By Sean Fenske, Editor-in-Chief

When it comes to medical device manufacturing, oftentimes, the focus is put on the clinical application, procedure, or unique technology within the device. As a result, other critically important aspects can sometimes become secondary considerations. This can lead to the need to make revisions later in the product development lifecycle, increasing costs and the time to market.

With this in mind, it’s important to collaborate with supply chain partners and contract manufacturers to ensure no aspect or step is neglected. Further, doing so as early as possible in the development process helps to eliminate conflicts between materials, manufacturing steps, or other aspects of the device’s fabrication. For example, bringing a coating expert into the equation can confirm alignment between the substrate and the material being coated.

To better understand other advantages of working with a coating supplier early in a device development process, a pair of representatives from ISurTec addressed a number of questions. In the following Q&A, Eric Guire, Chief Innovation Officer, and Kristin Taton, Chief Scientific Officer, speak on the benefits of early collaboration and several aspects to keep in mind when doing so.

Sean Fenske: What are the most desirable benefits medical device manufacturers are seeking from coatings?

Kristin Taton: At the core, medical device manufacturers are looking for coatings that deliver lubricity, durability, and biocompatibility—qualities that make devices safer, easier to use, and more effective for both clinicians and patients.

A lubricious coating reduces friction between the device and tissue, enabling smoother insertion and navigation through the vasculature. This improved performance can minimize tissue trauma, shorten procedure time, and lower the risk of complications, while helping devices work seamlessly with guidewires, introducers, and other system components.

Equally critical is durability and low particulate formation—the coating must remain intact throughout the procedure to ensure consistent performance and patient safety.

Biocompatibility is another non-negotiable; using coating solutions with a proven history of safe use gives OEMs confidence and helps streamline regulatory approval. In addition, choosing a fully synthetic coating that is formulated without water can provide valuable protection against intermittent endotoxin contamination down the road. Scrapping production lots due to high endotoxin levels can be a very expensive proposition.

At ISurTec, coatings are developed to embody this balance of performance and safety. Hydrophilic technologies are engineered to deliver smooth, reliable control without sacrificing stability or biocompatibility. This enables partners to innovate confidently, knowing their coatings will perform where it matters most—inside the body.

Fenske: When we mention collaboration between the OEM, CDMO, and coating provider, what exactly are we referring to? What is each party bringing to the equation?

Eric Guire: Collaboration between OEMs, CDMOs, and coating partners is about building a shared problem-solving team around the device and its lifecycle—not a linear handoff. Each group brings different strengths, and the real value comes from aligning those early, before design and testing are locked in. Often, good outcomes are achieved most efficiently when both the manufacturer and the coatings supplier can iterate rapidly as they select the best coating formulation and process. At ISurTec, we strive to deliver coatings and processes that exceed our customers’ targets, while paying careful attention to maximizing available efficiencies of in-line manufacturing.

Practically, collaboration means exposing the full picture: device design, materials, performance targets, and regulatory expectations, so the team can choose viable coating options and avoid dead ends caused by incompatible substrates or unrealistic requirements. The coating partner contributes deep expertise in coating chemistry and application, helping select and optimize coatings while aligning documentation and quality systems to fit the OEM’s processes.

The OEM brings the clinical vision, regulatory strategy, and system-level requirements, setting the guardrails for what the device must do and how it will be approved and marketed. The CDMO connects that vision to reality through rapid prototyping and process development, ensuring the device and coating can be manufactured consistently at scale. ISurTec’s role is to plug into that ecosystem as a coating specialist—helping OEMs and CDMOs turn complex requirements into practical, testable, and, ultimately, commercializable coating processes.

Fenske: Why is it important for this collaboration to take place early in the development process? What advantages are realized early, and what is lost if it happens later?

Guire: Early collaboration ensures coatings are designed into the device and process from the beginning, rather than being forced to fit after key decisions are already locked. When teams align early, they can choose compatible substrates, decide where the coating step belongs in the manufacturing flow, and set reproducible performance targets.

Engaging a coating expert upfront also shortens development time. Instead of trial-and-error, device teams are guided toward promising formulations, primers, and masking strategies, and can quickly adjust when durability, flexibility, or geometry introduces unique demands.

When collaboration happens late, the cost shows up as redesigns, material changes, and rework—sometimes requiring a different coating or even a different device configuration as timelines are tightening. Treating coatings as a core design input from the outset helps avoid roadblocks and keeps programs moving forward with fewer surprises.

Fenske: How is device innovation impacted by a coating technology and/or its application?

Guire: Coating technology enables vascular device use. In many cases, a device simply cannot perform its intended function without the right coating—whether that means reaching tighter vasculature, maintaining low-micron hydrated coating thickness tolerances when used with other vascular devices, or protecting sensitive surfaces over time under real clinical conditions. Thoughtful application choices—such as where a coating is applied, how thin it can be, and how it interacts with complex geometries—open the door to designs that would otherwise be too risky or unreliable to pursue.

Coatings also expand what devices can do beyond providing procedural lubricity. ISurTec has developed custom coatings that can deliver APIs, improve electrical properties for electrodes, or passivate against protein and tissue buildup, extending implant life and keeping critical pathways from clogging or fouling.

Looking ahead, emerging platforms like robotic surgery systems and next-generation implants will rely even more on advanced coatings for lubricity, stability, and surface control. As regulatory and material landscapes evolve, coatings also provide a path to reduce reliance on certain legacy chemistries while maintaining or improving performance. In that sense, coatings are not just supporting innovation—they are increasingly one of the levers that define what is possible in device design.

Fenske: Why is it also important to determine the testing of the coating technology early in development? What gains are achieved?

Taton: Determining the test methods for a coated device early is essential because it anchors the work in a strong quality framework from the beginning. When teams define tests and specifications upfront, they avoid shifting test methods over time, which makes comparison between early results with one method and later results with the finalized method difficult. Additionally, test methods can be validated early in the process, ensuring reliable results. This allows a clear, shared view of how coating performance and appearance will be evaluated.

Early clarity on testing also helps catch major problems early in the development process. If the coating test method isn’t accurate, or the criteria aren’t in line with the application, the testing will not detect problems until animal studies or later.

Thinking about testing early also forces practical decisions about where coating and testing happens and with what equipment—whether in-house or at a partner. That perspective helps design a process where coating application, inspection, and handling are aligned, reducing surprises and making it easier to maintain quality as the device moves from development into production.

Fenske: When it comes to substrate selection for coated medical devices, what are commonly overlooked aspects? What do stakeholders fail or neglect to consider?

Guire: Teams often focus on device geometry and mechanical performance but overlook how the chosen substrate will interact with the coating throughout the full manufacturing and use cycle. Certain materials, additives, or surface finishes can make adhesion more challenging, change how the dry coating responds to bending or forming, or create visible defects if the device is flexed aggressively in use.

Another commonly missed aspect is what is “built into” the substrate from extrusion or molding—such as mold release agents or lubricious additives—that can migrate to the surface and interfere with coating performance. If these are not considered at the material-selection stage, they can drive extra cleaning steps, additional surface preparation, or even late-stage material changes.

Finally, substrate selection is tightly linked to where and how the coating will be applied. A material that looks attractive on paper may require different equipment, surface treatment, or environmental controls to achieve a robust coating. Thinking through substrate-coating compatibility early—including cleanliness, additives, forming steps, and application environment—helps prevent surprises and keeps programs from having to revisit fundamental material choices late in development.

Fenske: How should medical device manufacturers think about choosing and partnering with a coating supplier?

Taton: Selecting a coating partner is ultimately a long-term decision about who will stand beside your product in the market for 10 or more years. This partner is not only supporting your device, but also the patients whose lives depend on it, so their commitment to service, transparency, and continuity matters just as much as their technology.

It is important to understand how a potential partner approaches product lifecycle decisions. Some suppliers may retire or replace coatings if they are no longer top priorities, leaving manufacturers with the burden of reformulation, revalidation, and potential supply disruption. Asking directly about long-term availability, change control, and how they handle portfolio updates can prevent painful surprises later.

The way a partner shares knowledge is also telling. A strong coating partner is willing to teach your team how to apply the coating, transfer process knowledge, and support bringing the capability in-house when it makes sense. At ISurTec, that is a core part of the relationship: enabling customers to own their process, understand their coating, and build devices that perform reliably over time, rather than keeping application methods opaque or locking teams into a single service model. ISurTec has enabled medical device manufacturers to manufacture their devices reliably for over 15 years and will always continue to support your team.

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