Design Realization/Detailed Design - Medical Device Design: Innovation from Concept to Market - page 155

Table 8.1: Typical Design Team Skills Map

Skills Relevant

Certification

Use CAD Undertake

Design
Calculations

Perform
DoE

Sterile
Packaging
Expert

Materials
Selection

Body

Employee 1 n/a X O O

Employee 2 CEng X X

Company 1 ISO 13485 X

Research Body 1 ISO 9001 X

Key: X = expert; O = has experience in this area

8.3.1 DHF Considerations for the “Lead Designer”
You will have appreciated, from previous chapters, that all regulatory bodies want a design
history file (DHF). Hence one of your main roles as lead designer is to ensure that the DHF
is populated and updated. This means that you need to ensure that you receive documentary
evidence from all of the participants, and that documentation is in the form you require.

Hence another consideration for the lead designer is contracts. You cannot run this level of
project on “word of mouth” instruction; all must be documented. Hence the two external
bodies in Table 8.1 need to have been selected on merit (documented); the PDS of their aspect
of the project has to be agreed and signed off; and your contract with them must ensure that
they provide you with the information you require for your DHF.

A more subtle aspect of dealing with external companies is security. You should always have
a non-disclosure agreement with all of your subcontractors. If the project is highly secret you
should ensure that they know it is so and that all is kept secret - do not rely on thinking they
know.

The final thing the lead designer needs to do is to organize regular design meetings to review
progress and agree on any design changes. These need to be regular, and with today's Internet
availability they can be done using video-conferencing. Again, all of this needs documenting,
agendas need to be set, and action plans need to be produced and monitored. Everything
needs to go into the DHF.

Even if you are doing the design all by yourself all of the above requires consideration as the DHF
must exist; you cannot escape the need for a populated DHF no matter how small your company.
While it is difficult to have meetings with yourself you will have meetings with subcontractors at
some time; you will make design decisions. They all need documenting in the DHF.

8.3.2 Phases of a Team
Because teams are so important to many industries and social networks, there has been much
research conducted to look at how they operate and how to make them operate better. This is