New Medical Devices Get To Patients Too Slowly

15While the US Food and Drug Administration has chiseled away pharmaceutical review times over the years to speed innovative drugs to market, the opposite seems to have occurred in the agency’s approval of medical devices.

Instead of speeding innovative first-mover products to market, devices such as implantable defibrillators or transcatheter heart valves, the FDA’s regulatory approval process appears to delay those approvals, which in turn adds to development costs borne by device manufacturers, according to Innovation under Regulatory Uncertainty: Evidence from Medical Technology, a new working paper by Ariel Dora Stern, an assistant professor at Harvard Business School.


About Peter Coffaro 1430 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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