___

• Alexander, K. and Clarkson, P.J., “A Validation Model for the Medical Devices Industry,” Journal of Engineering Design 13(3) (2002): 197–204.
• Booz and Allen, and Hamilton, New product management for the 1980s (New York: Booz, Allen, and Hamilton, Inc, 1982).
• Breslin, M., and Buchanan, R,. “On the Case Study Method of Research and Teaching in Design,” Design Issues 24(1) (Winter 2008): 36–40.
• Carayon, P and Hundt, A. S. and Wetterneck, T. B., “Nurses’ Acceptance of Smart IV Pump Technology,” International Journal of Medical Informatics 79(6) (2010): 401–411.
• Cooper, J. B. and Newbower, R. S. and Long, C.D., “Preventable Anesthesia Mishaps: A Study of Human Factors,” Quality and Safety in Health Care 11 (2002): 277–282.
• Cooper, R. G., “Stage-gate systems: A new tool for managing new products,” Business Horizons (May-June 1990): 44–54.
• Craven, M. P., Routes and requirements for realizing pervasive medical devices, Chapter 9, in Bardram J. E., Mihailidis A., Wan D. (Eds.), Pervasive Computing in Healthcare (CRC Press, Taylor & Francis Group, 2006), ISBN 084933621X.
• Deserti, A. and Rizzo, F., “Design and the Cultures of Enterprises,” Design Issues 30(1) (2014): Massachusetts Institute of Technology. DOI:10.1162/DESI_a_00247.
• Dewangan, V. and Godse, M., “Towards a Holistic Enterprise Innovation Performance Measurement System,” Technovation 34 (2014): 536–545.
• Hallbeck, M.S., How to Develop Usable Surgical Devices – The View from a US Research University, in: V.G. Duffy (Ed.), Advances in Human Factors and Ergonomics in Healthcare (Boca Raton: CRC Press, 2010).
• Kleinschmidt, E. J., and Cooper, R. G. “The Impact of Product Innovativeness on Performance,” Journal of Product Innovation Management 8 (1991): 240–251.
• Mkalaf, K. A. “A study of current maintenance strategies and the reliability of critical medical equipment in hospitals in relation to patient outcomes”, Doctor of Philosophy thesis, Faculty of Engineering and Information Sciences, University of Wollongong,. h ps://ro.uow.edu.au/theses/4676. (2015) Lauer, W. and Janss, A. and Ibach, B. and Radermacher, K., “Man–machine interaction in complex intraoperative orthopedic work systems, in: V.G. Duffy (Ed.),” Advances in Human Factors and Ergonomics in Healthcare. (2010).
• Lin, C and Wu, Y. J. and Chang, C and Wang, W and Lee, C. Y., “The Alliance Innovation Performance of R&D Alliances: The Absorptive Capacity Perspective,” Technovation 32 (2012): 282–292.
• Mahroum, S. and Al-Saleh, Y., “Towards a Functional Framework for Measuring National Innovation Efficacy,” Technovation 33 (2013): 320–332.
• Maisel, W. H., “Medical Device Regulation: An Introduction for the Practicing Physician,” Annals of Internal Medicine 140(4) (2004): 296–302.
• Martin, J. L. and Norrisb, B. J. and Murphyc, E. and Crowea, J. A., “Medical Device Development: The Challenge for Ergonomics,” Applied Ergonomics 39 (2008): 271–283.
• Medina, L. A. and Okudan Kremer, G. E. and Wysk, R. A., “Supporting Medical Device Development: A Standard Product Design Process Model,” Journal of Engineering Design 24(2) (2013): 83–119. DOI: 10.1080/09544828.2012.676635.
• Pietzsch, J.B. and Shluzas, L. A. and Paté-Cornell, M, L., “State-Gate Process for the Development of Medical Devices,” Journal of Medical Devices 3(2) (2009): 1–15. DOI: 10.1115/1.3148836
• Polisena, J., Jeffrey J., and Rana C. "A Proposed Framework to Improve the Safety of Medical Devices in a Canadian Hospital Context." Medical devices (Auckland, NZ) 7 (2014): 139.
• Rochford, L. and Rudelius, W., “New Product Development Process: Stages and Successes in the Medical Products Industry,” Industrial Marketing Management 26 (1997): 67–84.
• URL 1: Europa - Enterprise - Medical Devices website. http://europa.eu.int/comm/enterprise/medical_devices/ (accessed by Craven, 12 March 2005).
• URL 2: MEDDEV. Guidelines relating to medical devices directives, Europa – Enterprise – Medical Devices, http://europa.eu.int/comm/enterprise/medical_devices/meddev/ (accessed by Craven, 12 March 2005).
• URL 3: Device Advice website. Center for Devices and Radiological Health, Food and Drug Administration (FDA), USA, http://www.fda.gov/cdrh/devadvice/ (accessed by Craven, 15 March 2005).
• URL 4: Global Harmonization Task Force (GHTF) website. http://www.ghtf.org/ (accessed by Craven, 14 March 2005).
• URL 5: Medical Devicelink, the platform website for the medical device industry, http://www.devicelink.com/ (accessed by Craven, 31 March 2005).
• URL 6: Medical Device Technology (MDT), Medical devices online, http://www.medicaldevicesonline.com/ (accessed by Craven, 15 March 2005).
• URL 7: Institute of Electrical and Electronic Engineers (IEEE), Engineering in Medicine and Biology Society, Engineering in Medicine and Biology Magazine, http://www.ieee.org/organizations/pubs/magazines/emb.htm (accessed by Craven, 31 March 2005).