Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 82

Table 5.4: An example of the Performance Section in a PDS

Section 4: Performance

Number Comment Source

4.1 Temperature measurement: Focus group report

Measure T from 0-40°C to an accuracy
of 1% full scale deflection.

4.2 Deflection: Focus group report

The device should deflect 1 mm under
body weight.

4.3 Operating system: Focus group report

The software should operate
successfully on both PC and Mac
operating systems.

4.4 Servicing: Investigation report

Should operate successfully for 25 uses
between servicing intervals.

CASE STUDY 5.2
What dynamic loading would you expect for an average male walking in normal footwear?
From a standard gait analysis graph ( Figure 5.3 ) peak loading is about 1.2 × body weight.
Note: You do not need to be an expert in biomechanics to be able to design medical devices,
but you should be an expert in referring to the relevant texts!

1.25

1.0

1.75

1.5

1.25

0

Figure 5.3
Standard ground force reaction during normal gait.