When OEMs are looking to outsource production to a contract manufacturer (CM), they need to accomplish several goals:

  • Ensure a smooth transfer of production operations, including documentation, raw material, parts, and fixtures.
  • Achieve a shorter time to market than can be achieved by keeping procurement, inventory management, assembly, testing, packaging, and distribution in-house.
  • Continue to provide the technical assistance needed to help resolve any production or supply chain issues.

To those ends, OEMs should focus on a few key aspects of any potential CM partner as they whittle down all the competing firms in their search. Just as there are many different types of OEMs and original device manufacturers (ODMs), there are plenty of CMs. . .but not all of them are a good fit for your product, size, or industry. We’ve compiled a short list of the most important qualities OEMs should look for in order to select the best CM for them.

Expertise in the Materials and Processes Most Applicable to Your Product and Industry

A CM’s expertise is valuable for more than design for manufacturing (DFM) reviews during prototyping and before high-volume production. Production execution also requires automation, materials, and process knowledge, even if the best fabrication method or material grade is chosen.

A prime example of this is the choice of materials in silicone molded medical devices. Liquid silicone rubber (LSR) has been displacing high consistency rubber (HCR) as the preferred material for years. HCR, however may still be an OEM’s best choice in some cases, as the cost and performance tradeoffs between the two materials vary depending on the specific requirements of the product design. OEMs must face similar choices when it comes to deciding between medical-grade silicone rubbers and thermoplastic resins.

A CM which specializes in silicone molding can provide both general guidance and specific recommendations—backed by engineering data and lessons learned from previous projects.

The value of a CM’s expertise extends beyond material selection. Manufacturing is about much more than “what” (i.e. the materials) is used to make a product. The processes that make that product—the “how” –is just as important.

For injection molding production lines which must pass process validation for regulatory approval and which must remain under control, the scientific injection molding process is vital for determining the optimal molding process parameters. Besides helping to satisfy regulatory requirements, scientific injection molding also increases production efficiency and thereby lowers the cost per part.

And now to “where”. Medical devices are also increasingly manufactured in cleanroom facilities. Medical device OEMs therefore need CMs with cleanroom manufacturing facilities and the associated gowning procedures, material control, and air handling infrastructure in place.

Finally, we cannot mention medical device manufacturing without discussing the training, documentation, testing, inspection, validation and other processes necessary to achieve regulatory approval. A medical device CM must have a quality management system (QMS) which is compliant with at least FDA medical device requirements (and usually also ISO 13485). Just as important as satisfying current regulations is keeping in step with new ones, given how the FDA is attempting to keep up with new advances in the industry.

Necessary Production Capacity

To avoid the inconvenience of selecting, qualifying, and investing in a CM only to have to repeat the process all over again when production requirements outgrow the CM’s capacity, OEMs need to have a realistic estimate of the expected demand for their product over its lifetime, and they also need to verify if a potential CM can match that expected demand before that CM is chosen.

Here are some questions OEMs should ask:

  • How much floor space does your manufacturing facility have?
  • How many facilities will be involved in this project?
  • What is the staffing level at your facility (i.e. how many employees)?
  • How much warehouse space do you have for parts and finished goods inventory?
  • Do you have the shop floor space available for another production line if necessary?
  • Does your proposed production line or automated workcell have any reserve capacity to accommodate drastically increased production requirements in the future?

By asking the right questions, OEMs can avoid the costly mistake of outgrowing their CM.

Location That Aligns with Your Logistics Needs

With the emergence of “full-service” CMs, logistical concerns are becoming almost as important as production ones. Take location, for instance: the central United States is good for linking domestic suppliers, production, and customers in a tight, responsive supply chain. As an added bonus, there are no delays at customs or tariffs to worry about. The same cannot be said for supposedly cheaper overseas factories.

Another location advantage that a given CM can bring to the table is proximity to multiple transportation hubs (e.g. shipping ports, rail lines, highways, and major airports). From expediting urgent shipments via next-day air to facilitating continent-wide distribution, location can be almost as vital in logistics as it is in real estate.

As a premier contract manufacturer of molded medical devices, ProMed’s focus, expertise and passion lies in silicone molding, particularly LSR injection molding. With our large manufacturing facilities based in Minnesota and a talented team who can take a new design from concept to completion, ProMed continues to win the business and accolades of medical device OEMs.

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Top 3 Qualities to Look for When Choosing a Contract Manufacturer
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Top 3 Qualities to Look for When Choosing a Contract Manufacturer
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When OEMs are looking to outsource production to a contract manufacturer (CM), they need to accomplish several goals...
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ProMed Molding
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