Policy knowledge in innovation ecosystems of global biomedical ventures: Entrepreneurial communication in decision-making, risk-taking, and competitive advantage



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Biomedical innovation policy disproportionally impacts young ventures developing exciting new medical technologies, ranging from gene editing therapeutics to medical devices based on the latest artificial intelligence. While the technologies vary widely, these ventures have in common that their leaders must communicate in a way that inspires the collective imagination of the public, staff, and funders to construct successful technological futures. Such clear and persuasive communication is central to securing funding, achieving regulatory approval, and translating biomedical products into commercial products that generate revenues and change patient lives. Policy that aims to stimulate medical innovation is a unique aspect of this communication landscape. Using the United States (U.S.) 21st Century Cures Act of 2016 (Cures Act) as an entry point, this research study maps how global business leaders, investors, and scientific professionals leverage knowledge of innovation policy in biomedical ventures. From October 2019 to January 2020, uniquely situated prior to the COVID-19 outbreak, this research employed a multi-method approach to collect asynchronous online survey data (N = 82), unstructured interviews (N = 18), and communication artifacts from organizations referenced by interviewees through publicly available websites (N = 22). Participant recruitment was performed in accordance with IRB policy, as approved by the Texas Tech University IRB (TTU IRB #2019-588). Data were triangulated and visualized using methods rooted in Grounded Theory (GT), entrepreneurial communication, and situational analysis. Open and structured heuristic coding was performed across all data text and graphical data, producing 1040 highly saturated code groups, including topical constructs (clinical trials, ethics, and policy topics), communication information (media sources for innovation policy information), rhetorical devices (polarization, metaphors, and other argumentation), and global topics (related to multiple countries specific biomedical policy situation). A posthuman situational analysis lens was applied to the data to generate a novel social world visualization for innovation policy in biomedical ventures, and to posit a series of theories for systematic improvement in communication between the seven key social arenas identified in this research (biomedical product industry, government agencies and judiciary, financial and investment firms, insurance and payers, hospitals and health systems, patient associations, and university and academic centers). Results show that knowledge dissemination related to innovation policy is distinctly polarized between large and small business ventures and provides actionable insights to enhance communication at these interfaces, and thus facilitating positive commercial and social outcomes for young biomedical ventures. These results provide actionable insights for technical communications, business leaders, and policymakers to engage with innovation policy within their spheres of influence to improve how they make decisions, take risks, and establish competitive advantage for young ventures with exciting new biomedical technologies. The visualizations are also intended as a teaching resource, to enable scholars, students, and future practitioners an entry point into the complex landscape of biomedical product development.



Biotechnology, Regulatory, Business Communication, Competitive Advantage, Decision-making, Risk-taking, Strategy, Venture Capital, Grounded Theory, Situational Analysis