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Episode 163  |  30:58 min

Challenges related to Home Use Devices

Episode 163  |  30:58 min  |  09.10.2020

Challenges related to Home Use Devices

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This is a podcast episode titled, Challenges related to Home Use Devices. The summary for this episode is: What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences. Jon and Mike discuss challenges related to safety, risk, and usability when medical devices intended for "at home" environments interface with untrained end-users.

What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences. Jon and Mike discuss challenges related to safety, risk, and usability when medical devices intended for "at home" environments interface with untrained end-users.

Some highlights of this episode include:

  • Complications, Comorbidities, and COVID: Should medical devices intended to be used at home be controlled? And by who? Providers or patients?
  • Human Factors: Intended users of at home medical devices should influence summative and usability testing.
  • Parents and Other Populations: Smartphones don’t make all users smart, but simply frustrated. Home-use products that embrace technology may not be familiar or friendly to all intended users.
  • Risk Mitigation: Who can help with at-home products? Who actually reads and understands labels, manuals, and other instructions? That’s not pragmatic, realistic, or true usability.
  • Regulated vs. Non-Regulated Trend: Prudent engineering, design practices, and usability should still apply, regardless of classification and how devices are viewed by regulatory bodies.
  • Guidance or common sense? The more likely you are to need a technology, the less likely you are to be savvy with it.

Memorable quotes from this episode:

“Outside that facility, everything that you can imagine is possible as far as the user’s concerned, as far as the environment’s concerned. It really complicates things.” Jon Speer

“When you think about how technology is evolving so quickly, a lot of these ‘home use’ products are embracing this technology wave.” Jon Speer

“When it comes to risk mitigation, labeling should not be your primary way of mitigating risk.” Mike Drues

“Design your device in such a way that it’s as intuitive to your user population as possible without having to go read a manual or consult a label.” Jon Speer

“The more likely you are to need a technology, the less likely you are to be savvy with it.” Mike Drues

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Mike Drues
President
Michael Drues, Ph.D., is president of Vascular Sciences, an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical, and biotechnology companies. He has worked for — and consulted with — leading medical device, pharmaceutical, and biotechnology companies ranging in size from start-ups to Fortune 100s. Drues works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the U.S. and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS), and other regulatory and governmental agencies around the world. He is also an adjunct professor of medicine, biomedical engineering, and biotechnology at several universities and medical schools, teaching graduate courses in regulatory affairs and clinical trials, clinical trial design, medical device regulatory affairs and product development, combination products, pathophysiology, medical technology, translational medicine, and biotechnology. He received his B.S., M.S., and Ph.D. degrees in biomedical engineering from Iowa State University. You can contact Mike Drues directly at mdrues@vascularsci.com.

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