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Successful New Product Development by Optimizing Development Process Effectiveness in Highly Regulated Sectors: The Case of the Spanish Medical Devices Sector

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Abstract

Innovation is a key driver of sustainable competitive advantage and one of the key challenges for small-and medium-sized companies (SMEs) (O’Regan et al., 2006). Therefore, SMEs need to remain active in new product development (NPD). It is difficult for SMEs1 in regulated sectors to development new products, because heavy regulatory involvement imposes a number of difficulties on the NPD process. Products have to meet these strict regulations in terms of quality, safety, functionality, and manufacturability, which makes it difficult for SMEs to differentiate in terms of the effectiveness of the product concepts. However, there are big differences in the NPD performance of SMEs. Then, the questions are (1) how do SMEs in regulated sectors distinguish themselves in terms of innovation performance? And, (2) how can SMEs in regulated sectors be successful in NPD?

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References

  • Atun, R., Shah, S., and Bosanquet, N. (2002). “The Medical Devices Sector: Coming Out of the Shadow.” European Business Journal 14: 63–72.

    Google Scholar 

  • Biemans, W. G. (1989). Developing Innovations within Networks: With An Application to the Dutch Medical Equipment Industry. Doctoral Thesis: University of Eindhoven.

    Google Scholar 

  • Booz, Allen and Hamilton Inc. (1982). New Products Management for the 1980s. New York: Booz, Allen and Hamilton.

    Google Scholar 

  • Bretani, U. de and Kleinschmidt, E. J. (2004). “Corporate Culture and Commitment: Impact on Performance of International New Product Development Programs.” Journal of Product Innovation Management 21(5): 309–33.

    Article  Google Scholar 

  • Brown, S. L. and Eisenhardt, K. M. (1995). “Product Development: Past Research, Present Findings, and Future Directions.” Academy of Management Review 20(2): 343–78.

    Google Scholar 

  • Cabra J. F. (1996). “Examining the Reliability and Factor Structure of the Climate for Innovation Questionnaire.” Unpublished Master’s Thesis, State University College: Buffalo State University.

    Google Scholar 

  • Calantone, R. J. and Di Benedetto, C. A. (2002). “Performance and Time to Market: Accelerating Cycle Time with Overlapping Stages.” IEEE Transactions on Engineering Management 47(2): 232–44.

    Article  Google Scholar 

  • Carayannis, E. G. and Samanta Roy, R. I. (2000). “Davids Vs Goliaths in the Small Satellite Industry: the Role of Technological Innovation Dynamics in Firm Competitiveness.” Technovation 20: 287–97.

    Article  Google Scholar 

  • Chiesa, V., Coughlan, P., and Voss, C. A. (1996). “Development of a Technical Innovation Audit.” Journal of Product Innovation Management 13(2): 105–36.

    Article  Google Scholar 

  • Clark, K. B. and Wheelwright, S. C. (1992). “Organizing and Leading ‘Heavyweight’ Development Teams.” California Management Review (Spring 1992): 9–28.

    Google Scholar 

  • Clark, K. B. and Wheelwright, S. C. (1993). Managing New Product and Process Development. New York: The Free Press.

    Google Scholar 

  • Commission of the European Communities (2003). “Commission Recommendation of 6 May 2003 Concerning the Definition of Micro, Small and Medium-Sized Enterprises (notified under document number C (2003) 1422) 2003/362/EC.” Official Journal of the European Union 46 (L124): 36–41.

    Google Scholar 

  • Cooper, R. G., Edgett, S. J., and Kleinschmidt, E. J. (2004). “Benchmarking Best NPD Practices – I.” Research Technology Management (January-February 2004): 31–43.

    Google Scholar 

  • De Visser, M., DeWeerd-Nederhof, P. C., Faems, D., Van Looy, B., and Visscher, K. (2009). “Ambidexterity in NPD: The Impact of Differentiated Integration Structures on Innovation Performance.” In Best Paper Proceedings of the Academy of Management Annual Meeting 2009. Chicago, USA.

    Google Scholar 

  • DeWeerd-Nederhof, P. C., Altena, J., Visscher, K., and Fisscher, O. (2005). “Assessing Operational NPD Effectiveness and Strategic NPD Flexibility for the Design of New Product Development Configurations.” In CDRom Proceedings of the Cinet Conference. Sept. 4–6, 2005. Brighton, UK.

    Google Scholar 

  • DeWeerd-Nederhof, P. C., Bos, G. J., Visscher, K., Gomes, J. F., and Kekale, K. (2007). “Patterns in NPD: Searching for Consistent Configurations. A Study of Dutch, Finnish, and Portuguese Cases.” International Journal of Business Innovation Research 1(3): 315–36.

    Article  Google Scholar 

  • DeWeerd-Nederhof, P. C., Visscher, K., Altena, J., and Fisscher, O. A. M. (2008). “Operational Effectiveness and Strategic Flexibility. Scales for performance assessment of New Product Development systems.” International Journal of Technology Management 44(3/4): 354–72.

    Article  Google Scholar 

  • Eisenhardt, K. M. (1989). “Building Theory from Case Study Research.” Academy of Management Review 14(4): 532–50.

    Google Scholar 

  • Ekvall, G. (1996). “Organizational Climate for Creativity and Innovation.” European Journal of Work and Organizational Psychology 5(1): 105–23.

    Article  Google Scholar 

  • Feller, J., Parhankangas, A., and Smeds, R. (2006). “Process Learning in Alliances Developing Radical versus Incremental Innovations: Evidence from the Telecommunications Industry.” Knowledge and Process Management 13(3): 175–91.

    Article  Google Scholar 

  • Firth, R. W. and Narayanan, V. K. (1996). “New Product Strategies of Large, Dominant Product Manufacturing Firms: An Exploratory Analysis.” Journal of Product Innovation Management 31: 334–47.

    Article  Google Scholar 

  • Gatignon, H., Tushman, M. L., Smith, W., and Anderson, P. (2002). “A Structural Approach to Assessing Innovation: Construct Development of Innovation Locus, Type, and Characteristics.” Management Science 48(9): 1103–22.

    Article  Google Scholar 

  • Gatignon, H. and Xuereb, J. M. (1997). “Strategic Orientation of the Firm and New Product Performance.” Journal of Marketing Research 34: 77–90.

    Article  Google Scholar 

  • Griffin, A. (1997). “PDMA Research on New Product Development Practices: Updating Trends and Benchmarking Best Practices.” Journal of Product Innovation Management 14: 429–58.

    Article  Google Scholar 

  • Griffin, A. and Page, A. L. (1993). “An Interim Report on Measuring Product Development Success and Failure.” Journal of Product Innovation Management 10(4): 291–308.

    Article  Google Scholar 

  • Iansiti, M. (1993). “Real-world R&D: Jumping the Product Generation Gap.” Harvard Business Review 71(3): 138–47.

    Google Scholar 

  • Isaksen, S. G. and Lauer, K. J. (2002). “The Climate for Creativity and Change in Teams.” Creativity and Innovation Management 11(1): 74–86.

    Article  Google Scholar 

  • Johne, F. A. (1984). “How Experienced Product Innovators Organize.” Journal of Product Innovation Management 1(4): 210–23.

    Article  Google Scholar 

  • Kargar, J. and Parnell, J. A. (1996). “Strategy Emphasis and Planning Satisfaction in Small Firms: An Empirical Investigation.” Journal of Business Strategies 13(1): 42–64.

    Google Scholar 

  • Kessler, E. H. and Bierly, P. E. (2002). “Is Faster Really Better? An Empirical Test of the Implications of Innovation Speed.” IEEE Transactions on Engineering Management 49 (1): 2–12.

    Article  Google Scholar 

  • Langerak, F. and Hultink, E. J. (2005). “The Impact of New Product Development. Accelaration Approaches on Speed and Profitability: Lessons for Pioneers and Fast Followers.” IEEE Transactions on Engineering Management 25(1): 30–42.

    Article  Google Scholar 

  • Leenders, M. A. and Wierenga, B. (2002). “The Effectiveness of Different Mechanisms for Integrating Marketing and R&D.” Journal of Product Innovation Management 19(4): 305–17.

    Article  Google Scholar 

  • Lynn, G. S., Abel, K. D., Valentine, W. S., and Wright, R. C. (1999). “Key Factors in Increasing Speed to Market and Improving New Product Success Rates.” Industrial Marketing Management 28(4): 319–26.

    Article  Google Scholar 

  • McDonough III, E. F. (2000). “Investigation of Factors Contributing to the Success of Cross-Functional Teams.” Journal of Product Innovation Management 17: 221–35.

    Article  Google Scholar 

  • Millson, M. R. and Wilemon, D. (2000). “Managing Innovation in Medical Devices.” International Journal of Healthcare Technology and Management 2(5/6): 425–55.

    Article  Google Scholar 

  • O’Regan, N., Ghobadian, A., and Sims, M. (2006). “Fast Tracking Innovation in Manufacturing SMEs.” Technovation 26: 251–61.

    Article  Google Scholar 

  • Pettigrew, A. M. and Whipp, R. (1991). Managing Change for Competitive Success. Oxford: Basil Blackwell.

    Google Scholar 

  • Pullen, A. J. J., DeWeerd-Nederhof, P. C., Groen, A. J., Song, X. M., and Fisscher, O. A. M. (2009). “Successful Patterns of Internal SME Characteristics Leading to High Overall Innovation Performance.” Creativity and Innovation Management 18(3): 209–23.

    Article  Google Scholar 

  • Senker, J. (1991). “National Systems of Innovation, Organization, and Learning in Industrial Biotechnology.” Technovation 16(5): 219–29.

    Article  Google Scholar 

  • Shaw, B. (1998). “Innovation and New Product Development in the UK Medical Equipment Industry.” International Journal of Technology Management 15(3–5): 433–45.

    Article  Google Scholar 

  • Sosa, M. E., Eppinger, S. D., and Rowles, C. M. (2004). “The Misalignment of Product Architecture and Organizational Structure in Complex Product Development.” Management Science 50(12): 1674–89.

    Article  Google Scholar 

  • Swink, M. (1999). “Threats to New Product Manufacturability and the Effects of Development Team Integration Processes.” Journal of Operations Management 17(6): 691–709.

    Article  Google Scholar 

  • Takayama, M., Watanabe, C., and Griffy-Brown, C. (2002). “Alliance Strategy as a Competitive Strategy for Successively Creative New Product Development: The Proof of the Co-Evolution of Creativity and Efficiency in the Japanese Pharmaceutical Industry.” Technovation 22: 607–14.

    Article  Google Scholar 

  • Takeuchi, H. and Nonaka, I. (1986). “The New Product Development Game.” Harvard Business Review 64: 137–46.

    Google Scholar 

  • Thomke, S. H. (1997). “The Role of Flexibility in the Development of New Products: An Empirical Study.” Research Policy 26(1): 105–19.

    Article  Google Scholar 

  • Varela, J. and Benito, L. (2005). “New Product Development Process in Spanish Firms: Typology, Antecedents and Technical/ Marketing Activities.” Technovation 25: 395– 405.

    Article  Google Scholar 

  • Walsh, J. P. and Dewar, R. D. (1987). “Formalization and the Organizational Life Cycle.” Journal of Management Studies 24(3): 215–31.

    Article  Google Scholar 

  • Walsh, S. T. and Linton, J. D. (2001). “The Competence Pyramid: A Framework for Identifying, and Analyzing Firm and Industry Competence.” Technology Analysis & Strategic Management 13(2): 165–77.

    Article  Google Scholar 

  • Wheelwright, S. C. and Clark, K. B. (1992). “Creating Project Plans to Focus Product Development.” Harvard Business Review 70(2): 70–82.

    Google Scholar 

  • Yam, R. C. M., Guan, J. C., Pun, K. F., and Tang, E. P. Y. (2004). “An Audit of Technological Innovation Capabilities in Chinese Firms: Some Empirical Findings in Beijing, China.” Research Policy 33(8): 1123–40.

    Article  Google Scholar 

  • Yin, R. K. (1994). Case Study Research: Design and Methods (2nd edition). Thousand Oaks, CA: Sage Publications.

    Google Scholar 

  • Yin, R. K. (2003). Case Study Research: Design and Methods (3rd edition). Thousand Oaks, CA: Sage Publications.

    Google Scholar 

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Authors

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Hugo Tschirky Cornelius Herstatt David Probert Hans-Georg Gemuenden Massimo G. Colombo Thomas Durand Petra C. De Weerd-Nederhof Tim Schweisfurth

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© 2011 Annemien J.J. Pullen, Carmen Cabello-Medina, Petra C. de Weerd-Nederhof, Klaasjan Visscher, and Aard J. Groen

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Pullen, A.J.J., Cabello-Medina, C., de Weerd-Nederhof, P.C., Visscher, K., Groen, A.J. (2011). Successful New Product Development by Optimizing Development Process Effectiveness in Highly Regulated Sectors: The Case of the Spanish Medical Devices Sector. In: Tschirky, H., et al. Managing Innovation Driven Companies. Palgrave Macmillan, London. https://doi.org/10.1057/9780230306547_6

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