Folgen
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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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Fehlende Folgen?
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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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“It is essential to monitor (literature) and stay ahead of the curve so you are not surprised.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Veronika Valdova to discuss the complexities of clinical evaluation and documentation requirements under the EU MDR. They explore the challenges faced by manufacturers in compiling necessary documents, the role of automation tools in streamlining processes, and the importance of proactive monitoring in ensuring device safety and effectiveness. Veronika shares insights on various automation tools available in the market and emphasizes the need for proper configuration and understanding of these tools to maximize their benefits. The conversation concludes with key takeaways for practitioners in the field.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:47 Introducing Veronika Valdova
01:54 Understanding EU MDR Documentation Requirements
04:06 Challenges in Clinical Evaluation Documentation
06:32 Databases and Automation Tools for Clinical Evaluation
11:29 An Example Use Case of Literature Search Using a Database
13:53 Business Case for Post-Market Surveillance Using Automated Tools
18:36 A Second Example of a Medical Literature Search Tool
21:00 Emerging AI Tools to Analyze Literature Search for Reporting
23:39 Announcements, Key Takeaways and Closing Comments
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
LTR: Understanding the notified body perspective on clinical evaluation.
LTR: Clinical evaluation is a lifecycle process, not a one-time activity.
ACHIEVE: Post-market surveillance workshop.
Key Takeaways
* The documentation requirements in EU MDR are overwhelming.
* Finding appropriate benchmarks is a big challenge.
* Using automation tools can save a lot of time.
* You need to know how to configure the tools.
* Proactive monitoring is essential to avoid surprises.
* Get your information on equivalent devices in order.
* The purpose of a literature review is crucial.
* Plan accordingly for your documentation needs.
* AI tools for risk management are on the horizon.
* You need a human in the loop to verify AI outputs.
Keywords
Risk management, clinical evaluation, EU MDR, automation tools, medical devices, documentation requirements, post-market surveillance, literature review, regulatory compliance, safety and effectiveness
Select Databases and Automation Tools
* Orca1
* Hoodin
* IQVIA
* MedBoard
* HaloPV
About Veronika Valdova
Veronika Valdova specializes in preparing regulatory submissions for medical devices in the EU, specifically Clinical Evaluation (CER), Post-Market Clinical Follow Up (PMCF) reports and plans, and biocompatibility assessments. She is currently a Managing Partner/Consultant at Atete-Zoe, LLC, serving clients in medical devices, pharmaceuticals and drug-device combination products, both in the US and EU jurisdictions. She holds a DVM in Veterinary Medicine, and several certifications in MedDRA, MDR, Design and Interpretation of Clinical Trials, Epidemiology, Law and Good Clinical Practices.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“Cybersecurity is not something you want to try to just throw in at the last minute. Apply a security-by-design approach to incorporate security thinking and process from the earliest stages.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Jose Bohorquez to discuss the critical intersection of software development, cybersecurity, and risk management in the medical device industry. They explore the importance of mentorship, the challenges faced by startups, and the necessity of integrating cybersecurity from the earliest stages of product development. The conversation emphasizes the need for collaboration and knowledge sharing to navigate the complexities of regulatory requirements and ensure the safety and effectiveness of medical devices.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:11 Introducing Jose Bohorquez
01:18 The Importance of Mentorship in Digital Health
02:13 Challenges Faced by Startups in Medical Device Software
03:45 Cybersecurity Issues in Medical Devices
05:32 Three-Stage Development Model for Software and Cybersecurity
09:00 Understanding Knowledge Gaps in Cybersecurity
10:31 Best Practices for Secure by Design Approach
14:12 Integrating Safety and Cybersecurity Risk Management
17:35 Collaborating for Integrated Risk Management
20:09 The Interconnection of Cybersecurity and Safety Risks
22:03 Testing for Effectiveness of Security Controls
24:00 Announcements, Key Takeaways and Closing Comments
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
LTR: Medical device cybersecurity now more critical than ever.
LTR: It’s time to up our game on medical device cybersecurity.
ACHIEVE: Post-market surveillance workshop.
Key Takeaways
* Mentorship is crucial for learning from others' experiences.
* Startups often struggle with regulatory requirements in medical devices.
* Cybersecurity must be integrated early in the development process.
* A three-stage development model helps organize software and cybersecurity efforts.
* Knowledge gaps in cybersecurity can lead to significant risks.
* Secure by design principles are essential for effective risk management.
* Collaboration between teams is vital for successful product development.
* Verification and testing are critical components of cybersecurity.
* Understanding vulnerabilities is key to managing risks effectively.
* The longer you wait to address cybersecurity, the more difficult it becomes.
Keywords
Risk management, cybersecurity, software bill of materials, software development, medical devices, digital health, mentorship, secure by design, product lifecycle, collaboration, verification
About Jose Bohorquez, Ph.D.
Jose Bohorquez is the President of CyberMed, where he provides Cybersecurity consulting, penetration and fuzz testing, and FDA documentation for Medical Device Manufacturers. He also serves as President at Bold Type, specializing in medical device software development. He holds a Ph.D. in Electrical Engineering and Computer Science from MIT, and an MS in Electrical Engineering from University of Florida. In addition to his professional activities, he mentors Digital Health startups at Endless Frontier Labs, a 9-month program at NYU Stern School of Business.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“Understanding how a device operates in the clinical environment is critical for managing patient safety risks, especially for diagnostic devices.”
In this Let’s Talk Risk! conversation, Naveen Agarwal engages with Dr. Marc Rubinstein, head of medical safety at GRAIL, discussing the critical aspects of medical safety and risk management in the medical device industry. They explore Dr. Rubinstein's transition from clinical practice to the industry, the importance of integrating medical safety early in product development, and the challenges faced in managing risks associated with diagnostic devices. The conversation also highlights the significance of post-market surveillance, the relationship between cybersecurity and patient safety, and the necessity of cross-functional collaboration to ensure patient-centered outcomes.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:10 Introducing Dr. Marc Rubinstein
01:50 Integrating Medical Safety Early in Development
03:09 Challenges in Risk Management for Diagnostics
05:41 Collaborating with Medical Safety for Risk Analysis
09:15 Post-Market Surveillance and Learning from Real World Data
13:10 Leveraging Post-Market Experience for New Innovations
16:33 Linking Cybersecurity and Patient Safety
18:30 Best Practices for Post-Market Feedback for New Products
24:00 Key Takeaways and Closing Comments
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
LTR: Critical role of medical safety officer in medical devices.
LTR: Tips for clinicians transitioning into medical safety role.
LTR: Tips for improving collaboration in risk management.
ACHIEVE: Post-market surveillance workshop.
Key Takeaways
* Integrating medical safety early in product development is crucial for patient safety.
* Risk management in diagnostics involves understanding complex relationships between devices and patient outcomes.
* Post-market surveillance is essential for learning from real-world use and improving products.
* Cybersecurity risks must be considered even for non-life-sustaining devices.
* Cross-functional collaboration is key to effective risk management and patient safety.
* Education and training for users of medical devices are vital to prevent misuse.
* Understanding the severity and probability of risks is essential for accurate risk assessment.
* Feedback loops from post-market data can inform future product development.
* Patient safety should always be at the center of decision-making in medical device development.
Keywords
Medical safety, risk management, diagnostics, post-market surveillance, cybersecurity, cross-functional collaboration, patient safety, medical devices, healthcare industry, clinician insights
About Marc Rubinstein, MD, MBA
Marc Rubinstein is the head of Medical Safety at GRAIL where he is responsible for developing and implementing a robust medical safety program across the total product lifecycle. In a career spanning more than 10 years, he has held leadership roles at several MedTech companies including Baxter and Philips. Dr. Rubinstein is known as a collaborative executive, leading with a strong passion for patient safety, while also achieving full compliance with applicable regulatory requirements. He holds an MD with General Surgery residency at University of Southern California, and an MBA from University of Tennessee.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“What fascinates me about the AI auditor is that it is very strict on one hand, and very complete on the other hand.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eckhard Jokisch, a lead auditor with extensive experience in ISO 13485 and ISO 9001. They discuss the importance of building trust in the auditing process, the challenges of risk management in medical devices, and the innovative use of AI-based virtual auditors. Eckhard shares insights on how AI can enhance auditing efficiency while also addressing the concerns that arise from discovering more compliance issues. The conversation emphasizes the human aspect of auditing and the need for effective communication and understanding within organizations.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:00 Introducing Eckhard Jokisch
03:38 Building Trust as an Auditor
06:14 Understanding ISO 13485 Requirements for Risk Management
08:40 Importance of Management Responsibility in Audits
09:30 Exploring AI-Based Virtual Auditors
15:08 Balancing Findings and Concerns in Audits
18:49 Overcoming Mental Barriers with AI-assisted Audits
21:00 Announcements, Key Takeaways and Future Insights
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
LTR: How AI is transforming Quality in MedTech.
LTR: What we will need to lead in the age of AI.
GenieCert: Instant Audits for ISO-9001 and ISO-13485.
Key Takeaways
* Building trust is essential for effective auditing.
* AI tools can significantly enhance the auditing process.
* Risk management in ISO 13485 requires thorough documentation.
* Auditors should focus on human relationships during audits.
* Internal audits can benefit from AI-based tools.
* Finding more issues is a sign of improved scrutiny, not failure.
* Management must be involved in understanding audit findings.
* AI can help distribute workload among team members.
* Auditors need to overcome their initial distrust of automation.
* Effective communication is key to successful audits.
Keywords
Risk management, medical devices, ISO 13485, AI auditor, auditing, trust building, compliance, quality management, virtual auditor, healthcare
About Eckhard Jokisch
Eckhard Jokisch is a lead auditor for ISO 13485 and ISO 9001 compliance in MedTech. His professional experience spans over three decades in various roles ranging from software engineer, requirements analyst and manager, and Chief Technology Officer. He also served as a chartered PRRC at AuthReps.eu.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“When you over-collaborate, you confuse the word inclusion with something else. That’s when collaboration becomes ineffective.”
In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Dr. Ahmet Tezel discuss the critical role of collaboration in the medical device industry. They explore the balance between effective collaboration and o…
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“The learning for us is that we have to make the regulator’s job easier (in India).”
In this Let’s Talk Risk! conversation, Naveen Agarwal engages with Akram Sheikh, an industry leader in the Indian medical device sector. They discuss the rapid growth of the medical device industry in India, the challenges posed by new regulatory frameworks, particularly for software-based medical devices, and the importance of effective communication with regulators. Akram shares insights on change management, cybersecurity concerns, and the alignment of Indian regulations with global standards. The conversation also touches on career development opportunities for professionals in quality and regulatory affairs, emphasizing the need for continuous learning and adaptation in a fast-evolving industry.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
01:21 Introduction to the Medical Device Landscape in India
03:28 Growth and Challenges for Software Devices
05:14 Navigating Regulatory Changes for Software Medical Devices
07:03 Tips for Communicating with Regulators
11:28 Change Management in Software as a Medical Device
14:11 Cybersecurity Concerns in Medical Software
16:05 Aligning Indian Regulations with Global Standards
18:28 Career Tips for QA/RA Professionals
22:02 Closing Thoughts and Future Opportunities
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: Tips for SaMD development and success with FDA.
ACHIEVE: Post-market surveillance workshop.
Key Takeaways
* The Indian medical device industry is experiencing significant growth.
* Regulatory changes present both opportunities and challenges for startups.
* Software-based medical devices face unique regulatory hurdles.
* Effective communication with regulators is crucial for success.
* Change management processes are essential for software as a medical device.
* Cybersecurity remains a critical concern in medical software development.
* Understanding global regulatory standards can enhance market access.
* Quality and regulatory professionals should align closely with business needs.
* Continuous learning is vital for career advancement in this field.
* The current environment offers numerous opportunities for innovation.
Keywords
Medical devices, India, regulatory challenges, software, cybersecurity, career development, healthcare innovation, quality assurance, risk management, startup environment
About Akram Sheikh
Akram Sheikh is the Chief Operating Officer at Motherson Health & Medical, where he leads the business of surgical Fluorescence Imaging. He also serves as the Vice President of Quality and Regulatory Affairs. Previously, he spent 23 years at GE Healthcare, serving in various roles including positions of senior leadership. He holds a Bachelor’s degree in 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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“Many devices that pass the FDA human factors engineering review simply are not acceptable when they reach the marketplace.”
In this Let’s Talk Risk! conversation, Naveen Agarwal engages with Charles Mauro, a pioneer in human factors engineering. They discuss the importance of usability in medical devices, the challenges faced in the industry, and the need for rigorous human factors research. Charles shares insights from his extensive experience, emphasizing the significance of designing for the least capable user and the differences in regulatory approaches between the FDA and EU. The conversation also touches on the role of training, the impact of user profiles, and the necessity of integrating human factors into the design process early on.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:15 Introducing Charles Mauro
01:48 HFE Challenges in MedTech
05:10 HFE Lessons Learned From Apple
07:34 Understanding Risk Criteria Acceptability in Usability
11:27 Quantitative Measurement Methods in Human Factors
13:12 Regulatory Approach to Use Risks: FDA vs EU
14:53 User Profiles: Trained Professionals vs Lay Users
17:03 Designing for Extreme Percentiles
20:26 Designing Effective Instructions for Use (IFUs)
22:25 Encouraging Human Factors in Product Development
24:48 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 aspects of AR applications in MedTech.
LTR: Treat human factors as a driver of customer satisfaction, not a check-the-box.
ACHIEVE: Post-market surveillance workshop.
Key Takeaways
* Human factors engineering is a science, not an art.
* Designing for the least capable user captures the entire user distribution.
* Apple excels in first user experience but can be complex beyond that.
* Training should be mandatory for device use to minimize errors.
* Regulatory differences exist between FDA and EU in risk assessment.
* User profiles significantly impact usability testing outcomes.
* Quantitative measurement methods enhance understanding of human performance.
* Early integration of human factors research reduces usability errors.
* Market success can drive the adoption of human factors principles.
* The future favors human-centered design in product development.
Keywords
Human Factors Engineering, Usability Testing, Medical Devices, Risk Assessment, User Experience, FDA Regulations, Design Principles, User Profiles, Quantitative Measurement, Training
About Charles Mauro
Charles L. Mauro CHFP is President and Founder of MAURO Usability Science, a leading provider of neuroscience-based design research focused on UX optimization and usability for complex products and services. He was selected by the Human Factors and Ergonomics Society as a "Titan of Industry" for HF research. He is a Certified Human Factors Engineering Professional (BCPE 1312) with 50 years of experience consulting for demanding clients globally. He specializes in combining science-based research methodologies with structured problem-solving. Clients include Nike, Dyson, Apple, Microsoft, Goldman Sachs, Pfizer, Merck, Amazon, META, and industries covering high technology, medical/pharmaceutical, financial, heavy industrial, consumer, government/DOD, and startups.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“If you ready to take that step, be prepared to do the work. Mentoring is a two-way street.”
In this Let’s Talk Risk! conversation, Naveen Agarwal and Angelina Lisandrelli discuss the significance of mentoring in career development, emphasizing the personal and professional growth that comes from these relationships. Angelina shares her own journey with mentorship, highlighting the importance of believing in oneself and being prepared to invest in the mentor-mentee relationship. They explore the challenges faced in mentoring, the two-way nature of these relationships, and the need for trust and vulnerability. The discussion also touches on navigating poor mentorship experiences and the importance of community support in career decisions. Angelina concludes with key takeaways for aspiring mentees and mentors alike, encouraging proactive engagement in mentorship opportunities.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:00 Introducing Angelina Lisandrelli
01:26 How mentoring transformed Angelina’s education and early career
03:50 Why mentoring is important for QA/RA professionals
05:41 How to seek a mentor and nurture the relationship
10:07 Overcoming challenges in mentoring relationships
14:26 Mentoring is a two-way street
18:10 Building trust and vulnerability in mentoring
19:50 What qualifies someone as a mentor
21:30 Navigating poor mentorship management at work
26:45 Key takeaways and future conversations
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
LTR: Communicate to facilitate collaboration, not to impose opinions.
RAPS: RAPS mentoring program.
ACHIEVE: Post-market surveillance workshop.
Key Takeaways
* Mentoring is crucial for career development.
* Believe in yourself to succeed in mentorship.
* Prepare and invest in the mentor-mentee relationship.
* Overcoming challenges is part of the growth process.
* Mentorship is a two-way street; both parties learn.
* Asking questions is vital for personal and professional growth.
* Lean on your support network during tough times.
* Be ready to share your story and experiences.
* Anyone can be a mentor, regardless of their position.
* Building trust and vulnerability is essential in mentoring relationships.
Keywords
Mentoring, career development, mentorship challenges, personal growth, professional relationships, trust in mentoring, overcoming obstacles, two-way mentorship, career advice, community support
About Angelina Lisandrelli
Angelina Lisandrelli is currently the Director of Regulatory and Quality at RespirTech, a Philips company. Previously she was at Medtronic in leadership roles of increasing responsibility. She is a passionate champion of patient safety and public health through quality and regulatory excellence. She is also passionate about mentoring and coaching QA/RA professionals, guiding them as they embark on their careers, and helping to shape the future of healthcare regulation through nurturing the next generation of leaders. Angeilna serves as the Vice Chair of Membership at the Twin Cities Chapter of the Regulatory Affairs Professional Society. She holds a Bachelor’s degree in Chemistry.
Angelina was recently recognized as top 100 MedTech Leading Voice for her commitment to mentoring, patient safety and women in MedTech.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Hi everyone
Here is the recording of our second Substack Live session. We talked about cybersecurity for medical devices with Nidhi Gani.
Our discussion covered the recent Silk Typhoon cyber espionage incident, the implications of cyber attacks on patient safety, and the frameworks for managing cybersecurity risks in healthcare. Nidhi emphasized the shared responsibility of manufacturers and consumers in ensuring the security of medical devices and highlighted the evolving nature of cyber threats, including the role of AI in both attacks and defenses. The conversation concluded with practical takeaways for individuals and organizations to enhance their cybersecurity posture.
Here are some of the key points we discussed:
* Silk Typhoon is a nation-state actor specializing in cyber espionage.
* Cybersecurity threats can directly impact patient safety and healthcare systems.
* Vulnerabilities in medical devices can lead to serious health risks.
* The importance of post-market surveillance in managing cybersecurity risks.
* Manufacturers must take responsibility for the security of their devices.
* AI is being used in both cyber attacks and defenses.
* Cybersecurity is a culture that needs to be built into organizations.
* Consumers should demand secure medical devices for their safety.
* The landscape of cybersecurity is ever-evolving, requiring constant vigilance.
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
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
Summary
“If you are not in it, you are already late.”
In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Dr. Juan Daccach discuss the evolving landscape of leadership in the age of AI, particularly within the medical device industry. They explore the challenges of transitioning from clinical practice to corporate leadership, the importance of emotional intelligence, and the need for authenticity in leadership. Dr. Daccach shares insights from his recent Harvard Business Leadership Excellence Program, emphasizing the significance of adaptability and continuous learning. The conversation also addresses the implications of AI on job security, the necessity of maintaining human connections, and the critical role of quality and safety in AI implementation.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:00 Introducing Dr. Juan Daccach
01:30 Transitioning From Clinical to Corporate Leadership
03:30 Key Takeaways From Harvard Leadership Program
06:03 Growing with AI With Emotional Intelligence
10:13 Overcoming Imposter Syndrome Through Authentic Leadership
13:10 Nurturing Champions to Accelerate AI Adoption
15:25 Clarify the Purpose First, Then Select the Tools (e.g. AI)
16:52 Ensuring Safety and Quality in AI Implementation
20:26 Championing Innovation and Disruption
23:27 Addressing Job Security Concerns with AI
27:07 Embracing Emotional Intelligence in Leadership
30:28 Becoming Anti-Fragile in a Changing World
Suggested links:
* LTR - AI and the future of work for QA/RA professionals.
* LTR: Tips for clinicians transitioning into MedTech.
* Taleb: Antifragile - Things that gain from disorder (Talks at Google).
Key Takeaways
* AI is transforming industries, including medical devices.
* Leadership must adapt to the complexities of AI.
* Emotional intelligence is essential for effective leadership.
* Continuous learning and adaptability are key to success.
* Authenticity in leadership fosters trust and collaboration.
* AI can enhance efficiency but requires human oversight.
* Creating champions for change can drive innovation.
* Quality and safety must remain priorities in AI applications.
* Navigating job security concerns requires a focus on human value.
* The future of leadership involves balancing technology and humanity.
Keywords
AI, leadership, medical devices, emotional intelligence, innovation, corporate culture, safety, quality assurance, machine learning, human connection
About Dr. Juan Daccach
Juan Dacach, MD is currently the Vice President of Product Safety at Merz Aesthetics. Previously he was in various leadership positions in Medical Safety and Medical Affairs at various leading MedTech companies. He specialized in orthopedics, trauma and joint reconstruction during his medical training, residency and fellowship as an MD. As part of his continuing education in the industry, he also acquired certifications in quality, auditing, coaching and leadership communication.
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
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
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
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.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe -
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com
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…
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