Medical devices market in good shape with silicones

June 26, 2017
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Evolving from silicon, one of the earth’s most common elements, silicones are recognised for their versatile medical application potentials, hence achieving onward market demand, says Angelica Buan in this article.

Since the early days of silicone in the 1940s, pioneers in exploiting the potentials of the material included US firms Dow Corning and General Electric. Since then, silicones in medical manufacturing have come a long way, with technologies able to enhance silicones biocompatibility, among other needed properties, to make the material medical grade.

Transparency Market Research (TMR), in its report titled Medical Grade Silicone Market 2016 to 2024 dittos the use of silicones in implantable and disposable medical devices.
silicones

The biocompatible and hydrophobic properties of today’s medical grade silicone are also suitable for devices with critical functions such as defibrillators, heart pumps, and surgical reconstructive components. These properties are also found to extricate, if not minimise significantly, the risks of toxicity and adverse biological reactions.

Silicone has large number of properties like high binding capacity, heat, radiation and water resistance, low intermolecular force, electrical and thermal conductivity, resistance to solvents and oil, gas permeability, tear and tensile strength, transparency and colouring properties.

Expanding market size

At the current rate, market analysts post bright market prospects for medical silicones; and it is even brighter in the years to come. In a recent forecast by Markets and Markets, it said that by 2021, the medical silicones market size would reach US$ 7.2 billion at a CAGR of 9.4% during the forecast period.

With current impetus to control infection and its recurrence especially within the healthcare setting, single-use devices are highly viable. The growing demand for the disposable devices is a growth driver for medical silicones.

Meanwhile, TMR also attributes the increasing demand to “lifestyle shifts” as well as the “changing concepts of beauty”. These dynamics sustain the demand for cosmetic and plastic surgeries, which for the majority of us always tend to associate medical silicones with.

Persistence Market Research, in its 2017-2015 medical applications market forecast, finds that the significant revenue growth rate of this market is attributed to increasing usage for medical devices such as catheters, implants, drainage tubes and others. Aside from demand for disposable devices, growth drivers also include prosthetic implants, medical tapes and catheters. New products containing or making use of silicones are also tapping a wide user base.

Joint efforts support market demand

Additionally, Markets and Markets, also attributes the billion dollar growth to agreements and joint ventures between industry players, which means that the product will reach wider markets.

STC-Silicone

Among the recent collaborations, those between German chemical group Wacker and Brazilian silicone compounder STC Silicones; and Control Flo Medical and Degania Silicone, to mention a few, prove this point.

Under the recently formed deal, São Paulo-based STC is allowed to promote Wacker’s Elastosil silicone compounds. Since 2003, STC has been getting its supply of silicone raw materials and additives from Wacker and uses them to produce ready-to-process silicone compounds for the medical, automotive, electrical and household-product sectors.

In a related development, Control Flo Medical, a US-based urological medical device company and developer of the ResQ Catheter System, which is a patented disruptive technology and a first-in-class urinary blockage and drainage catheter, formed a design and supply agreement with Israel-based Degania Silicone.

device-maker

Degania Silicone specialises in the supply of in-dwelling medical catheters, silicone medical products and medical devices for critical care and operating rooms, as well as direct-to-customer products. The company has six facilities located in France, India, Slovakia, and Israel. The partnership is said to expand product offerings and quality of catheters for the markets the companies cover.

Silicones score amid demand for safer implants

While silicones have diverse applications in the medical and healthcare segments, its reputed biocompatibility makes it a preferred choice for cosmetic procedures, such as in breast implants. The global market for breast implants is anticipated to surge to nearly US$1.5 billion by the end of 2024, registering a CAGR of 4.1% during the forecast period of 2016 to 2024, as reported by Persistence Market Research.

The domination, in terms of revenue in 2015, is mainly due to the rising disposable income of women, particularly in developing regions, and increased focus on physical appearance. As well, the innovations in cohesive silicone breast implants provide a more novel and fitting variety for clients, depending on their needs.

Israel-based G&G Biotechnology has added an advanced twist to silicone breast implant product with the B-Lite lightweight breast implants (LWBI), which it claims is the world’s lightest breast implant. The proprietary B-Lite gel, with microspheres (made from high purity, biocompatible, borosilicates that are fixed physically and chemically into the cohesive gel), has a reduced density, and thus reduces the weight of the implant by up to 30%.

breast-implants

Meanwhile, two companies that recently received the US FDA approval for their breast implant products include Irish pharmaceutical company Allergan. Its Natrelle Inspira SoftTouch breast implants is a medium firmness cohesive silicone gel implant for women undergoing breast reconstruction, augmentation or revision surgery.

Medical and pharmaceutical products company, Johnson & Johnson’s subsidiary

gel-filled-breast-implantsMentor Worldwide, a US surgical aesthetics products supplier, also got the FDA nod for its MemoryGel Xtra silicone gel-filled breast implants. A new addition to the company’s line of global brand of breast implants, the product is said to offer extra fullness and projection for women.

Solidifying demand build-up with LSR

The LSR segment is a lucrative medical silicone application, and its global market stands to reach US$3.29 billion by 2025, with an estimated CAGR of 9% over this period from 2016, according to a Grand View Research forecast. It stated that demand is hinged on increasing applications in end-use segment, particularly in medical (in view of rising geriatric population) and electronics industries; as well as development of new materials.

What makes LSR ideal for such applications, particularly in implants and devices, are its unique properties, such as chemical inertness, heat resistance, flexibility, and low viscosity, reported Grand View Research. Projected as the fastest growing segment over the forecast period, medical silicone’s biocompatibility properties are harnessed for major applications in medical implants and devices; and equipment parts that include sterilised parts, valves, skin contact devices, infusion pumps and others.

medical-devices

Several players in this segment are currently making headlines with their advances in LSRs. US materials manufacturer Avantor (which merged with silicones manufacturer NuSil Technology in May) is pitching its next generation NuSil medical-grade MED-5800 Series LSRs for injection moulded implants.

American chemicals manufacturer, Momentive Performance Materials, brings into the market its Silopren LSR portfolio, featuring high thermal stability, high tear strength, and broad range of durometers. The LSRs are suitable for components used in the biopharmaceutical and medical industries, as well as in automotive gaskets, food packing valves, and infant care products.

Gains for medical tubing on PVC replacement, invasive surgery

The medical tubing market owes its expanding size estimated to reach nearly US$6 billion at a CAGR of 8% from 2016 to 2021, to the rising awareness on healthcare and improving quality of healthcare facilities, according to a Research and Markets report.

The global market is likewise driven by minimally invasive surgery, and also factoring into the growth is an increasing ageing population, especially in developing countries, the report said. Given the sterilisation capabilities and microwave property, silicone and other speciality polymers are replacing PVC in this application.

Product development is found as a major restraint in the medical tubing market and therefore, it is important that innovative products and technologies are developed to sustain growth for this segment.

hose

Global supplier of medical tubing solutions Natvar, a Tekni- Plex company, has expanded its medical tubing product portfolio by adding on silicone extrusion tubing capability, following its recent launch of thermoplastic microextrusion tubing.

Through its manufacturing facility in China, Natvar said that it is able to offer medical tubing at improved economics compared to North American supply options.

Meanwhile, US-headquartered Saint-Gobain Performance Plastics, specialising in single-use components and assemblies for bioprocessing, has introduced the ValPlus range of tubing products, which are USP-validated for particulate and endotoxin; and ISO-certified for Bioburden. It is also available for select sizes and formulations of some of its brands, including C-Flex and Sani-Tech tubings and hoses.

Improving wound care technologies with silicones

Lifestyle diseases that pose risks of wounds, injuries and surgeries are chiefly driving the market for advanced wound care, which is expected to reach more than US$13 billion by 2025 at a CAGR of 6.4% from 2017, according to Credence Research. The report points to the development of new products, enhanced technology and rising geriatric population as accelerators for the growth of this market.

Swiss wound care specialist Stratpharma has launched a wound care and scar management portfolio, including Strataderm, a rapidly drying, non-sticky, transparent, silicone gel formulation for the treatment of both old and new scars, as well as abnormal scar management. For hypertrophic scars and keloids, Stratacel is developed specifically for sensitive skin areas and for laser resurfacing procedures; while Stratamed film-forming gel-based wound dressing is approved for immediate use on open wounds and compromised skin.

Another new ware in the market is the “smart” scar-care pad using LSR, developed by the Hong Kong Polytechnic University (PolyU). A recent awardee at the International Exhibition of Inventions of Geneva, the pad, designed to treat hypertrophic scars from burns, surgeries and trauma, has the advantages of traditional pressure pads and silicone gel sheets rolled into one, according to PolyU. Citing patient reports, PolyU also stated that the pad is more durable and user-friendly compared to the traditional pad made of polyethylene

Cecilia-Li-Tsang

(PE) foam. It is because the pad can be easily trimmed to fit to the size of the scar and body contours while the fabrication of the PE foam sheets is time consuming and has to be made by occupational therapists, PolyU added. Moreover, the researchers say it is more durable, and can last for two to three months, compared to PE foam that may last only a few weeks.

Providing the benefits of pressure therapy and silicone gel on scar management, the pad is composed of a silicone stiffener, made of LSR, and medical-grade silicone gel sheet.

As described by the designer, Professor Cecilia Li-Tsang of the Department of Rehabilitation Sciences at PolyU, the silicone rubber’s smooth side is attached to the silicone gel sheet, which serves to moisturise the scar. The other side of the silicone stiffener is characterised by the circular silicone studs, which can be adjusted to shape curved or flat skin surfaces to provide even pressure under elastic bandages or pressure garments, she said.

Microbe-free devices with antimicrobial silicones

Safety and hygiene in terms of bacterial-resistance are key trends for advanced medical devices and are among the harbingers for the development of antimicrobial silicones

Momentive Performance Materials’s StatSil antimicrobial silicone elastomers used in medical device applications reduce the potential for microbial contamination of elastomers; and prevent the growth of microbes that can cause discolouration, strong odours and the formation of mildew, it says.

The StatSil antimicrobial silicone elastomers are a custom elastomer platform technology based on the direct incorporation of a silver-based antimicrobial additive into the base silicone elastomer.

Kaunas University of Technology (KTU) has developed an antimicrobial silicone that may be used for medical (such as for blood, urinary and respiratory catheters; and applicable for various tubes and implants), and household products; and are beneficial for use in hospitals, healthcare centres and like institutions. The four-year R&D was led by KTU PhD student Aiste Lisauskaite and her supervisor Dr Virginija Jankauskaite.

Lisauskaite, who presented her invention at the Lithuania-held Life Sciences Baltics Conference in 2016, explains that since the silicone has “antimicrobial effect both on gram-positive and on gram-negative microbial strains and fungi; its antimicrobial effect can be used in various situations, when there is a risk to acquire bacterial infection”. The commercialisation potential for their antimicrobial silicone invention is huge, the researchers said.

Thus, it can be concluded that modern medical devices would not be the same without the ubiquitous silicones.

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