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.
To truly understand device use scenario, one must observe with intention.
The unpredictability of the process can make it difficult to stay on track throughout every phase.
The agency addresses design and manufacturing considerations, along with device submissions for product approval.
A look at some common mistakes medical device companies make when approaching risk.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
Developing next-generation technology for medical devices is only half the battle when it comes to being first to market in today’s fast-paced global environment.