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Renewed Relationships for Full-Service Medtech Outsourcing

Challenges in recent years have led medical device manufacturers to revisit their outsourcing strategies and engagement with strategic partners.

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By: Sean Fenske

Editor-in-Chief

Innovation collaboration in medtech. Photo: Command Medical Products LLC

Supply chain struggles, geopolitical conflicts, and a worldwide pandemic put significant strain on medical device manufacturers’ (OEMs) abilities to develop and market their medtech solutions in a timely and cost-effective manner. Whether these challenges resulted in a critical component being unavailable or increased costs due to the region in which a manufacturing partner provided services, medtech organizations have taken notice. As a result, they are adjusting how they work with their development and production partners. 

To get more insight into how this has impacted contract manufacturing organizations (CMOs), MPO reached out to a bevy of representatives to hear their perspective on this ongoing evolution. In addition, they addressed a variety of additional questions involving important factors beyond the interaction with OEMs. Among those who participated in this roundtable discussion were: 

Sean Fenske: From your perspective, what is the outsourcing situation in medtech? Growing, shrinking, or about the same?

Mike Anderson: The medtech outsourcing situation is very positive and growing. This beneficial environment comes with ever-increasing requirements on CDMOs [contract development and manufacturing organization]. OEMs [original equipment manufacturers] are looking to the CDMOs to do more; modern CDMOs must consider complete lifecycle responsibilities. For most, this requirement will cause a strain on the organization. For ATL, we have supported the complete product lifecycle for the last 30 years, as evidenced by our more than 200 product launches and the maintenance and management of over 90 technical files. 

Bryan Blessing: More than anything, it appears OEMs have been hesitant to make decisions on moving manufacturing, which has been highly attributed to the changing tariff landscape. There has been hesitation to invest in a manufacturing transfer due to the risk of the tariff landscape changing. This has put programs on hold over the past year, but it appears that recently OEMs are moving forward with plans to outsource. 

Niall Cullen: Medtech outsourcing continues to play a critical role in helping OEMs bring products to market and ensure patients receive the therapies they need. But the nature of outsourcing has fundamentally changed. It is no longer primarily about adding capacity or reducing cost; OEMs are engaging partners earlier in the development cycle for design and manufacturing expertise, informing design tradeoffs, and derisking product ramps.

It is reshaping relationships, requiring deeper collaboration, stronger integration, and shared accountability. Outsourcing today is not only about delivering volume; it is about helping OEMs anticipate risk, engineer flexibility, and make the right decisions early, when they matter most.

Scott Drikakis: According to Precedence Research, contract manufacturing alone reached approximately $100 billion in 2025, with a near-term projected CAGR of 10% to 11%. These results can vary depending on the individual CDMO and their business model regarding finished device manufacturing versus component-level outsourcing.

John Faulkner: From our perspective, I think the market in medtech is growing. 

Tracy Gahagan: Outsourcing is growing and evolving. OEMs are seeking partners who can move fast, hit tight tolerances, and scale programs as they ramp. As devices get more complex, they’d rather work with trusted manufacturing partners who already have expertise, equipment, and teams in place.

Brandon Hoffman: From our perspective, outsourcing in medtech continues to grow. After post-COVID supply chain disruptions, the industry returned to steady year-over-year growth, with North American procedure volumes normalizing by late 2024. As demand rebounds, OEMs are increasingly relying on external partners to scale quickly and manage risk.

Outsourcing is also accelerating because next-generation devices combine multiple technologies, such as micro-molding, electronics, sensors, and drug delivery, making it impractical for OEMs to maintain all capabilities in-house. For example, in diabetes and drug-delivery applications, OEMs often outsource precision components like micro-molded cannulas to specialized CDMOs rather than invest in highly specialized equipment and expertise internally.

Finally, capital allocation has shifted toward innovation over manufacturing expansion. Many OEMs are prioritizing R&D and speed to market, using outsourcing partners to provide flexible, validated capacity without the burden of new facilities. As a result, outsourcing has become a strategic enabler of growth, not just a cost-control measure.

Chris Johnson: Outsourcing in medtech is continuing to grow. OEMs are increasingly relying on specialized partners to gain access to technical expertise, manage cost pressures, and improve speed to market. The strategic focus on core competencies, combined with regulatory and supply chain complexity, is further accelerating this trend.

Jim LaVersa: Outsourcing in medtech is clearly growing. Across our existing customer base, we’re seeing rising demand spanning a diverse range of medical sectors. New customers and prospects are increasingly seeking partners who can accelerate time-to-market and bring specialized manufacturing and in-house automation expertise to the table. Harmac has deliberately aligned its capabilities and resources to meet these expectations.

Neil Muchin: Outsourcing is growing but is also being redefined on a global scale. OEMs are moving away from fragmented supplier networks and toward fewer, more capable partners who can take ownership across the product lifecycle. The reality is that complexity has outpaced traditional outsourcing models. If a CMO cannot effectively support design, development, and scalable manufacturing in a coordinated way, it becomes a bottleneck. 

Nicole Ramus: Outsourcing in medtech is clearly growing. OEMs are increasingly relying on specialized partners to accelerate development timelines, access technical expertise, and maintain cost efficiency across the product lifecycle. The industry is also shifting toward deeper collaboration with partners who can support not just manufacturing, but design, development, and lifecycle management.

At the same time, outsourcing is no longer purely about capacity; it’s about strategic capability. OEMs want partners that can help mitigate risk, accelerate innovation, and guide products from concept through commercialization while maintaining quality and regulatory rigor.

Bill Ruth: From my perspective, outsourcing in the medtech industry continues to grow and evolve. OEMs are increasingly looking for partners that bring not only manufacturing capacity but also engineering expertise and regulatory understanding. As medical devices become more complex, OEMs recognize the value of working with specialized partners who can support them throughout the product lifecycle. We see this shift as a move toward deeper technical collaboration rather than transactional outsourcing.

Ward Sokoloski: Definitely growing. Innovation continues at all levels of the industry, from large multi-national OEMs to transformational startups.

Fenske: Did lessons learned/reactions from recent supply chain challenges affect this direction/change? How/Why?

Anderson: Yes. What the medical CDMO world experienced in recent years provides further testament to the vision of ATL. For more than a decade, ATL has operated and positioned ourselves for multi-site redundancy, product/program transfer, and complete lifecycle support. 

We have been able to evidence our ability to support this complete product lifecycle (i.e., concept, design, development, launch, ramp, scale, steady-state production, sustaining, and cost improvement), utilizing our proven track record for programs that have identifiable, consistent quality by ATL. 

Blessing: The last thing any decision maker wanted was to put forward the cost and effort to relocate manufacturing, only to learn that adverse changes in tariffs would make their investment not cost-effective. This led to a cooling period as everyone evaluated the political changes and how they would settle over time. It appears these holds have lifted, and we are seeing activity closer to 2024 levels.

Cullen: Like many industries, CDMOs have previously faced supply shortages and logistical constraints that had the potential to disrupt continuity and extend time to market. These disruptions can delay patient access to innovative solutions, underscoring the critical role of supply chain resilience. In response, CMDOs have had to deepen their understanding of supply chain risk and invest in more robust models, including greater vertical integration. Key focus areas include managing single-source dependencies, long lead times, tightly constrained materials, and other vulnerabilities embedded in program architecture.

The core lesson learned is that resilience must be designed from the outset, linking early risk mapping to material selection, tolerance strategies, and platform decisions to reduce downstream exposure.

CMDO partners play a critical role here. We can influence architecture and process decisions before supply chains are locked. We are seeing continued vertical integration to secure critical pathways, but also more intentional collaboration upfront to preserve flexibility. The shift is from managing disruption to engineering optionality from the start.

Drikakis: Absolutely. Post-COVID supply chain challenges and safety stock levels have emphasized the need for stronger collaboration and partnerships between strategic suppliers and OEMs, leading to greater transparency from our key OEMs. This has enabled us to increase investments in departments like program management and engineering, while expanding our global facilities to meet various regional needs.

Faulkner: In our business, you have to always be on top of your supply chain; that’s been a strength of ours and one upon which we focus. This allows us to be more in tune with what our customers need and less reactive. 

Gahagan: Absolutely. The past few years reinforced the importance of resiliency, redundancy, and transparency. OEMs are now prioritizing supplier diversification, geographic risk mitigation, and deeper collaboration with strategic partners. Long-term agreements, forecast sharing, and early supplier involvement have all increased as a result.

Hoffman: Yes, supply chain disruptions and changes in international trade policy prompted OEMs to reassess risk and resiliency across their global supply networks. While medical device regulations make supplier changes costly and complex, targeted remediation efforts have emerged—most notably selective onshoring and near-shoring.

Rather than broad reshoring, OEMs have shifted critical or higher-risk components closer to end markets, including near-shoring to regions such as the Dominican Republic, which offers established medtech manufacturing infrastructure, a skilled workforce, and proximity to North American markets. These moves help reduce lead times, logistics complexity, and geopolitical exposure while maintaining regulatory compliance and cost efficiency.

Johnson: Yes, recent supply chain disruptions reinforced the importance of strong outsourcing partnerships. Many OEMs reevaluated their supplier networks, prioritizing partners with robust quality systems, geographic diversity, and vertical integration to improve resilience. Rather than reversing outsourcing, the challenges drove more strategic and selective outsourcing decisions.

LaVersa: Absolutely. We’ve seen OEMs place greater value on Harmac developing robust supply chain strategies, dual sourcing/dual site approaches, and clearly defined risk mitigation frameworks. In response, Harmac has elevated its focus on customer service levels, inventory visibility, and continuity of supply, ensuring we remain a reliable, responsive partner in this increasingly complex environment. 

Muchin: One of the biggest lessons we have learned over the last few years is that supply chains built just for efficiency can be pretty fragile. OEMs saw firsthand that disruption isn’t theoretical; it actually happens, so now resilience is just as important as cost or speed. That is pushing companies to bring partners in earlier and to work with those who can handle more of the process, rather than relying on a variety of different vendors. At Cordica, our large manufacturing footprint gives us the flexibility to meet customers where they need us and support them as they scale, whether that’s domestically for regulatory confidence, in nearshore Mexico for cost-effective high-volume production, or in Singapore for Asia Pacific device manufacturing.

Ramus: Absolutely. The supply chain disruptions of the past several years highlighted the importance of resilience and forward-looking planning. Many OEMs are now prioritizing risk mitigation strategies, including supplier diversification, earlier collaboration with manufacturing partners, and more robust planning around materials and logistics.

These challenges also reinforced the value of partners who can help guide development decisions with manufacturability and scalability in mind from the start. When design, manufacturing, and supply chain considerations are integrated early, companies are better positioned to avoid costly delays and accelerate their path to market.

Ruth: Yes, recent supply chain disruptions reinforced the importance of resilience, transparency, and strong supplier relationships. OEMs are placing greater emphasis on supply chain visibility, geographic diversification, and partners who can demonstrate operational stability. For many companies, the past few years have highlighted that a reliable manufacturing partner is not just a supplier, it is a critical extension of their business. This has accelerated the trend toward strategic partnerships where manufacturers are involved earlier on. 

Greg Santorno: Absolutely. The last several years forced a reset. OEMs realized efficiency without resilience is a risk. Between geopolitical instability, tariffs, logistics disruptions, and supplier fragmentation, many companies found themselves exposed. What we are seeing now is a strategic shift toward consolidation and reshoring—fewer suppliers, deeper partnerships, and more accountability. 

From a strategic standpoint, it is about control across the product lifecycle. When you can align design for manufacturability and design for assembly early, control tooling in-house, scale production domestically, and automate intelligently, you reduce variability and long-term risk. That is where the industry is heading, and it aligns directly with how we have built Vantedge.

Fenske: Has your relationship with your suppliers changed as a direct result of the challenges encountered in recent years? If so, how?

Anderson: The highs and lows of the last number of years have enabled ATL’s supplier partners the opportunity to galvanize their relationships with us. Nobody had it easy in the last few years; it is during these times of challenge that you learn who your true partners are. ATL worked to exemplify the same to our OEM partners. 

Blessing: Suppliers have been eager to quote programs, and we have had very quick responses from industry when we have asked for quotes. We are seeing a more competitive environment for these supplier quotes. 

Cullen: Supplier relationships have evolved into deeper partnerships built on shared accountability. OEMs are engaging suppliers earlier, and they are not simply looking for execution. They expect perspective.

There is a clear shift toward valuing judgment alongside capability. OEMs want partners who will challenge assumptions, surface tradeoffs early, and align engineering, manufacturing, and regulatory considerations in parallel. The value of a supplier today is increasingly measured by the quality of decisions they help optimize early, not just by the problems they solve later.

This approach leads to stronger alignment and smoother scale-up. At Integer, our R&D ecosystem brings specialized labs, engineering expertise, and scalable manufacturing into a unified framework, so design decisions are made with commercialization in mind from the outset.

Drikakis: As Quasar has evolved into a full turn-key CDMO, it has necessitated maturing our supply chain process and adopting practices typically seen from OEMs. For instance, hiring supplier relationship managers to oversee our tier 2 and 3 suppliers has enabled us to be more transparent about the requirements from the customers we serve. This has fostered closer alignment on forecasting, on-time delivery, and continuous improvement initiatives.

Faulkner: I think our customers had trust in us before the worldwide issues began, and the horror stories they heard only solidified the importance of working with a partner—not just a manufacturer, but a team that can work and grow with you through the difficult times. 

Hoffman: Yes, supplier relationships have become more collaborative, transparent, and data-driven as a direct result of recent supply chain challenges. There is now greater emphasis on frequent communication, joint business and logistics planning, and shared predictive analysis to identify and mitigate risk earlier.

For example, rather than reacting to material shortages or freight disruptions after they occur, OEMs and suppliers are increasingly sharing demand forecasts, capacity plans, and lead-time scenarios to proactively manage constraints—especially for critical or long-lead components. This closer coordination allows both parties to address current issues more quickly and reduce the likelihood of future disruptions, strengthening long-term supply continuity rather than treating suppliers as transactional vendors.

Johnson: Yes, relationships have become more collaborative and transparent. There is greater emphasis on early supplier involvement, shared forecasting, and proactive risk management to avoid surprises. In most cases, the trend has shifted from transactional to more strategic, long-term partnerships, aligning top-to-top senior leadership from OEM and CMO to drive long-term stability, growth, and collaboration.

LaVersa: We’ve always kept close contact with our key suppliers and overall supply chain with regular face-to-face meetings when feasible, as we have long valued a collaborative working relationship. At Harmac, we involve our suppliers early in the product lifecycle and work closely with them day-to-day to help ensure visibility to demand, which directly improves continuity of supply, quality adherence, and proactive communication around our customers’ needs.

Muchin: In general, it has become more strategic, notably including localized capacity and regulatory considerations. The days of transactional sourcing are fading, and today, it is more so about alignment, visibility, and shared accountability. If your suppliers are not integrated into your planning and risk management, you are exposed. We treat our suppliers as strategic partners, integrated into our planning and risk management, rather than just transactional vendors.

Ramus: Yes, relationships across the supply chain have become more collaborative and transparent. Rather than purely transactional engagements, we’re seeing deeper partnerships where information sharing, joint planning, and proactive risk management are expected.

This shift reflects the reality that successful device development now requires a coordinated ecosystem of partners working together to anticipate challenges and respond quickly when conditions change.

Sokoloski: Forj Medical has strong relationships with our suppliers, and we’ve partnered with them to navigate the challenges in a way that continues to benefit our customers. By utilizing our international sites, we can direct the supply chain to regions that address the challenges.

Fenske: On the other hand, has your relationship with customers/OEMs changed in recent years? If so, how?

Anderson: Yes, our relationships with our customers have improved recently through advanced alignment. ATL is a know-how company with experts in electronically driven medical devices. CDMOs and OEMs must be aligned on what to expect from each other. These trusted partnerships are built on consistent quality, delivering on commitments, and being willing to say no when capabilities and needs do not align. 

Over the last number of years, many OEMs have been put in a position to challenge their partners to identify true capabilities. ATL and our partnerships with OEM customers are stronger today as a result of making and keeping commitments. 

Drikakis: The past few years have been tough due to supply chain and geopolitical issues, highlighting the importance of flexibility and partnership. I must admit these situations led to some difficult conversations about what true partnership and success look like. When we managed to align on these concepts, our relationships improved beyond expectations, but when we couldn’t, we wished them well because we understand we can’t be everything to everyone.

Faulkner: Our relationships have strengthened because we have been in the industry for 50 years and consistently deliver reliable support to OEMs of all sizes. 

Gahagan: Yes, OEMs expect more from their CMO. They want insight, innovation, and speed. We are increasingly engaged earlier in the product lifecycle, often supporting design for manufacturing, automation strategy, and rapid prototyping to accelerate time to market.

Johnson: Yes, OEM relationships have become more strategic and integrated. There is earlier engagement in the design and development cycle, along with greater transparency around demand planning, risk sharing, and long-term capacity alignment. The focus has shifted toward true partnership models rather than project-based engagements.

LaVersa: Yes, our relationships with customers have become notably closer and more collaborative. We’re engaging with OEMs earlier in the product lifecycle, not just at the manufacturing stage but upstream in design, regulatory planning, and supply chain strategy. This hands-on collaboration helps us deliver better outcomes for our customers while continuously strengthening how we work together. It’s the model we believe defines the best OEM/CDMO partnerships.

Muchin: Yes, we’ve definitely seen a shift in how we work with OEMs. They are no longer waiting until the design is finalized. They are bringing in partners like us much earlier because they understand that decisions made at the concept and design stage directly impact how a product scales, what it costs, and how smoothly it moves through the regulatory process. At Cordica, that’s a big part of how we work. We are involved early in product design, supporting CAD development, building prototypes, and then guiding that prototype through verification and validation testing, regulatory submissions, and even first-in-human studies when needed. Through our Catalyst design hub, we support the full development cycle, not just the front end. That early collaboration helps us, and our customers, work through challenges up front rather than trying to fix them later at scale. The expectation now is that a CMO is not just there to manufacture, but to help shape the product from the beginning so it can be produced efficiently and reliably.

Ramus: OEM relationships are evolving toward earlier and more strategic collaboration. Increasingly, OEMs want partners involved at the concept and design stages, not just during production.

This approach allows us to help guide design decisions with manufacturing insight, identify risks early, and accelerate development without sacrificing quality. It also enables a more iterative development model where solutions can be tested, refined, and improved quickly.

Ruth: Yes, OEM relationships have evolved toward deeper collaboration. Many customers are engaging manufacturing partners earlier in the development process to address design for manufacturability, supply chain considerations, and scalability from the outset. There is also increased focus on long-term strategic partnerships rather than short-term supplier relationships.

Sokoloski: Our customer relationships have grown stronger in recent years, especially following the combination of Minnetronix Medical and Intricon to form Forj Medical in late 2025. By uniting deep design expertise with scalable manufacturing capabilities, we’re able to support customers more seamlessly across the full product lifecycle—from concept to commercialization.

Both legacy organizations were built on solving complex technical challenges with strong engineering depth and a customer-first mindset. Today, as Forj Medical, customers increasingly view us as a strategic partner—not just a supplier—helping them navigate complexity and scale with confidence. For example, when our legacy Intricon automation partner was impacted during COVID, we made the strategic decision to bring that team in-house. This strengthened our vertical integration and now enables customers to scale intentionally and rapidly with greater control and responsiveness.

Fenske: Is M&A activity within the industry affecting the OEM/CMO relationship? If so, what is the impact?

Anderson: In the last few years, ATL has made three critical acquisitions, adding expertise and capabilities that are enabling growth within many OEM relationships. As mentioned, OEMs are seeking CDMOs to provide additional support and to unburden the OEM as much as possible. When you achieve “Trusted Partner” status, as ATL has, strategically aligning customers’ needs and requirements provides direction on where M&A teams can focus their efforts to grow a specific strategic partnership.

Blessing: We continue to see a shrinking pool of independent middle-market CMOs as M&A activity (particularly private equity acquisitions) has spread a growing gap between smaller outfits and larger, bureaucratic corporations. We have received feedback on the relationship advantage of remaining independent and privately owned.

Faulkner: I believe the answer to that question is yes, but for us, this is a positive result. As more and more M&A happens, there are fewer and fewer companies like ours. We have always said that when working with us, you will get the top-level feel of working with a big CM, but with the responsiveness of a small, family-owned company. We care about our customers’ products and want to partner and grow with them. This should be a win-win for both sides of the relationship, not just a venture capitalist looking to make as much as they can before they resell the business again.

Hoffman: Yes, M&A activity is influencing the OEM/CDMO relationship by accelerating the move toward integrated capabilities and more focused value propositions. As a CDMO, acquisitions are increasingly targeted to build competencies aligned with emerging technologies and future device needs.

While this involves some informed risk-taking, we’ve seen success in combining complementary niche technologies into integrated solutions. For example, merging capabilities such as micro-molding and steering technologies enables us to support OEMs developing next-generation devices that require tighter integration, higher precision, and fewer handoffs across suppliers. The result is greater value for OEM customers through simplified supply chains, faster development timelines, and access to broader technical expertise within a single partner.

Johnson: Yes, M&A activity is influencing the OEM/CMO dynamic. Consolidation among both OEMs and CMOs is driving supplier rationalization, expanded capabilities, and greater expectations around scale and geographic reach. At the same time, it is elevating the importance of cultural alignment and integration execution to maintain continuity and performance.

Muchin: Yes, and it is raising expectations. Consolidation has created larger platforms, but size alone does not solve complexity. OEMs are looking for partners that can combine scale with deep technical specialization. At the same time, we are seeing more focus on where that manufacturing happens. U.S.-based and nearshore capabilities are becoming a bigger part of the conversation as OEMs look to reduce risk, improve lead times, and stay closer to their end markets. At Cordica, having a footprint in the U.S., Mexico, and Singapore gives us the ability to offer that flexibility, which has become increasingly important as customers rethink how they structure their supply chains.

Ramus: M&A activity is definitely influencing the landscape. Consolidation among suppliers can create larger organizations with broader capabilities and greater vertical integration. In many cases, this enables partners to offer more comprehensive services across design, development, and manufacturing.

At the same time, it reinforces the importance of maintaining agility and customer focus. OEMs still value partners who are responsive, flexible, and willing to approach complex challenges creatively rather than forcing projects into rigid processes.

Sokoloski: M&A creates opportunities within the OEM/CDMO relationship. Forj Medical itself is the result of strategic M&A, bringing Minnetronix Medical and Intricon together to deliver greater scale and capability to our customers. By combining capital system design and manufacturing expertise with precision microelectromechanical sensor solutions for single-use devices, we offer a more integrated, end-to-end partnership. Customers benefit from streamlined sourcing, deeper technical alignment, and a partner positioned to support both their core systems and the disposable technologies that work alongside them.

Also, stronger, more full-service CDMOs benefit startups and smaller medical device companies that have the potential to be acquired by top OEMs. Our capabilities at Forj Medical, for example, provide risk mitigation for these smaller companies because we have an established and robust supply chain and can also help them prove out their prototypes to investors.

Fenske: What recommendations do you have for OEMs currently seeking new CMO suppliers? How can they best evaluate a prospective partner, and what traits should be considered most important? 

Anderson: I’ve written a couple of articles and blogs about this topic over my career. The most important thing for an OEM to do before engaging a CDMO is to identify the needs of the final product, then work backwards. What are the characteristics of the CDMO partner needed to fulfill the final product needs? One of the most gratifying statements a partner made to me was when an OEM executive said, “You are exactly who we need, you are a medical electronics company with the expertise to produce catheter-based devices. Too many component manufacturers are failing to support our electronics-based device needs”. Anyone who has spent time in the CDMO world has stories of developing a product, only to find that there is a lack of internal alignment and the project stalls, or worse, gets cancelled. Know your needs and ensure your partner will be able to fulfill those needs. 

Faulkner: I believe you want a company that will toe the line with you instead of being a player in the background. No one wants to be called a strategic supplier; you want to be in on a project together, working to accomplish goals as a team, even from different sides of the field. 

Gahagan: OEMs should evaluate suppliers on technical depth, process capability, quality, financial stability, capacity, and scalability. OEMs should also assess whether the CMO can think strategically and not transactionally.

Jay Gurgens: When OEMs are evaluating new manufacturing partners, I encourage them to look at the whole system, not just the capability list. Find a partner that truly understands how critical quality is. These are medical devices that impact real patients. The right partner treats quality not as a department, but as a culture and a non-negotiable responsibility.  Supply chain stability is also important. A U.S.-based footprint matters because it reduces risk and improves responsiveness. Then look at scalability and lifecycle support. Can this partner take you from prototype through full production without adding complexity? Look for a manufacturing partner that strategically aligns its technology and capacity investments with your broader portfolio strategy—a partner that plans with you. Scaling automation, facilities, and talent in sync with your portfolio so they can support you as a true long-term collaborator rather than simply a transactional supplier should be a search goal.

I would also pay attention to how they approach automation and operational excellence. Is it part of a disciplined, ongoing cost and quality strategy, or just equipment on the floor? Continuous improvement should be embedded in how they operate. Finally, technical depth matters. In medtech, you are building mission-critical devices. A true partner understands the clinical application, regulatory expectations, and what’s at stake. That combination of reliability, lifecycle support, operational discipline, and real device expertise is what separates a vendor from a long-term partner.

Hoffman: OEMs should begin by clearly defining their technical, operational, and lifecycle requirements. Transparent communication of expectations is critical. When CMOs fully understand the scope, timelines, and success criteria, they can accurately assess fit and propose appropriate solutions.

OEMs should evaluate partners based on full lifecycle alignment, from early development or late-stage validation through long-term commercial manufacturing. Fully understanding the support areas their supplier focuses on will provide future benefits, as external manufacturing requirements for medical devices are comprehensive and complex; rarely are these manufacturing solutions one-offs but rather strategic in nature.  

Johnson: OEMs should look beyond price and evaluate a CMO’s quality system maturity, regulatory track record, appetite for investment in new technologies, technical depth, and operational scalability. Early engagement in due diligence—onsite audits, leadership alignment, and review of risk management processes—is critical to assessing long-term fit. The most important traits are transparency, financial stability, cultural alignment, and a demonstrated ability to proactively manage risk and capacity.

LaVersa: OEMs seeking a new CDMO partner should look beyond metrics like size or revenue. Cultural alignment is often underestimated. It’s important to find a strong partner with values and ways of working that complement your own organization and make for a far more productive relationship. From there, strong quality systems and proven technical expertise are non-negotiable. And nothing replaces seeing the operation firsthand. We stress the importance of visiting our manufacturing facilities and meeting the teams who will actually work on your program, as this builds confidence that due diligence alone can’t provide. With 45 years of experience, Harmac has built its reputation on long-term partnerships, grounded in transparent communication, engineering support, and a genuinely collaborative approach.

Muchin: OEMs need to shift their perspective and view CMOs not just as vendors but as integral parts of their organization. The most important question is not “Can they manufacture this?” but “Can they take this from concept to scale successfully?” That means having technical expertise in complex, high-stakes devices. It involves design engineers who understand manufacturing constraints before the design is locked. And it means having a partner with enough capability breadth to keep the program under one roof: one quality system and one team accountable for the outcome.

Ramus: OEMs should look beyond basic manufacturing capability and evaluate whether a partner can truly contribute to product success. Important traits include:

  • A collaborative mindset and willingness to approach problems creatively
  • The ability to accelerate development without compromising quality or compliance
  • Experience guiding design for manufacturability (DFM)
  • Flexibility to begin development without requiring massive upfront commitments
  • A culture that supports iteration, learning, and continuous improvement

Large organizations sometimes bring additional bureaucracy, so an OEM should ensure its partner has the agility to move quickly while maintaining rigorous quality systems.

Ruth: OEMs should evaluate potential partners beyond cost considerations. Key factors to consider include regulatory compliance, quality systems, technical expertise, financial stability, and the ability to scale production. Cultural alignment and communication are also critical. The most successful partnerships occur when both organizations share a commitment to transparency, continuous improvement, and long-term collaboration.

Sokoloski: Ideally, customers will have a clear, well-defined scope of work (SOW) with which they can dialogue with a CDMO and assess the CDMO’s fit for the project. This allows both parties to quickly assess technical fit, capabilities, and execution expectations. More often, a customer—especially early in development—doesn’t know all the details of the SOW, or they may be missing critical elements of the SOW. This is where an experienced CDMO’s true value emerges. Having an experienced CDMO with a track record of successful, complex programs can help identify missing elements, anticipate downstream needs, and guide the OEM toward a complete and realistic plan. Once the customer verifies the capability, then the focus shifts to compatibility. Do the customer and CDMO share common values? Do their quality and compliance, project management, and supply chain systems and processes align? A CDMO’s systems and processes need to be clearly defined to allow for internal organizational execution while being flexible enough to work with the OEM’s systems and processes. 

I like to think of it like a Formula 1 race team. The CDMO is the engineering, innovation, analytics, technology, and pit crew. The customer is in the driver’s seat. The CDMO’s job is to design and tune the machine, anticipate needs, and execute flawlessly—so the OEM is set up to win.

Fenske: What steps must an OEM take to evolve from dealing with a CMO purely as a supplier to establishing a true collaborative partnership with that CMO?

Anderson: The OEM must identify the desired relationship, then communicate it internally and externally. If an OEM truly wants a collaborative partnership, each member of the team must understand that the CDMO will need engagement beyond a singular touch point. Throughout my career, the best partners are those who have encouraged holistic engagement to ensure alignment between their project team, their marketing team, their executives, and ATL.

Blessing: In our experience at Coastline, we strongly believe the best results in quality and price are achieved through a collaborative approach between OEM and CMO. When the OEM truly embraces the CMO as an extension of their manufacturing effort, this approach best positions the end device for success in the marketplace. 

Drikakis: It depends on the OEM. The top 20 medical OEMs have resources that CMOs usually do not possess, so the key question for the OEM is what success looks like. If the OEM is willing to share its long-range planning with its tier 1 suppliers so they can align resources and investments (including tier 2 suppliers), conversations and approvals tend to be easier to facilitate. When it comes to the often-used “non-binding” forecast for primary demand planning, it will ultimately depend on the CMO’s operating capital to meet the OEM’s needs.

On the other side of the equation, the CDMO/CMO has data on operational efficiency they can collaborate with the OEM to improve, such as supplier issues, Lean Six Sigma/Kaizen events, or automation. In most cases, however, the OEM must approve any changes, so finding a win-win outcome quickly shifts the relationship from OEM/supplier to a strategic partnership. The key is achieving a win-win rather than a “I win, you lose” scenario. 

Faulkner: I can understand the pressure OEMs have to get their product to market, but they then need to keep it on the market, hit their target GPs, and keep the ball moving forward. That said, without a solid relationship with a CMO, these tasks grow increasingly challenging. CMOs are present in the first layer in the development of the base of a product line, which makes it one of the most important pieces. Partner with a company that has the capabilities you need while also identifying the partner as a company you can believe in and trust. 

Gahagan: OEMs should involve the CMO early. They should share forecasts openly, align on KPIs, understand goals and objectives, as well as longer-term strategies. The OEM should treat the CMO as an extension of their team.

Hoffman: True partnerships start with early alignment: OEMs and CMOs should agree on the scope of work, set clear interface points, and determine decision-making authority.

Tiered governance structures ensure accountability and agility as projects transition from development to commercialization. This system allows quick issue resolution and adaptability, keeping both parties aligned throughout the program’s lifecycle.

Johnson: OEMs must view CMOs as strategic partners across the full product lifecycle—not only in early-stage development, but also in mature product support and lift-and-shift tech transfers. Transparent communication around forecasts, risk, and capacity planning is especially critical when transitioning established product lines to ensure continuity of supply and regulatory compliance. Formal governance, executive alignment, and jointly defined performance metrics help ensure both innovation programs and mature product transfers are executed with long-term stability in mind.

Muchin: The best partnerships start early, before the design is finalized, and are built on shared visibility. When OEMs include us in forecasting discussions, share constraints openly, and involve us in long-term planning, we can identify challenges and address them before they become costly. It’s a two-way street: the more context we have, the more value we can provide. This kind of transparency fosters trust, and trust is what turns a transactional relationship into a genuine partnership.

Ramus: The shift begins with earlier engagement and transparency. When OEMs involve partners early in development, they gain access to manufacturing insights that can reduce risk and improve product outcomes.

It also requires alignment around shared goals, including speed to market, product quality, and long-term commercial success, rather than focusing solely on unit cost. When both sides view the relationship as a partnership rather than a transaction, the collaboration becomes far more productive.

Santorno: It starts with mindset. A collaborative partnership requires early involvement and alignment at multiple levels of the organization. For us, that is where First Step comes in. When we engage early during new product development at the design for manufacturability/design for assembly stage, we are helping shape the outcome rather than reacting to it later. It allows us to flag risks, optimize geometry, align materials, and think through scalability before time and capital are committed. Since we are vertically integrated across machining, stamping, fabrication, tooling, and assembly, we can evaluate the entire manufacturing pathway, not just one piece of it. True partnership also requires alignment at the leadership level. Shared forecasts, disciplined sales and operations planning processes, and long-term visibility allow both sides to invest with confidence in automation, tooling, and capacity.

Sokoloski: OEMs often see a CDMO as a partner when the CDMO acts as an extension of the OEM’s resources—people power and capabilities. Just like an OEM setting a vision and goals for its employees, when the OEM shares the vision and goals of the project/product with the CDMO, the CDMO can build a better strategy for optimization over time, such as manufacturing improvements through new technologies and automation, leveraging regional cost benefits, and intentional generational improvements. 

Fenske: Conversely, what does a CMO need to do to illustrate to an OEM it is capable of being a collaborative partner in a medical device project?

Anderson: Collaboration is not only an engineer-to-engineer discussion, a sourcing person’s relationship with a salesperson, messaging about capabilities and expertise, or a conversation between executives. Collaboration is an all-encompassing alignment in which OEM and CDMO long-term strategies align, and people want each other’s success. Of the companies I have worked for, ATL does the best job of messaging internally that each customer is everyone within ATL’s customer. The result of this messaging is pride and awareness that what we do for our OEM partners ultimately benefits our fellow human beings around the world. This pride and awareness show up every time we host a customer visit, start a project, host a quality audit, negotiate a cost, and produce an electronically driven medical device. We have strategic account directors, who are ultimately accountable for the account, but we ensure our customers understand they are welcome to reach out to anyone within ATL to ensure our joint success.

Drikakis: Every OEM has a different approach to its suppliers and programs. If I had to simplify it, I would say the CMO needs to be flexible to the OEM’s needs while still respecting its business requirements. Sometimes, speed is the priority; other times, it’s capital or non-recurring engineering support. Quality and on-time delivery shouldn’t be the differentiator because they are non-negotiable in this industry. 

Faulkner: CMOs can have all the credentials, certifications, and capabilities under the sun, but there are 1000s of us. What separates the good from the not-so-good? Communication, transparency, and quality are the key factors that can help mold a relationship from a quote to a true partnership that can last for years. 

Gahagan: A CMO must invest in engineering, automation, and robust quality systems. They must communicate clearly, meet commitments, and bring forward ideas that reduce risk, cost, and variability. Demonstrating speed in quoting and prototyping is also critical.

Hoffman: A CMO must clearly align its specialized capabilities with the jointly defined scope of work and demonstrate the ability to support the program end-to-end. Increasingly, this includes robust development capabilities in addition to manufacturing excellence.

As technology convergence accelerates in medtech, OEMs value partners that can support early development, design optimization, and scale-up while maintaining regulatory rigor. These capabilities are critical regardless of where a device currently sits in its lifecycle.

Johnson: A CMO must demonstrate operational excellence through a strong quality system, regulatory compliance history, and consistent on-time delivery. Beyond execution, it needs to show technical depth, structured risk management, and the ability to support both new product introduction and complex tech transfers. Clear communication, data transparency, and executive engagement signal that the organization is prepared to operate as a true strategic partner rather than a transactional supplier.

LaVersa: A CDMO demonstrates true collaborative capability through a combination of technical depth, reliability, and proactive communication. At Harmac, we assign a dedicated project lead with clear accountability from the outset, ensuring our customers always know who owns what and where a project stands. We combine hands-on engineering support with regular project and business reviews. Ultimately, collaboration is built through consistent follow-through over time, and that track record is what transforms a supplier relationship into a genuine partnership.

Muchin: A CMO has to demonstrate that they understand the full lifecycle, not just their piece of it. That means anticipating scale challenges during development, building quality and regulatory considerations into the process early, ensuring design for manufacturability is addressed, and delivering consistency at volume. Partnership is earned by solving problems before they happen. A manufacturing partner with end-to-end capabilities helps OEMs “see around corners,” anticipate issues before they slow development, and ensure volumes are met.

Ramus: Bring value. CMOs need to demonstrate that
they bring more than manufacturing capacity to the table. This includes:

  • Providing design and development guidance
  • Supporting a lean development approach that encourages rapid iteration
  • Helping teams test concepts quickly and “fail fast” where necessary to accelerate learning
  • Maintaining strong quality and regulatory discipline
  • Supporting the full lifecycle from design through sustaining engineering and commercial scale

A partner that integrates these capabilities into a collaborative ecosystem can significantly reduce development risk while improving outcomes.

Sokoloski: A CDMO must clearly demonstrate its areas of excellence and what truly differentiates its capabilities. By demonstrating these areas and distinguishing its differentiated traits, a CDMO can help the OEM see the roadmap to success. These incremental gains over time become mutually beneficial to both the OEM and CDMO. That’s the secret sauce for a long-lasting partnership.

Fenske: Have just-in-time inventory management practices returned, or is there still an interest in a just-in-case strategy?

Anderson: We are no different from every other CDMO and OEM; we have our scars resulting from the pandemic. From ATL’s vantage point as a long-standing medical CDMO partner, OEM behavior has clearly evolved.

  • Pre 2020: Aggressive just-in-time (JIT) to minimize working capital
  • 2020–2022: Broad shift to just-in-case (JIC) due to supply chain fragility
  • Today: Selective JIT with targeted buffers

Today, we ask a lot more questions, dig deeper into situations, and discuss lessons learned before we determine a “Just In…” scenario. Medical OEMs are re-embracing JIT where risk is low, and predictability is high, but maintaining buffers where patient safety, regulatory exposure, or supply concentration creates unacceptable risk. Executives are no longer asking “Can we run lean?” They are asking, “Where is it safe to run lean—and where is it not?”

Faulkner: For us, we can not afford just-in-time strategies; pricing doesn’t allow it because of fluctuations. As the old saying goes, you’re a hero when you have what your customer needs and a dog when you don’t. 

Johnson: While elements of just-in-time have returned, most OEMs and CMOs are not operating as lean as they were pre-pandemic. There is still a clear shift toward more balanced “just-in-case” strategies, including strategic safety stock, dual sourcing, and longer planning horizons to protect continuity of supply. In most cases, the focus today is resilience first, efficiency second.

LaVersa: We prioritize continuity of supply over lean inventory efficiency. While efficiency remains important, we believe the risk of a line down event or interrupting supply to a customer far outweighs the cost of carrying strategic buffer inventory. We’ve adopted a hybrid approach, combining lean manufacturing principles with deliberate safety stock levels and dual sourcing where applicable, to balance operational efficiency with supply chain resilience.

Muchin: Just-in-time isn’t dead, but it’s being recalibrated. Efficiency still matters, but not at the expense of supply continuity. OEMs are now designing supply chains that can absorb disruption, not just optimize cost. Having U.S.-based and nearshore manufacturing capacity gives customers that resilience; it’s a hedge against volatility, not just a geography preference.

Ramus: Many companies are adopting a hybrid approach. Just-in-time principles still have value from a cost and efficiency standpoint, but recent disruptions have highlighted the risks of overly lean supply chains. As a result, companies are incorporating strategic buffers and better forecasting tools to ensure resilience without creating excessive inventory. 

Sokoloski: It’s a combination of both. All organizations are under pressure to improve working capital, so an element of JIT is necessary. However, neither OEM nor CDMO want to miss revenue opportunities. There will always be an element of risk-based decision-making to procure those long lead-time items or critical sole-sourced items that could jeopardize revenue.

Fenske: Have you encountered new and/or prospective clients seeking to leverage you as an additional supplier to enhance their supply chain resiliency strategy? Is this a new dynamic for you in recent years?

Anderson: I would not say that “supply chain resiliency” is a new approach to business. We are seeing an increase in OEMs engaging ATL as an additional or alternate supplier, specifically to strengthen supply chain resiliency. This is a practice that many good sourcing executives and personnel have been utilizing for decades. What we are seeing is the practice being elevated to a company standard, rather than just a nice-to-see. While ATL has always supported dual‑sourcing strategies, the intent, urgency, and senior‑level sponsorship behind these discussions are meaningfully different from those in the past.

Blessing: Yes, we have seen a surge of interest from many new and prospective clients contacting us to evaluate programs to transfer to our manufacturing location in Mexico. OEMs are re-strategizing their global supply chain based on tariffs and/or general resiliency.

Drikakis: Risk mitigation has become more critical in the past five years, so whether we are a primary or secondary supplier, we recognize the need. That’s why we offer dual-site validations when needed and have manufacturing locations worldwide. This supports our goal of being adaptable to our customers’ needs.

Faulkner: Yes, dual sourcing is something we are seeing more and more. While I don’t like it as a CMO, I validate projects on two different machines to avoid future problems, so I understand the mentality behind it and tolerate it. I think we are going to start seeing regional sourcing. No longer will dual sourcing be the main topic of conversation; it will be if Asia wants x product, OEMs will be forced to make the product in the country to avoid the geopolitical landscapes we all face now. 

Gahagan: Yes, more frequently. Many OEMs are qualifying secondary suppliers to reduce risk. This dynamic has increased since the pandemic and geopolitical disruptions.

Gurgens: Yes, and it has become the norm. Resilience has moved from a contingency plan to a sourcing requirement. Dual sourcing is no longer viewed as optional. It makes sense. OEMs are under pressure to ensure continuity, especially for critical components that support mission-critical devices. To adapt to that reality, we have intentionally built redundancy into our own model. We have duplicated core capabilities across sites, so customers are not dependent on a single location or a single line. We can support programs within a U.S.-based footprint and actually provide multiple paths to execution. From an operational standpoint, that gives our customers confidence. They are not relying on one point of failure, and they are not scrambling if something unexpected happens. Resilience today is designed into the supply chain upfront, and we have structured Vantedge to support that expectation.

Hoffman: Yes, this has become a much more pronounced dynamic in recent years, particularly in the post-COVID environment. The pandemic exposed the risks of highly concentrated supply chains built around single suppliers, single regions, and extended global logistics networks. As a result, many OEMs have reassessed long-standing sourcing strategies and are now intentionally building redundancy into their supply chains for critical programs to improve resiliency and continuity.

Ongoing geopolitical uncertainty and evolving tariff policies have further reinforced this shift. Tariffs have introduced cost volatility and long-term planning challenges, making it difficult for OEMs to rely on a single manufacturing footprint over the life of a product. In response, customers are increasingly seeking qualified secondary or parallel suppliers, not necessarily to immediately shift volume, but to create alternatives should market, regulatory, or trade conditions change.

This represents a meaningful evolution from pre-pandemic sourcing models that often prioritized cost efficiency above all else. Today, OEMs are taking a more balanced approach, weighing cost, capability, and risk together. For us, this has led to earlier, more strategic engagement with customers, focused not just on capacity, but on long-term supply chain resilience and geographic diversification, leveraging our global manufacturing network.

Johnson: Yes, more OEMs are intentionally adding qualified secondary or dual-source CMOs to strengthen supply chain resilience. While dual sourcing has always existed in regulated markets, the frequency and urgency of these discussions have increased in recent years. It reflects a broader shift toward risk mitigation and business continuity planning as core sourcing criteria.

LaVersa: Supply chain resilience is a priority we take seriously and our approach to achieving it looks somewhat different from the traditional dual-sourcing model. Rather than splitting volume across multiple vendors, the majority of our customers choose to consolidate with Harmac while benefiting from the fact we manufacture the same products across multiple Harmac sites globally. This dual-site model delivers the supply chain redundancy and risk mitigation OEMs are seeking, without the complexity, quality variability, and qualification burden that comes with managing multiple supplier relationships. It also allows us to optimize distribution logistics regionally, improving responsiveness and reducing costs for our customers. Consolidating volume within the Harmac network further enables the scale needed to justify meaningful investment in automation. It’s a model that balances resilience with efficiency, and one our customers find genuinely compelling.

Muchin: Yes, and it reflects a fundamental shift in mindset. Redundancy was once seen as inefficient. Now it is seen as necessary. OEMs are actively developing multi-supplier strategies to mitigate disruption. While we can provide a complete set of solutions, we can also step in as needed to help get a product to market. In some instances, suppliers have built in redundancy, as we do with our stick-to-skin converting capabilities with facilities in California, Massachusetts, and Singapore. This enables us to employ a dual-sourcing strategy within our company.

Ramus: Yes, this has become more common. Many OEMs are intentionally expanding their supplier base to reduce single-source dependencies. In some cases, we are brought in as a secondary supplier initially, but those relationships often evolve into broader development and manufacturing collaborations.

Sokoloski: Absolutely, and it’s a good business decision by the OEMs. Of course, we want to be the primary supplier rather than the alternative supplier. We have to earn the right to be the primary, which comes down to consistent execution, technical excellence, and delivering measurable value. We believe primary status isn’t awarded—it’s earned, every day.

Fenske: Have you been impacted or participated in the nearshoring/reshoring trend? Have OEM customers inquired about you moving to/opening a facility closer to them?

Anderson: We have many examples of supporting nearshoring and reshoring requests from our customers. ATL has been operating in China for more than 30 years. Almost 15 years ago, ATL’s founder, Brad Brown, initiated a plan that could be described as a “nearshoring” plan, which involved having ATL manufacture for the Western hemisphere from our locations in Costa Rica and Utah, and the Eastern hemisphere being supported by our locations in China and Taiwan. Brad’s vision created an organizational structure and manufacturing process that enabled ATL to support companies’ recent needs to nearshore and reshore.  

And yes, we have also had conversations about future facilities that will further benefit our customers. 

Faulkner: Yes, the political landscape has made it so OEMs are looking to bring products back to the U.S. Inevitably, this is a slow process because if it were simply about supply or quality, it would be easy to make the moves. When you have an established product line that you make 75% GP on, and you’re now looking at the economics of moving it stateside, shareholders have a hard time swallowing the loss they will be taking. 

Gahagan: Yes, there is sustained interest in North American manufacturing. OEMs are seeking partners with U.S.-based capabilities to reduce logistical risk and regulatory complexity.

Hoffman: Yes, selectively, and the interest in nearshoring is primarily driven by risk management and operational resilience rather than cost alone. Post-COVID, OEMs experienced firsthand the fragility of long, globally distributed supply chains, transportation disruptions, and limited visibility across distant suppliers. Nearshoring offers a way to shorten supply chains and increase responsiveness, particularly for critical or time-sensitive programs.

In addition, regulatory oversight, quality alignment, and tariff exposure have become more prominent considerations. OEM inquiries related to geographic proximity appear to be driven by simplifying collaboration across development, manufacturing, and quality teams, enabling more streamlined execution. Importantly, nearshoring isn’t a blanket strategy; OEMs typically evaluate it on a program-by-program basis as part of a broader approach that balances risk, capability, and long-term commercial objectives.

Johnson: Yes, nearshoring and regional manufacturing strategies have become more common topics of discussion, especially post-pandemic. OEMs are increasingly evaluating geographic footprint as part of their risk mitigation strategy, with interest in reducing transit times, geopolitical exposure, and logistics complexity. As a result, proximity to end markets and the ability to support regional/local supply chains are more prominent factors in sourcing decisions.

LaVersa: Nearshoring and reshoring have become significant priorities for OEMs seeking to reduce supply chain risk and improve responsiveness. This has long been central to Harmac’s global strategy and was a driving factor in our expansions into Ireland and Mexico. Our multi-site, global footprint positions us well to support these requirements, and we continue to actively evaluate opportunities to expand and align our facilities with the evolving geographic needs of our customers.

Muchin: Absolutely. Proximity has become a competitive advantage. OEMs are looking for partners with onshore or nearshore capabilities to reduce lead times, improve responsiveness, and de-risk their supply chains. It is not about abandoning global supply chains, but about making them more resilient. As mentioned earlier, this has made such a difference that it has become a core focus in our operations at Cordica Medical, which we believe distinguishes us from our competitors. Our Reynosa, Mexico, facility is TAA-compliant for manufacturing, including cleanroom assembly and packaging, so OEM customers selling to government channels like VA and DoD don’t have to worry about country-of-origin compliance. Our nearshore capacity can avoid offshore tariff risks and scale with program growth to ensure we meet our customers’ demands.

Ramus: There is definitely increased interest in regional manufacturing and supply chain proximity. OEMs are evaluating geographic diversification to reduce logistics risks, shorten lead times, and maintain better visibility into production and regulatory compliance. Often at VitalPath, catheter and component development thrives in a fast-paced, iterative environment. Having the logistical ability to be close to our customers is key. 

Ruth: Regional manufacturing strategies have gained momentum, particularly as companies look to shorten supply chains and reduce geopolitical risk. OEMs are seeking partners with a global footprint that can support regional production needs. Having manufacturing capabilities across multiple regions provides flexibility and allows us to better align with customer supply chain strategies.

Santorno: We are already aligned with that movement. Our manufacturing footprint is U.S.-based, and that has become increasingly strategic for OEMs. It is about more than proximity. It is about predictability, tariff mitigation, lead time compression, and stronger collaboration. When engineering teams can sit down together and solve problems in real time, programs move faster. When automation supports domestic production, cost competitiveness improves. Reshoring is not a short-term reaction. It is a long-term structural decision, and we are well-positioned to support them.

Sokoloski: Forj Medical has definitely been impacted. In fact, we just opened a new 53,000-square-foot site in Costa Rica. It features state-of-the-art manufacturing lines for automated and manual assemblies of components and finished medical devices, as well as a large cleanroom for producing devices used for surgical navigation, electrophysiology, diabetes, drug delivery, cardiovascular, advanced optics applications, and many other applications. Forj Medical’s Costa Rica operation will be the first in the country dedicated to custom electromagnetic sensors, biosensor devices, and microelectronic medical devices, built on a globally integrated supply chain and ISO-certified processes. Production will include coil winding, cable assembly, and other services.

Fenske: More OEMs seem to be seeking vertical integration from their supply partners. Have you encountered this, and how are you addressing the interest?

Anderson: Yes, we manage the request for vertical integration and evidence ATL’s vertically integrated capabilities and expertise on a daily basis. We address OEMs’ requests for vertical integration through strategic alignment. ATL operates in four market segments; these segments have been strategically identified and align with ATL’s engineering, manufacturing, and assembly capabilities. We continue to enhance and expand our vertical integration within the boundaries of our strategy. We do not attempt to be everything to everyone; we help partners find the right partner for their needs when there is no strategic alignment with ATL. 

Cullen: When OEMs discuss vertical integration, they are often responding to fragmentation across development and manufacturing. Multiple handoffs can create misaligned incentives, loss of context, and repeated assumption of resets between phases.

Vertical integration matters most when it preserves context. A coating decision, for example, cannot be evaluated independently of catheter construction, delivery dynamics, and downstream manufacturing realities. When those perspectives are integrated early, iteration cycles are faster, and fewer late-stage corrections are required.

There is also a cost and accountability dimension. A single accountable owner across critical elements of the supply chain reduces redundant validation, shortens transitions, and clarifies responsibility. Vertical integration is most effective when it aligns accountability, accelerates learning, and maintains the flexibility that OEMs need.

Faulkner: We are always open to working with our OEM partners to make things quicker, better, and faster for them. 

Hoffman: Yes, this is particularly true of larger OEMs looking to reduce supply chain complexity and manage fewer strategic partners. At the same time, smaller OEMs and startups are often seeking to extend their capabilities by leveraging external partners for design, development, and manufacturing.

We address both needs by offering scalable, integrated solutions, most often leveraging our development and manufacturing capabilities combined in a tailored approach properly scaled to each customer’s size, maturity, and growth strategy.

Johnson: Yes, to a degree, OEMs are increasingly seeking partners with broader vertical integration to reduce handoffs, compress timelines, and limit supply chain risk. However, they are also looking for specialized core competencies, not just a one-stop-shop experience. We’re addressing this by investing in state-of-the-art technologies, expanding in-house capabilities, strengthening strategic supplier networks where needed, and investing in automation and process control to deliver more complete, end-to-end solutions. The goal is to simplify the OEM’s supply chain while maintaining quality, traceability, and scalability.

LaVersa: Vertical integration is a key area of focus for Harmac. We continuously seek opportunities to add value within the manufacturing process, including bringing the production of purchased components in-house. For the majority of our products, our process begins with raw resin and ends with a finished, packaged medical device ready for market. This truly end-to-end capability helps customers simplify their supply chain, reduce complexity and cost, and work with a single accountable partner across the full manufacturing journey.

Muchin: We are seeing a clear shift toward vertical integration, driven by the need to reduce complexity and risk. Every additional handoff in the supply chain creates potential for delays, misalignment, or quality issues. At Cordica, we address that by aligning design, manufacturing, quality, and regulatory aspects from the start, so the product and the production process are developed together. That allows us to scale more predictably and avoid the disconnects that often happen when those steps are separated. For OEMs, the benefit is a more streamlined path to commercialization with fewer surprises along the way. Our strategy of having multiple manufacturing capabilities allows us to supply our own facilities with subcomponents when needed, reducing our reliance on other manufacturers.

Ramus: Yes, and it aligns with the broader shift toward full-service partnerships. OEMs increasingly value suppliers that can support multiple phases of the product lifecycle from design and prototyping to manufacturing, scale, and sustaining engineering.

This reduces complexity in vendor management and creates stronger alignment across the development process. We vertically integrate at VitalPath as much as possible from internally manufactured parts—laser cut components and pull wires—to extrusions, coiling, and braiding. Having vertical integration as a manufacturer is key to controlling cost, quality, performance, and timelines. 

Sokoloski: Forj Medical has seen this trend and has been aggressively responding. This is a large part of why Forj Medical was created. By bringing together precision microelectromechanical technologies with capital equipment design and manufacturing capabilities, we deliver two critical elements of a total system solution with one ecosystem. This vertically integrated model reduces complexity, strengthens technical alignment between reusable systems and single-use components, and accelerates time to market. For OEMs, it means fewer handoffs, tighter collaboration, and a partner built to support the full ecosystem—not just a piece of it.

Fenske: One industry trend seems to be the transition of suppliers from CMO to CDMO (contract design/development and manufacturing organization). Do you offer design and development services, or do you plan to? 

Anderson: Yes, one distinguishing characteristic of ATL is that, beyond design and development services, our engineering team can support a product from concept and voice-of-customer interactions through the complete device development process. We further enhance our value proposition by quantifying our quality and regulatory capabilities. ATL has created and is maintaining over 90 technical files. We have submitted regulatory filings with the FDA, MDR, and various other international notified bodies and global regulatory agencies. ATL separates itself from other CMOs and CDMOs by having 30 years of OEM experience at our Cardiff, Wales, location.  

Drikakis: Definitely. Quasar originally started as a CMO nearly 40 years ago, and through M&A and investments, has expanded its offerings to become a CDMO with design facilities in Ireland, the USA, and Israel.

Faulkner: We keep three different engineers on staff to address design-related issues. Often, we’ll begin working with a new company that has designed a product but doesn’t understand some manufacturing aspects (for example, injection molding). They are unfamiliar with the changes that should be made to help with design for manufacturability. In addition, we work behind the scenes with many different design houses that recommend clients to us because of our reputation for being able to handle low volumes and grow with them as they scale. 

Hoffman: Yes, this has been a deliberate and ongoing evolution for us. We have offered design and development services for some time, and we continue to invest in expanding these capabilities as device complexity increases. Today, we support customers across early concept development, focused research activities, clinical support, full design and development, and manufacturing. This broader CDMO model allows us to engage earlier in the product lifecycle and help customers make better-informed decisions that improve manufacturability, scalability, and time to market.

A key example of this strategy is the 2026 opening of our NICE facility—Nashville Innovation Center of Excellence. NICE was established to enable earlier, more collaborative engagement with customers at the ideation and concept stages of development. This engagement includes access to technologies that drive innovation, such as our steering technology, as well as collaborations in early development and access to key subject matter experts.

As OEMs face increasing pressure to deliver more complex devices under tighter timelines, funding constraints, and limited internal resources, the CDMO model becomes essential. The shift from CMO to CDMO is not simply about offering more services; it’s about deeply integrating design, development, and manufacturing while proactively bringing emerging technologies to the forefront. By introducing capabilities OEMs may not yet be aware of such as advanced steering miniaturization or novel manufacturing approaches, a CDMO helps expand what’s technically and commercially possible. This tighter integration accelerates innovation, reduces risk, and strengthens the overall value proposition by turning manufacturing expertise into a strategic advantage across the product lifecycle.

Johnson: The broader industry trend toward CDMO models reflects OEM interest in specialized offerings, earlier engagement, and streamlined product realization. While manufacturing execution remains our core focus, we have found design and development support—whether in-house or through structured engineering collaboration—adds value when aligned with core competencies. Any expansion into CDMO capabilities must be deliberate, ensuring the same rigor in quality systems, regulatory compliance, and technical expertise that defines the manufacturing platform.

LaVersa: Harmac Medical Products operates as a full-service CDMO, offering design support, feasibility assessment, and design for manufacturing (DFM) expertise, including prototype development. Alongside our core manufacturing capabilities, this approach allows us to engage with OEMs from early concept through commercialization, driving manufacturing efficiency, enhancing product reliability, and supporting meaningful innovation at every stage.

Muchin: The shift from CMO to CDMO is not just a trend; it is a response to how complex medical devices have become. At Cordica, we already operate with that integrated mindset, whether we are engaging early in design and development or partnering with OEMs to scale their products. We provide full-cycle product development, from concept through regulatory clearance, but what sets us apart is how closely that work is integrated with manufacturing from the beginning. Too often, products are designed in isolation and then handed off, which creates challenges when it comes time to scale. We take a different approach by aligning design, process development, regulatory requirements, and manufacturing early, so the product is built for scalability, quality, and efficiency from day one. For OEMs, that reduces risk, shortens timelines, and avoids costly redesigns later in the process. That is ultimately what the CDMO model should deliver. Not just more services, but better outcomes.

Ramus: The shift toward CDMO capabilities reflects the need for deeper collaboration in product development to ensure scalability as well as enhance the performance of the device with technical expertise. Supporting design and development allows manufacturing considerations to be incorporated early, which improves manufacturability, reduces risk, and accelerates time to market.

At VitalPath, we answer that need for deeper collaboration with flexible and rapid response design and development services from concept through commercialization with an eye for DFM at every step along the way. We can focus on CDMO for performance, scale, or both, depending on the customer and product needs.

Ruth: The shift from CMOs to CDMOs is becoming progressively more important as customers prioritize partners that can support both development and manufacturing. At Roechling Medical, we see strong value in integrating design, engineering, and production capabilities. By engaging earlier in the development process, we can provide design for manufacturability, material expertise, and engineering support to help optimize products from the start. This approach benefits our customers through faster time to market, reduced development risk, and more efficient scale-up into production. Ultimately, it allows us to act as a true partner, supporting innovation while ensuring a smooth and reliable transition into manufacturing.

Here’s what we offer today: full lifecycle support that includes early requirements capture, concept validation and rapid prototyping, design for manufacturability optimization, process development with pilot runs, verification and validation execution, complete design transfer into production, and regulatory and quality documentation support. We engage at any stage, and our goal is to help our customers move faster with fewer handoffs and a smoother path to commercialization.

Sokoloski: Yes, Forj Medical is the only single-source, vertically integrated medical device CDMO that partners end-to-end on the most complex, high-stakes programs—reducing risk, accelerating execution, and eliminating handoffs from concept to commercialization.

Fenske: Are you incorporating or seeking to incorporate artificial intelligence (AI) into your manufacturing processes? If so, in what ways?

Anderson: Yes, ATL’s efforts to incorporate AI throughout our engineering and manufacturing processes are led by a Master’s Degree Computer Science Engineer, with artificial intelligence education through Stanford. We are also influenced by the messaging that Jensen Huang has been sharing. That being said, differentiate each job by considering purpose and task. AI can complete a task; the human purpose cannot be replicated by AI. Caring for people cannot be replicated by AI.

Faulkner: Of course! If you are not utilizing this tech, you’re going to be behind the curve. We have some proprietary systems we have developed that enhance our internal processes and help our team throughout the facility. 

Hoffman: Yes, we are already incorporating AI as part of our broader operational excellence strategy, with a strong focus on improving quality, efficiency, and reliability across our manufacturing operations. One key area of application is advanced vision systems, where AI-enabled inspection supports more consistent, real-time quality monitoring. These systems enhance defect detection, reduce subjectivity in inspection processes, and help ensure tighter process control—particularly important as devices become smaller, more complex, and more highly integrated.

In addition, we are increasingly leveraging data analytics and AI-driven models to support predictive maintenance. By analyzing equipment performance data, process trends, and historical maintenance patterns, we can better anticipate potential failures before they occur. This approach improves equipment uptime, reduces unplanned downtime, and supports more proactive maintenance planning, which is critical in highly regulated manufacturing environments where consistency and reliability are essential.

Johnson: Yes, AI and advanced data analytics are increasingly being evaluated to enhance manufacturing performance, but must be validated. Primary applications include predictive maintenance, process optimization, automated inspection, and real-time quality monitoring to improve yield and reduce variability. The focus is practical implementation—leveraging data to drive measurable gains in efficiency, traceability, and compliance rather than adopting technology for its own sake.

Muchin: At Cordica, the focus is on using data-driven and automated systems to enhance process stability, enable real-time adjustments, and strengthen inspection capabilities. The goal is not just automation but reducing variability and improving outcomes at scale. The use of data-driven automation at the right place in the manufacturing process aids quality control, timeliness, and overall efficiency.

Ramus: AI and advanced analytics are increasingly being explored to improve manufacturing efficiency, predictive maintenance, process monitoring, and quality control. These technologies have the potential to enhance consistency while enabling more proactive decision-making across production environments.

Fenske: As a result of the concerns around EtO (ethylene oxide) sterilization, are you exploring alternatives more often than before? Are your customers requesting alternatives?

Anderson: A suitable alternative to EtO has yet to be identified. Alternative sterilization methodologies would have to meet, or come close to meeting, EtO’s acceptance by regulatory bodies, capacity, price, ability to render products sterile using traditionally accepted methods, and contract sterilization infrastructure.

ATL, in partnership with our OEM partners, continually monitors and researches various sterilization methodologies and is committed to advancing alternatives as our customers aim to achieve them.

Faulkner: We move as our customers dictate us to. We are always working to make suggestions, keeping an eye on the industry, and seeing where things are going. We handle a lot of sterile products through our plant and are always seeking the best and least environmentally impactful ways to do business. 

Johnson: Concerns around EtO availability and regulatory scrutiny have, in some cases, increased customer inquiries about alternative sterilization methods. While EtO remains essential for certain devices, OEMs are more frequently evaluating options such as gamma, e-beam, and X-ray where technically feasible. The approach is driven by risk mitigation and long-term supply continuity rather than a wholesale shift away from EtO.

Muchin: Yes, we are seeing more proactive conversations around sterilization strategy. OEMs are evaluating alternatives earlier in the development process to avoid downstream challenges. It reinforces the importance of considering sterilization as part of the overall product and manufacturing design, not something addressed at the end. For packaging-intensive products, we design and qualify packaging systems that protect device integrity, including oxygen and moisture barriers, through sterilization, transit, and extended shelf life. Our expertise spans sterile-barrier materials, sealing, validation, and collaboration with sterilization partners to ensure products are regulatory-compliant and ready to ship releases. For devices in which coatings, adhesives, and other materials are sensitive to sterilization, we conduct pre-design verification to eliminate risk and confirm material compatibility before full-scale testing.

Fenske: Are tariffs still impacting your business (or did they ever)? If so, have you gotten a better handle on this dynamic, or is it still a significant challenge? 

Blessing: While tariffs have been a hot topic over the past year and certainly posed challenges for all, we have been fortunate to lean on certain free trade agreements to alleviate the most significant impacts to business. When applicable, focusing on a supply chain largely based in North America has allowed for USMCA compliance and, as such, has been a beneficial strategy to manage this dynamic.

Faulkner: Again, the political landscape has impacted all of us—some for the better in terms of transfer programs, reshoring, or price increases. The tariffs and war in Iran are starting to impact our outlook for the rest of the year. 

Hoffman: Yes, tariffs continue to impact our business, our customers, and the overall cost of healthcare delivery. While we have improved internal processes to manage these dynamics, sudden policy changes remain challenging.

Given the United States’ historical leadership in medical device innovation and exports, the industry would benefit from trade policies that balance economic objectives with continued global competitiveness.

Johnson: Tariffs have certainly impacted sourcing strategies, particularly for components or materials with global supply chains. Most organizations have adjusted through supplier diversification, pricing strategies, and regional manufacturing alignment, but the dynamic still requires active monitoring. While more manageable today, trade policy uncertainty remains a planning consideration.

Muchin: Tariffs remain a factor in some raw materials, but they are part of a broader shift toward managing global risk. Companies are adapting by building greater flexibility into their supply chains and identifying potential alternatives for manufacturers to avoid or reduce tariffs. When possible, we source raw materials as locally as possible, given the options available. 

Ramus: Tariffs and geopolitical considerations remain part of the broader supply chain planning landscape. Many companies are addressing these challenges through diversified sourcing strategies and regional production capabilities.

Fenske: Do your product development protocols address sustainability or recyclability? Is this something customers request?

Anderson: Yes, ATL’s product development protocols increasingly address sustainability, but always through the lens of patient safety, regulatory compliance, and product performance. Customer interest and inquiries have grown in recent years, and while sustainability is rarely the primary design driver, it is now a consistent and explicit consideration during development. ATL engineers evaluate resins, metals, and consumables not only for biocompatibility and manufacturability, but also for waste impact, sterilization compatibility, and the ability to consolidate components or reduce part count. Where customer requirements allow, we favor materials and designs that minimize scrap and enable more efficient processing.

Faulkner: This is something we care deeply about, but we are customer-driven in terms of the specifications for a particular project. However, OEMs need to understand they cannot blindly ask CMOs to become more environmentally sustainable without a cost associated with it. Everyone wants to ensure they are manufacturing sustainably and being environmentally conscious, but when there is a price tag associated with it, does it continue?

Johnson: Sustainability is becoming a more frequent consideration in product development discussions, particularly around material selection, packaging optimization, and waste reduction. While patient safety and regulatory compliance remain primary drivers, some OEMs are requesting support for recyclability assessments and environmental impact reduction initiatives. The level of emphasis varies by customer and end market, but sustainability is still a trending topic.

LaVersa: Sustainability is an increasingly important consideration across the medtech industry. At Harmac, we build environmentally responsible practices into our development and manufacturing processes, actively working to reduce our carbon footprint and minimize waste to landfill. We’re also seeing growing demand from OEMs requesting alternative recyclable materials and solutions that lower environmental impact.

Muchin: Sustainability is becoming more visible in customer discussions, particularly around materials and process efficiency. While performance and compliance remain the priority, there is growing interest in solutions that also reduce environmental impact. We are factoring that into development conversations, exploring sustainable materials and process improvements that align with the market’s direction.

Ramus: At VitalPath, we tend to deal with single-use products in the catheter space. Sustainability is becoming increasingly important. OEMs are asking more questions about material selection, waste reduction, and product lifecycle impact. While patient safety and regulatory compliance remain the top priorities, sustainability considerations are gradually being integrated into development strategies.

Ruth: Our commitment to sustainability and recyclability is a fundamental aspect of our business. As an organization, we recognize the critical role we play in shaping a more sustainable future. We have a global sustainability officer as well as a sustainability board with local representatives at each site. We engage with Ecovadis as well as other assessment services to assess and manage sustainability practices within our supply chain. 

Fenske: When faced with an OEM customer who presents consistent requests for a percentage cost reduction year over year, does it cause a rift in the relationship or a reevaluation of whether the customer’s business is worth it? (or, have you experienced this at all?)

Anderson: ATL’s goal is to help our OEM partners achieve the most competitive market position possible. We do not allow cost-downs or price increases to create a “rift” in our relationships. We have a long-term outlook and recognize that costs will fluctuate multiple times over the life of a product. ATL’s Cost Improvement Planning (CIP) is how we work with our customers to improve our costs in support of them achieving year-over-year cost improvements. 

Drikakis: Every OEM aims to reduce costs, and most CMOs share this goal. The difference lies in how they achieve it. If the OEM expects the CMO to simply dilute margins, the conversation becomes more difficult. When cost reduction or purchase price variance aligns with continuous improvement or resource coordination for events, it’s easier to find a mutual win. Ultimately, it depends on the maturity of the partnership and each party’s willingness to find a solution.

Faulkner: Absolutely, we work with both OEMs and distributors of our own product. I think this is the most significant topic among these questions. If the relationship is solely based on price, I am more apt to walk away from the business. We bring too many advantages to our customers that go unseen daily to be treated as a transactional relationship. The relationship needs to be a two-way street, and we understand the pressures our customers face. However, we also face similar pressures and would like to feel we are treated equally. 

Gahagan: Cost reduction is part of the industry. The key is collaborative value engineering rather than unilateral price compression. When approached strategically, it strengthens partnerships rather than creating friction.

Gurgens: In medtech, year-over-year cost improvement is expected. We assume from the beginning that value improvement will be part of the relationship. The difference is in how it is approached. When it is collaborative and grounded in data, it creates mutually beneficial outcomes for both sides. We look at process optimization, automation investments, yield improvements, design refinements, and material strategies. There are usually opportunities to improve efficiency without compromising performance or quality. Our preference is always to optimize the relationship, not just the price. When both teams are aligned around long-term program success and total cost of ownership, cost discussions become strategic rather than transactional. That kind of alignment is what supports strong collaboration over time.

Hoffman: Ongoing cost pressure is a reality across the medical device industry, and we approach it as a shared challenge rather than a source of tension. When addressed early and transparently, year-over-year cost reduction goals can strengthen partnerships by encouraging collaboration and alignment around long-term objectives. Our focus is on understanding the business drivers behind these requests and working with customers to identify sustainable cost improvements without compromising quality, performance, or supply continuity.

During development, we support cost optimization through design for manufacturability, material selection, and process simplification—addressing cost drivers before a product reaches commercialization. In manufacturing, we focus on operational efficiency through continuous improvement initiatives, yield optimization, automation where appropriate, and data-driven process enhancements. In parallel, strategic sourcing plays an important role by leveraging supplier relationships, improving demand visibility, and optimizing material and component costs.

The most effective cost reduction efforts occur when they are approached holistically across the full product lifecycle. When OEMs and CMOs are aligned on this strategy, cost optimization becomes a value-creating exercise that reinforces long-term partnerships rather than prompting reevaluation of the relationship.

Johnson: Annual cost reduction expectations are common in medtech and don’t inherently create friction when organizations are strategically aligned; we want our customers to be successful in the market because their success drives ours. However, sustained pressure without alignment on year-over-year volume growth, new program awards, or broader engagement can strain the relationship. The most productive approach is collaborative cost-out initiatives focused on process improvement, automation, and design optimization rather than unilateral price concessions.

LaVersa: Cost pressures are a reality in medtech, but the strongest relationships still focus on value. At Harmac, our response is to work collaboratively with customers to identify genuine efficiencies: process improvements, automation opportunities, and waste reduction initiatives that create real savings without compromising quality or reliability. Transparent, open dialogue is central to how we manage these conversations. It keeps relationships productive and ensures that when cost targets are set, they’re grounded in shared understanding rather than unilateral expectation.

Muchin: Cost pressure is part of the industry, but it has to be balanced with maintaining quality and performance. The most productive relationships focus on continuous improvement and value creation, finding efficiencies through integration, automation, reducing handoffs, optimizing processes, not just price reduction. When both sides are aligned on that, it strengthens the partnership rather than creating friction.

Ramus: Cost reduction discussions are common in the medical device industry, and the reality is price pressures are affecting everyone across the value chain. While this is a natural tension point, in the healthiest relationships, these conversations are approached collaboratively rather than adversarially. Strategic partnerships are key. When OEMs and manufacturing partners engage in transparent discussions about cost drivers, they can work together to identify solutions that benefit both sides. That might include design optimization, manufacturing innovation, supply chain improvements, or exploring new ways to expand the partnership across the product lifecycle.

Ultimately, the goal should not simply be pushing price reductions but finding smarter and more sustainable ways to deliver value. When both sides work together with openness and a shared focus on efficiency and innovation, it strengthens the relationship and creates mutually beneficial outcomes over the long term.

Fenske: The industry is experiencing a shortage of skilled labor for many positions. How is your company addressing this, and what are you doing to attract/retain/develop talent?

Blessing: With our manufacturing based in Tijuana, Mexico, we have not faced the same labor shortage as many other regions. We pay very close attention to the skilled labor pool required to support our OEM customers, and fortunately, Mexico is well-positioned with a growing wealth of talent that has increased significantly over the last decade. 

Drikakis: One of Quasar’s key differentiators is our strong emphasis on employee engagement. We believe success comes from an engaged workforce, and we work hard to develop our team. For any OEM partnering with Quasar, we provide reports on our employee engagement score so our customers can see how we operate. 

Faulkner: We are located in a great area where we do not feel those pressures for skilled labor. While we are not completely immune, we have a great team, and many employees have been with us for a long time. 

Hoffman: We are addressing this through a combination of proactive workforce planning, targeted recruitment, and long-term talent development strategies aligned with our growth objectives. Close collaboration between our operations, engineering, and HR leadership teams ensures we are anticipating future skill needs, not just reacting to immediate gaps, especially in areas such as advanced manufacturing, automation, and data-driven operations.

A key element of this strategy is building stronger, more direct pipelines to emerging talent through academic partnerships. Our collaboration with Vanderbilt on our Nashville Innovation Center of Excellence (NICE) enables us to engage earlier with engineering and medical technology students through internships, hands-on research, and real-world development projects. By co-locating near Vanderbilt and the Vanderbilt Institute for Surgery and Engineering, we gain access to a strong ecosystem of academic and clinical innovation while providing students with exposure to regulated medical device development and manufacturing environments. 

In parallel, we remain focused on retaining and developing existing talent through continuous learning, technical training, and career progression opportunities. As digitalization, AI, and advanced manufacturing technologies become more embedded in our operations, investing in our people at all levels is essential. By combining internal development with strong university partnerships, we are building a sustainable talent strategy that supports both our current customer commitments and our long-term vision for innovation and growth.

Johnson: The skilled labor shortage remains a real challenge across manufacturing and engineering roles, particularly as specialization continues to narrow the available talent pool. We’re addressing it through investment in training and upskilling programs, along with creating clear career pathways to retain high performers. Just as important, we’re investing in automation and process innovation to augment our workforce and make roles more engaging and sustainable long term.

Muchin: We believe talent drives quality. That means investing in our people through structured training, cross-functional teams, and clear paths to advancement. A strong culture with real growth opportunities drives both recruitment and retention. For our customers, that stability means experienced teams with real program knowledge and continuity across projects. Our operator training programs and in-house test development capabilities are examples of how we build internal expertise, benefiting both employees and customers.

Ramus: Attracting and retaining talent requires meaningful investment in training, mentorship, and professional development. At VitalPath, we place a strong emphasis on culture, ensuring it is experienced consistently across the organization, regardless of role or title. We strive to create an environment where engineers and technical professionals can take on challenging, meaningful work that ultimately contributes to improving patient outcomes. This combination of a strong culture, opportunities for growth, and purpose-driven projects is critical to engaging and retaining top talent

Ruth: We recognize the challenges posed by the industry-wide shortage of skilled labor. To address this, we’ve implemented several strategies to attract, retain, and develop talent. We actively engage in apprenticeship programs for our tool room and mold shop. These apprenticeship programs allow us to train and mentor individuals who are new to the industry. Apprenticeships provide hands-on experience, practical skills, and exposure to real-world scenarios. 

We offer employer-of-choice programs and incentives to attract top talent. We create an environment where skilled professionals want to work and grow. We also invest in training and development, prioritizing continuous learning and fostering a positive corporate culture. 

Santorno: The widening talent gap in medtech is one of the defining issues facing our industry. As devices become more complex and precision requirements tighten, the need for highly skilled machinists, toolmakers, and engineers only increases. That creates real risk for manufacturers supporting mission-critical applications. We tackle it in a very practical way. We invest in automation where it makes sense, because it helps with consistency and efficiency. But we also know machines do not think. They do not problem-solve. That still takes skilled people. Craftsmanship, engineering judgment, and the ability to troubleshoot in real time are things you develop through experience, and we are intentional about building that bench strength alongside our technology. Through Hobson & Motzer, a Vantedge Medical company, we have maintained a dedicated tool room and a formal apprenticeship program for decades. This is not a new initiative. It is embedded in how we operate. Seasoned toolmakers and engineers mentor apprentices coming out of trade schools and technical programs, passing down practical knowledge that cannot be learned from a manual alone. That combination of structured training and hands-on experience ensures continuity. It protects institutional knowledge, strengthens quality systems, and prepares the next generation to take on increasingly complex work. For us, building talent is not optional. If we want to continue delivering precision at scale for the future of medtech, we have to invest in people with the same discipline and long-term commitment that we apply to technology and automation.

Sokoloski: Forj Medical developed a robust process to address this in both our hourly and salaried positions. We have an apprenticeship program for technical positions such as toolmakers and technicians. We have an internship program for engineering, quality, finance, IT, supply chain, and continuous improvement with nearly 20 positions planned for 2026. Most of our FTEs come from our internship program. Once the new hires join the team, we have additional programs such as our Leading, Engaging, Accelerating Professionals (LEAP) program. The LEAP program engages and retains early-career professionals in engineering, manufacturing, and technology. It serves as a personal and professional development hub, blending community service with social connection and skill-building. It is a model for inclusive workforce development in our industry.

Fenske: What trend(s) in medtech will you be following in the near- and/or long-term you expect to become more important or could have a significant impact on the industry? Explain.

Anderson: Renal Denervation—I watched Geoff Martha from Medtronic’s presentation at the JP Morgan event in January. I will be watching with interest to see how Medtronic’s Simplicity Spyral Renal Denervation device competes with big pharma. 

Pulsed Field Ablation—The explosion we’ve seen with pulsed field ablation (PFA) within electrophysiology is something we all will be monitoring. Given ATL’s history of energy-based device expertise, PFA is another energy modality for which we can provide support in the concept, design, development, and manufacturing of next-generation devices. The trend I am interested in participating in with PFA is the non-cardiac application of pulsed field ablation.

Miniturization of imaging—About eight years ago, ATL began producing single-use scopes and camera-based devices. We developed our PREVOYANCE family of products, including camera assembly, proximal end cable assembly, and camera control unit, with the goal of enabling mechanical and other engineers to develop next-gen camera-based imaging devices. As cameras continue to get smaller, engineers will continue to incorporate cameras into devices where they have historically not been able to be included, enabling better procedure effectiveness and patient outcomes.

Cullen: The next phase of medtech will be defined by compressing development timelines while increasing predictability at scale. Design for manufacturability will move from best practice to baseline expectation, with earlier alignment between engineering intent and production realities.

We will also see continued advancement of higher-performance and lower-cost materials and processes that expand devices into clinical applications previously out of reach. Integration of electronics and digital capabilities will create smarter systems with enhanced visualization and real-time data feedback. At the same time, AI will be applied more broadly across manufacturing and business processes to drive efficiency, quality, and scalability.

For OEMs, these trends directly shape partner selection. The differentiator will not simply be speed, but the ability to compress cycles without increasing risk, to standardize intelligently rather than rigidly, and to resolve tradeoffs early. The organizations that lead will not just move faster. They will make fewer late-stage corrections because the right decisions were made earlier.

Faulkner: The sustainability aspects are something to keep an eye on, and the political landscapes around the globe. 

Hoffman: We continue to closely watch the convergence of advanced technologies, particularly AI, robotics, and computer-controlled devices, which is driving increased demand for miniaturization, sensing, and highly integrated systems. These trends are fundamentally changing how devices are designed and manufactured, requiring greater precision, tighter tolerances, and closer alignment between development and production.

As a result, specialized capabilities such as micro molding and advanced materials processing are becoming increasingly critical. At the same time, our investment in steering and vision technologies enables us to partner more deeply with OEMs to help shape what comes next—supporting innovation earlier in the design process and translating complex ideas into manufacturable, scalable solutions. Together, these capabilities position us not just to follow industry trends, but to actively help define the next generation of medical devices.

Johnson: Several trends will continue to shape medtech in both the near and long term. Increased regulatory scrutiny and supply chain resilience planning will remain front and center, influencing sourcing strategies and operational models. Longer term, advancements in automation, data analytics, and AI—along with greater demand for vertically integrated and technically specialized partners—are likely to significantly impact how products are designed, transferred, and manufactured.

LaVersa: The integration of AI and advanced automation into medtech manufacturing will continue to accelerate. The CDMOs that invest ahead of that curve will be the ones best positioned to serve OEM needs over the long term. A meaningful differentiator for Harmac is our ability to design and build custom automation in-house, which compresses time-to-market for our customers and ensures our equipment is optimized for the specific products we manufacture. Looking further ahead, we see AI playing an expanding role in quality systems and process optimization, to name a few. We are actively developing capabilities in these areas to ensure we remain a forward-looking partner for our customers.

Muchin: One of the biggest trends is the increasing complexity of devices combined with continued pressure to accelerate timelines. That is driving demand for more integrated partners who can connect design, manufacturing, regulatory, and supply chain into a single, scalable system. Companies that can deliver that level of coordination will have a clear advantage. We see this particularly in the development of catheters needed for precision and performance in the healthcare industry. From TAVR delivery systems to neurovascular thrombectomy catheters, the devices that improve patient outcomes require manufacturing partners skilled in precision engineering, materials science, and regulatory compliance. That’s the area where Cordica Medical excels.

Ramus: Several trends stand out:

  • Greater collaboration between OEMs and development/manufacturing partners
  • Increased outsourcing of both manufacturing and product development
  • Growing device complexity, particularly in connected and digital health technologies
  • Increased emphasis on supply chain resilience and risk mitigation
  • Adoption of more iterative, lean development models that enable faster innovation
  • The increase in the popularity and availability of ASCs (ambulatory surgery centers) will impact buying decisions and drive additional innovation for device design that is accessible for these largely physician-owned facilities.

Sokoloski: AI is certainly an area everyone is exploring. The opportunity to improve efficiency and analytics will be tremendous. The use of AI will continue to require a CDMO that has the technical talent to verify and validate the AI output, as well as heightened empathy, listening, and judgment skills to ensure the intention and use are most impactful. 

Fenske: Do you have any additional comments you’d like to share regarding the OEM/CMO relationship within the medical device development and manufacturing community?

Faulkner: I think when an OEM can look for a partner rather than just another part of their supply chain, overall business will grow for both sides. 

Gahagan: The relationship between OEMs and CMOs is shifting from transactional to strategic. The most successful partnerships are those built on shared transparency, shared accountability, and shared growth objectives. In today’s medtech environment, collaboration is a competitive advantage.

Hoffman: At Nissha Medical Technologies, our growth strategy is centered on evolving the OEM/CMO relationship into a long-term, value-driven partnership model. As medical devices become more complex and development cycles compress, OEMs increasingly need partners that can engage earlier, integrate more deeply, and support the full product lifecycle—from concept and design through commercialization and scale. Our strategy reflects this shift, focusing on tighter alignment, transparency, and shared accountability with our customers.

We are investing intentionally in specialized capabilities, development infrastructure, and enabling technologies that allow us to contribute meaningfully upstream while maintaining excellence in manufacturing execution. These investments allow us to help OEMs reduce risk, accelerate time to market, and translate complex ideas into manufacturable solutions.

Ultimately, our growth is driven by helping customers succeed. By combining deep technical expertise, disciplined operations, and early, collaborative engagement, we aim to be a strategic partner that supports innovation today while helping shape what comes next in medical device development and manufacturing.

Johnson: The OEM/CMO relationship continues to evolve toward deeper strategic alignment rather than transactional engagement. In an environment defined by regulatory complexity, supply chain risk, and cost pressure, long-term collaboration built on transparency, shared accountability, and executive alignment is increasingly essential. The most successful partnerships are those where both organizations invest in mutual growth, innovation, and operational excellence.

LaVersa: The OEM/CDMO relationship, at its best, is a true partnership—built on trust, transparency, and shared goals. As a mid-tier CDMO, Harmac prides itself on being highly responsive and genuinely customer-focused in a way that larger organizations often struggle to replicate. We work hand-in-hand with our customers every day—not just to deliver high-quality manufactured products, but to provide real value, engineering support, and the kind of collaborative engagement that makes a measurable difference in their business.

Muchin: The relationships are becoming more strategic and more interdependent. OEMs are seeking partners that can contribute beyond execution and help navigate complexity across the lifecycle. The strongest outcomes come from early alignment, shared accountability, and a focus on long-term success rather than short-term transactions. At the end of the day, everything we build touches patient care. That’s why we treat every program, whether it’s a catheter delivery system, a wound care product, or a diagnostic component, with the same level of engineering rigor. The OEMs we partner with aren’t just customers; they trust us with products that impact lives.

Ramus: The most successful partnerships recognize that medical device development is not a linear process. It requires a collaborative ecosystem that blends design, manufacturing, sustaining engineering, and commercial expertise.

A lean development approach that includes embracing iteration, rapid learning, and phased long-term planning allows teams to move faster while maintaining the quality and reliability required in healthcare. When OEMs and CMOs operate as true partners, they can significantly accelerate innovation while reducing risk across the entire product lifecycle.

Ruth: We are fortunate to contribute to an industry that transforms lives, whether it’s a life-saving device, a diagnostic tool, or an implant. Our work matters. It’s not just about the products; it’s about patient well-being. Our loved ones deserve nothing but the best quality of care.

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