By Sean Fenske, Editor-in-Chief

Finding the right manufacturing partner can make a world of difference in the success of a project. While some service providers will help bring a company to the finish line, others will provide an optimal route through the capabilities offered. They can speed time to market, provide critical design input early, reduce costs, and save a company on managing multiple vendors.

For organizations requiring a coating for their project, identifying an expert that also offers manufacturing capabilities can be the difference in the outcome. Having that experience coupled with the coating knowledge will provide design, engineering, and manufacturing recommendations that can guide the project to success.

To help further explain the benefits of working with such a supply chain partner is Niall Cullen, VP, Product Marketing at Integer. In the following Q&A, he explains manufacturability, the benefits of early involvement, and how coatings can impact a device’s product lifecycle.

Sean Fenske: When referring to manufacturability, what are we talking about? What is manufacturability?

Niall Cullen: Manufacturability in medical device development refers to the ability to efficiently and reliably produce devices that meet strict quality, regulatory, and performance requirements. It includes considerations such as material selection, process capability, scalability, cost-effectiveness, and risk mitigation. At Integer, manufacturability also means integrating technologies such as medical coatings and surface treatments early in the design process to ensure devices can be consistently produced at scale while maintaining performance and biocompatibility.

Consistency from the first device to the millionth is critical, particularly for coatings, where variables such as humidity, surface preparation, and cleanroom conditions can influence results. Achieving the right durability and longevity requires understanding both the coating and the substrate. Integer’s experience with complex substrates, such as microcatheters, allows us to anticipate challenges early and deliver the appropriate balance of durability and lubricity for the intended application.

Fenske: When should manufacturability be addressed in the product development lifecycle? Why? When should the manufacturing partner be brought into the project?

Cullen: Manufacturability should be considered from the earliest stages of device design. Engaging a manufacturing partner such as Integer during concept and prototype development helps identify potential challenges early, optimize materials and processes, and integrate coatings and surface treatments effectively. This ensures designs are not only innovative but also scalable for production, regulatory compliance, and long-term performance.

Early collaboration reduces complexity, streamlines the supply chain, and minimizes risk, ultimately leading to a more robust and manufacturable solution. Integer simplifies this process by offering development, manufacturing, and coating capabilities within a single partner. This is particularly important for coatings, where multiple variables influence performance.

Understanding both the device and the clinical environment it must navigate enables informed coating and surface preparation decisions early in development. Trade-offs, such as lubricity versus durability, can then be evaluated upfront to determine the best solution for the application.

Fenske: In the development and manufacturing of devices that navigate tortuous paths, what are the critical considerations?

Cullen: Devices designed to navigate tortuous anatomy, such as guidewires and catheters, must balance flexibility, lubricity, durability, and biocompatibility. Surface coatings are essential in achieving this balance. Technologies such as PTFE and hydrophilic coatings reduce friction and support smooth device navigation while maintaining durability and biocompatibility.

Coatings must also adhere reliably to substrates, withstand mechanical stresses, and minimize particulate generation to reduce procedural risk. Experience in manufacturing devices used in complex anatomies, such as with neurovascular microcatheters, provides valuable insight into the durability and lubricity required for these applications.

Coatings are evaluated through testing that reflects real-world clinical conditions. Technologies known to perform well in demanding applications, such as Biocoat’s hydrophilic coatings, are selected based on demonstrated performance. In many cases, coating selection follows testing to ensure the optimal balance of properties for the device’s clinical pathway.

Fenske: In the development and manufacture of these types of devices, what role do coatings play?

Cullen: Coatings and surface treatments play a critical role in device performance by providing functional properties such as lubricity, wear resistance, antimicrobial protection, and dielectric insulation.

Integer offers a broad portfolio of coating technologies, including PTFE, hydrophilic, anodic, parylene, ion implantation, IBAD, and surface texturing, each designed to address specific device requirements. Integrating coating solutions early in development improves manufacturability, supports regulatory compliance, and enables more effective device testing and validation.

Coatings are often applied to address challenges identified during development. Hydrophilic coatings are particularly important for microcatheters navigating tortuous anatomy, while parylene is commonly used for dielectric protection or insulation of exposed electronics. A broad technology portfolio allows solutions to be selected based on application requirements rather than a single coating approach.

Fenske: What advantages are realized from working with a company that has expertise in coatings technologies and is also a manufacturer of medical devices?

Cullen: Working with a coatings expert that is also a device manufacturer reduces supply chain complexity by consolidating development, manufacturing, and coating processes with a single partner. This vertical integration improves communication, accelerates timelines, and strengthens quality control.

Integer’s advanced coating technologies and manufacturing capabilities provide customers with deep technical expertise and a platform designed to support scalability and innovation. By combining development, manufacturing, and coatings, Integer delivers an integrated platform that helps minimize risk while ensuring consistent, high-quality results.

Through Integer Medical Coatings’ “One Partner, One Platform” approach, customers can source coated components directly, simplifying logistics and reducing the coordination challenges that often arise in multi-vendor environments. Since Integer manages both the substrate and coating, accountability is streamlined, and handling, inspection, and lead times can be reduced.

Fenske: When it comes to coatings, what aspects are overlooked by designers or not appropriately considered in the development or manufacture of a medical device?

Cullen: Coating selection and integration are sometimes underestimated during device development. Factors such as adhesion, durability, biocompatibility, particulate generation, and regulatory compliance can significantly affect both device performance and manufacturability.

Compatibility between coatings and substrates, the influence of coatings on mechanical properties, and the need for specialized surface treatments, such as those supporting osseointegration or antimicrobial protection, are also frequently overlooked. Engaging a coatings expert early helps ensure these considerations are addressed before they become late-stage challenges.

The trade-off between lubricity and durability is another key factor that is often not fully appreciated until later in development. Evaluating these trade-offs early helps ensure the selected coating delivers the right balance of performance for the device’s clinical application.

Test method alignment remains essential for success. Most OEMs rely on internal, proprietary testing procedures rather than standard ASTM or ISO methods to specify coating performance requirements. This reliance can result in miscommunication owing to the lack of a universally understood technical framework. Establishing clear functional requirements at the outset, together with deployable verification strategies, significantly streamlines the development process. Therefore, early, transparent, and precise engagement with customers is imperative.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Cullen: Medical device manufacturers should prioritize manufacturability and coating integration from the beginning of product development. Partnering with a company that offers comprehensive capabilities, such as Integer, provides access to coating technologies, engineering expertise, manufacturing capabilities, and an integrated supply chain.

This approach simplifies development, reduces risk, enhances device quality, and supports regulatory compliance. Integer’s expertise in design, manufacturing, and coating technologies enables us to support medtech companies in developing reliable, scalable, high-performance devices.

Continued investment in coating technologies and surface modifications ensures new solutions are developed to meet the evolving needs of the medtech industry. By advancing innovation and R&D, Integer is positioned to support customers as device complexity and clinical demands continue to grow.

Click here to learn more about Integer >>>>>