Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 38: How medical safety professionals can serve as culture brokers in MedTech
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LTR 38: How medical safety professionals can serve as culture brokers in MedTech

Insights from a Let's Talk Risk! conversation with Mark Armstrong
Transcript

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Who is responsible for patient safety in a medical device manufacturing organization?

When asked this question, a common response is likely to be that it is a shared responsibility across the entire organization. After all, everyone should be thinking about patient safety in their specific role and perform their duties such that patient safety is not compromised.

It is true that no single individual or department can be held completely responsible for safety. But when everyone is responsible, no one is really responsible!

In this Let’s Talk Risk! conversation, Mark Armstrong explains how medical safety professionals can serve as culture brokers by translating the language of different functions to help create a central awareness of patient safety. Each function within a large, complex organization, is understandably focused on their specific goals and objectives. R&D is responsible for developing new products and improving the existing ones with design changes. Clinical affairs is responsible for planning and generating clinical evidence to support regulatory submissions. Manufacturing is responsible for consistently producing high quality product at low cost. Medical affairs is responsible for building external relationships with key opinion leaders.

There is a need to bridge the gap among these functional areas which often operate in silos. This is where Medical Safety professionals have a key role to play as a culture brokers to create and nurture a common culture of patient safety.

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

About Mark Armstrong

Mark Armstrong is currently the Director of Medical and Pharmacovigilance Safety and Beckton Dickinson. Combining his advanced education in both Medicine and Biomedical Engineering, he has served in clinical and medical safety roles for over 10 years at various leading MedTech organizations. In his current role, he serves as the primary Safety Physician support for Pharmacovigilance and provides internal medical/clinical consultation during design and development as well as during post-market surveillance activities.

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.

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.

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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!