Abstract
R&D stands for Research and Development and while research is essential for new product development in biotechnology, the development and its integration with research (the transfer from research to development) is underexplored. Without efficient and successful process development, biotech companies would not sustain in the long run as process development is a necessary condition en route to industrial commercialization. Based on qualitative interviews with 31 biotech companies and experts, we test a framework with technological, operational and organizational boundary conditions influencing the transfer between product and process development. Our results uncover two additional dimensions: relational and market determinants. We further identify uncertainties in the transfer and investigate if standardization can mitigate these uncertainties and eventually facilitate the integration of product and process development. We find that standardization is a beneficial mechanism for successful integration of the front end of process development activities. The present investigation contributes to the understanding of standards as a knowledge and technology transfer instrument for complex and critical development activities.
Highlights
IntroductionR&D stands for Research and Development and while research is essential for new product development in biotechnology, the development and its integration with research (the transfer from research to development) is underexplored
R&D stands for Research and Development and while research is essential for new product development in biotechnology, the development and its integration with research is underexplored
The aim of this paper is to answer three fundamental questions: What are the boundary conditions and uncertainties related to the transfer between product and process development? Does product and process development happen sequentially or in parallel? How can the transition from product to process development be facilitated with the help of standardization? The paper is organized as follows: In the first section, we examine the foundations of process development
Summary
R&D stands for Research and Development and while research is essential for new product development in biotechnology, the development and its integration with research (the transfer from research to development) is underexplored. A good example here is Tesla which has come up with the affordable model 3—their first electric car aimed towards the mass market for a starting price of 35,000 USD To enter this market with 500,000 pre-orders, the production needs to significantly scale-up which has caused quite some difficult for Tesla.. The engineering literature acknowledges efficient transfer or integration of development activities as critical success factors in NPD (Gerwin and Barrowman 2002).. Prior innovation management and technology transfer literature mainly focus on product development, whereas accompanying process development is underexplored (Lu and Botha 2006). The Integrated Product Development (IPD) literature recognizes IPD as the critical paradigm for NPD and is defined by an ‘‘overlap and interaction between activities in the new product development process’’ Process development capabilities and an integration of product-process development are crucial determinants of overall product development performance and productivity (Ettlie and Reza 1992; Pisano 1996)
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