Designing medical technology for resilience: integrating health economics and human factors approaches

References

• Cresswell K, Sheikh A. Organizational issues in the implementation and adoption of health information technology innovations: an interpretative review. Int J Med Inform. 2013;82(5):e73–e86.
   PubMed Web of Science ®Google Scholar
• Institute of Health Economics. Optimizing adoption and diffusion of medical devices at the system level. Edmonton, AB, Canada: Institute of Health Economics; 2015.
   Google Scholar
• Langhan ML, Riera A, Kurtz JC, et al. Implementation of newly adopted technology in acute care settings: a qualitative analysis of clinical staff. J Med Eng Technol. 2015;39(1):44–53.
   PubMedGoogle Scholar
• National Institute for Health and Care Excellence. NICE and NHS England consultation on changes to the arrangements for evaluating and funding drugs and other health technologies assessed through NICE’s technology appraisal and highly specialised technologies programmes. United Kingdom: National Institute for Health and Care Excellence; 2017.
   Google Scholar
• Taylor H Accelerated access review: final report - Review of innovative medicines and medical technologies. United Kingdom, 2016. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/565072/AAR_final.pdf
   Google Scholar
• Jones CH, Glogowska M, Locock L, et al. Embedding new technologies in practice–a normalization process theory study of point of care testing. BMC Health Serv Res. 2016;16(1):591.
   PubMedGoogle Scholar
• Kyratsis Y, Ahmad R, Holmes A. Technology adoption and implementation in organisations: comparative case studies of 12 English NHS trusts. BMJ Open. 2012;2(2):e000872.
   PubMed Web of Science ®Google Scholar
• EUnetHTA. Methods for health economic evaluations - a guideline based on current practices in Europe. EUnetHTA Stockholm, Sweden, 2015. [cited 2017 Dec 10]. Available from: http://www.eunethta.eu/
   Google Scholar
• Methods for health technology assessment of medical device: a European perspective. [cited 2017 Dec 10]. Available from: http://www.medtechta.eu
   Google Scholar
• Tarricone R, Callea G, Ogorevc M, et al. Improving the methods for the economic evaluation of medical devices. Health Econ. 2017;26:70–92.
   PubMed Web of Science ®Google Scholar
• Craig JA, Carr L, Hutton J, et al. A review of the economic tools for assessing new medical devices. Appl Health Econ Health Policy. 2015;13(1):15–27.
   PubMed Web of Science ®Google Scholar
• Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs—same or different? Value in Health. 2009;12(4):402–404.
   PubMed Web of Science ®Google Scholar
• Nemeth C, Wears R, Woods D, et al. Minding the Gaps: creating resilience in health care. In: Henriksen K, Battles JB, Keyes MA, et al., Editors. Advances in patient safety: new directions and alternative approaches - Vol. 3: performance and tool. Rockville, MD, US: Agency for Healthcare Research and Quality; 2008.
   Google Scholar
• Fuchs S, Olberg B, Panteli D, et al. Health technology assessment of medical devices in Europe: processes, practices, and methods. Int J Technol Assess Health Care. 2016;32(4):246–255.
   PubMed Web of Science ®Google Scholar
• Holden RJ, Carayon P, Gurses AP, et al. SEIPS 2.0: A human factors framework for studying and improving the work of healthcare professionals and patients. Ergonomics. 2013;56(11). DOI:10.1080/00140139.2013.838643.
   PubMed Web of Science ®Google Scholar
• Jakovljevic M, Arsenijevic J, Pavlova M, et al. Within the triangle of healthcare legacies: comparing the performance of South-Eastern European health systems. J Med Econ. 2017;20(5):483–492.
   PubMed Web of Science ®Google Scholar
• Woods DD. Resilience engineering: redefining the culture of safety and risk management. Hum Factors Ergon Soc Bull. 2006;49(12):1–3.
   Google Scholar
• Nemeth C, Cook R. Reliability versus resilience: what does healthcare need? Proc Hum Factors Ergon Soc Annu Meet. 2007;51(11):621–625.
   Google Scholar
• British Standards Institution. BS 65000:2014. London, UK: BSI standard limited; 2014.
   Google Scholar
• Hollnagel E. Resilience Engineering. 2016. [cited 2017 Dec 10]. Available from: http://erikhollnagel.com/ideas/resilience-engineering.html
   Google Scholar
• Tugade MM, Fredrickson BL. Resilient individuals use positive emotions to bounce back from negative emotional experiences. J Pers Soc Psychol. 2004;86(2):320–333.
   PubMed Web of Science ®Google Scholar
• Laprie J. Resilience for the scalability of dependability. In: Fourth IEEE international symposium on network computing and applications. Eds 5-6 2005. DOI: 10.1109/NCA.2005.44
   Google Scholar
• Campbell B. Home-made, adapted and modified devices in surgical practice. Ann R Coll Surg Engl. 2008;90(3):251–252.
   PubMed Web of Science ®Google Scholar
• Greene JA. Do-it-yourself medical devices — technology and empowerment in American health care. New England J Med. 2016;374(4):305–308.
   PubMed Web of Science ®Google Scholar
• Jakovljevic M, Vukovic M, Chen -C-C, et al. Do health reforms impact cost consciousness of health care professionals? results from a nation-wide survey in the Balkans. Balkan Med J. 2016;33(1):8–17.
   PubMed Web of Science ®Google Scholar
• International Organization for Standardization. IEC 62366-1:2015. Brussel, CE: CEN; 2015.
   Google Scholar
• International Organization for Standardization. ISO 9241-11:1998: ergonomic requirements for office work with visual display terminals (VDTs). Part 11: guidance on usability. Brussels, BE: CEN; 1998.
   Google Scholar
• Blandford A, Keith S, Butterworth R, et al. Disrupting digital library development with scenario informed design. Interact Comput. 2007;19(1):70–82.
   Web of Science ®Google Scholar
• Petrie H, Bevan N. The evaluation of accessibility, usability and user experience. In: Stepanidis C, Editor. The universal access handbook. London, UK: CRC Press; 2009. p. 1–16.
   Google Scholar
• Blandford A, Furniss D, Vincent C. Patient safety and interactive medical devices: realigning work as imagined and work as done. Clinical Risk. 2014;20(5):107–110.
   PubMedGoogle Scholar
• Borsci S, Buckle P, Hanna GB. Why you need to include human factors in clinical and empirical studies of in vitro point of care devices? Review and future perspectives. Expert Rev Med Devices. 2016;13(4):405–416.
   PubMed Web of Science ®Google Scholar
• Hollnagel E, Wears RL, Braithwaite J From Safety-I to Safety-II: a white paper. The Resilient Health Care Net: Published simultaneously by the University of Southern Denmark, University of Florida, USA, and Macquarie University, Australia 2015. [cited 2017 Dec 10]. Available from: http://resilienthealthcare.net/onewebmedia/WhitePaperFinal.pdf
   Google Scholar
• Kostkova P. Grand challenges in digital health. Frontiers in Public Health. 2015;3:134.
   PubMedGoogle Scholar
• Huddy JR, Ni MZ, Barlow J, et al. Point-of-care C reactive protein for the diagnosis of lower respiratory tract infection in NHS primary care: a qualitative study of barriers and facilitators to adoption. BMJ Open. 2016;6(3):1–9.
   Web of Science ®Google Scholar
• Schaeffer NE. The role of human factors in the design and development of an insulin pump. J Diabetes Sci Technol. 2012;6(2):260–264.
   PubMedGoogle Scholar
• US Food and Drug Administration. Cook medical recalls central venous catheter and pressure monitoring sets and trays due to tips that may split or separate. (Eds), USA: FDA; 2016.
   Google Scholar
• US Food and Drug Administration. Class 2 device recall ingenuity TF PET/MR. (Eds), USA: FDA; 2015.
   Google Scholar
• Thompson M, Heneghan C, Billingsley M, et al. Medical device recalls and transparency in the UK. Bmj. 2011;342:1–3.
   Google Scholar
• Vincent C, Blandford A. Designing for safety and usability: user-centered techniques in medical device design practice. Proc Hum Factors Ergon Soc Annu Meet. 2011;55(1):793–797.
   Google Scholar
• Borsci S, Macredie RD, Martin JL, et al. How many testers are needed to assure the usability of medical devices? Expert Rev Med Devices. 2014;11(5):513–525.
   PubMed Web of Science ®Google Scholar
• Ijzerman MJ, Steuten LMG. Early assessment of medical technologies to inform product development and market access. Appl Health Econ Health Policy. 2011;9(5):331–347.
   PubMedGoogle Scholar
• IJzerman MJ, Koffijberg H, Fenwick E, et al. Emerging use of early health technology assessment in medical product development: a scoping review of the literature. Pharmaco Economics. 2017;35(7):727–740.
   PubMed Web of Science ®Google Scholar
• Carvalho H, Barroso AP, Machado VH, et al. Supply chain redesign for resilience using simulation. Comput Ind Eng. 2012;62(1):329–341.
   Web of Science ®Google Scholar
• Haimes YY. On the definition of vulnerabilities in measuring risks to infrastructures. Risk Anal. 2006;26(2):293–296.
   PubMed Web of Science ®Google Scholar
• Donaldson KM, Ishii K, Sheppard SD. Customer value chain analysis. Res Eng Des. 2006;16(4):174–183.
   Web of Science ®Google Scholar
• World Health Organization. Western Pacific Regional strategy for health systems based on the values of primary health care, 2010.
   Google Scholar
• National Institute for Health and Care Excellence. Assessing cost effectiveness. In: National Institute for Health and Care Excellence. The guidelines manual. London, UK: National Institute for Health and Care Excellence; 2012.
   Google Scholar
• Porter ME. What is value in health care? New England J Med. 2010;363(26):2477–2481.
   PubMed Web of Science ®Google Scholar
• Jakovljevic MB, Vukovic M, Fontanesi J. Life expectancy and health expenditure evolution in Eastern Europe—DiD and DEA analysis. Expert Rev Pharmacoecon Outcomes Res. 2016;16(4):537–546.
   PubMed Web of Science ®Google Scholar
• Arrow KJ. Uncertainty and the welfare economics of medical care. Bull World Health Organ. 2004;82(2):141–150.
   PubMed Web of Science ®Google Scholar
• Varabyova Y, Blankart CR, Greer AL, et al. The determinants of medical technology adoption in different decisional systems: A systematic literature review. Health Policy. 2017;121(3):230–242.
   PubMed Web of Science ®Google Scholar
• Oosterhoff M, van der Maas ME, Steuten LMG. A systematic review of health economic evaluations of diagnostic biomarkers. Appl Health Econ Health Policy. 2016;14(1):51–65.
   PubMed Web of Science ®Google Scholar
• Martelli N, Devaux C, Van den Brink H, et al. A systematic review of the level of evidence in economic evaluations of medical devices: the example of vertebroplasty and kyphoplasty. PloS One. 2015;10(12):e0144892.
   PubMed Web of Science ®Google Scholar
• Vallejo-Torres L, Steuten LMG, Buxton MJ, et al. Integrating health economics modeling in the product development cycle of medical devices: A Bayesian approach. Int J Technol Assess Health Care. 2008;24(4):459–464.
   PubMed Web of Science ®Google Scholar
• Jakovljevic M, Ogura S. health economics at the crossroads of centuries – from the past to the future. Frontiers in Public Health. 2016;4:115.
   PubMed Web of Science ®Google Scholar
• Buisman LR, Rutten-van Mölken MPMH, Postmus D, et al. The early bird catches the worm: early cost-effectiveness analysis of new medical tests. Int J Technol Assess Health Care. 2016;32(1–2):46–53.
   PubMed Web of Science ®Google Scholar
• Wiklund ME, Kendler J, Strochlic AY. Usability testing of medical devices. London, UK: CRC Press; 2015.
   Google Scholar
• International Organization for Standardization. ISO 14971. Brussels, BE: CEN; 2012.
   Google Scholar
• Migliore A, Ratti M, Cerbo M, et al. Health technology assessment: managing the introduction and use of medical devices in clinical practice in Italy. Expert Rev Med Devices. 2009;6(3):251–257.
   PubMed Web of Science ®Google Scholar
• Kinsman L, Rotter T, James E, et al. What is a clinical pathway? Development of a definition to inform the debate. BMC Med. 2010;8(1):1–3.
   PubMedGoogle Scholar
• International Organization for Standardization. ISO 9241-210:2010. Brussels, BE: CEN; 2010.
   Google Scholar
• Borsci S, Federici S, Bacci S, et al. Assessing user satisfaction in the era of user experience: comparison of the SUS, UMUX, and UMUX-LITE as a function of product experience. Int J Human–Computer Interaction. 2015;31(8):484–495.
   Web of Science ®Google Scholar
• Mcknight DH, Carter M, Thatcher JB, et al. Trust in a specific technology: an investigation of its components and measures. ACM Trans Manage Inf Syst. 2011;2(2):1–25.
   Google Scholar
• Venkatesh V, Davis FD. A theoretical extension of the technology acceptance model: four longitudinal field studies. Manage Sci. 2000;46(2):186–204.
   Web of Science ®Google Scholar
• WHO. Health technology assessment of medical devices. Geneva, Switzerland: WHO; 2011.
   Google Scholar
• International Federation of Medical and Biological Engineering. Overall Report of IFMBE-HTAD activities during the period 2012-2015. International Federation of Medical and Biological Engineering. 2016. [cited 2017 Nov 28]. Available from: http://htad.ifmbe.org/
   Google Scholar
• WHO. Human resources for medical devices, the role of Biomedical Engineers. eds. series, Geneva, Switzerland: WMdt, WHO Document Production Services; 2017.
   Google Scholar
• Borsci S, Buckle P, Uchegbu I, et al. Integrating human factors and health economics to inform the design of medical device: a conceptual framework. In: Eskola H, Väisänen O, Viik J, et al., Editors. EMBEC & NBC 2017: joint conference of the European medical and biological engineering conference (EMBEC) and the Nordic-Baltic conference on biomedical engineering and medical physics (NBC), Tampere, Finland, June 2017. Singapore: Springer Singapore; forthcoming. 2017. p. 49–52.
   Google Scholar