[vc_row][vc_column][vc_column_text]A human factors validation study is conducted to demonstrate that your medical device can be used by its intended users without serious use errors or problems. It’s required testing for most products as they’re finalized — before they go to market [...]
[vc_row][vc_column][vc_column_text]A human factors validation study is an exercise to prove a market-ready product’s usability and safety in the hands of representative end users.
You may know this as summative usability testing. However, the FDA dislikes this term as it can “omit esse [...]
Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for what benefit? HFE actually serves two immensely valuable purposes and vastly benefits the medical dev [...]
[vc_row][vc_column][vc_column_text]From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a safe, effective, straightforward, and delightful way.
But the [...]
[vc_row][vc_column][vc_column_text]Consider a time when you opened up a new product. Maybe you just bought an IKEA desk, and you are super excited to get to using your new "FOLUBAN." You open the box, pull out the pieces, and a paper falls out with drawings of tiny people guiding you on how to as [...]
[vc_row][vc_column][vc_column_text]Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a catalyst for deep collaboration and clear communication.
It can b [...]
[vc_row][vc_column][vc_column_text]It goes without saying that medical devices should be both safe and effective. But those qualities are really just the baseline. If a product is safe and effective but doesn’t actually solve users’ problems, it won’t matter. To put it another way, the real [...]
[vc_row][vc_column][vc_column_text]The last thing a medical device manufacturer wants to receive in response to their FDA filing is a “request for additional information.” It’s usually not a deal killer, but at the very least it’s going to delay the approval process and ultimately your pr [...]
Have you ever said to yourself of a product, “WOW, it feels like they designed this just for me!” or “I didn’t even know I needed one of these?” It’s a great feeling. Some company out there cared enough to solve your problem and put a smile on your face. In the healthcare world, that [...]
[vc_row][vc_column][vc_column_text]After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches you with a major problem. The product has missed the mark by being t [...]
[vc_row][vc_column][vc_column_text]Our brains are like a GPS mapping app, automatically adapting to a constant stream of information and only occasionally asking us to choose an alternative route.
That automatic decision-making process driven by our subconscious is both a blessing and a cu [...]