By Sean Fenske, Editor-in-Chief

Finding the right partner for a particular project can often seem to be more challenging than the development of the medical device itself. Many qualified organizations provide a wealth of benefits (there may be even more, however, that aren’t the right fit but may claim to be). Additionally, differentiating one from another can also be puzzling.

As a result, gaining insights from those involved in successful working arrangements can be extremely beneficial. Individuals who have vast experience in managing outsourcing relationships, whether from the perspective of the OEM or the contract manufacturer, can provide best practices in ensuring you select the right match for a future development project.

Fortunately, Doug Hutchison, Chief Commercial Officer at Confluent Medical Technologies, took time to share some of his knowledge in the following Q&A. He explains the factors driving the continued push for outsourcing, the value of working with a vertically integrated organization, why end-to-end manufacturing is important, and common challenges.

Sean Fenske: From your company’s perspective, what’s happening within the outsourcing space for medical device manufacturing?

Doug Hutchison: We’re seeing a clear shift toward strategic outsourcing partnerships rather than transactional vendor relationships. OEMs are looking for partners who can provide multiple key manufacturing capabilities instead of just one offering. They need partners that not only offer strong manufacturing capacity but also product development, materials expertise, and scalability. The demand for integrated solutions, from concept through commercialization, is accelerating, particularly as devices become smaller, more complex, and more performance-driven. Being a supplier that has expertise in only one area can be challenging to compete when other suppliers have similar expertise and offer other value capabilities. Confluent’s vertically integrated model allows us to deliver on that need with precision, consistency, and speed.

Fenske: What are the primary drivers of outsourced manufacturing, especially for minimally invasive technologies?

Hutchison: For minimally invasive technologies, precision, performance, and time-to-market are critical. OEMs increasingly rely on partners with specialized materials and process expertise, such as advanced polymer tubing, nitinol components, and balloon catheter technologies, to achieve the required miniaturization and functionality. Outsourcing enables OEMs to leverage established manufacturing infrastructure and deep technical experience, allowing them to focus internal resources on innovation and clinical strategy while accelerating product development timelines.

Fenske: Why is it important to identify a company with experience in end-to-end manufacturing (i.e., vertically integrated) versus a company that does one or two steps really well?

Hutchison: A vertically integrated partner like Confluent eliminates the fragmentation and risk that come with managing multiple suppliers. When all critical processes from materials selection to product development, assembly, and validation are managed under one roof, communication improves, lead times shorten, and quality is inherently more consistent. This approach also provides better design feedback early in development, helping to optimize manufacturability and scalability from the start. Ultimately, it ensures the device design intent is preserved through every stage of production.

Fenske: What are the common challenges encountered with a company moving a project from concept to commercialization? Where can issues take place? Are these minimized with a vertically integrated partner?

Hutchison: Common challenges include gaps between design and manufacturability, process variability across suppliers, and slow iteration cycles. These often occur when multiple vendors are involved, and information gets lost between handoffs. Confluent minimizes these challenges through our integrated structure, combining engineering, materials science, and manufacturing teams under one system. This integration allows us to quickly identify potential issues, implement design improvements, and validate processes in a controlled, efficient environment—all of which accelerate time to market and reduce risk.

Fenske: As the outsourcing company is not the “manufacturer of record” on a device, how should an OEM expect their manufacturing partner to handle key aspects, such as project management and/or risk management?

Hutchison: OEMs should expect their manufacturing partner to act as an extension of their internal team, collaborating proactively, managing risk, and maintaining rigorous traceability. At Confluent, we integrate program management, regulatory alignment, and quality control into every stage of development. Our teams operate with the same discipline and accountability as an internal manufacturing group, ensuring our customers maintain full confidence in compliance, performance, and reliability from prototype to production.

Fenske: What aspect of the outsourcing relationship is often overlooked or considered less important, but is a truly critical factor between both parties?

Hutchison: Transparency and technical collaboration are often underestimated. The best outcomes come when OEMs and manufacturing partners share a deep technical dialogue early and throughout the lifecycle of a program. This fosters faster innovation, fewer surprises, and stronger performance outcomes. At Confluent, our subject matter experts work side by side with our customers’ engineers to optimize design, material selection, and process performance from the very beginning.

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 medical device manufacturers?

Hutchison: The future of medical device innovation depends on trusted partnerships that combine advanced materials science, process engineering, and scalable manufacturing. Confluent Medical Technologies is uniquely positioned to support that vision, offering end-to-end capabilities, a vertically integrated supply chain, and decades of experience, enabling next-generation minimally invasive devices. Whether developing a breakthrough catheter system or a life-saving Nitinol component, our goal is simple: to help our customers bring their ideas to life with speed, precision, and confidence.

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