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When Regulators are Unable to Manage Industry Cross-Overs

We are seeing more movement of products across industries and the inability of regulators to catch these. Take for example the case of wearables that do not need prescriptions (like the glucose monitors) and the impact it has on people who do not understand how the body works (great article here by the BBC). The same article states, "The FDA’s 510(k) regulatory process evaluates medical devices for safety and efficacy, but marketing claims are not part of the review." Meanwhile they get data from consumers who pay hefty prices.

Or think of the inability of music innovations (like bone conducting earphones) to provide hearing aids and hence preventing people with hearing problems get low cost solutions for deafness. These hearables were held back by the regulatory hurdles. It took till 2022 to get over the counter hearing aids and they are still expensive! The cost differential ~$2000 per ear for an FDA approved hearing aid versus sound ~ $600 (for a pair) amplification devices (music industry) like the AirPod, is huge! Hence the FDA needed to come up with some new regulations for Personal Sound Amplification Product (PSAPs).

While these are two examples at two ends of the spectrum, it highlights why we cannot only take an industry perspective - we need a more holistic perspective of the impact on the individual and society, Many of these devices use AI and so data privacy is also another aspect that needs to be considered. I do not think here the issue is about having a regulatory sandbox, it really is about policy makers, getting out of their comfort zone and understanding the problem from the human point of view - an agile government issue. Too often we get lost in the documentation without a human centric perspective (yes it includes all stakeholders).


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