Formative Testing: Your Medical Product Design Strategy Can’t Work Without It

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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 usually means helping a person truly in need, which is especially gratifying.

Seasoned medical product developers know that an excited customer reaction doesn’t happen by accident. On the contrary, it takes a lot of work — the result of a goal that must be established early on and adhered to over the project duration. It requires putting customers at the center of your medical product design process, which is much harder than it sounds. In fact, we’ve found that most companies don’t do it very well, and in making this observation, we’re not alone. The FDA noticed also, and in 2007, published a standard (IEC 62366) that recognizes how to do it effectively.

This standard articulates what the FDA refers to as formative testing. It’s really just a fancy term that describes the idea of including the needs of end-users of your product early and often throughout design. This white paper will explain what formative testing is, why it’s the key to connecting with your customer, and how it can fuel your bottom-line profits.

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