Solving Complex Problems | Ep. 1

hsDNA

Industrial design as a whole, is a wide open and diverse field that touches lives every day in nearly every activity. The big differentiation between industrial design in consumer product development and medical product development are the certification processes and quality. Each of which is super important to how products are brought to commercialization.

For the very best design firms, they will even go one step further than that and bring back to the doctors and nurses the updated prototype for what HS Design of New Jersey calls, “formative evaluations” and “formative tests.” Alden states, “We will bring these concepts to them, maybe in prototype forms, maybe in a wireframe, depending on the sophistication of the product. It may be a picture, and if it's simple enough, we'll have prototypes for them to hold and talk through. We'll actually get their insight on which is their preferred, and we do that in a quantitative method where we'll have an actual ranking and result of the preferences.”

The added benefit of going into such depth is that this process also gets through the full documentation process that the FDA likes to see. Having done such heavy lifting as the process is underway, when the approved product goes into market or production and the final validation called the summative test is administered, the product will be brought to those users which participated on the front end, as well as new users using it for the first time. The users will be watched in use, making sure that they can operate the new product. The Summative Test will grade whether the product has a training curve or whether it has instructions for use, but the goal is to have the users maneuver the product inherently on their own, without use error. To Tor Alden, “...that really is the differentiation in a nutshell between medical product development and a consumer, for example. If a consumer product fails, the user might get frustrated. In a medical product, the user might die.”