From materials to market

Evolving materials and technologies are pushing original equipment manufacturers (OEMs) of medical devices to innovate while ensuring their products are safe, effective, and compliant with ever-changing regulations. A thorough device assessment, conducted with your materials supplier, can significantly improve the design and development process. Taking the time to carefully assess medical-grade polymers and the manufacturing and regulatory requirements accompanying them can help OEMs speed devices to market with fewer bumps along the way.

Start early, stay informed

A device assessment is a holistic evaluation examining the entire scope of a medical device and its intended application, from the environment where it will operate to its manufacturing and regulatory constraints. Performing an assessment early in the design process helps OEMs gain valuable insights into the most suitable materials, manufacturing methods, and potential pitfalls throughout a product’s life cycle. For instance, at Lubrizol, device assessments go hand in hand with decades of experience in material science, advanced polymers, and an intimate understanding of regulatory frameworks.

Materials: Much more than chemistry

One of the most significant decisions in the design of any device is the choice of materials. Rarely straightforward, it requires a thorough understanding of material interactions with the body and with all parts of the device under specific use conditions.

Thermoplastic polyurethanes (TPUs), for example, are a go-to material for devices and dressings such as catheters, wound care films, and implantable devices because they offer a unique combination of flexibility and strength and can be fine-tuned for specific mechanical and biological performance. But choosing the right TPU isn’t as simple as selecting from a catalog; it takes a deeper look at what the device really needs to perform at its best.

Depending on the application, a material’s biocompatibility; resistance to hydrolysis, oxidation, or chemical attack; method of sterilization [e.g., ethylene oxide (EO) or gamma]; and aging (shelf-life requirements) must be evaluated. In applications where the device will be exposed to blood and tissue for an extended period, selecting a polycarbonate-based TPU over a polyester- or polyether-based TPU can make an appreciable difference in performance. Polycarbonate-based TPUs are particularly good at standing up to moisture and oxidation, making them a solid choice for devices in contact with blood for extended periods – think pacemakers or long-term infusion catheters.

TPUs offer some great benefits, but they’re just one option among many medical-grade polymers. Depending on what the device needs to do, materials such as silicones, polyamides, and fluoropolymers might be the better fit – each with its own strengths. Choosing the right material isn’t just about knowing the specs – it’s about understanding the application’s intent. When OEMs get this part right, they can speed up innovation and take their devices’ performance to the next level.

How manufacturing plays in

It’s not uncommon for devices to excel in theory, only to run into unexpected challenges on the manufacturing floor. These setbacks often happen because key production details were overlooked early in the design process.

This is where materials suppliers play a crucial role, stepping in with formal device assessments to bridge the gap between design and manufacturing, whether that involves extrusion and molding processes or more complex bonding and reflow techniques. Medical devices typically combine materials with very different properties, and they need to function seamlessly together. A materials supplier can help to confirm these materials will bond correctly and maintain strength.

A catheter needs a stiff section for precise control and delivery, but it also requires a soft, flexible tip to avoid injury and navigate tortuous paths for location and placement. These two parts are often made from different materials – a strong polyamide for the rigid section and a softer TPU for the tip. The challenge is making sure the polyamide holds its shape while the soft tip stays flexible, even after multiple rounds of sterilization. A good manufacturing partner ensures these materials bond together correctly and continue to perform as they should for the long haul.

Bringing in the right materials and manufacturing experts early offers room for creative problem-solving that can prevent expensive redesigns or delays. OEMs also need flexibility in materials production, especially during prototyping. Lubrizol, for instance, offers custom formulations in small quantities to full production runs, whether hundreds or hundreds of thousands of pounds of material are required, allowing manufacturers to meet early-stage needs without overcommitting to large quantities.

Custom solutions for complex devices

The ability to fine-tune solutions to meet specific demands is another benefit of a medical device assessment. It’s about ensuring everything – from material properties to the manufacturing approach – aligns perfectly with how the device functions. Many devices need materials that do more – such as resisting bacteria, showing up clearly in imaging, or delivering medication through surface coatings. A proper assessment helps make sure these specialized needs are met.

Cardiovascular or peripheral balloons for angioplasty need materials that are incredibly flexible yet strong enough to hold up under pressure. Meanwhile, long-term implants have a different challenge: they require polymers that can last for years inside the body without breaking down. Tailoring materials for each use – whether it’s focusing on durability, biocompatibility, or other key traits – can make a huge difference in how well the device performs and how it impacts patients.

What sets good materials suppliers apart is their knack for building custom solutions fitting the exact needs of each project. Suppliers often work directly with OEMs to optimize formulas and properties and/or adjust materials to suit production methods – for example, a robust and dependable drug-delivery device that also needs to release medication at a predictable rate. This type of collaboration invites better all-around outcomes.

Managing regulatory reviews

OEMs are no strangers to the obstacles in navigating the regulatory maze. That’s where device assessments show their real value. Meeting the stringent requirements from the U.S. Food and Drug Administration (FDA) or European regulators is serious business, but a good assessment helps catch problems early, ensuring everything is on track before any issues snowball into expensive delays.

A materials partner can make this process smoother by providing the detailed documentation needed for everything from quality systems to biocompatibility. They also offer FDA Device Master Files (MAFs), which can simplify the regulatory submission process.

And it’s not just the FDA that needs attention. In Europe, for instance, the Medical Device Regulation (MDR) brings added focus to devices using animal- derived materials, demanding extensive risk assessments. To help OEMs get through this, some materials suppliers have developed alternatives that don’t rely on animal-based ingredients but still deliver the performance needed.

In the end, having a supplier who deeply understands their materials – and can adjust them to fit unique needs – leads to better product and patient outcomes across the board.

Looking ahead

In the rapidly evolving field of medical device development, kicking things off with a thorough materials and manufacturing assessment can make all the difference. It’s about setting the stage for smarter decisions, whether that’s choosing optimal materials, streamlining production, or smoothly navigating approvals. By working with experts right from the beginning, OEMs can design devices that perform well and are easier to produce and fully compliant – ultimately saving time, cutting costs, and ensuring a product that’s ready to hit the market. From Lubrizol’s experience, flagging potential issues early on – especially ones that might not have been on the radar – can save companies valuable development time that is often measured in months.

In an industry where every detail matters – whether it’s the polymer used or how the device is sterilized – the insights gained from a comprehensive assessment can be the key to success. Suppliers’ expertise in materials, manufacturing, and regulatory processes gives OEMs a reliable partner to guide them through the entire development journey, from concept to market.

Lubrizol
https://www.lubrizol.com/ health/medical

About the authors: Eric Mabry is the senior manager of new product development at Lubrizol. Jennifer (Jen) Green is senior global technical business development manager on Lubrizol’s Medical Polymers team.