How to Integrate Usability into your Medical Device

April 1, 2020


Medical device usability is a critical, yet confusing component of medical device design, development, regulatory, marketability, and product success. Although three things are clear when it comes to your processes around usability for your medical device: do it early, do it right, and don’t try to cut corners.

In this episode Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research, joins Jon Speer as his guest to discuss this topic, stressing the importance of usability and how you can integrate usability into your medical device.



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Some highlights of this episode include:

  • Usability: Align and combine with other components to produce a successful medical device product and business.  

  • Design Controls: Who are your users? What are their medical device needs? What appeals to them? What are they using now?  

  • Risk Management: Start usability testing and human factors engineering early on and throughout the design process to mitigate errors and last-minute changes.

  • Perpetual Perfection: Why waste your time? Communicate with users to identify what problems need to be solved to intuitively and quickly use a medical device.

  • Founderitis and stagnated beliefs can prevent innovation and objective ideas that would otherwise be helpful to improve patients’ quality of life when designing, developing, and producing products.  

  • Real World Usability Expectations: User testing, risk assessment, simulated environment with distractions, instructions/training, and documentation.  

  • Usability Issues and Challenges: If you wait to wait to do usability and only do summative evaluation, unanticipated user errors arise and require changes.



Isabella Schmitt

Proxima Clinical Research

FDA Design Control Guidance


MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru YouTube Channel

Greenlight Guru


Memorable Quotes from this episode:

“Make sure that you’re making a device that people can use.” Isabella Schmitt

“Start with usability pretty early on.” Isabella Schmitt

“Design a device that is intuitive to whoever your user may be.” Isabella Schmitt

“People perceive usability as yet another thing that they have to do in the design and development of products.” Jon Speer



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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