Manufacturing Supply Chain - Medical Device Design: Innovation from Concept to Market - page 254

CHAPTER 10
Manufacturing Supply Chain
10.1 Introduction
There is no doubt that the last thing most designers concern themselves with is how a device
is going to be made. Right at the very start of this topic, we saw that the best way to develop
a device is to have the potential manufacturers in at the start. However, one still has to find
them. This chapter concerns itself with the rigors of making, maintaining, and regulating your
supply chain.
The word “manufacturer” leads to infernal confusion. Under EC rules, as the device
specifier and holder of the CE mark you are the manufacturer, as you are in the USA (as
the specification developer). However, this does not stop you from subcontracting aspects
of the manufacturing process to someone else - but you must do this properly and within a
framework.
10.2 Identifying Potential Suppliers
Once again, your quality manual should have a procedure for purchasing. The first part of this
purchasing procedure always contains the identification of suppliers. You will not be able to
get away with purchasing items at random; under the medical devices regulatory framework
you must name suppliers for all critical components/services. In the case of the FDA it is a
part of the 510(k) submission, and changing a supplier may make your 510(k) invalid; that is
somewhere you do not want to go.
There are no hard and fast regulations, but I can give you some rules to follow. There is no
regulation that states who you must go to, but common sense should suggest that you only
use a supplier who already provides components and services in your classification. Hence
one would not normally use a company to make a Class III (EC) device if they have only ever
made items up to Class I.
Rule of manufacturing 1: Always use a supplier who has supplied items to others in your
classification that are similar in nature to your device.
If you work with your supply chain you will find that obeying Rule 1 is not difficult. All you
need do is ask; most suppliers are more than happy to show off their portfolio of customers
and products.