Many factors, including cultural, economic, technical, and regulatory influences, affect how different technologies come together for today's medical diagnostic products. An analysis of the development of automated immunoassay systems reveals that companies used a variety of approaches to access needed technologies, that mature technologies play an important role in the development of new products, and that implementation seemed more important in these companies than strategy.

Fueled by high returns on its investments, the pharmaceutical industry in the United States has flourished for the past 50 years. The regulatory strategy of demanding stringent testing then allowing market-based pricing has allowed private companies to fund ambitious research and development activities with the assurance that these investments will be recovered. However, aggressive managed-care cost-containment strategies threaten the companies' ability to recoup research and development expenses and may affect their willingness to invest in future innovative research.

On the basis of two case histories of medical device innovation, two aspects of demand are identified: (a) the prospect of new markets and (b) information about user needs. Conditions for direct interaction between the user and producer in the innovation process are identified. The article concludes with some normative implications for the publicly designed generation of new medical technology.

The development of new medicines requires a lot of time and the efforts of many researchers. One of the most taxing parts of this endeavor is the need for long-term toxicity studies in different animals. This paper describes the development of two different medicines: zimeldine, an antidepressant, and omeprazole, a compound that acts against a specific enzyme in the gastric mucosa that is necessary for the production of gastric acid. Zimeldine was launched in the international market but had to be withdrawn when it caused severe unexpected adverse reactions. Omeprazole has been marketed successfully after a prolonged development phase characterized by difficult problems with the toxicity studies. Against the background of these two descriptions, this article questions the rationale for the present rules for long-term toxicity studies and emphasizes the need for leaders in the pharmaceutical industry to have a solid scientific background in order to be able to decide whether to abandon a project.

The pulmonary artery catheter (PAC) is an invasive hemodynamic monitoring device that is used extensively in critical care units. This technological advance allows the critical care physician and nurse to closely monitor physiological functions at the bedside. There have been no formal evaluations of the impact of this device on patient care. Reviews and observational studies have yielded different conclusions regarding risks and benefits to patients. This has resulted in much editorial comment expressing divergent opinions on the value of the PAC, but there has been no scientific evidence to guide practice and no apparent effect on the use of these devices. The PAC and other medical monitoring devices must be evaluated with respect to their impact on patient care.

This paper examines the characteristics of the process of innovation as applied to a range of contraceptive technologies. Whereas the understanding of how and why innovation works or does not work has grown in the past few decades in such professional fields as electronics, aviation, and optics, only the first attempts are currently under way in medicine. Borrowing from other fields, this paper proposes a theoretical underpinning to the process of innovation as it would apply to the development of medical technology. Subsequently, it documents this process with regard to contraceptive technology (oral contraceptives, injectables, intrauterine devices, implants, and surgical contraception), providing a framework of first-, second-, and third-generation definitions of development. A number of observations about the importance of certain supply- and demand-side determinants of the direction and rate of medical innovation conclude the essay.

Medical technology will contribute to improving the health status of people in developing countries only when it is carefully implemented after proper planning. Providers, users, health ministry employees, and industry all share responsibility for proper planning and careful implementation.

This article discusses the methodology of the OTA Project on Drug Labeling in Developing Countries. This report describes (a) the process of the project; (b) observations from a field visit to Thailand; (c) the development of the multinational pharmaceutical industry; and (d) influences on multinational pharmaceutical companies from their home countries, host countries, international organizations, selfregulation, and public interest groups. The results of the assessment will appear in the final report to Congress.

Little is known about how information diffuses to clinicians and influences their purchase and use of new technology. This is especially true about the role of the scientific literature. As a case study, we examined the literature for magnetic resonance imaging (MRI) during the years preceding and the first five years following its clinical introduction. Using a computerized retrieval system, we identified approximately 1,700 citations in which MRI was the major topic. The clinical literature on MRI was heavily concentrated in radiology journals. Less than 28% of articles compared MRI with alternative diagnostic technologies. During the first five years of clinical availability, the diffusion patterns of scientific articles and operational units mirrored the example set by computerized tomography (CT), in that a substantial number of units were purchased in both research and nonresearch settings before studies were available comparing them to alternative diagnostic technologies. These patterns of diffusion, combined with other studies of the MRI literature's content and methodology, suggest that less comprehensive and objective sources of information were important in early purchasing decisions. This study also suggests that the present readership and publication patterns of professional journals may not facilitate effective, rapid information dissemination about innovations to a broad spectrum of clinicians.

This economic assessment of the implementation of magnetic resonance imaging (MRI) in a French hospital examines data on the diagnostic resources used in neurology and neurosurgery before and after MRI was available. Given a similar patient population and case mix, there was no change in the resources used other than the addition of MRI. So far, MRI appears to be a complement to, and not a substitute for, other imaging techniques used in neuroradiology. The focus of this work is purely economic; its conclusions do not challenge the major scientific contributions of MRI.

This paper details the costs of two types of quality assurance activities in radiotherapy: in vivo dosimetry, intended to check the delivered dose, and portal imaging to check the treated volume. For both activities, either on-line or off-line techniques may be used. Describing the costs allows the calculation of which techniques are most COSt-efficient for different radiotherapy departments.

Carotid endarterectomy (CE) surgery for asymptomatic patients remains controversial despite hundreds of published studies and recent randomized trials. Safety and efficacy are assessed using a quantitative synthesis method derived from meta-analysis and a “critical multiplist” inference approach. In addition, multivariate analyses reveal that use of a surgical shunt could further improve CE outcomes. Methods are examined for both their “confirmatory” and “exploratory” value.

In Connecticut there was considerable variation by town of residence in the proportions of patients diagnosed in 1985–1988 receiving transurethral resection only, prostatectomy, and irradiation (without surgery) for local-stage prostate cancer and receiving endocrine surgery for late-stage prostate cancer. Age and socioeconomic variables were examined as predictors of this variation.