By Sean Fenske, Editor-in-Chief
 
Environmental considerations are growing in interest across manufacturing and within many industries. Medical device manufacturing is no exception. While these developers have to make patients and their safety the number one priority when designing products, environmental considerations and sustainability are quickly rising in terms of importance on their lists.
 
But sustainability isn’t only about the environmental impact, at least in terms of medical device coatings. When speaking about sustainability, suppliers of coatings also point to long-term availability as another important factor that falls under the umbrella of the word. Regulatory impact and implications can also be a factor. As such, sourcing medical device coatings sustainably can be key to a company’s overall success strategy.
 
To help clarify this trend and why it’s important for medical device makers who are considering sustainable coatings, Kevin Hess, president of Surface Solutions Group, LLC, offered his insights in response to several questions around this topic. The following Q&A covers sustainable coatings, why they are important, application considerations, challenges of their use, and more.
 
Sean Fenske: Most understand sustainable plastics, but what are sustainable coatings? What’s the difference with them compared to other coatings?
 
Kevin Hess: Sustainable coatings focus on formulations that are not only environmentally benign, but also ensure consistent availability in the foreseeable future. This means relying on materials and processes not impacted by regulatory demands, and can be sustainably sourced or manufactured over extended periods. Traditional coatings might be reliant on finite resources, from a regulatory standpoint, or have environmentally detrimental manufacturing chemicals, posing both availability and environmental concerns.
 
Fenske: What’s driving the interest in sustainable coatings?
 
Hess: It’s a blend of practical and ethical considerations. On the practical side, there’s a growing recognition that we need coatings that are going to be available in the long term. Relying on regulatory sensitive materials could spell trouble down the line, whether it’s resource scarcity or price volatility. So, ensuring the coatings we use today are going to be around tomorrow is a strategic move.
 
Then, on the ethical front, there’s a real push to reduce the environmental impact of these products. Regulations are increasingly leaning toward sustainability, and let’s face it, public sentiment is too. Companies that get ahead of these changes are better positioned to navigate future regulatory landscapes and consumer expectations.
 
In a nutshell, transitioning to sustainable coatings isn’t just good for the planet; it’s becoming a business imperative. It’s about staying ahead of the curve, ensuring a stable supply chain, and being prepared for the future.
 
Fenske: Are the application areas/use cases limited with sustainable coatings or can they be used just as any other coating can?
 
Hess: The ideal goal is to have sustainable coatings that are functionally equivalent to traditional ones, offering the same levels of durability, adhesion, and corrosion resistance. However, the composition of sustainable coatings can differ substantially, given the focus on long-term availability and reduced environmental impact.
 
So, what does this mean practically? Well, before making the switch, thorough compatibility and performance testing are essential. This isn’t a one-size-fits-all kind of situation. Some sustainable coatings may be plug-and-play, interchangeable with their traditional counterparts, but others may require adaptations in application techniques or even machinery settings.
 
The point is, while sustainable coatings aim to cover the same range of applications as traditional ones, there may be nuances in how they perform or how they need to be applied. That’s why it’s crucial to collaborate with materials scientists and engineers to ensure the chosen coating is up to the task, especially in a field as stringent as medical devices.
 
Fenske: What challenges can emerge with sustainable coatings? Are there any sacrifices that need to be made?
 
Hess: First off, the material properties. Sustainable coatings are made from different polymers compared to traditional ones, so they can have variations in key parameters like hardness, adhesion, and corrosion resistance.
 
Secondly, let’s talk about costs. Shifting to a new type of coating may entail some upfront investment. This could be due to the cost of the raw materials themselves or the R&D required to make them compatible with existing production processes.
 
So, while sustainable coatings offer long-term benefits, the transition isn’t without its hurdles. In some cases, it’s just a matter of swapping out one for the other. In others, more testing is required, and you need a solid transition plan, possibly involving multidisciplinary teams to sort out these details. But the long-term gains make it a challenge worth tackling.
 
Fenske: Is sustainability important primarily for single-use devices or is it just as important in reusable products?
 
Hess: Regardless of whether a device is single-use or reusable, supply chain stability is a core concern.
 
For single-use devices like guidewires or catheters, using a sustainable coating helps ensure a more predictable, stable supply chain. You don’t want to get into a situation where a key material suddenly becomes scarce or skyrockets in price, affecting your whole production line. So, adopting coatings with sustainably sourced materials provides a layer of security against those kinds of disruptions.
 
Now, when we talk about reusable devices, like surgical instruments or diagnostic machinery, the supply chain focus shifts slightly but remains crucial. Here, it’s about long-term availability of coating materials for maintenance or reapplication. A reusable device is designed to last for years, maybe even decades. The last thing you want to discover is that a coating, essential for its functionality, is no longer available. That’s a logistical nightmare and a financial strain, to say the least.
 
So, it’s not just an environmental issue; it’s also a strategic, supply chain-centered decision. Whether the device is single-use or reusable, the rationale for choosing a sustainable coating is strongly rooted in ensuring supply chain continuity and stability.
 
Fenske: What aspect regarding the use of sustainable coatings are not often considered or overlooked? Are there factors that need to be decided to ensure the coating is suitable for a project?
 
Hess: Typically, the most overlooked aspect when changing to a sustainable coating is marketing. The marketing needs for a specific color need to be addressed early in the development process. Making changes to the color of a material might seem mundane but it requires reformulation of the colorant packages that make up the solids in the coating. This can have an impact on the performance of the coating and if the change is made after performance testing is complete, it could require repeating performance testing and, ultimately, delay a product launch.
 
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?
 
Hess: At Surface Solutions Group (SSG), we take pride in technical knowledge. We continue to work with our chemists and formulation partners to develop coatings that will be complaint to current regulatory requirements and future changes.
 
An example of this is SSG’s extensive R&D work that created our new sustainable GlideMed™ medical device coatings. Based on proven coating technology, they are a good alternative to traditional PTFE coatings. They are water-based, low friction, and biocompatible, and are available in two formulations—one that contains no PTFE and one that is low PTFE. GlideMed coatings are also free from any PFOA, PFOS, solvent, and hex chrome compounds. These properties make it sustainable and REACH and RoHS compliant.
 
When it comes to medical devices, there is no one-size-fits-all coating. That is why we have developed one of the largest coating portfolios in the industry—13 in all currently. We work alongside our customers to help them choose the coating that’s right for their application, and they give us their feedback. This proactive, collaborative approach ensures our customers have many options at their disposal to develop the next generation of medical devices.
 
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