The word device conjures up imagery of quite technical products, such as pacemakers, surgical tools, respirators and the like. Clearly, though, medical devices include a much more varied list of products, ranging from wound dressings, toothbrushes, wheelchairs, medical beds to high end medical systems such as MRI scanners and surgical robots. Devices for home use such as inhalers, glucose meters and devices to treat sleep apnoea are included as well, making for a very large product group indeed.
A modern CT scanner - an enormous machine, and also a medical device (Image credit: Siemens).
2. When performing market research and user interviews, interviewers need to be aware of the influence the language used can have on the answers provided. The term medical device, as mentioned above, is typically perceived as very technical and this can bias interviewees to interpret questions in a more limited way.
Clearly, from a commercial point of view, both aspects are important: The first point is because meeting medical device regulations is a statutory requirement and, crucially, the responsibility to find out whether regulations apply to a company's product lie with the business selling the product.
Finding out whether a product is regulated as a medical device and what class it falls into is unfortunately not always easy, especially with products that are new to the world, or products that straddle the line between the consumer, wellness and medical spaces, such as Nike's FuelBand launched earlier this year.
The second point introduced earlier explained the risk of biasing interviewees with technically-sounding language such as the word device. Using biased language in market research and user interviews has the potential to limit the scope of answers interviewees provide; when used to drive product strategy, this could lead to inadequate products. Fortunately, this can easily be avoided by using more neutral language. It is worth noting at this point that this guideline applies to any situation in which insights are sought from potential users, be it via surveys, focus groups, interviews, or any other research technique that involves an exchange of words (oral or written).