Medical device or a gadget. The difference explained
The shades of the gadgets marketMedical 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 bound 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.
Is a medical device a gadget?Because of the demand for great design and UX we see more and more medical devices that look like a gadget. Easy, simple to use. Today they look more like modern, classy i-stuff rather than old-fashioned hospital devices that we’re used to seeing in hospitals. However – what is under the hood makes a difference and the whole legal process which is inevitable to call a gadget a medical device. And that’s not the whole story. Healthcare experts, such as doctors, may evaluate a patient’s medical requirements using equipment in hospitals that are often large, sophisticated and very expensive. In contrast, healthcare gadgets are small tools used at home or on the go for the convenience of patients. Before being authorized for use in healthcare institutions, hospital machines undergo rigorous testing and this is a great topic for another post. Let’s focus on a medtech gadgets you could use yourself. Anytime and anywhere. As an example I could cite one of the products designed and produced by Consonance for a major player on the pharmaceutical market in Poland – USP Zdrowie. The Tru Plus looks like a gadget, however the device for pain reduction is based on TENS (transcutaneous electrical nerve stimulation). The TRU Plus medical device consists of an electrostimulator, an electrode and a charger. The device generates electrical impulses, which are transmitted to nerve fibres through electrodes placed on the skin and relieve pain. The electrostimulator has a three-stage professional treatment program that includes thirty levels of pulse intensity. This allows the user to tailor the stimulation to their own needs. The electrode is replaceable and after several dozen uses it can be easily replaced by buying an additional set. That said – the product above before going public, needed to get certificates and CE marks to get an allowance of sale in the EU. But still – it’s easier to pass regulations in contrast to hospital devices.
Legal requirements for medtech gadgetsFormally, 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.
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