image source: Human Factors and Medical Devices on FDA website

by Walt Maclay

Recently, I attended a fascinating panel discussion that explored the increasing importance of understanding human factors and user experience in the design and successful use of a medical device for home care or self-care. Medical devices like insulin pumps and home dialysis systems are now intended to be used not by trained medical personnel but by patients and caregivers. The FDA has also spotlighted the need for increased attention to human factors. In the Device Advice: Comprehensive Regulatory Assistance area of their website, they now devote a section to Human Factors and Medical Devices. If you are contemplating or actively designing a medical device intended for home use or self-care, I recommend reading the summary of the panel discussion  “Learnings from Medical Devices Development Panel: Human Factors Evolution” and “15 tips for medical product development“.