“ 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 ”
– Timon LeDain , Internet of Things ( IoT ) Director , Macadamian
– 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 precertification 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 .”
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