S1E2 | How do I design, verify and validate a medical device?

**Season Two has rebranded to "Women in MedTech With Kayleen Brown**

In the second episode of MedtechWOMEN Talks, our guest Kathryn Rieger, PhD, Sr. Director, Human Factors & User Research at Intuitive, shares her insights on the medical device product development cycle from the perspective of "The Engineer."

Drawing from her unique background in military tech and auto tech and her extensive experience in medtech, Dr. Rieger shares insights into how engineers influence the essential stages of the medical device product development cycle.

In the episode, Dr. Rieger emphasizes the rigorous nature of verification and validation processes in medtech, underlining the importance of document control and thorough testing to ensure device safety and functionality. She also highlights the role of clinical studies in pre-market validation, underlining the significance of balancing safety considerations with regulatory compliance. Additionally, Dr. Rieger discusses the growing role of AI and machine learning in optimizing development processes while prioritizing user needs and safety.

TL;DR - Key takeaways:

1. Integrating user experience and safety is crucial in medical device development.

2. A multidisciplinary approach to medtech product development is key.

3. Effective collaboration and communication are critical to successful product launches.

Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical for providing vital support.

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