Description
Title: So You Think You Have an Idea: An Academic Translational Research Risk Reduction Conceptual Model
Abstract: Clinical and basic science components are included in translational research for new medications, medical devices, and diagnostics, which calls for multidisciplinary expertise and resources. that cannot all be found in a simple laboratory or clinical setting alone. We suggest that “translational” research should be viewed as a defined process from basic science through manufacturing, regulatory, clinical testing, and marketing in order to be successful. The authors describe a method they have found effective for locating and exploiting scholarly innovation. In the academic setting, novelty is highly valued while factors such as data’s ability to be replicated, scaled, reimbursed, or used commercially are given less weight. In other words, the relative neglect of clinical, regulatory, reimbursement, manufacturing, and intellectual property freedom to operate almost always results in more questions and doubts about the potential of the proposed product, thereby inhibiting further interest, when investors, strategic companies, or other later stage stakeholders evaluate academic efforts at translational research. In contrast, industry-based R&D frequently places a focus on manufacturing, regulatory, and commercial aspects. It’s not so much that academics deliberately choose to ignore those fundamental components of translation development; rather, they lack inclusion in university environments’ incentive structures or culture. An efficient “translation” of academic project concepts into useful clinical solutions helps translational researchers more quickly develop and advance new and better medical products that address validated needs by recognizing and methodically addressing this mismatch of approach and lack of common language. The authors offer a summary and framework that academic researchers can use to define the components of a market-driven translational program, including problem identification and validation, defining the conceptual model of disease, and risk evaluation and mitigation tactics.
Keywords: translational bioengineering; translational research; medical technology; innovation; health care; risk; conceptual health model
Paper Quality: SCOPUS / Web of Science Level Research Paper
Subject: Bioengineering
Writer Experience: 20+ Years
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