Brian Higgins, VP of sales and marketing at Sil-Pro, was a part of the staff written article, “Not All Contract Manufacturers Are Created Equal.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.

Q: What are the primary reasons an OEM will seek out a contract manufacturer?
Higgins: Cost. Most OEMs have much higher overhead costs due to facility occupancy rates. Their variable costs can also be higher; trying to forecast volumes and balance the level of staffing required to meet demand. There are also contingency advantages where multiple contract manufacturers can ensure continuity of supply if production issues are encountered.

Q: How do medical device contract manufacturers stand out from their competition?
Higgins: Responsiveness. Whether a mature product transfer or new launch, there are multiple considerations that need to be illustrated to manage risk factors from traceability to continuity of supply.

Q: Are there still concerns from the OEM regarding IP when working with a contract manufacturer?
Higgins: It’s clearly understood from a Contract Design element, when creating new products from a set of performance requirements, supplied by the OEM.

IP ownership is typically defined in the terms of the contract. “Trade Secret” manufacturing processes can be developed and retained by the CM.

Q: How do you ensure clear lines of communication with a partner OEM?
Higgins: Defining roles and responsibilities for key points of contact from each party can greatly reduce the response time from both CM and OEM.

Q: How do you earn the trust of an OEM who has been “burned” by another contract manufacturer?
Higgins: Demonstrated performance with other programs can reduce the concerns with an OEM. Determining the root cause of their previous concerns and illustrating your ability to mitigate those issues with your systems and processes.

Q: How can a contract manufacturer be a valuable ally when it comes to the validation process for a medical device?
Higgins: Leveraging previous validation protocols to reduce cost and time for the OEM.