2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for Devices and Radiological Health (CDRH)? 

Today’s guest is Mike Drues from Vascular Sciences. We discuss the recent FDA report that outlines the CDRH’s regulatory science priorities, all of which are important, some more than others. However, there are a couple big ones missing. Listen to this episode for actionable tips on how you can develop your own list of priorities for 2020.

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Some highlights of this episode include:

• A comparison of historical context from the same reports in 2016 and 2017 to 2020, identifies 8 out of 10 of the same top priorities:
  • Big Data, biocompatibility, real-world evidence, clinical performance, clinical trial design, computational modeling, patient input, and digital health/cybersecurity.
• What two priorities are missing in 2020 report?
  • Reprocessing reusable medical devices: Not all devices are properly reprocessed to prevent deaths and cross-contamination between patients.
  • Human factors and usability: Companies still struggle with the concept of making medical devices easy to use and/or understand.
• Why did these two priorities drop off 2020 list? A lack of high-profile reports from popular press about companies and medical devices causing problems.
• What two top priorities from past reports reappear for 2020? Healthcare-associated infections, and precision medicine and biomarkers. 
• Medical device industry should develop its own list of top usable and actionable priorities. Effective communication with FDA may result in a consensus.

Links:

Center for Devices and Radiological Health (CDRH)

CDRH’s Regulatory Science Priorities

Episode 2: Should design controls have prevented recent reprocessing tragedy?

Episode 52: Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

Episode 98: Impact of Artificial Intelligence and Machine Learning on Medical Devices

Medical Device Manufacturers Association (MDMA)

Mike Drues

Greenlight Guru’s Enhanced Change Management Capabilities Announcement

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru

Memorable Quotes from this episode:

“A lot of companies struggle with the concept of useability and human factors and ergonomics.” Mike Drues

“Everything that I am hearing from a regulatory perspective is that the expectation for useability and human factors is more of a priority now than it ever has been.” Jon Speer

“Our industry, and especially the regulatory component of it, is a very reactive as opposed to proactive industry.” Mike Drues

“We appreciate your priorities. We would just like to hear a little more further thoughts and analysis.” Mike Drues

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