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Regulatory review of new product innovation: Conceptual clarity and future research directions

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  • Boakye, Derrick
  • Sarpong, David
  • Mordi, Chima

Abstract

Regulatory review of new product innovation (NPI) has come to dominate contemporary discourse on innovation management. However, there continue to be a lack of clarity on how normative and scientific logics of evaluation combine to influence the regulatory review process. To bring some much-needed clarity, we draw on the diverse literature streams on regulatory reviews and NPI to unpack how the regulatory review process may play out in practice. We then explicate four varieties of regulatory review concerns that frequently affect regulatory decisions: speed and delays, safety and efficacy, cost and uncertainty, and routines. We go further to present eight propositions regarding these concerns to extend our understanding on how they may constitutively influence regulators decisions in articulating the value of NPIs and their potential to shaping innovation trajectories. We conclude by outlining and highlighting rich opportunities for future research.

Suggested Citation

  • Boakye, Derrick & Sarpong, David & Mordi, Chima, 2022. "Regulatory review of new product innovation: Conceptual clarity and future research directions," Technological Forecasting and Social Change, Elsevier, vol. 175(C).
    • Handle: RePEc:eee:tefoso:v:175:y:2022:i:c:s0040162521008507
    DOI: 10.1016/j.techfore.2021.121419
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    as
    1. Lacy Glenn Thomas, 1990. "Regulation and Firm Size: FDA Impacts on Innovation," RAND Journal of Economics, The RAND Corporation, vol. 21(4), pages 497-517, Winter.
    2. Raghu Garud & Michael A. Rappa, 1994. "A Socio-Cognitive Model of Technology Evolution: The Case of Cochlear Implants," Organization Science, INFORMS, vol. 5(3), pages 344-362, August.
    3. James E. Prieger, 2002. "Regulation, Innovation, and the Introduction of New Telecommunications Services," The Review of Economics and Statistics, MIT Press, vol. 84(4), pages 704-715, November.
    4. Francisco Polidoro, 2020. "Knowledge, routines, and cognitive effects in nonmarket selection environments: An examination of the regulatory review of innovations," Strategic Management Journal, Wiley Blackwell, vol. 41(13), pages 2400-2435, December.
    5. DiMasi, Joseph A. & Hansen, Ronald W. & Grabowski, Henry G. & Lasagna, Louis, 1991. "Cost of innovation in the pharmaceutical industry," Journal of Health Economics, Elsevier, vol. 10(2), pages 107-142, July.
    6. Vogel, David, 1990. "When Consumers Oppose Consumer Protection: The Politics of Regulatory Backlash ," Journal of Public Policy, Cambridge University Press, vol. 10(4), pages 449-470, October.
    7. Prieger, James E., 2007. "Regulatory delay and the timing of product innovation," International Journal of Industrial Organization, Elsevier, vol. 25(2), pages 219-236, April.
    8. Douglas J. Miller, 2021. "Corporate Renewal through Internal Innovation: The Four 'R's of Corporate Bricolage," Strategic Management Review, now publishers, vol. 2(2), pages 323-354, September.
    9. Manders, Basak & de Vries, Henk J. & Blind, Knut, 2016. "ISO 9001 and product innovation: A literature review and research framework," Technovation, Elsevier, vol. 48, pages 41-55.
    10. David J. Teece, 2012. "Dynamic Capabilities: Routines versus Entrepreneurial Action," Journal of Management Studies, Wiley Blackwell, vol. 49(8), pages 1395-1401, December.
    11. David Dranove & David Meltzer, 1994. "Do Important Drugs Reach the Market Sooner?," RAND Journal of Economics, The RAND Corporation, vol. 25(3), pages 402-423, Autumn.
    12. Sidney G. Winter, 2003. "Understanding dynamic capabilities," Strategic Management Journal, Wiley Blackwell, vol. 24(10), pages 991-995, October.
    13. Jakob Edler & Paul Cunningham & Abdullah Gök & Philip Shapira (ed.), 2016. "Handbook of Innovation Policy Impact," Books, Edward Elgar Publishing, number 16121.
    14. Olson, Mary K., 2008. "The risk we bear: The effects of review speed and industry user fees on new drug safety," Journal of Health Economics, Elsevier, vol. 27(2), pages 175-200, March.
    15. Amankwah-Amoah, Joseph, 2016. "Emerging economies, emerging challenges: Mobilising and capturing value from big data," MPRA Paper 85625, University Library of Munich, Germany.
    16. Josh Lerner & Ramana Nanda, 2020. "Venture Capital's Role in Financing Innovation: What We Know and How Much We Still Need to Learn," Journal of Economic Perspectives, American Economic Association, vol. 34(3), pages 237-261, Summer.
    17. Markus C. Becker, 2004. "Organizational routines: a review of the literature," Industrial and Corporate Change, Oxford University Press and the Associazione ICC, vol. 13(4), pages 643-678, August.
    18. Anne S. Miner & Michael P Ciuchta & Yan Gong, 2008. "Organizational Routines and Organizational Learning," Chapters, in: Markus C. Becker (ed.), Handbook of Organizational Routines, chapter 8, Edward Elgar Publishing.
    19. Foucart, Renaud & Li, Qian Cher, 2021. "The role of technology standards in product innovation: Theory and evidence from UK manufacturing firms," Research Policy, Elsevier, vol. 50(2).
    20. Carpenter, Daniel P., 2004. "Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator," American Political Science Review, Cambridge University Press, vol. 98(4), pages 613-631, November.
    21. Dale H. Gieringer, 1985. "The Safety and Efficacy of New Drug Approval," Cato Journal, Cato Journal, Cato Institute, vol. 5(1), pages 177-201, Spring/Su.
    22. James Prieger, 2008. "Product innovation, signaling, and endogenous regulatory delay," Journal of Regulatory Economics, Springer, vol. 34(2), pages 95-118, October.
    23. Henry Grabowski & Y. Richard Wang, 2008. "Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act," Journal of Law and Economics, University of Chicago Press, vol. 51(2), pages 377-406, May.
    24. Mary K. Olson, 2000. "Regulatory Reform and Bureaucratic Responsiveness to Firms: the Impact of User Fees in the FDA," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 9(3), pages 363-395, June.
    25. Thayaparan Gajendran & Graham Brewer & Siegfried Gudergan & Shankar Sankaran, 2014. "Deconstructing dynamic capabilities: the role of cognitive and organizational routines in the innovation process," Construction Management and Economics, Taylor & Francis Journals, vol. 32(3), pages 246-261, March.
    26. Downer, John, 2011. "On audits and airplanes: Redundancy and reliability-assessment in high technologies," Accounting, Organizations and Society, Elsevier, vol. 36(4), pages 269-283.
    27. Gino Cattani, 2006. "Technological pre-adaptation, speciation, and emergence of new technologies: how Corning invented and developed fiber optics," Industrial and Corporate Change, Oxford University Press and the Associazione ICC, vol. 15(2), pages 285-318, April.
    28. Amankwah-Amoah, Joseph, 2016. "Emerging economies, emerging challenges: Mobilising and capturing value from big data," Technological Forecasting and Social Change, Elsevier, vol. 110(C), pages 167-174.
    29. Martha S. Feldman, 2000. "Organizational Routines as a Source of Continuous Change," Organization Science, INFORMS, vol. 11(6), pages 611-629, December.
    30. Brian T. Pentland & Martha S. Feldman, 2005. "Organizational routines as a unit of analysis," Industrial and Corporate Change, Oxford University Press and the Associazione ICC, vol. 14(5), pages 793-815, October.
    31. Blind, Knut & Petersen, Sören S. & Riillo, Cesare A.F., 2017. "The impact of standards and regulation on innovation in uncertain markets," Research Policy, Elsevier, vol. 46(1), pages 249-264.
    32. Joshua S. Gans & David B. Ridley, 2013. "Innovation Incentives under Transferable Fast-Track Regulatory Review," Journal of Industrial Economics, Wiley Blackwell, vol. 61(3), pages 789-816, September.
    33. Donbesuur, Francis & Ampong, George Oppong Appiagyei & Owusu-Yirenkyi, Diana & Chu, Irene, 2020. "Technological innovation, organizational innovation and international performance of SMEs: The moderating role of domestic institutional environment," Technological Forecasting and Social Change, Elsevier, vol. 161(C).
    34. Bert Van Wee & David Banister, 2016. "How to Write a Literature Review Paper?," Transport Reviews, Taylor & Francis Journals, vol. 36(2), pages 278-288, March.
    35. Olson, Mary K, 1995. "Regulatory Agency Discretion among Competing Industries: Inside the FDA," The Journal of Law, Economics, and Organization, Oxford University Press, vol. 11(2), pages 379-405, October.
    36. Cédric Gossart, 2005. "Routines and the sustainable lock-out of Moroccan oil refineries," Post-Print hal-02549780, HAL.
    37. Knut Blind, 2016. "The impact of regulation on innovation," Chapters, in: Jakob Edler & Paul Cunningham & Abdullah Gök & Philip Shapira (ed.), Handbook of Innovation Policy Impact, chapter 15, pages 450-482, Edward Elgar Publishing.
    38. Daniel Carpenter & Jacqueline Chattopadhyay & Susan Moffitt & Clayton Nall, 2012. "The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety," American Journal of Political Science, John Wiley & Sons, vol. 56(1), pages 98-114, January.
    39. Vernon, John A. & Golec, Joseph H. & Lutter, Randall & Nardinelli, Clark, 2009. "An exploratory study of FDA new drug review times, prescription drug user fee acts, and R&D spending," The Quarterly Review of Economics and Finance, Elsevier, vol. 49(4), pages 1260-1274, November.
    40. Markus C. Becker, 2004. "Organizational routines : a review of the literature," Post-Print hal-00279010, HAL.
    41. Usama Awan & Shazia Nauman & Robert Sroufe, 2021. "Exploring the effect of buyer engagement on green product innovation: Empirical evidence from manufacturers," Business Strategy and the Environment, Wiley Blackwell, vol. 30(1), pages 463-477, January.
    42. Grabowski, Henry G & Vernon, John M & Thomas, Lacy Glenn, 1978. "Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry," Journal of Law and Economics, University of Chicago Press, vol. 21(1), pages 133-163, April.
    43. Gerben van der Panne & Cees van Beers & Alfred Kleinknecht, 2003. "Success and Failure of Innovation: A Literature Review," International Journal of Innovation Management (ijim), World Scientific Publishing Co. Pte. Ltd., vol. 7(03), pages 309-338.
    44. Danquah, Michael & Amankwah-Amoah, Joseph, 2017. "Assessing the relationships between human capital, innovation and technology adoption: Evidence from sub-Saharan Africa," Technological Forecasting and Social Change, Elsevier, vol. 122(C), pages 24-33.
    45. Mary K. Olson, 1997. "Firm Characteristics and the Speed of FDA Approval," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 6(1), pages 377-401, June.
    46. Hai Guo & Jintong Tang & Zhongfeng Su, 2014. "To be different, or to be the same? The interactive effect of organizational regulatory legitimacy and entrepreneurial orientation on new venture performance," Asia Pacific Journal of Management, Springer, vol. 31(3), pages 665-685, September.
    47. DiMasi, Joseph A. & Hansen, Ronald W. & Grabowski, Henry G., 2003. "The price of innovation: new estimates of drug development costs," Journal of Health Economics, Elsevier, vol. 22(2), pages 151-185, March.
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