Category Archives: Medical Devices

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