Bringing a CDMO+ Service Model to Surgical Instruments—An Orthopedic Innovators Q&A

By Sean Fenske, Editor-in-Chief

Many medical device OEMs, including those within the orthopedic technology space, are shifting from working with contract manufacturing organizations (CMOs) to contract development and manufacturing organizations (CDMOs). Partnering with an organization that understands not only the manufacturing, but also the important factors of the design and development phase is key.

But is that enough? Isn’t there more involved in the production of a medical device beyond the design and manufacture of it? What about the company that needs an instrument to accompany their device but isn’t interested in doing anything for it in-house? Can they identify a company that can handle not only the design and manufacturing, but also the packaging, labeling, logistics, and even regulatory aspects?

One company is promoting itself as a CDMO+ service provider. While the CDMO is familiar to many, the plus indicates there’s more that’s available as an offering. To help explain exactly what that is, Jens Haverkamp, General Manager of Komet Medical, responded to several questions. In the following Q&A, he explains what the plus means for its customers.

Sean Fenske: The industry has been showing a preference for CDMOs over the traditional CMO partner. What’s driving this shift?

Jens Haverkamp: Based on our experience, OEMs are placing greater focus on their core competencies as time and cost pressure continue to rise. Development cycles are getting shorter, time to market is becoming more critical, and R&D resources must be used more efficiently.

Therefore, OEMs are looking for partners that can do more than simply manufacture a finalized design. Partners that can take on responsibility early in the product development process with expertise in manufacturability, production processes, and validations, but also provide deep product-specific knowledge, will be the top choices for OEMs. This helps ensure products are designed from the outset for their intended application as well as efficient, scalable production.

Fenske: You are offering what you call CDMO+. In your model, what does the plus represent?

Haverkamp: The plus represents the next step in the evolution of the CDMO model, with services that extend beyond development and manufacturing. Our goal is not only to support OEMs with product development and manufacturing, but also to reduce complexity throughout the entire product lifecycle—from the initial portfolio concept to a market-ready product. This can help shorten development and regulatory timelines, reduce costs, and improve quality and reliability.

This support can begin even before product development through portfolio and product range consulting. Together with the OEM, we may assess, for example, which saw blade variants are needed to build a competitive portfolio for a specific power system.

In addition to fully customized product development, OEMs can draw from our broad catalog portfolio of existing cutting and fixation instruments and market them under their own brand. They can also use proven design elements, such as established cutting geometries, for new products. We also offer validated sterile and non-sterile packaging concepts.

For us, a project does not end with a manufactured and packaged instrument. Regulatory support is a key part of the plus. We also aid customers in setting up and updating their technical product documentation and helping complete the required registrations in their target markets. Our goal is to support the OEM through a fully documented, market-ready product.

When requested, we can assume even greater responsibility and serve as the legal manufacturer for a wide range of cutting and fixation instruments—the private label solution.

Our CDMO+ model is modular and can be tailored not only to each customer, but also to each project. An OEM may use traditional contract manufacturing for one product while transferring responsibility for a significantly larger portion of the overall process to us for another, including development, manufacturing, packaging, and technical documentation. This flexibility allows customers to combine different service models across their portfolio and choose the level of support that best meets the requirements of each project.

Fenske: Why is a private (or white) label offering for surgical instrumentation attractive to orthopedic device manufacturers?

Haverkamp: Private labeling allows an orthopedic OEM to offer a fully documented, market-ready surgical instrument under its own brand, while Komet Medical acts as the legal manufacturer. For example, the OEM designs and manufactures a new implant for which they act fully as the legal manufacturer. The specific cutting tools needed to place the implant can be fully branded and marketed under the OEM’s corporate identity, although production, documentation, and CE certification come from Komet Medical.

For the OEM, the key benefit is simplicity. Instead of setting up and maintaining the complete technical documentation internally, Komet Medical assumes all applicable legal manufacturer responsibilities for the product. This advantage is becoming even more important as regulatory requirements, particularly under the EU MDR, continue to grow more complex and resource intensive.

Important to know: The model is not limited to our catalog products. Fully customized products can often be offered under our private label model as well by adding these products to our product family platforms.

Fenske: How flexible is your offering when it comes to off-the-shelf product and packaging solutions versus fully customized development?

Haverkamp: OEMs do not have to choose between an off-the-shelf solution and a completely new development at the beginning of the project. Instead, we can tailor the level of customization to the specific requirements of each project. For that reason, every project begins with a shared understanding of the OEM’s requirements, timeline, and current stage of development.

Catalog instruments can provide an efficient starting point for projects with tight timelines, or when an OEM prefers to build on proven solutions to reduce cost and risk. Alternatively, proven design elements can be combined with custom features. This means that not every detail has to be developed from scratch.

The same applies to packaging. They can use existing validated sterile or non-sterile concepts and choose among suitable options.

Fenske: How do you manage such a broad range of services? Which processes do you keep in-house, which do you outsource, and why?

Haverkamp: Our general approach is to maintain direct control over our processes rather than simply coordinate a network of external service providers. Therefore, we have nearly all the capabilities and services in-house, from turning, grinding, laser cutting, gun drilling, and heat treatment to cleaning, quality inspection, and non-sterile and sterile packaging in our own cleanroom. Specialized processes such as diamond coating, surface treatments (electropolishing and bead blasting), and coatings (including TiN and DLC) are also integrated into our internal operations.

This high level of vertical integration reduces external handoffs, dependencies, and coordination effort. It also gives us direct access to the relevant expertise and enables us to closely align, control, and continuously monitor the individual processes.

Process reliability is another important advantage. We qualify, validate, and continuously monitor our manufacturing, cleaning, and packaging processes ourselves. This supports reproducible quality, full traceability, and reliable scaling into full-volume production.

Just as important is our highly qualified team of developers, design engineers, regulatory specialists, project managers, and many other experts who make this comprehensive offering possible.

Fenske: What unexpected benefits are realized from working with your CDMO+ model? What feedback have you received from your customers and were they surprised by an aspect of your offering?

Haverkamp: Many customers are surprised by how flexible and far-reaching our CDMO+ model is. Rather than offering every customer the same fixed set of services, we combine our capabilities and services to create the right solution for each project.

Regulatory support is often the biggest eye-opening aspect. OEMs frequently underestimate how much complexity can be reduced through our regulatory expertise and how far our support can extend toward a fully documented, market-ready product.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Haverkamp: CDMO+ is not simply about offering the broadest possible range of services and capabilities. It is about understanding the project and the OEM’s requirements as a whole and providing the right support throughout the product lifecycle when needed.

An equally important part of our philosophy is building close, trusted relationships with our customers. Our goal is not a short-term supplier relationship, but a long-term partnership in which both sides succeed together. That means taking responsibility, communicating openly, and solving challenges together.

For us, CDMO+ therefore combines broad capabilities and lifecycle support with holistic thinking and long-term reliability to support OEMs from the initial product idea through commercialization and beyond.

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