At the 4th Annual MPO Symposium hosted by Medical Product Outsourcing (MPO) medical device manufacturers, regulatory, business development, and strategists gathered to discuss and share knowledge and explore outsourcing strategies for improved outcomes.
The "Building the Bridge Between OEM Design and Outsourced Manufacturing" session was staffed with an impressive panel of representatives and moderated by Ben Dunn, Managing Director of Covington Associates. Some sage advice was offered by one of the panelists, Ron Jellison, Executive Director of Business Development for KMC Systems, Inc. for how to select a medical device manufacturing partner.
Ron identified three key areas to focus on when considering a medical contract manufacturer during the product design phase:
1) Seek a medical contract manufacturing partner with relevant experience in the technologies offered in your product. Medical device manufacturers that have the pertinent technical knowledge and expertise will likely have the complimentary manufacturing techniques and proven processes.
2) Understand the pricing models that will be used for the finished good cost of your product. Medical device manufacturers can provide pricing models for finished goods before they know what the raw material or labor costs will be. A formula based pricing model can be used to understand the expected finished good cost while the product is being designed utilizing targeted material and assembly/test labor estimates.
3) Assess the quality system of the manufacturer. Many times large OEM's will perform an audit of an outsourced manufacturer to be sure that there is a quality systems alignment. In the case of a start-up OEM, the fact that an outsourced manufacturer can provide a certified quality system can be an asset.