Let's Talk Risk! Podcast

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.

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.

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.

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.

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

“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.

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

“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