Summary

“The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.”

In this special episode of the Let’s Talk Risk! conversation, host Naveen Agarwal brings together a panel of medtech safety and risk management leaders to discuss key takeaways from IMSC26 in Boston.

The conversation highlights why the conference has become a unique gathering place for the medtech safety community: a forum where risk, quality, regulatory, clinical, and engineering professionals can speak a shared language and challenge each other’s thinking.

The panel explores several major themes: moving beyond compliance, bringing patient perspective into risk management, understanding QMSR as a shift toward risk-based quality systems, strengthening judgment and critical thinking, and using AI as a thinking partner rather than a replacement for expertise.

Listen to the full 47-minute podcast or jump to a section of interest listed below.

Chapters

00:00 – Introduction and Panel Overview01:23 – Bijan Elahi on the Growth and Vision of IMSC06:23 – Proactive Safety from Clinic to Home08:28 – Patient Safety as the Central Stakeholder Theme10:15 – FDA, QMSR, and the Shift Toward Risk-Based Thinking18:53 – Design Control, Agile Software, and Surgical Robotics22:11 – Hidden Influences, Judgment, and Psychological Safety34:26 – AI as a Tool, Not a Replacement for Expertise40:00 – Career Day, Final Takeaways, and IMSC27 Preview

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Suggested links:

LTR: Tips for Improving Collaboration in Risk Management.

LTR: From Procedures to Judgment - Leading Through QMSR Inspections.

LTR: LTR Risk Coach - AI-Powered Decision Support Tool.

Key Takeaways

* IMSC has become a true medtech safety community.The conference gives risk professionals a rare space to connect, compare experiences, and realize they are not alone in the challenges they face.

* Patient safety must be more than a slogan.The panel emphasized that patient perspective needs to show up directly in risk management, especially where traditional harm categories may miss emotional, psychological, or lived-experience impacts.

* Risk management is not just a compliance exercise.It is a human practice that requires collaboration, judgment, shared language, and cross-functional maturity.

* QMSR raises the bar for risk-based thinking.The discussion framed QMSR as a move toward connected quality systems where FDA may look at whether decisions, processes, and subsystems work together around patient safety.

* Judgment cannot be fully proceduralized.Procedures matter, but good risk decisions also require critical thinking, psychological safety, leadership, and comfort with ambiguity.

* AI can strengthen risk thinking, but it cannot replace expertise.The panel warned against over-reliance on AI while recognizing its value as a tool to organize thinking, challenge assumptions, and preserve institutional knowledge.

Keywords

IMSC26, medtech safety, medical device risk management, patient safety, QMSR, FDA, risk-based thinking, quality culture, critical thinking, AI in medtech, design control, safety architecture, patient perspective, regulatory strategy, risk management maturity

Guest Speakers

Bijan Elahi as an award-winning medical device risk management author, professor and consultant.

Dr. Olaf Hedrich is the Chief Medical Safety Officer at Medtronic.

Michelle Lott is an executive advisor in regulatory strategy, principal and founder at LeanRAQA, LLC.

Aaron Joseph is a principal consultant at Sunstone Pilot.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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 other 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.

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