851
Views
6
CrossRef citations to date
0
Altmetric
Research Articles

Design Thinking as a Complement to Human Factors Engineering for Enhancing Medical Device Usability

ORCID Icon, & ORCID Icon
Pages 34-50 | Received 09 Jan 2018, Accepted 04 Jan 2019, Published online: 21 Jan 2019

References

  • Abras, Chadia, Diane Maloney-Krichmar, and Jenny Preece. “User-centered Design.” In Encyclopedia of Human-Computer Interaction, edited by W. Bainbridge. Thousand Oaks: Sage Publications 37, no. 4 (2004): 445–456.
  • Adams, Robin S., Shanna R. Daly, Llewellyn M. Mann, and Gloria Dall'Alba. “Being a Professional: Three Lenses into Design Thinking, Acting, and Being.” Design Studies 32, no. 6 (2011): 588–607. doi: 10.1016/j.destud.2011.07.004
  • Babineaux, Ryan, and John D. Krumboltz. Fail Fast, Fail Often: How Losing Can Help You Win. New York: TarcherPerigee, 2013.
  • Bate, Paul, and Glenn Robert. “Experience-Based Design: From Redesigning the System Around the Patient to Co-Designing Services with the Patient.” Quality and Safety in Health Care 15, no. 5 (2006): 307–310. doi: 10.1136/qshc.2005.016527
  • Beuscart-Zéphir, Marie-Catherine, Sylvia Pelayo, and Stéphanie Bernonville. “Example of a Human Factors Engineering Approach to a Medication Administration Work System: Potential Impact on Patient Safety.” International Journal of Medical Informatics 79, no. 4 (2010): e43–e57. doi: 10.1016/j.ijmedinf.2009.07.002
  • Bevan, Nigel, James Carter, and Susan Harker. “Iso 9241-11 Revised: What Have We Learnt About Usability Since 1998?” Paper presented at the international conference on human-computer interaction, 2015.
  • Bjögvinsson, Erling, Pelle Ehn, and Per-Anders Hillgren. “Design Things and Design Thinking: Contemporary Participatory Design Challenges.” Design Issues 28, no. 3 (2012): 101–116. doi: 10.1162/DESI_a_00165
  • Bogner, Marilyn Sue. Misadventures in Health Care: Inside Stories. New York: Psychology Press, 2003.
  • Boston-Fleischhauer, Carol. “Enhancing Healthcare Process Design with Human Factors Engineering and Reliability Science, Part 1: Setting the Context.” JONA: The Journal of Nursing Administration 38, no. 1 (2008): 27–32. doi: 10.1097/01.NNA.0000295632.80345.3d
  • Brown, Tim. Change by Design: How Design Thinking Changes Organizations and Inspires Innovation. New York: HarperCollins, 2009.
  • Brown, Tim, and Jocelyn Wyatt. “Design Thinking for Social Innovation.” Development Outreach 12, no. 1 (2010): 29–43. doi: 10.1596/1020-797X_12_1_29
  • Buttron, Stephan. “The Importance of Human Factors & Usability Engineering in Medical Devices.” NAMSA Global Regulatory Pulse, 2017. Accessed December 4, 2018. https://www.namsa.com/european-market/human-factors-usability-engineering-in-medical-devices/.
  • Carayon, Pascale. “Human Factors in Patient Safety as an Innovation.” Applied Ergonomics 41, no. 5 (2010): 657–665. doi: 10.1016/j.apergo.2009.12.011
  • Carayon, Pascale. “Human Factors of Complex Sociotechnical Systems.” Applied Ergonomics 37, no. 4 (2006): 525–535. doi: 10.1016/j.apergo.2006.04.011
  • Carayon, Pascale. “Top Management’s View on Human Factors and Patient Safety: Do They See It?” In Healthcare Systems Ergonomics and Patient Safety, edited by Riccardo Tartaglia, Sebastiano Bagnara, Tommaso Bellandi, and Sara Albolino, 42–46. London: Taylor & Francis, 2005.
  • Carayon, Pascale, Tosha B. Wetterneck, A. Joy Rivera-Rodriguez, Ann Schoofs Hundt, Peter Hoonakker, Richard Holden, and Ayse P. Gurses. “Human Factors Systems Approach to Healthcare Quality and Patient Safety.” Applied Ergonomics 45, no. 1 (2014): 14–25. doi: 10.1016/j.apergo.2013.04.023
  • Cross, Nigel. Design Thinking: Understanding How Designers Think and Work. Oxford: Berg, 2011.
  • Dabbs, Annette De Vito, Brad A. Myers, Kenneth R. McCurry, Jacqueline Dunbar-Jacob, Robert P. Hawkins, Alex Begey, and Mary Amanda Dew. “User-Centered Design and Interactive Health Technologies for Patients.” CIN: Computers, Informatics, Nursing 27, no. 3 (2009): 175–183.
  • Dankelman, J., F. Painter, B. Schanker, D. Samaha, and J. Hansen. “Increasing Complexity of Medical Technology and Consequences for Training and Outcome of Care.” World Health Organisation Background Paper 4 (2010): 1–20.
  • Design Council. “Eleven Lessons: Managing Design in Eleven Global Companies-Desk Research Report.” Design Council, 2007.
  • Donaldson, Molla S., Janet M. Corrigan, and Linda T. Kohn. To Err Is Human: Building a Safer Health System. Vol. 6. Washington, DC: National Academies Press, 2000.
  • Dorst, Kees. “The Core of ‘Design Thinking’and Its Application.” Design Studies 32, no. 6 (2011): 521–532. doi: 10.1016/j.destud.2011.07.006
  • Dul, Jan, Ralph Bruder, Peter Buckle, Pascale Carayon, Pierre Falzon, William S. Marras, John R. Wilson, and Bas van der Doelen. “A Strategy for Human Factors/Ergonomics: Developing the Discipline and Profession.” Ergonomics 55, no. 4 (2012): 377–395. doi: 10.1080/00140139.2012.661087
  • Dunne, David, and Roger Martin. “Design Thinking and How It Will Change Management Education: An Interview and Discussion.” Academy of Management Learning & Education 5, no. 4 (2006): 512–523. doi: 10.5465/amle.2006.23473212
  • Evans, Gerald W., and Waldemar Karwowski. “A Perspective on Mathematical Modeling in Human Factors.” In Advances in Human Factors/Ergonomics, 3–27. Amsterdam: Elsevier, 1986.
  • Ferlie, Ewan, Louise Fitzgerald, Martin Wood, and Chris Hawkins. “The Nonspread of Innovations: The Mediating Role of Professionals.” Academy of Management Journal 48, no. 1 (2005): 117–134. doi: 10.5465/amj.2005.15993150
  • Fisher, B. “Community Development in Health–a Literature Review.” Health Empowerment Leverage Project, 2011. http://www.healthempowermentgroup.org.uk.
  • Food and Drug Administration. Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design. Washington, DC: Food and Drug Administraiton, 2011.
  • Gawron, Valerie J., Colin G. Drury, Rollin J. Fairbanks, and Roseanne C. Berger. “Medical Error and Human Factors Engineering: Where Are We Now?” American Journal of Medical Quality 21, no. 1 (2006): 57–67. doi: 10.1177/1062860605283932
  • Gosbee, John. “Human Factors Engineering and Patient Safety.” Quality and Safety in Health Care 11, no. 4 (2002): 352–354. doi: 10.1136/qhc.11.4.352
  • Gulliksen, Jan, Bengt Göransson, Inger Boivie, Stefan Blomkvist, Jenny Persson, and Åsa Cajander. “Key Principles for User-Centred Systems Design.” Behaviour and Information Technology 22, no. 6 (2003): 397–409. doi: 10.1080/01449290310001624329
  • Hegde, Vaishali, and Dev Raheja. “Design for Reliability in Medical Devices.” Paper presented at the Reliability and Maintainability Symposium (RAMS), 2010.
  • Hignett, Sue, and John R. Wilson. “The Role for Qualitative Methodology in Ergonomics: A Case Study to Explore Theoretical Issues.” Theoretical Issues in Ergonomics Science 5, no. 6 (2004): 473–493. doi: 10.1080/14639220412331303382
  • Holden, Richard J. “Cognitive Performance-Altering Effects of Electronic Medical Records: An Application of the Human Factors Paradigm for Patient Safety.” Cognition, Technology & Work 13, no. 1 (2011): 11–29. doi: 10.1007/s10111-010-0141-8
  • Jun, G. J., Ander Altuna, J. R. Ward, Ran Bhamra, Stephen Rogers, Amalin Dutt, and Priyal Shah. “Challenges in Applying Human Factors Approaches to Health Service Design.” In Human Factors in Organizational Design and Management. Amsterdam: Elsevier, 2014.
  • Karsh, B.-T., R. J. Holden, S. J. Alper, and C. K. L. Or. “A Human Factors Engineering Paradigm for Patient Safety: Designing to Support the Performance of the Healthcare Professional.” Quality and Safety in Health Care 15, no. suppl 1 (2006): i59-i65. doi: 10.1136/qshc.2005.015974
  • Karwowski, Waldemar. “The Discipline of Human Factors and Ergonomics.” Handbook of Human Factors and Ergonomics 4 (2012): 3–37.
  • Kramme, Rüdiger, Klaus-Peter Hoffmann, and Robert Steven Pozos. Springer Handbook of Medical Technology. Berlin: Springer Science & Business Media, 2011.
  • Lauretta McLeod, Poppy, and Sharon Alisa Lobel. “The Effects of Ethnic Diversity on Idea Generation in Small Groups.” Paper presented at the Academy of management, 1992.
  • Licht, Deborah M., Donald J. Polzella, and Kenneth R. Boff. Human Factors, Ergonomics and Human Factors Engineering: An Analysis of Definitions. Dayton, OH: Crew System Ergonomics Information Analysis Center, 1993.
  • Liedtka, Jeanne. “Perspective: Linking Design Thinking with Innovation Outcomes Through Cognitive Bias Reduction.” Journal of Product Innovation Management 32, no. 6 (2015): 925–938. doi: 10.1111/jpim.12163
  • Liedtka, Jeanne, Andrew King, and Kevin Bennett. Solving Problems with Design Thinking: Ten Stories of What Works. New York: Columbia University Press, 2013.
  • Lim, Youn-Kyung, Erik Stolterman, and Josh Tenenberg. “The Anatomy of Prototypes: Prototypes as Filters, Prototypes as Manifestations of Design Ideas.” ACM Transactions on Computer-Human Interaction (TOCHI) 15, no. 2 (2008). doi: 10.1145/1375761.1375762
  • Lin, Laura, Kim J. Vicente, and D. John Doyle. “Patient Safety, Potential Adverse Drug Events, and Medical Device Design: A Human Factors Engineering Approach.” Journal of Biomedical Informatics 34, no. 4 (2001): 274–284. doi: 10.1006/jbin.2001.1028
  • Lockwood, Thomas. Design Thinking: Integrating Innovation, Customer Experience, and Brand Value. New York: Skyhorse Publishing, Inc., 2010.
  • Long, Christian. “Teach Your Students to Fail Better with Design Thinking.” Learning & Leading with Technology 39, no. 5 (2012): 16–20.
  • Martin, R. L. The Design of Business: Why Design Thinking Is the Next Competitive Advantage. Boston: Harvard Business Press, 2009.
  • Martin, Jennifer L., and Julie Barnett. “Integrating the Results of User Research Into Medical Device Development: Insights from a Case Study.” BMC Medical Informatics and Decision Making 12, no. 1 (2012): 74. doi: 10.1186/1472-6947-12-74
  • Martin, J. L., E. Murphy, J. A. Crowe, and B. J. Norris. “Capturing User Requirements in Medical Device Development: The Role of Ergonomics.” Physiological Measurement 27, no. 8 (Aug 2006): R49-R62. doi: 10.1088/0967-3334/27/8/R01
  • Martin, Jennifer L., Beverley J. Norris, Elizabeth Murphy, and John A. Crowe. “Medical Device Development: The Challenge for Ergonomics.” Applied Ergonomics 39, no. 3 (2008): 271–283. doi: 10.1016/j.apergo.2007.10.002
  • Mascitelli, Ronald. “From Experience: Harnessing Tacit Knowledge to Achieve Breakthrough Innovation.” Journal of Product Innovation Management 17, no. 3 (2000): 179–193. doi: 10.1016/S0737-6782(00)00038-2
  • Matern, Ulrich, and Dirk Büchel. “Usability of Medical Devices.” In Springer Handbook of Medical Technology, 59–71. Dordrecht: Springer, 2011.
  • McDonagh, Deana, and Joyce Thomas. “Rethinking Design Thinking: Empathy Supporting Innovation.” Australasian Medical Journal 3, no. 8 (2010): 458–464. doi: 10.4066/AMJ.2010.391
  • Medicines and Healthcare Products Regulatory Agency. Human Factors and Usability Engineering e Guidance for Medical Devices Including Drug-device Combination Products. Medicines and Healthcare Products Regulatory Agency, 2016. Accessed December 4, 2018. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/528495/MHRA_Human_factors_draft_guidance_June_2016.pdf.
  • Meister, David. The History of Human Factors and Ergonomics. Boca Raton, FL: CRC Press, 1999.
  • Middleton, Blackford, Meryl Bloomrosen, Mark A. Dente, Bill Hashmat, Ross Koppel, J. Marc Overhage, Thomas H. Payne, et al. “Enhancing Patient Safety and Quality of Care by Improving the Usability of Electronic Health Record Systems: Recommendations from Amia.” Journal of the American Medical Informatics Association 20, no. e1 (2013): e2-e8. doi: 10.1136/amiajnl-2012-001458
  • Moran, Thomas P., and John M. Carroll. “Overview of Design Rationale.” In Design Rationale: Concepts, Techniques, and Use, edited by Moran and Carroll, 1–19. Boca Raton, FL: CRC Press, 1996.
  • National Research Council. The Role of Human Factors in Home Health Care: Workshop Summary. Washington, DC: National Academies Press, 2010.
  • Norman, Donald A. Emotional Design: Why We Love (or Hate) Everyday Things. New York: Basic Civitas Books, 2004.
  • Norman, Donald A., and Andrew Ortony. Designers and Users: Two Perspectives on Emotion and Design. New Jersey: Lawrence Erlbaum Associates, 2006.
  • Norris, Beverley J. “Systems Human Factors: How Far Have We Come?” BMJ Quality and Safety 21, no. 9 (2012): 713–714. doi: 10.1136/bmjqs-2011-000476
  • Ogilvie, Tim, and Jeanne Liedtka. Designing for Growth: A Design Thinking Toolkit for Managers. New York: Columbia University Press, 2011.
  • Oudshoorn, Nelly E. J., and Trevor Pinch. How Users Matter: The Co-Construction of Users and Technologies. Cambridge, MA: MIT Press, 2003.
  • Owen, Charles L. “Design Thinking: Driving Innovation.” The Business Process Management Institute, 2006. 1–5.
  • Papantonopoulos, Sotiris. “How System Designers Think: A Study of Design Thinking in Human Factors Engineering.” Ergonomics 47, no. 14 (2004): 1528–1548. doi: 10.1080/00140130412331290916
  • Patel, Vimla L., and T. G. Kannampallil. “Human Factors and Health Information Technology: Current Challenges and Future Directions.” Yearbook of Medical Informatics 9, no. 1 (2014): 58.
  • Pelayo, S., and M. S. Ong. “Human Factors and Ergonomics in the Design of Health Information Technology: Trends and Progress in 2014.” Yearbook of Medical Informatics 10, no. 1 (2015): 75.
  • Perkin, Neil, and Peter Abraham. Building the Agile Business Through Digital Transformation. London: Kogan Page Publishers, 2017.
  • Phillips, Chandler A., Daniel W. Repperger, and David B. Reynolds. “Human Factors Engineering.” Wiley Encyclopedia of Biomedical Engineering, 2006.
  • Plattner, Hasso, Christoph Meinel, and Larry Leifer. Design Thinking Research: Building Innovators. Dordrecht: Springer, 2014.
  • Plattner, Hasso, Christoph Meinel, and Ulrich Weinberg. Design Thinking. Dordrecht: Springer, 2009.
  • Radhadevi, Nadimpalli, Veeranna Balamuralidhara, Teggina Math Pramod Kumar, and Valluru Ravi. “Regulatory Guidelines for Medical Devices in India: An Overview.” Asian Journal of Pharmaceutics (AJP): Free Full Text Articles from Asian Journal of Pharmaceutics 6, no. 1 (2014): 10–17.
  • Rahman, Chowdury M. L., Syed Misbah Uddin, and Mohammad Iqbal. “Importance of Human Factors in Industrial Engineering and Design.” SEU Journal of Science and Engineering 8, no. 1–2 (2014): 7–13.
  • Razzouk, Rim, and Valerie Shute. “What Is Design Thinking and Why Is It Important?” Review of Educational Research 82, no. 3 (2012): 330–348. doi: 10.3102/0034654312457429
  • Reason, James. The Human Contribution: Unsafe Acts, Accidents and Heroic Recoveries. Boca Raton, FL: CRC Press, 2017.
  • Rivera, A. Joy, and Ben-Tzion Karsh. “Human Factors and Systems Engineering Approach to Patient Safety for Radiotherapy.” International Journal of Radiation Oncology*Biology*Physics 71, no. 1 (2008): S174-SS77. doi: 10.1016/j.ijrobp.2007.06.088
  • Rosenzweig, Elizabeth. Successful User Experience: Strategies and Roadmaps. Burlington, MA: Morgan Kaufmann, 2015.
  • Samaras, George M., and Richard L. Horst. “A Systems Engineering Perspective on the Human-Centered Design of Health Information Systems.” Journal of Biomedical Informatics 38, no. 1 (2005): 61–74. doi: 10.1016/j.jbi.2004.11.013
  • Sawyer, Dick, K. J. Aziz, C. L. Backinger, E. T. Beers, A. Lowery, and S. M. Sykes. Do It by Design: An Introduction to Human Factors in Medical Devices. Washington, DC: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.
  • Schaeffer, Noel E. The Role of Human Factors in the Design and Development of an Insulin Pump. Thousand Oaks, CA: SAGE Publications, 2012.
  • Schuh, JoAnn C. L. “Medical Device Regulations and Testing for Toxicologic Pathologists.” Toxicologic Pathology 36, no. 1 (2008): 63–69. doi: 10.1177/0192623307309926
  • Seidel, Victor P., and Sebastian K. Fixson. “Adopting Design Thinking in Novice Multidisciplinary Teams: The Application and Limits of Design Methods and Reflexive Practices.” Journal of Product Innovation Management 30 (2013): 19–33. doi: 10.1111/jpim.12061
  • Sharples, Sarah, Jennifer Martin, Alexandra Lang, Michael Craven, Sonja O’Neill, and Julie Barnett. “Medical Device Design in Context: A Model of User–Device Interaction and Consequences.” Displays 33, no. 4–5 (2012): 221–232. doi: 10.1016/j.displa.2011.12.001
  • Thimbleby, Harold. “Human Factors and Missed Solutions to Enigma Design Weaknesses.” Cryptologia 40, no. 2 (2016): 177–202. doi: 10.1080/01611194.2015.1028680
  • Thirumalai, Sriram, and Kingshuk K. Sinha. “Product Recalls in the Medical Device Industry: An Empirical Exploration of the Sources and Financial Consequences.” Management Science 57, no. 2 (2011): 376–392. doi: 10.1287/mnsc.1100.1267
  • Thoring, Katja, and Roland M. Müller. “Understanding Design Thinking: A Process Model Based on Method Engineering.” Paper presented at the DS 69: Proceedings of E&PDE 2011, the 13th international conference on engineering and product design education, London, UK, 08.-09.09. 2011.
  • Tideholm, Axel, and Oscar Rydén. Design Thinking as Facilitator for Innovation in Swedish Healthcare: A Case Study at Karolinska University Hospital. Göteborg: Chalmers University of Technology, 2015.
  • Tschimmel, Katja. “Design Thinking as an Effective Toolkit for Innovation.” Paper presented at the ISPIM Conference Proceedings, 2012.
  • Vincent, C. J., Y. Li, and A. Blandford. “Integration of Human Factors and Ergonomics During Medical Device Design and Development: It's All About Communication.” Applied Ergonomics 45, no. 3 (May 2014): 413–419. doi: 10.1016/j.apergo.2013.05.009
  • Vosper, Helen, Sue Hignett, and Paul Bowie. “Twelve Tips for Embedding Human Factors and Ergonomics Principles in Healthcare Education.” Medical Teacher 40, no. 4 (2018): 357–363. doi: 10.1080/0142159X.2017.1387240
  • Walton, Merrilyn, Helen Woodward, Samantha Van Staalduinen, C. Lemer, F. Greaves, D. Noble, B. Ellis, L. Donaldson, and B. Barraclough. “The WHO Patient Safety Curriculum Guide for Medical Schools.” BMJ Quality & Safety 19, no. 6 (2010): 542–546. doi: 10.1136/qshc.2009.036970
  • Ward, James R., and P. John Clarkson. “An Analysis of Medical Device-Related Errors: Prevalence and Possible Solutions.” Journal of Medical Engineering & Technology 28, no. 1 (2004): 2–21. doi: 10.1080/0309190031000123747
  • Weinger, Matthew Bret, Daryle Jean Gardner-Bonneau, and Michael E. Wiklund. Handbook of Human Factors in Medical Device Design. Boca Raton, FL: CRC Press, 2010.
  • Wilson, John R. “Fundamentals of Ergonomics in Theory and Practice.” Applied Ergonomics 31, no. 6 (2000): 557–567. doi: 10.1016/S0003-6870(00)00034-X
  • Woodson, Wesley E., Barry Tillman, and Peggy Tillman. Human Factors Design Handbook: Information and Guidelines for the Design of Systems, Facilities, Equipment, and Products for Human Use. New York: McGraw-Hill, 1992.
  • Xie, Anping, and Pascale Carayon. “A Systematic Review of Human Factors and Ergonomics (Hfe)-Based Healthcare System Redesign for Quality of Care and Patient Safety.” Ergonomics 58, no. 1 (2015): 33–49. doi: 10.1080/00140139.2014.959070
  • Xie, Anping, Pascale Carayon, Randi Cartmill, Yaqiong Li, Elizabeth D. Cox, and Michelle M. Kelly. “Facilitators and Barriers to Multi-Stakeholder Collaboration in the Redesign of the Family-Centered Rounds Process.” Paper presented at the proceedings of the human factors and ergonomics society annual meeting, 2014.
  • Zahabi, Maryam, David B. Kaber, and Manida Swangnetr. “Usability and Safety in Electronic Medical Records Interface Design: A Review of Recent Literature and Guideline Formulation.” Human Factors: The Journal of the Human Factors and Ergonomics Society 57, no. 5 (2015): 805–834. doi: 10.1177/0018720815576827
  • Zhang, Jiajie, Todd R. Johnson, Vimla L. Patel, Danielle L. Paige, and Tate Kubose. “Using Usability Heuristics to Evaluate Patient Safety of Medical Devices.” Journal of Biomedical Informatics 36, no. 1–2 (2003): 23–30. doi: 10.1016/S1532-0464(03)00060-1

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.