The 'Non-medical Device' Loophole

There’s a phrase in brand management that “your brand is not what you say it is, it’s what they say it is”. Basically, it doesn’t matter how you describe and present yourself, other people’s perceptions determine your reputation.

I recently heard an advertisement for a diagnostic product that straddled the medical, healthcare and wellness sectors. I was mowing a lawn at the time and don’t recall the details. However, I remember thinking that it sounded impressive and the ad’ signed-off with a rapidly delivered note that “this is not a medical device”.  It sounded like a medical device, acted like one and will doubtless inform health decisions. Either the product isn’t quite as good as it claims and won’t bear the scrutiny of a regulator. Or the product is fantastic but the title of medical device and a regulator’s stamp isn’t worth the huge investment of time and money.

Loophole: an ambiguity or inadequacy in a system, which can be used to circumvent or otherwise avoid the purpose

It occurred to me that the consumer will ultimately decide if the product is worthwhile, so while the ‘non-medical device’ loophole exists, I suspect that more producers will forego status (that is invisible to most consumers anyway) in favour of approximately 2 years of revenue and £Ms in cost savings. For commercial products that are borderline medical devices, it would be easy to argue that qualifying as a medical device is something to be avoided. Tone down the product claims and intended use statement, get smart with the messaging - and sell it.

If more products are being self-identified as non-medical, irrespective of anyone else’s opinion, this will blur the already grey area where regulation is concerned. Obviously, there is a requirement for approving the use of products that are unambiguously medical devices. They need to be safe and reliable. Even for borderline medical devices, no reasonable person wants a free-for-all where markets are flooded with inferior goods. Standards need to be upheld – but if producers are making claims to deliberately avoid an expensive and time-consuming period of testing, there needs to be an alternative way to review and publicly report product standards. Perhaps like the UK’s Food Standards Agency do with the Food Hygiene Ratings – a low hygiene rating in the window is never great for business. The best products made with the highest standards will obtain a good (and trustworthy) review and sub-par products get exposed. The regulatory environment needs to be shaped to attract adoption, not repel it.  

I’m still an advocate for allowing devices with medium to low risk to launch as soon as the producer believes that their product does the job that it claims. The risks need to be stated clearly and the product must be registered and labelled as ‘regulatory approval pending’. It will get products to market quicker but still encourages companies to work within a regulatory framework – rather than looking for loopholes to avoid them.

As ever, thoughts and feedback welcome.

Richard