Medical device designers are looking to crowdfunding sites to help raise the money they need for their product-development efforts. Massachusetts-based Airing, for example, is raising money on Indiegogo to develop a disposable medical device to treat sleep apnea, according to Rebecca Robbins in the Boston Globe. She reports, “This summer, hundreds of customers have paid between $70 and $270 for a future supply of the device—which they won’t receive until July 2017. If it comes at all. No refunds. No guarantees.”
Another company, Empatica, with offices in Cambridge, is planning to ship in December a wristband designed to detect signs of an oncoming seizure. Robbins reports that one prospective customer paid $199 to preorder the device on Indiegogo and has not been discouraged by delays in the product’s availability.
Robbins cites the gamut of medical-device regulatory requirements—from pacemakers (requiring rigorous FDA review in the United States) to bedpans, with devices listed on crowdfunding sites typically found in the middle. The regulatory process can take months and thousands of dollars—which the crowdfunding sites can help raise.
Writes Robbins, “William Maisel, acting director of the FDA’s Office of Device Evaluation, said through a spokesman that medical device companies must follow the agency’s marketing and advertising regulations, regardless of how they raise funds. The FDA didn’t respond to questions about the legality of specific crowdfunding practices.”
She adds, “Lawyers and agency observers say it’s unlikely the FDA will devote its limited resources to regulating the practice unless it appears patients are being harmed.”
Robbins’s story was produced by Stat, a national publication from Boston Globe Media Partners that will launch online this fall with coverage of health, medicine, and life sciences.
See related article, “Medical devices need government, insurance support.”