What to Look for When Choosing a Medical Device Contract Manufacturing Organization (CMO)

There are several challenges medical device innovators face when creating a medical device, which can be mitigated or resolved with the right CMO. They include:

• Cost of design and production. Supply issues and supply chain disruptions over the past year have added additional costs to the development and manufacturing of the medical device. The right CMO can spot these issues and reduce costs, save money in the long run and still help bring a product to market. We work with polymers, so we know which polymers will produce the right device functionality for your design needs. We help address the options to discuss costs and any potential issues we foresee with it.
• Government regulations. Each year, government regulatory bodies (FDA, accredited ISO 13485 Certification Bodies, etc.), introduce new regulations and programs (ie. EU MDR, MDSAP), which can add to the cost or delay the speed-to-market for a new medical device. Negotiating your way through this minefield should be a serious part of your CMO decision, because the right one will have years of experience navigating in the regulatory arena.
• Risk prevention & mitigation. Taking action to reduce an organization’s exposure to potential risks and reduce the likelihood that those risks will happen. Given the realities, both FDA & ISO Quality System requirements mandate risk analysis and risk mitigation throughout the development process. A robust contract review performed by the CMO is most effective way of meeting customer standards and requirements.

As you can see, the right CMO will streamline the production process and provide the support you need to mitigate risk and manage the project from start to finish. What you get, in the end, is a medical device or component ready for manufacturable production. Your CMO partner helps you navigate through the potential pitfalls of regulation and supply issues. The process can bring your medical device to market faster and at a lower expense to you.

Now that you understand how the right CMO can benefit you in the long run, what criteria do you list to make the right choice? Let’s look at the key components that go into the decision.

In order for the CMO to reduce risk, speed production and limit the costs, you need to consider:

• You want your contract manufacturing organization to be more than a contractor or “job shop.” The right CMO will partner with you, becoming an operational arm of your company in a way. Doing so allows for easier communication and understanding about what is needed on both sides. These partnerships have clear lines of communication between you and the CMO and can communicate your needs effectively to others in the process. It is also important to know what your device needs and that your requirements are up front in the process.
• If the CMO you’re looking at is unaware of the latest technologies in medical device manufacturing, then you should consider looking elsewhere. The right CMO will be up-to-date on the latest methods of building medical devices, because the latest methods can make products faster and cheaper. The employees who manufacture the product should be experienced and capable of creating a top-quality product with a faster turnaround.
• Supply chain management. How do you negotiate possible supply chain issues? For example, during the pandemic, supplies from around the world had trouble being delivered on time or at all. A CMO will know how to get through these issues, and offer solutions that will make sure supplies get through and the product is built. You also want to be sure the CMO has experience in finding quality materials to build your device. Different people have original ideas of what quality is, so finding a CMO with strong vendor relationships smooths this concern.
• Speed-to-Market. With years of experience within the right CMO, you should be able to get to the market faster. In this industry, that’s important so that your innovations are first or ahead of the competition. Delays by a CMO can prevent you from getting to the market fast or at all. However, a CMO with experienced people can help produce your device and bring your product to those who need it faster and more effectively.
• Managing costs. Of course, if the CMO you choose does all the things listed above, but you still find you’re going far above your budget, you may not have the right CMO fit. The most experienced contract manufacturing organization will provide all the services listed above, but also keep cost at the front of their mind to reduce it as much as possible, while still producing a quality device.

The history page on our website says it all. Flexan was founded with collaboration and partnership at the forefront. We have decades of experience in helping companies just like yours create the medical device they want, while keeping costs top-of-mind, using elastomers and polymer compounds. We focus our entire business model on becoming a partner with you to help progress from the conception stage to market, providing guidance on each decision along the way.

The first step in choosing Flexan as your CMO is to contact us and discuss what your project is. We’ll work with you to create a contract manufacturing relationship that works for you and for the medical device you want to bring to market. Contact us today.