How Closer Coating Partnerships De‑Risk the Medtech Device Lifecycle—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

Medical device manufacturers are getting better about involving their contract manufacturing partners earlier in the development process. While this offers an array of advantages, not following this model with critical supply partners can be detrimental. Gaining the insights of these suppliers early in the product lifecycle helps avoid rework or redesigns at a later phase, which adds cost and time.

One such supplier where a proactive approach adds tremendous value is the coatings provider. While some reach out early, other device makers work with a distributor and do not have the ability to give or get engineering input on their coating selection. And because they are not accustomed to speaking directly with the lab that developed the formulation and gaining access to their expertise and experience, they miss out on the technical expertise that is needed to optimize their device.

One such coating supplier is changing that dynamic. ISURTEC has established a commercial model that bypasses the middleman and works directly with device manufacturers. In the following Q&A, two representatives from the organization—Dr. Eric Guire, Chief Innovation Officer, and Dr. Maria Holm, Chief Operating Officer—speak to this arrangement and why it’s so important for their customers.

Sean Fenske: What is the traditional model for accessing medical device coatings? What are the challenges with this model?

Drs. Eric Guire & Maria Holm: Traditionally, when a device team realizes it needs a hydrophilic coating, it outsources that capability, either by licensing technology from a coating company or purchasing through a distributor. In many cases, that access is tied to royalty-bearing agreements and layered distributor fees, so the cost of the coating scales with the commercial success of the device rather than remaining a straightforward material expense.

The technical challenge is similar: when a distributor sits between the OEM/CDMO and the scientists who created the coating, critical details about the device, substrate, and use environment can be lost or delayed. That makes it harder to quickly troubleshoot, optimize, or even confirm the recommended coating is the right one, especially for teams that know they need a coating but do not yet know all the testing, preparation, and lifecycle considerations that go with it.

At ISURTEC, we intentionally moved away from that model. We work directly with device manufacturers under royalty-free licensing and supply agreements, so customers are not penalized for their own growth. In addition, since they are talking with the people who developed the chemistry, they get a collaborative, consultative partner—one that can rapidly iterate, share data from extensive research, and help align coating selection, process, and testing with the evolving demands of the device.

Fenske: Why is a partnership with a coating developer advantageous? What benefits can be enjoyed that aren’t realized in the distribution model?

Drs. Eric & Holm: Let the SMEs (subject matter experts) be your guide. When you work directly with the team that developed the coating, you gain deep subject matter expertise in surface modification chemistry, not just as a supplier. We bring decades of data from different substrates, geometries, use cases, and coating functionalities, so you are not re-solving problems that have already been worked through many times in the lab. That depth allows us to quickly narrow in on what’s likely to work—and what is not—rather than asking you to learn coatings by trial and error.

This direct model also changes the way development feels. We like to be involved as early as possible so we can help you think through aspects of the device that will impact coating performance and durability, then iterate quickly together as the design evolves. For new device development, it is common to work with a customer’s engineering team to help with material selection, so unique challenges associated with a substrate material can be identified early. Instead of a distributor relaying questions and providing potentially incomplete answers, you have a responsive, hands-on team that can talk directly about chemistry, processing, quality questions, and test data.

Finally, there is a very practical benefit: cost transparency. By working directly with ISURTEC, you avoid potential distributor markups and the extra margin required to “sit in the middle,” while still getting a consultative, research-driven partner. That combination—royalty-free access, expert guidance, and quick, data-backed iteration—is difficult to achieve, and it is where customers often tell us they feel the difference in both speed and confidence.

Fenske: What level of customization is available by working with the coating developer? Are these adjustments to stock products, or is a custom solution available?

Drs. Eric & Holm: The answer is both—and knowing where to start on that spectrum is part of what an experienced coating developer brings to the conversation.

In most cases, the right starting point is an established coating platform, optimized to meet the specific requirements of the device. This approach is faster, more economical, and less risky than starting from scratch, and it draws on a validated scientific foundation that has already been tested across a wide range of predicate applications. Small, targeted adjustments to an existing formulation can yield meaningful improvements in adhesion, lubricity, durability, or compatibility with a specific substrate—without the timeline and cost implications of full custom development.

When performance requirements genuinely exceed what any established platform can deliver, a capable coating developer can go further. At ISURTEC, we have developed entirely new coating solutions, including drug-eluting platforms and systems designed for substrates that conventional hydrophilic coatings cannot reliably address—for specific customer applications. In each case, that development was accelerated by prior scientific work, which means we are not starting from zero even when the solution is novel.

The strategic question is not “Can we customize?” It is “Where on the spectrum does the science and business case align?” Our role is to help device teams answer that question with data rather than assumptions—recommending incremental optimization when feasible and committing to bespoke development when the device’s performance requirements and commercial trajectory justify the investment. For new treatment modalities or enabling technologies, our team excels at creating manufacturing-friendly coatings to address important advancements that occur in the medtech space.

Fenske: When working directly with the coating developer, when should the device maker enlist its assistance? What is the optimal timing for its involvement?

Drs. Eric & Holm: As early as possible—and earlier than most teams currently do.

The inflection point is when the device’s intended application is defined, and substrate evaluation begins. At that stage, a coating developer can contribute real value to material selection, manufacturability assessment, and design decisions that will shape what is achievable downstream. That input costs relatively little at the concept stage. It can cost significantly more if it comes after those decisions are made. We recommend reaching out for advice (we are happy to share our experience) or feasibility testing when performing material selection early in device development.

The industry’s common practice—bringing a coating provider in the loop as design lock approaches—is one of the most reliably expensive habits in medical device development. By the time design lock is reached, substrate, geometry, and manufacturing process are committed. If the chosen materials are difficult or impossible to coat reliably, the remediation options are all painful: late-stage redesign, acceptance of a forced-fit coating solution that may have little margin for error in manufacturing, or custom formulation development to work around constraints that should not have existed. In the end, addressing coatings late in development can be slow, expensive, and risky. Reach out early for an opinion and some guidance.

We have worked with development teams who came to us mid-program and found themselves considering substrate changes because of coating challenges that were not apparent at the concept stage. Those are hard conversations, and they are largely avoidable. Coatings look like a small detail on the device specification, but they have an outsized effect on clinical performance, product reputation, device manufacturability, and patient outcomes. Treating them as an afterthought is a risk that does not show up on the project schedule until it is expensive to address.

The practical guidance is simple: find a coating partner who values collaboration as much as chemistry. Early design discussions should be an opportunity to leverage experience, challenge assumptions, and identify the best path forward—not simply another line item on a quote. The goal is to build a partnership that delivers better devices, faster development, and long-term success for both organizations. That is the standard we hold ourselves to at ISURTEC, and it is where we consistently see the best outcomes for device programs.

Fenske: I know you touched on cost earlier, but can you explain a bit more? What is the overall impact on cost from working directly with the coating developer versus going through a distributor?

Drs. Eric & Holm: The cost impact is direct and measurable: you remove a layer of margin from every purchase without giving up anything of technical value.

When coatings are purchased through a distributor, additional costs such as that distributor’s marketing, sales operations, and supply chain infrastructure can increase the overall cost of the transaction. Those are real costs, but they do not contribute to the performance of the coating, the quality of the technical support, or the reliability of the supply relationship. They are overhead margin built into the model to sustain a layer that, from a technical standpoint, is adding distance rather than value.

At ISURTEC, we bring those functions in-house and pass the benefit directly to the customer. We sell directly at the same price we have charged our distribution partners. There is no premium associated with direct access, and our customers have direct access to our technical support. OEMs and CDMOs that have operated under the assumption that going direct means paying more are typically surprised to find the opposite is true—and that the savings come with ISURTEC’s signature customer support and technical expertise.

Fenske: What unexpected gains are achieved from this direct collaboration? What aspect of the partnership most surprises medical device manufacturers who have previously only accessed coatings through a distributor?

Drs. Eric & Holm: One of the biggest surprises is how quickly teams can move when they have direct access to the people who developed the coating. As they are building new devices, customers can come straight to ISURTEC for advice and begin using our coatings in their development work right away. They discover they are not just getting products; they are getting targeted, experience-based guidance on what our coatings can do, what they cannot do, and how to make the best use of them in their specific application. The result is an educated customer that makes better-informed decisions down the road as coating know-how is passed on to larger manufacturing operations.

Teams are often struck by the level of hands-on troubleshooting and support ISURTEC provides throughout the life of a project. Whether it’s a manufacturing challenge, a performance question, or a supply chain issue, our customers have direct access to the technical experts who understand their application and are committed to helping them find the right solution. We view these conversations as an essential part of a successful partnership, ensuring customers have the support they need when new challenges arise.

That responsiveness is grounded in something simple but powerful: our name is on every coating we deliver, and we care deeply that it performs in the field—not just in the lab. That same commitment also means being honest about where we can add the most value. If another solution is a better fit for the application, we’ll say so. Our goal is to help customers build the best possible device, even when that means recommending a different path.

The other unexpected gain is relational. Customers quickly realize they are treated as colleagues and partners, not just accounts. We check in, ask how things are going, and invite tough questions because we learn from those challenges too. That ongoing dialogue feeds back into our R&D—informing where we need faster processing, how to handle more nuanced materials, and how coatings must evolve as devices target ever more distal anatomies and support increasingly complex procedures. Based on our experience, our customers welcome this combination of genuine enthusiasm for the science, proactive follow-up, and a shared mission—to get devices safely helping patients.

Fenske: What should OEMs and CDMOs look for in a coating supplier, and how does ISURTEC approach that role?

Drs. Eric & Holm: If I could offer one piece of advice, it would be this: choose a coating supplier willing to share what they know and grow with you. You should be able to ask how the coating behaves, how to apply and test it, and how to adjust your process over time—and get clear, thoughtful answers. That kind of openness is essential if you want to scale, transfer technology, or eventually bring coating in-house without unacceptable surprises.

At ISURTEC, we’ve built our model around being that kind of partner. Our IP is proprietary and protected, but we are happy to teach you how to use it on your device: how to coat, how to interpret test results, and how to troubleshoot when something changes in your process. We see our role as shepherding you through the full lifecycle of the device—early feasibility, scale-up, and, when you’re ready, vertical integration.

As devices push further distal, employ more advanced materials, and demand more from their coatings, that open-partnership mindset matters even more. We’ll bring our ideas, our problem-solving, and our latest developments—like hydrophilic platforms that can replace multiple steps or enable historically difficult substrates—to help your design perform at its best. In short, look for a partner whose success is aligned with your long-term independence and growth; that’s the role we are committed to playing.

Fenske: What final message would you share with device manufacturers about coating partnerships?

Drs. Eric & Holm: When you work with ISURTEC, you are not just buying coating; you are gaining a partner that is genuinely invested in your device and your mission. Our scientists love this work, know these products deeply, and stay close to where the industry is headed, which means you get passion and expertise in the same conversation. We see it as our responsibility to help you understand what’s possible, where the risks are, and how to get the most from the coating.

We also believe a coating partner should be centered on you and your patients. Our model is intentionally open: no royalties, no “black box” processes, and a willingness to teach you or your coating service provider how to apply, test, and scale our technology correctly when you are ready. As your programs grow, we want to be the partner that helps you move smoothly from early development through commercialization and, when it makes sense, into in-house coating.

Finally, we are proud of the portfolio we have built because it reflects that philosophy. Products like ISURGLIDE PLUS, our SR330 solution for difficult-to-coat surfaces, and our 955 primer are designed to simplify complex challenges, combine steps where possible, and help you drive efficiency through your process. If you are looking for a coatings partner that will share what we know, stand alongside your team, and keep innovating as your devices become more demanding, that is the relationship we are here to build.

Fenske: Is there anything else you’d like to tell medical device manufacturers about working with ISURTEC?

Drs. Eric & Holm: There is one thing we would emphasize: we see coatings as a collaborative discipline, not a commodity. When you bring ISURTEC into a project, you get a team that is deeply curious about your device, your clinical goal, and your constraints. We enjoy learning about what you are building just as much as you want to understand what our coatings can do, and that mutual curiosity is where a lot of the best problem-solving happens.

We also know that innovation does not stop at the lab bench. Many of our products exist because we listened carefully to where customers were struggling—hard-to-coat materials, multi-step processes, and the need for durable performance on increasingly complex geometries—and then designed solutions that remove friction instead of adding it. That same mindset drives our future roadmap; every conversation with you feeds back into how we evolve the portfolio.

If you are looking for a coatings partner who will answer the phone, share practical know-how, and stay with you from the first prototypes through scale-up and beyond, that is exactly how we operate. Our goal is simple: to make sure your coating is never the weak link in an otherwise great device—and to do that in a way that respects your independence, your budget, and your mission to help patients.

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