Medical device or gadget? What to make and who to trust

Klaudia Luks, R&D Engineer 23.1.2019 | 8 min read

The shades of the gadgets market

Medical gadgets belong to the broader category of consumer electronics related to bodily function and health management. Technologically innovative, they arouse interest primarily with their clever functions, compact size and modern design. Among them we find devices for relaxation, stress reduction and sleep monitoring, and those used in sports and recreation. As technology advances, their creators are bounded only by their imaginations. One example of this is intelligent cutlery with a built-in accelerometer to control an appropriate rate of eating.

The gadgets market is expanding dynamically. Constantly appearing on it are new products and latest versions adapted to customers’ changing expectations and needs. More and more attention is being paid to UX design issues, meaning that most gadgets have a fashionable, modern look and are portable, easy to use and, not only do not connote illness but are also a stylish addition to an outfit. Their ease of use extends their reach to a wide group of users, and not just the younger age group.

Legal requirements

Formally, every electronic device put on the market in the European Union must have a CE declaration. Thus, the manufacturer declares that the product meets the “New Approach Directives” for its intended use. For most medical gadgets, the following directives will apply: low voltage LVD 2014/35/EU and electromagnetic compatibility EMC 2014/30/EU. Depending on the sophistication of the product and the form of power supply, sometimes (e.g. simple battery-powered devices) the manufacturer can prove the product’s compliance with the directives through internal testing of the ergonomic features and the manner of performance and operation according to intended purpose. Even if it is necessary to outsource tests to an appropriate laboratory, they will be easier to pass and much cheaper than the applicable tests for products classed as medical devices, which are subject to Directive 93/42/EEC. This shortens product development time and reduces the costs of getting to market, which often translates into a competitive product price, increasing its availability to the average user.

Why then, despite the high demand for medical gadgets, the ease of bringing them to market, and their consumer attractiveness, do we at Consonance deal not in gadgets, but in medical devices?

The stable world of products

Introducing a medical device onto the market can be complicated and time-consuming, as Magdalena Kocot has written (article here). Preparing full certification documentation and ensuring compliance with the medical device directive involves a significant portion of the team. It takes longer to create a new version of a medical device than a gadget, because all planned changes need to be introduced in accordance with extensive procedures and legal regulations, of course after carrying out the applicable tests. However, what may initially seem to be a disadvantage for the manufacturer turns out, on deeper reflection, to be an important advantage in medical devices. The stringent requirements on medical devices guarantee a precise design and detailed documentation, which minimises the risk of product malfunction and errors. Manufacturers show greater attention to detail and caution because, in the case of medical devices, stable and fully predictable operation has a real impact on the health and life of the patient.

Medical devices also differ from gadgets in their target market. Gadgets are personal devices, usually used in the home by non-professional users. Medical devices are used on a large scale, including by medical facilities and hospitals. Doctors, who use medical devices in their practice, take responsibility for their operation. Obviously, it would seem that with the choice of a gadget or a medical device, they will decide on the one designed and built with the greatest precision and then meticulously tested according to strict procedures. Tests performed in an accredited laboratory for numerous clients (professional ones in particular) will be more reliable than basic tests carried out independently at a manufacturer’s premises.

Another point to consider is the use of a device as a component in a larger system. When providing medical software with the medical device status, we include full documentation to facilitate certification of the entire system, to gain partner trust and to reduce the time needed to bring the entire system to market.

When more expensive means cheaper

It’s hard to argue with the fact that pre-market testing costs are greater than for medical gadgets. However, it should be remembered that this is a one-off cost, independent of sales volume. Meanwhile, medical device status means that the market cost of the device can be lowered by its reduced VAT rate. Medical device status, within the meaning of the law on medical devices, qualifies for the 8% tax rate. In addition, in some cases medical device status allows you to apply for a refund of purchase from the National Health Fund. Thus, in the long-term, including cost-wise, a medical device wins out.

Dealing with the definition

Can any medical gadget be transformed into a medical device with the right input of effort? Only if the product is compatible with the definition of a medical device that includes devices (but also software or material) intended for diagnosis, monitoring or therapy. So, not every health-related idea can be transformed into a medical device, but if a product meets the definition of a medical device, it is worth putting in more work to ensure its reliability and full supervision over the documentation, and preparing it for research and testing. Not only will business partners appreciate it, but so too will customers, whose awareness is growing by the day.