Dave Liebl, chief commercial & technology officer at Intricon, has one main piece of advice for wearable biosensor manufacturers. “If you think there’s a chance that your device would be a medically approved and recognized data source for making medical diagnoses or deliver therapeutic values, then you should start the development of that product with that in mind,” he said in a recent interview with Design News.
“If you focus your product development just as a consumer device and then you seek a medical regulatory approval later, you have to go back and repeat so many design activities,” he explained. “But, if you do them in parallel, you can do it for some incremental additional cost, but it’s not exorbitant.”
Excerpt from the article:
Liebl encouraged manufacturers to think about the ultimate intent of their devices, asking whether their product is truly for a full diagnostic analysis that is completely reliable and gives clinicians all the information they need, whether it is a screening device that indicates whether more testing is needed, or whether it is just for consumer interest.
“Those tiers need to be understood and explored in how you choose to develop a product; choose with the end in mind,” he said.