Medical Device Contract Manufacturer Involvement ... When?

Do you struggle with determining when is the right time to involve a medical device contract manufacturer ?
medical device contract manufacturer

This can be the most important decision in determining whether your product meets all your manufacturing goals and is released to market on time. Ron Jellison, KMC Systems' VP of Business Development, spoke at the 4th Annual MPO Symposium in 2011 to the importance of how to get the medical device contract manufacturer (CM) involved at the right time.


"We've been involved as early on as the time the OEM selected the designer where they also made the determination of who the manufacturer was going to be.." Jellison said. He went on to say while this is not the most common model, it can be very effective. This allows the manufacturer to be involved in the design reviews and give input into the design of the product. This makes sure that once the product has been transitioned to manufacturing, the product easily fits the manufacturing and testing capabilities for a smooth production and product launch.

Jellison also touched on a more common scenario; "The most common model is where the CM is selected prior to the completion of the development process. For example, you may have an engineering prototype build, then you may be doing another interim build prior to a release to manufacturing, where you involve a CM. This has been a successful model that has worked for us as well."

"The thing you have to remember is that when you outsource to a contract manufacturer you are going to be using the CM's suppliers. That's one of the benefits that the CM brings, is that [supply chain] management. You're better off involving the CM's supplier base during product development while you still have access to the design team ... now you get your first look at fabricated parts coming of the design drawings, and the ability to evaluate whether the design intent has been successfully transferred before you commit to production."

Jellison also spoke to the importance of relationship building and the need for honest, open communication not only to build trust but to truly understand the customer's needs. He gave examples of the way a CM adds value for two different types of customers needs.

1) A start up company that is looking to develop their product and transition to manufacturing is the first type of customer. In most cases, the start up is looking to leverage the CM's FDA audited quality processes as well their design, manufacturing and supply chain management capabilities.

2) An established OEM could be looking to enter the Total Product Life Cycle at any phase needing design or manufacturing services or both. “As far as the OEM goes,” Jellison stated “their going to look to see how they map to your processes ... it all comes down to terminology and how our terms match to their terms. They pretty much want to see how you match to their overall quality system.” The value to an OEM is to find a CM that can be a seamless extension of their own internal organization with the ability to offload their non core related tasks to a CM. Thus, freeing up internal OEM resources to focus on their core competencies.

Watch the final two parts of our MPO Video Series to learn more about WHEN to get a CM involved, and HOW to build and maintain the relationship between OEM and CM.


Watch MPO Video Series

Topics: Medical Product Manufacturing, KMC360, medical device, medical device manufacturer, medical device outsourced manufacturer, outsourced manufacturer, medical device contract manufacturer, KMC Systems, medical device contract manufacturing