In the past, medical device companies could rely on a limited set of manufacturing capabilities or skill sets to deliver a wide range of product configurations. However, today’s devices increasingly require a wider range of competencies, including specialized and varied material processing technologies and the integration of materials with electronics. These demands require extended partnerships with specialist manufacturers, while also putting pressure on internal teams (medical, regulatory, legal, etc.) to be in lockstep.

That’s why cross-functional collaboration isn’t just an industry buzzword—it’s the only path forward for companies to succeed. At Theragen, where our focus is delivering innovative solutions to patients recovering from spinal surgery, our teams and our partners are committed to a manufacturing model that is collaborative, digitally integrated, and built on shared accountability. To keep pace with innovation and regulatory demands, we must continue developing strategies that allow seamless coordination across internal functions and external partners.

Self-Assessment and Sourcing the Right Partner

The orthopedic contract manufacturing market is experiencing rapid growth—valued at $6.62 billion in 2023, it’s expected to reach $22.10 billion by 2034. But before rushing into a relationship with any manufacturing partner, it’s crucial to evaluate your company’s internal strengths and limitations. It’s not only an exercise in humility, but also the first step towards identifying which capabilities should remain in-house versus outsourced to specialized partners.

And while it’s natural to be drawn to a candidate’s big name or the size of their capabilities, it’s critical to source the one that fits your operational scales and goals. What matters is partnering with a company that views your success as mutually beneficial and is committed to growing alongside you. At Theragen, we’ve learned that our operations are optimized when both our team and our partners are fully integrated in our workstreams—so we always look for alignment in values, timelines, and transparency with any potential manufacturer. An external supplier should be viewed as an extension of your team, not just a service provider.

Coordination Strategies and Shared Operating Frameworks

The quality assurance segment of outsourcing is expected to grow at a compound annual growth rate (CAGR) of 15%, reflecting companies’ increasing dependence on third-party partners for compliance, ISO 13485 adherence, and audit readiness. However, it’s important to remember that while you may outsource activities, you don’t outsource responsibility and quality—especially around compliance. It remains your company’s responsibility to translate compliance obligations into clear agreements, shared processes, and documented practices that align with those used by manufacturing partners.

For example, at Theragen, we’ve established a mutual understanding with our manufacturing partners: no process or product changes can occur without our prior knowledge and approval. When a change is proposed by our partner, they’re required to provide the information for our review. Only after we’ve reviewed and approved the change do we generate the documentation that allows our manufacturing partners to move forward. This ensures we’re in full control of our processes, reinforcing trust in our regulatory and quality systems while maintaining compliance at every stage.

While maintaining a cadence of communications through a variety of methods, such as business reviews with score cards, weekly tactical check-ins, and transparent reporting, both organizations can continue to be held accountable. Another method is to utilize relationship maps, which can help clarify roles across both organizations to prevent miscommunication and maintain efficiency. Implementing these processes takes time and effort—but will pay in dividends as your organization will face inevitable roadblocks in the future.

Leveraging Collaboration to Solve Challenges Proactively

Now that your operational frameworks are set in place, it’s up to you to maintain active collaboration across your internal teams and manufacturing partners to anticipate obstacles, respond quickly, and improve your product. By being on the same page as your manufacturing partners, you can address quality issues in a timely manner—enabling both organizations to detect issues early and coordinate quickly with suppliers to help avoid escalation and ensure product integrity.

At Theragen, our device requires hundreds of components in play at any given time. This means that a single end-of-life part can cause delays—that’s why we require foresight in the supply chain and lean on the expertise of our manufacturing partner to ensure we’re never in that position. We have worked with them to build in these processes, such as conducting multiple tests, securing the needed FDA approvals, and staying on top of internal documentation, to ensure smooth operations.

Planned product improvements are another important example of why practicing early collaboration with manufacturing partners is essential. Whether changes are driven by customer feedback or long-term strategies, like system upgrades or new features, input from your manufacturing partners ensures ideas are feasible, compliant, and scalable. Their involvement from the beginning helps avoid delays, reduce rework, and ensure improvements can be executed reliably.

Collaboration Isn’t a Trend; It’s a Requirement

In today’s fast-paced, quality-driven medical device market, successful outcomes hinge on strong partnerships, shared frameworks, and proactive planning. The most effective manufacturers are no longer just making parts—they’re strategic contributors.

Richard Pearce is currently the COO and VP R&D of Theragen Inc. For the last 25 years, he has worked on bringing therapeutic orthopedic medical devices to market and building fast-growing, commercially successful enterprises. This experience has taught Pearce that the most sustainably successful products are those that can be proven to deliver meaningful clinical patient outcomes, and significant cost benefits to the system—and that the most sustainably successful companies are those that are laser-focused on serving the patients and healthcare providers.