Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 22

Medical devices for clinical evaluation come under a whole different regime. Surgeons,
engineers, and scientists often need to conduct evaluations before obtaining clearance
to market. This means that the device they intend to use must be cleared for clinical
investigation. We will examine this in more detail in later chapters. Once again, this is not a
“get out clause” and the diligence required is probably higher than with a commercial device.
It is “experimental” so not all of the pitfalls, side effects, or clinical issues will have been
ascertained. Therefore the design process needs to be failsafe in its approach.
2.4 Classification Models
One of the big issues with medical devices companies is the number of times they have to
apply for a CE mark or for an FDA clearance to market. However, it is rare for a company to
step outside of their comfort zone; and even more rare to review the process that took them to
the eventual outcome. It is possible to learn from the activity itself, be it a success or a failure.
Hence it makes sense to learn from the past, but even better to plan to learn from the now .
The regulatory steps that were taken to reach the ultimate outcome need to be recorded and
analyzed. It is possible to save the company a lot of time by learning from previous successes
and previous failures.
Processes govern the whole of the medical devices industry, yet one of the most important
tasks (the determination of classification) is often overlooked. It should be the first thing
to be done; even at the “Oooh, what about this for an idea?” stage there should be an
initial estimate of classification. Hence the idea that all medical devices companies have
a classification process is not such a daft idea. One must remember that the costs of
administering medical devices grow disproportionately with each classification level;
removing an idea, at an early stage, due to offensively large expenditure profile is just as
important as developing a new, money spinning idea.
Figure 2.7 illustrates a typical flow chart developed for determining if a device is Class I
(within Europe). While this does not match completely with the USA it is worthwhile, if only
to understand your idea better or even to second-guess the classification panel. There is no
reason why you shouldn't produce one of these for each of the devices you intend to market.
At the very least it tracks your decision-making process and can be signed off as a part of
your technical file. Note that all of the rules that do not end with a Class I device have been
removed.
This flow chart has turned the classification rules on their head; instead of “What is the
classification?” the question has become “Is my device Class I?” This is probably the best
bottom-up type of approach to take. After all, we would all save loads of money in relation to
auditing, administration, and insurance if all or our products were the lowest class possible.
There is no credit, no medal, and no prestige in placing your devices in a class too high for
their worth. Do not fall into the trap of “I will play safe and make it a higher classification”;
this is not the idea and defeats the whole purpose of this chapter.