Webinar Series: Medical Devices, Usability, and Human Factors

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Medical Devices, Usability, and Human Factors: What you Need to Know

Usability is a must-have in the medical device industry. But are you perplexed about how to start incorporating usability into your development plan? Not to worry! Our three-part webinar series will walk you through the concept of usability step-by-step. Whether you are just starting out in the medical device development field or looking for ways to improve your current design process, this series is a must-watch!

The three-part series includes:

Usability: Where to Start
Industrial Design Best Practices
Human Factors FDA Requirements

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Why you should care about Usability and Human Factors

Product use errors are part of more than one third of device incidents reported to the FDA. That is why human factors studies are required for most medical device submissions. But beyond regulatory requirements, developing a device that is easy to use and developed with the user in mind will result in a device that users will enjoy working with.

If you start your development and then talk to end users, the probability of a redesign increases. If you fail summative testing, costs escalate, and timelines increase. Incorporating usability into your design plans early will lead to a better and safer product, reduced time to market, and reduce your capital burden.

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Resources

3D printing of organ next to computer screen

June 29, 2022

3D Printing of Medical Devices at the Point of Care

FDA Action on 3D Printing of Medical Devices at the Point of Care In the medical device field, manufacturers and regulators are constantly trying to balance the advantages of new and emerging...

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....

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