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.

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…

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.

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

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.

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…