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研究生： 黃羽霈
Huang, Yu-Pei
論文名稱： 醫療器材研發轉譯關鍵因子-以成大SPARK為例
Key Factor for Medical Device Translational Research: Based on NCKU-SPARK Program
指導教授： 張志涵
Chang, Chih-Han
學位類別： 碩士
Master
系所名稱： 工學院 - 生物醫學工程學系
Department of BioMedical Engineering
論文出版年： 2022
畢業學年度： 110
語文別： 英文
論文頁數： 68
中文關鍵詞： 醫療器材 、研究轉譯 、創新創業 、邏輯斯迴歸 、未滿足臨床需求 、法規路徑規劃
外文關鍵詞： medical device, translational research, innovation, entrepreneurship, logistic regression, unmet clinical needs, regulatory pathway
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    • 從研究中獲得的知識，如果無法轉化為行動或產品則影響甚微。本研究旨針對成大 SPARK 生醫與醫材轉譯輔導人才培育計畫，探討由學術研究成功轉譯為醫療器材的可能關鍵因素。針對 2013 年～ 2020 年間參與成大 SPARK計畫的 90 組醫材轉譯團隊，根據可用數據回顧每個團隊的七項因子，且每項因子給予 1～4 評分（4分優於1分），然後應用邏輯斯迴歸（Logistic regression）確認轉譯成功與這七個因子的關聯性。由統計分析的結果顯示在七個因素中，臨床需求定義和法規途徑規劃可視為影響轉譯成功的顯著因子，而團隊進入狀態、市場調研和團隊參與度的這三個因素則為次要因子，專利保護和團隊的成員背景被認定為不顯著因子。確認臨床未滿足需求的重要性與對醫療器材開發的一般認知非常吻合；然而，專利保護卻令人驚訝地被排除在醫材成功轉譯的關鍵因素之外。這可能是因為本研究中的成功定義係基於 SPARK-TAIWAN 計畫辦公室的定義，即進入下一個轉譯階段的四個里程碑之一，而非完成上市的醫療器材產品。總結，學術研究團隊的成功醫療器材翻譯，最重要的兩個因素是定義臨床未滿足需求與法規路徑，而市場調研和團隊參與度也是關鍵因素。

    Knowledge obtained from research is with little impact if not translated into an action or product. This study aimed to identify the possible key factors for a successful medical device translation, from academic research, in the SPARK program of National Cheng Kung University (NCKU-SPARK). In total 90 teams, focusing on medical device translation, incubated in the NCKU-SPARK, from 2013 to 2020, were selected for this study. Based on the available data, seven factors of each team were reviewed and a score from 1 to 4, 4 is better than 1, was assigned to every factor in each team. Logistic regression was then applied to relate the success of translation with these seven factors. The results show that among the seven factors, two factors, the clinical need definition and the regulatory pathway planning were identified to be statistically significant factors to the success of translation. Three factors, the team’s entry status, market analysis and team dedicating were identified to be minor significant factors. The patent protection and team members’ background were identified as statistically insignificant factors. The importance of identify unmet clinical need match well with general understanding in medical device development, however, the patent protection was surprisingly excluded from the key factors of a successful medical device translation. This might be due to the fact that the definition of success in this study, based on the definition from program office of SPARK-TAIWAN, is not the completion of a marketed medical device but one of the four milestones to move to the next translation phase. In conclusion, for a successful medical device translation from academic research team, the two most important factors are the clarify of unmet clinical need and regulatory pathway while market analysis and team dedicating are also the key factors.

    中文摘要 I Abstract II 誌 謝 III Contents V List of Figures VIII List of Tables IX Chapter 1 Introduction 1 1.1 General Background Information 1 1.1.1 Characteristics of Medical Device Industry 1 1.1.2 Opportunities and Challenges for Interdisciplinary Technology to Approach Medical Device Industry 3 1.2 Research Translation for Medical Device 4 1.2.1 Significances of Research Translation 5 1.2.2 Barriers to Research Translation 6 1.2.3 Success Factors of Research Translation 8 1.3 Introduction of SPARK Program 11 1.3.1 The Origin and Mission of Stanford-SPARK Program 12 1.3.2 Operation in SPARK-TAIWAN Program 14 1.3.3 Core Value and Mission in NCKU-SPARK program 16 1.3.4 Performances of Accelerating Research Translation in NCKU-SPARK Program 17 1.4 Literature Review–Exploration for Biomedical Research Translation Programs 18 1.5 Motivation and Research Framework 19 Chapter 2 Research Methods 22 2.1 Operation and Management of NCKU-SPARK Program 22 2.2 Statistics and Data Analysis 25 2.2.1 Database Establishment for NCKU-SPARK Program 25 2.2.2 Data Mining with Logistic Regression Model 36 2.2.3 Exploration of Success Probability with Logistic Regression 37 Chapter 3 Results 39 3.1 Definition and Encoding of Independent Variables 39 3.2 Analytical Results of Logistic Regression 42 3.2.1 Model Selection 42 3.2.2 Estimations of Coefficient and Odds Ratio 44 Chapter 4 Discussion 46 4.1 Exploration of Counseling Factors and Individual Cases 46 4.1.1 Team's entry status before enrolling NCKU-SPARK Program 47 4.1.2 Clinical Need Definition 48 4.1.3 Market Analysis 50 4.1.4 Regulatory Pathway Planning 52 4.1.5 IP Protection 55 4.1.6 Team's Dedicating 56 4.1.7 Team Members' Background 58 4.2 Limitations of the Study 61 Chapter 5 Conclusion and Prospect 62 References 65

    1. Global medical devices market. Expert Market Research. 2020.
    2. Dang, A. and Sharma, J.K., Economics of medical devices in India. Value in Health Regional Issues, 2019. 18: p. 14-17.
    3. Lee, M., et al., What are the features of successful medical device start-ups? Evidence from KOREA. Sustainability, 2019. 11(7): p. 1948.
    4. Lee, M. and Yoon, K., Ecosystem of the medical device industry in South Korea: A network analysis approach. Health Policy and Technology, 2018. 7(4): p. 397-408.
    5. Lee, M., et al., Innovative distribution priorities for the medical devices industry in the fourth industrial revolution. International Neurourology Journal, 2018. 22(Suppl 2): p. S83-S90.
    6. Lee, M., Strategies for promoting the medical device industry in Korea: An analytical hierarchy process analysis. International Journal of Environmental Research and Public Health, 2018. 15(12): p. 2659.
    7. Manbachi, A., et al., Starting a medical technology venture as a young academic innovator or student entrepreneur. Annals of Biomedical Engineering, 2018. 46(1): p. 1-13.
    8. Rubio, D.M., et al., Defining translational research: Implications for training. Academic medicine : journal of the Association of American Medical Colleges, 2010. 85(3): p. 470-475.
    9. Reis, S.E., et al., Reengineering the national clinical and translational research enterprise: The strategic plan of the national clinical and translational science awards consortium. Academic Medicine, 2010. 85(3): p. 463-469.
    10. Lin, B.B., et al., The critical path program in Taiwan. Drug Information Journal, 2009. 43(3): p. 311-317.
    11. Sung, N.S., et al., Central challenges facing the national clinical research enterprise. Journal of the American Medical Association, 2003. 289(10): p. 1278-1287.
    12. Woolf, S.H., The meaning of translational research and why it matters. Journal of the American Medical Association, 2008. 299(2): p. 211-213.
    13. Khoury, M.J., et al., The continuum of translation research in genomic medicine: How can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genetics in Medicine, 2007. 9(10): p. 665-674.
    14. Pienta, K.J., Successfully accelerating translational research at an academic medical center: The university of Michigan-Coulter translational research partnership program. Clinical and Translational Science, 2010. 3(6): p. 316-318.
    15. Butler, D., Translational research: Crossing the valley of death. Nature, 2008. 453(7197): p. 840-842.
    16. Wensing, M. and Grol, R., Knowledge translation in health: How implementation science could contribute more. BMC Medicine, 2019. 17(1): p. 88.
    17. Li, T.-W., et al., Assurance of medical device quality with quality management system: An analysis of good manufacturing practice implementation in Taiwan. BioMed Research International, 2015. 2015: p. 670420.
    18. Sandberg, W.R. and Hofer, C.W., Improving new venture performance: The role of strategy, industry structure, and the entrepreneur. Journal of Business Venturing, 1987. 2(1): p. 5-28.
    19. Han, J.H. and Shin, J.K., Analysis of failure factors: Dynamic ERIS. Journal of Strategic Management Conference Proceedings, 2004. 1: p. 75-97.
    20. Meslin, E.M., et al., Mapping the translational science policy ‘valley of death’. Clinical and Translational Medicine, 2013. 2(1): p. e14.
    21. Mayhew, S., Trends in discovery externalization. Nature Reviews Drug Discovery, 2010. 9(3): p. 183-183.
    22. Kim, E.S., et al., Accelerating biomedical innovation: A case study of the SPARK program at Stanford University, School of Medicine. Drug Discovery Today, 2017. 22(7): p. 1064-1068.
    23. Daria, M.-R. and Kevin, G., A practical guide to drug development in academia: The SPARK approach. 2014: Springer.
    24. Mosedale, A., et al., An impact review of a Western Australian research translation program. PLOS ONE, 2022. 17(3): p. e0265394.
    25. Hall, E.G., et al., A reconsideration of university gap funds for promoting biomedical entrepreneurship. Journal of Clinical and Translational Science, 2022. 6(1): p. e28.
    26. King, C.E., et al., Introducing entrepreneurship into a biomedical engineering capstone course at the University of California, Irvine. Technology & Innovation, 2019. 20(3): p. 179-195.
    27. Brightman, A.O., et al., Advancing medical technology innovation and clinical translation via a model of industry-enabled technical and educational support: Indiana Clinical and Translational Sciences Institute’s Medical Technology Advance Program. Journal of Clinical and Translational Science, 2021. 5(1): p. e79.
    28. Hua, S., et al., Current trends and challenges in the clinical translation of nanoparticulate nanomedicines: Pathways for translational development and commercialization. Frontiers in Pharmacology, 2018. 9: p. 1-14.
    29. Balas, E.A. and Elkin, P.L., Technology transfer from biomedical research to clinical Practice: Measuring innovation performance. Evaluation & the Health Professions, 2013. 36(4): p. 505-517.
    30. Milliken, F.J. and Martins, L.L., Searching for common threads: Understanding the multiple effects of diversity in organizational groups. Academy of Management Review, 1996. 21: p. 402-433.
    31. Kleinbaum, D.G. and Klein, M., Logistic Regression. 3rd ed. Statistics for Biology and Health. 2010: Springer New York, NY.
    32. Stack, R.S. and Harrington, R.A., Biomedical innovation: A risky business at risk. Science Translational Medicine, 2011. 3(96): p. 96cm23.
    33. Schwartz, J.G., et al., Needs-based innovation in cardiovascular medicine: The Stanford biodesign process. JACC: Basic to Translational Science, 2016. 1(6): p. 541-547.
    34. Maurer-Ertl, W., et al., Recall of the ASR XL head and hip resurfacing systems. Orthopedics, 2017. 40(2): p. e340-e347.
    35. Byun, J.Y. and Sung Min, K., Road map in increased efficiency from medical device product planning to technology commercialization. Regular Research Food Drug Cosmetics, 2017. 12: p. 59-74.
    36. Mas, J.P. and Hsueh, B., An investor perspective on forming and funding your medical device start-up. Techniques in Vascular & Interventional Radiology, 2017. 20(2): p. 101-108.
    37. Turakhia, M.P., et al., Diagnostic utility of a novel leadless arrhythmia monitoring device. American Journal of Cardiology, 2013. 112(4): p. 520-524.
    38. Brinton, T.J., et al., Outcomes from a postgraduate biomedical technology innovation training program: The first 12 years of Stanford Biodesign. Annals of Biomedical Engineering, 2013. 41(9): p. 1803-1810.
    39. Aghion, P., et al., Academic freedom, private-sector focus, and the process of innovation. The RAND Journal of Economics, 2008. 39(3): p. 617-635.
    40. Young-Hyman, T., Cooperating without co-laboring: How formal organizational power moderates cross-functional interaction in project teams. Administrative Science Quarterly, 2017. 62(1): p. 179-214.
    41. Schaufeli, W.B., et al., The measurement of work engagement with a short questionnaire: A cross-national study. Educational and Psychological Measurement, 2006. 66(4): p. 701-716.
    42. Marks, I., et al., Treatment of posttraumatic stress disorder by exposure and/or cognitive restructuring: A controlled study. Archives of General Psychiatry, 1998. 55(4): p. 317-325.
    43. Schaufeli, W.B. and Bakker, A.B., Job demands, job resources, and their relationship with burnout and engagement: A multi-sample study. Journal of Organizational Behavior, 2004. 25(3): p. 293-315.
    44. Zhang, M.J., et al., You think you are big fish in a small pond? Perceived overqualification, goal orientations, and proactivity at work. Journal of Organizational Behavior, 2016. 37(1): p. 61-84.
    45. Erdogan, B. and Bauer, T.N., Perceived overqualification and its outcomes: The moderating role of empowerment. Journal of Applied Psychology, 2009. 94(2): p. 557-565.
    46. Arvan, M.L., et al., Too good for your job? Disentangling the relationships between objective overqualification, perceived overqualification, and job dissatisfaction. Journal of Vocational Behavior, 2019. 115: p. 103323.
    47. A. Agarwal, U., Linking justice, trust and innovative work behaviour to work engagement. Personnel Review, 2014. 43(1): p. 41-73.
    48. Bitzer, M., et al., Toward an economically optimal team design in IT-related innovation projects. International Journal of Innovation and Technology Management, 2020. 17(08): p. 2150001.
    49. Phillips, K.W. and O'Reilly, C.A., Demography and diversity in organizations: A review of 40 years of research. Research in Organizational Behavior 1998. 20: p. 77-140.
    50. Barrick, M.R., et al., Relating member ability and personality to work-team processes and team effectiveness. Journal of Applied Psychology, 1998. 83(3): p. 377-391.
    51. Karn, J.S., et al., A study into the effects of personality type and methodology on cohesion in software engineering teams. Behaviour and Information Technology, 2007. 26(2): p. 99-111.

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