Outsourcing Medical Device Manufacturing - OEM Top Concerns

Choosing a well-established CM and setting a strong working relationship is not straight forward because there are many aspects to the relationship, from the technical to the intangible.

They must be addressed from the starting line.

In this article, we take a look at some of those top concerns that your product design and production groups face when outsourcing your medical device production.

We also discuss the key actions that can be taken to eliminate your doubts and concerns.

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The Design Stage

Large OEMs

When it comes to outsourcing design, the approach will often differ depending on the OEM’s size. Large OEMs usually transfer a complete and final design to the CM with the expectation for a fast production start. However, large OEMs can benefit greatly when they provide the option for an experienced CM to give input during the actual design stage thus providing guidance into Design For Manufacturability (DFM). The benefit will mean time and money that can and will be saved later.

Small size OEMs

In the case of smaller OEMs, the approach is very different compared to larger OEMs.

It is common for smaller OEMs to not have a full in-house design team or the capabilities needed to deliver a manufacture-ready design. Turning to a CM who can provide design services and also be the one to carry out the production too offers a great advantage. A CM can lend valuable guidance in optimizing the device design and production, thus helping the smaller OEM go from prototype to finished product expeditiously and with minimum need for redesign.

Finding a CM that Understands the Market of Your Device

Finding a CM that understands the market of the device is also especially important if you will be outsourcing portions of the design. The CM’s team will work with your design group throughout the development process. An experienced CM will also know how to best navigate the Design Controls process with an eye on regulatory approval of the finished device. Finally, it is critical that the CM place strong intellectual property protections to ensure the design remains secure.

The Process Control Stage

One of the hardest things for many OEMs when working with a contract manufacturer is your perceived loss of control over the production of your medical device. You have so far overseen your production process from start to finish so making the move to outsourced manufacturing a challenging decision. Entrusting a CM to manage your product supply chain and quality controls along with all of the other elements of production will be a major shift in your philosophy.

The good news is that this does not have to be a major roadblock to outsourcing. Many contract manufacturers partner with the company instead of simply taking over production. You retain input into the process, even if the device is being manufactured by another company.

In addition, professional CMs work hard to build trust over time. Ultimately, that trust can eliminate many concerns about control over the medical device production.

Added Cost

Of course, the cost is a leading concern for any OEM considering making the jump to outsourced medical device production. The price will often play a significant role in selecting a CM.

However, it is important not to let cost cloud your judgment. Considerations of whether a CM is a right fit for your company in terms of capabilities, collaboration, and market are just as critical as price, if not more. Often, it is these CM characteristics that will determine whether the partnership will be both lasting and profitable.

Finding a Contract Manufacturer

Trust is key when choosing a contract manufacturer.

While many OEMs have concerns about medical device manufacturing outsourcing, problems can be kept to a minimum when working with a compatible CM.

Ultimately, the success of the relationship will come down to trust.

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