Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 52: The key to success as a risk practitioner in the medical device industry.

LTR 52: The key to success as a risk practitioner in the medical device industry.

Insights from a Let's Talk Risk! conversation with Carolyn (Beres) Blandford

“Risk management is inherent to all our roles, whether you are in Regulatory, Quality or R&D, but it is not something we spend a lot of time on”.

Risk management in the medical device industry is often seen as a check-the-box activity for regulatory compliance. In this Let’s Talk Risk! conversation, Carolyn Blandford encourages us to not be satisfied with this status quo and help create a dedicated focus on risk management across all processes of the quality system.

How can you be a better partner? How can you help build your product’s story from start to finish during development, and later during the post-market phase?

This is a leadership opportunity for risk practitioners. It is not enough to build a deep technical knowledge of risk management, but also be mindful of how communication occurs within your organization. Combine your technical know-how with good communication skills to help your team make the best possible decision.

This is the key to success in a risk management role.

Listen to this Let’s Talk Risk! conversation with Devon Campbell, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:01:58 Introduction

00:04:15 How risk management helps build and sustain the product story

00:05:15 Transitioning into a risk management role

00:08:12 Why we need to create dedicated risk management roles

00:10:35 How to lead change by starting small and showing impact

00:12:50 Our role in shaping a culture of quality

00:15:13 Audience Q&A, general discussion

00:32:30 Closing comments and key takeaways

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About Carolyn (Beres) Blandford

Carolyn (Beres) Blandford is currently a Senior Project Management Consultant at IPM Integrated Project Management Company. She has over 20 years of professional experience in the in-vitro diagnostic (IVD) industry, first in a scientific role, later moving into a Quality Management role. She developed a strong interest in risk management as a Quality Manager, where she also led the charge to create a dedicated focus on risk management in the organization. Using her strong research, communication and project management skills, she currently supports her clients in planning and implementing strategically critical initiatives.

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.

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!