Summary

“Our true end goal is to be proactive in safety versus reactive. Bring in your medical safety early and often.”

How do we figure out why our medical device(s) are failing to perform as intended in the real-world clinical environment? This is where Medical Safety Officers can help us truly understand the root cause(s) during a CAPA investigation.

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Bettina Brant, Senior Director of Medical Safety at Medtronic, to discuss the critical role of medical safety officers in various processes, including CAPA, risk analysis, product development, and post-market surveillance. The conversation emphasizes the importance of collaboration, proactive safety measures, and the integration of user feedback in the development of medical devices to ensure patient safety.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:40 Introducing Bettina Brant

02:55 Understanding CAPA and the Role of Medical Safety Officers

05:47 Investigating CAPA: Insights from Medical Safety

09:27 Risk Analysis: Severity Levels and Hazard Identification

12:15 Understanding How Users Interact with Medical Devices

14:10 Role of Medical Safety Officer in New Product Development

16:20 Including Human Factors Engineering Early in Product Development

19:00 Project Management and Early User Involvement

20:18 Post-Market Surveillance and Feedback Into Product Development

23:44 Key Takeaways and Closing Thoughts

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Suggested links:

LTR: A clinician’s insights on risk and collaboration in MedTech.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Bring your medical safety team in early and often.

* The earlier the better to ensure patient safety.

* Collaboration with medical safety officers is crucial.

* Understanding user experience can prevent issues.

* Risk analysis must consider high-risk populations.

* Human factors engineering should be prioritized early.

* Project managers can facilitate early user involvement.

* Post-market surveillance is essential for continuous improvement.

* The voice of the patient must be included in all processes.

* Failing fast can lead to better product outcomes.

Keywords

Medical safety, CAPA, risk management, patient safety, product development, human factors, post-market surveillance, healthcare, quality management, medical devices

About Bettina Brant

Bettina Brant is the Senior Medical Safety Director at Medtronic, where she applies her experience in the Level 1 Trauma center to guide the development of safe and effective medical devices. She is a motivator and a team-builder, with excellent communication and problem-solving skills, that has helped her deliver excellent results with cross-functional leadership in a matrix organization. She is also a member of the Board of Directors of Hot Mess Rescue, a non-profit, women led community supporting women in need. She holds Bachelor’s degree in Nursing and a Master’s in Nursing Administration, Leadership and Management.

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, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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