中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

August 31-September 2 2022 | SWEECC H1&H2

How to Overcome Silicone Scarcity and Keep Manufacturing Moving

2022-04-01

There are many challenges facing the global medical device market today. Despite strong demand for lifesaving and life-enhancing technologies, there remains unprecedented roadblocks along the medical device-development highway.

Supply chain disruption, labor shortages, rising materials costs and more, causing delays in engineering and manufacturing. Instability in the supply chain is perhaps the greatest of these challenges. Shortages with raw materials, components and sub-assemblies can significantly delay delivery of these products that provide critical therapies to patients.

Although we can't predict when industry suppliers will return to a more steady state, optimizing our engineering and manufacturing processes has led to one approach to lessen the reliance on existing supply disruptions. For example, if a specified material isn't readily available, medical device manufacturers can explore alternative materials. Of course, specifying high-performance materials for a medical device application is complex. There are stringent material specifications to consider such as temperature, environment, compatibility, hardness, compression, and regulatory requirements. However, through materials science and novel use of familiar materials as alternatives, manufacturers can discover critical-to-function medical device components that deliver superior results in trials, on the manufacturing floor and in the field.

Keep material options open

For next-generation medical devices, liquid silicone rubber (LSR) is often the default material of choice. LSR provides great stability, temperature tolerance and a low compression set. It’s also the go-to because of its biocompatibility with body tissue. Medical device engineers are highly familiar with LSR as it meets most regulatory requirements and performs predictably. LSR is also simple to formulate because it’s made up of only two or three core ingredients. This simplicity is key as medical device engineers strive to keep costs down and introduce products to market faster.

However, one viable material alternative being considered for medical device applications is custom black rubber. Custom black rubber has long been a critical material in manufacturing and has opened doors to new opportunities for medical device engineers. LSR and custom black rubber have many similar characteristics such as excellent electrical insulation, good cold temperature flexibility, high temperature tolerance, resistance to chemical and strong compression. Both materials also offer a clean surface finish, flame retardance, biocompatibility and compliance with various industry regulations.

Adding custom black rubber formulations into the materials mix empowers medical device engineers to select the best compound for their specific product development. Because custom black rubber compounds contain many ingredients, the number of formulations is limitless. Having a secondary materials choice is good practice when dealing with supply chain uncertainty, and it can be a catalyst for cost savings, improved reliability and greater design control. By collaborating with materials scientists early in the development process, medical device engineers have greater control over how materials behave, and they can adjust criteria such as elongation, tear strength, cure states, compression sets and more, as necessary.

A strong case for custom black rubber

Custom black rubber formulations are not new to medical device manufacturing. In fact, custom black rubber is particularly well suited for medical devices as it provides outstanding resistance to steam/hot water, polar fluid, polar solvents and alkaline-based cleaners. It offers excellent abrasion resistance, which mitigates catastrophic tears and leaks. Medical device components made with custom black rubber are also designed to resist ozone, aging and UV rays.

Medical device applications require components to withstand extreme temperature fluctuations. Custom black rubber is exceptionally temperature stable—from -60° to +302° F. It also has a tensile range of 500-3000 psi and allows for 600% elongation so rubber seals avoid creating leak paths and move as intended.

With efforts to get products to market faster, it might seem counterintuitive to start anew and explore material alternatives. However, the reality is that customization can save time. Medical device components carefully developed with custom black rubber often improve clinical trial success rates and can simplify other parts of the product development process.

Exploring the untapped potential of custom black rubber provides medical device manufacturers an alternative for their applications. By working with experienced materials scientists, medical device engineers can unearth superior results through custom-built material formulations using novel materials. Materials flexibility offers new opportunities while overcoming supply chain instability and delivering products to market, faster.

Don Bonitati is the director of global medical market at Minnesota Rubber & Plastics.

Article source: Qmed