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Technology and Health Care is intended to serve as a forum for the presentation of original articles and technical notes, observing rigorous scientific standards. Furthermore, upon invitation, reviews, tutorials, discussion papers and minisymposia are featured.
The following types of contributions and areas are considered:
1. Original articles:
Technology development in medicine: New concepts, procedures and devices associated with the use of technology in medical research and clinical practice are presented to a readership with a widespread background in engineering and/or medicine.
Significance of medical technology and informatics for healthcare: The appropriateness, efficacy and usefulness deriving from the application of engineering methods, devices and informatics in medicine and with respect to public health are discussed.
2. Technical notes:
Short communications on novel technical developments with relevance for clinical medicine.
3. Reviews and tutorials (upon invitation only):
Tutorial and educational articles for persons with a primarily medical background on principles of engineering with particular significance for biomedical applications and vice versa are presented.
4. Minisymposia (upon invitation only):
Under the leadership of a Special Editor, controversial issues relating to healthcare are highlighted and discussed by various authors.
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?
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.
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.
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.
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.
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.
Keywords: Healthcare costs, technology assessment, insurance data, outcomes research, FDA
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.
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.
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.
Abstract: The development of technology transfer programs at universities throughout the US was catalyzed by the passage of the Bayh–Dole Act in 1980. This landmark legislation allowed universities to own and manage all inventions developed by their employees with federal funding. An effective technology transfer program requires: productive and innovative researchers; clear, supportive policies; knowledgeable professional staff; and adequate funding for operating expenses and for patenting inventions. When all four components are in place, technology transfer can enhance the university’s ability to interact with industry and can make a significant contribution to economic development at the local, state and national level.
Abstract: This manuscript reviews the sequence of events surrounding the development of a proposed diagnostic test for periodontal disease based on analysis of a host mediator in gingival crevicular fluid (GCF). The mediator is lysosomal β -glucuronidase (β G), a marker of granule release from polymorphonuclear leukocytes. Preliminary studies were conducted to evaluate the most reproducible method of collecting GCF and analyzing the data. This was followed by analysis of the mediator in GCF in a variety of cross-sectional and short-term longitudinal studies, and eventually by a study of the relationship of β G in GCF to disease progression (probing attachment…loss) in a single center longitudinal trial. Development of an academic-industrial collaboration allowed the project to progress, as a rapid, practical assay system was developed, and a multi-center longitudinal trial was conducted. The multicenter trial indicated that patients with elevated β G in GCF were at 6 to 14 times higher risk for experiencing probing attachment loss. The technical, regulatory, business and marketing issues surrounding the introduction of a diagnostic test for periodontal disease were considered. While technical and regulatory issues were not major impediments, business and marketing concerns contributed to a decision to halt development of the test. Specifically, there was concern about acceptance of the test by practitioners and third party reimbursement. Underlying these issues were the multifactorial nature of periodontal disease, and the lack of a direct cause and effect relationship of test results to disease outcome. While analysis of β G in GCF is not currently available as a diagnostic test for periodontal disease, the development process has identified important issues for the introduction of diagnostic tests, including consideration of the relationship of test results to treatment, the need to integrate diagnostic tests into dental practice, and an appreciation of the financial and health care benefits derived by practitioners and patients with use of such tests.
Abstract: OmniGene Diagnostics. Inc. has applied the principles of genetic engineering to develop species-specific DNA probe tests for eight periodontal pathogens (Porphyromonas gingivalis, Prevotella intermedia, Actinobacillus actinomycetem-comitans, Fusobacterium nucleatum, Eikenella corrodens, Campylobacter rectus, Bacteroides forsythus, and Treponema denticola). The test requires minimal effort on the part of the clinician: subgingival plaque samples are collected from the patient and sent through the mail for analysis by OmniGene Diagnostics’ fully licensed clinical reference laboratory. Results are transmitted to the practitioner by phone, fax, or mail. The use of diagnostic tests for periodontal pathogens is a relatively new concept in dentistry and acceptance of…the OmniGene Diagnostics tests by the dental marketplace has been slower than anticipated. OmniGene Diagnostics’ challenge for the future is to persuade the dental community that monitoring periodontal pathogen levels, as well as other clinical indicators of disease, is essential to providing optimal care to the periodontitis patient.
Abstract: Universities and dental schools are increasingly emphasizing the importance of transferring technology based upon faculty research into marketable products. One area of current interest to dentistry involves the utilization of recombinant DNA and protein purification technologies to produce therapeutics based upon the biologic activity of the proteins. This work builds upon the discovery and characterization of several families of protein capable of inducing potent biological responses both in vitro and in vivo. It is motivated by the need to provide patients with additional alternatives for the prevention, diagnosis, arrest or repair of a number of oral conditions or their sequela…such as periodontitis, caries, and neoplasia. This article addresses some incentives and disincentives extant within academic institutions encountered during the development of a therapeutic agent for the regeneration of the periodontium. Incentives include professional rewards associated with the development of new therapeutics and disincentives include conflicts between traditional measures of academic achievement and the nature of the work associated with the development of such products. Some ideas for the resolution of disincentives are presented.
Abstract: For thirty years now oral implants and methods for implantation have been developed further to assure a lifetime stability of these devices and to optimize function and esthetics. Coming from osteosynthesis the Institut Straumann in cooperation with leading clinicians had a considerable share in this development. Out of this longtime cooperation an institutionalized form was devised, where clinicians, material scientists and engineers were united in the International Team for oral Implantology (ITI). This scientific organization, although legally and financially independent from Institut Straumann, works in close cooperation with the company in an unique form of symbiosis. The ITI takes care…of research and education of clinicians and practitioners and it gives the needed input for the development of new products to the Institut Straumann as its exclusive licensee. The company again pays license fees to the ITI Foundation enabling thus a continuous scientific clinical research. Over many years a whole philosophy and implant system – the ITI Dental Implant System – was developed this way with its sound scientific background.
Keywords: Dental implants, ITI Dental Implant System, technology transfer, cooperation between research and industry
Abstract: This paper describes my attempt to develop a new technology for sampling the contents of the gingival crevice. Following a brief introduction on the potential of the gingival crevice as a prognosticator of periodontal health, the problems associated with attempting to fulfill this potential are discussed. These problems include difficulties in identifying a crevice component or property that was correlated with disease, the shortcomings of the paper strip method used for sampling from the crevice, and finally difficulties in defining periodontal disease and finding clinical parameters useful for correlation with biochemical studies. A new technology for sampling the contents…of the gingival crevice is described. This technology is based on immunomagnetic capture in which antibody coated magnetic microspheres are introduced into the sulcus. Following the capture of antigens, the micro spheres are removed and the amount of antigen quantified by immunochemical assays. This paper describes attempts to develop this technology into a commercial product and includes experiences with raising capital and marketing the discovery. A brief discussion of the role of the scientific community, the practicing dentist and insurance coverage to the technology transfer process is included. Finally, some suggestions for improving the technology transfer process are included.