Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 81

Table 5.3: An Example of the Technical Section in a PDS

Section 3: Technical

Number Comment Source

3.1 Static weight: World Health Organization

The maximum static load is based on 95% male
in the UK = 96 kg.

3.2 Dynamic loading: Introduction to

Biomechanics **

Due to ambulation maximum dynamic load is
120% body weight.

3.3 Environmental humidity: Investigation report

Can be used in totally dry to totally immersed
environments: hence humidity 0-100%.

3.4 Environment temperature: Investigation report

Can be used from North Pole to Equator: hence
− 40°C < T < 40°C.

3.5 Working temperature: Focus group report

In sterilization temperature can reach + 130°C.

3.6 Measure temperature: Focus group report

The device should measure temperature from
0-40°C.

**When quoting from textbooks or journal papers use Harvard referencing - most university websites have a free guide.

before it requires servicing or calibrating? This section will almost certainly be populated
with numbers ( Table 5.4 ).
Do not forget that when it gets to the end-user the device has to operate as it did when it left
the factory. How is that to be judged and ensured? This is important for many devices as it is
written in stone in all regulations that the device must perform, and be shown to perform, as
intended in situ - not just in the factory or in the laboratory.

5.3.1.4.1 Biomechanics
It is within the “performance” and “technical” sections of the PDS that we should find
information related to biomechanics. Biomechanics is the study of the animal as an electro-
mechanical or mechatronic system in order to reveal distinctive parameters. I am unable to
give this subject the justice it deserves; there are whole topics on small aspects of the subject.
So, I have decided to mention it by name, mention its importance, and tell you how important
it is that you obtain access to relevant biomechanics reference texts. There are numerous
topics on biomechanics; some are all about modeling; some reveal actual numbers; some are
about human movement; and some are about electrical modeling of neurological systems.
Whatever you are designing there will be related information within a biomechanics textbook,
somewhere. Two topics you may wish to consider for your shelf are Enderle and Bronzino
(2011) and Webster (2009) . The first presents biomedical engineering concepts from first
principles; the second concentrates on medical-related instrumentation.