Biomaterials form the very fabric of the medical devices market. Frost & Sullivan has identified novel biomaterials that are driving market growth, and the larger market trends with which they align.
Biomaterials are substances that are engineered to make them suitable for interaction with a biological system. This definition immediately opens the floodgates for examples: metals used for orthopedic implants, materials used for intraocular lenses and polymers used for suturing, to name a few, would qualify as biomaterials. Indeed, biomaterials form the very fabric of the medical devices market. And since the entire industry is built on (or by) biomaterials, there is no consensus of the boundaries of the market and no common understanding of its size. Market reports from various sources even present conflicting pictures of the global market potential, ranging from as much as $151.65 billion to a more modest $130.17 billion by the end of 2021.
The one metric that different analysts agree upon is that this is a high-growth market, consistently exhibiting double-digit annual growth. What would be of interest to medical device companies and to material scientists is an understanding of the specific areas of the biomaterials industry that are driving growth and the reasons for their popularity. Frost & Sullivan has explored this and identified novel biomaterials that are driving market growth, and the larger market trends with which they align.
Over the last five years, polyetheretherketone (PEEK) has emerged as the preeminent polymer used in the medical device industry. PEEK’s importance stems from its thermoplastic properties and its ability to retain its mechanical strength even at high temperatures. However, what makes PEEK really valuable to medical device manufacturers is its resistance to corrosion and degradation, and its non-ferromagnetic nature. Together, these properties make PEEK an ideal candidate for spinal and orthopedic implants. PEEK is compatible with magnetic resonance imaging (MRI) in a way that metallic implants are not.
Simplify Medical (Sunnyvale, Calif.) has developed a PEEK-based spinal implant, Simplify Disc, for cervical disc replacement. The mechanical strength of PEEK and its resistance to wear is exemplified by the thinness of the disc on offer. Simplify’s discs have a thickness of as little as 4 mm, while most discs in the market are 6 mm or more. Simplify Disc is currently limited in clinical applications in the United States to investigational use only. It has a CE mark, however, and is available in Germany and the United Kingdom.
UK-based Invibio Biomaterial Solutions, a subsidiary of Vitrex, is exploring the use of PEEK in designing cranial, maxillofacial and active medical implants. Vitrex currently markets a range of orthopedic and dental implants fabricated using PEEK.
Bioceramics find application in dental implants and as bone cements or fillers. Their rigidity and their resistance to abrasion make them useful as coatings on metallic implants, pacemakers and kidney dialysis machines. Ceramic materials such as zirconia, alumina and silicon carbide are bioinert, meaning they do not react with or otherwise elicit any immune response from the body. This makes them useful as coatings for hip and knee implants.
An emerging trend in the design of bioceramics is to go beyond inertness and impart them with antimicrobial and regenerative capabilities. DSM Biomedical (Heerlen, Netherlands) recently announced a research partnership with Cerapedics (Westminster, Colo.) to develop peptide-added bone grafts. The idea behind infusing DSM’s bioceramic material (a carbonated apatite matrix) with a synthetic small peptide (P-15) is to augment cellular proliferation, adhesion and growth at the site of implant or bone fill.
Metals such as stainless steel and titanium have for decades been central to medical implants, and the emergence of metallic additive manufacturing (popularly known as 3-D printing) has reinforced their importance. Hitherto, 3-D printing was seen as a preserve of polymeric materials, but that is changing rapidly. Companies including German-based Emerging Implant Technologies (EIT) and British engineering company Renishaw are offering 3-D printing services for medical applications using high-performance metals. Renishaw 3-D prints patient-specific implants, surgical guides and implants with intricate and complex geometries.
Perhaps the biggest impact that metal 3-D printing will have on the health care market is with the manufacturing of nitinol. The alloy of nickel and titanium is known for its super-elasticity (10 to 30 times that of ordinary metals) and its shape memory, or its ability to return to its original shape after the thermomechanical stimulus is withdrawn. Nitinol has become the metal of choice to manufacture stents and other implants that undergo flexion. However, its use has remained a challenge to material and device companies. Elementum 3D (Erie, Colo.) has developed a proprietary additive manufacturing technique to fabricate health care products using nitinol and other “ultra-materials,” a term the company coined for high-performance metals.
The Road Ahead
The future of biomaterials is intricately associated with remodeling and regeneration. Naturally occurring biocompatible scaffolds such as chitosan and collagen are being studied for wound healing and tissue regeneration. The idea is to have biomaterial start mimicking the extracellular matrix so that wound regeneration is accelerated. With this goal in mind, biomaterials used in the future will not be static, but will evolve to become integrated with the body.
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