Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 76

In most textbooks on design, e.g., Hurst (1999) and Ulrich & Eppinger (2003) , you will find
that a general PDS has the following sections:

l

Introduction and Scope: a resume of the need.

l

Performance Requirements: a complete dialogue of what the “thing” needs to do and how
to behave.

l

Manufacturing Requirements: a complete dialogue of how the “thing” should be made,
treated, packaged, etc.

l

Acceptance Requirements: a complete dialogue of what needs to be done before the
“thing” can be put on the market.

l

Environmental Requirements: a dialogue concerning environmental impact, disposal,
waste, etc.

These section titles have probably left you none the wiser. They are far too brief to help. I
prefer to use the term “requirement” when something is required ; the term “factor” when
something puts limits on your design (closing down your design space); and the term
“indicator” when dealing with design objectives that one would like to achieve. Hence I
prefer to categorize by source (or if you wish “voice of the…”):

l

Customer

l

Regulatory and statutory

l

Technical

l

Performance

l

Sales

l

Manufacturing

l

Packaging and transportation

l

Environmental

You may well wish to add to the list - that is absolutely fine. Equally you may wish to
expand some into smaller bits - that is fine too. There is no single PDS format to stick
to. However, let us look at each source in turn and see what it is we are supposed to be
discerning.

What is an actual PDS? It is a document and as a consequence it is a controlled document that
you need to develop and approve beforehand (and put into your quality document). You will
not be able to include everything, but you should include your main headings and numbering.
Figure 5.2 gives you some idea of how one looks. It is always good to start with a summary of
the statement of need to link it to the PDS; the two documents are linked and so go together
as one. Remember that as your design develops you will need PDS documents for individual
subassemblies and components; hence a summary links these PDS documents with the main
one. Also, you will have started part numbering the main device and its subcomponents so
this is accommodated too.