Increasing populations and significant economic growth in emerging countries along with aging populations in advanced countries create potential for an expansion and a stable demand for the global medical equipment industry. The US, Western Europe, and Japan, countries with higher per-capita incomes, well-developed healthcare systems and medical facilities, hold an almost 80% share of the medical equipment market. The high degree of risk management and tremendous amounts of time and money required for the development of medical equipment means the majority of that share is held by major manufacturers in the US and Europe; and is viewed as an area with a high added value. However, cost reduction by major manufacturers pursued through global acquisitions has increased in response to price restrictions in developing countries and efforts by advanced nations to reduce medical expenses. More companies are pursuing new market entry in cooperation with manufacturers, medical facilities and research institutions in the US and Europe, especially in developing countries in the Asian region, including China, which represents the greatest expansion in demand. Globalization of production bases is also accelerating, acceleration similar to what has happened in the automobile industry. In addition, because medical equipment is different from pharmaceutical products, it is necessary to develop a structure capable of facilitating collaborative sales, acquisition of medical authentication in individual regions, and improving the skill of medical staff.
Recent increases in population and per-capita income in emerging countries have spurred rapid growth in demand for home appliances and automobiles and this signals the potential for increased demand as lifestyle in those nations continues to improve. With the rate of aging in leading countries around the world by 2030 predicted to be more than twice that of 2015, steady growth in demand for medical equipment and advances in technological innovation are expected. Furthermore, recent developments in medical technology designed to address the aging of society means improved lifestyles for the elderly and the potential for increasing demand in regenerative medicine with a focus on the recovery and maintenance of motor functions.
Measurement devices for biological phenomena (CT, MRI, etc.),
Specimen inspection and analysis devices, Diagnostic systems, etc.
Artificial internal organ apparatus and assistance devices, Treatment devices, Surgical instruments, etc.
Eighty percent of the demand for machined products in the medical equipment field is for implants (artificial joints, dental-use) as well as trauma and surgical instruments made from difficult-to-machine materials such as titanium alloys, stainless alloys and cobalt-chromium alloys. These products differ from conventional items because they must be made from approved materials with highly specific characteristics. The materials that go into the production of medical equipment are very similar to those used in the manufacture of aircraft parts, chosen because they are lightweight and have superior corrosion-resistance. The demand for even lighter weight and longer life implant parts has prompted a shift from titanium alloy to cobalt-chromium alloy, a material that also exhibits high mechanical strength. The disadvantage of cobalt-chromium alloy, however, is its extremely low machinability compared with titanium alloy. Cobalt-chromium alloy reduces the working life of cutting tools to one third that of tools used on titanium alloy. In addition, CFRP and ceramics are used with increasing frequency in medical equipment. This steady development of new materials means an increase in cutting difficulty.
The difficult-to-cut and uniquely shaped parts found in medical equipment are a challenge to machine efficiently.
Improving machining efficiency and product life requires total applications, from CAD/CAM programs through to the final cutting tools.
Of the materials used in the manufacture of medical equipment, cobalt-chromium alloy is the most difficult to cut. However, compared with titanium alloys, it exhibits better abrasion resistance and contributes to extended product life; and this makes the manufacture of thin products such as sliding surfaces in artificial joints and small items such as spines implants and screws possible. On the other hand, however, it also has high tensile strength and welds easily. This makes it important to select machining tools with high abrasion resistance.
Due to the excellent biocompatibility, titanium alloy Ti-6Al-4V is the most commonly used material for medical equipment parts. Titanium has low thermal conductivity and produces high cutting heat temperature therefore it is essential to have tools with high heat-resistance and forms that ensure low heat generation.
Stainless steel materials are used often for small parts. Austenitic stainless steels (SUS315L/SUS317L) and precipitation hardening stainless steels (SUS630) have completely different cutting characteristics. Deep-hole drilling into austenitic stainless steels is very difficult because of the need to remove the chips produced.