Introduction - Medical Device Design: Innovation from Concept to Market - page 9

Canada has its own level of complexity (with CAMDCAS), and Japan's is even more complex.
However, one has to accept that the application processes are as different as they could possibly
be - but at the end of the day the application is about how you present your design to the
authorities; how you do your design is always the same, wherever you are!
At this stage it is worth discussing liability. Ultimately it is the manufacturer who has the
ultimate responsibility for liability. However, as with any other discipline, their insurers
will try and pass liability down the food chain. Hence it is important, when acting as a
subcontractor, that you have relevant insurance in place - and that you never exceed your own
level of experience. But, as the designer, one is the hub of the activity. Without the designer
nothing happens, no device exists, and there is nothing to present for sale. Hence the product
lives and dies at your hands, so your knowledge of the medical devices regime is fundamental.
Your adherence to the structured design processes is essential, and your communication with
others is of paramount importance. That is why Figure 1.1 includes the image of a newborn
baby; this is just how the medical device designer must picture their device. It must be treated
with the care and diligence one would apply to a newborn baby; it is, after all, your baby.
1.4 Summary
In this chapter we saw how design and continual improvement are essential to medical device
design. We were also introduced to the main policing bodies and regulations that control the
medical device environment. By now you should be aware that this is a highly regulated arena,
and as such any design work has to be up to the mark and should not be approached lightly,
frivolously, or with gay abandon. Therefore you now have a few tasks to complete this chapter:
Task 1: Locate and familiarize yourself with the FDA website and your country's EC
competent authority site.
Task 2: Download the Medical Devices Directive (with amendments).
Task 3: Download the In-Vitro Diagnostics Directive (with amendments).
Task 4: Download the relevant FDA Food and Drugs Act sections (21 CFR 800 series)
Task 5: Read them!
References
European Community (1990). Active Implantable Devices Directive . 90/385/EC.
European Community (1993). Medical Devices Directive . 93/42/EC.
European Community (1998). In-Vitro Diagnostics Directive . 98/79/EC.
FDA (2004). Federal Food, Drug, and Cosmetic Act (FD&C Act) CFR 21 .
Jobs, S. (2000). Apple's one dollar a year man. Fortune , 24th January.
Wikipedia (2011). Sinclair C5 . < http://en.wikipedia.org/wiki/Sinclair_C5 > cited 16.05.11.