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.
Technology should streamline the healthcare process for both patients and clinicians.
Companies should not underestimate the importance of investing in user experience design.
As software becomes more complex and connected, device manufacturers must address more risks.
Human factors addresses not only the obvious or physical, but also digs deep.
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.