“If you’re not having fun designing medical devices, you’re doing it wrong.” That’s Andrew J. DiMeo, Sr., Ph.D. And he is most likely some of the underappreciated leaders in medtech. Not as a result of…

“If you’re not having fun designing medical devices, you’re doing it wrong.”

That’s Andrew J. DiMeo, Sr., Ph.D. And he is most likely some of the underappreciated leaders in medtech.

Not as a result of folks do not discover his work. Because good technique disappears into execution.

Andrew formed how I take into consideration consumer wants and launched me to the BioDesign course of. He did the summary framing work in Couplet Care, Inc.’s earliest days. He steered us away from a one-size-fits-all regulatory mannequin and located the fitting path for a Class II 510(okay) exempt gadget. He pioneered DHFRI, or design historical past file-ready ideation, a considering course of that saved us compliant and versatile on the similar time.

When we transitioned to manufacturing, our engineering workforce was impressed by how organized the switch package deal was. That readability got here from Andrew’s strategic framing years earlier.

The higher the technique, the extra apparent it appears in hindsight. That’s the lure. The work that makes good tasks attainable will get taken with no consideration as soon as execution begins.

Andrew’s inventive excellence and revolutionary considering helped us not simply meet regulatory necessities, however achieve this in a manner that saved us nimble and ahead.