When does something become a medical device?

01 Nov 2022 6min read

Team Discussion

Multiple authors

Many people use medical devices as part of their daily lives but may be completely unaware of it. An example of this becomes increasingly relevant each October in the form of coloured contact lenses! Many Halloween celebrators using vibrant lenses may be oblivious that they could actually be popping sophisticated medical devices into their eyes. That is, if the contacts follow FDA guidance.

When I recently discovered the medical status of cosmetic lenses, I realised the important issue of safety and understanding the line between consumer products and medical devices.

Medical device or consumer good?

It is important that the distinction is made between consumer goods and devices that could have implications on an individual’s health. People can unknowingly put themselves at risk of physical damage by using seemingly harmless items, simply by not having sufficient knowledge of the materials used or expiration dates. This ‘line’ between consumer products and medical devices can become skewed with misleading marketing, which could certainly be attributed to the case of decorative contact lenses.

Halloween costumes are often marketed towards people through platforms they use every day. A recent study investigated material surrounding ‘contact lenses’ on the social media platform TikTok, finding that 98% of the studied material promoted decorative lenses, of which a minute amount encouraged users to seek out advice from a certified eye-care provider. As a user myself, I have received information about consumer products from social media and with these findings in mind, I was interested to explore how this could have implications on blurring the lines between consumer goods and medical devices.

Medtech and the 'couch to 5k' phenomenon

A colleague of mine explored a similar topic, looking at the line between MedTech and sports technology, including wearable devices. The NHS has launched many healthcare campaigns over the years, including celebrity partnerships like ‘couch to 5k’ – because who doesn’t want to be cheered on by Michael Johnson through a pair of headphones? It is only logical that companies like Fitbit have increased in popularity as healthcare has become more technological. No longer are heartrate monitors considered exclusively for patients with heart conditions, they have now become fashionable, wearable devices.

Though Fitbit watches are not regarded as medical devices, some similar wearable monitors are classified as such and marketed not only toward athletes, but to everyday fitness enthusiasts. While such devices often promote healthy lifestyle habits, they too must be understood within a medical context. Individuals may not think of a fitness watch they received as a gift or bought at a sports shop as a medical device, but it is important that consumers understand the meaning behind the detailed health insights these gadgets provide.

In a recent study in the Cardiovascular Digital Health Journal, a patient was given a commercially available heart rate monitor-enabled smartwatch. It was acknowledged that wearable monitoring devices can provide on-demand, engaging health data. However, for those who are susceptible to health anxiety and especially with an existing health condition, the insights could encourage excessive concerns about their wellbeing and the effectiveness of any care they may be receiving. Conclusions such as this could be applied beyond a clinical context: consumers should be educated on the nature of insights provided by their device to avoid issues of confusion and anxiety. This information could be helpfully conveyed, first and foremost, in the commercial advertisement of the device that consumers are exposed to.

person checking health statistics on smart watch

Did you know: teeth whitening kits are medical devices too

Another prevalent product on social media is the at-home teeth whitening kit. Influencers followed by millions of (mostly) young adults have been promoting teeth whitening products for years. This includes brands that promote their LED devices combined with teeth whitening formulas that are ‘used by dentists’. Once again, it is probable that this audience is unaware that many of these kits belong in the Class 1 category of medical devices. This means that, though they cannot be FDA approved, they are required to adhere to other critical quality and regulatory standards. In the UK, consumers are warned about the quantity of hydrogen peroxide used in these products. When kits from a selection of large retailers were investigated by Which? magazine, it was revealed that 58% contained amounts over the legal limit for at-home kits and 31% over the legal amount for dentists. With such heavily promoted products, it is important that consumers are well informed on the regulatory quality of these whitening devices by a dental professional, as recommended by the NHS.

So how can the lines be 'unblurred'?

The device examples included in this blog demonstrate that, while something can promote positive mental and physical health benefits for a consumer, it is important that, as the NHS and FDA have advised, individuals consult a healthcare professional when using a medical device of any form. Quality and regulatory requirements are an integral part of device development and the way in which they can be conveyed commercially is dependent on the company’s methods of information distribution from advertising to packaging design.

There are some impressive technologies that are paving the way for innovative, commercially available medical devices and as someone who loves a trip to the gadget section of any department store, I look forward to seeing new developments – with clear labelling of regulatory adherence of course!

Join the conversation

Looking for industry insights? Click below to get our opinions and thoughts into the world of
medical devices and healthcare.