Design Realization/Detailed Design - Medical Device Design: Innovation from Concept to Market - page 154

things you will do through experience. In the end, as with riding a horse, the more you do it
the better you get; and if you do fall off - get straight back on!

8.3 Assemble Your Detailed Design Team
As I have already stated, hopefully you are following a holistic model and you have thought
about this much earlier in the project. However, even in the most holistic of models it is
worth confirming your design team at this stage. The first thing to decide is who is the lead
designer? They are the team coach; they are the team's manager; they are the film's director.
They assemble the best team for the job.

Assuming you are the lead designer, here are some questions you should ask yourself in order
to decide your team membership:

l

Will I be using any subcontractors to supply elements of the design?

The most common people here are companies who supply sterilization trays, people who
supply sterile packaging solutions, and people who supply transportation packaging. But do
not forget the people who produce your instructions for use, the people who produce your
labels, and the people who will actually make the item.

l

Who is going to be making the device?

Will you be using subcontractors? Do they need to have certain certificates (e.g., ISO 9001, or
ISO 13485)?

l

Do you need technical support?

Are you able to do the design calculations? Are you able to perform any necessary
experiments? Do you need material selection advice?

You need to think of your design team as a sports team. If you were coaching a baseball
team you would not have a team that could only hit a ball, with no pitchers. If you were
coaching a soccer team you would not have 11 goalkeepers on the pitch. So in your team
you need a balance of skills. Each project will have its own demands so the main aim
of the “lead designer” is to decide what skill set is required and then match this against
people. A good way of doing this is to produce a skills requirements map, as illustrated
by Table 8.1 .

You cannot foresee all potential requirements but you should be able to envisage major
requirements. It is also important to not only identify who has the real skill in that area, i.e.,
the team's expert, but also those who have had experience of working in that area (say from a
previous project). You will be amazed how this latter level of skill is beneficial; if only not to
reinvent the wheel.