Clearly one of the great struggles with medical device product design is to understand and finely tune the design input for our devices.  It is difficult but the payoff can be great when done well – pays off with development efficiency, greater certainty with safety risk control, and ultimately in customer satisfaction.

In our training courses, one concept we paint to help in understanding is the following:

“Two different companies, when presented with the same intended use and user needs, will typically arrive at similar, but usually slightly different design input.  But both companies will provide products that meet the intended use and user needs.

Now taking this one step further, two different design teams, when presented the same design input, will likely approach the lower level design differently.  One team may use more software and more microprocessors than the other team.  However, both teams will ultimately make an argument that they have fulfilled the design input.”

Do you struggle with this as well?  Would you like help or to discuss with us?  Leave us a message …