Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 86

car. Do not underestimate the trauma a device goes through moving from A to B. You may
well have to specify tests to ensure your packaging is correct (these are called accelerated
life tests ).

Also, do not forget that the packaging has to it into a vehicle of some kind. It is so easy to
forget this simple basic concept and then find out that your design doesn't fit into your biggest
van or, even worse, will not fit into a standard shipping container. Talk to your distribution
arm, talk to your shippers…it really is that easy.

5.3.1.8 Environmental
The green agenda is now written in law in virtually every state. We all have a role to
play in the recycling and disposal of waste ( Table 5.8 ). At present the healthcare system
is not very green, but that does not mean that we can't be. So long as we meet all the
requirements laid down in Section 5.3.1.2 we can minimize waste. I am sure this section
is going to grow as people start measuring waste by sector and identify healthcare as
a significantly nongreen industry. Hence I am sure medical devices manufacturers will
soon be determining carbon footprints, putting recycling labels on outer boxes, and using
recycled cardboard.

However, don't forget that some devices actually rely on the use of very harmful
substances that emit noxious fumes or electromagnetic radiation. In these circumstances
we are not immune to environmental regulations and our design will need to ensure that
they have been met.

Table 5.8: An Example of the Environmental Section in a PDS

Section 8: Environmental

Number Comment Source

8.1 External packaging: Focus group report

All external packaging to be
recyclable.

8.2 Internal packaging: Focus group report

No recycled packing materials may
be in contact with the device.

8.3 Disposal: Focus group report

Disposal of the device limited to
“sterile sharps” restrictions.

8.4 Servicing: Standards review

By-products of servicing to
be disposed of meeting the
requirements of relevant
standards.