Medical contract manufacturers fill an important niche in the medical device industry and in the general healthcare ecosystem. By outsourcing the production of medical components and even completely assembled devices, OEMs can meet delivery deadlines, reduce costs associated with production overhead, and stay lean and focused on core, value-adding activities like innovation, marketing, and strategy. Medical contract manufacturers make components for, and even complete assemblies of products for Class I, II, & III medical devices and components.
Medical CMs Meet Regulatory Requirements
Aside from those benefits, medical contract manufacturers already have the procedures, equipment, and policies in place to meet regulatory requirements. Process validation, traceability, documentation, and training are mandated by the FDA. Since medical devices are used to deliver patient care and even support or sustain life, they are subject to higher levels of regulation.
Inspection: Verifying Quality Product
With high levels of regulation comes heavy focus on inspection on the part of the contract manufacturer, as they have to perform the inspections and associated processes that ensure quality end products for their customers. First article inspections, in-process production inspections, and final inspections on outgoing product enable timely process corrections and when necessary, the interruption of production in order to implement necessary changes (like those resulting from CAPAs) which minimize errors in the future.
Those inspections and process improvements rely on data. Medical contract manufacturing staff operates and maintain in-house metrology labs, where skilled quality engineers and techs use sophisticated measuring equipment like CMMs to obtain detailed and accurate measurements, thus ensuring that each part meets product specifications.
Part inspection, however is only part of the a medical CM’s overall quality infrastructure. The Quality personnel need to know what features of the part need to be inspected, what the required specifications are, how often and other related details. This information is documented in a control plan, which the medical CM needs to periodically review and update.
Inspection activities and the control plans that document them in turn support process validation. In addition, the gathering and analysis of the data proves that the whole manufacturing process reliably produces parts that meet the specified requirements. Process validation, like maintaining control plans, require ongoing effort and investment from the contract manufacturer. The fruit of that investment is the reliable delivery of high quality product for the CM’s customers.
Finally, medical device contract manufacturers rely on processes which identify, quantify, and reduce production process risks. The most important of these is a Process Failure Mode Effects Analysis (PFMEA), which is a document that should be created before production and updated throughout the product’s lifecycle. It’s a powerful tool for assessing and alleviating risk in any process, but is especially appropriate for medical device manufacturing since lives depend on the end product.
Medical contract manufacturers also assist OEMs with design for manufacturing (DFM) analysis of their designs, adjusting parameters such as wall thickness and draft angles to ensure that critical performance requirements are met and that downtime and scrap are minimized. Not only does DFM reduce costs resulting from downtime, but also ensures that production—and thus delivery targets—continue to be met.
Supply Chain Management
Another service medical contract manufacturers provide is supply chain management: parts and raw material procurement, warehousing, managing production schedules, hiring and retaining the necessary staff (like assemblers, technicians, and engineers). Tied to this is managing lead times with vendors. We’ve mentioned above the economies of scale that contract manufacturers enjoy; with that scale comes increased leverage for negotiating lower prices and shorter lead times with suppliers, a cost and logistical bonus for the OEM.
Freeing Up OEM Resources
Since medical contract manufacturers provide on-demand production capacity that can scale from small runs of design prototypes to millions of parts per year, OEMs don’t have to be stuck with the fixed costs of in-house production (like floor space, personnel salaries and their benefits) whenever they’re not being fully utilized. For many medical device OEMs, additional up front capital investment can seriously hamper their future growth. By relieving this hurdle, contract manufacturers enable their customers to more quickly react to market conditions.
Kitting, Packaging, & Secondary Operations
Besides just making the parts, medical contract manufacturers are increasingly providing additional value-added services like device assembly, product packaging, ultrasonic welding, parts decoration, and part sterilization.
These services that can be performed within the contract manufacturer’s clean rooms provide a real value to OEMs, eliminating the need to perform these secondary operations in their own facility.
By providing production capacity and support at multiple points in the manufacturing process, medical contract manufacturers help produce the devices that improve patients’ lives.
Crescent Medical Plastics, our clean room injection molding division, consistently produces superior plastic components for your medical device assembly. With over 70 years of injection molding and manufacturing experience, we’ve produced a vast variety of medical plastic parts.