Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 100

15 Environmental:

8.1 Packaging to be recyclable (if

possible)

8.2 Invasive device, disposed as

clinical sharp

Approved/Not Approved
Signed
Date
PDS.doc version 1.0 Approved by:

Date: 17.5.2010

You should see that little has changed. All that has been removed is the word “drill” where it
is not required. Now your design is free to select any hole production method from punches,
broaches, lasers, borers, water jet - anything you can think of, even drill bits. Your design
process will pick the best and most appropriate solution.

Hopefully, from the above, you will see that the wording of the specification need not be
lengthy. The statements should be brief, concise but informative. They should not leave
things open to conjecture and, wherever possible, they should point the reader to the source
of further information. Notice also that the specification does not provide solutions, it only
provides the boundaries for the design space. I know this was a drill bit, and hence the image
is in your mind, but this was intentional so that you can imagine the PDS - if I had picked
something too abstract you would not have been able to relate to the PDS.

The main thing to recognize is that the next person in the trail could lift this document and
produce the design without asking any further questions. They will need to refer to the
documents stated in the sources, but that is good practice. This is not a drafting exercise, there
are still things to decide and some design choices to be made.

The other thing to note is that a good PDS will satisfy all auditors that you have clearly
investigated your inputs and hence have met the requirements discussed in Chapter 4.

5.5 Summary
In this chapter we examined the process to develop a statement of need and a full product
design specification (PDS). We saw that the PDS is influenced by sources in the data cloud
and that you, as the designer, have to use every tool at your disposal to gain access to the
information.

We looked at the sources in detail and we also looked at methods to conduct efficient
research. It was concluded that for each section of the PDS a brief report describing where the
information came from should be written.