Introduction
Micro manufacturing technology is used to create tiny features on large parts or complete tiny microscopic parts for micro devices. One enabling technology, micro machining, has been in existence in Europe since the early 1900s, driven by the Swiss watch industry and the manufacture of other related precision components. In the 1960s, the emergence of electronics created a need for miniature and micro electrical connectors. Japan and the United States were at the forefront of this growth in micro electrical componenet manufacturing. In the 1980s, computer technology led the demand for micro components, as did the need for minimally invasive surgical instruments that created a need for smaller devices made from exotic materials..
DEVELOPING MARKETS
Since that time, additional micro markets have developed in the aerospace, medical, electronics, and microfluidic niches. These industries have continued to push the demand for light-weight, microscopic parts or microscopic features on larger parts. OEMs continually require new products that create smaller, less invasive, fluid-induced, and/or space saving micro devices. These products require integrated, micro, and automated solutions to ensure their success out of the gate. The smallest parts are usually the ones that cause the most headaches and are also usually the enabling components of an entire device’s function. The need exists in industry for competent micro manufacturing product and service suppliers to fulfil the demand for product and feature miniaturisation. Industry also requires the supply of information that details “how” to manufacture in the micro world.
The United States technology industry is positioned extremely well to create new and innovative microscopic components, but as it stands, the up-take of enabling technologies has been broadly limited to a select few who had the foresight to invest during the economic downturn in the early 2000s. More and more supplier companies and OEMs are emerging in the area of micro manufacturing, but they are struggling to catch up with those who have already invested years of research in it.
New micro manufacturers have suffered from the dearth of information available to guide them in their attempts to manufacture micro parts efficiently, although this situation is beginning to change. More importantly, so is the lack of a shared network throughout the micro machining industry. The emergence of micro related conferences such as those hosted by the Society of Manufacturing Engineers (SME) and MANCEF, the growth in the stature and reach of publications such as Commercial Micro Manufacturing (CMM) magazine, and the emergence of exhibitions devoted to the micro manufacturing niche are all beginning to provide an environment for superior information provision and industry networking.
While the majority of micro machining components are made in Switzerland, Austria, Germany, and Japan, newly emerging technology providers and micro manufacturing companies can be found in the United States as well as Singapore, China, and Malaysia.
US-based micro technologies are in their infancy relatively speaking, and need to learn from European and Asian technology providers and users that have a long history in micro manufacturing. For example, much can be achieved by looking at the watch-making and micro electronics industries in these regions that re-established users of micro manufacturing technologies and techniques.
Many new products exist today due to the use of micro manufacturing. In the early stages of micro moulding, for example, there were only two or three micro moulding machines available on the market that were considered precise enough machines. Today, there are dozens of micro moulding machines on the market. There are also thousands of companies entering into this market in the United States with varying levels of success — both technology users and technology and service suppliers — and so the environment for successful implementation of micro manufacturing is evolving almost by the day. The choice of technology and service suppliers in the United States and elsewhere around the world is growing fast, as is the ability to learn from the experience of your industry peers through intelligent networking.
OPPORTUNITIES IN THE MEDICAL NICHE
As already mentioned, various industry niches are utilising micro manufacturing technologies in the United States, but it is perhaps in the area of medical device manufacture that most growth in product miniaturisation is occuring at present. The medical device sector is leading the way in the up-take of micro manufacturing technologies, with its enormous potential for the development of innovative micro medical components, as well as for suppliers of micro technologies and services that can cater for this importnat niche. US suppliers are responding to this demand. News from the important International Manufacturing Technology Show (IMTS) held recently in Chicago is that many traditional “macro” product and service suppliers are diversifying into the micro niche. The ability for technology and service suppliers to cater for the demands of industries that require sophisticated precision and micro services is important for these suppliers to remain competitive and versatile enough to adapt when the demand from traditional industry niches contract in times of economic uncertainty.
With a large ageing population in the United States and most developed countries around the world, diagnosis and treatment of diseases is a trillion dollar opportunity, and is rising faster than the growth of the economy. Miniaturisation trends in treatment of diseases account for many new high-volume products in in-vitro diagnostics as well as lower volume requirements in minimally invasive surgery. Micro manufacturing/biomedical applications include:
• Drug delivery devices, microfluidic chips, micro pumps, and micro chemical analysis systems
• Implants and components for minimally invasive surgery for the medical device industry (micro motors and micro mirrors in endoscopes and catheters, components for heart pacemakers)
• Microphone components in hearing aids
• Equipment and consumables for diagnostics, blood pressure and IR thermometers, micro mirrors for ophthalmology
• Pressure sensors in respiratory equipment.
Despite the potential, however, medical device validation from concept to production can take two to five years or more. Several iterations and designs of tens to hundreds of thousands of parts must be tested to achieve the functional requirements to achieve FDA acceptance. For this reason, costs for validation have the tendency to far exceed the manufacturing costs of the devices.
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialities called panels. The three most common classes are based on the degree of control necessary to assure the various types of devices are safe and effective.
Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.
Class II devices are those for which general controls for Class I devices alone are not sufficient to assure safety and effectiveness. Class II devices are also subject to special controls. Most medical devices are considered Class II devices, and include powered wheelchairs, infusion pumps, surgical drapes, and some pregnancy test kits. 43% of medical devices fall under this category.
Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. These devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. About 10% of medical devices fall under this category. Premarket approval (PMA) is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Examples of Class III devices that require a PMA include replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.
Obviously, the higher the class, the more onerous the validation aspect of production, which must be considered before embarking on a strategy to cater for this market niche.
Micro systems markets for medical applications will grow from $600 million to $2 billion from 2004 to 2009. Largest revenue products are microfluidic chips, pressure sensors, and drug delivery systems. With the recent drop in the US dollar compared to many other global currencies, many acquisitions in the medical device sector are in progress. Mergers are also common, and in the United States, cooperation is often with an instrumentation company, i.e. Caliper/Agilent and Micronics/Honeywell.
In conclusion, there are certainly opportunities for US-based companies to compete and also create strategic alliances with companies abroad. Companies that can adapt quickly and economically enough to new market trends and technologies will inevitably be successful in the US as in any country.
Donna Bibber is a well-known micro manufacturing expert and the Technical Partner in microPEP, East Providence, RI. USA. microPEP provides a one-stop design and manufacturing solution for small and micro component applications. microPEP’s core competencies include micro moulding, micro stamping, micro optics moulding, and speciality plating.
