{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T09:31:01Z","timestamp":1789551061420,"version":"build-2803163510"},"reference-count":44,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2017,1,31]],"date-time":"2017-01-31T00:00:00Z","timestamp":1485820800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004963","name":"Seventh Framework Programme","doi-asserted-by":"publisher","award":["HEALTH\u2010F3\u20102012\u2010305694"],"award-info":[{"award-number":["HEALTH\u2010F3\u20102012\u2010305694"]}],"id":[{"id":"10.13039\/501100004963","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Economics"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost\u2010effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device\u2010specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. \u00a9 2017 The Authors.<jats:italic>Health Economics<\/jats:italic>Published by John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/hec.3479","type":"journal-article","created":{"date-parts":[[2017,1,31]],"date-time":"2017-01-31T09:16:57Z","timestamp":1485854217000},"page":"13-29","source":"Crossref","is-referenced-by-count":46,"title":["Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments"],"prefix":"10.1002","volume":"26","author":[{"given":"Oriana","family":"Ciani","sequence":"first","affiliation":[{"name":"Evidence Synthesis and Modelling for Health Improvement, Institute of Health Research University of Exeter Medical School Exeter UK"},{"name":"Centre for Research on Health and Social Care Management Universit\u00e0 Bocconi Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Britni","family":"Wilcher","sequence":"additional","affiliation":[{"name":"Evidence Synthesis and Modelling for Health Improvement, Institute of Health Research University of Exeter Medical School Exeter UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anoukh","family":"van Giessen","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands"},{"name":"Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA) Maastricht University Medical Centre Maastricht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rod S.","family":"Taylor","sequence":"additional","affiliation":[{"name":"Evidence Synthesis and Modelling for Health Improvement, Institute of Health Research University of Exeter Medical School Exeter UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,1,31]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462309090333"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2147\/MDER.S63869"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2014.04.006"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1067\/mcp.2001.113989"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.healthpol.2013.03.017"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40258-014-0104-y"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462315000185"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d2748"},{"key":"e_1_2_9_10_1","unstructured":"Council of The European Communities1993.Council Directive 93\/42\/EEC concerning medical devices.93\/42\/EEC."},{"key":"e_1_2_9_11_1","volume-title":"\ufffcGalway City and County Economic and Industrial Baseline Study","author":"Cunningham J","year":"2015"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1109094"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.313.7052.275"},{"key":"e_1_2_9_14_1","doi-asserted-by":"crossref","DOI":"10.1093\/oso\/9780198529446.001.0001","volume-title":"Methods for the Economic Evaluation of Health Care Programmes","author":"Drummond M","year":"2005"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2008.00476_1.x"},{"key":"e_1_2_9_16_1","unstructured":"Eunethta2015.\ufffcTherapeutic medical devices guideline."},{"key":"e_1_2_9_17_1","unstructured":"Eunethta Joint Action 2 Work Package 8.2016.HTA Core Model\u00aeversion 3.0(Pdf) [Online]. 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