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美国医疗工具和设备制造业
美国医疗工具和设备制造业包括约11000家公司，他们的年收入为750亿美元。其中的大公司包括强生、通用电气医疗集团,西门子医疗系统,美敦力公司。行业中主要集中的50个最大的公司占总收入的75%左右。下面分析的范围包括在医疗领域生产眼科、牙科、外科医疗用品和器械的供应和设备制造商。这一分析不包括公司生产和制造的x射线或电子医疗装置和设备。
这个市场已经由于政府参与和法律责任问题而出现了明显的影响,最终会影响一个组织的底线。医疗成本继续呈指数增加，导致私人保险公司和如老年医疗保险制度等政府计划开始限制支付一些需要医疗用品和设备的医学治疗。根据这一点,当市场试图提高医疗设备的价格，它看到了一个来自医生和医院的更大的阻力，反过来，就是为什么在过去的10年行业的手术和医疗器械只有百分之十五左右的增长率。除了这些限制,对监管机构的依赖已经使公司的成本越来越高。
The Us Medical Supplies And Devices Manufacturing Industry Economics Essay
The US medical supplies and devices manufacturing industry includes about 11,000 companies with combined annual income of $75 billion. Major companies include Johnson & Johnson, GE Healthcare, Siemens Medical Systems and Medtronic. The industry is highly concentrated with the 50 largest companies accounting for about 75 percent of revenue. The scope of the following analysis involves medical supply and device manufacturers that produce ophthalmic, surgical and dental instruments and supplies used in the medical field. This analysis does not include companies that produce and manufacture x-ray or electro-medical devices and equipment.
This market has seen significant effects due to government involvement and legal liability concerns that can have an ultimate impact on an organization’s bottom line. Healthcare costs are continuing to experience an exponential increase causing private insurers and government programs such as Medicare to limit payments for several medical treatments that require medical supplies or devices. In light of this, the market is seeing a greater resistance from doctors and hospitals when it tries to increase prices on medical devices, which in turn, is why the industry has only seen around a five percent increase in surgical and medical instruments in the last 10 years. In addition to these limitations, the dependence on regulators has come with a high cost to companies. Increased government regulation has increased overall compliance costs, thus reducing overall revenues. To add to these costs, new medical devices introduced in the United States also require approval from insurers, and if the insurers deem the devices to be too expensive, despite approval by the FDA, they can be unsuccessful and cost organizations a great deal. To offset these high costs, United States lawmakers are urging the Government Accountability Office to investigate why medical manufacturers do not receive incentives to develop products to treat rare diseases, similar to the incentives that drug companies receive. Overseas, products marketed in Europe require a CE mark of approval under the European Union Medical Device Directive to help maintenance quality excellence. Also, products often require an ISO 9000 certification of quality. As government policies continue to provide strict regulation on this market, organizations will continue to have to weigh the costs of doing business.
In addition to governmental policies, the market also experiences a high level of legal liability. Companies are at high risk of being held liable for injuries to be allegedly caused by their products. As a result of the lawsuits, investigations and recalls, the costs and availability of liability insurance are a major concern, despite the company’s questionable liability. Other legal costs are caused by litigations over patents, licenses and intellectual property (IP) rights due to the rapidly evolving medical industry technology. One study has shown that medical devices are a common cause of child visits to the ER, citing that approximately 70,000 children visit the ER each year due to medical device injuries. Recent research has discussed concerns that most medical device products are designed for adults, thus, there is safety risk among children. This risk has caused the FDA to begin reviewing the potential for device warnings on products, creating added expense for manufacturers.
Economic
It has been seen where many industries and markets have been affected by the global economic downturn; however, the growth of the medical devices and supplies industry has remained untouched due largely to its essential nature. Even those markets that are slowing in the US are seeing growth in other countries that are continuing to develop. The US, in particular, imports an equal amount of what it exports, with 45 percent of the imports being shipped from just three countries; Mexico, Ireland and China. Additionally, there are three states alone that account for 30 percent of the total US industry. This tight import and export market could create problems with the industry if just one state or country were to have issues. The US industry is also experiencing a move of several manufacturers to lower cost countries due to the small production runs that require a high level of labor-intensive production.
Technology
Increased international standardization and shortened clinical testing has also led to much shorter development cycles for medical devices compared to pharmaceutical and drug development. Through industry consolidation and movement to major conglomerates in the industry there is increasing homogeneity between companies and products. This rapid product life cycle drives continuous advancements and requires a higher percentage toward R&D to gain/retain market share. For many products there has been further blurring of industry sectors due to a move toward pharmaceutically coated implants and devices. Many new product developments are focused on quality of life enhancement rather than health maintenance and life saving products due to a higher return on investment for these products. Technology development can also be stifled by medical ethics and religious debate (stem cell research, in-vitro fertilization, cloning, and devices and procedures to otherwise artificially extend life, for example).
Social
Advanced in standards of living and aging demographics are causing an increased demand for all medical services and products. Globally, in the year 2000, the number of people over the age of 65 was estimated to be 420 million or 6.9% of the world population. In 2030, the population over 65 is projected to be 973 million or 12%. Ethically there are several increasing questions centering on medical devices. In many cases doctors and hospitals are paid for information and research by the medical companies potentially leading to a conflict of interest. The World Health Organization (WHO) has also created a special group to address medical devices. They have also asked if it is ethical to not provide products to emerging markets or to patients that cannot afford the product. It raises the ethical question as to how much profit is acceptable when people's health is at stake. These factors will undoubtedly cause an increased demand for medical products, but could severely impact the profitability of products. The issues facing the industry are summarized by the following quote by Dr. Ronald Hollis:
"Since most folks want to go to heaven, but no one is ready to go now, they are going to make choices with their money to buy whatever they need to extend life for another day. It’s a unique advantage of the medical device market."
Dr. Ronald L. Hollis, President & CEO, Quickparts.com, Inc
New Entrants
The medical device industry has a very competitive landscape which is being driven by population demographics and advances in medical knowledge and technology. Much attention must be given to company size in terms of financial ability to finance manufacturing and R&D as well as specialization ability -including technical innovation and market segment. The financial cost of products, operations, technology and bringing the medical device product to market can prove to be expensive. For example, the Medical Device User Fee and Modernization Act (MDUFMA), which was implemented on October 4, 2004, raised the fees for Premarket Approval Applications (PMAs) and PMA supplements rose over 34 percent. Original PMA fees increased from $154,000 to $206,811.
The medical device industry is such an industry that has a high barrier which denotes that it will have fewer firms entering it. There are strict medical device regulations for product approval by the FDA, which include establishment registration, medical device listing, PMA (501) K or premarket approval, investigational device exemption (IDE) for clinical studies, quality system (QS) regulation, labeling requirements and medical device reporting (MDR). Couple this with the need for copyrights and patents and the barrier rises even higher to enter this industry.
Another challenge posed to new entrants deals with the incentive program for device makers. In the third quarter of this year, US lawmakers asked the government to investigate the reasons why medical device makers don’t receive the same incentive to manufacture products for rare diseases given to drug companies. In addition, due to the large size of the competitors in this market, there is a barrier to entry for small companies as these large companies can utilize their economies of scale. There’s also a significant increase in the number of mergers and acquisitions within the medical device industry which has already proven to change the structure of firms and the delivery of medical technology to patients. (See ) |
