As compared with other materials for medical device applications, polymers are comparatively light weight, flexible and low cost. They offer ease of processing, non-ferrous properties and superior biocompatibility, enabling the next generation of implants, single-use/disposable devices and developments in packaging. Some of the major trends that are impacting medical device growth.
Rising incidence of Hospital Acquired Infections (HAIs)
Hospital acquired diseases/nosocomial infections/hospital associated infections represent a segment in the healthcare industry that needs critical focus. The market of hospital acquired disease testing, a market comprising services and products associated with testing methods used to diagnose hospital acquired diseases, has bloomed in the past few years due to many factors. Some of these factors include the rising prevalence of such diseases in the geriatric and neonatal population on the global front and a steady rise in government initiatives for managing these conditions. Global hospital acquired disease testing market, which valued US$2.2 bln in 2012, could achieve growth at a healthy CAGR of 19.3% between 2013 and 2019 and value nearly US$7.5 bln by 2019, as per Transparency Market Research. Hospital acquired urinary tract infection testing acquired the majority percent revenue shares of the overall market in 2012 due to high prevalence and morbidity rates associated with condition. This segment of the global hospital acquired disease testing market is expected to grow at a CAGR of 18.1% during the forecast period, and value nearly US$2,188.8 mln by 2019. Demand for diagnostic services for conditions such as pneumonia and surgical site infections is also expected to remain high from lesser developed countries in the Asia-Pacific regions. Market of this segment is expected to grow at a CAGR of 20.1% during the forecast period. Some factors that led to a blooming growth in these regions include strict implementation of healthcare guidelines laid down by institutions such as the US Centers for Disease Control and Prevention, and highly sophisticated healthcare infrastructure. Public health systems in the European Union are encouraging the coordination between medical practitioners and healthcare providers to cooperatively come up with better, faster, and economic methods for the management and prevention of nosocomial diseases. Countries in the Asia Pacific represent the markets with huge growth potential for the global hospital acquired disease testing market due to factors such as poor infrastructure, high population and lack of adherence to sanitation practices.
Popular disinfectants help control the spread of HAIs, but can damage the polymer materials in medical devices and lead to pitting, cracking, color changes, among others.
To counteract these negative effects, material suppliers are developing new polymers with higher levels of chemical resistance specifically for medical device applications.
Strides in designing and material properties as polymers replace metals
New plastic resins, combined with scientific process development and validation, are now making inroads in the medical industry, as they lower costs, as well as offer more flexible designs and improved single-use and reusable instruments. Some of these high-performance materials offer similar mechanical properties to stainless steel, but are lighter and offer more design freedom and lower processing costs. Soft-touch thermoplastic elastomers (TPEs) are increasingly being used for handles of surgical instruments in place of machined metal or hard plastic, as they offer a more comfortable, ergonomic feel and a more secure grip. TPEs also allow for color coding, as well as OEM branding that can be incorporated into the handle design. High performance polymers offers advantage of cost and performance in medical devices. Engineering plastics can rival metals when it comes to tensile strength, as well are lighter, cheaper, more flexible, and easier to process. Plastics can be used to replace steel devices by incorporating simple design modifications. Resources for designing with plastics are expanding within the medical industry. Plastic material suppliers are increasing their focus on the medical industry, and adding resources to aid in plastic adoption and metal-to-plastic conversion. Processors who traditionally have worked exclusively with metals are adopting and generating expertise with plastic manufacturing methods. With steadily increasing healthcare costs and vast technology improvements, designers across the medical field are learning to increase performance and decrease costs through the utilization of specialty plastics.
"Cost Cutting" is the new mantra for survival for medical device companies to continue to make money as prices face continued pressure. The sector has always been challenged with increasingly complex technologies and tough quality and regulatory hurdles, taxation structure, payment reforms, globalization, etc. Healthcare providers are responding by exploring opportunities to increase efficiencies and reduce costs. Great attention is being paid to detailed design of the product in a bid to eliminate excess cost wherever possible. Improvements in material offer benefits like increased production rates and lower manufacturing costs. Suppliers are helping device makers reduce expenses is by providing novel materials and processing techniques to replace current approaches. Also medical device manufacturers are scouting for reliable, compliant, and cost-efficient supplier partners. Many medical device companies have been enticed by low-cost operations in foreign markets for component sourcing, in an effort to reduce total cost of ownership related to medical device manufacturing.
Increase in home health care
Medical providers' efforts to reduce costs by taking a more holistic approach to healthcare will spur a doubling in the global market for home health technologies in the coming years, according to IHS Technology. Worldwide revenue for home healthcare devices and services will rise to US$12.6 bln in 2018, up from US$5.7 bln in 2013. The home healthcare market consists of six distinct segments: independent living services, consumer medical devices, telehealth, personal emergency response systems (PERS), wearable technologies and health gaming.
Healthcare providers are focusing on patient centered care to increase the quality of medical treatment. With this, medical firms hope to attain lower healthcare expenditures during the lifetime of patients. Home health technologies will play an important role in the continuum of care and in the concept of constantly managing patients' health. A major trend in the rise of home health technologies is convergence. From a technology standpoint, the market will experience device convergence, meaning that home health products will become richer in features. The same phenomenon also will occur in services where IHS expects convergence among independent living services, telehealth and PERS. Meanwhile, the quantity of patient-generated data will grow exponentially with the increasing use of home health technologies. Furthermore, there is a trend of consumerism in healthcare, implying a renewed focus on the patient and on patient needs. This not only is happening in the market for home health technologies, but also in clinical care, healthcare information technology (IT), and other parts of the medical sector.
Growing use of biodegradable and bioresorbable polymers
In recent years, there has been growing interest for the use of sustainable biopolymers, and major developments in the use of biopolymers for medical applications. Biodegradable polymers has been used in medical applications such as tissue replacement, bone augmentation and fixation, as well as controlled drug delivery. Polylactide and polylactide-co-glycolide based devices are used to fix bone fractures, suture materials and develop sheets to prevent adhesion. They are also used for blood vessel prostheses and drug delivery. These polymers are excellent candidates for applications in the medical field because of their versatility, biocompatibility and ability to degrade in vivo. Use of bioresorbable polymers in medical devices has exploded over the past several years. By using a resorbable polymer, costs to the patient and the risk of infection are reduced since there is no need to retrieve the iplant with a second surgical procedure. Medical implants made from bioresorbable polymers degrade completely and are excreted from the body leaving no trace behind. They constantly find new applications in medicine, particularly in the areas of drug delivery (drug-eluting stents), bone augmentation and fixation (screws), and tissue regeneration and replacement (scaffolds). They exceptional chemical and mechanical properties and have a proven safety track record. In the body, these polymers do not evoke an inflammatory response, they exhibit no toxicity and all of the degradation products are completely metabolized. They can be easily processed into final product forms, via extrusion and injection molding, yielding parts that exhibit a long shelf life that can be terminally sterilized. Polymer properties and the rate of degradation can be adapted to meet the most stringent of applications by modifying the polymer composition and molecular weight. By eliminating follow-up surgery to remove the implant, these devices reduce both healthcare costs and infection risk for patients.
Sustainability, Regulations and Environmental Concerns
Medical devices are subject to strict general controls and procedural regulations. The development and use of standards is vital to ensuring the safety and efficacy of medical devices. Numerous regulatory agencies and standards organizations collaborate to establish the accepted standards for medical equipment. Standard‐setting activities include the development of performance characteristics, characterization and testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, or other technical or policy criteria, as per http://depts.washington.edu. Knowledge of, and conformance to, standards recognized by the FDA is key if you want the device to be approved for sale in USA. Rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The core legal framework onsists of 3 directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives. Medical device companies are beginning to respond to the public's growing awareness of, and interest in, environmental concerns.