Summary

“Be diligent, because one day, you might rely on the very device you helped design.”

In this deeply personal and technically insightful episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Rick Wedge, a seasoned expert in risk management and design control for drug-device combination products.

Rick shares his remarkable journey - from developing biosensors early in his career to depending on a glucose monitoring system to manage life without a pancreas. His story bridges the technical and human sides of medical innovation, revealing how living with diabetes transformed his understanding of patient experience, vigilance, and empathy in risk-based decision-making.

Together, Naveen and Rick explore:

* The evolution of continuous glucose monitoring (CGM) technology

* What held back CGMs for decades, and what finally made them viable

* How real-world data and device reliability shape patient trust

* Why risk management must include emotional and psychological dimensions of user experience

* The leadership challenge of turning “patient-centricity” from a slogan into a daily practice

This conversation reminds every MedTech professional that behind every risk file is a real human story—and sometimes, that story could be our own.

Chapters

00:00 – Introduction: The human side of risk and living with diabetes

02:00 – Rick’s medical journey and sudden onset of diabetes

06:00 – Emotional and psychological recovery after surgery

10:30 – From biosensors to combination products: a full-circle career

13:30 – The rise of CGM technology and what made it possible

18:00 – Data overload, trust, and the benefit-risk balance

24:00 – Failures, vigilance, and lessons for risk professionals

26:00 – Empathy as a leadership skill in risk management

29:00 – Closing reflections: patient-centricity as personal mission

Suggested links:

* LTR: Why risk practitioners must build the empathy muscle.

* LTR: The most important question - who is taking the risk?.

* FDA: Dexcom G6 De Novo database entry.

Key Takeaways

* Risk is personal: The devices we design may one day keep us alive.

* Empathy is technical: Design controls must reflect real human experience.

* Patient-centricity needs proof: It’s shown in practice, not posters.

* Data empowers, and overwhelms: More information isn’t always better.

* Reliability builds trust: Every sensor failure is a lesson in vigilance.

* Benefit-risk is dynamic: Even mature devices demand continuous balance.

* Innovation carries responsibility: Breakthroughs require humility and care.

* Experience changes perspective: Living the risk reshapes professional judgment.

* Leadership starts with listening: Empathy drives safer, smarter teams.

* Technology evolves, so must we: Staying curious sustains both progress and safety.

Keywords

Risk management, design control, combination products, empathy, patient experience, diabetes, continuous glucose monitoring, benefit-risk, medical devices, leadership

About Rick Wedge

Rick Wedge is a risk management and design control leader with extensive experience in drug-device combination products. Over more than two decades in MedTech and pharma, he has led global initiatives in quality systems, design controls, and risk management aligned with ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

A trained scientist with a Ph.D. background in electrochemical biosensors, Rick began his career developing glucose sensors - technology that later became essential to his own health journey. Today, he combines deep technical expertise with a passion for patient-centric design and regulatory excellence, inspiring professionals to view risk management through both a technical and human lens.

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.

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