Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 62

4.5.1 New Product Procedure
Figure 4.3 illustrates a typical sequential design procedure.

You will notice that everything relies upon the identification of the need produced in the
overall procedure and as shown in Figure 4.1 . Firstly, a project champion or project lead
needs to be appointed. It is this person's job to make sure that the project runs to schedule
that it follows all the procedures, and that the document trail is complete. The procedure now
expands the need by developing a full product specification in the clarification procedure . The
procedures follow in line until final approval for release (we will examine these individual
procedures in the next sections). In a documented procedure it is difficult to present anything
but a serial, waterfall type activity flow. However the procedure only shows activity, it does
not show information flow. Remember, the improved design models were all concerned with
communication; the order in which the activities happened remained the same.

Need from Fig 4.1

Appoint lead

Review DHF: ensure it is up-to-date
and complete.
Ensure all approvals are signed off

Open new
Design History File
(Design File)

Clarification

Product specification

no yes

Conceptual
design

Detailed
design

Evaluation/
validation

Release

Approved?

no

Embodiment Prototype Prototype Approved?

yes

yes yes yes

Approved? Approved? Approved? Product

no no no

Decide where feedback applies

Figure 4.3
A typical new product procedure.