The Evolving Role of the Manufacturing Partner—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

Medical device organizations have been outsourcing manufacturing for decades. While they focused on ideation and development, they left the full production of the line to manufacturing experts. In more recent years, this trend has transformed, resulting in manufacturing partners being brought into the development process earlier.

One of the primary goals of this shift is to gain insights into strategies to optimize aspects of the product earlier, prior to design freeze, to ensure a smoother transition into manufacturing. Gaining input from those involved in the production of the device through design for manufacturing and other recommendations can be invaluable in saving time to market and cutting costs that could result from expensive revisions.

As this dynamic is still in flux, industry is still seeking recommendations on best practices for this relationship and how to make it more efficient. With this in mind, Jeff Miller, Vice President of Sales & Marketing at MRPC, participated in an interview on the topic. In the following Q&A, he shares his view on how to get the most out of this relationship and what benefits are enjoyed.

Sean Fenske: Many explain that an OEM should view a manufacturing partner as an extension of itself. What does this mean, and what does a supplier need to do to justify this viewpoint?

Jeff Miller: What “extension of itself” means is that a medical OEM views the contract manufacturer as a partner who is invested in the relationship in a much deeper way than just transactionally. The relationship is much more collaborative, strategic, and successful when the contract manufacturer is truly an extension of the OEM. The contract manufacturer must function like an internal member of the team, embedded in the organization as a true contributor.

The OEM needs to be able to share and integrate its quality requirements, its culture, its engineering methodology, and its overall design and manufacturing mindset into the contract manufacturer relationship—and truly have the opportunity to embed itself into the contract manufacturer’s organization and work collaboratively as one cohesive unit.

In turn, the contract manufacturer must provide a robust quality system, transparency, open communication, engineering depth, a strong Design for Manufacturability (DFM) mindset, and a long-term relationship orientation.

Fenske: The role of the manufacturing partner has entered the equation earlier in the development phase. As such, are they involved with early steps such as material selection? If so, how?

Miller: Yes, and this trend of earlier involvement is driven by a need from the OEM. The need is for design and manufacturing input from the contract manufacturer, well before the design is solidified and changes can no longer be made. The importance of this activity is further amplified because improving manufacturability, evaluating costs and quality, and optimizing scalability can be complicated for the OEM, if at all possible.

Successful manufacturing partnerships involve the contract manufacturer as early as possible, perhaps during prototyping or the early design phase. Whether related to material selection, gate location, tooling design, or other DFM activities, earlier involvement is significant because it corresponds directly to reduced costs, ease of manufacturing, reduced time-to-market, and improved quality.

Material selection is a particularly important example because the right partner can help evaluate not only performance requirements, but also manufacturability, scalability, and long-term supply continuity.

Fenske: How does the manufacturing partner help prepare for scalability and design for automation?

Miller: A good manufacturing partner is always contemplating not only the present, but also the future state of the program. These discussions can help drive decisions that will set the program up not only for success now, but for long-term scalability as well.

For example, tool cavitation, CAPEX needs, facility planning, automation strategy, and validation requirements are all factors that must be considered when employing a forward looking, scalable product line. The earlier these conversations happen, the easier it becomes to design a manufacturing process that can support growth without major disruption later.

Fenske: You already mentioned DFM, but can you expand on the role the partner plays with it? Where can they provide assistance and expertise?

Miller: The DFM partner must be involved early, and it’s where a contract manufacturer truly “wins” for their customer. DFM is where a contract manufacturer’s knowledge translates most directly into real gains in time-to-market, reduced costs, improved quality, and manufacturability.

DFM is a continuous collaboration between both parties, specifically the requirements of the OEM and the manufacturing knowledge and experience of the contract manufacturer.

A partner who is engaged, has the engineering talent, and possesses the expertise to participate in this early dialogue and execute effectively is ultimately going to be successful for the customer. This collaboration often extends beyond the initial product launch and helps establish a stronger foundation for long-term production success, scalability, and process optimization. That’s the ultimate return on the robust execution of a DFM process and early engagement.

Fenske: What unexpected benefits are revealed from bringing in a manufacturing partner earlier in development? What pleasant surprises are enjoyed?

Miller: The overarching benefits from bringing a manufacturing partner in earlier are a common theme throughout this discussion. These benefits include driving out costs, improving designs, reducing time-to-market, and improving manufacturability.

One of the biggest, unexpected benefits is often the level of collaboration and transparency that develops between the OEM and the contract manufacturing partner. When both teams are aligned early in development, potential issues can be identified sooner, communication improves, and decisions are made with a better understanding of long-term manufacturing implications.

The main point of these activities, as a byproduct, is exceeding expectations in every facet of the manufacturing process. This is an undeniable edge for our OEM partners.

Fenske: Ultimately, what is the definition of a true, full-service partner? What should OEMs expect from them?

Miller: A full-service partner is not only concerned with delivering what was asked of them; ultimately, they are concerned with success for their customer. It’s a bit nuanced, but these two objectives can oftentimes conflict. A true partner is willing to identify those conflicts early, have difficult conversations when necessary, and help guide the customer toward the best long-term outcome for the program.

OEMs should expect transparency, collaboration, engineering engagement, and proactive communication from a partner committed to supporting the program from development through launch and scale-up.

That is what defines a true, full-lifecycle manufacturing partner today.

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?

Miller: For OEMs, bringing the right manufacturing partner in early creates opportunities to improve manufacturability, reduce risk, accelerate time-to-market, and develop processes that can scale with future demand.

At MRPC, we believe the strongest partnerships are built on transparency, technical collaboration, and a shared commitment to long-term success. As devices become more complex and performance expectations continue to rise, that level of partnership is more important than ever.

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