Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.

In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.

Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.

• Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.
• Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by doing their work correctly.
• Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. They should not have to overcome barriers and adapt to the device. It should be easy to use, safe, and supportive.
• Determine if you are on track when developing a product by conducting formative evaluations of tasks that need to be done and how they should be done.
• When done with development, a summative evaluation shows the use of a medical device does not come with any unacceptable risks. It offers proof of use.
• Opportunities for Improvement: Some mistakes that Michaela has observed include not meeting or listening to users, starting too late, and not conducting formative before summative evaluations for feedback. 

“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.”

“You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.”

“Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.”

“See usability as something that you have to do constantly. It’s not a one-time activity that you do.”

Michaela Kauer-Franz

Custom Medical

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