An expert’s guide to developing medical devices
Excerpt from the Article:
When it comes to designing and building novel medical devices to meet the needs of patients and healthcare systems, developers should rely on the core skills of engineering and design to inform their process. But there are “lessons learned” that are unique to the medical device development process.
- Human Factors Engineering as a Means to Mitigate Potential Harm for the Patients
Human factors engineering is a critical part of the product development process. And for medical device development, this work is mandated thanks to the medical device regulations put forth by the FDA.
Human factors engineering is defined as the interaction between humans and systems. It can apply to everything from a button’s size to the room that the product will be in.
Human factors engineering activities, such as user-testing, provide product development teams with vital data that should be used to help inform and evolve a product’s design. In the medical device development process, this data can be used to identify misuse of a product, helping to root out potential harm to the end-user.
Medical device developers need to integrate human factors engineering into their development process, not only because it’s mandated by the FDA, but as good design practice for thorough user research and testing.
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