TY - STD TI - Laxmi V: Medical devices: technologies and global markets. In: BCC Research; 2018. ID - ref1 ER - TY - JOUR AU - Kirisits, A. AU - Redekop, W. K. PY - 2013 DA - 2013// TI - The economic evaluation of medical devices: challenges ahead JO - Applied health economics and health policy VL - 11 UR - https://doi.org/10.1007/s40258-012-0006-9 DO - 10.1007/s40258-012-0006-9 ID - Kirisits2013 ER - TY - JOUR AU - Drummond, M. AU - Tarricone, R. AU - Torbica, A. PY - 2016 DA - 2016// TI - Incentivizing research into the effectiveness of medical devices JO - The European journal of health economics : HEPAC : health economics in prevention and care VL - 17 UR - https://doi.org/10.1007/s10198-016-0820-3 DO - 10.1007/s10198-016-0820-3 ID - Drummond2016 ER - TY - BOOK AU - Markiewicz, K. PY - 2017 DA - 2017// TI - Early technology assessment of new medical devices PB - University of Twente CY - Holland ID - Markiewicz2017 ER - TY - JOUR AU - O'Regan, N. i. c. h. o. l. a. s. AU - Ghobadian, A. b. b. y. AU - Sims, M. a. r. t. i. n. PY - 2006 DA - 2006// TI - Fast tracking innovation in manufacturing SMEs JO - Technovation VL - 26 UR - https://doi.org/10.1016/j.technovation.2005.01.003 DO - 10.1016/j.technovation.2005.01.003 ID - O'Regan2006 ER - TY - JOUR AU - Kaplan, A. V. AU - Baim, D. S. AU - Smith, J. J. AU - Feigal, D. A. AU - Simons, M. AU - Jefferys, D. AU - Fogarty, T. J. AU - Kuntz, R. E. AU - Leon, M. B. PY - 2004 DA - 2004// TI - Medical device development: from prototype to regulatory approval JO - Circulation VL - 109 UR - https://doi.org/10.1161/01.CIR.0000134695.65733.64 DO - 10.1161/01.CIR.0000134695.65733.64 ID - Kaplan2004 ER - TY - JOUR AU - Bartelmes, M. AU - Neumann, U. AU - Lühmann, D. AU - Schönermark, M. P. AU - Hagen, A. PY - 2009 DA - 2009// TI - Methods for assessment of innovative medical technologies during early stages of development JO - GMS Health Technology Assessment VL - 5 ID - Bartelmes2009 ER - TY - CHAP AU - Grunwald, A. AU - Achternbosch, M. ED - Doorn, N. ED - Schuurbiers, D. ED - Poel, I. ED - Gorman, M. E. PY - 2013 DA - 2013// TI - Technology Assessment and Approaches to Early Engagement BT - Early engagement and new technologies: Opening up the laboratory PB - Springer Netherlands CY - Dordrecht UR - https://doi.org/10.1007/978-94-007-7844-3_2 DO - 10.1007/978-94-007-7844-3_2 ID - Grunwald2013 ER - TY - JOUR AU - Pietzsch, J. B. AU - Pate-Cornell, M. E. PY - 2008 DA - 2008// TI - Early technology assessment of new medical devices JO - Int J Technol Assess Health Care VL - 24 UR - https://doi.org/10.1017/S0266462307080051 DO - 10.1017/S0266462307080051 ID - Pietzsch2008 ER - TY - JOUR AU - Huot, L. AU - Decullier, E. AU - Maes-Beny, K. AU - Chapuis, F. R. PY - 2012 DA - 2012// TI - Medical device assessment: scientific evidence examined by the French national agency for health - a descriptive study JO - BMC Public Health VL - 12 UR - https://doi.org/10.1186/1471-2458-12-585 DO - 10.1186/1471-2458-12-585 ID - Huot2012 ER - TY - JOUR AU - Schnell-Inderst, P. AU - Mayer, J. AU - Lauterberg, J. AU - Hunger, T. AU - Arvandi, M. AU - Conrads-Frank, A. AU - Nachtnebel, A. AU - Wild, C. AU - Siebert, U. PY - 2015 DA - 2015// TI - Health technology assessment of medical devices: what is different? An overview of three European projects JO - Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen VL - 109 UR - https://doi.org/10.1016/j.zefq.2015.06.011 DO - 10.1016/j.zefq.2015.06.011 ID - Schnell-Inderst2015 ER - TY - JOUR AU - Soenksen, L. R. AU - Yazdi, Y. PY - 2017 DA - 2017// TI - Stage-gate process for life sciences and medical innovation investment JO - Technovation VL - 62-63 UR - https://doi.org/10.1016/j.technovation.2017.03.003 DO - 10.1016/j.technovation.2017.03.003 ID - Soenksen2017 ER - TY - JOUR AU - Alan, G. AU - Terry, Y. AU - Celia, B. AU - Richard, L. PY - 2010 DA - 2010// TI - Early-stage valuation of medical devices: the role of developmental uncertainty JO - Value Health VL - 13 UR - https://doi.org/10.1111/j.1524-4733.2010.00726.x DO - 10.1111/j.1524-4733.2010.00726.x ID - Alan2010 ER - TY - STD TI - De Pinho Campos K, Norman CD, Jadad AR: Product development public-private partnerships for public health: a systematic review using qualitative data. Soc Sci Med (1982) 2011, 73(7):986–994. ID - ref14 ER - TY - JOUR AU - Henshall, C. AU - Schuller, T. PY - 2013 DA - 2013// TI - Health technology assessment, value-based decision making, and innovation JO - Int J Technol Assess Health Care VL - 29 UR - https://doi.org/10.1017/S0266462313000378 DO - 10.1017/S0266462313000378 ID - Henshall2013 ER - TY - JOUR AU - Lehoux, P. AU - Miller, F. A. AU - Daudelin, G. AU - Denis, J. L. PY - 2017 DA - 2017// TI - Providing value to new health technology: the early contribution of entrepreneurs, investors, and regulatory agencies JO - Int J Health Policy Manag VL - 6 UR - https://doi.org/10.15171/ijhpm.2017.11 DO - 10.15171/ijhpm.2017.11 ID - Lehoux2017 ER - TY - JOUR AU - Lehoux, P. AU - Williams-Jones, B. AU - Miller, F. AU - Urbach, D. AU - Tailliez, S. PY - 2008 DA - 2008// TI - What leads to better health care innovation? Arguments for an integrated policy-oriented research agenda JO - Journal of health services research & policy VL - 13 UR - https://doi.org/10.1258/jhsrp.2008.007173 DO - 10.1258/jhsrp.2008.007173 ID - Lehoux2008 ER - TY - JOUR AU - Sculpher, M. AU - Drummond, M. AU - Buxton, M. PY - 1997 DA - 1997// TI - The iterative use of economic evaluation as part of the process of health technology assessment JO - Journal of health services research & policy VL - 2 UR - https://doi.org/10.1177/135581969700200107 DO - 10.1177/135581969700200107 ID - Sculpher1997 ER - TY - JOUR AU - IJ, M. J. AU - Koffijberg, H. AU - Fenwick, E. AU - Krahn, M. PY - 2017 DA - 2017// TI - Emerging use of early health technology assessment in medical product development: a scoping review of the literature JO - PharmacoEconomics VL - 35 UR - https://doi.org/10.1007/s40273-017-0509-1 DO - 10.1007/s40273-017-0509-1 ID - IJ2017 ER - TY - JOUR AU - Tarricone, R. AU - Torbica, A. AU - Ferre, F. AU - Drummond, M. PY - 2014 DA - 2014// TI - Generating appropriate clinical data for value assessment of medical devices: what role does regulation play? JO - Expert review of pharmacoeconomics & outcomes research VL - 14 UR - https://doi.org/10.1586/14737167.2014.950233 DO - 10.1586/14737167.2014.950233 ID - Tarricone2014 ER - TY - JOUR AU - Hartz, S. AU - John, J. PY - 2008 DA - 2008// TI - Contribution of economic evaluation to decision making in early phases of product development: a methodological and empirical review JO - Int J Technol Assess Health Care VL - 24 UR - https://doi.org/10.1017/S0266462308080616 DO - 10.1017/S0266462308080616 ID - Hartz2008 ER - TY - JOUR AU - Markiewicz, K. AU - Til, J. A. AU - IJ, M. J. PY - 2014 DA - 2014// TI - Medical devices early assessment methods: systematic literature review JO - Int J Technol Assess Health Care VL - 30 UR - https://doi.org/10.1017/S0266462314000026 DO - 10.1017/S0266462314000026 ID - Markiewicz2014 ER - TY - JOUR AU - Retèl, V. P. AU - Hummel, M. J. M. AU - Harten, W. H. PY - 2008 DA - 2008// TI - Early phase technology assessment of nanotechnology in oncology JO - Tumori Journal VL - 94 UR - https://doi.org/10.1177/030089160809400222 DO - 10.1177/030089160809400222 ID - Retèl2008 ER - TY - JOUR AU - Ijzerman, M. J. AU - Steuten, L. M. G. PY - 2011 DA - 2011// TI - Early assessment of medical technologies to inform product development and market access JO - Applied health economics and health policy VL - 9 UR - https://doi.org/10.2165/11593380-000000000-00000 DO - 10.2165/11593380-000000000-00000 ID - Ijzerman2011 ER - TY - JOUR AU - Ballini, L. AU - Minozzi, S. AU - Negro, A. AU - Pirini, G. AU - Grilli, R. PY - 2010 DA - 2010// TI - A method for addressing research gaps in HTA, developed whilst evaluating robotic-assisted surgery: a proposal JO - Health research policy and systems VL - 8 UR - https://doi.org/10.1186/1478-4505-8-27 DO - 10.1186/1478-4505-8-27 ID - Ballini2010 ER - TY - CHAP AU - Djanatliev, A. AU - German, R. PY - 2013 DA - 2013// TI - Prospective healthcare decision-making by combined system dynamics, discrete-event and agent-based simulation BT - Proceedings of the 2013 winter simulation conference: simulation: making decisions in a complex world PB - IEEE Press CY - Washington, D.C. UR - https://doi.org/10.1109/WSC.2013.6721426 DO - 10.1109/WSC.2013.6721426 ID - Djanatliev2013 ER - TY - JOUR AU - Demers-Payette, O. AU - Lehoux, P. AU - Daudelin, G. PY - 2016 DA - 2016// TI - Responsible research and innovation: a productive model for the future of medical innovation JO - Journal of Responsible Innovation VL - 3 UR - https://doi.org/10.1080/23299460.2016.1256659 DO - 10.1080/23299460.2016.1256659 ID - Demers-Payette2016 ER - TY - JOUR AU - Siebert, U. PY - 2003 DA - 2003// TI - When should decision-analytic modeling be used in the economic evaluation of health care? JO - Eur J Health Econ VL - 4 UR - https://doi.org/10.1007/s10198-003-0205-2 DO - 10.1007/s10198-003-0205-2 ID - Siebert2003 ER - TY - JOUR AU - Migliore, A. AU - Ratti, M. AU - Cerbo, M. AU - Jefferson, T. PY - 2009 DA - 2009// TI - Health technology assessment: managing the introduction and use of medical devices in clinical practice in Italy JO - Expert review of medical devices VL - 6 UR - https://doi.org/10.1586/erd.09.2 DO - 10.1586/erd.09.2 ID - Migliore2009 ER - TY - JOUR AU - Cosh, E. AU - Girling, A. AU - Lilford, R. AU - McAteer, H. AU - Young, T. PY - 2007 DA - 2007// TI - Investing in new medical technologies: a decision framework JO - J Commer Biotechnol VL - 13 UR - https://doi.org/10.1057/palgrave.jcb.3050062 DO - 10.1057/palgrave.jcb.3050062 ID - Cosh2007 ER - TY - JOUR AU - Rogers, M. J. AU - Gupta, A. AU - Maranas, C. D. PY - 2002 DA - 2002// TI - Real options based analysis of optimal pharmaceutical Research and Development portfolios JO - Ind Eng Chem Res VL - 41 UR - https://doi.org/10.1021/ie020385p DO - 10.1021/ie020385p ID - Rogers2002 ER - TY - JOUR AU - Pietzsch, J. B. AU - Shluzas, L. A. AU - Paté-Cornell, M. E. AU - Yock, P. G. AU - Linehan, J. H. PY - 2009 DA - 2009// TI - Stage-gate process for the development of medical devices JO - Journal of Medical Devices VL - 3 UR - https://doi.org/10.1115/1.3148836 DO - 10.1115/1.3148836 ID - Pietzsch2009 ER - TY - STD TI - Yock PGe, Zenios SAe, Brinton TJe, Kumar UNe, Watkins FTJe: Biodesign: the process of innovating medical technologies, Second edition. edn: Cambridge New York: Cambridge University Press; 2015. ID - ref33 ER - TY - BOOK PY - 1994 DA - 1994// TI - Defining primary care: an interim report PB - The National Academies Press CY - Washington, DC ID - ref34 ER - TY - JOUR AU - Dhruva, S. S. AU - Bero, L. A. AU - Redberg, R. F. PY - 2009 DA - 2009// TI - Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices JO - Jama VL - 302 UR - https://doi.org/10.1001/jama.2009.1899 DO - 10.1001/jama.2009.1899 ID - Dhruva2009 ER - TY - JOUR AU - Kramer, D. B. AU - Mallis, E. AU - Zuckerman, B. D. AU - Zimmerman, B. A. AU - Maisel, W. H. PY - 2010 DA - 2010// TI - Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007 JO - Am J Ther VL - 17 UR - https://doi.org/10.1097/MJT.0b013e3181ca8105 DO - 10.1097/MJT.0b013e3181ca8105 ID - Kramer2010 ER - TY - JOUR AU - Teherani, A. AU - Martimianakis, T. AU - Stenfors-Hayes, T. AU - Wadhwa, A. AU - Varpio, L. PY - 2015 DA - 2015// TI - Choosing a qualitative research approach JO - Journal of graduate medical education VL - 7 UR - https://doi.org/10.4300/JGME-D-15-00414.1 DO - 10.4300/JGME-D-15-00414.1 ID - Teherani2015 ER - TY - JOUR AU - Foley, G. AU - Timonen, V. PY - 2015 DA - 2015// TI - Using grounded theory method to capture and analyze health care experiences JO - Health Serv Res VL - 50 UR - https://doi.org/10.1111/1475-6773.12275 DO - 10.1111/1475-6773.12275 ID - Foley2015 ER - TY - JOUR AU - Kleinsasser, A. M. PY - 2000 DA - 2000// TI - Researchers, reflexivity, and good data: writing to unlearn JO - Theory Pract VL - 39 UR - https://doi.org/10.1207/s15430421tip3903_6 DO - 10.1207/s15430421tip3903_6 ID - Kleinsasser2000 ER - TY - JOUR AU - Bridgelal Ram, M. AU - Grocott, P. R. AU - Weir, H. C. PY - 2008 DA - 2008// TI - Issues and challenges of involving users in medical device development JO - Health expectations : an international journal of public participation in health care and health policy VL - 11 UR - https://doi.org/10.1111/j.1369-7625.2007.00464.x DO - 10.1111/j.1369-7625.2007.00464.x ID - Bridgelal Ram2008 ER - TY - JOUR AU - Castner, J. AU - Sullivan, S. S. AU - Titus, A. H. AU - Klingman, K. J. PY - 2016 DA - 2016// TI - Strengthening the role of nurses in medical device development JO - J Prof Nurs VL - 32 UR - https://doi.org/10.1016/j.profnurs.2016.01.002 DO - 10.1016/j.profnurs.2016.01.002 ID - Castner2016 ER - TY - JOUR AU - Ana, F. J. AU - Umstead, K. A. AU - Phillips, G. J. AU - Conner, C. P. PY - 2013 DA - 2013// TI - Value driven innovation in medical device design: a process for balancing stakeholder voices JO - Ann Biomed Eng VL - 41 UR - https://doi.org/10.1007/s10439-013-0779-5 DO - 10.1007/s10439-013-0779-5 ID - Ana2013 ER - TY - JOUR AU - Hummel, J. M. AU - Rossum, W. AU - Verkerke, G. J. AU - Rakhorst, G. PY - 2000 DA - 2000// TI - Medical technology assessment: the use of the analytic hierarchy process as a tool for multidisciplinary evaluation of medical devices JO - The International journal of artificial organs VL - 23 UR - https://doi.org/10.1177/039139880002301108 DO - 10.1177/039139880002301108 ID - Hummel2000 ER - TY - JOUR AU - Huygens, S. A. AU - Rutten-van Molken, M. P. AU - Bekkers, J. A. AU - Bogers, A. J. AU - Bouten, C. V. AU - Chamuleau, S. A. AU - Jaegere, P. P. AU - Kappetein, A. P. AU - Kluin, J. AU - Mieghem, N. M. PY - 2016 DA - 2016// TI - Conceptual model for early health technology assessment of current and novel heart valve interventions JO - Open Heart VL - 3 UR - https://doi.org/10.1136/openhrt-2016-000500 DO - 10.1136/openhrt-2016-000500 ID - Huygens2016 ER - TY - JOUR AU - Kesselheim, A. S. AU - Xu, S. AU - Avorn, J. PY - 2014 DA - 2014// TI - Clinicians’ contributions to the development of coronary artery stents: a qualitative study of transformative device innovation JO - PLoS One VL - 9 UR - https://doi.org/10.1371/journal.pone.0088664 DO - 10.1371/journal.pone.0088664 ID - Kesselheim2014 ER - TY - JOUR AU - Shah, S. G. AU - Robinson, I. PY - 2006 DA - 2006// TI - User involvement in healthcare technology development and assessment: structured literature review JO - International journal of health care quality assurance incorporating Leadership in health services VL - 19 UR - https://doi.org/10.1108/09526860610687619 DO - 10.1108/09526860610687619 ID - Shah2006 ER - TY - JOUR AU - Shah, S. G. AU - Robinson, I. PY - 2007 DA - 2007// TI - Benefits of and barriers to involving users in medical device technology development and evaluation JO - Int J Technol Assess Health Care VL - 23 UR - https://doi.org/10.1017/S0266462307051677 DO - 10.1017/S0266462307051677 ID - Shah2007 ER - TY - JOUR AU - Baerlocher, M. O. AU - Millward, S. F. AU - Cardella, J. F. PY - 2009 DA - 2009// TI - Conflicts of interest in the development of new interventional medical devices JO - Journal of vascular and interventional radiology: JVIR VL - 20 UR - https://doi.org/10.1016/j.jvir.2008.11.013 DO - 10.1016/j.jvir.2008.11.013 ID - Baerlocher2009 ER - TY - JOUR AU - Bouchard, S. AU - Barkun, A. N. AU - Barkun, J. S. AU - Joseph, L. PY - 1996 DA - 1996// TI - Technology assessment in laparoscopic general surgery and gastrointestinal endoscopy: science or convenience? JO - Gastroenterology VL - 110 UR - https://doi.org/10.1053/gast.1996.v110.pm8608903 DO - 10.1053/gast.1996.v110.pm8608903 ID - Bouchard1996 ER - TY - JOUR AU - DePasse, J. W. AU - Carroll, R. AU - Ippolito, A. AU - Yost, A. AU - Santorino, D. AU - Chu, Z. AU - Olson, K. R. PY - 2014 DA - 2014// TI - Less noise, more hacking: how to deploy principles from MIT's hacking medicine to accelerate health care JO - Int J Technol Assess Health Care VL - 30 UR - https://doi.org/10.1017/S0266462314000324 DO - 10.1017/S0266462314000324 ID - DePasse2014 ER - TY - JOUR AU - Donovan, A. AU - Kaplan, A. V. PY - 2012 DA - 2012// TI - Navigating conflicts of interest for the medical device entrepreneur JO - Prog Cardiovasc Dis VL - 55 UR - https://doi.org/10.1016/j.pcad.2012.10.008 DO - 10.1016/j.pcad.2012.10.008 ID - Donovan2012 ER - TY - JOUR AU - Gelijns, A. C. AU - Russo, M. J. AU - Hong, K. N. AU - Brown, L. D. AU - Ascheim, D. D. AU - Moskowitz, A. J. PY - 2013 DA - 2013// TI - Dynamics of device innovation: implications for assessing value JO - Int J Technol Assess Health Care VL - 29 UR - https://doi.org/10.1017/S0266462313000561 DO - 10.1017/S0266462313000561 ID - Gelijns2013 ER - TY - JOUR AU - Hamilton, C. PY - 2007 DA - 2007// TI - Critical assessment of new devices JO - Perfusion VL - 22 UR - https://doi.org/10.1177/0267659107076877 DO - 10.1177/0267659107076877 ID - Hamilton2007 ER - TY - JOUR AU - Hulstaert, F. AU - Neyt, M. AU - Vinck, I. AU - Stordeur, S. AU - Huic, M. AU - Sauerland, S. AU - Kuijpers, M. R. AU - Abrishami, P. AU - Vondeling, H. AU - Flamion, B. PY - 2012 DA - 2012// TI - Pre-market clinical evaluations of innovative high-risk medical devices in Europe JO - Int J Technol Assess Health Care VL - 28 UR - https://doi.org/10.1017/S0266462312000335 DO - 10.1017/S0266462312000335 ID - Hulstaert2012 ER - TY - JOUR AU - Lu, C. Y. PY - 2014 DA - 2014// TI - Uncertainties in real-world decisions on medical technologies JO - Int J Clin Pract VL - 68 UR - https://doi.org/10.1111/ijcp.12434 DO - 10.1111/ijcp.12434 ID - Lu2014 ER - TY - JOUR AU - Maetzler, W. AU - Klucken, J. AU - Horne, M. PY - 2016 DA - 2016// TI - A clinical view on the development of technology-based tools in managing Parkinson’s disease JO - Movement disorders: official journal of the Movement Disorder Society VL - 31 UR - https://doi.org/10.1002/mds.26673 DO - 10.1002/mds.26673 ID - Maetzler2016 ER - TY - JOUR AU - Mike, V. AU - Krauss, A. N. AU - Ross, G. S. PY - 1998 DA - 1998// TI - Responsibility for clinical innovation. A case study in neonatal medicine JO - Evaluation & the health professions VL - 21 UR - https://doi.org/10.1177/016327879802100101 DO - 10.1177/016327879802100101 ID - Mike1998 ER - TY - JOUR AU - Raab, G. G. AU - Parr, D. H. PY - 2006 DA - 2006// TI - From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology--part 1: issues in medical device assessment JO - Journal of the American College of Radiology : JACR VL - 3 UR - https://doi.org/10.1016/j.jacr.2006.02.005 DO - 10.1016/j.jacr.2006.02.005 ID - Raab2006 ER - TY - JOUR AU - Shah, S. G. AU - Robinson, I. AU - AlShawi, S. PY - 2009 DA - 2009// TI - Developing medical device technologies from users' perspectives: a theoretical framework for involving users in the development process JO - Int J Technol Assess Health Care VL - 25 UR - https://doi.org/10.1017/S0266462309990328 DO - 10.1017/S0266462309990328 ID - Shah2009 ER - TY - JOUR AU - Abel, D. B. AU - Eikelboom, B. C. AU - Fogarty, T. J. AU - Strandness, D. E. PY - 1996 DA - 1996// TI - The role of randomized trials in the investigation of rapidly evolving technologies JO - Journal of endovascular surgery : the official journal of the International Society for Endovascular Surgery VL - 3 UR - https://doi.org/2.0.CO;2 DO - 2.0.CO;2 ID - Abel1996 ER - TY - JOUR AU - Baim, D. S. AU - Donovan, A. AU - Smith, J. J. AU - Briefs, N. AU - Geoffrion, R. AU - Feigal, D. AU - Kaplan, A. V. PY - 2007 DA - 2007// TI - Medical device development: managing conflicts of interest encountered by physicians JO - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions VL - 69 UR - https://doi.org/10.1002/ccd.21150 DO - 10.1002/ccd.21150 ID - Baim2007 ER - TY - JOUR AU - Caparelli, C. AU - Carpino, G. AU - Brunetti, G. AU - Larizza, P. AU - Guglielmelli, E. PY - 2015 DA - 2015// TI - A preliminary health technology assessment of a guidance system for interventional radiology JO - Conference proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society IEEE Engineering in Medicine and Biology Society Annual Conference VL - 2015 ID - Caparelli2015 ER - TY - JOUR AU - Conway, D. AU - Quatrara, B. AU - Rodriguez, L. PY - 2012 DA - 2012// TI - A better fit: industry collaboration with nurse-clinicians in the development and redesign of a pneumatic compression device JO - Orthop Nurs VL - 31 UR - https://doi.org/10.1097/NOR.0b013e318274261e DO - 10.1097/NOR.0b013e318274261e ID - Conway2012 ER - TY - JOUR AU - Govil, A. AU - Hao, S. C. PY - 2016 DA - 2016// TI - Integration of new technology into clinical practice after FDA approval JO - Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing VL - 47 UR - https://doi.org/10.1007/s10840-016-0171-0 DO - 10.1007/s10840-016-0171-0 ID - Govil2016 ER - TY - JOUR AU - Ray, P. P. AU - Amaral, J. F. AU - Hinoul, P. PY - 2017 DA - 2017// TI - Innovation best practices in the medical device industry JO - Tech Vasc Interv Radiol VL - 20 UR - https://doi.org/10.1053/j.tvir.2017.04.004 DO - 10.1053/j.tvir.2017.04.004 ID - Ray2017 ER - TY - JOUR AU - Steinberger, J. D. AU - Denend, L. AU - Azagury, D. E. AU - Brinton, T. J. AU - Makower, J. AU - Yock, P. G. PY - 2017 DA - 2017// TI - Needs-based innovation in interventional radiology: the biodesign process JO - Tech Vasc Interv Radiol VL - 20 UR - https://doi.org/10.1053/j.tvir.2017.04.006 DO - 10.1053/j.tvir.2017.04.006 ID - Steinberger2017 ER - TY - JOUR AU - Vecht, J. A. AU - Segesser, L. K. AU - Ashrafian, H. AU - Rao, C. AU - Skapinakis, P. AU - Saso, S. AU - Darzi, A. AU - Athanasiou, T. PY - 2010 DA - 2010// TI - Translation to success of surgical innovation JO - European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery VL - 37 UR - https://doi.org/10.1016/j.ejcts.2009.08.032 DO - 10.1016/j.ejcts.2009.08.032 ID - Vecht2010 ER - TY - JOUR AU - Egan, J. PY - 2006 DA - 2006// TI - Adding the clinician to medical device innovation JO - Medical device technology VL - 17 ID - Egan2006 ER - TY - JOUR AU - Chaturvedi, J. AU - Logan, A. AU - Narayan, G. AU - Kuttappa, S. PY - 2015 DA - 2015// TI - A structured process for unmet clinical need analysis for medical device innovation in India: early experiences JO - BMJ Innovations VL - 1 UR - https://doi.org/10.1136/bmjinnov-2014-000010 DO - 10.1136/bmjinnov-2014-000010 ID - Chaturvedi2015 ER - TY - JOUR AU - Redberg, R. F. PY - 2007 DA - 2007// TI - Evidence, appropriateness, and technology assessment in cardiology: a case study of computed tomography JO - Health affairs (Project Hope) VL - 26 UR - https://doi.org/10.1377/hlthaff.26.1.86 DO - 10.1377/hlthaff.26.1.86 ID - Redberg2007 ER - TY - STD TI - Wei-Tek T, Mojdehbakhsh R, Rayadurgam S: Experience in capturing requirements for safety-critical medical devices in an industrial environment. In: Proceedings 1997 High-Assurance Engineering Workshop: 11–12 Aug 1997 1997; 1997: 32–36. ID - ref71 ER - TY - JOUR AU - Garmer, K. AU - Liljegren, E. AU - Osvalder, A. -. L. AU - Dahlman, S. PY - 2000 DA - 2000// TI - Usability evaluation of a new user Interface for an infusion pump developed with a human factors approach JO - Proceedings of the Human Factors and Ergonomics Society Annual Meeting VL - 44 UR - https://doi.org/10.1177/154193120004400134 DO - 10.1177/154193120004400134 ID - Garmer2000 ER - TY - JOUR AU - Weir, H. AU - Grocott, P. AU - Ram, M. B. PY - 2006 DA - 2006// TI - The nurse’s role in contributing to new device development JO - Nurs Times VL - 102 ID - Weir2006 ER - TY - JOUR AU - Siebert, M. AU - Clauss, L. C. AU - Carlisle, M. AU - Casteels, B. AU - Jong, P. AU - Kreuzer, M. AU - Sanghera, S. AU - Stokoe, G. AU - Trueman, P. AU - Lang, A. W. PY - 2002 DA - 2002// TI - Health technology assessment for medical devices in Europe. What must be considered JO - Int J Technol Assess Health Care VL - 18 ID - Siebert2002 ER - TY - JOUR AU - Zietman, A. AU - Ibbott, G. PY - 2012 DA - 2012// TI - A clinical approach to technology assessment: how do we and how should we choose the right treatment? JO - Semin Radiat Oncol VL - 22 UR - https://doi.org/10.1016/j.semradonc.2011.09.008 DO - 10.1016/j.semradonc.2011.09.008 ID - Zietman2012 ER - TY - JOUR AU - Ferguson, M. PY - 2014 DA - 2014// TI - Medical devices are different to pharmaceuticals in the health technology assessment process JO - Journal of comparative effectiveness research VL - 3 UR - https://doi.org/10.2217/cer.14.17 DO - 10.2217/cer.14.17 ID - Ferguson2014 ER - TY - JOUR AU - Bunker, J. PY - 1998 DA - 1998// TI - When and How to Assess Fast-changing Technologies: A Comparative Study of Medical Applications of Four Generic Technologies JO - BMJ VL - 316 UR - https://doi.org/10.1136/bmj.316.7142.1468b DO - 10.1136/bmj.316.7142.1468b ID - Bunker1998 ER - TY - JOUR AU - Cook, J. o. n. a. t. h. a. n. A. AU - Ramsaya, C. r. a. i. g. R. AU - Fayers, P. e. t. e. r. PY - 2004 DA - 2004// TI - Statistical evaluation of learning curve effects in surgical trials JO - Clinical Trials: Journal of the Society for Clinical Trials VL - 1 UR - https://doi.org/10.1191/1740774504cn042oa DO - 10.1191/1740774504cn042oa ID - Cook2004 ER - TY - JOUR AU - Campbell, G. AU - Yue, L. Q. PY - 2016 DA - 2016// TI - Statistical innovations in the medical device world sparked by the FDA JO - J Biopharm Stat VL - 26 UR - https://doi.org/10.1080/10543406.2015.1092037 DO - 10.1080/10543406.2015.1092037 ID - Campbell2016 ER - TY - JOUR AU - Bonangelino, P. AU - Irony, T. AU - Liang, S. AU - Li, X. AU - Mukhi, V. AU - Ruan, S. AU - Xu, Y. AU - Yang, X. AU - Wang, C. PY - 2011 DA - 2011// TI - Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting JO - J Biopharm Stat VL - 21 UR - https://doi.org/10.1080/10543406.2011.589650 DO - 10.1080/10543406.2011.589650 ID - Bonangelino2011 ER - TY - JOUR AU - Lilford, R. J. AU - Braunholtz, D. A. AU - Greenhalgh, R. AU - Edwards, S. J. L. PY - 2000 DA - 2000// TI - Trials and fast changing technologies: the case for tracker studies JO - BMJ: British Medical Journal VL - 320 UR - https://doi.org/10.1136/bmj.320.7226.43 DO - 10.1136/bmj.320.7226.43 ID - Lilford2000 ER - TY - JOUR AU - Abenstein, J. P. PY - 2006 DA - 2006// TI - Technology assessment for the anesthesiologist JO - Anesthesiol Clin VL - 24 UR - https://doi.org/10.1016/j.atc.2006.08.001 DO - 10.1016/j.atc.2006.08.001 ID - Abenstein2006 ER - TY - JOUR AU - Ballard, G. T. PY - 1996 DA - 1996// TI - Medical and dental technology assessment JO - Technology and health care: official journal of the European Society for Engineering and Medicine VL - 4 UR - https://doi.org/10.3233/THC-1996-4307 DO - 10.3233/THC-1996-4307 ID - Ballard1996 ER - TY - JOUR AU - Ferguson, M. AU - Kim, M. AU - Patel, P. AU - Stockwell, B. PY - 2014 DA - 2014// TI - The impact of medical device use on hospital costs JO - Value Health VL - 17 UR - https://doi.org/10.1016/j.jval.2014.03.015 DO - 10.1016/j.jval.2014.03.015 ID - Ferguson2014 ER - TY - JOUR AU - Porter, M. E. PY - 2010 DA - 2010// TI - What is value in health care? JO - N Engl J Med VL - 363 UR - https://doi.org/10.1056/NEJMp1011024 DO - 10.1056/NEJMp1011024 ID - Porter2010 ER - TY - JOUR AU - Heath, I. PY - 2004 DA - 2004// TI - View of health technology assessment from the swampy lowlands of general practice JO - Int J Technol Assess Health Care VL - 20 UR - https://doi.org/10.1017/S0266462304000832 DO - 10.1017/S0266462304000832 ID - Heath2004 ER - TY - JOUR AU - Vagelos, P. R. PY - 2007 DA - 2007// TI - Innovation and industry-academia interactions: where conflicts arise and measures to avoid them JO - Cleve Clin J Med VL - 74 UR - https://doi.org/10.3949/ccjm.74.Suppl_2.S12 DO - 10.3949/ccjm.74.Suppl_2.S12 ID - Vagelos2007 ER - TY - JOUR AU - Haute, A. PY - 2011 DA - 2011// TI - Managing perceived conflicts of interest while ensuring the continued innovation of medical technology JO - J Vasc Surg VL - 54 UR - https://doi.org/10.1016/j.jvs.2011.05.108 DO - 10.1016/j.jvs.2011.05.108 ID - Haute2011 ER -