1. Venture capital for device manufacturers has been drying up for a while: “‘For five years, this industry has been in a world of hurt,’ says longtime venture capital investor Jonathan Fleming.”
2. The slowdown is partly the fault of the FDA. Russell describes the experience of NeuroPace, a company making an implant to short-circuit seizures:
“With clinical data in hand, the company applied for FDA approval in early 2010, but it took the agency nearly four years to grant it. ‘They were nonresponsive, arbitrary, and they didn’t hold to their own timelines. It was close to an adversarial relationship,’ says Fischer, who has shepherded products from four different implantable device companies through the FDA’s Premarket Approval (PMA) review process in three decades. ‘In my mind, it took a lot longer than it should have.’ The lengthy review time strained the company’s finances and will continue to pinch until NeuroPace reaches profitability.”
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.