Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 80

Table 5.2: An Example of the Regulatory Section in a PDS

Section 2: Regulatory and Statutory

Number Comment Source

2.1 Medical Devices Directive: EC/97/42

Must meet the essential and general
requirements of the Medical Devices Directive.

2.2 FDA: FDA 21 CFR 801

Labeling must meet FDA requirements.

2.3 Material: FDA recognized consensus

standards. Standards review.

Material must comply with ISO 5838-1:1995.

2.4 Testing: Standards review.

Screws to be tested to meet ASTM 543.

2.5 N 60601-1: Medical Electrical Equipment

-General requirements for basic safety and
essential performance.

Standards review.

It is within this section that you describe the environment in which the device operates ( Table
5.3 ). Will it be steam sterilized or gamma irradiated or both? Will people cover it with alcohol
and set fire to it? Don't forget it has to be transported so although it may be used in a nice clean
OR theater, it may have flown in a baggage hold at −20°C and then crossed a desert at +40°C.
All possible technical limitations need to be considered. You need to use all of your experience
and discussions with end-users, supply chain, and sales force to fully understand the technical
requirements your device will be put through. You also need to think about protecting the user.
Are you emitting noxious fumes or ionizing radiation? Will the user be sitting in front of a
VDU screen all day? What does your design have to do to meet these technical limitations?

Don't forget ergonomics and “usability.” At the end of the day someone has to use your
device; hence they must be able to use it. Ergonomics, man-machine interface, usability and
anthropometric data are all concerned with fitting the device to “man.” Quite often this comes
from the customer in the form of “I must be able to do this with my left hand”; you need to
decipher this into technical data. What, technically, does “using with the left hand” mean?

As with the previous section, this section contains two further reports: investigation and focus
group. We shall meet these in more detail later.

5.3.1.4 Performance
Now we are getting into interesting territory. Just what does the device have to do and
how well should it do it? Imagine setting the performance for a car. How fast should it go?
How fast should it accelerate? How many miles per gallon should it do? All of these are
performance characteristics. You will need to set criteria that someone can use to assess your
device. Again, some of this will be determined from discussions with end-users, however
some will come through your study of the subject area. For example, your device may need to
measure temperature from 0-100°F with an accuracy of ±2%. How many times can it be used