Earlier this year the US Food and Drug Administration (FDA) heralded the forthcoming launch of its pre-certification pilot program for new digital health software which it hopes will help revolutionise the regulation of digital healthcare solutions in the US and allow innovations to safely reach the global market in a timely way, to the benefit of end users.
"We need to modernise our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices," said FDA Commissioner Scott Gottlieb, M.D.
Warming to this user-centric theme, in a July FDA blog post, Gottlieb wrote: "This new program embraces the principle that digital health technologies can have significant benefits to patients' lives and to our healthcare system by facilitating prevention, treatment and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings."
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Creators of SaMD (Software as a Medical Device) products like the Canada-based Macadamian - a user experience design and software development company focused on the development of healthcare solutions - is excited about the potential less regulatory oversight will bring for smaller and more nimble companies, like theirs, to compete in the same space as larger corporations.
"With the advent of more complex solutions, like our My Diabetes Coach which leverages machine learning and artificial intelligence, the software and the medical device are merging," says Macadamian's Internet of Things (IoT) Director Timon LeDain. "The FDA has implemented the pre-certification pilot program to balance risk management with the agile development process. Software has shown itself to be capable of looking at a medical image and providing a diagnosis that matches or exceeds what experts could achieve."
Macadamian has also worked with the likes of Transcendent Technologies on projects such as the forthcoming Lifepod - an Amazon Alexa-powered virtual caregiver and digital health assistant - and specialise in creating connected healthcare solutions. LeDain observes innovations can take years to reach the market, affecting manufacture, marketing and sale, with the increased cost ultimately transferred to the consumer. He thus applauds the opportunity to improve patient outcomes with the reduced regulatory burdens of the FDA program while driving down the costs of delivering healthcare.
"The pros outweigh the cons and demonstrate the FDA is aware of its impact on healthcare innovation and is looking at 'out of the box' approaches to address this," he says. "Some might argue the pendulum could swing too far towards the deregulated space with potential adverse health events as a result, but I don't see this outweighing the benefits. There's already proof unregulated products like the Apple Watch and Owlet Care's baby monitor have saved countless lives by providing consumers with information they previously never had access to."
Source: Healthcare Global (View full article)
Posted by Dan Corcoran on November 6, 2017 07:41 AM
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