Summary

“85% of the medical devices in India are imported. There is now a strong focus on developing internally but also make healthcare more accessible to the masses.”

In this Let’s Talk Risk! conversation, Naveen Agarwal engages with Rajesh Kathuria, a seasoned quality executive, to discuss the rapid growth of the MedTech industry in India and the accompanying regulatory changes. They explore the importance of quality standards, particularly ISO 13485, and how these standards are essential for both domestic and international markets. Rajesh shares insights on the evolving expectations of quality in the industry, the opportunities for quality regulatory professionals, and the importance of continuous learning and collaboration in achieving career growth. The conversation emphasizes the need for a cultural shift in quality assurance roles, moving from a policing mentality to becoming enablers within organizations.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introducing Rajesh Kathuria

03:15 Growth of the MedTech Industry in India

07:55 ISO 13485 Based Regulatory Framework

09:15 How High Expectations Drive Product Quality

12:30 Going Beyond ISO 13485 Compliance to Product Quality

16:07 Making a Commitment to Quality and Career Growth

22:30 Regional and Cultural Differences in Quality Expectations

25:05 Final Thoughts and Advice for QA/RA Professionals

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Tips for making customer focused decisions.

LTR: Communicate to collaborate, not to impose opinions.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* The MedTech industry in India is projected to grow significantly by 2030.

* Quality expectations are rising due to increased access to global products.

* Regulatory changes are aligning Indian standards with global norms.

* Quality assurance professionals must adapt to new challenges and opportunities.

* Continuous learning and application of quality tools are essential for career growth.

* Cultural differences impact quality expectations across regions.

* Collaboration between quality and other departments is crucial for success.

* Benchmarking against global standards can drive improvement in quality.

* Quality should be viewed as an enabler rather than a policing function.

* Networking with experienced professionals can accelerate learning and growth.

Keywords

MedTech, India, quality standards, regulatory changes, healthcare, ISO 13485, career growth, quality assurance, Southeast Asia, healthcare access

About Rajesh Kathuria

Rajesh Kathuria is currently the Owner and Director at KMS Solutions, B.V, providing strategic consulting services in Quality and Regulatory for medical device companies. He is a seasoned leader with over 20 years of industry experience in senior leadership positions. He holds a Bachelors degree in Mechanical Engineering and Graduate degree in Management with specialization in International Marketing and Finance. He is also a certified ISO 13485 lead auditor and has extensive experience of auditing/working in various geographies and different global regulations.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Hi everyone

Here is the recording of our first Substack Live session. We did have some technical glitches, but it was a lot of fun to talk about the potential impact of tariffs on pharma and medical device supply chains.

My guest was Marco who writes about risk and resilience On the Edge of Resilience on his Substack. Please go check it out and subscribe.

Here are some of the key points:

* Pharma imports into the US could face up to 25% in tariffs.

* Tariffs on pharma and med device imports could be more than $60 billion.

* The impact of tariffs could lead to increased costs for consumers.

* Companies need to build capacity to handle supply chain disruptions.

* Investing in resilience should be viewed as a strategic necessity.

* The conversation around supply chain costs needs to shift to investment.

* Risk management must include both proactive and reactive strategies.

* Understanding vulnerabilities in supply chains and mitigating risks is critical.

* The medical device industry faces unique challenges in managing costs and risks.

We will do this again in future. Feel free to suggest topics of interest to you.

Join me for my next live video in the app

Summary

“Our true end goal is to be proactive in safety versus reactive. Bring in your medical safety early and often.”

How do we figure out why our medical device(s) are failing to perform as intended in the real-world clinical environment? This is where Medical Safety Officers can help us truly understand the root cause(s) during a CAPA investigation.

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Bettina Brant, Senior Director of Medical Safety at Medtronic, to discuss the critical role of medical safety officers in various processes, including CAPA, risk analysis, product development, and post-market surveillance. The conversation emphasizes the importance of collaboration, proactive safety measures, and the integration of user feedback in the development of medical devices to ensure patient safety.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:40 Introducing Bettina Brant

02:55 Understanding CAPA and the Role of Medical Safety Officers

05:47 Investigating CAPA: Insights from Medical Safety

09:27 Risk Analysis: Severity Levels and Hazard Identification

12:15 Understanding How Users Interact with Medical Devices

14:10 Role of Medical Safety Officer in New Product Development

16:20 Including Human Factors Engineering Early in Product Development

19:00 Project Management and Early User Involvement

20:18 Post-Market Surveillance and Feedback Into Product Development

23:44 Key Takeaways and Closing Thoughts

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: A clinician’s insights on risk and collaboration in MedTech.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Bring your medical safety team in early and often.

* The earlier the better to ensure patient safety.

* Collaboration with medical safety officers is crucial.

* Understanding user experience can prevent issues.

* Risk analysis must consider high-risk populations.

* Human factors engineering should be prioritized early.

* Project managers can facilitate early user involvement.

* Post-market surveillance is essential for continuous improvement.

* The voice of the patient must be included in all processes.

* Failing fast can lead to better product outcomes.

Keywords

Medical safety, CAPA, risk management, patient safety, product development, human factors, post-market surveillance, healthcare, quality management, medical devices

About Bettina Brant

Bettina Brant is the Senior Medical Safety Director at Medtronic, where she applies her experience in the Level 1 Trauma center to guide the development of safe and effective medical devices. She is a motivator and a team-builder, with excellent communication and problem-solving skills, that has helped her deliver excellent results with cross-functional leadership in a matrix organization. She is also a member of the Board of Directors of Hot Mess Rescue, a non-profit, women led community supporting women in need. She holds Bachelor’s degree in Nursing and a Master’s in Nursing Administration, Leadership and Management.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“More importantly than ever, a good product development and risk-based approach is going to be critical.”

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Michael Nilo discuss the current state of the FDA amidst significant staff cuts and organizational chaos. They explore the implications for regulatory affairs professionals, t…

Summary

“Is it good enough for myself as well as my family and the community at large?”

How do we keep the patient front and center when making design decisions for a medical device? How can we balance functionality with safety without over-engineering a device that becomes difficult to use and cost-prohibitive?

In this Let’s Talk Risk! conversation, Naveen Agarwal explores these questions with Peter Braido, VP of R&D at MediView XR, about his extensive experience in the medical device industry. They talk about the intersection of engineering and patient experience, the challenges of balancing safety and performance in product development, and the importance of cross-functional collaboration. Peter shares personal insights from his journey, including the impact of his own health experiences on his work, and emphasizes the need for soft skills in technical leadership. The discussion also touches on the significance of creating a closed-loop feedback system in medical devices and the innovative concept of biomimicry in engineering.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:55 Introducing Peter Braido

03:12 Focusing on the Patient in Engineering Medical Devices

05:22 Balancing Safety and Performance in Medical Device Development

08:45 Navigating Trade-offs in Device Longevity and Quality of Life

11:13 Fostering Patient Focus and Design Excellence through Mentoring

13:53 Managing Competing Requirements: Business vs. User Needs

16:50 Building Soft Skills and Nurturing Cross-Functional Collaboration

20:14 Creating a Closed Loop Feedback System for Medical Device R&D

24:53 Lessons from Nature: Biomimicry in Engineering

28:44 Key Takeaways and Closing Thoughts

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Understanding human factors aspect of AR applications in medical devices.

LTR: A fast growing frontier: AR/VR driving innovation in MedTech.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Live your legacy and make an impact.

* Quality of life is difficult to quantify.

* Perfection is the enemy of goodness.

* You cannot do anything on your own.

* Always keep the patient first in mind.

* Weighing risks and competing requirements is crucial.

* Soft skills are as important as technical skills.

* We need to align across the board.

* Research should solve specific clinical solutions.

* Engage with cross-functional teams early and often.

Keywords

Medical devices, risk management, patient safety, engineering, innovation, cross-functional collaboration, biomimicry, product development, healthcare technology, leadership

About Peter N. Braido

Peter Braido is the VP or R&D at MediView XR, Inc., where he is leading augmented reality enabled innovation for medical applications. He has held various positions in medical device R&D over his 25 year career at many leading MedTech companies. He has worked on next generation transcatheter cardiovascular implants, pulsed field ablation technologies, and XR/AI/Robotics. He holds a Bachelor’s and Master’s degrees in Mechanical Engineering, and various certifications in machine learning for healthcare.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“If there is a risk in your design for a device used in a hospital setting, you have qualified people there. But at home, there is no more safety net. So (AI) software risk becomes even more important.”

In this Let’s Talk Risk! conversation, Erhan Ilhan shares how software is increasingly being used as a medical device in our industry. As a result, we have to pay more attention to software risk management. Software failure will occur, but we need to understand the sequence of events leading to hazardous situations and think of controls to mitigate their impact.

In this episode, Naveen Agarwal and Erhan Ilhan discuss the complexities of software risk management in the medical device industry. They explore the differences between software and hardware risks, the importance of usability testing, the challenges of estimating software failure probabilities, and the integration of cybersecurity risks into overall risk management. The discussion also highlights the significance of post-market surveillance and the impact of emerging technologies like AI and ML on medical devices.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

01:05 Introducing Erhan Ilhan

02:10 Understanding Software Risk vs. Hardware Risk

03:12 Understanding Software Failures and Estimating Probability

05:20 Potential Effect of Recent Update to IEC 62304

06:36 Importance of Post-Market Surveillance in Software Risk Management

07:42 Usability Testing and Human Factors in Software Risk Management

12:35 Estimating Probability of Software Failure in FMEA

18:30 Cybersecurity Risk Management for Software as a Medical Device

22:55 AI/ML, GenAI in Medical Devices and Home Health

29:42 Final Thoughts and Key Takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Tips for medical device software risk analysis.

LTR: Cloud computing in MedTech.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Software risk management is essential for patient safety.

* Software does not pose direct harm like hardware can.

* Assuming a software failure probability of one is incorrect.

* Real-world data is crucial for improving software safety.

* Usability testing should involve diverse user demographics.

* Cybersecurity risks must be assessed alongside safety risks.

* Post-market surveillance is vital for ongoing risk management.

* AI and ML are transforming the medical device landscape.

* Risk control measures should be clearly defined and integrated.

* Always prioritize patient safety in software development.

Keywords

Software risk management, medical devices, usability testing, cybersecurity, post-market surveillance, AI, ML, IEC 62304, ISO 14971, quality assurance

About Erhan Ilhan

Erhan Ilhan is the Head of Quality and Regulatory at Circadia Health, where he has been building the company’s Quality Management System (QMS), driving ISO 13485 implementation, and leading the regulatory strategy for Circadia’s software and hardware-based medical devices. His work includes preparing 510(k) submissions, managing FDA interactions, and leading AI/ML-focused pre-submissions to help define the regulatory pathway for Circadia’s AI-driven clinical decision support software.At Circadia, Erhan also leads design quality assurance activities, oversees risk management and cybersecurity compliance, and works closely with cross-functional teams to embed quality into every stage of product development — from design to manufacturing and post-market surveillance.Prior to Circadia, Erhan held various engineering and quality leadership roles at GE Healthcare, Abbott, Danaher, Medtronic, and Glooko. With deep expertise in software development, design controls, verification and validation, design transfer, test method development, production and process controls, risk management, and regulatory submissions, he has contributed to a wide range of medical device and digital health products. His work spans implantable pacemakers and neuromodulation devices, Continuous Glucose Monitoring (CGM) systems, insulin pumps, diabetes management platforms, mobile and web health applications, and cloud-based algorithm engines.Erhan holds a Bachelor’s degree in Industrial and Electrical Engineering and a Master’s degree in Computer Science, blending technical depth with a strong foundation in quality and regulatory compliance.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“Clinicians need to to trust the (AI) algorithm, and knowing how it works helps them understand where it might fail, or where extra attention might be needed.”

In this episode of the Let's Talk Risk Podcast, Dr. Jay Vaishnav discusses the rapid growth of artificial intelligence (AI) in the medical technology (MedTech) field, particularly in Radiology.

She shares insights from her extensive experience at the FDA and in MedTech, both in roles ranging from scientific to medical affairs and regulatory affairs, emphasizing the importance of understanding the regulatory landscape, navigating benefit-risk assessments, and the challenges of AI model validation.

The discussion also covers innovations in triage and notification systems, the future of AI in clinical care, and best practices for regulatory professionals. Dr. Vaishnav highlights the need for transparency in AI development and the importance of involving clinicians early in the process. She concludes with career insights and the value of mentorship in navigating the evolving landscape of MedTech.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introducing Dr. Jay Vaishnav

01:50 The Rise of AI/ML devices in MedTech

04:40 FDA perspective on benefit-risk

06:05 Managing risk of clinician over-reliance on AI

08:25 Case study: De Novo granted for a triage & notification AI device

11:56 Challenges in developing triage & notification AI devices

14:00 Current stat and barriers to adoption of AI technologies in healthcare

15:35 The need for explainability in AI/ML devices

17:16 Future directions for AI/ML in MedTech

18:00 Why clinician involvement in AI/ML development is important

19:12 Best Practices for QA/RA professionals

21:30 Career insights and power of mentoring

27:46 Closing comments

Suggested links:

* DEN 170073 - ContaCT viz.AI, Inc..

* LTR: AI in MedTech.

* LTR: Regulating Generative AI.

Key Takeaways

* AI is growing rapidly in MedTech, especially in radiology applications.

* Regulatory considerations are crucial for AI applications.

* Benefit-risk assessments are complex and vary by device indication.

* Triage applications can significantly improve patient outcomes.

* AI models face challenges with false positives and negatives.

* Cultural mistrust of AI algorithms can hinder adoption.

* Involving clinicians early in AI development is essential.

* Transparency about AI limitations is necessary for trust.

* The future of AI in healthcare is promising but uncertain.

* Career growth opportunities exist for regulatory professionals in AI.

Keywords

AI, MedTech, FDA, regulatory affairs, machine learning, healthcare, medical devices, radiology, clinical applications, patient safety.

About Jay Vaishnav, Ph.D.

Dr. Jay Vaishnav is currently Director of Regulatory Affairs at Canon Medical Informatics, where she leads US regulatory strategy and FDA submissions for Canon's portfolio of Healthcare IT solutions. She holds a Ph.D. from Harvard in theoretical physics, and after some time in academia moved to the FDA, spending over seven years there in positions of increasing responsibility. She eventually joined the medical device industry in Medical Affairs before moving into a Regulatory role.She is a Fellow of the Regulatory Affairs Professional Society, an occasional instructor at UCSC Silicon Valley Extension, and co-editor of the book "From X Rays to AI: Navigating US Regulations in Radiological Health."

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

Summary

“The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.”

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Yu Zhao discuss the P…

Summary

“To AI or not to AI is no longer a question.”

In this Let’s Talk Risk! conversation, Naveen Agarwal and Michelle Wu discuss the transformative role of AI in the regulatory space, particularly in healthcare and life sciences. They explore key trends observed at the JP Morgan Healthcare Conference, share real-world use cases of AI applications, and address concerns about trust, job security, and privacy in the context of AI adoption. Michelle emphasizes that AI is an enabler rather than a replacement, and highlights the importance of adapting workflows to integrate AI effectively. The discussion concludes with key takeaways on leveraging AI for enhanced productivity and strategic decision-making.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introducing Michelle Wu of NyquistAI

03:00 Key Trends from the JP Morgan Healthcare Conference

06:36 AI Use Cases in Regulatory Applications

09:59 Trusting AI in Legal Contexts

11:49 AI in Product Development, M&A and Growth

14:40 AI's Role in Regulatory Intelligence

18:25 Addressing Job Security Concerns with AI

22:11 AI in IDE and Early Clinical Phase

25:40 Managing Privacy Concerns and IP Protection

27:05 Managing Risk of Errors from Hallucination and Data Quality

28:40 Announcements, Final Thoughts and Key Takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: AI and the future of work for QA/RA professionals.

LTR: A strategic approach to regulatory success with GenAI devices.

LTR: How GenAI is transforming Quality in MedTech.

Key Takeaways

* AI is an enabler, it's not a replacement.

* AI will challenge and shake up our traditional way of work.

* The best way to adopt AI is to revamp existing workflows.

* Trusting AI is a work in progress.

* AI can help optimize resources, save time, and reduce costs.

* AI can cut down the time for research and decision-making.

* We need multilingual professionals who can communicate AI effectively.

* AI will not take away jobs, but those who leverage AI will excel.

* Data privacy and security are critical in AI applications.

* Experimenting with AI solutions can build confidence and skills.

Keywords

AI, regulatory applications, healthcare, Nyquist AI, JP Morgan Healthcare Conference, trust in AI, product development, job security, data privacy, risk management

About Michelle Wu

Michelle Wu is the Co-Founder and CEO of NyquistAI, where her team is building the world’s largest AI-empowered data platform for Life Sciences innovators. She has over 10 years of hands-on experience in connecting real-life business needs with the right technical solutions, as well as a deep understanding of the challenges and opportunities in the life science industry. Previously she launched two other startups and also served as a Strategic Planning and BDL Manager at Novartis. Michelle holds a Bachelor’s degree in Foreign Languages with minor in Economics, and an MBA in Healthcare and Investment.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.”

Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically…