Hostname: page-component-745bb68f8f-b95js Total loading time: 0 Render date: 2025-01-12T04:26:49.192Z Has data issue: false hasContentIssue false
  • English
  • Français

Benefits of and barriers to involving users in medical device technology development and evaluation

Published online by Cambridge University Press:  18 January 2007

Syed Ghulam Sarwar Shah  and
Ian Robinson
Syed Ghulam Sarwar Shah
Affiliation:
Brunel University
Ian Robinson
Affiliation:
Brunel University
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: This study investigated the benefits of and barriers to user involvement in medical device technology development and evaluation.

Methods: A structured review of published literature in peer-reviewed journals was conducted.

Results: This literature review revealed that the main benefits of user involvement were an increased access to user needs, experiences, and ideas; improvements in medical device designs and user interfaces; and an increase in the functionality, usability, and quality of the devices. On the other hand, resource issues, particularly those of time and money were found the key impediments to involving users in the development and evaluation of medical device technologies. This study also has categorized both the benefits of and barriers to user involvement.

Conclusions: The involvement of users in medical device technology development and evaluation requires resources, which are limited; however, this involvement is essential from both users and manufacturers perspectives.

Keywords

UserMedical devicesUser involvementBenefits and barriersDevelopment and evaluationAssistive devicesHealthcare technology
Type
RESEARCH REPORTS
Information
International Journal of Technology Assessment in Health Care , Volume 23 , Issue 1 , January 2007 , pp. 131 - 137
Copyright
© 2007 Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Bairstow PJ, Mendelson R, Dhillon R, Valton F. 2006 Diagnostic imaging pathways: Development, dissemination, implementation, and evaluation. Int J Qual Health Care. 18: 51– 57.Google Scholar
Batavia AI, Hammer GS. 1990 Toward the development of consumer-based criteria for the evaluation of assistive devices. J Rehabil Res Dev. 27: 425– 436.Google Scholar
Bobrowski PE, Wilemon D. Restructuring to achieve integration in the medical technology development process. In: Proceedings of managing in a global environment - IEEE International Engineering Management Conference. Eatontown, NJ: October 25–28, 1992: 67– 70.
Bray DD. 2000 Creative collaboration: User-centered design in practice. MD&DI. March: 76– 89.Google Scholar
Brockhoff K. 2003 Customers' perspectives of involvement in new product development. Int J Technol Manage. 26: 464– 481.Google Scholar
Brooks NA. 1991 User's responses to assistive devices for physical disability. Soc Sci Med. 32: 1417– 1424.Google Scholar
Buckley KM, Tran BQ, Prandoni CM, Clark HM. 2002 Training future providers in home care and telehealth technologies: A collaborative effort between nursing and biomedical engineering. Home Health Care Manag Pract. 14: 362– 371.Google Scholar
Buhler C. 1996 Approach to the analysis of user requirements in assistive technology. Int J Ind Ergon. 17: 187– 192.Google Scholar
Buhler C, Hoelper R, Hoyer H, Humann W. 1995 Autonomous robot technology for advanced wheelchair and robotic aids for people with disabilities. Rob Auton Syst. 14: 213– 222.Google Scholar
Campbell AJ, Cooper RG. 1999 Do customer partnerships improve new product success rates? Ind Market Manag. 28: 507– 519.Google Scholar
Conway HA, McGuinness NW. 1986 Idea generation in technology-based firms. J Prod Innov Manage. 3: 276– 291.Google Scholar
Conway S. 1993. The role of users in the innovation process. Doctoral Working Paper Series, No 10 (NS). Aston Business School, Birmingham, UK;
Craig J, Russell C, Patterson V, Wootton R. 1999 User satisfaction with realtime teleneurology. J Telemed Telecare. 5: 237– 241.Google Scholar
Craven MP, Martin JL. 2004. How does the healthcare industry involve users in medical device development?—Pointers for UbiHealth. Paper presented at UbiHealth 2004: The 3rd International Workshop on Ubiquitous Computing for Pervasive Healthcare Applications. Nottingham, England: September 6– 7
De P, Ferratt TW. 1998 An information system involving competing organizations. Commun ACM. 41: 90– 98.Google Scholar
De P, Ferratt TW. An interorganizational information system in the health care arena: Insights gained from a hierarchical analysis. In: Agarwal R, ed. Proceedings of the 1998 ACM SIGCPR Conference on Computer Personnel Research. Boston, MA: March 26–28, 1998: 214– 223.
Deslandres V, Pierreval H. 1997 Knowledge acquisition issues in the design of decision support systems in quality control. Eur J Oper Res. 103: 296– 311.Google Scholar
Franz CR, Robey D. 1984 An investigation of user-led system design: Rational and political perspectives. Commun ACM. 27: 1202– 1209.Google Scholar
Fundin AP, Bergman BLS. 2003 Exploring the customer feedback process. Measur Bus Excell. 7: 55– 65.Google Scholar
Gales L, Mansour-Cole D. 1995 User involvement in innovation projects: Toward an information processing model. J Eng Technol Manage. 12: 77– 109.Google Scholar
Gallivan MJ, Keil M. 2003 The user-developer communication process: A critical case study. Inf Syst J. 13: 37– 68.Google Scholar
Garmer K, Liljegren E, Osvalder A-L, Dahlman S. 2002 Application of usability testing to the development of medical equipment. Usability testing of a frequently used infusion pump and a new user interface for an infusion pump developed with a human factors approach. Int J Ind Ergon. 29: 145– 159.Google Scholar
Garmer K, Liljegren E, Osvalder A-L, Dahlman S. 2002 Arguing for the need of triangulation and iteration when designing medical equipment. J Clin Monit Comput. 17: 105– 114.Google Scholar
Garmer K, Ylven J, MariAnne Karlsson IC. 2004 User participation in requirements elicitation comparing focus group interviews and usability tests for eliciting usability requirements for medical equipment: A case study. Int J Ind Ergon. 33: 85– 98.Google Scholar
Gemunden HG, Ritter T, Heydebreck P. 1996 Network configuration and innovation success: An empirical analysis in German high-tech industries. Int J Res Mark. 13: 449– 462.Google Scholar
Glen JMW, Lord M. 1996 New product development processes within the UK medical device industry. Med Eng Phys. 18: 670– 676.Google Scholar
Government of USA. Assistive Technology Act of 1998. Public Law 105–394. Vol. 112 STAT.; Nov. 13, 1998: 3627– 3662.
Gronbaek K, Kyng M, Mogensen P. 1993 CSCW challenges: Cooperative design in engineering projects. Commun ACM. 36: 67– 77.Google Scholar
Gruner KE, Homburg C. 2000 Does customer interaction enhance new product success? J Bus Res. 49: 1– 14.Google Scholar
Habermeier KF. 1990 Product use and product improvement. Res Policy. 19: 271– 283.Google Scholar
Handels H, Rinast E, Busch C, et al. 1997 Image transfer and computer-supported cooperative diagnosis. J Telemed Telecare. 3: 103– 107.Google Scholar
Hasu M. 2000 Constructing clinical use: An activity-theoretical perspective to implementing new technology. Technol Anal Strateg Manage. 12: 369– 382.Google Scholar
Hasu M, Engestrom Y. 2000 Measurement in action: An activity-theoretical perspective on producer-user interaction. Int J Hum Comput Stud. 53: 61– 89.Google Scholar
Herstatt C, von Hippel E. 1992 From experience: Developing new product concepts via the lead user method: A case study in a “low-tech” field. J Prod Innov Manage. 9: 213– 221.Google Scholar
Hummel M, van Rossum W, Omta O, et al. 2001 Types and timing of inter-organizational communication in new product development. Creativ Innov Manage. 10: 225– 233.Google Scholar
Hummel MJM, Rossum Wv, Verkerke GJ, Rakhorst G. 2002 Product design planning with the analytic hierarchy process in inter-organizational networks. R&D Manage. 32: 451– 458.Google Scholar
Kauppinen M, Kujala S, Aaltio T, Lehtola L. Introducing requirements engineering: How to make a cultural change happen in practice. In: Proceedings of the IEEE Joint International Conference on Requirements Engineering. September 9–13, 2002: 43– 51.
Kittel A, Marco AD, Stewart H. 2002 Factors influencing the decision to abandon manual wheelchairs for three individuals with a spinal cord injury. Disabil Rehabil. 24: 106– 114.Google Scholar
Kristensson P, Gustafsson A, Archer T. 2004 Harnessing the creative potential among users. J Prod Innov Manage. 21: 4– 14.Google Scholar
Kristensson P, Magnusson PR, Matthing J. 2002 Users as a hidden resource for creativity: Finding from an experimental study on user involvement. Creativ Innov Manag. 11: 55– 61.Google Scholar
Kyng M. 1991 Designing for cooperation: Cooperating in design. Commun ACM. 34: 65– 73.Google Scholar
LaBahn DW, Ali A, Krapfel R. 1996 New product development cycle time: The influence of project and process factors in small manufacturing companies. J Bus Res. 36: 179– 188.Google Scholar
Lacey G, Slevin F. Putting the user at the centre of the design process. In: Abstracts of the proceedings of International Conference on Technology and Aging. Toronto, ON, Canada: Sept. 12–14, 2001: 65.
Lasky FD, Boser RB. 1997 Designing in quality through design control: A manufacturer's perspective. Clin Chem. 43: 866– 872.Google Scholar
Lettl C, Gemunden HG. 2005 The entrepreneurial role of innovative users. J Bus Ind Market. 20: 339– 346.Google Scholar
Lichter H, Schneider-Hufschmidt M, Zullighoven H. 1994 Prototyping in industrial software projects-bridging the gap between theory and practice. IEEE Trans Software Eng. 20: 825– 832.Google Scholar
Lilien GL, Morrison PD, Searls K, et al. 2002 Performance assessment of the lead user idea-generation process for new product development. Manage Sci. 48: 1042– 1059.Google Scholar
Liljegren E, Osvalder A-L. 2004 Cognitive engineering methods as usability evaluation tools for medical equipment. Int J Ind Ergon. 34: 49– 62.Google Scholar
Lin L, Isla R, Doniz K, et al. 1998 Applying human factors to the design of medical equipment: Patient-controlled analgesia. J Clin Monit Comput. 14: 253– 263.Google Scholar
Lin L, Vicente KJ, Doyle DJ. 2001 Patient safety, potential adverse drug events, and medical device design: A human factors engineering approach. J Biomed Inform. 34: 274– 284.Google Scholar
Luck R. 2003 Dialogue in participatory design. Design Stud. 24: 523– 535.Google Scholar
Luthje C. 2003. Customers as co-inventors: An empirical analysis of the antecedents of customer-driven innovations in the field of medical equipment. Paper presented at 32nd European Marketing Academy Conference (EMAC). Glasgow, UK: May 20–23
Marshall R, Case K, Oliver R, et al. 2002 A task based ‘design for all’ support tool. Robot Comput Integr Manuf. 18: 297– 303.Google Scholar
McLaughlin J, Skinner D. 2000 Developing usability and utility: A comparative study of the user of new IT. Technol Anal Strateg Manage. 12: 413– 423.Google Scholar
Miettinen R, Hasu M. 2002 Articulating user needs in collaborative design: Towards an activity-theoretical approach. Comput Support Coop Work. 11: 129– 151.Google Scholar
Morrison PD, Roberts JH, Midgley DF. 2004 The nature of lead users and measurement of leading edge status. Res Policy. 33: 351– 362.Google Scholar
Mulholland SJ, Packer TL, Laschinger SJ, et al. 2000 Evaluating a new mobility device: Feedback from women with disabilities in India. Disabil Rehabil. 22: 111– 122.Google Scholar
Neale MR, Corkindale DR. 1998 Co-developing products: Involving customers earlier and more deeply. Long Range Plann. 31: 418– 425.Google Scholar
Nijssen EJ, Biemans WG, de Kort JF. 2002 Involving purchasing in new product development. R&D Manage. 32: 281– 289.Google Scholar
Noyes JM, Starr AF. Working with users in system development: Some methodological considerations. Integrating HCI in the Lifecycle, IEE Colloquium on. April 11, 1995: 7/1– 7/3.
Obradovich JH, Woods DD. 1996 Users as designers: How people cope with poor HCI design in computer-based medical devices. Hum Factors. 38: 574– 592.Google Scholar
Ogawa S. 1998 Does sticky information affect the locus of innovation? Evidence from the Japanese convenience-store industry. Res Policy. 26: 777– 790.Google Scholar
Olson EL, Bakke G. 2001 Implementing the lead user method in a high technology firm: A longitudinal study of intentions versus actions. J Prod Innov Manage. 18: 388– 395.Google Scholar
Ornetzeder M. Assessing technology from the users' perspective. Possibilities and limitations of focus group discussions illustrated by ecological housing construction. In: Proceedings of Technological Studies: User Involvement in Technological Innovation, International Summer Academy. Deutschlandsberg, Austria: July 8–13, 2001: 155– 166.
Ornetzeder M, Rohracher H. 2006 User-led innovations and participation processes: Lessons from sustainable energy technologies. Energ Policy. 34: 138– 150.Google Scholar
Powers DM, Greenberg N. 1999 Development and use of analytical quality specifications in the in vitro diagnostics medical device industry. Scand J Clin Lab Invest. 59: 539– 543.Google Scholar
Rauterberg M, Strohm O, Kirsch C. 1995 Benefits of user-oriented software development based on an iterative cyclic process model for simultaneous engineering. Int J Ind Ergon. 16: 391– 409.Google Scholar
Ritter T, Walter A. 2003 Relationship-specific antecedents of customer involvement in new product development. Int J Technol Manage. 26: 482– 501.Google Scholar
Rohracher H. 2003 The role of users in the social shaping of environmental technologies. Innov Eur J Soc Sci Res. 16: 177– 192.Google Scholar
Samuelsson K, Larsson H, Thyberg M, Gerdle B. 2001 Wheelchair seating intervention. Results from client-centered approach. Disabil Rehabil. 23: 677– 682.Google Scholar
Shah SGS, Robinson I. 2006 User involvement in healthcare technology development and assessment: Structured literature review. Int J Health Care Qual Assur. 19: 500– 515.Google Scholar
Shaw B. 1985 The role of the interaction between the user and the manufacturer in medical equipment industry. R&D Manage. 15: 283– 292.Google Scholar
Shaw B. 1998 Innovation and new product development in the UK medical equipment industry. Int J Technol Manage. 15: 433– 445.Google Scholar
Stickle MS, Ryan S, Rigby PJ, Jutai JW. 2002 Toward a comprehensive evaluation of the impact of electronic aids to daily living: Evaluation of consumer satisfaction. Disabil Rehabil. 24: 115– 125.Google Scholar
Tsai W-T, Mojdehbakhsh R, Rayadurgam S. Experience in capturing requirements for safety-critical medical devices in an industrial environment. In: Proceedings of 2nd IEEE High-Assurance Systems Engineering Workshop. Washington, DC: August 11–12, 1997: 32– 36.
Urban GL, von Hippel E. 1988 Lead user analyses for the development of new industrial products. Manage Sci. 34: 569– 582.Google Scholar
von Hippel E. 1986 Lead users: A source of novel product concepts. Manage Sci. 32: 791– 805.Google Scholar
von Hippel E, Thomke S, Sonnack M. Creating breakthroughs at 3M8. Harv Bus Rev. 1999: 47– 57.Google Scholar
Voss CA. 1985 The role of users in the development of applications software. J Prod Innov Manage. 2: 113– 121.Google Scholar
Woodside AG, Breaux R, Briguglio E. 1998 Testing care-giver acceptance of new syringe technologies. Int J Technol Manage. 15: 446– 457.Google Scholar
World Health Organization (WHO). 2003. Medical device regulations: Global overview and guiding principles. Geneva: WHO;