Insulin infusion pump technology has been around for quite a few years but has been very slow to gain popularity among the diabetic community. In the past several years however it has caught on, and many who have chosen to make the investment have discovered an enormous advantage, in terms of health and well-being. A simple device that more closely mimics natural pancreatic cycles than traditional insulin injections can make a huge difference in a person’s life when constant disruptions from high and low blood sugars are quickly removed.
Unfortunately, even as the popularity of the insulin pump is spreading, not veryone who could potentially benefit from insulin pump therapy has access to it. An insulin pump costs $4000. 00, and most insurance companies do not cover it, and with accompanying medical supplies costing an average of $187. 00 per month, pump therapy is not financially feasible to most diabetics. The pump as a technology is incredibly innovative and cost efficient, because the increased control over blood sugars prevents complications from diabetes and costly surgeries to fix them.
Technically, the device is not very complicated and shouldn’t be expensive to manufacture. The high cost f a pump is largely due to the fact that the company who developed it, Minimed, must pay for its years of research and development, clinical trials, as well as turn a profit, and Minimed is also one of only two companies in the world who produce insulin pumps. Minimed as a company and the insulin pump as a technology are not very different from other biotechnology development firms and other new medical technologies.
The trends in the industry are essentially the same; huge amount of capital are necessary to fund the prolonged process of developing, testing, and getting FDA approval on new medical technologies; hence private firms have merged as lead developers of biotechnology. In the following discussion, I will use Minimed and the insulin pump as a sort of case study, or platform for which to discuss medical technology and its facets; the industry, development, government approval and regulation, technology assessment and ultimately, distribution.
Unlike other types of technological innovations, medical technology is subject to strict regulation by the Food and Drug Administration. Beginning with the Medical Device Amendments of 1976 and subsequent Congressional mandates, new medical technologies have been subjected to the ame strict regulations that all other new medicines and food additives are, if not even stricter review, since technological innovation is difficult to asses. The FDA has in fact created a department specifically devoted to medical devices, The Center for Devices and Radiological Health (CDRH).
Currently under review by the CDRH is a exciting new and greatly improved insulin pump, one that will actually continuously measure blood glucose, administer insulin and automatically adjust insulin dosage to the level of blood glucose (as opposed to the insulin pump that is currently on the market, which only administers insulin). This new device will be, in effect, an artificial external pancreas. The CDRH has published a guideline for medical device manufacturers to provide information to the administration during pre-market release review2.
Devices will receive extra scrutiny by the administration when they meet one or more of the following criteria: Device features or methods of using it are new Information provided by the device is crucial to the safety of the patient Device performs tasks which are crucial to patient safety Evidence exists of errors with similar devices (or device components) Device operation or characteristics is complex, unusual or otentially dangerous, or, Device will be used by patients or lay-users These criteria were adopted by the CDRH’s Division of Device User Programs and Systems Analysis in order to weigh human error likelihood of a new device into the approval or rejection decision.
A recent report of patient death by accidental morphine overdose highlights the importance of incorporating human factors3 and user interface4 considerations into the design of medical devices. The device which the patient was using was similar in concept to an insulin pump: a patient-controlled subcutaneous morphine infusion device. The error apparently occurred when the patient was programming the pump; when entering the concentration of morphine, the device’s default concentration was set at the lowest possible concentration. Thus, if a patient accidentally left the programmed concentration at 0. 1 mg/mL, when in fact the actual concentration of morphine was 1 mg/mL, the patient would receive a ten-folddose of morphine.
Speaking from the perspective of someone with personal experience with infusion pumps, this type of error is very easy to make (in fact I’ve made the same error myself), however it is completely voidable by setting defaults so that an error in programming would have less disastrous effects. Such foresight involves paying careful attention to user interface which is exactly the kind of precaution that criteria number six is intended to address. Of the criteria that is listed above the new glucose-monitor-and- insulin- pump-in-one meets all six; hence, while the technology for an artificial external pancreas exists now, such technology will probably not be on the market for at least another five years.
Federal regulations are not the only factor that has sl owed down the development and introduction of medical technologies. The technology to develop the modern insulin pump for example, has been around since the late 70’s5. The medical technology industry however has faced unique challenges that developers of other types of technology have not had to deal with. The first is the one discussed above: the fact that developers of medical technology face far more stringent regulations than those of nonmedical technology. A second challenge unique to the medical technology industry is that development requires multidisciplinary expertise. That is, medical devices are not usually developed by an entrepenuar who single- handedly invents and patents something.
Development of the insulin pump for example probably involved a doctor or scientist, who foresaw the medical utility and specifications of the device; an electronics engineer, who designed the motor, circuitry and perhaps casing; a software engineer, who programmed the device to respond to commands as well as programmed the device to be programmed, and perhaps a human factors expert, who specified the user interface. Some technologies however, are so complex and advanced that at least part of the design of the device must be contracted out to specialized firms that are leaders in specific types of technology (but not necessarily edical technology). One such company, LRE Technology Partner GmbH (Nrdlingen, Germany) specializes in building products around optical components; such products have both non medical and medical applications6.
The technology LRE developed is used in machines such as blood-sugar measurement devices, which use the color of a blood sample to determine a patient’s blood glucose level; LRE applied the same technology to develop a water-purity monitor. Development firms like LRE run up against additional roadblocks when they take on medical technology projects, especially as mall companies encounter unfamiliar regulations written specifically for the medical field. For example, ground leakage current has to be lower on medical instruments that on commercial equipment to reduce danger to the patient. Development of medical technology is substantially set back when different parties from different professional cultures are forced to interact with one another and participate simultaneously in the design process.
The sort of conventional method of technology development has traditionally been that engineers would come up with paper-and-pencil sketches that would be tossed to others for feedback; physicians however ay not comprehend such highly technical drawings. One solution development firms have begun to employ is to contract consulting services from other medical device manufactures who have more experience with medical device regulations. Another strategy is to use 3-D CAD, which allows all groups involved in the design phase of a project to have the same picture of the developing product. In the US, approval of a new device by the FDA by no means guarantees that it will be offered those who could benefit from it.
Although the US leads the world in expensive diagnostic and therapeutic procedures7, urrently we have no comprehensive universal health care system; 43. 4 million Americans, or 16. 1 percent of the total population have no health coverage8. Industrialized nations have basically two policy options on how to treat health care. The first is to regard health care like any other commodity in a free market, such as housing, and the second is to universalize health care and control expenditure via central government. The policy option one believes in depends largely on whether one regards health care as a good or service like any other, or one regards health care as a fundamental service that should be guaranteed.
The US is the last highly developed industrialized nation to not have some sort of universal or near universal health care plan in place; Canada, France, Japan, Sweden, and the United Kingdom, all cover over 98% of their populations via public health care, and Germany covers 92. 2% of its population. Suprisingly even though only 84% of the population is covered by some form of health insurance, health care expenditure as a percentage of gross domestic product is far higher in the U. S. (13. 5% in 19949) than in the countries listed above. The gap between the US’s expenditure and that of other ountries has been growing since the 1960’s, and the gap is expected to widen further, with expenditure hitting over 16% of GDP in 2010, when the baby boomers hit retirement10. The US however is not alone in its trend of rising health care costs.
The pinch is being felt throughout industrialized nations, in part because of the growing size of the aging population, but according to the NY Times, “about half the growth in real per-capita health costs is associated with medical technology. “11 Paradoxically, while technological innovation is usually thought of as reducing cost and increasing efficiency, in health are, new technology is often less invasive and less costly, which results in the technology being applied to larger groups of people and raising overall costs. For all our spending on health care and technology, the health of the average American, as measured by life expectancy and infant mortality is actually lower than the nations listed above.
Even for the 84% of Americans counted as having health coverage, the fact alone does not guarantee access to new medical technologies that they could benefit from. HMO’s, the fastest spreading form of health insurance in the US, have ssentially no legal responsibility for providing the latest developed medical technology and procedures to their members. In deciding whether or not to approve new technologies for coverage, HMO’s typically rely on panels of experts for recommendations, but then weigh cost-effectiveness into the decision of whether or not to approve a new technology, and ultimately the HMO itself, not a government regulatory agency or any other centralized authority, has the discretion of whether or not to approve a new technology.
Under the free-market ideology of health care it is reasoned that embers (consumers) of health care plans will shop around and buy the plan that offers the best benefits at the lowest price, and this process will keep prices down and efficiency up. However health care differs from other consumer goods on a number of points. Many are excluded from buying health care altogether because of preexisting conditions. Also, it is often difficult to predict future illnesses; one cannot evaluate plans by examining each and every procedure they do and do not cover. In addition, many consumers have no choice over the plan they buy; the choice is made for them by their employer. For these reasons consumers are not as likely to shop for plans and hence, prices are not kept down and efficiency is not kept up.
Government subsidized health care such as Medicare is pretty straightforward: there is a list of approved medicines, technologies and procedures that are covered and those that are not on the list are not covered; additions to the list are passed by the Senate. On March 15, 1999, Senator Susan Collins (R-ME) introduced Senate Bill S. 2292,12 which will extend Medicare coverage to the insulin pump for seniors with type I diabetes. A similar House Bill HR. 3814 introduced in 1998 failed. Collins argues for her bill by asserting that coverage of the insulin pump will actually save Medicare money by preventing complications associated with poor blood sugar control in diabetics. Treatments for complications such as diabetic retinopathy, nueropathy, kidney and liver failure and gangrene can become very costly indeed.
The irony of Collins’ bill, indeed of the whole American health care system is this; an insulin pump for type I diabetic aged 65 or over is like throwing a dixie cup full of water on Hell. Type I diabetes means that a person has had diabetes at least since adolescence, and complications from diabetes arise from poor lood sugar control over a span of many years. Giving a senior type I diabetic and insulin pump will not prevent complications from arising if that person has had poor control all their lives; giving a newly diagnosed young person an insulin pump will save the government a fortune. But there is no comprehensive health care system in place to ensure that cost- effective technology will be delivered to those who need it at the appropriate time.
The same concept applies to many other forms of preventative health care, and is a major reason why health care costs in this country are so high. The government will pay to ensure that major ealth problems are treated, but it is much more effective and cost- efficient to prevent those problems from ever occurring in the first place. It has been suggested that perhaps the US, with its free-market system of healthcare, plays a major role in providing financial incentive to private firms to develop new medical technologies. Since HMO’s and health insurance companies in the US have far less bargaining power with biotech firms than do centrally planned universal health care systems in other industrialized nations.
In response to this I would like to point out that in most countries with universal systems, private care is still vailable to those who are willing to pay for it. However on the whole, compensations to biotech firms in countries with universal care is still far less than in the US Thus this is a valid argument, and the true answer to the dilemma requires a value judgement; that is, is it more important for us as a nation to continue developing high tech medical solutions that will only benefit a portion of the population, or is it better for us to guarantee health care to our citizens as a fundamental right while at the same time accepting a slower pace of medical technological innovation?
