Insulin Infusion Pump

“There is a crisis of identity in public health. To ensure conditions in which people can be healthy we must work to change the underlying societal conditions. Public health has rarely been able to go beyond pointing at these larger issues such as poverty, economic globalization, and lack of political will.”1

- Jonathan Mann, 1997

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 everyone 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 of 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 emerged 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 same 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 potentially 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