Having dual sourcing of important components causes additional work, takes more time and negotiation price could be less successful with half the volumes.
If you add this to the fact that you also double your suppliers with additional supplier control, validations and possible Notified Body involvement, the natural question would be: Why on earth would I do this?
The simple answer to this question is risk management.
With the situation in the world right now, procuring components, especially electronic components could be difficult. And as a medical device manufacturer you cannot change components at a whim.
Change control and verifications demand time as well as resources. Also, the fact that everything is “just in time” these days means that if your single supplier runs into problems, delays can quickly become severe problems. Another scenario would be that the supplier ceases operations entirely for some reason. What do you do then? How much of the components do you have in stock before you run out? This is especially a problem if you outsource parts of the manufacturing itself or buy finished parts to be included in your device.
A real-life scenario was when a critical supplier who manufactured complicated parts to the legal manufacturer suffered a major natural disaster causing the entire production to be halted for more than a year. That caused a huge setback when all shipment of devices was halted once the stock ran out.
So, for components or details that cannot be easily replaced, a second supplier can be a good idea. Also, for price negotiations it can be a good thing to be able to match the prices between two suppliers. If delays or if serious problems occur at one manufacturer, this could be more efficiently handled if you already have a replacement.
The most difficult part is probably to sell in the idea to the management team since it will add costs. Especially if you haven’t had any problems so far. But even though you never had a fire at home, you still continue to pay your home insurance.
So, plan ahead and make your disaster management process include the risk of catastrophic events not only on your site, but also at critical suppliers.
What will you do? What level of safety do you need? It all depends on the criticality of the components you require, and the risks associated with it.
If you would like to know more or if you need guidance, contact us at email@example.com or firstname.lastname@example.org