For decades, silicone rubber has been the material of choice for implantable devices. Its high chemical inertness, durability, tensile strength, availability in a wide range of durometers, wide temperature range, and ease of molding by many methods has made the material a mainstay of medical devices of all types, but especially for long-term implants.
This tradition has been further reinforced by the growing supply of medical-grade silicone, which is extensively tested for purity and biocompatibility in order to meet the FDA’s requirements for products implanted in the human body for more than 29 days. Testing of the raw silicone however, is only part of the effort needed to guarantee the biocompatibility of the final product. This is why process controls at device manufacturers are also required in order to ensure a silicone device’s quality and safety.
As more suppliers are able to meet these requirements and offer wider portfolios of medical-grade silicone formulations, the number of possible applications and types of implantable devices made with silicone continues to grow, as does the medical grade silicone market.
Expanding Applications of Biocompatible Silicone
Take one current development as an example. Recently, medical silicone tubing with embedded reinforcements has hit the market, which augments silicone’s natural flexibility with additional stiffness and strength. Braided or spiral monofilaments of stiffer resins, or even stainless steel, are located in the wall of the tubing provided enhanced burst, kink, and wear resistance—all qualities necessary for tubing which needs to conform around organs and through existing passageways as it is inserted into the body. This new development can meet the current pressing need for more durable and smaller implantable medical devices.
Another advancement for silicone implantable devices, which has just been achieved in the laboratory, can drastically reduce the costs of implants that need to be custom made for optimal fit inside the patient. A university laboratory in Florida has developed a way to 3D print these implants out of soft silicone, skipping the time-consuming and expensive process of conventionally molding these custom parts, a process that can take weeks. The breakthrough in this case is the ability to 3D print parts by using oil-based microgels, a welcome achievement since that material’s flexibility and pliability makes it ideal for implants that are located in and around delicate internal organs. Although this technology is at an early stage in the development process, it does demonstrate how medical-grade silicone continues to be at the forefront of new implantable devices.
The Growing Medical-Grade Silicone Market
With more types of biocompatible silicones becoming available, and a growing number of applications for them, the market growth of medical-grade silicone rubbers is expanding at an increasing rate. According to one report released last August, the market size for these silicones is forecasted to hit $1.6 billion by 2022, expanding at a compounded annual growth rate (CAGR) of 6.1% from 2017 to 2022. Two factors driving this growth are rising demand in the Asia Pacific region for devices such as surgical implants, and a growing elderly population whose medical needs are often met by products fabricated out of medical-grade silicone (especially implantable devices).
Biocompatible silicone is a popular choice for implantable medical devices, particularly those that require flexibility and durability. More medical niches continue to be filled as the manufacturing and formulation choices become more plentiful. In an industry accustomed to innovation and evolving regulations, silicone’s presence in implants will only grow more rapidly.
ProMed works meticulously with OEM engineers to ensure new product designs for their silicone implantable devices reach the market before their competitors’ products. We challenge ourselves daily and strive to be at the forefront of the latest advancements in biocompatible silicone materials, processing techniques, and applications. How can we turn your latest innovation into the next groundbreaking medical product?