This is the last in a series of blog postings in which we present a top-ten list of common errors encountered in the context of medical projects. Of course, such a ranking depends on personal observations and individual experience – and hence has a subjective outcome. Please feel invited to tell us about your perspective in the comments section!
In the past nine entries to this series we focused on particular errors that happen in medical projects, but today’s posting takes things to the next level: It is about the fundamental error of not even realizing that one is building a medical product in the first place.
On a first glance, this may seem like a made-up issue. How can a manufacturer of medical devices – usually a big corporation that has been building those for decades – become oblivious to the fact that they market medical products? This is easy to answer (they don’t), but it also is the wrong question. In fact, it contains at least three false assumptions:
- First of all, the term medical product includes much more than just medical devices. And what’s more, the term medical device includes more than just… well, medical devices – as counterintuitive as that may be. Standalone software, for example, can be a medical device. The same goes for mobile applications (read: apps). More about that below.
- Secondly, it is simply not true that medical products are only marketed by big corporations. It may have been like that at some point in the past, at least mostly, but it is no longer true in the dynamic world of start-ups and innovative business models, where software eats every industry and unexpected competitors attack long-established markets.
- As a consequence, we aren’t talking about traditional organizations that suddenly forget what they’ve been doing all along – but about new organizations or even individuals (e.g., developers that release medical apps into app stores) that create and market medical products in some form of untroubled ignorance.
The last item on this list is particularly tricky: People who are not aware of the laws for medical products are not aware of the definitions of medical products, either. Hence, they are tempted to believe that their product need not adhere to regulations because “My software is not used in a device” or “My app is not used in hospitals” or “The README clearly says that people can only use my product at their own risk”. But none of these excuses are relevant at all: As stated beautifully and to the point in Article 1 (2a) of the Medical Device Directive (93/42/EEC), for example, it is the intended use that makes any instrument, apparatus, appliance, software, material or other article a medical device (as long as it does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means).
It is important to note that the term intended use refers to the true purpose of a product. You cannot circumvent regulations by stating a harmless purpose when the product is obviously an insulin pump and every customer who buys it will employ it as one. As soon as your device has one of the following functions, for example, it is covered by the MDD (quote):
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception.
(We did not go into the IVDD or the AIMDD here because it does not change the point.)
This comprises the end of our series on the Top Ten Errors in Medical Projects. Thank you for staying with us, we hope you enjoyed the ride!
- Top Ten Errors in Medical Projects – #2: Classification Gibberish
- Top Ten Errors in Medical Projects – #3: Late Safety
- Top Ten Errors in Medical Projects – #4: Risk Analysis Gone Wrong
- Top Ten Errors in Medical Projects – #5: V for Vendetta
- Top Ten Errors in Medical Projects – #6: As Low As Reasonably Practicable
- Top Ten Errors in Medical Projects – #7: The 100% Confusion
- Top Ten Errors in Medical Projects – #8: Eager Beaver / Lazy Bum
- Top Ten Errors in Medical Projects – #9: Process versus Project
- Top Ten Errors in Medical Projects – #10: Clinical Something!