London: Sage Publications Ltd. Etzkowitz, H., Ranga, M., Benner, M., Guaranys, L., Maculan, A. M., & Kneller, R. 2008. Case Study Research: Design and Methods, (2nd Ed): Thousand Oaks, CA: Sage Publications Inc. Youtie, J., & Shapira, P. 2017. The iteration makes the entrepreneurs and companies understand needs, wants, and preferences of their customers (Hart, 2012; Jrvinen et al., 2014; Ries, 2011). Likewise, lean commercialization aims to have a working prototype with the main functions and safety so that it can be tested by consumers. Stage-Gate Process for the Development of Medical Devices. https://doi.org/10.1016/j.sbspro.2015.01.285, https://doi.org/10.1109/ITMC.2011.5995939, https://doi.org/10.1109/PICMET.2008.4599765, https://doi.org/10.2189/asqu.2005.50.3.329, https://doi.org/10.1007/s11187-009-9254-y, http://publications.gc.ca/pub?id=365765&sl=0. The observed technologies came from various sectors electronics, cleantech, healthcare, chemical production, and information technology which were categorized as high-tech industries according to Eurostat (2016). In Proceedings of 8th International Scientific Conference Management of Technology Step to Sustainable Production: 3742, Porec, Istria, Croatia. Neither ideas nor bright minds are in short supply but the brilliant minds dreaming up the near-impossible or creatively solving difficult business challenges might need support in understanding the processes or frameworks that can help accelerate discovery and development or commercialize and market the resulting products and solutions. Regulatory bodies took a lead role in helping to define policy frameworks to guide those trajectories while suppliers and companies in adjacent markets arose in response to the needs of biopharmaceutical companies. The Fundamentals of Commercialization Strategy By AmerisourceBergen A three-step strategy for brand success. All the while, new entities continued to come into existence or merge within this ecosystem in response to changing market conditions and the opportunities they present. This result aligns with the claims of several authors about the benefits of the lean startup methodology (Gaffney et al., 2014; Gbadegeshin & Heinonen, 2016; Ibba et al., 2018; Jrvinen et al., 2014; Kruuti, 2016; Moogk, 2012; Shimasaki, 2018). Therefore, opportunities abound for companies seeking to operate within the biopharma ecosystem. For example, whereas most previous strategic analy-sis highlights the level of appropriability as a driver of strategic choice, our framework suggests that the key driver of effective commercialization strategy should be the "type" of appropriability (e.g. There are several topics, many books written on this, and many a business school program seeking to teach students on how to approach business. US Department of Defense: Arlington, VA, May 2011; http://www.dodmrl.com/MRL_Deskbook_V2.pdf. Early adopters value access to newest technologies over and above tested/proven technology. The main aim of a minimum viable product is to examine the workability of a new idea with potential customers (Blank, 2013; Furr et al., 2014; Ries, 2011). Only the high-technologies developed by the participants were considered, and they were selected based on these criteria: the technology must be developed from a basic research or have high-level of R&D activities; it must have process and product complexities; it must employ state-of-the-art or cutting-edge know-how; and it must be associated with advanced economic growth and technological development. The first biologic emerged from a nebulous cloud of ideas, inspiration, innovation, and energy. In applying the lean startup methodology to commercialization, a new term is proposed: lean commercialization. In L. Casper & K. Smolander (Eds. The ideation phase, the business process phase, and the stakeholder phase. Therefore, searching for new means of commercialization is essential (Gbadegeshin, 2017a; Still, 2017). Other analyses related to human resources, material acquisition and supply chains, factory siting and manufacturing processes, and any other business development related issues can be done at this stage. The stages are: Googling the idea or new technology, developing uniqueness, conceptualizing the new technology, developing prototypes, testing prototypes, and analyzing test data. Similarly, the empirical cases in this study confirmed that pivoting could start from this stage. On the Commercialization of Trailing Knowledge and IP. However, to understand what those might be, it is important first to describe the dynamic state of the ecosystem itself. PhD, co-founded 6 companies, and presently works as CEO of two co-founded companies. This article examines how digitalization influences the commercialization of high technologies in the life sciences industry. The second stage of lean commercialization is Developing the prototype. The primary aim of this phase was to understand their logic in commercializing high-technologies. Blank (2013) and Jrvinen and colleagues (2014) elucidate that the lean startup methodology can be distinguished from the traditional approaches in relation to strategy, new product development, organization structure, and operational perspectives. This evaluation process will guide . The framework represents a transformation of new technology and knowledge to products and services through the application of the lean/agile methodology. How can digital health platforms and apps develop commercialisation pathways? Journal of Product Innovation Management, 29(3): 508509.https://doi.org/10.1111/j.1540-5885.2012.00920_2.x. He also thanks his colleague, Mr. Ezak Ofem, for his feedback on the manuscript. The method is highly relevant for empirical studies and for theory building (Creswell, 2009; Eriksson & Kovalainen, 2008). The first phase was named commercialization activities, the second phase was named technology progress, and the last phase was named expert validation. Technology Commercialization Factors, Frameworks and Models. Authors retain full copyright to their individual works. Models and Methods of University Technology Transfer. Meanwhile, there is a need for quick diffusion of innovations due to economic pressures for companies and research institutes. The complete biologic development pipeline (Figure 1) starts with basic research and terminates with approved and commercialized biologics that undergo postmarket monitoring. 4 Sauser B, et al. Pharmaceutical Research and Manufacturers of America: Washington, DC, 2018; http://phrma-docs.phrma.org/industryprofile/2018/pdfs/2018_IndustryProfile_BioFuelingEconomy.pdf. Because the pace of innovation and discovery within the biopharmaceutical ecosystem remains strong, it is nearly impossible to describe all unique and creative opportunities or solutions currently in development. Similarly, transforming new technologies that have been developed from series of research and development investments is an important source of income for companies and government (Cornford, 2002; Gibson & Naquin, 2011; Hindle & Yencken, 2004). We link strategy to the commercialization environment - the microeconomic and strategic conditions facing a firm that is translating an "idea" into a value proposition for customers. This study analyzes the scientific literature on Life Cycle Assessment-based (LCA-based) industrialization and commercialization of geosynthetics for infrastructures in the field of Industry 4.0, by applying a scientometric study. Common features of high technologies are novelty, complexity, resource intensity, and high levels of R&D (Schrier & Hallin, 2017; Steenhuis & de Bruijn, 2006). Ries (2011) advocates failing quickly, learning lessons, and thinking about the way forward. Galway, Ireland, December 14, 2013.https://tuhat.halvi.helsinki.fi/portal/files/29946700/0bcc9075da894620f1 Parviainen, P., Tihinen, M., Kriinen, J., & Teppola, S. 2017. Professional services include firms that provide consulting, advertising, public relations, accounting, employment services, and so on. Eurostat. In contrast, a test result is negative when the aforementioned conditions are not met. This theory deals with business opportunities with a high level of uncertainty (Fisher, 2012). Part of the growth & portfolio planning . Blank, S. 2013. Building a Sustainable Start-Up? In Proceedings of the PICMET08 Conference, Cape Town. Operational companies serving the biopharmaceutical industry provide real-estate support, transportation/shipping, construction, waste management, and warehouse/storage support. The fourth and fifth principles, innovation accounting and buildmeasurelearn are more practical, and they constitute the application aspect of the lean startup methodology (Gaffney et al., 2014). Winter 2018; https://www.rdmag.com/article/2018/03/2018-global-r-d-funding-forecast-snapshot. 2013. Research: Bioz, Inc. (Los Altos, CA) is an emerging life-science software company that has developed a proprietary artificial intelligence (AI) platform to search, aggregate, and analyze usage information relative to scientific products, reagents, and services used by academic and biopharmaceutical researchers worldwide. The former measures system-wide readiness, whereas the latter is a measure of a systems ability to accept and integrate the new technologies (4). Figure 2. Victoria, BC: British Columbia Statistics. Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies. (Eds.) Gbadegeshin, S. A. Manufacturing Readiness Level Deskbook, Version 2.0. How Lean Startup Is Being Applied in Established Organisations. Moreover, high-technologies are made more complicated by the advent of digitalization (Gbadegeshin, 2018b). As spelled out in the Commercial Framework box, this takes into consideration both the cultural elements of smaller businesses and the process approaches of larger organizations. Note, there are smaller chasms that exist between each of the customer categories and different challenges exist to bridge the gap. Commercial application Multiple #commercialization pathways now exist for #digitalhealthtools | 20 comments on LinkedIn Similarly, the composition of the commercialization team helps or hinders the commercialization process (Gbadegeshin, 2017b). On the other hand, some organizations possess breakthrough products or technologies but struggle to make themselves heard and differentiate their offerings among thousands of other vendors and suppliers in the marketplace. However, the participants also agreed that limited knowledge of the lean startup methodology could be an obstacle to the successful application of the logic. Similarly, scholars examining the lean startup methodology argue that testing reveals the practicality or reality of the new technology (e.g., Apilo et al., 2015; Gbadegeshin & Heinonen, 2016; Ibba et al., 2018; Jrvinen et al., 2014; Kruuti, 2016; Moogk, 2012; Shimasaki, 2018; Tran, 2015). International Journal of Scientific & Engineering Research, 5(1): 17431748. 2012. The growth curve is widely used to describe the maturity levels of industries, companies, technologies and products. If the test result is neutral, the commercialization team can pivot. Commercialization is the method of introducing new products or services to the market. IP protection Securing assets (photo: Getty images) 4. 2012. Technology Innovation Management Review, 2(3): 2326.http://doi.org/10.22215/timreview/535, Morse, J. M., Barnett, N., Mayan, M., Olson, K., & Spiers, J. However, there are a few topics that we feel are core to helping organizations ground their commercialization strategies. Interdisciplinary Journal of Research in Business, 2(9): 2642. A test result is positive if the collected data showed that the new technology fulfils its primary purpose, potential customers are satisfied with it, or a business model is able to be achieved. Abingdon, UK: Routledge. Paper ID: 08R0018.https://doi.org/10.1109/PICMET.2008.4599765, Apilo, T., Fiegenbaum, I., Still, K., Jaring, P., Wallin, A., Komi, M., & Suciu, G. 2015. This stage is also common to many commercialization frameworks, though under different names. Commercialization Process of High Technologies: Case Study of Finnish University Spin-off. These analyses are essential for commercialization and building a technology-based company (Al Natsheh et al., 2013). Guerrero, M., Urbano, D., Fayolle, A., Klofsten, M., & Mian, S. 2016. Research Policy, 42(2): 423442.https://doi.org/10.1016/j.respol.2012.09.007, Pietzsch, J. A good targeting strategy asks: Who should we target? Al Natsheh, A., Gbadegeshin, S. A., Rimpilinen, A., Imamovic-Tokalic I., & Zambrano, A. Tremendous opportunities exist within this ecosystem. PhD, founded 5 companies, and presently works as a Chief Engineer in one of the companies. Ries, E. 2011. TEM Journal, 1(3): 200207, Maine, E., & Garnsey, E. 2007. When working together, trust and open sharing of information between the partners are required. Some adopters include MilliporeSigma, Qiagen, Sciex, and Thermo Fisher Scientific. Based on the 2016 PhRMA results (2), at least 30 major sectors contribute indirectly to the biologics pipeline. The method was initially developed for the entrepreneurs and startups, but due to its broader applicability and potential benefits, larger and more mature companies are now also employing it (Apilo et al., 2015; Blank, 2013; Gaffney et al., 2014; Hakin, 2014). These entrepreneurs believed that little or small resources needed to be invested in initial commercialization activities, while hoping for the best. Test results can be positive, neutral, and negative. Potential customers (i.e., the testers) must be made aware that a minimum viable product is not a final product. This pipeline spans 1015 years, and development of a successful candidate can cost an average of US$1.4 billion (1). In view of these findings, there is indeed a need for a framework to enlighten and guide technology entrepreneurs in applying lean startup methodology in their commercialization adventures. MSc, previously worked as an R&D Manager, and presently works as a Senior Business Advisor for new high-tech companies. The TIM Review received partial funding fromFedDev Ontario's Investing in Regional Diversification initiative. It involves a decision to compete directly with incumbents, emphasizing commercialization of the idea and the rapid growth of market share rather than control of the idea's development.. Investing in Innovation to Enable Global Competitiveness: The Case of Portugal. Commercialization is the process of transforming a new product or service all the way from conceptualization to actual sale. Harvard Business Review, 91(7/8): 1415. Profile of the British Columbia Technology Sector. Miles, M. B., & Huberman, A. M. 1994. Commercialization Framework Commercialization Framework April 19, 2022 Print | PDF. Case studies: Applying the lean startup methodology in commercialization. Ideation process Generating and developing ideas (photo: Getty images) 2. As the company continues up the growth curve, it reaches an inflection point at which its sales start to taper off until slowly it reaches a level of maturity. The team must have adequate knowledge about the lean startup methodology. Due to the nature of high-technologies and their industries, the need for rapid commercialization, the need for skillful personnel to manage business operations, the importance of customer satisfaction, and the emergence of the digitalization phenomenon (Hemil & Vanhanen, 2016), the lean startup methodology is linked to the term acceleration (Hemil & Jaring, 2018). He argued that this methodology made the company and its commercialization team develop their new technology in accordance with the needs and wants of the consumers. Hakin, E. 2014. 5 OSD Manufacturing Technology Program, Joint Service/Industry MRL Working Group. Similarly, the four business advisors interviewed in phase 3 confirmed that firms are following the process described above while explaining that commercialization activities have changed over the last two decades. This means that lean commercialization users need to start the whole process afresh. Insights in Engineering Leadership White Paper. Over the past decade or so, the term biopharma has emerged to describe the results of industry consolidations in which large pharmaceutical organizations have either acquired or merged with biotechnology companies. The collected data were analyzed with a content analysis tool that enabled the reduction of bulk qualitative data through codification, theme development, and result reporting (Creswell, 2009; Miles & Huberman, 1994). For example, Maine and Garnsey (2007) called it customization of R&D, Pietzsch and colleagues (2009) name it design and development, and Gbadegeshin (2017b) termed it prototyping and development. London: Sage Publication Inc. Denzin, N., & Lincoln Y. Development of a Mobile Application Using the Lean Startup Methodology. As the company in the emerging phase starts to gain traction, that company starts toramp upthe growth curve. Measurement strategy requires feasible variables that make up those goals. Pivoting means that problems discovered in the minimum viable product test are addressed and re-tested, the minimum viable product is introduced to a new market, or the new technology is repurposed. Overview of the methodology followed in this study, Application of the lean startup methodology to the commercialization process. Accessed September 15, 2018:http://thenextweb.com/entrepreneur/2013/08/06/do-lean-startup-principles Eldred, E. W., & McGrath, M. E. 1997. You can use the Ansoff Matrix as a strategic framework to understand what growth strategy is more suited based on the market context. The study makes a practical contribution through its framework, which assists technologists and scientists in their commercialization adventures. Int. No matter where a company resides within the ecosystem, nor what product or service it offers, at least three concepts or frameworks can be immensely valuable if understood and applied correctly within the context of the biopharmaceutical ecosystem: technology readiness level (TRL), manufacturing readiness level (MRL), and commercialization. PhD, founded 3 companies, and presently works as a Senior Business Advisor for new high-tech companies. It also helps users to learn from their trials and simultaneously develop market and customers for their technologies. Procedia - Social and Behavioral Sciences, 169: 5360.https://doi.org/10.1016/j.sbspro.2015.01.285. This is the main motivation for proposing lean commercialization, which is developed from studying different high-technologies from different industries. Rosa, J. Lean Start-up Methodology for Enterprises: How Established Companies Can Leverage Lean Startup Methodology for Sustaining and Disruptive Innovation. Journal of Technology Transfer, 42(6): 13621376.https://doi.org/10.1007/s10961-016. The author concludes that: For those contemplating starting a biotechnology company, or those in a development stage company, making use of capital efficiency and lean startup, open-innovation frameworks can leverage the capital raised, and greatly improve your likelihood of success.. Preclinical Research: As research progresses, scientists work to further narrow the list of potential target molecules. Verification Strategies for Establishing Reliability and Validity in Qualitative Research. Technology Based Entrepreneurship: Measurement Technology Perspective. However, it starts with basic research: the process of learning more about the world and filling in gaps in our knowledge related to diseases and treatments. According to Gbadegeshin and Heinonen (2016), pivoting can start from the prototype development stage. Currently, 50 companies have integrated these badges onto their websites, with a backlog of vendors requesting such integration. Making new technologies available and acceptable in marketplaces (Tanev & Frederiksen, 2014) requires the creation of new businesses, the revamping of existing enterprises, and the employment of people (Gbadegeshin, 2017a, b; Still, 2017). The experts also made it known that startup phenomenon, digitalization influences, and money making pressures are compelling entrepreneurs to apply lean startup logic as some authors have also noted (e.g., Apilo et al., 2015; Ibba et al., 2018; Kruuti, 2016; Shimasaki, 2018). commercialization strategy on competitive dynamics. This framework should inform the strategic choices required to engage access stakeholders with differentiated and tailored value propositions supported by evidence obtained from answers to: The growth curve (Figure 5) often is used to describe the maturity levels of industries, companies, technologies, and products. It does not exist in a two-dimensional static environment at one point in time, but rather in a four-dimensional plane propelled forward in time as it constantly evolves, grows, and transforms. His research interests include commercialization, high technology, the lean startup methodology, entrepreneurship, business internationalization, and family-run businesses. Technological Forecasting & Social Change, 78(8): 12991309.https://doi.org/10.1016/j.techfore.2011.04.004. Commercialization strategy is an all-encompassing plan that organizes technology transfer office goals to commercialize a university's technologies. ), Software Business: Towards Continuous Value Delivery: 5th International Conference, ICSOB 2014: 5871. Bricolage: Theoretical and Contemporary Uses in Entrepreneurship Studies. https://ikhlaqsidhu.files.wordpress.com/2014/08/elpp-project-1-lean-star https://doi.org/10.1016/j.techfore.2011.04.004, https://doi.org/10.1007/s11187-016-9755-4, https://doi.org/10.1088/2053-1613/2/3/035001, https://doi.org/10.1111/j.1540-5885.2012.00920_2.x, https://doi.org/10.1016/S0166-4972(03)00023-3, https://doi.org/10.1007/978-3-319-91602-6_21. Paphos, Cyprus, June 1618, 2014. Classical small-molecule pharmaceutical products have a distinct chemical composition and are manufactured using chemical raw-materials. 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