Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 88

Standards

Patients

Packagers

Central
Sterilization

Literature
reviews

Nurses

Clinicians

manufacture

Initial Risk
Analysis

Sales

Customers

End
users

R&D

Regulations

Sources cloud

Trade
Literature

Develop product
specification

Need from Fig 4.1

File documentary evidence
In DHF

Check with
sources

Redraft

Pass for
approval

Figure 5.4
The data cloud and its interaction with the PDS.

unbiased opinions concerning the requirements for a device. However, they may not be
totally au fait with the subject or discipline hence the comments they make are not written
in stone and should be taken at face value until confirmed. It is sometimes worth having one
antagonistic focus group member who plays “devil's advocate” 5 to ensure that both sides of
an argument are explored.

There are many ways that focus groups are run and there is no model of good practice.
However it is a truism to say that good food and libation normally sets tongues wagging

5 A “devil's advocate” is a person who is given the specific task of questioning a statement irrespective of their
belief in order to give fair hearing to both sides of an argument.