Let's Talk Risk! Podcast

Summary

“The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.”

In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opportunities in bringing innovative medical devices…

Summary

“MedTech in India is poised to generate $50 billion in revenues by 2030.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges faced in regulatory compliance and offers career advice based on his extensive experience in the field. The conversation highlights India's potential to become a significant player in the global MedTech market by 2030.

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

Chapters

00:20 Introducing Sanjay Arudi

01:25 Current State of MedTech in India

03:24 Government Initiatives and Domestic Manufacturing

07:44 How Tariffs Might Impact MedTech Companies

09:12 Regulatory Environment for Medical Devices

14:06 Post-Market Surveillance and Reporting Requirements

19:50 Regulatory Compliance Challenges in India

22:33 Career Insights and Advice from Sanjay

25:31 Announcements, Key Takeaways and Future Outlook

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

Suggested links:

LTR: An exciting growth opportunity for MedTech in India.

LTR: Navigating the regulatory landscape for SaMD in India.

ACHIEVE: FMEA Workshop.

Key Takeaways

* India's MedTech industry is projected to generate 50 billion by 2030.

* Government initiatives are crucial for expanding healthcare access.

* 80% of medical devices in India are currently imported.

* The CDSCO license facilitates entry into multiple markets.

* Post-market surveillance is becoming increasingly important.

* Regulatory compliance requires collaboration with regulators.

* Transparency in reporting adverse events is essential for patient safety.

* India's healthcare market is rapidly evolving post-COVID.

* Investments in domestic manufacturing are on the rise.

* Career success in regulatory roles requires active contribution and solution-oriented thinking.

Keywords

MedTech, India, healthcare, regulatory environment, government initiatives, post-market surveillance, medical devices, industry growth, career advice, healthcare innovation

About Sanjay Arudi

Sanjay Arudi is the Vice President of Regulatory and Quality at GE Healthcare. He has over 30 years of professional experience in engineering, management and senior leadership roles. His expertise includes product transfers, program management, implementation of Quality & Regulatory requirements across Design, Sourcing, Manufacturing, Install Base & Commercial activities. He has many years of experience in working with global regulators in creating a compliant & friendly manufacturing environment. He holds a Bachelor’s degree in Polymer Science & Technology.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments,

Severity Rating has been incorrectly selected for many assays’ false result failure modes.

Additionally, FDA found issues with procedures for CAPA, Nonconformances and Design Controls:

* Criteria for escalating nonconformances to CAPA are not defined clearly

* No process for assessing risk assessment of individual nonconformances

* Severity classification of nonconformances released to the field is not adequately defined

* No criteria for escalating complaints to CAPA based on trend analysis

* CAPA actions are not verified and validated for effectiveness and additional adverse effect(s) on the finished devices

* Inadequate procedures for verification and validation of design changes

🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice.

Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:

* FDA: Warning letter, Beckman Coulter Inc., CMS 678042, March 15, 2024.

* K011920, EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, cleared July 2, 2001.

* K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM, cleared June 14, 2013.

* K221225, Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, cleared November 10, 2022.

* Beckman Coulter: Therapeutic Drug Monitoring Flyer FL-47564.

Summary

“The 2025 conference was held in Amsterdam and it really was an amazing success.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Bijan Elahi, a leading authority in medical device safety risk management. They discuss the recent 2025 International Medical Device Safety Risk Management conference held in Amsterdam, focusing on the evolution of patient-centric safety, the importance of education in the field, and the key themes that emerged from the conference. Bijan shares insights on the future of medical device conferences and the need for collaboration and community support in advancing safety practices.

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

Chapters

00:15 Introducing Bijan Elahi

01:05 2025 International Medical Device Safety Risk Management Conference

04:28 Growing Awareness of Patient Safety in MedTech

07:21 Pre-Conference Education Day: Enhancing Knowledge

10:40 Key Themes from the 2025 Conference

12:51 Recognizing the Role of Physicians in Risk Management

14:00 Looking Ahead: 2026 International Conference Planning

17:19 Live Stream and Recording of Conference Presentations

19:23 Support Needed for 2026 Conference

22:30 Announcements, Key Takeaways and Closing Comments

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

Conference Recordings:

Conference recordings are available until Jul 31, 2025 at €99.5.

Suggested links:

LTR: Critical role of medical safety officer in medical devices.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: FMEA Workshop.

Key Takeaways

* The 2025 conference in Amsterdam was a unique gathering of experts.

* Patient safety should be the guiding principle in medical device design.

* Education is crucial for enhancing knowledge in safety risk management.

* AI and machine learning are becoming central topics in medical device safety.

* Collaboration among professionals is essential for advancing safety practices.

Keywords

Medical device, safety risk management, patient safety, international conference, education, AI, collaboration, healthcare, risk assessment, ISO 14971

About Bijan Elahi

Bijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He has trained over 10,000 professionals worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Summary

“We still see companies having difficulty in accepting risk management as a tool for better decision making. Risk is often seen as a blocker rather than an enabler.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal and Brett Travaglio discuss the challenges and opportunities in risk management within the medical device industry. Key themes include cultural resistance to risk management, the importance of clear roles and responsibilities, the integration of project management principles, and the evolving role of AI in enhancing risk management practices. The discussion emphasizes the need for training and collaboration among cross-functional teams to effectively navigate the complexities of risk management in a dynamic regulatory environment.

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

Chapters

00:15 Introducing Brette Travaglio

01:10 Organizational Barriers in Risk Management

03:46 Training for Improved Team Collaboration

08:34 Applying Project Management Skills for Excellence in Risk Management

10:39 Improving Basic Understanding of Risk Management

13:09 Navigating the Current Regulatory Chaos

15:42 How AI-Assisted Reviews will Impact FDA Reviews

19:17 Using AI to Prepare Regulatory Submissions

24:12 Handling Device Deficiencies in Clinical Trials

25:32 Using Ambient AI to Improve Healthcare Delivery

26:49 Announcements, Key Takeaways and Closing Comments

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

Suggested links:

LTR: Collaboration that drives innovation, not delays.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: FMEA Workshop.

Key Takeaways

* Cultural resistance is a significant barrier to effective risk management.

* Risk management is often perceived as a tedious exercise.

* Clear roles and responsibilities are crucial for effective risk management.

* Training for collaboration is essential in cross-functional teams.

* Project management principles can enhance risk management practices.

* Understanding risk management standards is vital for compliance.

* Companies should build internal strength to navigate regulatory challenges.

* AI can provide valuable insights for risk management.

* Training is necessary for effective AI integration.

* Collaboration must be a conscious effort, not assumed.

Keywords

Risk management, medical devices, regulatory affairs, AI in healthcare, project management, collaboration, training, quality assurance, risk assessment, industry challenges

About Brette Travaglio

Brette Travaglio is the President and Consultant for Drug, Medical Devices, Biologics and Combination Product Manufacturers at Quality Solutions Now (QSN). She has over 25 years of industry experience at leading organizations with expertise in R&D, quality, regulatory affairs, and process improvement. At QSN, she leads a team to provide hands-on project management and consulting services to drug, medical device, biologics, and combination product manufacturers. QSN’s proprietary process, qsnFLOW™, enables them to quickly deploy highly skilled professionals to tackle challenges with flexibility, scalability, and cost-effectiveness. She holds a Bachelors degree in Aerospace Engineering, and Masters in Business Administration and Industrial Engineering.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Summary

“Communities of practice are more than just knowledge sharing platforms. They serve as engines for standardization and cross-functional alignment across various business units.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ronak Dunung, a rising star in medical device risk management. They discuss Ronak's journey into risk management, the importance of creating a community of practice within organizations, and the challenges and successes associated with fostering collaboration and knowledge sharing. The conversation emphasizes the need for leadership support, measuring success, and building excitement among participants, while also highlighting the unexpected cultural impacts that such communities can have. Ronak shares insights on mentorship opportunities and the importance of continuous learning in the field of risk management.

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

Chapters

00:20 Introducing Ronak Dunung

02:53 Creating a Community of Practice for Risk Management

06:00 Overcoming Challenges in Establishing a Community of Practice

07:23 Securing Leadership Support

11:29 Measuring Success and Engagement

13:41 Gamifying to Increase Engagement and Adoption

19:36 Building Leadership Skills Through Mentoring

24:16 Announcements, Key Takeaways and Closing Comments

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

Suggested links:

LTR: Collaboration that drives innovation, not delays.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Creating a community of practice is essential for knowledge sharing.

* Top management must support risk management initiatives.

* Engagement metrics are crucial for measuring community success.

* Building excitement is key to maintaining participation.

* Communities provide opportunities for informal mentorship.

* Cultural impact is a significant outcome of community practices.

* Small, deliberate changes can lead to cultural shifts.

* Communities can pilot new strategies for risk management.

* Recognition and rewards can enhance participation.

* Leadership skills can be developed through community involvement.

Keywords

Risk management, community of practice, leadership support, engagement, mentorship, medical devices, organizational culture, success metrics, continuous learning, collaboration

About Ronak Dunung

Ronak Dunung is a Senior Manager and Process Owner of Risk Management at a leading MedTech. He specializes in creating effective risk management and strategies in compliance with ISO 14971 requirements for medical devices. He has over 15 years of industry experience in both engineering and risk management leadership. He holds a Bachelor’s degree in Biomedical/Medical Engineering.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

The EYE-SYNC(R) device uses a modified virtual reality headset, connected to a tablet, to track eye movement in response to visual stimuli for assessment of a concussion. In a recent warning letter, FDA cited the following issue with software risk analysis:

Your Risk Management Procedure, SOP-10011, Rev 002, states that the level of risk is determined by Risk Priority Numbers(RPN) and that the design (b)(4) will use the severity and occurrence rating scales described in the procedure. However, your software (b)(4), RA-10110, Rev 006, does not use RPNs, and the impact and probability scale used to calculate inherent and residual risk are not adequately defined within SOP-10011.

When software risk analysis is not correctly done, it can have a serious impact on design verification and validation. As a result, the device may fail to reliably function during real-world use, leading to serious risk of harm from false negative, false positive and unreliable results.

🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice.

Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:

* FDA: Warning letter issued to NeuroSync, Inc., CMS 705489, May 09, 2025.

* DEN170091, EyeBox, Predicate device for EYE-SYNC, granted December 28, 2018.

* K202927, EYE-SYNC 510k clearance, October 2, 2021.

* YouTube: Podcast with Scott Anderson, CCO, SyncThink, 2022.

Summary

“If your device fails 1 out of 100 times, you might think it is good. But if that one time is in the middle of surgery, or when the parent is using it for their children, you are bringing harm.”

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Mitra Soltani delve into the critical relationship between reliability and safety in medical devices. They discuss the importance of effective communication and leadership in engineering, the challenges faced by startups in balancing speed and reliability, and the significance of assumption registers in the design process. Mitra shares her career journey, pivotal moments, and offers valuable advice for aspiring professionals in the QA/RA field.

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

Chapters

00:25 Introducing Mitra Soltani

04:14 Link Between Safety and Reliability

05:52 Understanding the Connection With Design Inputs

07:07 How Using an Assumption Register Can Help With Reliability

10:31 Challenges in Startups: Balancing Speed and Reliability

14:00 Training for Success: Preparing Teams for Reliability

15:33 An Example of Testing for Reliability Before Launch

20:41 Career Reflections: Pivotal Moments and Lessons Learned

23:20 Career Tips for QA/RA Professionals

25:17 Closing Comments and Key Takeaways

Suggested links:

* LTR - Fidelis lead recall, probability and statistics, and career tips with Eric Maas.

* LTR: It’s time to start applying system safety to medical devices.

* Mitra Soltani: Superstars of Tomorrow.

Key Takeaways

* Reliability and safety are interconnected in medical devices.

* Effective communication is essential for engineers.

* Assumption registers help clarify design expectations.

* Startups often overlook reliability in their rush to market.

* Training early can enhance team effectiveness.

* Decisions made early in a career can shape future opportunities.

* Understanding user environments is crucial for design success.

* Designing for worst-case scenarios is necessary for reliability.

* Learning from decisions is key to professional growth.

* Leadership must prioritize reliability in product development.

Keywords

Medical devices, risk management, reliability, safety, engineering, startups, communication, leadership, career development, assumption register

About Mitra Soltani

Mitra Soltani is a reliability engineer, innovator and consultant in the medical device industry. In a career spanning over 15 years, she has worked on a variety of complex electromechanical medical devices, including the VERITAS vision system, a next-generation cataract surgery platform that enhances patient outcomes and surgeon efficiency. Specializing in embedded hardware design, she has delivered over 7 medical and commercial devices, from concept to market, while driving strategic decisions that boost efficiency and deliver cost savings. She has a Bachelor’s degree in Electrical, Electronics and Communications Engineering, and numerous continuing education certifications.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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

In March, 2025, FDA announced the Class I recall of the Tack Endovascular System (TES), indicated for treating dissection of the blood vessels after they are widened using a balloon or stent (angioplasty):

Philips is recalling Tack Endovascular Systems due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant. All customers should stop using the Tack Endovascular System immediately. Philips will no longer distribute this system for use.

In an Urgent Field Safety Notice sent to customers, Philips disclosed potential harms to patients:

The following harms were observed or could reasonably be expected: failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

TES was an innovative solution to a tough medical problem - treating dissections below the knee, where complex anatomical variations present unique challenges not easily resolved using conventional stents.

So, what went wrong? Innovative technology, FDA-approved device, excellent safety and effectiveness results in multiple clinical trials. Apparently these were not sufficient for market success.

🎧Listen to this brief audio summary of this case and lessons QA/RA and Clinical professionals can apply in practice.

Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. A total of 16 sources were used to generate this summary. Here are a few key resources:

* P180034, Intact Vascular, Inc., Approved April 2019.

* P190027, Intact Vascular, Inc., Approved April 2020.

* Philips Press Releases, Issued April 27, 2020, June 03, 2021, June 13, 2022.

* Philips Urgent Fields Safety Notice, January 2025.

* Anatomy, Bone Pelvis and Lower Limb: Popliteal Artery, https://www.ncbi.nlm.nih.gov/books/NBK537125/.

* Popliteal Artery and Its Branches; AJR 150:435-437, February 1988, 0361 -803X/88/1 502-0435 © American Roentgen Ray Society.

Summary

“Know your device, prepare your biological evaluation plan and apply a risk-based approach.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with biocompatibility expert Marina Daineko to discuss the intricacies of biocompatibility assessments for medical devices. They explore the upcoming updates to ISO 10993-1, the importance of a risk-based approach, and the distinction between effects and endpoints in biocompatibility. Marina shares insights on common challenges faced in biological assessments, the implications of cumulative contact exposure, and the role of environmental controls and data analytics in ensuring patient safety. The conversation emphasizes the need for a comprehensive understanding of biocompatibility in the context of evolving materials and regulatory standards.

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

Chapters

00:15 Introducing Marina Daineko

01:16 Quick Update on Proposed Changes in ISO 10993-1

03:42 Applying a Risk-Based Approach in Biocompatibility

05:58 Endpoints vs. Biological Effects in Biocompatibility

10:27 Navigating Uncertainty at FDA in Biocompatibility Evaluation

13:25 Clarifying Endpoints in Biocompatibility Evaluations

15:01 Common Challenges in Biocompatibility Evaluations

16:22 Connecting Design and Process FMEA to Ensure Biocompatibility

18:19 Understanding Requirements for Cumulative Contact Exposure

22:06 Environmental Controls and Data Analytics for Biocompatibility

24:49 Future Considerations: Nanomaterials and Patient Safety

26:39 Announcement, Closing Comments and Key Takeaways

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

Suggested links:

LTR: Understanding risk-based thinking.

LTR: Tips for a risk-based approach to auditing Quality Systems.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Know your device thoroughly.

* Prepare a comprehensive biological evaluation plan.

* Apply a risk-based approach and understand its implications.

* Stay updated with the latest standards and guidelines.

* Consider cumulative contact exposure in assessments.

* Connect design and process FMEAs for better traceability.

* Utilize data analytics for environmental monitoring.

* Engage cross-functional teams in risk management processes.

* Understand the systemic toxicity of materials used in devices.

* Be proactive in addressing challenges related to advanced materials.

Keywords

Biocompatibility, ISO 10993-1, risk-based approach, medical devices, biological assessments, cumulative contact exposure, environmental controls, data analytics, patient safety, advanced materials

About Marina Daineko

Marina Daineko is a Biocompatibility Consultant at Intrinsic Medical Group (IMG), with an MSc in Analytical Chemistry and over 10 years of experience in the medical device industry. She is a Certified Biological Evaluator and Subject Matter Expert in ISO 10993-1:2018. Marina is the author of 15 scientific papers and holds 2 patents in the field of material science. In recognition of her contributions, she was nominated for the Women in Tech Award in 2023 and was named one of the top 25 MedTech Leading Voices on LinkedIn.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.