What is a medical device? | PDD

What is a medical device?


on October 31 2012

Over many years of working on medical devices in different contexts, what has often struck me is that people have very different notions of what constitutes a medical device. While this may seem like a pedantic point of semantics, there are valid reasons to reflect on this question more profoundly.

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.

You may use a medical device every morning ( above image credit: Philips. Featured image credit: AED on Flickr).

A modern CT scanner – an enormous machine, and also a medical device (Image credit: Siemens).

“So why does this matter?” I hear you ask. Two reasons come to mind specifically.
1. If you are developing a new product that relates to human health, there is a good chance that it qualifies as a medical device and this will mean that you have to understand the associated regulatory requirements. Typically, the more critical the product is to health, the higher the regulatory oversight will be, so it is important to determine early on in the development whether your product is a medical device or not, and also what class it falls into.
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.
Nike’s FuelBand is a health-related consumer product but is not regulated as a medical device (Image credit: Nike).
Good places to start exploring whether a product you are developing will be regulated are the websites of the Food and Drug Administration (FDA) and the US regulator for medical devices. It is also good to read the top level EU directive on medical devices, 93/42/EEC.
It is worth noting that while there is a lot of overlap and increasing international harmonization for medical device regulation, differences remain, so it is important to understand the statutory requirements for all target markets in which the product is to be launched commercially.
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).
A focus group situation (Image credit: PDD).
From personal experience, I can say that even switching to terms such as medical products or health products will conjure up different imagery in the minds of consumers and patients interviewees. Frequently, a need can also be addressed with a service, so framing questions in a more general way, using terms such as product and/or service, will ensure that your questions don’t pre-select a solution, or class of solution, for the interviewee.