#332: Regulatory Strategy and the Advantage of Diversity in MedTech

Description:

In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.

Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.

Highlights of the episode include:

1. Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian young men, resulted in compromised health outcomes for others.
2. Evolution and Transparency of the FDA: Nada traced the journey of the FDA, illustrating its transformation towards greater transparency and predictability. Emphasizing the human touch behind FDA's decisions, she dispelled the myth of the FDA being an impersonal "black box".
3. Global Regulatory Movements: Highlighting a shift in the MedTech landscape, Nada pointed to the trend of global regulatory harmonization, particularly noticeable in the realm of software-based medical devices.
4. Importance of User-Centered Design: Nada and the panel emphasized the significance of involving patients early in the design phase. Using tools like personas and human factor tables can lead to products that truly cater to users' needs, ensuring both usability and safety.
5. Embracing Learning in MedTech: Nada's hope for companies to learn from past oversights and adapt to changing regulations stressed the crucial role of iteration and learning in medical device innovation.
6. Navigating Modern MedTech Challenges: From addressing the significance of thorough documentation practices to discussing the challenges of regulating AI-driven medical devices, the discussion underscored the ever-evolving MedTech arena and the imperative need for regulators to stay updated.

This episode paints a comprehensive picture of the medical device industry, addressing both its challenges and its advancements.

Quote:

"Medical devices shouldn't be designed with a one-size-fits-all approach. We've seen firsthand the impact of biases, like with pulse oximeters. It's crucial that we validate devices across diverse populations to ensure safety and efficacy for all."

Reference Links:

• Nada Hanafi
• MedTech Color
• MedTech Innovator
• Veranex
• Etienne Nichols
• True Quality Roadshow
• Greenlight Guru Academy
• Greenlight Guru Software