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Device Advice by RQM+ RQM+
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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing.
RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties.
Please visit RQMplus.com to learn more.
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Live! #79 – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut
This was recorded 6 June 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
Summary
The conversation discusses the proposed rule by the FDA for wound care devices and its potential impact on the industry. The panelists highlight the importance of wound care and the need for regulations to protect public health. They also discuss the concerns and criticisms surrounding the proposed rule, including the lack of scientific evidence supporting the need for reclassification. The panelists address questions about the criteria for classification, the impact on innovation and product availability, and the timeline for finalizing the rule. Overall, the conversation emphasizes the importance of balancing regulatory requirements with the need for innovation and patient care. The conversation focused on the proposed rule change by the FDA regarding wound care products and the potential impact on the industry. The participants discussed the concerns and challenges related to additional testing requirements, product classification changes, and labeling requirements. They also explored the potential opportunities for innovation in wound care. The conversation highlighted the need for collaboration between industry and the FDA to address the concerns and find a balance between patient safety and regulatory requirements.
Takeaways
The proposed rule by the FDA for wound care devices has raised concerns and criticisms within the industry.
There is a lack of scientific evidence supporting the need for reclassification and the proposed rule's impact on innovation and product availability.
The FDA's focus on antimicrobial resistance is a key concern, but the panelists question the scientific rationale behind the proposed rule.
The timeline for finalizing the rule is estimated to be one to two years, with potential legal challenges expected.
Balancing regulatory requirements with the need for innovation and patient care is crucial in the wound care industry. The proposed rule change by the FDA regarding wound care products has raised concerns and challenges for the industry.
Additional testing requirements are a major concern for manufacturers, as they can be costly and time-consuming.
Product classification changes, particularly being bumped into the PMA category, can have significant implications for manufacturers.
Collaboration between industry and the FDA is crucial to address concerns and find a balance between patient safety and regulatory requirements.
There may be potential opportunities for innovation in wound care, particularly in the development of technologies that address antimicrobial resistance.
It is important for manufacturers to stay informed, engage with the FDA, and be prepared for potential changes in regulations.
Chapters
00:00 Introduction and Overview
04:04 Why Wound Care Matters
17:36 Impact on Innovation and Product Availability
28:20 Wound Prevention and Patient Impact
31:09 Scientific Evidence and Concerns
34:47 Proposed Rule Changes and Societal Impact
35:46 Challenges of Showing AMR Clinically
37:43 Pretextual Changes and Labeling
39:49 Exploring Other Technologies for AMR Concerns
42:05 Concerns and Poll Results
51:51 Working with FDA and Closing
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Strategy for First-in-Human Studies (1/2) – MedTech CRO: Strategy Development Series
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
❓ What are the objectives and benefits of conducting 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? What are the key considerations and best practices for manufacturers?
We have answers.
🏥 Here's the first video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟭/𝟮). Join VP of Strategic Regulatory Affairs Sew-Wah Tay and VP of Global Regulatory Affairs Jaishankar Kutty, Ph.D. as they discuss crucial strategic considerations for first-in-human (FIH) studies.
𝗪𝗮𝘁𝗰𝗵 𝗮𝗻𝗱 𝘆𝗼𝘂 𝘄𝗶𝗹𝗹 𝗹𝗲𝗮𝗿𝗻:
📎 The objectives and benefits of conducting FIH studies
📎 Key considerations and best practices for manufacturers
📎 How to navigate early-stage challenges effectively
Don't miss this strategic guidance that will help you streamline your FIH study process and make informed decisions. Watch now... and stay tuned for part two!
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Teaser: Introducing Our Clinical Trials Educational Video Series
🎓 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗼𝘂𝗿 𝗻𝗲𝘄 𝗲𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝘃𝗶𝗱𝗲𝗼 𝘀𝗲𝗿𝗶𝗲𝘀 𝗼𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀.
Our VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D., welcomes you to a free series designed to share our wealth of knowledge and best practices in clinical trial strategy, execution, and regulatory expertise.
𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗶𝘀 𝘀𝗲𝗿𝗶𝗲𝘀:
✨ In-depth insights from industry experts
🛠️ Practical tips and best practices
📄 Comprehensive and interactive learning opportunities, including technical briefs, white papers, webinars, and RQM+ Live! panel discussions
𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝘃𝗶𝗱𝗲𝗼𝘀 𝘄𝗶𝗹𝗹 𝗰𝗼𝘃𝗲𝗿 𝘁𝗵𝗿𝗲𝗲 𝗸𝗲𝘆 𝗮𝗿𝗲𝗮𝘀:
📊 Clinical trial strategy
⚙️ Clinical trial execution
📜 Regulatory expertise in clinical trials
𝗥𝗤𝗠+ 𝗶𝘀 𝗮 𝗹𝗲𝗮𝗱𝗶𝗻𝗴 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢, with a legacy spanning 40 years in the industry, and we plan to show you many of the reasons why through this content. Stay tuned to our LinkedIn page and podcast in the coming months and feel free to share the news with your networks! We'll be providing as much value as we can. 📚
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Scott Edwards, Managing Director | Excellence Spotlight
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
"Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way."
Scott Edwards, Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview.
𝗦𝗼𝗺𝗲 𝗼𝗳 𝗦𝗰𝗼𝘁𝘁'𝘀 𝗔𝗱𝘃𝗶𝗰𝗲?
🔘 Establishing solid relationships and fostering a strong culture of quality are crucial in the medical device industry.
🔘 Understanding the FDA's perspective and navigating corporate politics are important for success.
🔘 Listening to and learning from experienced mentors is extremely important for newcomers in the field.
🔘 Before making changes, it is essential to understand the existing processes and the impact of decisions on patients.
We hope you enjoy this interview with Scott hosted by VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D.!
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Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan
This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
Summary
In this conversation, panelists discuss the crucial role of Notified Bodies in the EU regulatory environment for IVDs and medical devices. They highlight the challenges faced by manufacturers due to changing regulations and the consultative nature of Notified Bodies, emphasizing the differences between the decentralized EU regulatory structure and the US system.
The panelists provide updates on the extended transition timelines for IVDR implementation and introduce the concept of structured dialogue as a means to address uncertainties and provide clarity for manufacturers. They also delve into the importance of governance for Notified Bodies in assessing regulatory changes and ensuring compliance.
The expertise and qualifications of Notified Body personnel are emphasized, with a focus on their technical background, skills, and attitude. Manufacturers are encouraged to provide clear and comprehensive technical documentation to facilitate effective interactions with Notified Bodies.
The role of Team NB in harmonizing processes among Notified Bodies is discussed, along with the potential limitations of relying solely on MedTech Europe guidance, which represents industry perspectives and may not fully align with regulatory requirements.
Throughout the conversation, the panelists share their backgrounds and expertise in the IVD and medical device regulatory field, providing valuable insights into the complex landscape of EU regulations and the critical role played by Notified Bodies in ensuring compliance and market access for manufacturers.
Takeaways
Notified Bodies are essential for ensuring compliance and market access for IVDs and medical devices in the EU.
Manufacturers must navigate a challenging and evolving regulatory landscape, working closely with Notified Bodies to address uncertainties and maintain compliance.
Clear technical documentation, expertise, and harmonized processes are key factors in fostering successful interactions between manufacturers and Notified Bodies.
While industry guidance can be helpful, manufacturers must ultimately ensure their compliance with the official regulatory requirements.
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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices
𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨
RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including:
✅ The 4-year phase-in timeline for compliance
✅ Expanded enforcement discretion for certain LDTs
✅ Grandfathering clause for currently marketed LDTs
Watch now to learn how this rule impacts your business and what steps you need to take to ensure compliance.
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