Materials flexibility is key

With a surging aging population, continuing implications from the global pandemic, and mortality rates for cancer, obesity, heart disease, and other health conditions on the rise, medical device manufacturers are a key stakeholder in global health. Medical device manufacturing of the next generation of critical-to-function products will require innovation, agility, and overcoming challenges in the global community.

Worldwide supply chain challenges are perhaps the biggest obstacle to navigate. Medtech manufacturers need unfettered access to raw materials, componentry, and sub-assemblies to deliver products to people faster. Manufacturers that can respond quickly and with agility to these challenges will be better positioned to meet the needs of their customers and gain a competitive advantage.

Explore alternative materials

Choosing a high-performance material for medical device applications requires consideration of numerous performance specifications, including temperature, compatibility, hardness, environment, compression, and regulatory requirements. When designing medical devices, many engineers turn to tried-and-true liquid silicone rubber (LSR). It’s a consistent option for temperature tolerance, a low compression set, and great stability. LSR is also a common material choice for medical devices due to its body tissue biocompatibility.

However, supply chain management best-practices recommend engineering and manufacturing teams explore a full spectrum of materials, to avoid protentional production disruptions. One reliable, yet sometimes overlooked material option for medical device applications is custom black rubber, which can produce critical-to-function components that deliver superior results in trials, manufacturing, and in the field.

Custom black rubber provides medical device engineers with new opportunities for additional or alternative market value. Engineering teams have greater control of the formulation process and can choose the compounds according to product specifications. Custom black rubber compound formulations are near endless due to the number of ingredient combinations available.

Why custom black rubber

LSR and custom black rubber have many properties in common. For example, both materials have high temperature tolerance, excellent electrical insulation, good cold temperature flexibility, and resistance to chemicals. Custom black rubber has operating temperatures from -49°F to 320°F (-45°C to 160°C), with special grades up to 392°F (+200°C). It also has exceptional mechanical performance and is compatible in most sterilization environments. There’s low, long-term compression set with specific custom black rubber compounds and long life in polar solvents, steam, and hot water.

Custom black rubber compounds are suitable for contact with alkaline cleaning fluids, have high wear resistance, and minimal creep and permeation. In addition, they are tested in accordance with ASTM, SIS, and FDA and compliant with FDA CFR177.2600, 3-A, USP Class VI, Cytotoxicity (USP 87), NSF, KTW, and WRAS.

Material flexibility required

Having flexibility with the materials used to develop critical-to-function components can help medical device engineers and manufacturers navigate these challenging and uncertain times. Material flexibility can also lead to greater design control, cost savings, and improved reliability. Working with materials scientists, medical device engineers can alter black rubber formulations and manipulate how the material performs, modifying criteria such as elongation, cure states, compression sets, and more.

Custom black rubber is ideal for medical device development challenges such as sealing against harsh chemicals and fluids by providing excellent abrasion resistance, which is key for mitigating leaks and tears. With temperature stability from -67^°F to 302^°F (-55^°C to 150^°C), medical device components made from custom black rubber can endure extreme high or low temperatures. It also allows for 600% elongation and a tensile range of 500psi to 3,000psi to avoid creating leak paths.

Lean on the experts

Engaging material science experts, who have deep experience and resources, early in the development of a next-generation medical device can bring a successful product to market faster. By establishing the correct design criteria at the beginning, building production-intent prototypes, testing, and ensuring the ability to manufacture at scale, this early collaboration optimizes innovation process. Whether an application requires LSR, another compatible material, a turnkey multi-shot part with million-dollar tooling, a complex overmolding, or a system-critical part, by following a thorough innovation process, you can expect to see superior results.

About the author: Don Bonitati is director, global medical market at Minnesota Rubber & Plastics and can be reached at DBonitati@mnrubber.com or 952.927.1400.

Minnesota Rubber and Plastics
https://www.mnrubber.com