Supplier management is about a balance of controls, Brian Dense told a lunch and learn group during MD&M East this week. Medtech companies need to assess the trustworthiness of suppliers and react accordingly.

“If you have a supplier that is, for example, ISO 13485 certified, that you have a long relationship with, and that you trust, it's ok to pull back your supplier controls,” said Dense. If, on the other hand, you are working with a supplier, perhaps one that specializes in the service you need, that isn’t as good at quality, then medical device firms need to adjust their controls to protect themselves.

“But you can’t hold your company to choosing only exceptionally controlled suppliers so rigorously that you lose out on innovation,” said Dense.

One important idea, Dense said, is getting the quality agreement before all other materials, including the supplier agreement. “The quality agreement sets out what you expect of your company and your supplier,” he said. “They should be general enough to cover everything, but specific enough to define every party’s responsibilities.” That includes the medtech firm’s responsibilities—Dense cautioned attendees not to leave themselves out of the quality agreement.

Some other advice Dense passed along was to keep the supplier agreement and the quality agreement separate, but he did note that the supplier agreement can refer to the quality agreement.

If nothing else, Dense said the agreement must contain a single phrase that should never be left out, as it sets the tone for any and all interactions. That phrase is:

“The supplier agrees to notify client to all proposed changes. Client requires this notification prior to supplier implementing the proposed change to facilitate client assessment of all affects of such changes on any and all client products.”

That is: Tell your supplier clearly that they can’t change ANYTHING about the products or services supplied without explicit communication before that change is implemented.

—Heather Thompson is editor-in-chief for MD+DI