Technology and Health Care - Volume 4, issue 3

Authors: Rossomando, Edward F.

Article Type: Introduction

DOI: 10.3233/THC-1996-4301

Citation: Technology and Health Care, vol. 4, no. 3, pp. 245-247, 1996

Authors: Slavkin, Harold C.

Article Type: Research Article

Abstract: In the span of just a few decades, the advent of recombinant DNA technology as well as other tools of biotechnology have revolutionized the health sciences - dentistry, medicine, nursing and pharmacy. The original federal investment in basic science research, primarily through the creation of the National Institutes of Health and several other federal agencies, has delivered truly incredible dividends. Currently, this nation has 1,200 biotechnology companies which contribute over $11 billion a year to the nation’s economy. These sales are expected to reach approximately $50 billion in the next decade. In addition to the creation of nearly 100,000 highly …skilled jobs and contribution to the nation’s economy, biotechnology provides the promise and some uncertainty to vastly improve the quality of life throughout the world. Yet do we have a strategy which encompasses federal, state and private sector policies and an infrastructure sufficient to sustain a substantial basic science investment to fuel the engine of technology and a process that enhances the quality of life for all Americans? Show more

DOI: 10.3233/THC-1996-4302

Citation: Technology and Health Care, vol. 4, no. 3, pp. 249-253, 1996

Authors: Alix, James E.

Article Type: Research Article

Abstract: The general rule is that a “product of nature” is not patentable. However, living entities, such as multicellular living organisms including animals, may be patented if they result from human intervention and the patent application relating thereto meets the other requirements of the patent statute. In early 1995, the United States Patent Office adopted biotechnology guidelines making it easier to meet some of those requirements, thereby encouraging even greater activity in this field.

DOI: 10.3233/THC-1996-4303

Citation: Technology and Health Care, vol. 4, no. 3, pp. 255-258, 1996

Authors: Tylenda, Carolyn A.

Article Type: Research Article

Abstract: Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity …to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtraining permission to market medical devices in the United States. Show more

DOI: 10.3233/THC-1996-4304

Citation: Technology and Health Care, vol. 4, no. 3, pp. 259-267, 1996

Authors: Goodson, J. Max

Article Type: Research Article

Abstract: Development of new drug therapy is difficult for large companies and almost unheard of by individuals. This autobiographical account of the development of the tetracycline fiber delivery system for periodontal therapy (Actisite® ) relates experiences of a scientist between 1976 and 1994 which lead to FDA approval. In this account, the author acknowledges some of the key people, companies and institutions who were important in this development, makes observations concerning the process itself and offers suggestions for those who might consider commercial development of a scientific concept.

DOI: 10.3233/THC-1996-4305

Citation: Technology and Health Care, vol. 4, no. 3, pp. 269-282, 1996

Authors: Simon, Murray

Article Type: Research Article

Abstract: This article serves as an overview of the status of dental technology as the profession approaches a new century. Its purpose is to define various ways in which dental manufacturers and marketers can better understand the thinking of the dental professional, those factors that influence their thought processes and how to use this information to develop more effective and predictive marketing strategies. With the advent of more complex and expensive dental technologies, e.g., video imaging, digitized radiology, electronic data transmission, etc., the dentist is faced with a variety of decisions relating to purchasing, implementation and costs/benefits analysis that go …beyond the normal daily concerns of delivering competent dental care. It is no longer enough for a manufacturer to make a good product; successful marketing strategies must also include a means for guiding the dentist in the successful integration of these technologies into their offices. In order for dental marketers to meet the competitive demands of this advanced technology era, there must be a commitment to the development of strategic information through the use of third party, customized marketing research. Too much of the input currently used to develop marketing strategies is anecdotal, inherently biased and often not representative of the target market as a whole. It is hoped that this article will effectively challenge the reader to look at the development of dental products and services from a somewhat different, less traditional perspective and that it will provide the impetus and direction for creating better targeted and more rewarding marketing strategies. Show more

DOI: 10.3233/THC-1996-4306

Citation: Technology and Health Care, vol. 4, no. 3, pp. 283-289, 1996

Authors: Ballard, Gerald T.

Article Type: Research Article

Abstract: Spiraling costs dictate that healthcare expenditures be limited to medical products and services of demonstrated safety and effectiveness, if quality care is to be provided at affordable cost. Scientifically conducted, randomized controlled trials are essential elements of this process. Applicable governmental regulatory procedures are reviewed. These serve as the foundation of the technology assessment process and should not be restricted or curtailed. Healthcare provider groups may make significant contributions in this area, when scientific investigation and objective research are emphasized. Technology manufacturers must promote and support objective analysis of their products. Healthcare insurers are assuming greater responsibility and involvement in …outcomes research and technology assessment. The process by which this is accomplished by a major insurer is described. Private insurers and governmental agencies should share data in a consolidated research effort. This will require data base adjustments for compatibility and comparability in inter-agency analysis. Insurance company data bases are significant public health assets that have yet to be utilized to the fullest extent. Show more

Keywords: Healthcare costs, technology assessment, insurance data, outcomes research, FDA

DOI: 10.3233/THC-1996-4307

Citation: Technology and Health Care, vol. 4, no. 3, pp. 291-303, 1996

Authors: McKay, Michael

Article Type: Research Article

Abstract: Periodontal diseases are,in part, the result of an interaction of the patient’s immune system with the local bacterial population. We can measure the result of the interaction and sometimes repair it. We can identify the bacteria involved in the process. What we cannot do is measure the patient’s immune regulators; therefore we cannot predictably measure the recrudescence of disease activity or differentiate before hand the presence of refractory disease. We need fast, comfortable, inexpensive methods to measure the patient’s immune regulators.

DOI: 10.3233/THC-1996-4308

Citation: Technology and Health Care, vol. 4, no. 3, pp. 305-309, 1996

Authors: Golub, Lome M. | Schuler, Eugene K. | Gallagher, Brian M.

Article Type: Research Article

Abstract: The authors, including an academic-inventor, the director of the University’s tech-transfer office, and the CEO of a “start-up” pharmaceutical company based on the professor’s (and his colleague’s) inventions, relate the history and current status of their interactions. To start, the basic research leading to the “eureka” experiment (such things really do happen) is summarized: namely, the discovery of (i) the surprising ability of the tetracycline antibiotics to inhibit mammalian tissue-destructive proteinases (collagenase, gelatinase) during a variety of disease processes, e.g., periodontitis, the arthritides, osteopenia/osteoporosis, sterile corneal ulcers, tumor invasion/metastasis/angiogenesis, and (ii) a series of chemically-modified, non-antibacterial analogs of tetracyclines to …inhibit these enzymes without producing typical antibiotic side effects. The role of the University in obtaining the services of patent attorneys, and its assistance in developing the strategy to deal with an industrial partner, is addressed. Above all, the authors stress the need for close cooperation and collegial interactions between all three groups in this high-risk (but potentially high-benefit-to-the-public) enterprise. Show more

DOI: 10.3233/THC-1996-4309

Citation: Technology and Health Care, vol. 4, no. 3, pp. 311-316, 1996

Authors: Lavine, William S. | Greenblatt, Irwin M.

Article Type: Research Article

Abstract: A number of “state of the art” diagnostic procedures based on data generated by technological advances in microbiology, immunology and molecular cell biology have been developed to assist the dentist in identifying patients at risk of acquiring periodontal disease or who are currently experiencing loss of periodontal attachment. This paper challenges the assumptions upon which these tests are based and presents an alternative hypothesis of the natural history of periodontal disease. This hypothesis considers the microflora of the oral cavity and the inflammatory response of the host to be part of an ecosystem which has evolved over many years of …interaction and adaptation between unicellular and multicellular organisms. These interactions have resulted in the selection of biological strategies that provide intrinsic benefits to the host and to the microorganisms comprising the indigenous flora. Show more

DOI: 10.3233/THC-1996-4310

Citation: Technology and Health Care, vol. 4, no. 3, pp. 317-322, 1996