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1	PROMOTING BREAKTHROUGH MEDICAL INNOVATION: INSIGHTS FROM AN ANALYSIS OF RECENT TRANSFORMATIVE DRUGS, BIOLOGICS AND MEDICAL DEVICES Xu, Shuai 02 May 2016 (has links) Given the recent concern from multiple healthcare stakeholders that the pipeline of medical innovation is slowing, this thesis provides insights on how to spur breakthrough medical innovation in present day. The findings and recommendations are derived from one of the largest collections of interview transcripts from biomedical innovators (n=143) responsible for developing critical devices, drugs and diagnostics used in medicine today. An exemplary case (coronary artery stent) was selected for an in-depth analysis, which included a detailed recounting of stent development and an exhaustive analysis of the patent literature. External factors either catalyzed (e.g., supportive institutions, strong underlying science and collaboration) or hindered (e.g., technology transfer challenges, lack of funding and onerous conflict of interest rules) the development process. Strategies aimed towards promoting transformative medical innovation should focus on institutional-level policies targeting early stages of innovation. This includes providing individuals with unique expertise with the capacity to pursue innovative work. Technology transfer processes should be simplified to enable collaboration for individuals between institutions with disparate expertise. Policymakers should continue to support basic science research, which underlies future innovations. In contrast, policies that increase reimbursement or reduce taxes for industry or extend patent terms are less likely to impact transformative innovation. medical innovation FDA medical technology drug development device development
2	Sociogenèse d’une spécialité médicale : le cas de radiologie interventionnelle / Sociogenesis of a medical specialty : the case of interventional radiology Mignot, Leo 19 December 2017 (has links) Initiée dans les années 1960, la radiologie interventionnelle comprend les actes médicaux invasifs ayant pour but le traitement ou le diagnostic d’une pathologie réalisés sous guidage ou sous contrôle d’un moyen d’imagerie. L’enjeu de la thèse est de développer l’analyse sociohistorique de l’émergence d’une spécialité médicale – la radiologie interventionnelle – et d’en étudier les stratégies de légitimation. Trois axes d’investigation interdépendants sont plus particulièrement privilégiés. Le premier d’entre eux vise à comprendre comment est née cette pratique médicale en établissant l’archéologie des innovations dont elle résulte. Dans le deuxième, il s’agit d’analyser les stratégies de valorisation et les modes de faire-valoir de la radiologie interventionnelle. Les velléités d’autonomisation des radiologues interventionnels les ont ainsi conduits à mobiliser différents registres de légitimité (légitimité scientifique, légitimité professionnelle dans le champ médical, légitimité régulatoire). Le troisième axe permet quant à lui la prise en compte de la question de la démarcation sociale et des frontières. Étant porteuse d’une transgression de la dichotomie établie entre sphères diagnostique et thérapeutique, la radiologie interventionnelle a de fait entraîné une reconfiguration des relations entre spécialités. L’investigation s’appuie sur une méthodologie plurielle combinant entretiens semidirectifs, observations in situ (bloc opératoire, scanner, réunions de concertation pluridisciplinaire, consultations) et exploitation de données scientométriques. Une mise en perspective internationale avec la situation canadienne permet d’étudier l’impact des contextes nationaux sur la diffusion et la reconnaissance de la radiologie interventionnelle. / Introduced in the 1960s, interventional radiology includes invasive medical procedures for the treatment or diagnosis of a pathology performed under the guidance or control of an imaging device. The aim of the thesis is to develop the sociohistorical analysis of the emergence of a medical specialty – interventional radiology – and to study its legitimization strategies. Three interdependent lines of inquiry are privileged in particular. The first aims to understand how this medical practice was born by establishing the archaeology of the innovations that gave rise to it. In the second, it is a question of analyzing the strategies of valorization and the ways of valuing interventional radiology. The interventional radiologists’ desire for independence has led them to mobilize different registers of legitimacy (scientific legitimacy, professional legitimacy in the medical field, regulatory legitimacy). The third line of inquiry allows for the issue of social demarcation and boundaries to be taken into account. As it is a means of transgressing the established dichotomy between the diagnostic and therapeutic spheres, interventional radiology has in fact led to a reconfiguration of the relations between specialties. The investigation is based on a methodology combining semi-directive interviews, in situ observations (operating theater, multidisciplinary consultation meetings, consultations) and the use of scientometric data. An international perspective on the Canadian situation makes it possible to study the impact of national contexts on the dissemination and recognition of interventional radiology. Sociologie des sciences Sociologie du champ médical Innovation médicale Spécialités médicales Radiologie interventionnelle Sociology of science Sociology of medicine Medical innovation Medical specialties Interventional radiology
3	Pharmacogenetics, controversies and new forms of service delivery in autoimmune diseases, acute lymphoblastic leukaemia and non-small-cell lung cancer Sainz De la fuente, Graciela January 2010 (has links) Pharmacogenetics (PGx) and personalised medicine are new disciplines that, gathering the existing knowledge about the genetic and phenotypic factors that underpin drug response, aim to deliver more targeted therapies that avoid the existing problems of adverse drug reactions or lack of drug efficacy. PGx and personalised medicine imply a shift in the way drugs are prescribed, as they require introducing diagnostic tools and implementing pre-screening mechanisms that assess patients' susceptibility to new or existing drugs. The direct benefit is an improvement in drug safety and/or efficacy. However, neither pharmacogenetics nor personalised medicine, are widely used in clinical practice. Both technologies face a number of controversies that hamper their widespread use in clinical practice. This thesis investigates the scientific; technological; social; economic; regulatory and ethical implications of PGx and personalised medicine, to understand the enablers and barriers that drive the process of technology diffusion in three conditions: autoimmune diseases, acute lymphoblastic leukaemia and non-small cell lung cancer.The thesis uses concepts of the sociology of science and a qualitative approach, to explore the arguments for and against the use of the technology by different actors (pharmaceutical and biotechnology companies, researchers, clinicians, regulators and patient organisations). The core of this analysis lies in the understanding of how, diagnostic testing (TPMT testing in the case of autoimmune diseases, acute lymphoblastic leukaemia, and EGFR testing in the case of non-small-cell lung cancer) may affect the existing drug development and service delivery mechanisms, with a particular focus on the user-producer interactions and feedback mechanisms that underpin diffusion of medical innovations and technological change in medicine.The thesis concludes by identifying gaps in knowledge and common issues among TPMT and EGFR testing, which might be used, in the future, to inform policy on how to improve PGx service delivery through a public Health System such as the NHS. 615.5
4	Le rôle de l'innovation médicale dans la croissance macro-économique / The role of medical innovation in macroeconomic growth Toubon, Hector 09 December 2016 (has links) Cette thèse a pour objectif de mettre en évidence les déterminants de l'innovation médicale et ses effets sur la croissance économique. Elle repose sur la construction d'une base de données répertoriant les dépenses et les consommations de biens et services de santé entre 1980 et 2010, ainsi que sur trois modèles théoriques. Les résultats établis, pour les cohortes nées entre 1923 et 2010, mettent en évidence que les innovations médicales sont essentiellement déterminées par les variations démographiques. Par ailleurs, même si ces innovations médicales ont historiquement permis l'apparition d'importantes économies d'échelles, elles ne jouent pas actuellement un rôle moteur dans la croissance macro-économique. En effet, dans les conditions actuelles de stabilité des courbes de survie, cette mécanique de l'innovation médicale n'apparaît pas comme une force motrice de la croissance macro-économique de court terme. Les effets multiplicateurs de l'innovation médicale sur la croissance économique seraient donc, à court terme, négatifs ou nuls. / This thesis aims to highlight the determinants of medical innovation and its impact on economic growth. It is based on building a database of spending and consumption of health goods and services between 1980 and 2010, and also on three theoretical models. Established results for cohorts born between 1923 and 2010 show that medical innovations are mainly determined by demographic changes. Moreover, even if these medical innovations have historically allowed the emergence of significant economies of scale, they do not currently play a leading role in macro-economic growth. Indeed, in the current conditions of stability of the survival curves, the mechanics of medical innovation does not appear as a driving force for macroeconomic growth short term. The multiplier effects of medical innovation on economic growth would be, on the short-term, negative or zero. Innovation médicale Croissance économique Macro-Économie Incitations à innover Démographie Transition démographique Demande induite de santé Capital santé Anthropologie Comptabilité intergénérationnelle Medical innovation Economic growth Macroeconomics Incentives to innovate Demography Aging Induced demand for health Health capital Anthropology Intergenerational accounting 334.1
5	Lethargic Medical Innovation Implementation Scene Awakened by COVID-19 : Identifying barriers and facilitators for medical innovations within prenatal care in Sweden Kouvela, Christina January 2021 (has links) Maternal health has been found to lag significantly behind in medical innovations compared to other branches of medicine such as radiology. Prenatal care, being part of maternal health, seems to be no different. Driven by this fact, this study first attempts to investigate the state of innovation implementation within the context of prenatal care in Sweden. Then, it continues with the identification of critical barriers and facilitators for the implementation of medical innovations within the same field and context as medical innovations are at some point necessary. Considering the nature of the issues at hand a qualitative study was deemed more suitable and hence was conducted. The overall work consists of a literature review alongside a planned and executed empirical study. The empirical study was conducted as a single case study comprising of three stakeholder groups that were of interest. These were: doctors, midwives, and healthcare managers. Participants were approached using a combination of convenience and snowball sampling. A series of semi-structured interviews were conducted with actors located throughout Sweden. With the help of thematic analysis, a holistic view supported by all three stakeholder groups was able to arise leading to multi-faceted insights. Results show that the medical innovation implementation state within prenatal care in Sweden could have been characterised as lethargic before the arrival of the COVID-19 pandemic as no significant medical innovations had emerged in the field until then. However, it is discovered that COVID-19 signalled the end of this reality and abruptly moved the existing innovation implementation climate. Furthermore, regarding the potential introduction of medical innovations in prenatal care, important barriers and facilitators were discovered. The findings of the study can be of use to actors attempting to implement medical innovations in the future within prenatal care or other clinical areas and contexts. healthcare Swedish healthcare COVID-19 healthcare transformation digital transformation innovation medical innovation implementation barriers facilitators prenatal care antenatal care pregnancy monitoring Övrig annan teknik
6	Disruptive Transformations in Health Care: Technological Innovation and the Acute Care General Hospital Lucas, D. Pulane 24 April 2013 (has links) Advances in medical technology have altered the need for certain types of surgery to be performed in traditional inpatient hospital settings. Less invasive surgical procedures allow a growing number of medical treatments to take place on an outpatient basis. Hospitals face growing competition from ambulatory surgery centers (ASCs). The competitive threats posed by ASCs are important, given that inpatient surgery has been the cornerstone of hospital services for over a century. Additional research is needed to understand how surgical volume shifts between and within acute care general hospitals (ACGHs) and ASCs. This study investigates how medical technology within the hospital industry is changing medical services delivery. The main purposes of this study are to (1) test Clayton M. Christensen’s theory of disruptive innovation in health care, and (2) examine the effects of disruptive innovation on appendectomy, cholecystectomy, and bariatric surgery (ACBS) utilization. Disruptive innovation theory contends that advanced technology combined with innovative business models—located outside of traditional product markets or delivery systems—will produce simplified, quality products and services at lower costs with broader accessibility. Consequently, new markets will emerge, and conventional industry leaders will experience a loss of market share to “non-traditional” new entrants into the marketplace. The underlying assumption of this work is that ASCs (innovative business models) have adopted laparoscopy (innovative technology) and their unification has initiated disruptive innovation within the hospital industry. The disruptive effects have spawned shifts in surgical volumes from open to laparoscopic procedures, from inpatient to ambulatory settings, and from hospitals to ASCs. The research hypothesizes that: (1) there will be larger increases in the percentage of laparoscopic ACBS performed than open ACBS procedures; (2) ambulatory ACBS will experience larger percent increases than inpatient ACBS procedures; and (3) ASCs will experience larger percent increases than ACGHs. The study tracks the utilization of open, laparoscopic, inpatient and ambulatory ACBS. The research questions that guide the inquiry are: 1. How has ACBS utilization changed over this time? 2. Do ACGHs and ASCs differ in the utilization of ACBS? 3. How do states differ in the utilization of ACBS? 4. Do study findings support disruptive innovation theory in the hospital industry? The quantitative study employs a panel design using hospital discharge data from 2004 and 2009. The unit of analysis is the facility. The sampling frame is comprised of ACGHs and ASCs in Florida and Wisconsin. The study employs exploratory and confirmatory data analysis. This work finds that disruptive innovation theory is an effective model for assessing the hospital industry. The model provides a useful framework for analyzing the interplay between ACGHs and ASCs. While study findings did not support the stated hypotheses, the impact of government interventions into the competitive marketplace supports the claims of disruptive innovation theory. Regulations that intervened in the hospital industry facilitated interactions between ASCs and ACGHs, reducing the number of ASCs performing ACBS and altering the trajectory of ACBS volume by shifting surgeries from ASCs to ACGHs. Disruptive Disruptive Innovation Theory Disruptive Transformations Disruptive Innovation Innovation Technology Technological Innovation Medical Innovation Medical Technology Medical Advancement Laparoscopy Laparoscopic Surgery open surgery appendectomy cholecystectomy bariatric surgery weight loss surgery appendectomies cholecystectomies inpatient outpatient ambulatory ambulatory surgery ambulatory surgery center acute care general hospital hospital acute care hospital general hospital health care healthcare hospital industry health care industry Clayton Christensen Clayton M Christensen Michael Porter Harvard Business School Virginia Commonwealth University CMS Health policy public policy public administration organizational theory organization theory Population Ecology Theory Competitive Strategy policy analysis John Kimberly Organization Size Structural Inertia liability of smallness health spending health care cost specialty medical facility open system niche width dynamic outpatient department technology shift surgical setting surgical setting shift medical facility shift substitution threat health system system level analysis Ecological Approach hospital trends ambulatory surgery trends reimbursement rate Medicare CMS coverage decision P J DiMaggio DiMaggio and Powell w w Powell Hannan and Freeman M T Hannan Organizational change minimally invasive surgery less invasive surgery Prospective Payment System Outpatient Prospective Payment System entreprenuerial physician health care organization health care management Roice Luke Carl Ameringer new technology surgical utilization elective surgery Medicare Payment Advisory Commission MedPAC coverage decision trends in surgery abdominal surgery surgical variation physician-owned physician ownership physician autonomy outpatient clinic utilization trends unnecessary surgery Pfeffer Salancik technology diffusion redefining health care interdisciplinary research health care delivery panel design diffusion of hospital technology state variation regional variation local health care market government intervention medical facility health care capacity focused factory advances in health care physician organization relationship hospital competition medical specialization hospital expansion medical arms race integrated care integrated health system J E Wennberg health care transformation reimbursement scheme surgical volume Florida Wisconsin policy making health policy analysis competitive dynamics center of excellence intervening factor service line competition service-line competition surgical reimbursement innovative business model innovative technology environmental influence established firm new market entrant patient safety sophisticated technology Harvard Divinity School Social and Behavioral Sciences

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