Rephonic
Artwork for Let's Talk Risk!
Risk Management
Medical Devices
FDA
Cybersecurity
In Vitro Diagnostics
Medical Device Industry
Quality Management
Artificial Intelligence
Machine Learning
Product Change Control Processes
IEC 62366-2
Usability Engineering
Ecosystem
Healthcare Delivery
ISO 13485
Augmented Reality
Regulatory Compliance
Patient Safety
Data Diversity
Quality Assurance

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management proces... more

PublishesTwice weeklyEpisodes133Founded2 years ago
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Artwork for Let's Talk Risk!

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Summary

“EU MDR is the spiritual ancestor of the EU AI Act”.

In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying b... more

In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especi... more

YouTube

Summary

“Wireless coexistence is not a checkbox. It’s a risk management approach”.

In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless scientist, to explore the ... more

YouTube

Summary

“Management listens when you connect patient risk to product requirements and business goals.”.

In this Let’s Talk Risk! conversation, host Naveen Agarwal and Richard Matt delve into the complexities of communicating risk to senior executiv... more

YouTube

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Recent Guests

Richard Matt
A seasoned industry leader with many years of leadership experience at companies such as Pfizer, Hospira, Exeter, and Medtronic.
Episode: LTR 123: Richard Matt on Effective Risk Communication
Tibor Zechmeister
Head of Quality and Regulatory at flynn.ai
flynn.ai
Episode: LTR 122: Tibor Zechmeister on PSUR Best Practices
Michelle Lott
Regulatory strategist, principal and founder at Lean RAQA LLC
Lean RAQA LLC
Episode: LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Attrayee Chakraborty
Quality system engineer specializing in regulatory affairs and quality management systems.
Analog Devices
Episode: LTR 120: Atty Chakraborty on India's Rising MedTech Sector
Kristen Petersen
Principal Medical Writer and EU MDR Specialist with many years of industry experience.
Global Regulatory Writing & Consulting
Episode: LTR 118: Off-Label Use with Kristen Petersen
Queenita Fernandes
A physician with extensive experience in healthcare, clinical practice, and the pharma and medical device industries.
Episode: LTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation
Priyanka Murawala
Expert in biological evaluation of medical devices with over 20 years of experience.
Consultant for Med Tech Clients
Episode: LTR 116: Priyanka Murawala on ISO 10993 Update, Biocompatibility, Learning from Recalls
Dr. Michael Lichtenberg
An interventional angiologist based in Germany with over 20 years of experience in deep venous interventions and peripheral artery disease.
Episode: LTR 115: Startup Lessons from EU MedTech Shark Tank
Sanjay Arudi
VP of Regulatory and Quality at GE Healthcare in India
GE Healthcare
Episode: LTR 114: What QA/RA Professionals Need to Know About Rapidly Growing MedTech in India

Host

Naveen Agarwal
Host of conversations centered around risk management in the medical device industry, focusing on collaboration, best practices, and regulatory compliance.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#226
Ireland/Technology

Talking Points

Recent interactions between the hosts and their guests.

LTR 123: Richard Matt on Effective Risk Communication
Q: Did Richard find that the communication with middle management was even harder than with upper management?
Richard observed huge variability; sometimes middle management was less receptive but emphasized the need for engagement and collaborating with middle management.
LTR 120: Atty Chakraborty on India's Rising MedTech Sector
Q: What is your opinion about the medical regulation in India versus EU MDR or other global regulations?
The Indian regulations since 2017 are similar in philosophy to EU MDR, focusing on risk classification and quality management systems, aiming for global harmonization.
LTR 69: A quick update on the 4th edition of IEC 60601
Q: What should manufacturers expect in the first edition of IEC 60601?
Manufacturers should be aware of new requirements, particularly with cleaning, sterilization, and disinfection, which will be more detailed in the new edition.
LTR 69: A quick update on the 4th edition of IEC 60601
Q: What is your perspective on why risk practitioners should be interested in all different kinds of standards?
It's important because for the development of any product, you need risk management, especially for medical devices. Having someone involved in the development gives your company an edge, as they will understand the standard better and be a knowledge-seeker in the industry.
LTR 118: Off-Label Use with Kristen Petersen
Q: Does this necessarily mean that a PMCF study should consider the off-label use?
Yes, incorporating off-label use into PMCF activities can provide useful insights for evaluation.

Audience Metrics

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Frequently Asked Questions About Let's Talk Risk!

What is Let's Talk Risk! about and what kind of topics does it cover?

Focused on navigating the complexities of risk management in the medical device industry, discussions frequently cover regulatory compliance, risk assessment practices, and the integration of artificial intelligence within risk management frameworks. The conversation emphasizes collaboration among industry professionals to enhance understanding and tackle common challenges in implementing effective risk management processes. Noteworthy is the commitment to continuous learning through shared experiences, which is likely to resonate with professionals looking to advance their knowledge in risk management strategies within a highly regulated environment. The series stands out for its practical insights, highlighting real-world applications and... more

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Which podcasts are similar to Let's Talk Risk!?

These podcasts share a similar audience with Let's Talk Risk!:

1. Global Medical Device Podcast powered by Greenlight Guru
2. Let's Combinate - Drugs + Devices
3. DeviceTalks Podcast Network
4. The Mel Robbins Podcast

How many episodes of Let's Talk Risk! are there?

Let's Talk Risk! launched 2 years ago and published 133 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Let's Talk Risk!?

Recent guests on Let's Talk Risk! include:

1. Richard Matt
2. Tibor Zechmeister
3. Michelle Lott
4. Attrayee Chakraborty
5. Kristen Petersen
6. Queenita Fernandes
7. Priyanka Murawala
8. Dr. Michael Lichtenberg

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