Category Archives: Design Input Requirements

How Do You Capture User Needs for a Medical Device?

Why do you engage in medical device product development? The ultimate purpose is to solve unmet clinical needs. To develop products, technologies, and services which sustain and improve quality of life. If your experience as a medical device product developer has been anything like mine, starting a new project is often very fuzzy and raises more questions than answers. How you start a project is very important. And this is something that took me many attempts before I truly understood. What do you need to start a new medical device product development project? If your company is anything like those I've worked with, chances are the reason to start a project is often times very vague. Basically, it boils down to someone making a financial commitment to begin the endeavor. But as a product developer, you...

Medical Device Design Control Traceability Using UniDoc

If you are familiar with medical device product development, I'm guessing you've seen the FDA Design Control Waterfall diagram. FDA describes Design Controls in a linear fashion: user needs, design inputs, design process, design outputs, design verification, medical device, design validation. Chances are your product development and design control processes do so as well. But do medical device projects really follow this linear path? httpv://www.youtube.com/watch?v=6R-ehHOf1WM What if you had the ability to take each individual component through of your medical device product development project through the entire design control process at its own pace? What if you could do this and ensure all Design Controls for that component were documented, traceable, and so on? You don't have a tool that can do this right now. UniDoc does this....

The Ability to Zig Zag Through Medical Device Product Development

If you have been a part of medical device product development, there is a good chance you are somewhat familiar with the image below: Most refer to this as the FDA Design Control waterfall diagram (the origin is actually Health Canada) and is referenced in FDA Design Control Guidance document. Since starting my career as a product development engineer for a medical device company and my first exposure to this image, I have been fascinated by it. In many respects, the image is pretty good at showing the progression of Design Controls during product development. Many interpret and infer that Design Controls = Product Development. There is definitely a dependent relationship of sorts. Design Controls are generally part--albeit...

What Comes First: Design Input Requirements or Prototype?

Okay, this is kind of a trick question. Actually, what should come first the the unmet clinical need. But once you've identified the unmet clinical need, what do you do next? Do you define the product's design inputs? Or do you proceed to building some type of prototype? I've taken both approaches. And I've often wondered which is best--which is correct. I think I now know which approach makes the most sense. Build the prototype first. Why? A prototype is so much better at communicating than words can ever be. Put a prototype in the hands of end-users, and they can tell you everything that is right about it. More importantly, they can tell you everything that is wrong too. Capturing and documenting design input requirements becomes so much easier when end-users are able to conceptualize the...