Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 39: Overcoming challenges in linking risk management with design controls

LTR 39: Overcoming challenges in linking risk management with design controls

Insights from a Let's Talk Risk! conversation with Daniel Roberts

No transcript...

A common challenge for risk practitioners in the medical device industry is to efficiently link their risk management process with the design controls process.

The output of risk management activities needs to be linked to the design process before design inputs are finalized. However, this proves to be quite challenging in practice. One reason is that a lot of work in the industry is often done in functional silos

In this Let’s Talk Risk! conversation, Daniel highlights the importance of building trust between different functions, especially Quality and R&D organizations. Leaders in these organizations need to create and nurture a collaborative work environment where engineers can feel safe and empowered to work together for the common goal of developing innovative, safe and effective products.

One specific example where cross-functional collaboration is especially useful is when we are try to establish reliability levels required for different functional requirements for a device under considerations. It requires a lot of trade-offs, which should be driven by a careful analysis of stakeholder expectations, regulatory requirements and the state of art. It is also useful to engage with medical/clinical colleagues to collect early clinical input to support these decisions.

Listen to this Let’s Talk Risk! conversation with Daniel Roberts which also includes an open discussion with the audience.

About Daniel Roberts

Daniel Roberts is currently the Founder and Principal at Medical Device How, a MedTech consulting firm focused on personalized medical device strategies in the areas of Design Controls, Digitalization, Smart QMS, QMS training, Cybersecurity and Career Coaching. He has worked at several leading medical device manufacturers over the last 20 years in a variety of roles ranging from Quality and Compliance to R&D. He is also a certified ISO 13485 Internal Auditor.

About Let’s Talk Risk! with Dr. Naveen Agarwal

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.


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.

If you enjoyed this episode, consider becoming a free or paid subscriber.

Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
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 process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!