Speed to market matters for every medical device original equipment manufacturer (OEM). It is a critical industry driver as customers demand innovation and stakeholders expect the OEM to not just lead, but to dominate. Yet, the journey to rapid innovation is filled with challenges: coordinating engineering resources, working with supply chain partners, scheduling test labs, alignment with complex internal development processes, and navigating regulatory requirements. For a large orthopedic OEM, bureaucracy, complex processes, and distributed teams inhibit speed to market. Meanwhile, for a challenger or smaller startup, the lack of an end-to-end process, limited capital, and unfamiliarity with regulatory nuances present obstacles. Further, all businesses, regardless of size, are beset by competing priorities.

In a professional kitchen, everything is ready in the right place since each second counts as the team works in concert to deliver a premium service. Similarly, to drive speed to market, an engineering team must have the right mix of technical resources: implant designers; finite element engineers; surgical experts; and manufacturing, prototyping, and testing engineers—all in the same place, working together seamlessly with the necessary resources. This accelerates the iterative sequential design process essential for orthopedic implant and instrument development, enabling rapid design, ideation cycling, analysis, surgical review, and performance evaluation.

This solution also eliminates a problem faced by many OEMs—a manufacturing supply partner offers design for manufacturing support, but they receive a product that’s been submitted for 510(k) and the design is essentially already locked. This results in launch stresses between the supplier and the OEM over the feasibility of manufacturing a 510(k)-cleared device that has little to no flexibility for adjustments.

Enter CDMO+—the smarter engineering solution. Imagine having everything you need in one place: a team comprised of surgical technique leaders; product, design, and manufacturing experts; and testing specialists housed alongside end-to-end manufacturing. In addition, this is all supported by a leading, top-tier regulatory group.

The Three Unique Elements of CDMO+

1. A Proven Process: Streamlined product development with end-to-end manufacturing and post-market surveillance, reducing iterative design cycles.

The CDMO+ model addresses the OEM’s need for a proven, reliable process. A specialist company with device experience, rapid prototyping, full-scale manufacturing, and regulatory support can ideate and develop implants and instruments, leveraging its deep expertise.

The best designs need refinement for performance optimization. While design engineers rapidly build out concepts, typically, the development cycle starts to stretch out at the point of prototyping and testing. Even with the most responsive prototype suppliers, the production cycle can be weeks—not days—and as a result, the development team is backing up against cadaver lab schedules and the expediting of parts.

At every stage of this cycle, a proven product development process accelerates the sequencing. Co-located rapid prototyping cells create samples ranging from 3D-printed plastic and metal samples to fully machined implants, assemblies, and instruments. As a true end-to-end process provider, the CDMO+ team has every necessary element for the finishing process. This allows for new product development (NPD) engineers to fine-tune surface processing, obtain the best results, and get products into the hands of surgeons and technical experts, thus creating truly usable samples and cutting time to the evaluation labs.

Since the design process is iterative and test results highlight areas for optimization, feedback can be rapidly incorporated and retested within the current setups. This translates into not just quicker development, but also enhanced product performance and quality as design optimization is no longer traded off against long testing widows. Faster development and superior products, where innovation and quality are never compromised, is the ultimate goal and able to be achieved under one roof.

2. Cross-Functionally Trained and Aware Engineers: “You can’t really understand another person’s experience until you’ve walked a mile in their shoes.” —Mary T. Lathrap

To build cross-collaboration and a shared common understanding, a company’s leadership team might consider developing an engineering rotation program. The objective of such a program is simple: broaden the range of experiences of engineers so they understand the development process from the point of view of their colleagues in other departments. Over a fixed time-period (for example, a two-year period in six-month increments), engineers are exposed to a range of end-to-end disciplines from conceptual development to production including: design, NPD quality, regulatory/clinical, process/manufacturing engineering, operations quality, continuous improvement, etc.

The growth plans are tailored to each engineer considering their desired endpoint and the areas of greatest impact. This builds versatility and exposes the team to the broad range of efforts required to design, develop, manufacture, and maintain medical devices. Engineers who cycle through the rotation understand the capabilities and constraints of the other teams participating in the design process, enabling them to work more effectively and collaboratively. Ultimately, this will drive improved outcomes in terms of design performance and development times based on a better appreciation for how the team works to meet the OEM needs.

3. Expertise and Muscle Memory: Better designs and better outcomes delivered faster through learning and repetition.
Specialization matters—as the CDMO+ teams evolve, they accumulate a wealth of experience and shared knowledge. Where an OEM might release a specific new product line type every few years, the CDMO+ teams are repeating new product launches frequently across a portfolio of diverse customers. This repetition builds invaluable muscle memory. It is then honed through development and exposure to an extensive array of proprietary knowledge and intellectual property related to medical device development, surgical techniques, and historic performance, as well as the closed-loop feedback from post-market maintenance.

Rather than starting from scratch with each design, the product development process leverages past experiences, minimizing trial and error. This not only shortens development time, but also accelerates speed to market and revenue generation compared to a large OEM. By continuously refining expertise, the CDMO+ model drives efficiency and innovation.

The Benefits of the CDMO+ Approach

Adopting a holistic approach to product development, the CDMO+ model leverages co-located, end-to-end processes and a team of seasoned engineers from diverse disciplines.

Capitalizing on a proven, scalable model—honed through extensive experience and repetition in implant development—yields substantial advantages. Development cycles can be slashed by as much as 30% to 60%, thanks to specialization, which enhances implant quality and drives significant advancements in instrumentation. Synchronous development and rapid iterations lead to superior product refinement and performance, setting a new standard in the industry. 

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Rich Warren is the chief commercial officer (CCO) at Resolve Surgical Technologies, an Orthopedic CDMO+. In this role, he is responsible for the commercial strategy, new product engineering, and regulatory group. Before joining Resolve Surgical Technologies, Warren served as the CCO for Medical Manufacturing Technologies Inc. (MMT). There, he led strategic sales and marketing activities and oversaw the TotalCare forward stocking program, which set the benchmark for aftermarket service and support. Previously, Warren spent 15 years at the LISI Group of companies in commercial and general management roles, where he delivered strong, meaningful growth in its medical and aerospace business units. In addition to his time at LISI, Warren also held various roles at GKN and has a master’s degree in mechanical engineering.