Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
Skin is an ever-changing organ. Its complexity makes it a challenge when designing wearable devices. When you design adhesives and devices that are made to stick to skin, there’s a lot to consider. Start your design with skin in mind. Learn more by reading “Meeting the challenges of skin.”
Skin is a window—it can indicate our overall health. And when it’s damaged, it can hurt both psychologically and physically.
Cost justification and lack of material compatibility continue to create hurdles, but industry stakeholders have been coming together to help drive innovation.
As medical devices using software and wireless communication become more ubiquitous, hackers are becoming more advanced in their methods.
For reliable systems, we need a different mindset.
Sharing more information with design partners on device function and its inherent risks can help guide better decisions during the product development process, and keep patients safer.
There are too many unique needs on the part of both manufacturers and providers. More collaboration is needed.
Modern technologies have taken biomaterials to another level, but hurdles remain in developing next-generation materials.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.