Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 90

5.4.2 Regulatory Bodies
There can be little doubt that these are an unmissable first port of call, either directly before
or directly after talking to the customer. Each of the main regulatory bodies has guidance
documents, copies of relevant statutes, and even people at the end of a telephone. All of which
is a valuable library of information.
Taking the FDA website as an example ( www.fda.gov ) one of the most useful items is the 510(k)
search. This single item enables you to identify any previously approved devices that may be
similar to yours, and as a consequence reveals valuable information about classification, etc. The
UK's MHRA website ( www.mhra.gov.uk ) hosts all of the guidelines, documents, and links to
documents that enable you to start building your specification in relation to CE marked devices.
In relation to standards the FDA hosts a database of standards where consensus has been
reached. In other words, designing to a cited standard means that it is recognized by the
FDA. Just opening and examining the database gives you a valuable starting point for your
standards review - once again a valuable resource.
Many people overlook the recall, vigilance, and notifications databases. These give fantastic
insights into failure modes…allowing you to learn by the mistakes of others.
5.4.3 Immersion
One of the best ways to find out what a design needs is to immerse yourself in the area. An
actor would call this method acting . If the device is to be used in an OR theater then try and
get into one; if it is to be used by nursing staff on a ward, go to one and observe. Irrespective
of the complexity of the design, immersion into the environment is second to none. Recently
one of my students was working on the design of a wheelchair attachment; I made him spend
a day in a wheelchair to understand the environment from the perspective of the end-user.
That day was worth its weight in gold!
If you can get into the actual environment you will learn so much about the requirements.
You will identify the questions to ask. Another reason is to learn “the language” of the
environment. Often terms used in the clinical context can be different to those used in others.
For example the word “distraction” clinically means moving two items apart, not something
that disrupts your concentration. You have to immerse yourself in the environment to
understand the language just as you would to learn a foreign language.
Sometimes immersion is hard to achieve - for example you may not be able to witness an
operation directly. However training videos are always available as are clinical textbooks. These
do not give the full picture but will enable you to think of the right questions in a focus group.
This is a good basis for your investigation report. Using your experiences and recollections
of your period of immersion and tying this up with your own expertise and some further