3. Not having a regulatory strategy early on
Medical device startups need to quickly understand what the regulatory requirements are so that they can plan for it, according to Nelson. “I’ve seen that hold up companies, and in one case, it killed a company.”
The startup that went under, which Nelson described as a neurostimulator company, didn’t want to talk with U.S. FDA until it was absolutely necessary. “By that time, it was too late to understand what the FDA required them to do. … They didn’t have enough money to go back and address what the FDA wanted,” Nelson said.
People starting medtech companies can fool themselves into thinking that they understand FDA regulations. “People try to say they have a 510(k). Sometimes they’re right. Sometimes they’re wrong.”
It’s good to have a regulatory consultant involved at the beginning, even if they just start out helping a bit here and there, providing input on strategy and planning, according to Nelson.
