Manufacturing technology
have some reimbursement,” says Christensen. “If there’s no money, it’ll always be one person in a corner with a maker bot trying to make it work. To do it right, you need the right kit, and you need the right people, and you need time. And all of that means you need money.”
The right call
As manufacturers will happily explain, 3D printing can get very expensive, very quickly. Many of them still outsource it themselves. Oddly, hospitals in the US have a bit of an advantage there. “If you’re going to sell an anatomic model, you would have to clear it by the 510K pathway as a class two medical device,” explains Christensen. “But if you’re a hospital – even if you want to make your own implants – you can do it without any oversight by the FDA.” At least, they can for now. As the prospect of hospitals creating their own implants has become less fanciful (the Mayo Clinic has implemented metal AM, for instance), regulators, too, have begun to pay more attention. According to a recent discussion paper it published on the topic, the FDA is considering three models for regulating point of care AM. The first would see manufacturers selling certified medical device production systems that hospitals could install for on-label use. Otherwise,
manufacturers could take on the regulatory burden by co-locating small facilities in hospitals, or hospitals could themselves choose to be regulated as medical device manufacturers. Whatever happens, Silvestro welcomes the prospect of greater regulatory involvement. Hospitals today – with their legal departments, review boards and device committees – do not use the ‘practice of medicine’ concept as a cover for undercutting medical device manufacturers while evading regulatory scrutiny.
“The biggest challenge right now is not having a defined pathway,” Silvestro explains. “If you look at the literature of different hospitals on how they get devices through development, it’s a completely different route for almost every single device.” As might be expected, what Christensen calls the “democratisation of manufacturing” isn’t happening all that smoothly. Nonetheless, it’s opened a new book on how hospitals care for their patients – and we’re not going back to the old one. “Think of all the regenerative medicine technologies for replacing human tissue,” says Christensen. “That isn’t here yet, but when it is, technology-wise, I think one of the ways it will happen most often is at the point of care.” CHOP started by modelling hearts; one day, it might make them. ●
Medical Device Developments /
www.nsmedicaldevices.com
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