Device Advice by RQM+

In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management.

From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspects of data management across the study lifecycle:

🏁 Study Start-Up: Collaborating with cross-functional teams to build user-friendly, robust databases with carefully considered edit checks.

🏃‍♂️ Ongoing Maintenance: Proactively cleaning data, generating oversight listings, and locking data progressively to ensure smooth deliverables later on.

🎯 Database Lock: Achieving efficiencies that enable rapid timelines from last patient visit to lock.

Noel also discusses key differences in data management approaches between medical devices, IVDs, and pharma. While the core principles of data reliability and integrity are universal, he notes the generally "lighter touch" in MedTech vs. the extensive external data reconciliation often required in pharma.

This discussion is a great example of the critical thinking required to deliver top-tier data management services customized to each client's unique needs. This is what we do at RQM+. Thank you to Noel for this look at what goes on behind the curtain to ensure the success of the clinical trials we support!

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While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here.

In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professional as you'll 𝘦𝘷𝘦𝘳 find in regulatory affairs and as she embarks on her well-deserved retirement, she generously takes the time to impart her wisdom and provide guidance to those aspiring to build a successful career in regulatory affairs. 👩‍🏫

In her presentation, which features a brief introduction from RQM+ VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D., Nancy discusses the importance of embracing challenges, building credibility, and fostering positive relationships with colleagues and regulatory bodies. She emphasizes the significance of understanding the "why" behind regulations and encourages others to seek new opportunities and innovative approaches.

She also shares the story of her son Matthew, who relies on numerous medical devices daily. This personal connection underscores the crucial role regulatory affairs professionals play in ensuring the safety and effectiveness of products that directly impact patients' lives. 🦼

We believe Nancy's insights and personal story will inspire everyone, but especially those in RA/QA. Her words can help guide your own career path and help you to navigate the complexities of the regulated industry with confidence and purpose.

And from RQM+, Nancy... we couldn't possibly put into words how much we appreciate you and the positive contributions you've made to our clients over the years. You've changed the MedTech industry for the better in immeasurable ways. Thank you. 🙏

With that said, she's not done yet! Join Nancy on Tuesday, 16 April for her live webinar: Aligning Your QMS with the FDA's QMSR Updates. See this link for more information and to register (or watch on demand after 16 April).

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This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion 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

The conversation in this part focuses on the importance of quality systems and compliance in preventing negative impacts on customers, patients, and reputation. The panelists discuss the history and evolution of FDA regulations for medical devices, the potential consequences of not following these regulations, and the need for a strong quality culture within organizations. They also highlight the significance of effective communication, continuous improvement, and proactive remediation activities in staying ahead of compliance risks and device recalls. The conversation highlights the importance of making quick decisions in the medical device industry, especially when it comes to recalls and addressing patient risk. It is crucial to have a concise committee with the right players and a designated decision-maker. Organizations should err on the side of being conservative and prioritize patient safety over financial concerns. Complaint handling and CAPA (Corrective and Preventive Actions) are key components of a robust quality management system. It is important to have a culture of quality that starts from the top and encourages open communication and collaboration. Internal audits and continuous inspection readiness are essential for maintaining compliance and reducing the cost of non-quality. Lack of leadership accountability is identified as a significant barrier to creating a culture of quality.

Takeaways

• Quality systems and compliance are crucial in preventing negative impacts on customers, patients, and reputation.
• Understanding the history and evolution of FDA regulations for medical devices provides context for the importance of compliance.
• Non-compliance with FDA regulations can lead to various consequences, including warning letters, product recalls, import detention, and civil money penalties.
• A strong quality culture within an organization is essential for maintaining compliance and preventing compliance issues.
• Effective communication, continuous improvement, and proactive remediation activities are key in staying ahead of compliance risks and device recalls. Quick decisions need to be made in the medical device industry, and a concise committee with the right players and a designated decision-maker is essential.
• Organizations should prioritize patient safety over financial concerns and err on the side of being conservative when it comes to recalls and addressing patient risk.
• Complaint handling and CAPA are crucial components of a robust quality management system.
• A culture of quality that starts from the top and encourages open communication and collaboration is necessary for maintaining high-quality products.
• Internal audits and continuous inspection readiness are important for staying compliant and reducing the cost of non-quality.
• Lack of leadership accountability is a significant barrier to creating a culture of quality.

Chapters

00:00 Introduction and Overview

04:12 Evolution of FDA Quality System Regulation

07:17 Consequences of Non-Compliance

12:29 FDA 483 Citation Data

29:10 Making Decisions and Recalls

32:31 CAPA and Complaint Handling 39:22

Creating a Culture of Quality

45:01 Takeaways and Conclusion

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In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, Dr. Sew-Wah Tay. It was tough to share just a single quote from this interview! Jaishankar Kutty, Ph.D. definitely helped bring out the best in Sew-Wah.

With a rich background in science and engineering, Sew-Wah's had an incredible career. She's a master of interdisciplinary innovation and can skillfully navigate regulations and clinical trials... all with a commitment to teamwork.

She also refuses to give up in the face of seemingly impossible challenges. We could share some quotes from her around that but we encourage you to watch the interview to hear them right from Sew-Wah. 🎧

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RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip.

In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 📖

Highlights:

• Notified body reviewers play a crucial role in the review process of clinical evaluation reports (CERs) under the MDR.
• Manufacturers should appreciate the challenges faced by notified bodies and provide clear and comprehensive information in their CERs.
• The review process is time-constrained, and reviewers rely on sampling and calibration to navigate through the documentation.
• Different reviewers may generate different questions based on their background and experience, but the goal is to enable an effective review of the CER.

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🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Study Director Adam Eason's journey has shown his willingness to embrace the unknown and leverage seemingly every experience when solving complex scientific problems.

🔬 His diverse experience includes drug development, environmental chemistry, and polymer chemistry testing. In the interview, you'll hear just how important 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻 and 𝗽𝗿𝗼𝗯𝗹𝗲𝗺-𝘀𝗼𝗹𝘃𝗶𝗻𝗴 𝘀𝗸𝗶𝗹𝗹𝘀 are in this role as Senior Study Director.

👥 Sharing achievements with this team? 𝗧𝗵𝗮𝘁'𝘀 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁, 𝘁𝗼𝗼, and leads to a positive work environment and efficient projects.

We hope you'll join us in celebrating Adam's impactful contributions to RQM+ / Jordi Labs clients and the inspiration he offers his teammates! 🙏

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Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. Director of Data Operations and has expertise that bridges gaps between data management, clinical operations, and regulatory compliance. His forward-thinking approach has elevated our clinical trial methodologies and consistently ensured the success and integrity of our trials.
Starting with a pharmacology degree and skills as an excellent project manager, Noel's career is like many at RQM+: connecting scientific rigor with operational excellence.
🤝 A Belief in Partnership: Noel thrives on building empowered teams and fostering transparent, collaborative relationships with clients. His approach is about being "proactively reactive," anticipating needs, and customizing solutions to fit each unique project.
🔥 Inspiring to Others: Beyond the accolades, Noel finds joy in mentoring, inspiring his teams, and contributing to groundbreaking medical advancements. He knows when his team shines, he does as well.
🌱 Advice for the Future: To those embarking on their journey in clinical research or data management, Noel emphasizes flexibility, open-mindedness, and courage to use one's unique skills to innovate and improve project delivery.
Noel has contributed a significant amount to clinical research and data management for our clients at RQM+ and it's an honor for us to celebrate that in this interview. 🙏
Thank you to Jaishankar Kutty, Ph.D. for conducting the interview as well!

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🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Services / Jordi Labs team.

In this week's Excellence Spotlight interview, she shares her fascinating journey with Lab Services Chief of Staff, Christine Santagate, RAC (welcome to the Excellence Spotlight, Christine 👋).

🎓 With roots deeply planted in analytical and physical chemistry from Boston College and a Master's from Illinois Institute of Technology, Kaitlin's dedication to mastering the science behind medical devices and pharmaceuticals – paired with her passion for improving lab operations – has led to truly transformative (no exaggeration) innovations at RQM+ / Jordi Labs.

Kaitlin is an enormous reason RQM+ / Jordi Labs is often referred to as the ‘Gold Standard’ in extractable-leachable testing and is held in extremely high regard by the FDA.

🧽 Her advice to aspiring scientists? Be a sponge. Absorb knowledge, engage in diverse projects, and never shy away from asking why. This curiosity and commitment to continuous learning is why Kaitlin is at the forefront of her field today.

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Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA related to Adverse Event (AE) Reporting. Today, it's time to shine the spotlight on her and only her in our newest Excellence Spotlight. 🔦

A quick glance at what Anastassia brings to RQM+ and our clients:

🔍 Technical Savvy and Storytelling: Her impressive background in science and medicine, enriched by her experiences from Kyrgyzstan to New York University, empowers her to provide incredible value to RQM+ clients and regulatory bodies alike.

💡 From Clinical Medicine to Regulatory Expertise: Transitioning from a prospective medical career to leading in regulatory affairs, she uses her clinical insights to drive innovation and provide cutting-edge solutions for our clients.

🤝 Relationships and Empowerment: Rooted in the importance of relationships, Anastassia fosters a culture of success and confidence within her team. Collaboration and empowerment are words you'll hear often at RQM+, and Anastassia is no exception.

Please feel free to comment and join us in celebrating Anastassia's wonderful story and the meaningful impact she has on RQM+, our clients, and the wider MedTech community. 🙏

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In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient process, allowing for the submission of a single summary report for AE data collected in PMCF studies.

🍿 You'll want to watch for...

Valuable FDA Insights: Learn about exemptions and variants for AE reporting.

Efficient Data Collection: Discover how surveying healthcare providers and analyzing anonymous patient data leads to meaningful AE data collection.

FDA Collaboration: Understand the FDA's approach to determining reporting requirements and encouraging the proactive collection of real-world data.

Streamlined Reporting Process: A single summary report could replace multiple individual reports, easing the burden on manufacturers.

From exemptions and variances to collaborative reporting efforts, this discussion between Anastassia Young, MS and Jaishankar Kutty, Ph.D. is packed with valuable information that can help your company navigate the AE reporting more effectively.

🕒 Jump to a specific segment in the video:

00:00 Introduction and Background
01:00 FDA Discussion on Adverse Event Reporting
03:05 Exemptions and Variants for Reporting
04:26 Collaboration with FDA for Reporting
05:14 Streamlining Reporting Process
06:11 Summary and Blog Announcement
07:06 FDA's Mission and Collaboration

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This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for 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

The panelists discuss the requirements for claiming equivalence under the MDR and provide examples of devices that are impacted. They also address actionable steps and next steps for manufacturers. The discussion covers the importance of PMCF studies and the evidence levels required. The panelists also clarify the requirements for claiming equivalence to devices with expired CE marks and within product families. The conversation covers topics such as technical equivalence and benchtop testing data, PMCF studies and registries, changes in PMCF under MDR, the difference between level 3 data producing registries and level 4 data producing retrospective studies, the purposes of registries and surveys, accessing data without a contract, the need for sufficient clinical evidence, acceptance of the new interpretation by notified bodies, reviewers' perspective on equivalence, the timing of the guidance, and action items for manufacturers.

Takeaways

• Manufacturers can claim equivalence with other devices to leverage their clinical data, even for new devices.
• The MDCG 2023-7 guidance clarifies the requirements for claiming equivalence under the MDR.
• PMCF studies must generate level four data for class three and implantable devices.
• Claiming equivalence to devices with expired CE marks can be high-risk and should be approached with caution.
• Claiming equivalence within product families requires careful consideration of the differences in materials and clinical indications. Technical equivalence requires connecting a story with appropriate data.
• PMCF studies have changed under MDR, with the nomenclature shifting from proactive and reactive to general and specific activities.
• Registries provide continuous data over the lifetime of a device, while surveys offer a snapshot in time.
• Manufacturers can access data without a contract by relying on publicly available information, reverse engineering, or comparative testing.
• The need for sufficient clinical evidence and the requirement to demonstrate clinical, technical, and biological equivalence remain unchanged.
• Notified bodies are accepting the new interpretation of equivalence.
• Manufacturers should revisit their product portfolios and consider leveraging the new guidance.
• Understanding the nuances of the guidance document is crucial.
• Manufacturers should have discussions with their notified bodies to align on the application of the guidance.
• Consider salvaging indications for devices that have been narrowed and explore the possibility of conducting PMCF studies.
• Read the guidance document thoroughly and seek expert assistance if needed.

Chapters

• 00:00 Introduction and Agenda
• 01:06 Introduction to RQM Plus
• 01:31 Introduction to Panelists
• 10:09 Examples of Devices Impacted
• 21:26 PMCF Studies and Evidence Levels
• 25:03 Claiming Equivalence to Devices with Expired CE Marks
• 28:50 Claiming Equivalence to Multiple Manufacturers and Devices
• 32:18 Claiming Equivalence within Product Families
• 35:00 Technical Equivalence and Benchtop Testing Data
• 35:30 PMCF Studies and Registries
• 36:36 Changes in PMCF under MDR
• 37:32 Level 3 Data Producing Registries vs Level 4 Data Producing Retrospective Studies
• 39:04 Different Purposes of Registries and Surveys
• 40:29 Accessing Data without a Contract
• 43:05 What Hasn't Changed: Need for Sufficient Clinical Evidence
• 44:20 Acceptance of the New Interpretation by Notified Bodies
• 46:17 Reviewers' Perspective on Equivalence
• 52:28 Timing of the Guidance and Revisiting Product Portfolio
• 55:05 Action Items for Manufacturers

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🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/QA practice.

With a rich background from University of California, Berkeley and Georgia Institute of Technology, as well as experience as a lead reviewer at the FDA, Song's journey is impressive... and this is exactly the experience and capability she brings to RQM+ clients.

📜 Regulatory Expertise: Song brings exceptional regulatory knowledge to the table, navigating the landscape of EU MDR submissions with precision. Her work is instrumental in guiding our clients through the intricate processes, ensuring compliance.

✍️ Masterful Technical Writer: Whether it's grant writing for space science or crafting medical device documentation, Song's ability to convey complex ideas with clarity is superb.

🧠 Mathematical Prowess: Song's interest in mathematics isn't just a hobby—it's a tool in her arsenal, helping her to creatively solve regulatory challenges with a unique analytical rigor.

🌟 Impact on RQM+ Clients: Song's contributions have been pivotal. From leading successful EU MDR submissions to offering strategic regulatory advice/consulting, she has continually elevated our client's projects.

Watch the interview and discover more about how Song's blend of scientific rigor, regulatory expertise, and passion for continuous learning make her a cornerstone of RQM+'s success.

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🔬 Meet RQM+ Director of Biological Evaluation Consulting, Taryn Meade, in our latest Excellence Spotlight interview!

Jaishankar Kutty, Ph.D. describes her as "elegant, talented, quietly confident, and always understated," but we're not going to be understated here! It's time to deservedly shine the spotlight on Taryn and what she brings to RQM+ and our lab clients.

With a decade in medical device and pharmaceutical development, Taryn stands out as an undeniable expert in biological safety evaluation. Taryn comes to RQM+ from the esteemed Jordi Labs, who was acquired by RQM+ in 2022.

Some highlights 🔦

🥼 Lab Expertise: Taryn's unparalleled skill set in the laboratory is matched only by her deep understanding of bioethics and ISO 10993 standards. Her critical role in guiding RQM+ clients through challenging regulatory landscapes is nothing short of impressive.

🧪 Critical Thinking: With a foundation in chemistry and a knack for logical analysis, Taryn anticipates challenges and produces strategic solutions that ensure product safety and compliance, setting her apart in the biocompatibility field.

📖 A Passion for Learning: Taryn's career trajectory is marked by a relentless pursuit of knowledge, tackling new challenges and expanding her expertise beyond her comfort zone. Learn more in the interview!

🛡️ Bioethical Strength: Above all, Taryn's unwavering commitment to patient safety and ethical compliance underscores her role as an admirable leader. Taryn's exceptional lab prowess not only elevate our lab services team and capabilities, but ensure RQM+ remains at the forefront of delivering industry-leading safety evaluations for our clients.

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We deliver full lifecycle materials science and chemical characterization capabilities. RQM+ / Jordi Labs is often referred to as the ‘Gold Standard’ in extractable-leachable testing and is held in extremely high regard by the FDA. Our expertise spans from conceptual bench top testing and prototyping through design verification and validation, preclinical testing, and post-market lifecycle management.

Services include:

• Material and Chemical Characterization
• Toxicological Risk Assessments
• Extractable-leachable Analysis
• Biological Evaluations
• Polymer Investigation
• Expert Scientific Consulting Across the Development Lifecycle and Post-Market Phase

Learn more and book a consultation with us here.

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📢 Hear Jaishankar Kutty, Ph.D.'s four-minute summary on MDCG 2023-7 and how you can benefit from attending next week's RQM+ Live! panel discussion: New Clinical Evidence Pathways for Legacy and New Devices.

🎟️ RSVP for the 22 February event here.

Why are we talking about this?

To address and clarify potential misinterpretations of Article 61, Items 4, 5, and 6, highlighted by the formation of an MDCG task force.

End goal of next week's panel?

To answer audience questions and provide a robust discussion that leads to a renewed understanding of equivalence in the EU for everyone who attends.

🔗 RSVP and we'll email connection details. We'll be sharing exclusive content with those who sign up.

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🎟️ ⁠RSVP for the 22 Feb. panel and get exclusive content.⁠

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🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art and standard of care, in justifying the quantity of clinical data.

Jai also discusses certain aspects of uncertainty that will face other followers in this technology space. Finally, there is time spent on some critical post-market areas that regulators could be focusing on for this device, and they they almost certainly will be focusing on for other devices to follow (perhaps in the pre-market phase). 📊

🕒 Timestamps if you'd like to jump ahead:

00:00 Introduction and Basis of Approval
03:22 Clinical Data and Outcomes
06:14 Regulatory Uncertainties for Device Manufacturers
10:33 Post-Market Areas of Focus for Regulators

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From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Excellence Spotlight interview.

A snapshot of Garrett’s background and impact to RQM+ clients:

🔬 Bioengineering Brilliance: Garrett has built a career that blends engineering expertise with clinical savvy. His work has spanned the full spectrum of device development, and notably embodies a holistic approach to innovation in the pulmonary space.

📊 Clinical Evaluation Know-How: As a pivotal figure in navigating EU MDR, Garrett has sharp insight when it comes to clinical evaluations and post-market data generation for legacy devices. A theme across many RQM+ consultants: His knack for transforming complex regulatory challenges into straightforward solutions has made him an indispensable asset to manufacturers facing the demands of EU MDR compliance.

📝 Exceptional Analytical Writing Skills: Garrett’s transition from the lab to leading PMCF studies illustrates his ability to critically analyze data and articulate findings. His writings not only meet standards, but exceed them when it comes to clinical and post-market documentation, setting a high benchmark for quality.

Garrett's journey at RQM+ underscores the value of interdisciplinary expertise in regulatory. His work positions our clients to succeed in the near- and long-term as industry requirements evolve. His ongoing contributions continue to set the standard for clinical and post-market excellence at RQM+.

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📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Senior Consultant at RQM+. Hear her story in our newest Excellence Spotlight interview.

Just a snippet of what sets Elizabeth apart:

🧠 Deep Regulatory Knowledge: With a background that combines legal savvy with regulatory expertise, Elizabeth can dissect the most intricate compliance challenges and offer strategic solutions that drive client success.

✍️ Exceptional Writing Ability: Elizabeth has a knack for translating complex regulatory requirements into compelling narratives that not only meet compliance standards, but also strategically position products for market success. This is key for clarifying the path to approval for cutting-edge medical technologies.

🔝 Setting the Standard: Elizabeth leads by example and her teams complete projects at the highest level of quality. Her leadership directly contributes to RQM+'s reputation for delivering excellence in RA/QA consulting.

Elizabeth’s story is definitely a reminder of how versatility and a willingness to embrace change can lead to unexpected and rewarding paths. Her contributions to RQM+ our clients have not just enhanced our capabilities, but have ensured RQM+ stays at the forefront of MedTech.

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💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation.

Takeaways: 👇

Expert Review Insights for a Novel Extravascular ICD: Get an insider's perspective on the stringent review process by the EU expert panel, including the critical evaluation of safety, efficacy, and novel features of the device.

Data Analysis Deep Dive: Discover the importance of comprehensive data in device approval, from early feasibility studies to pivotal trial results, and how this impacts device certification.

Navigational Guide for Manufacturers: Essential strategies for #MedTech manufacturers on conducting clinical trials, ensuring regulatory compliance, and addressing the expert panel's concerns to accelerate innovation to market.

Future of Cardiac Devices: Engage with these two thought leaders (please ask questions in the comments if you have them!) on the evolution of cardiac care technologies, the role of continuous data assessment, and the significance of post-market surveillance in validating long-term device performance.

There's a ton to unpack in this one and we hope you come away with value after watching! 🙏

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🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey in our newest Excellence Spotlight interview.

Here's why Laurie is an invaluable asset to RQM+ and our clients:

🌍 Global Regulatory Savvy: From her biology beginnings to navigating the complex pathways of international regulations, Laurie's career spans many roles and geographies. Her deep understanding of global requirements combined with a hands-on approach has been instrumental in guiding RQM+ clients through intricate compliance challenges.

🔬 Scientific Acumen: Laurie's foundation in molecular biology and her initial aspirations in research have shaped her meticulous attention to detail. This scientific precision has been pivotal in her success in managing quality and regulatory processes, ensuring every project meets the highest standards.

🛠️ Project Management Whiz: Transitioning into project management was a natural evolution for Laurie, reflecting her ability to steer complex regulatory submissions and strategic initiatives. Her role as a portfolio owner at RQM+ highlights her expertise in aligning business objectives with regulatory requirements, ensuring client success.

Continuous growth, learning, and adapting to the evolving needs of the MedTech industry perfectly describes Laurie. Like many at RQM+, her ability to bridge the gap between regulatory requirements and business objectives makes her a cornerstone of the team.

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MedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance.

What makes a good EU MDR program from a maintenance perspective?

We answered this question in RQM+ Live! #72, featuring:

• Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek
• Brian Dahl – Vice President of Quality and Regulatory, Starkey Hearing
• Jaishankar Kutty, Ph.D. Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+

🎥⏯️🕗 Watch the entire panel and see the questions we covered on demand here.

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Meet Nicholas Wilson, Ph.D. – Principal, Clinical and Post-Market Practice – in our new Excellence Spotlight interview.
What makes Nicholas special? A lot! Please listen to his story in the interview, but here are just a few reasons RQM+ clients love working with Nicholas:

🌍 Global Expertise: From his beginnings in New Zealand to significant stints in Sydney, Barcelona, Abu Dhabi, Zurich, and the UK, Nicholas's international experience has given him an unparalleled perspective in clinical research and regulatory strategies. His diverse background and first-hand understanding of complex global regulations helps him to be a trusted advisor to RQM+ clients worldwide.

📊 Data Analysis and Research: Nicholas's interest in research led to his impressive credentials, including seven peer-reviewed publications as the first author. His expertise in analyzing and interpreting complex data is a cornerstone of his approach, ensuring our RQM+ clients benefit from data-driven insights and strategies.

🧠 Technical Lead: Nicholas is the technical lead on various projects, adeptly managing medical writers and steering projects to successful conclusions. His ability to translate intricate medical concepts into actionable strategies is a testament to his profound technical knowledge and leadership skills.

Nicholas's path is a vibrant one of risks, challenges, and continuous learning, making him an incredibly valued and unique member of the RQM+ team. Over the course of his career, he's pushed the boundaries of what's possible in clinical research and regulatory strategy. All of us - colleagues at RQM+, clients he impacts, and the industry he helps shape - are better for it. 🙏

PS – Thank you as always to Jaishankar Kutty, Ph.D. for the interview!

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Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal.

All current transition timelines have been extended by 2.5 years with new deadlines ranging from 31 December 2027 for highest risk devices to 31 December 2029 for the lower risk devices.

There are some conditions around these transition deadlines, including:

• No significant changes can be made to the device
• PMS and vigilance requirements under IVDR must be met
• An IVDR compliant QMS must be implemented by 26 May 2025
• An application must be lodged with the notified body at least two years ahead of the transition deadlines

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This show was recorded 18 January 2024. Download the slides from this presentation (including bonus slides not presented) by submitting 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. 🙏

Brief

With the forthcoming restrictions on Per- and Polyfluoroalkyl Substances (PFAS), medical device manufacturers are on the brink of a significant industry shift. PFAS, known for their versatile properties, have been integral in the production of various medical devices. However, with the phase-out of these substances by the end of 2025, manufacturers must navigate the transition with precision and strategic foresight.

This session will begin with a short presentation to set the stage, and will be followed by a panel discussion bringing together RQM+'s leading experts in regulatory affairs, quality assurance, and lab services, to delineate a proactive approach for manufacturers.

We will dissect the three-step process required to phase out PFAS used in medical devices, addressing the identification of alternative materials, the intricacies of materials testing and verification, and the critical steps for successful documentation submission to regulatory bodies.

Topics with timestamps

00:00:00 - Introduction and Agenda Setting
00:02:12 - Introduction of Panelists
00:04:51 - Impact of 3M Exiting the Business
00:07:42 - Understanding the Supply Chain and Material Changes
00:10:32 - Concerns with Finding Alternative Materials
00:13:28 - Preliminary Testing for Material Replacements
00:16:07 - Limitations in Impact Assessment and Supplier Engagement
00:18:39 - Environmental Concerns and Supply Continuity
00:21:28 - Regulatory Impact
00:24:23 - Identifying and Restricting PFAS
00:27:26 - Implications of Material Changes in Medical Devices
00:30:11 - Considerations for Material Changes under EU Regulations
00:32:51 - Data on Dose Response for Safety Standards
00:35:21 - The Challenges of Chemical Characterization
00:38:08 - Considering Potential Material Changes in FDA Submissions
00:41:00 - Potential Impact on Performance Specifications
00:43:45 - Evaluating Biological Safety Risks
00:46:34 - Minimizing Testing Burden and Overwhelming Notified Bodies
00:49:06 - The Importance of Clinical Evaluations
00:51:45 - Impact on Clinical Evaluation and Biological Safety
00:54:27 - Sensitivity and Analytical Instrumentation
00:57:18 - Chemical Characterization and Contamination
01:00:04 - The Importance of CEM characterization and supplier controls
01:02:46 - The Importance of FDA Buy-in
01:05:48 - Explaining the Thinking Behind the Process
01:08:38 - Risks in Material Manufacturing
01:11:31 - The Benefits and Challenges of Targeted Analysis
01:14:12 - Material Change and Analytical Terms
01:17:07 - Detailed Risk Assessment and Impact Assessment
01:20:16 - Ensuring the Availability of Critical Products
01:22:21 - Conclusion

Panelists

• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
• Kevin Rowland – Director of R&D
• Taryn Meade – Director of Biological Evaluation Consulting
• James Wrenn – Director of Solutions Delivery
• Alexia Haralambous – Senior Principal (former FDA)

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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏

1. Our new Excellence Spotlight interview featuring RQM+ Senior Principal and former FDA-er Alexia Haralambous – a mastermind in spinal devices and global regulatory affairs.

2. Alexia has just been added as a panelist to next week's RQM+ Live! show: Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers. Will you join? If interested, please RSVP at the link in the comments. In addition to the discussion, we'll be sharing a short presentation, too. All who RSVP will receive an exclusive download of the slides presented, as well as bonus content... perfect for sharing with colleagues (including managers).

Back to Alexia! Here's just a snippet of what she brings to RQM+ and our clients:

Technical Strength: Alexia's journey, starting at Johns Hopkins and leading through pivotal roles at the FDA and Stryker, has honed her into a global regulatory expert. Her comprehensive experience and technical capability have proved to be an enormous benefit for the clients she supports.

From FDA to Industry: Her transition from FDA reviewer to industry leader wasn't just a career change, but a stepping stone to greater challenges and achievements. At Stryker, she gained insights and experience with quality management systems, EU MDR, and global strategy, rounding out her understanding of industry operations.

Global Regulatory Expert: At RQM+, Alexia applies her skills across a variety of therapeutic areas, supporting startups and larger companies alike. Her diverse experiences make her an invaluable resource for our clients... and in next week's PFAS panel discussion!

Alexia's expertise and adaptability exemplify the spirit of RQM+. Her ability to synthesize a wide range of experiences into effective strategies makes her a standout member of our team. We think if you watch her full interview there's a lot to learn from her unique perspective.

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🎆 Happy new year! We're bringing the most positive energy we can to start 2024 with a heartwarming and uplifting RQM+ Excellence Spotlight interview with Niki Caporali Spaniel, RAC.

Niki's journey blends a deep-seated passion for healthcare with an extremely impressive command over regulatory strategies, reflecting a career built on empathy, expertise, and a commitment to advancing MedTech.

What does Niki bring to the table for RQM+ clients? Two highlights:

🛠️ Technical Excellence: With a sharp eye for regulatory nuances, she's been instrumental in steering clients through challenging landscapes, turning obstacles into opportunities for growth and compliance.

💞 Empathetic Leader: Niki's warmth and empathy (watch or listen to the interview!) resonate in every project and her genuine care for clients' success is clear at every step. Niki turns a sometimes impersonal world of regulations into a journey of shared goals and mutual success.

Again, we thought Niki's interview was the perfect way to start off the new year. Her story is a reminder of the incredible human element behind every medical breakthrough. Please feel free to comment and join us in celebrating Niki's wonderful story and the meaningful impact she has on RQM+, our clients, and the wider MedTech community. 🙏

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🎄 This week's Excellence Spotlight shines on a standout member of our clinical and post-market team, Senior Consultant / Capability Manager, Lindsay Wright.

A snapshot of what Lindsay brings to RQM+ and our clients 👇

Biomedical Engineering and Mechanical Engineering Ingenuity: Lindsay started her journey at the University of Pittsburgh, first excelling in bioengineering, then going further, receiving her master's degree in mechanical engineering.

Translating Science to Solutions: Lindsay’s transition from regenerative medicine to regulatory affairs illustrates her ability to apply scientific principles to real-world challenges. Her experience in R&D and regulatory roles at RQM+ has been instrumental in navigating the complex pathways to market for diverse medical devices and IVDs.

Client Collaboration: Lindsay excels in synthesizing varied inputs and collaborating with diverse teams, allowing her to deliver regulatory documents of the highest standard.

We think Lindsay perfectly embodies the consistent pursuit of knowledge and the versatility required in the ever-evolving landscape of medical device regulation. RQM+ is proud to have Lindsay as a key contributor to our success and the success of our clients. 🙏

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After a lull which has now picked up with FDA approvals, what's next for renal denervation? RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. shares the knowns and unknowns in a new video clip.

📝 Quick summary

Renal denervation is a technology that aims to control blood pressure by disrupting renal nerve activity through a minimally invasive, irreversible procedure. Clinical trial data is mixed, with modest reductions in blood pressure observed. Skepticism and uncertainties surround the technology due to risks, lack of markers for procedural success, and unclear durability of benefits.

The post-market phase is crucial for generating more data and addressing unanswered questions. Patient population and risk-stratified benefit-risk analysis are important considerations, and a clinical outcomes study is needed to evaluate the impact of renal denervation on cardiovascular events.

💭 Takeaways

• The state of play and the adjunctive nature of renal denervation in treating resistant hypertension in some patients.
• Strong focus on what’s lacking from a benefit-risk perspective today and what needs to be studied in the post-market phase.

🕒 Timestamps

00:00 Introduction and Background
01:26 Renal Denervation as a Therapy for Hypertension
02:25 Technology and Procedure of Renal Denervation
03:21 Clinical Trials and Efficacy of Renal Denervation
04:46 Skepticism and Uncertainties Surrounding Renal Denervation
06:15 Post-Market Phase and Expectations
07:41 Challenges and Questions for Renal Denervation
08:58 Patient Population and Benefit-Risk Analysis
10:15 Risks and Modest Benefits of Renal Denervation
10:44 Need for Clinical Outcomes Study
11:14 Conclusion

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➕ Today's Excellence Spotlight features Principal RA/QA Rostislav Stoykov. With a strong foundation in biomedical and clinical engineering, Rostislav has masterfully navigated the complex regulatory landscape and made significant contributions in the medical device industry.

Highlights from his conversation with Jaishankar Kutty, Ph.D.:

🎓 Biomedical and Clinical Engineering Roots: Rostislav’s journey began with a dual degree in biomedical and clinical engineering, a remarkable start that set the stage for his multifaceted career. His technical ability laid the foundation for his future successes in product management and RA/QA roles.

🌐 Navigating Regulatory Landscapes: With roles ranging from leading MDD remediation programs to being the regulatory lead for global legal manufacturers, Rostislav's experience is vast. Perhaps most impressive and as Jai points out in the interview, has been his consistent ability to remain calm and find successful paths in many challenging regulatory scenarios.

🧩 Holistic RA/QA Approach: Rostislav emphasizes the inseparability of quality and regulatory aspects in the medical device field. His expertise in both areas has allowed him to tackle comprehensive challenges and implement effective solutions, ensuring the delivery of high-quality, compliant products.

Rostislav exemplifies the blend of technical knowledge, strategic thinking, and regulatory acumen that is essential for the highest performance and impact in today's device industry. This is exactly what RQM+ strives to bring to every client and project.

RQM+ is proud to have Rostislav as a key member of our team, continually elevating our capabilities and impact in the industry. 🙏

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🚨 Hear Jaishankar Kutty, Ph.D. discuss the critical impact of PFAS phase-out on medical device manufacturing and then, 🎟️ RSVP to our January 2024 event for exclusive downloadable content.

We hope you find Jai's commentary to be an excellent summary of the topic! Our January presentation and panel, Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers, will go significantly deeper, providing proactive strategies to navigate this major shift.

A few quick takeaways from Jai's clip...

🔬 PFAS substances have significant ramifications on medical device and IVD manufacturing.

🇪🇺 The proposed EU reach restriction and 3M's decision to stop manufacturing PFAS substances have regulatory and supply chain implications.

🔍 Device manufacturers need to identify PFAS substances used in their products and find alternate materials.

⚖️ Regulatory assessments and potential legal ramifications should be considered in the process.

Again, for substantially more on this topic and exclusive content, RSVP for the brief presentation and panel at this link.

-

🎟️ RSVP for the Jan. 18th panel and access exclusive downloads.

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This show was recorded 30 November 2023 and can be viewed on our website ⁠⁠⁠⁠here⁠⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. We have a ton of on-demand content there, too. Thank you for tuning in! 🙏

Takeaways

• LDTs have historically been subject to enforcement discretion by the FDA, but as they have become more complex and used in higher-risk settings, the FDA is proposing regulations to ensure their safety and effectiveness.
• Examples of issues with LDTs include false positive or false negative results, misdiagnosis, and fraudulent practices.
• IVDR regulations in the EU are influencing the FDA's approach to LDT oversight, and manufacturers may need to comply with both sets of regulations.
• Preparing for LDT regulations involves understanding the current LDT portfolio, identifying gaps in data and validation, and considering the impact on resources and timelines.
• Potential pitfalls include challenges in determining the classification of LDTs, ensuring compliance with validation requirements, and managing resource constraints.
• The proposed rule has received significant feedback and comments, with some expressing concerns about the need for regulation and the potential impact on innovation and patient access to tests.
• Implementing LDT regulations may require significant financial resources, including costs for testing, clinical trials, and quality management systems.
• The chances of the proposed rule going into effect are uncertain, but the FDA is committed to addressing the concerns and evidence of issues with LDTs.

Chapters

00:00 Introduction

03:25 History and Background of Laboratory Developed Tests (LDTs)

05:46 Impact of FDA Regulations on LDTs

08:41 Examples of Issues with LDTs

14:00 Speculation on the Regulatory Process

18:38 Influence of IVDR Regulations on FDA

20:38 Opportunities for IVD Manufacturers

25:51 Preparing for LDT Regulations

28:06 Potential Pitfalls and Challenges

35:15 Comparison of LDT Regulations with IVDR

41:41 Comments and Feedback on the Proposed Rule

44:35 Scenario: Using FDA-Cleared Test with Different Specimen Types

46:21 Supporting Team Members in Implementing Changes

51:49 Realistic Cost of Implementing LDT Regulations

52:14 Chances of Proposed Rule Going into Effect

52:18F DA's Mission and Authority to Regulate

53:17 Closing Remarks and Call to Action

Panelists

• Nancy Morrison, RAC – Vice President, Intelligence & Innovation
• Margot Borgel, Ph.D. – Director, IVD Intelligence & Innovation
• Eila Pattee, Principal Consultant
• Andrew Lakey, Ph.D. – Senior Consultant
• Theresa Miles – VP, Client Portfolio Management (moderator)

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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏

➕ The plus is the people at RQM+ and today's Excellence Spotlight features Torrie DeGennaro, a star in biomedical engineering and quality assurance at RQM+. Torrie's innovative approach to PMCF data collection has been pivotal in securing MDR certification for numerous legacy devices. She's also a key contributor to our AI clinical evidence platform, Fern.ai.

Highlights from her conversation with Jaishankar Kutty, Ph.D.:

🧬 Biomedical Engineering Expertise: With a robust background in BME focusing on biomechanics, Torrie's journey from contract manufacturing to quality assurance showcases her depth in the field and adaptability to diverse roles in medical device development.

🌐 PMCF Innovation: Torrie's role in evolving PMCF data collection methods has not only supported MDR certification, but also opened new avenues for legacy device compliance. Her tenacity and innovative thinking have been key in navigating the challenges posed by changing regulations.

🤝 Teamwork and People Skills: Beyond her strong technical capabilities, Torrie's ability to collaborate effectively, adapt to new challenges, and lead projects underscores her exceptional interpersonal skills. Her capacity to work closely with teams and clients, understanding their unique needs and perspectives, sets her apart.

Torrie's journey is a testament to her sharp intellect and simply put, her ability to get things done. We're thrilled to have such a dynamic and versatile professional driving progress and excellence at RQM+ and for our clients. 🙏

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➕ Today's Excellence Spotlight proudly features our Director of Global Audit Practice, Dr. Richard Freeman. Richard's journey from academia to industry has made him a standout expert in product development, process development, and quality systems, to name just a few.

Highlights from Richard's interview with Jaishankar Kutty, Ph.D.:

🧪 Science and Innovation: Beginning his career with a strong focus on chemistry, Richard's passion for creating novel molecules and his expertise in organic synthesis have been instrumental in his success. His work in developing novel antibiotics and antiretroviral inhibitors exemplifies his commitment to impactful scientific advancement.

🌍 From Academia to Industry: Richard's transition from academic research to industry ("industry got lucky," as Jai points out! 🍀) highlights his adaptability and prowess in applying scientific knowledge to real-world applications. His experience in synthesizing chiral molecules and working on biocompatible coatings for medical devices demonstrates his ability to translate complex scientific concepts into practical solutions.

🌐 Global Impact: Richard's contributions extend beyond the lab. From aiding in the development of coronary stents to improving antimicrobial wound dressings, his work has had a significant impact on global healthcare. His role in shaping medical device regulations in Saudi Arabia and leading RQM+'s global audit practice underscore his influence in the field.

We think Richard's journey is a testament to one of the most important traits a person can have: curiosity. His diverse experience and ability to overcome complex challenges make him an invaluable asset to our team at RQM+. We're honored to have him with us, shaping the future of medical devices and healthcare. 🙏

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➕ In today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁, we're extremely excited to feature Senior Consultant Andrew Lakey, Ph.D. Andrew is a multidisciplinary scientist whose career spans academia, industry, and notified body experience, making him a vital asset to our IVD team.

Key insights from our interview:

🔬 From Forensics to IVDs: Andrew's journey began with forensic science, leading to a deep dive into microfluidics and nanotechnology. His transition to IVD diagnostics showcases his adaptability and dedication to scientific advancement.

🧪 Creative Problem Solving: Andrew's background in R&D has honed his problem-solving skills, particularly for developing innovative diagnostic solutions. His ability to think differently (🍏 Steve Jobs, is that you?) has been key to overcoming numerous R&D challenges.

🌐 Academic to Industry Transition: Moving from academia to a regulated industry environment, Andrew quickly adapted to stringent quality systems. This shift highlights his ability to evolve and master new areas, enhancing the RQM+ team's expertise in regulatory and quality aspects of IVD development.

Andrew's unique experiences – from aiding zoo elephants to navigating the complexities of IVD product development – definitely demonstrate his exceptional versatility and technical expertise. We're honored to have him at RQM+, where he continues to make significant contributions to the field and our clients. 🙏

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💬 "Stay ready so you don't have to get ready." – Brandy Chittester, Senior Director of Clinical Operations
In a new Excellence Spotlight interview, we're thrilled to talk with Brandy Chittester, a key figure in clinical research at RQM+. Brandy skillfully bridges the gap between technical expertise and operational excellence.

Some highlights:

🔍 The Journey from Engineering to Clinical Research: Starting her career in mechanical engineering, Brandy's passion for biomedical applications led her to clinical research.

📈 Critical Thinking and Innovation: Brandy's engineering background has been fundamental in her success in clinical research. Her methodical approach to problem-solving ensures that every project under her watch is handled with precision and a keen eye for detail.

🤝 Mentorship and Team Building: Beyond her technical skills, Brandy excels in fostering team growth and mentoring new talent. Her philosophy of 'staying ready so you don't have to get ready' resonates deeply with our team, enhancing collaboration and staying true to everyone's commitment to excellence.

Brandy's unique blend of engineering acumen and clinical research expertise makes her an invaluable asset to RQM+ and our clients. We're proud to have her as a part of our team, continually driving innovation and excellence in clinical research. 🙏

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🎙️ Our Excellence Spotlight series proudly showcases the technical excellence personified by our team. Senior Principal Engineer, Hrishikesh Gadagkar, Ph.D., stands as a paramount example of this dedication.

Three highlights from our newest interview:

🛤️ Tech Trailblazer in Med Devices:

Leading from the front in areas ranging from diagnostic imaging to wearable technology, Rishi has a track record of steering complex projects to success. His skill in navigating the intricacies of product development and regulatory pathways is spectacular... as is his commitment to technical excellence in everything he does.

🔌 Scientific Insights and Innovation:

With a Ph.D. in Electrical Engineering and a 𝘸𝘦𝘢𝘭𝘵𝘩 of experience across medical device domains, Rishi stands out as an innovator. His journey from engineering breakthroughs to strategic regulatory approvals illuminates his role as a cornerstone at RQM+.

🤝 Empathetic Leadership and Mentorship:

Rishi's leadership extends beyond project management to embody the essence of mentorship. His empathetic approach and ability to cultivate a deep understanding of client needs make him an exemplary team player. His philosophy? To approach every challenge with the grace of a teacher and the focus of a scholar.

Rishi's contributions to RQM+, our clients, and the medical device industry are a testament to his exceptional expertise and steadfast dedication. A heartfelt thank you to Rishi for his influential impact and for setting a standard of excellence we all aspire to! 🙏

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🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are starting off this week with plenty of good things to say in a new MedTech Voices video.

This time, they unpack the EU MDR expert panel's evaluation of a novel resorbable device aimed at revolutionizing hernia repair procedures.

Why watch (or listen) 👇

🔍 Scrutinizing the Longevity of Resorbable Devices:
Understand the balance between durability and resorption rates in implantable devices and why this matters for patient outcomes.

🌐 Exploring the Interplay of Device Design and Clinical Trials:
Discover the implications of a device’s material composition, such as P4HB and PGA, on its performance and the intricacies of clinical trial design that capture this data effectively.

🔬 Data Assessment Through an Expert Lens:
Learn how the expert panel dissect presented data — from safety to performance — and the significance of stratification in clinical evidence for specific surgical applications.

📊 Emphasizing Post-Market Surveillance:
Explore the crucial role of post-market clinical follow-up (PMCF) plans and how they contribute to understanding the long-term impact of medical devices.

📝 Critical Analysis of Notified Body and Manufacturer Data:
Hear how a well-conducted review can influence the perception of a device's safety and performance, and what the consensus from an expert panel signifies for the future of device approval.

As always, if you have any feedback or questions we hope you'll let us know! 🙏

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➕ Meet Senior Director of Project Management Cari Kniola in our newest Excellence Spotlight interview 👇

Cari navigates clinical trials with expertise and commitment. Her 26+ years of experience in clinical research elevates the capacity of RQM+ to serve clients and drive innovation. Cari's journey into this field is as fascinating as her work, transitioning from a background in veterinary technology to becoming a linchpin in advancing medical device research.

🎯 Specializing in Medical Device Research

As an integral part of our clinical trial team, Cari specializes in regulatory submissions for medical device trials. Her deep understanding of regulatory frameworks and close relationships with both the FDA and European notified bodies ensures RQM+ clients have the best strategies for successful product approvals.

🔬 Expertise that Makes an Impact

Cari’s expertise is instrumental in helping our clients navigate complex regulatory landscapes. From initial trial designs to final submissions, she provides the kind of guidance that can only come from years of hands-on-experience. It’s team members like Cari who make RQM+ the go-to firm for the top medical device manufacturers.

🌐 Globally Recognized Talent
Cari’s contributions don't just benefit RQM+, they enrich the entire #MedTech industry. She regularly collaborates with top clinical researchers and has presented her research at international conferences. Her work has received accolades from industry peers and helped her become a globally recognized talent in the field.

We are grateful to have Cari as part of the RQM+ team, driving excellence in MedTech. 🙏

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This show was recorded 26 October 2023 and can be viewed on our website ⁠⁠⁠here⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏

Listen in as Boston Scientific's Sr. Global Regulatory Intelligence & Advocacy Manager joined RQM+ experts for a special edition of our Live! show, all about the month's industry events! This session brings together insights from an array of events our team attended throughout October, such as the RAPS Convergence and The MedTech Conference (AdvaMed). We've soaked in knowledge, experiences, and taken note of industry updates. Now, we're excited to come together and share the crux of what we've discovered — the revelations, shifts, and noteworthy advancements.

We'll touch upon:

• Key topics from a broad spectrum of events
• Crucial shifts in industry practices and guidelines
• Overarching themes that resonated across various conferences
• Answering questions and providing clarity on intricate topics

Whether you attended any of the October events or not, this session is a golden opportunity to gain a consolidated perspective of the busiest month in MedTech and draw connections between different events.

Panelists:

• Olga van Grol-Lawlor – Sr. Global Regulatory Intelligence & Advocacy Manager, Boston Scientific
• Amie Smirthwaite, Ph.D. – Sr. VP of Intelligence & Innovation, RQM+
• Nancy Morrison, RAC – Vice President, Intelligence & Innovation, RQM+ (moderator as well)
• Dirk Steenmans – Global Head, Clinical and Post-Market Practice, RQM+

Timestamps:

• 4:11 -- What events did everyone attend and what was your role in those events?
• 8:19 -- Were there any trends you saw across conferences or that applied around the world?
• 21:07 -- It's understood that manufacturers are unhappy about the MDR, but precisely what aspects of the MDR are causing problems?
• 33:02 -- What was the most debated or discussed session at any of the conferences?
• 41:59 -- How do I find SSCPs posted on EUDAMED?
• 42:33 -- How complete is real-world evidence? What about the use of registries? What's the data being collected? (Amie's "IT DEPENDS" sign makes its first appearance!)
• 50:38 -- What is the latest on post-market surveillance? When can I stop doing PMCF? Do I need a WET device?
• 57:24 -- What are you most hopeful about?

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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏

🎙️ Our Excellence Spotlight series and host Jaishankar Kutty, Ph.D. are back this week with a feature on RQM+ Senior Project Manager, Ethan Elshoff, MPH, MBA.

Three standout points from the interview:

📊 Mastery in Business Analytics and Healthcare Strategy: Ethan possesses a unique combination of business analytics, healthcare strategy development, and project management expertise. His educational foundation, with a Master's in both Public Health and Business Administration, positions him as a vital contributor for RQM+ and our clients.

⚙️ Leader in Operational Excellence: Steering the AI capability enhancements and clinical data collection programs, Ethan is at the forefront of driving our company's innovation. His role in developing the retrospective chart review data collection for PMCF activities showcases his dedication to ensuring our clients meet the highest standards.

🤝 Team Player with Outstanding People Skills: Whether he's working with technical or non-technical staff, Ethan has the natural ability to adapt and work cohesively. His approach, which he likens to water 💧, allows him to tailor his interaction based on the personalities and roles within a team.

As an integral part of RQM+, Ethan consistently showcases the incredible value he brings to our clients and the healthcare sector as a whole. As we always say and mean wholeheartedly at the end of these posts, thank you, Ethan, for your unwavering commitment and the unparalleled expertise you bring to the table every day! 🙏

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Today we're shining the spotlight on Principal Consultant Dr. Catherine Kang! We love this interview and hope you'll listen. With an engineering foundation, deep roots in biomaterials, cell biology, and tissue engineering, Catherine's expertise doesn't stop there. She stands tall in neuroscience, medical writing, and especially in combination products – merging drugs and devices.

🔍 Three highlights about Catherine...

From Research to Regulatory Mastery:

With a passionate start in academic research, Catherine elegantly transitioned to the regulatory world driven by her personal goals and a focus on family. Listen to the clip to hear how.

Combination Products Visionary:

We don't use "visionary" lightly! Catherine's vast experience enabled her to develop a quality system and processes that optimize the development of combination products, ensuring both compliance and effectiveness. This systemic approach has positioned her as a true industry leader in this space.

Commitment Beyond Work:

Watching this clip will make it obvious, but Catherine takes immense pride when her clients succeed, illustrating her dedication to collaborative victories... which is a theme at RQM+. You'll also learn her journey showcases an incredible balance between technical prowess and personal priorities, a testament to her character.

🌐 Value to RQM+ and clients...

Catherine's exceptional expertise in combination products sets her apart. Her unparalleled skills and continuous evolution in this niche space have made her an invaluable asset to RQM+ and our clients.

📚 For aspiring regulatory experts...

Catherine's journey exemplifies the power of continual learning, reinvention, and understanding priorities. She illustrates that with determination, one can seamlessly transition, grow, and excel in any chosen path.

Thank you, Catherine Kang, for your dedication, knowledge, and the immeasurable value you bring to RQM+ and our esteemed clients every day! 🙏

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🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are back and looking into the expert panel's insights on a shoulder replacement system; a device that has the potential to redefine orthopedic solutions.

Why you should watch 👇

📘 Deep Understanding of Clinical Evidence:
Dive into the intricacies of what constitutes 'sufficient' clinical data and why it's paramount in regulatory processes.

⚙️ Beyond the Basics:
Learn about the multiple facets and variables of shoulder replacement, its implications, and the criticality of data stratification.

👀 Tackling Challenges in Data Collection:
A closer look at the hurdles in gathering comprehensive data, addressing follow-ups, and deciphering the critical findings.

📈 Potential for Better Treatments:
Explore how improved data analysis and presentation can lead to groundbreaking treatments in the orthopedic space, making a difference in countless lives.

If you have any feedback or questions, please let us know! 🙏

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Meet RQM+ Director of R&D (and "detective" 🕵️) Kevin Rowland in our new Excellence Spotlight...

🔍 Two highlights about Kevin...

True Mastery in Analytical Chemistry:
Kevin’s foundation in engineering and chemistry allows him to employ high-end instrumentation and sophisticated methods to tackle the most challenging projects in analytical chemistry, ensuring the accuracy and reliability of results in highly regulated tests.

Development of Innovative Processes:
Kevin is proud to have developed transformative processes for chemical characterization projects along with a team of brilliant chemists. His innovations and publications have proposed new advantageous approaches and have contributed to creating safer, lifesaving medical devices.

🌐 Value to RQM+ and clients...

Kevin’s unmatched technical skills, profound problem-solving abilities, unwavering commitment to patient safety, and strong customer focus make him a valued asset at RQM+. Kevin is one of the key reasons we are able to consistently optimize the speed and quality of chemical characterization studies for clients.

🔬 Inspiration for aspiring scientists...

For anyone at the early stages of their career, Kevin’s journey illustrates the importance of not accepting the status qu and continually striving for improvement. His can-do, will-do, and must-do attitude spur innovation and progress in the scientific community.

Thank you, Kevin, for your unwavering dedication and the incredible value you bring to RQM+ and our clients every day! 🙏

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This show was recorded 28 September 2023 and can be viewed on our website ⁠⁠here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏

The extension of the EU MDR compliance timeline offers a reprieve for medical device manufacturers, but this extended window comes with its own set of challenges and conditions. As the interim deadlines approach, it’s critical for manufacturers to fully understand their obligations and the ramifications of failing to meet them.

In this high-impact panel discussion, thought leaders from a notified body,  manufacturer, and RQM+ come together to unpack the complex landscape of EU MDR compliance in light of Regulation 2023/607 and the transition from MDD/AIMDD to MDR 2017/745.

This is a must-attend session for those dealing with legacy device transitions and meeting upcoming MDR deadlines.

Topics include:

• Understanding key dates: The anatomy of interim deadlines and the conditions for extended transitional arrangements
• Mastering documentation: What manufacturers need to include in their MDR applications for a successful assessment by notified bodies
• Staying compliant: Best practices for incorporating the requirements of MDR 2017/745 into existing Quality Management Systems
• Certificates and self-declarations: Proving the extended validity of your device’s CE certificate and navigating self-declaration protocols
• Risk management: Avoiding common pitfalls that can delay or derail your transition to MDR compliance
• A look into the future: How early compliance can give manufacturers a competitive edge and allow for design and market adaptability

Attendees will leave the session equipped with actionable insights for navigating this complex regulatory environment, including a deeper understanding of the strategic and tactical steps needed for a successful transition.

Panelists:

• Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek
• Brian Dahl – Vice President of Quality and Regulatory, Starkey
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
• Matt Burger – Vice President, Business Development, RQM+ (moderator)

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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏

This week we're delighted to feature Principal Consultant Diane Cox, whose expertise in FDA, ISO, risk, and compliance within the medical device and IVD industries is an invaluable asset to RQM+ and the clients we serve.

We hope you'll watch, but here are some highlights:

🎓 Diane holds a degree in biology and began her journey in the lab managing DNA sequencing projects, garnering extensive experience in GLP compliance early in her career.

🧬 Despite her deep involvement with the complexities of DNA sequencing, she emphasizes the importance of simplification in quality processes to avoid misinterpretation and to ensure conciseness and clarity for diverse audiences.

🤝 Diane is not just a scientist; she's an empathetic listener, seeking to understand clients thoroughly before offering solutions, ensuring their concerns are addressed and their company cultures are respected.

🌿 She's driven to develop and improve processes that are enduring and impactful for the users, reflecting her strong commitment to patient safety and quality improvement.

🔄 Diane’s ability to maintain and nourish client relationships post-project completion is noteworthy, creating a cycle of trust and mutual growth between her and the clients.

We find Diane’s journey inspiring and hope you do, too! Her devotion to fostering relationships and her commitment to excellence (we hope you've noticed this theme with all of our Excellence Spotlight clips) are critical to RQM+ and the success of our clients. A huge thank you to Diane for her enduring passion and dedication, and also to Jaishankar Kutty, Ph.D. for leading the interview. 🙏

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This show was recorded 21 September 2023 and can be viewed on our website ⁠here⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏

We all know: ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers.

One of the key challenges in achieving this goal is selecting and managing materials effectively, while maintaining supplier controls and identifying opportunities for proactive design changes.

In this panel discussion, experts in medical device development, regulatory compliance, and material science will share their insights on navigating material risks and implementing strategies to improve medical device safety.

Topics will include:

• Best practices for material selection and supplier controls in medical device development
• Strategies for proactive risk management, including early identification and mitigation of material-related risks
• Approaches to biocompatibility testing and regulatory compliance in medical device development
• The changing landscape of medical device regulation and its impact on material selection and supplier controls
• Case studies and practical examples of effective material risk management in medical device development

Attendees will come away from this session with a better understanding of how to navigate material risks in medical device development and implement effective strategies for improving safety and quality.

Panelists

• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
• Kevin Rowland – Director of R&D, RQM+
• Taryn Meade – Director of Biological Evaluation Consulting, RQM+
• Christine Santagate – Chief of Staff, Lab Services (moderator)

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Join our Medical Director Sally Sennitt and VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. as they dissect the expert panel review of a groundbreaking neurostimulator designed to treat focal epilepsy in adults. 🧠⚡

Why watch?🤔

1️⃣ Gain Insights into the Complexities of Regulatory Approvals:
Understand the expert panel's concerns over data sufficiency and quality, and learn why a well-defined intended use is crucial.

2️⃣ Learn the Importance of Comprehensive Data:
Dive into the nitty-gritty of patient selection, stimulation parameters, and electrode locations; see what’s lacking and what could be improved.

But there's more...

👀 Extra Focus on Safety & Performance:
This clip raises important questions about the device’s safety in terms of its impact on seizure frequencies, which translates to several valuable lessons applicable to a wide range of devices.

📈 Potential for Patient Impact:
Given the prevalence of refractory epilepsy and limitations of existing treatments, it's easy to appreciate the significant opportunity this device could present... if only the data were better analyzed and presented.

We encourage any discussion in the comments and would love to hear your thoughts or questions about this complex, innovative device. 🙏

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🌟 Today, we’re delighted to present another episode of our Excellence Spotlight series, featuring RQM+ Senior Principal Engineer, Pooja Roychoudhury!

🛠 With over 12 years (!) at RQM+, Pooja is a tour de force in design quality engineering, risk management, usability, 𝘢𝘯𝘥 𝘴𝘰 𝘮𝘶𝘤𝘩 𝘮𝘰𝘳𝘦, as you'll hear in the clip. Her multi-disciplinary educational background, including engineering and an MBA, has set the stage for her to be a role model in what we call the six C's of Learning – from critical thinking to customer success.

💕 But what truly sets Pooja apart are the life-changing impacts of her projects. She was instrumental in the development of a migraine drug that drastically improved a patient's quality of life, and she's even seen her work on a neonatal CPAP system help a neighbor's infant just released from the NICU. These moments provide her with the unstoppable energy she definitely has to keep improving human lives every day.

Thank you, Pooja, for your invaluable contributions to RQM+ and the broader medical community. 🙏

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This show was recorded 31 August 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠. Thank you for listening!

Certification of Class D devices present additional challenges for manufacturer's due to the additional requirements for these high-risk devices.

The challenges are further complicated because the infrastructure required in the IVDR is not fully in place. While notified bodies are moving forward with certification of these devices, the path forward and current state of play can be confusing. The targets seem to be constantly changing, making it difficult to prepare for certification of these devices.

In this Live! show we discuss:

• Current status on EURLs and draft common specifications
• What steps notified bodies are taking in lieu of EURLs
• What can you do to be prepared for your technical review
• And much more, including answering your questions!

Panelists:

• Margot Borgel – Director, IVD Intelligence & Innovation
• Bethany Chung, Ph.D., RAC – Principal Regulatory Scientist
• Lindsay Wright – Senior Consultant / Capability Manager
• Nancy Morrison, RAC – Vice President, Intelligence & Innovation (moderator)

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🔦 Today, we're back with a BONUS Excellence Spotlight video featuring two case studies from Vice President of Technical, Jonathan Gimbel. Here's a link to Jon's original feature if you haven't seen it.

While these case studies will obviously demonstrate Jon's wealth of experience in action (even though he's shy about it!), we also hope they demonstrate the true depth of expertise at RQM+ and our dedication to helping clients through a multitude of challenges, including navigating the complex landscape of regulations and quality standards.

👷‍♂️ Case Study 1: From Ground Up to Success 👷‍♂️
Jon collaborated with a small company that had a groundbreaking wound healing device for negative pressure wound therapy. With a strong belief in their product but limited regulatory understanding, Jon and the RQM+ team stepped in. They meticulously audited the company, identified gaps, and much more. From developing a comprehensive quality system to guiding them through FDA audits and even drafting the 510(k) submission, this partnership yielded a full-service solution.

🏥 Case Study 2: Transforming Adversity into Collaboration 🏥
Amid recalls and warning letters, RQM+ played a pivotal role in restoring harmony at a company facing challenges with understanding FDA requirements. By assisting in recall resolutions, obtaining critical 510(k) submissions, and fostering a collaborative relationship with the FDA, Jon and the team transformed an adversarial dynamic into a collaborative one.

Again, we hope these case studies demonstrate RQM+'s commitment to supporting clients through every twist and turn! At RQM+, we're thankful for Jon's deep knowledge and leadership.

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