed Central have played a pivotal role in advancing open access, while traditional publishers have also adopted hybrid models that allow authors to make their articles open access upon payment of a fee.

Benefits of Open Access

  1. Increased Visibility: OA publications are more widely read and cited, which increases the impact of research.
  2. Equity: OA ensures that researchers from underfunded institutions and developing countries can access the latest findings and foster global academic collaboration.
  3. Public Engagement: By making research freely available, OA bridges the gap between academia and the public, promoting informed societal discourse.

Challenges in the Digital Era

Despite its numerous benefits, the transition to digital publishing has presented several challenges:

  1. Quality Control and Predatory Journals: The ease of digital publishing has led to the proliferation of academic journals, including predatory journals that exploit the OA model. These journals often lack rigorous peer review and publish substandard research for profit, undermining the credibility of academic publishing.
  2. Financial Sustainability: The traditional subscription model provided a steady revenue stream for publishers. While democratizing access, the OA model raises questions about financial sustainability. Many OA journals rely on article processing charges (APCs) paid by authors, which can be a barrier for researchers without sufficient funding.
  3. Technological Barriers: While digital platforms have enhanced accessibility, they also require a robust technological infrastructure. Researchers in regions with limited Internet access or digital literacy may still face barriers in accessing and publishing research.
  4. Data Security and Privacy: The digital environment pose risks related to data security and privacy. Ensuring the integrity and confidentiality of scholarly work in an online setting is paramount, requiring continuous advancements in cybersecurity measures.
  5. Intellectual Property Concerns: The shift to digital formats has sparked debates over intellectual property rights. Balancing the open dissemination of knowledge with the protection of authors’ rights and preventing unauthorized use or distribution of content remains a complex issue.

4. Future of Academic Publishing

Integration of Advanced Technologies

The future of academic publishing is poised to integrate advanced technologies and to further enhance the research ecosystem:

  1. Artificial Intelligence (AI): AI can streamline the peer-review process, detect plagiarism, and assist in identifying relevant literature, making the publication process more efficient and robust.
  2. Blockchain Technology: Blockchain can provide secure and transparent records of publication histories, ensuring the integrity and traceability of scholarly work.
  3. Data-Driven Insights: Big data analytics can provide valuable insights into research trends, impact metrics, and collaboration networks, informing strategic decisions in academic publishing.

5. Enhanced Collaboration and Interdisciplinary Research

Digital platforms facilitate collaboration across geographical and disciplinary boundaries. The future of academic publishing will likely see increased interdisciplinary research, addressing complex global challenges through a holistic approach.

6. Continued Advocacy for Open Access

The push for OA is expected to intensify, driven by advocacy from academic communities, funding agencies, and policymakers. Sustainable OA models that balance accessibility with financial viability are crucial in shaping the future of academic publishing.

The evolution of academic publishing from print to digital has transformed the dissemination and accessibility of scholarly research. While the digital revolution has brought significant benefits, it has also introduced new challenges that require ongoing adaptation and innovation. As technology continues to advance, the academic community must navigate these changes thoughtfully, ensuring that the pursuit of knowledge remains inclusive, credible, and impactful. The future of academic publishing holds immense potential, promising to further democratize access to knowledge and foster a vibrant, interconnected global research community.

At Turacoz Healthcare Solutions, we understand the evolving landscape of academic publishing and are committed to supporting scholars in navigating these changes. Beyond our expertise in journal publication, we offer a comprehensive range of academic services designed to enhance the quality and impact of scholarly work. Our services include book writing, thesis writing, authoring book chapters, and providing tailored support to meet the diverse needs of the researchers. Whether you are crafting a detailed monograph, developing a critical thesis, or contributing to collaborative volumes, Turacoz Healthcare Solutions is your partner with academic excellence. Reach out to us at www.turacoz.com  to ensure that your work achieves its full potential in the digital age.

Beware of Botstuff: Managing the Knowledge Risks from AI Chatbots

Medical Devices, Medical Publishing, Medical Writing

In the digital era, AI-driven chatbots have become ubiquitous, transforming how we interact with information and automate processes across various sectors. From customer service to content creation, chatbots, powered by advancements in large language model (LLM) technology, are reshaping the interactive landscape. However, the rapid integration of these tools into daily operations comes with its own set of challenges, particularly concerning the accuracy and reliability of the information they generate. This blog explores the concept of “botshit”—the misleading or inaccurate content produced by chatbots—and offers strategies to manage these knowledge risks effectively.

Understanding the Challenge of Botshit

“Botshit” refers to instances where chatbots, despite their sophisticated algorithms, generate coherent yet factually incorrect or misleading content. This phenomenon arises because chatbots do not truly “understand” the data they process; rather, they predict responses based on patterns identified in their training data. Consequently, this can lead to what is known as “hallucinations,” or responses that, while sounding plausible, are entirely fabricated or distorted.

The risks associated with botshit are not trivial. They can range from minor inaccuracies that confuse major errors that could potentially lead to financial loss, reputational damage, or even legal challenges. As such, identifying and mitigating the epistemic risks of chatbot interactions is crucial for organizations that rely on these technologies for delivering critical information and services.

Framework for Managing Knowledge Risks

To effectively manage the risks posed by AI chatbots, organizations can adopt a structured framework that categorizes chatbot usage based on the importance of response accuracy and the feasibility of verifying these responses. Here’s how organizations can navigate these risks across different scenarios:

  • Authenticated Mode: This mode applies when the accuracy of chatbot responses is critical, and verification is challenging. High-risk industries such as healthcare, finance, and legal often fall into this category. Strategies include implementing stringent validation processes, maintaining rigorous oversight, and integrating human checks to verify chatbot outputs before any critical decision-making or dissemination of information.
  • Autonomous Mode: When accuracy is less critical and easily verifiable, chatbots can operate more freely. This mode is suitable for tasks like generating generic customer service responses or managing low-stakes interactions where errors can be quickly identified and corrected without significant consequences.
  • Automated Mode: In scenarios where both the importance of accuracy and the ease of verification are high, chatbots can be used to automate routine tasks efficiently. However, regular audits and spot checks should be instituted to ensure ongoing reliability, such as in data entry tasks or report generation where accuracy is paramount.
  • Augmented Mode: Suitable for creative or brainstorming tasks where the veracity of information is less critical and harder to verify. In these cases, chatbots can be used as tools to spark human creativity and innovation, with the understanding that their outputs require subsequent human interpretation and refinement.

Implementing the Framework

Deploying this framework involves several practical steps:

  • Risk Assessment: Evaluate the specific functions and tasks assigned to chatbots within the organization to identify potential risk areas.
  • Protocol Development: For each category of chatbot use, develop specific protocols and guidelines that outline how chatbots should be managed to mitigate risks.
  • Training and Awareness: Educate employees about the capabilities and limitations of chatbots. Ensure they understand how to interact with chatbot technology effectively and how to escalate issues when inaccuracies arise.

Technological and Organizational Guardrails

In addition to the strategic framework, establishing both technological and organizational guardrails is essential to safeguard against the misuse of AI-generated content:

Technological Guardrails: Implement advanced data verification tools, enhance the transparency of chatbot decision-making processes, and ensure that AI models undergo regular updates and audits to improve their accuracy and reliability.

Organizational Guardrails: Develop clear policies and guidelines that dictate the acceptable use of chatbots. These policies should address ethical considerations, data security, and the alignment of chatbot deployment with overall organizational objectives and values.

Supplementing Human Intelligence

Generative AI like ChatGPT and Claude represent a powerful form of intelligence augmentation that can greatly enhance human productivity and creativity. But like any tool, they have limitations that must be clearly understood and mitigated against when appropriate.

By taking a thoughtful approach that combines the speed and assistance of AI with human judgment, oversight, and domain expertise, we can harness the incredible benefits of language models while managing the inherent knowledge risks and gaps in their training.

The most effective uses of generative AI will involve symbiotic collaboration between humans and machines, with each complementing the other’s strengths. Humans provide contextual reasoning, real-world validation of knowledge, and guidance for the AI’s knowledge acquisition. In turn, the AI provides a multiplier on human intelligence by rapidly generating ideas, analysis, and facilitating tasks.

Looking Ahead

As AI technology continues to evolve, so too will the strategies to mitigate its associated risks. Continued research and development will be critical in refining AI models to reduce errors and enhance their understanding of context and nuance. Furthermore, as regulatory frameworks around AI usage mature, organizations will need to stay informed and compliant with new guidelines and standards.

Conclusion

AI chatbots offer significant benefits, from enhancing operational efficiency to enriching customer engagement. However, managing the knowledge risks associated with their use is crucial to avoid the pitfalls of botshit. By implementing a structured risk management framework and establishing robust guardrails, organizations can harness the power of AI chatbots responsibly and effectively, ensuring that these tools augment rather than undermine the integrity of their operations and decision-making processes.

As these models continue to evolve and learn, the human-AI partnership will become an increasingly powerful combination for solving problems and expanding our collective knowledge and capabilities.

Artificial Intelligence in Medical Device Industry

Medical Devices, , , , , , , , ,

What is artificial intelligence (AI)?

As per the Merriam Webster dictionary, AI is “the capability of a machine to imitate intelligent human behavior”.

The recently released proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS defines AI system as a “software that is developed with one or more of the techniques and approaches that can, for a given set of human-defined objectives, generate outputs such as content, predictions, recommendations, or decisions influencing the environments they interact with”. According to this document, AI techniques and approaches include the following1:

(a) Machine learning approaches, including supervised, unsupervised and reinforcement learning, using a wide variety of methods including deep learning;

(b)Logic- and knowledge-based approaches, including knowledge representation, inductive (logic) programming, knowledge bases, inference and deductive engines, (symbolic) reasoning and expert systems;

(c)Statistical approaches, Bayesian estimation, search, and optimization methods;

Birth of AI into the Healthcare Field

Changes Brought by AI in the Medical Device Field

AI has brought about many revelations in healthcare field. It would be difficult to sum it all up in one blog hence we would be looking into some of the changes brought by AI into healthcare.

So, what do you think about an automatic blood pressure monitor at your homes? Well, yes, that is a change brought out by AI since it mimics the activity of a trained physician in detecting the sounds that are generated when a blood pressure cuff changes the flow of blood through the artery and in reporting the diastolic and systolic blood pressure measurements3.

Many such devices are available in the market that does not require a physician nearby, instead you can work on it by yourself.

And now companies are equipping themselves with machine learning to monitor patients using sensors and automate delivery of treatment using connected automated mobile apps. Ex: Medtronic launched the MiniMed 670G system, which is AI trained on algorithms that help to self-adjust insulin delivery once we feed the amount of insulin required for a given time 4.

So, as AI integrated medical devices are slowly becoming part of our lifestyles, shouldn’t the safety concerns around it be more stringent.

Regulations around AI integrated medical devices

An AI/ML screening tool for the eye disease occurring due to diabetic retinopathy, was cleared (in 2018) to aid in diagnostic decision by the FDA. It was cleared since it was a tool which was based on a ‘locked’ algorithm, which means that they don’t evolve over time and do not require new data to alter their performance. It is important that regulators follow stringent rules regarding software as a medical device using AI or machine learning (ML) so that they do not provide approval based on an already existing algorithm5.

As per a recent (2020) article published in the Nature, regulators must not restrict their evaluation to the AI/ML-based medical devices only but also assess the entire systems associated with it, for approval. The key things that should be done to attain a full system approach include5:

a) Collecting entire data such as current regulatory and legal mandate information, reimbursement decision of insurers, data quality of any third-party providers, any ML algorithms developed by third parties etc.

b) Issuing a limited authorization which would track factors discussed above

c) Seeking approval from a specific hospital, with specific trained and authorized users, and

d) Obtaining detailed hospital level information such as how the AI/ML-based medical device software is integrated into the workflow and staffing levels, the practice style and training of the physician, etc.

As for European Union is concerned, it is planning to tighten its regulations regarding AI by implying additional requirements on the use of AI in medtech along with heavy fines for those companies that fail to adhere to the EU requirements on AI. An official from the European Commission’s health group stated that “An AI medical device… would be now more secure, in the sense that it will also be complying with the MDR obligations and in addition those aspects of AI that could be creating some worries and some concerns would be handled by the new AI regulations. So, the two would be ensuring that the system is secure and trustworthy and so on6.”

Since AI is a vast and rapidly evolving topic, stay tuned to reading more about in our upcoming blogs/posts. Also, if you find our blogs to be interesting and you want to take the next step in advancing your knowledge on EU MDR and CER, consider our CER training class. Our experts are also available to help you with end-to-end CER development and gap analysis. Please contact us at [email protected]

References:

1) Proposal for a Regulation of the European Parliament and of the Council LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206

2) Demystifying AI in Healthcare: Historical Perspectives and Current Considerations. https://www.physicianleaders.org/news/demystifying-ai-in-healthcare-historical-perspectives-and-current-considerations

3) Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance. https://www.ethos.co.im/wp-content/uploads/2020/11/MACHINE-LEARNING-AI-IN-MEDICAL-DEVICES-ADAPTING-REGULATORY-FRAMEWORKS-AND-STANDARDS-TO-ENSURE-SAFETY-AND-PERFORMANCE-2020-AAMI-and-BSI.pdf

4)https://emerj.com/ai-sector-overviews/ai-medical-devices-three-emerging-industry-applications/

5)https://www.nature.com/articles/s41746-020-0262-2#Sec4

6)https://www.medtechdive.com/news/eu-plans-to-impose-additional-regulations-on-medtech-ai-products-other-hi/600022/

FDA’s Recent Recalls: Ensuring Patient Safety

Medical Devices, ,

According to the US Food and Drug Administration (FDA), a ‘device recall’ is defined as, “when a manufacturer takes a correction or removal action to address an issue with the medical device that violates the FDA law”1. 

According to the FDA, a recall measure can be classified as1: 

Class I recall type is considered as the most serious type since these devices would result in serious injuries or death. Here, we elucidate this based on some real-life examples.

Some of the Recent Medical Device Recalls

The unique selling property of the Emblem subcutaneous Implantable Cardioverter Defibrillator (S-ICD) electrode (Boston Scientific) was that the lead is implanted just under the skin along the sternum, thus requiring a minimally invasive procedure. In the conventional ICD systems, the leads pass through the large veins from the surgically implanted device into the heart.

Boston Scientific is recalling the Emblem S-ICD electrode as it is associated with increased rate of fractures at a specific point distal to the proximal sensing ring (see image above).  Death can occur due to cardiac arrest as with the fractured device it is impossible to provide therapy for slowing down very fast heartbeats. The FDA reported 27 complaints of electrode body fractures, of which 26 were serious injuries and one death. Thereby, announcing a Class I recall on the Boston Scientific Emblem S-ICD electrode. This measure led to a recall of 19,919 devices that were manufactured and distributed in market between March 2016 to November 2020 2.

In another recent recall case, the manufacturing company (Philips) has voluntarily recalled its ventilator and other breathing devices indicated for patients with sleep apnoea since they posed a significant health risk. These devices were in market since 2009; however, the manufacturing company (Philips) received few complaints about the device around 2020. Further investigations revealed that these complaints rose due to the polyester-based polyurethane (PE-PUR) sound-reducing foam associated to reduce sound and vibration in these devices, which may penetrate to the device’s air pathway and, ultimately find a way to enter the body of the user either via inhalation or ingestion. In addition, the foam tends to off-gas certain chemicals which could be harmful during operation. The manufacturing company has received complaints about instances where presence of black debris/particles were observed in some of these device parts such as outlet, humidifier, tubing, and mask. These instances elevated the risk of particulate exposure in the user which irritates the skin, eye, and respiratory tract leading to headache, asthma, and adverse effects to kidneys and liver as well as possible toxic carcinogenic effects. With respect to off-gassing, the potential risks include headache/dizziness, irritation, hypersensitivity, nausea and vomiting along with possibility of toxic and carcinogenic effects. Although these issues sound serious and could be life-threatening, to date, no death has been reported due to these. The manufacturer eventually decided to recall about 4 million ventilators and breathing machines which were in market between 2009 and April 26, 20213.

Among the two examples, the first one is a typical case of a Class I type recall by FDA since there were reports of serious events and death, whereas the second one showcases that the manufacturing company was alert enough to voluntarily recall their devices on noticing complaints associated with it. Cited here were just the few examples of the recalls that were announced this year. In order to view the detailed list of all the devices that were recalled please check the below link

https://www.fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls

How does FDA Ensure Patient Safety?

One of the pivotal roles and responsibilities of FDA include protection of public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. With respect to medical devices, FDA executes a robust program at every stage of a device’s life cycle to evaluate the safety of medical devices 4.

The FDA supervises the adverse event reports and other issues related to medical devices. Since the medical device market is enormous, to monitor all medical devices seamlessly, the devices are classified based on their potential risk as follows4:

Conclusion

To protect and promote public health, FDA’s Center for Devices and Radiological Health (CDRH) improvises its regulatory monitoring strategies now and then, to ensure the best effective use of the medical devices available on the US market without compromising on the quality and safety measures.

If you find our blogs to be interesting and you want to take the next step in advancing your knowledge on EU MDR and CER, consider our CER training class (link for our training class here). Our experts are also available to help you with end-to-end EU CER development and gap analysis please contact us at [email protected]

References

  1. FDA. What is a Medical Device Recall? 2021 [Available from: https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall.
  2. FDA. Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 2021 [Available from: https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-recalls-emblem-s-icd-subcutaneous-electrode-model-3501-due-risk-fractures.
  3. FDA. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication 2021 [Available from: https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks.
  4. FDA. Medical Device Safety Action Plan: Protecting Patients and Promoting Public Health  [Available from: https://www.fda.gov/files/about%20fda/published/Medical-Device-Safety-Action-Plan–Protecting-Patients–Promoting-Public-Health-%28PDF%29.pdf.

Four Things All Class I Manufacturers Must Do by May 26

Medical Devices, ,

Class I devices are the lowest risk medical devices. However, the manufacturers of these devices also need to act immediately to comply with the new European Union (EU) Medical Devices Regulation (MDR); otherwise, they risk being unable to place their devices on the EU market after May 26, 2021.

As many Class I devices are being up classified, the manufacturers of these devices will require notified body (NB) review for the first time to comply with the EU MDR. Manufacturers will be relieved to know that these devices have been given a grace period till May 26, 2024. Current Class I devices may also move to Class I reusable surgical instruments (Ir), which is a newly added subclassification in MDR 2017/745. Other Class I devices such as devices with measuring function (Im), or Class I sterile (Is) devices, which have a valid MDD certificate, can be sold in the EU market till May 25, 2024. However, if manufacturers of these Class I devices do not act now, they may not know if their devices need to be re-classified. For the rest of the Class I devices, as well as for Class Is/Im devices requiring a new certificate, the timeline to comply with the new regulation remains May 26, 2021.

Through this blog, we would like to highlight the key requirements for Class I device manufacturers to place their devices on the market as per the recent EU Regulation 2017.

Checklist items for placing Class I medical devices on the market:

As most of the Class I device manufacturers self-certify their devices, it is unlikely to have a relevant quality management system (QMS) or clinical data available with them. Hence, they may require significant remediation work before May 26.

To comply with the EU MDR, Class I device manufacturers must establish and implement a risk management system to reduce risks as far as possible without adversely affecting the benefit-risk ratio.

Involvement of the Notified Body (NB)

The NB needs to be involved for Class Is, Class Im, or Class Ir devices. As per Annex IX, the manufacturer of such a device must establish, document, and implement a QMS. Additionally, with respect to Annex II, the manufacturer must lodge with the NB an application for assessment of technical documentation relating to the device. However, the involvement of the NB in those procedures shall be limited:

  • in the case of 1s devices, to the aspects relating to establishing, securing and maintaining sterile conditions;
  • in the case of 1m devices, to the aspects relating to the conformity of the devices with the metrological requirements;
  • in the case of 1r devices, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use.

Intervention by NB is not required for other Class I devices. As the QMS system remains proportionate to the risk class, the requirement is less complex for Class I manufacturers, but they need to meet the QMS requirements set out in Article 10 of the EU MDR. As per this article, Class I manufacturers must provide the required technical documentation in an official Union language dictated by the concerned Member State when requested by the Competent Authority (CA).

EU Declaration of Conformity

Manufacturers of other Class I devices can continue to self-certify. According to Article 19, the EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. However, manufacturers of these devices will need to update technical documentation (set out in Annexes II and III) by May 26, 2021.

CE-marking

Manufacturers of Class I devices will have to gather all relevant clinical information, especially for devices that are self-certified under MDD. This will apply to even those manufacturers whose Class I devices have been on the market for 20+ years. Manufacturers can either use already available post-market data or perform a post-market clinical follow-up study (PMCF) to provide clinical information in technical documents (set out in Annexes II & III). Hence, manufacturers of those Class I devices that have got a grace period till May 26, 2024, should not wait till the last day. They should make a robust system now to start collecting clinical data.

Post-market surveillance (PMS)

  1. Class I device manufacturers need to establish and maintain a post-market surveillance (PMS) system, which should be integrated into the QMS. According to Article 83, manufacturers shall plan, establish, document, implement, maintain, and update a PMS system for every device.
  2. The PMS plan of the manufacturer must include PMCF plan or a justification why PMCF is not applicable.
  3. Reporting time frames have been tightened in the EU MDR. As per article 87, a serious public health issue should be reported within two days. Whereas, in the event of death or an unanticipated serious deterioration in a person’s state of health, the report should be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days. For all other cases apart from the above two, the manufacturer must report any serious incident immediately and not later than 15 days, which was 30 days earlier as per MDD.
  4. As a follow-up of reporting a serious incident, the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned (Article 89).
  5. Finally, all Class I device manufacturers are expected to prepare a PMS report (Article 85) summarizing the results and conclusions of the analysis of all the data from the market. This report will be updated when necessary, for example, when the intended benefits are not achieved or when there is a change in the benefit-risk balance. The report can be requested by the CA at any time from May 26, 2021, irrespective of the type of Class I device (with or without grace period).
  6. If PMS data analysis provides evidence that a device placed on the market is not in conformity with the MDR, the manufacturer is obliged to take the immediate necessary corrective action, which can be either bringing that device to conformity, or withdraw it, or recall it.

Conclusion

Class I device manufacturers need to take immediate action to comply with EU MDR. If manufacturer’s Class I device (exception: Is, Ir, Im) was self-certified under MDD, then it must be compliant under EU MDR by May 26, 2021. If the device has been up classified as per EU MDR, certification from NB will be required to place the device on the market. Manufacturers need to gather all relevant clinical information through PMS activities and PMCF studies for devices which are self-certified under MDD to achieve CE marking under EU MDR before May 26, 2021. A QMS must be established which will include documentation of PMSP and PMSR for all Class I devices by May 26, 2021. For devices, reclassified as class Ir, and the devices already placed on the market in accordance with the MDD (Is and Im), the manufacturers have got a grace-period of three more years to fully comply with the new EU regulation. These manufacturers should start conducting a gap analysis to guarantee that all the necessary requirements are fully completed at the date of the application of MDR. Non-conforming devices will no longer be allowed to be on the EU market.

EUDAMED – European Database for Medical Devices

Medical Devices, , , , , , , ,

Background

According to European Commission a web-based portal EUDAMED is being developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The system consists data on medical devices that have been collected and registered by Competent Authorities and the European Commission and can only be accessed by these same parties. The amount of data which will be available to the European Authorities through EUDAMED is the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR) Article 33. This data collection with EUDAMED was established by the Medical Device Directive (MDD) Article 14a. But the amount of data made available to the European Authorities has been minimal compared to what is envisaged in the new EU MDR. This ‘MDR EUDAMED’ is intended to provide more data, of higher quality and with a wider accessibility. EUDAMED aims at improving transparency and coordination of information regarding medical devices available on the EU market.

Database Access

The ‘MDR EUDAMED’ will not only be used by the National Competent Authorities (NCAs) and the European Commission. Depending on the type of user, only certain levels of the databank can be accessed. It will also be accessed by:

  • Medical Devices Coordination Group (MDCG)
  • Notified Bodies (NBs)
  • Economic Operators (EOs – manufacturers, authorized representatives, importers, sponsors)
  • Experts
  • Non-European Competent Authorities (NCAs)
  • And the public, including medical institutions and the press

Database Module

EUDAMED will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable. EUDAMED is structured around 6 interconnected modules and a public website:

  • Actors ((NCA’s, EOs, NB’s) registration
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

One of the key objectives of the Medical Devices Regulation (MDR) is transparency aiming at providing a larger access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market. These obligations in MDR will be applicable once the EUDAMED is fully functional.

Key information accessible to the public in EUDAMED:

  • Registration of all manufacturers, their authorized representatives and importers placing medical devices on the EU market
  • Registration of devices, the core elements of the UDI database of part B of Annex VI, including the basic UDI and UDI-DI of devices
  • Registration of certificates of conformity, their scope and validity period
  • List of notified bodies designated under the MDR, their identification numbers and their conformity assessment activities through a link to NANDO database and the list of their subsidiaries
  • Scientific opinions of the expert panels and the written justification of the notified body where it has not followed the scientific opinion of the expert panel
  • Clinical investigation reports and their summary
  • The summary of safety and clinical performance reports for implantable devices and class III devices
  • Manufacturer incident reports (partial access) and the field safety notices for Vigilance activities
  • Summary of the results of market surveillance activities on their national territory by each EU Member State.

Key information publicly available outside EUDAMED

  • National measures taken by competent authorities for the placing on the market of single use devices which are reprocessed
  • Types and levels of fees levied by Member States for funding activities carried out by the competent authorities
  • National measures governing the assessment, designation, and notification of notified bodies
  • List of standard fees from notified bodies
  • Summary of each Member State report on its monitoring and on-site assessment activities regarding notified bodies
  • Commission annual summary report of the peer review activities of authorities responsible for notified bodies,
  • Declaration of interests of top-level management of notified bodies
  • Declaration of interests of each member of the MDCG, of its sub-groups except for stakeholder organizations, and of the advisors within the expert panels and expert laboratories
  • Advice provided by the expert panels
  • Names and affiliation of the members of the MDCG.

Important EUDAMED Dates

For the EU Commission this development and implementation of EUDAMED is a high priority. And with help of MDCG, it is going to release different modules as soon as they become functional. Currently the deployment of Actor registration (first module) is planned for December 2020. The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be presented as soon as they are operational. Most of the requirements on Transparency and public access to information linked to the EUDAMED, are planned to become fully functional by May 2022. The official web address of the EUDAMED public website will be “ec.europa.eu/tools/eudamed”. It will be available once it is in production and not before.

Turacoz Healthcare Solutions understands medical device regulatory MDR requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].

References

  1. https://ec.europa.eu/health/md_eudamed/overview_en
  2. https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/transparency_factsheet_en.pdf

 

Medical Device Industry and COVID-19: Regulatory Modifications to Consider

Medical Devices, , , , , , , , , , ,

Background

The COVID-19 outbreak is a public health crisis that this generation has never seen before and has presented itself as an unprecedented challenge to the health industry including the Medical Device and Regulatory framework.

There is tremendous burden being faced by first responders and health institutions. Simultaneously, there is increasing pressure on national authorities, EU member states, and economic operators to supply vitally important medical devices at the time of adoption of Regulation (EU) 2017/745.

The unanticipated crisis has had a significant impact on placing devices on the market in the Union while halting the designated work of the notified bodies. The commission recognizes the role of Personal Protective Equipment (PPEs) such as medical gloves, surgical masks, and equipment for intensive care in the current pandemic and has therefore decided to prioritize the demands of such equipment thereby avoiding any potential market disruption.

MDR defers till 2021

Therefore, the European Commission released a proposal earlier in April to defer without any alterations to the guidelines, the enforcement of the EU Medical Devices Regulation (MDR) for a year, applicable from May 26th, 2020. However, the commission made no deferments for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022. The aim of the deferment has been to ease the pressure on the medical fraternity to be able to cope and focus with the current crisis and minimize risk to medical professionals.

National Derogation

In scenarios of a public health crisis, such as COVID-19 the Regulation (EU) 2017/745 allows the commission to extend the validity of a national derogation for a limited period of time in exceptional cases for member states in response to address Union-wide shortages of vitally important medical devices in an effective manner.

The Commission has agreed with the European standardization organization to make originally copyright standards (including EN 149 and 14683) freely and fully available by the national standardization bodies. Manufacturers can download a copy for free from the online catalogues of the national standardization bodies.

Furthermore, Directives 90/385/EEC and 93/42/EEC of the regulation empower national authorities on duly justified requests to place medical devices on the market for whom relevant conformity assessment has not been completed but substantial evidence is available to prove interest of public health, patient safety, and health.

Market approval of devices without CE marking

In exceptional circumstances, products can be placed on the market even if no CE marking has been affixed upon them, given that the following conditions are fulfilled:

  • The products manufactured are in accordance with one of the EN standards or other standards referred to in the WHO guidelines
  • The products are part of a purchase organized by the relevant Member State authorities;
  • The products are only made available for the healthcare workers;
  • The products are only made available for the duration of the current health crisis; and
  • The products are not entering the regular distribution channels and made available to other users.

This approval, may bring some relief from the intense pressure on manufacturers to complete the MDD/AIMDD work by giving them an additional year while ensuring devices reach hospitals. Meanwhile, the European parliament and the Council continue to work together to adopt the legislation as mandated implementation date.

Take home message

It is important to note and acknowledge that the framework of manufacturers, regulatory bodies, and agencies continue to work on collaborating and collectively contributing in ensuring that medical devices are used safely amongst patients in this evolving pandemic.

Turacoz Healthcare Solutions understands medical device regulatory requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].

Borderline Medical Devices – European Commission Update (December 2017)

Medical Devices, , ,

When a device seems to fit onto the definitions of two or more product types, and cannot be clearly classified as a medical device, an in vitro diagnostic medical device, or an active implantable medical device, it is referred to as a borderline medical device. The 18th version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (Borderline Manual) was issued by the European Commission’s Medical Devices Expert Group (MDEG) on Borderline and Classification in December 2017. The manual complements MEDDEV 2.1/3 Rev. 3, which provides guidance on borderline products and other medical devices that incorporate pharmacological or biological substances. The appropriate classification of a medical device is important as it determines the device’s authorization process and marketing strategy. From a regulatory standpoint, the classification is usually based on its primary mode of action, intended use, and product claims.

The updated Borderline Manual includes recommendations on a total of 94 devices, including guidance on the classification of 12 additional product types; however, these recommendations are not legally binding. It is important to note that the decisions on the classification of a product remain a competence of the Member States, which may lead to different interpretations among different countries within the EU. However, to ensure a uniform approach, difficult cases may be discussed in the informal MDEG; the consensus statements from this meeting are published in the Borderline Manual.

The revised Borderline Manual indicates that the following products should generally be classified as medical devices:

  • Mobile application for the assessment of moles (Class I)
  • Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa)
  • Alum styptic pencils (Class IIa)
  • Dura guard for use with a craniotome (Class III)
  • Heart bypass cannulae (Class III)
  • Tissue expanders used in the breast (Class III)

On the contrary, the following products should, in principle, not be considered as medical devices:

  • Mobile application for managing pictures of moles
  • D-mannose for the prevention of urinary tract infections
  • 8-MOP solution in extracorporeal photochemotherapy
  • Products intended to reduce the effect of alcohol
  • Radiation shields
  • Microplate washers

It is important to note that based on criteria proposed by the Court of Justice of the European Union (CJEU) for borderline determinations, each product’s assessment should include several elements and be very factual; however, the guidance provided in the Borderline Manual often lacks such a detailed and balanced review. Moreover, some of the positions taken in the Borderline Manual may require reconsideration due to potential reclassifications brought by new European Commission Regulations. The new Regulations broaden the definition of a medical devices and also include some products without medical purpose within the purview of the new rules (especially products for aesthetic use). Although changes introduced by the new regulations may help resolve some of the existing borderline questions, divergent views on the classification of more complex products may persist.

Turacoz Healthcare Solutions, a medical communication company, specializes in various kinds of medical writing documents (Publication, Regulatory and Medico marketing) which covers a vast arena of clinical trials, drugs, medical devices, health economics and outcome research, observational studies etc.  We take pride in providing customized, guideline compliant documents which are well within the committed timelines.

Medical Devices in Healthcare: Their Classification System and The Marketing Approval Process

Medical Devices

Introduction

Medical device is an essential part of healthcare system. It is utilised for diagnosis, prevention and treatment of the disease as well as for patient care. It covers a broad range of products, starting from simple bandage to drug delivery pumps. Over the past two decades, the demand of safe and effective medical devices has increased tremendously. This has been achieved by constantly updating and improving the regulatory framework and implementing them in the process. Moreover, the regulatory authorities across the world are working towards smoothening of the process of registration of the medical devices.

Medical devices have different classification systems and marketing approval processes for different regions. The classification systems and marketing approval processes for United States of America (USA), Europe (EU) and Canada have been discussed below.

United States of America

The medical devices, in USA, are regulated by US Food and Drug Administration (USFDA), while the law, 21 CFR (code of federal regulation), describes the regulations of medical devices. FDA’s Centre for Devices and Radiological Health (CDRH) regularly monitors trends that point towards future product development and is responsible for pre- and post-market supervision of devices in US.

Classification of medical devices

US classifies medical devices into three categories:

  1. Class I General Controls
  • With Exemptions
  • Without Exemptions
  1. Class II General Controls and Special Controls
  • With Exemptions
  • Without Exemptions
  1. Class III General Controls and Premarket Approval

The USFDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. A panel is assigned to determine the class of medical device and decides for the exception applicable to the device.

Marketing Approval Process

Firstly, the medical devices are classified according to the FDA searching database meeting the requirements of Quality system regulation (QSR) for which Quality management system (QMS) is implemented according to the 21 CFR part 820. Clinical trial data are submitted for some of the devices of class II and all the devices of class III followed by submission of Investigational Device Exemption (IDE) report followed by submission of 510(K) premarket notification or premarket approval application. Some premarket submissions such as PMA (Premarket Approval), De Novo (Evaluation of Automatic Class III Designation) and HDE (Humanitarian Device Exemption) are also required for submission, if applicable. Most of the devices under class II are required to submit 510(K) clearance form whereas, the devices under class III are required to submit PMA approval letter issued by FDA. Once all the clearance is submitted, FDA quality system inspects the manufacturing facilities for its compliance with QSRs. After that, the medical device listing and registration of competent company is done by using FURLS system on the FDA website in accordance with 21 CFR Part 807. The steps for issuing market approval for medical devices in the US are depicted in Figure 1.

 

Figure 1: Steps for medical devices market approval in the US

 

Europe

There is no single body in EU, as in India and USA, to regulate medical devices. However, a decentralized procedure of marketing authorization is followed in EU for regulating medical devices. A third party, i.e. notified bodies, is responsible for issuing Quality Assurance certificates as well as for assuring post-approval compliance to QMS.

European commission has established three directives which are regulated by Medical Devices Directives (MDD) and are allocated to regulate the safety and marketing of medical devices. The three directives are:

  • Medical Device Directive (MDD 93/42/EEC)
  • Active Implantable Medical Device Directive (AIMDD 90/42/EE)
  • In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC)

Classification of medical devices

Europe follows a risk-based classification system which are broadly classified into 3 classes:

  • Class I – Low risk
  • Class IIa – Medium risk
  • Class IIb – Medium/high risk
  • Class III -High risk

Marketing Approval process

The market approval of medical devices in Europe is very different from the regulations in US. First the EU derivative which applies to the medical devices is identified followed by the determination of the class of the medical device according to the Annex IX. For class II and III QMS is implemented for the device in accordance with Annex II or V of the MDD. An authorized representative of Europe is then appointed who can take care of all the regulatory issues. A notified body audits QMS and all the technical documents after which the device registration is done followed by the registration of the competent authority with EU member state. Declaration of Conformity is then prepared which ensures the compliance of medical device with applicable Directive. Finally CE mark certificate for the device is affixed and placed it in market. Additionally, a Conformité Européene or European Conformity (CE) mark certificate is required to commercialize medical devices. The steps required for market approval of medical device in Europe are shown in Figure 2:

 

Figure 2: Steps for medical devices market approval in Europe

 

Canada

The medical devices in Canada are regulated by Health Canada. Therapeutic Product Division (TPD) of health Canada classifies medical devices on the basis of Risk-Based Classification System (RBCS). Health Canada follows a four-class scheme to classify medical devices according to the risk to the human body. Among the four classes, medical devices that possess lowest risk on human body fall under class I while the medical devices with high risk fall under class IV.

Marketing approval in Canada

For issuing market approval of medical device in Canada, first the class of the medical device is determined i.e. from class I to IV in accordance with schedule 1, part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282 as published by Health Canada. Except for class 1 medical devices, implement an ISO 13485:2003 QMS for all the devices followed by audit. Health Canada generally issues two types of licences for market approval of medical devices. These are the Health Canada Medical Device Establishment License (MDEL) and the Health Canada Medical Device License (MDL). MDEL is required for the devices that come under class I while the devices of class II and IV needs to have MDL for the device. Health Canada then reviews Canadian MDL application and Premarket Review Document.The approved application and certificates are posted on the official website of Health Canada and then the device is marketed. The steps for market approval of a medical device in Canada are shown in Figure 3:

 

Figure 3: Steps for medical devices market approval in Canada

 

Turacoz Healthcare Solution (THS) always aims to keep professionals updated about rules and regulations of drugs and devices of different countries. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Report (CER) and Common Technical Documents (CTDs) Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry.

Regulations of Drug Approval in United States, European Union and Canada

Medical Devices,

Introduction

Drug regulations can be defined as the overall control of drug by following rules and regulations which are enforced by the government to protect the health and well-being of humans. They are crucial for ensuring high quality of the drug by confirming its efficacy, safety and quality. Every country has its own regulatory authorities such as the United States Food and Drug Administration (US-FDA for US), the European Medicines Agency (EMA for Europe) and Therapeutic Products Directorate (TPD for Canada which frame the regulatory requirements for development, approval, manufacturing and marketing of the drugs.

Regulations for Drug Approval in United States

USA is the main regulatory agency in the world and hence, it has the strictest standards for approving a new drug in US market. The regulator y authority of US, i.e., USFDA, is responsible for the safety regulation of the food and drug products in US. The drug approval process in US includes filing of Investigational New Drug (IND) application followed by New Drug Application (NDA).

Investigational New Drug Application

Once the drug is found to be safe, as per the reports of the preclinical trails, IND application (IND) is filed to the FDA to start the clinical trials or Phase I trial. The sponsor appointed by the firm or institution is responsible for submitting the IND application to the FDA for which a pre-IND meeting with FDA may be arranged in order to discuss the intended protocol for conducting the trial. The sponsor also provides information related to the chemistry, manufacturing details and quality control of the investigational drug.

New Drug Application (NDA)

After completion of all the clinical trials (i.e. Phase I, II and III trials), if the studies confirm the safety and effectiveness of the investigational drug, the manufacturer can file a New Drug Application (NDA) to the FDA for manufacturing and selling the drug in the US market.

Regulations for Drug Approval in Europe

The regulatory authority of the Europe, i.e., EMA, is responsible for the safety of the public in Europe. Prior to approval for marketing in EU, the applicant has to follow two regulatory steps mentioned below:

  • Clinical trial application
  • Marketing authorization application (MAA)

Clinical Trial Application

In Europe, the drug can be approved by four types of procedures depending upon the drug class and preference of the manufacturer. The four procedures are presented in Figure 1

Figure 1: Drug approval procedures followed in Europe

Marketing Authorization Application

The MAA is an application which is submitted by a drug manufacturer to the EMA in order to seek permission to market a developed drug product in Europe. MAA is approved at both, the state or centralized levels while the clinical trial application is approved at the state level only.

Regulations for Drug Approval in Canada

Therapeutic Products Directorate (TPD) is Health Canada’s federal authority which regulates the drugs and medical devices in Canada for human use. The applicant must present the scientific evidence on the product’s safety, effectiveness, and quality to the directorate in order to obtain permission to sell a drug product.

The Canada’s system of regulating a drug is quite similar to US. If an applicant wants to get marketing authorization in Canada then a new drug submission (NDS) must be compiled with clinical trial information and details of production, packaging, labelling, conditions for use and side effects must be submitted to TPD. Post-submission, it undergoes administrative screening to check the completeness of the document with appropriate format followed by review and assessment of safety, efficacy and quality. The TPD then evaluates the submission and communicates the deficiencies of the NDS to the sponsor to resolve them. After all the issues have been resolved, TPD issues a notice of compliance (NOC).

Turacoz Healthcare Solutions (THS) provides end-to-end regulatory writing support for clinical trials which includes Prescribing Information (PI), Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reposts (CERs) and Common Technical Documents (CTDs).

Regulations of Medical Devices in India: An Update

Medical Devices

Medical devices comprise of a vast range of equipment, ranging from a single pair of tongs to a heart-lung machine. Along with medicines and allied healthcare technologies, medical devices are important for modern patient‑centric care in all sorts of clinical settings like bedside, rural clinics, or metro hospitals. Medical devices have improved the quality of healthcare by making diagnosis, prevention, treatment, and monitoring of diseases simpler and efficient.

Indian medical device industry

Medical device industry is a huge industry, manufacturing wide range of products. In India, the medical device industry has a relatively small share of the global market when it is compared to the size of its economy. India ranks twentieth in the world in medical device market and it is fourth largest market in Asia. Most of the medical devices are imported in India which constitutes over 65% of the total market. The Indian medical device industry is driven by foreign manufacturers. The largest medical device manufacturing segment (53.7%) in India comprises of medical electronics, hospital equipments, and surgical apparatus. Around 31.3% of the medical device industry deals with medical disposables and consumables while diagnostic reagents and implants contributes to 7.9% and 7.1% of the market share respectively (Figure 1).

 

Figure 1*: Components of Indian Medical Devices Industry

*Source: Sethi R, Popli H, Sethi S. Medical Devices Regulation in United States of America, European Union and India: A Comparative Study. Pharm Regul Aff. 2017;6(1):1-9.

Medical devices regulations in India (CLAA scheme)

The Central Drug Standard Control Organization (CDSCO) has assigned a particular division i.e. Medical Device and Diagnostics Division which is dedicated to regulate the medical devices. Under the Central Licensing Approval Authority (CLAA) scheme, the CDSCO notified some of the medical devices and diagnostic kits which are being regulated for the manufacture, import and sale of the medical devices. These medical devices are also called as notified devices. The medical devices are regulated by Drugs and Cosmetics Act (1940) and Rules (1945) for the purpose of import, manufacture, sales and distribution. Currently, fourteen medical devices are notified under the CLAA scheme which are mentioned below:

  1. Disposable Hypodermic Syringes
  2. Disposable Hypodermic Needles
  3. Disposable Perfusion Sets
  4. In-vitro Diagnostic Devices for HIV, HBsAg and HCV
  5. Cardiac Stents
  6. Drug Eluting Stents
  7. Catheters
  8. Intra Ocular Lenses
  9. V. Cannulae
  10. Bone Cement
  11. Heart Valves
  12. Scalp Vein Set
  13. Orthopaedic Implants
  14. Internal Prosthetic Replacements

Current medical device rules (2017) in India

The Government of India has realized the need for framing separate rules and regulations for medical devices in order to improve the Indian regulatory system for medical devices. Hence, Government of India has issued a draft of medical devices to help the medical device industry and will separate the regulatory norms for manufacturing of medical devices from drugs. The draft of medical device was issued on January 31, 2017 and came into force on January 31, 2018.

The new rules and regulations for medical devices will create a novel and different regulatory apparatus by creating a separate registration process for medical devices. The key features of medical device rules, 2017, are summarized below:

  • The new rules have classified the medical devices on the basis of risk. These classes include:
  • Class A – Low risk

(e.g. catheters, surgical dressings)

  • Class B – Low moderate risk

(e.g. disposable hypodermic needles, orthopedic implants)

  • Class C – Moderate high risk

(e.g. cardiac stents, internal prosthetics replacements)

  • Class D – High risk

(e.g. drug eluting stents, heart valves)

  • The Indian regulators will have unique identification for their devices.
  • The medical devices should follow the standards established by the Bureau of Indian Standards (BIS). Where no relevant standard of any medical device has been laid down, then those devices should follow the standards laid down by International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards.
  • Licenses will remain valid indefinitely which are issued to the device registrants, along with the payment of the license retention fees, unless cancelled or surrendered.
  • Licenses and registration certificates received before the implementation of the new rules will be valid till expiry or after an 18-month period following implementation, whichever is later.
  • Test license will be valid only for one year.
  • The manufacturing sites of the devices will be audited by the notified bodies.
  • Medical devices for which trials are not required will need only a pilot study on a smaller population in order to test the safety and performance of the device followed by a pivotal trial on a large population.
  • These rules would be imposed by Central Licensing Authority and State Licensing Authority
  • The Central Licensing Authority is responsible for importing medical devices of all classes, and manufacturing of class C and D medical devices. Also, it is responsible for clinical investigation and approval of investigation of devices, and co-ordination with the State Licensing Authorities.
  • The State Licensing Authorities are responsible for the manufacturing, sale, and distribution of the devices that fall under class A or B, and also, control of sale, stock, exhibit, or offer for sale or distribution of in-vitro medical devices (IVDs) of all classes.

The new rules for medical devices will improve the accessibility and affordability of medical devices globally and will create a favourable and encouraging environment for development and innovation of new medical devices in India. The main objective of Government of India, through these rules, is to develop the confidence of the investors in medical device industry in India and to maintain the quality of all devices as per the international standards.

Turacoz Healthcare Solutions (THS) always aims to keep professionals updated on the current rules and regulations pertinent to regulatory affairs. Turacoz is dedicated towards providing scientific/medical writing support to the industry and academia. With expertise in various clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Document (CTD), and Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry.

Clinical Evaluation Report for Medical Devices-Role of Medical Writer

Medical Devices

Clinical Evaluation Report for Medical Devices

Clinical evaluation report (CER) is a document containing information regarding clinical evaluation of a medical device. CER is intended to be reviewed by the Notified Body (NB). Clinical evaluation refers to an organized procedure (Figure 1) used to collate, compile, and analyze clinical data related to a medical device. The clinical data includes updated published information on a medical condition and the medical device which is obtained from various databases. It also includes pre-clinical and clinical data, quality control data, and risk management and post-market surveillance related inputs which are obtained from manufacturers, quality and safety scientists, respectively. The clinical information also includes the instructions to be followed while using the medical device. The CER is prepared as per the guidelines mentioned in MEDDEV 2.7/1 Rev. 4 (June 2016). It specifies the structure as well as content to be added in the CER.

 

Figure 1: Organized procedure followed for Clinical Evaluation of a Medical Device

(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)

 

MEDDEV 2.7/1 Rev. 4 (June 2016)

MEDDEV 2.7/1 Rev. 4 (June 2016) is the guideline followed to prepare the CER. It includes summary of CER, updated published information about medical condition for which the medical device is used, as well as complete information about device under evaluation (Figure 2).

Figure 2: Table of content for development of Clinical Evaluation Report

(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)

Role of Medical Writer in the Development of Clinical Evaluation Reports

Medical writer plays an essential role in development of CERs. According to the requirements of MEDDEV 2.7/1 Rev. 4 (June 2016), the medical writer performs various activities (Figure 3).

Figure 3: Role of a medical Writer in development of Clinical Evaluation Report

Turacoz Healthcare Solutions, a medical communication company, provides latest updates on medical devices. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs), Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the Pharma and different sectors of Healthcare Industry.