系統識別號 U0026-2407201815013000
論文名稱(中文) 開發中國家的市場進入障礙對複雜產品系統(CoPS)的影響:以ASEAN醫院銷售醫療設施為例.
論文名稱(英文) Market Entrance Barriers to Complex Products and Systems (CoPS) in Developing Economies: Case of Medical Device Commercialization in ASEAN Hospitals
校院名稱 成功大學
系所名稱(中) 國際企業研究所
系所名稱(英) Institute of International Business
學年度 106
學期 2
出版年 107
研究生(中文) 阮國維
研究生(英文) Nguyen Quoc Duy
學號 R66057010
學位類別 碩士
語文別 英文
論文頁數 78頁
口試委員 指導教授-史習安
中文關鍵字 none 
英文關鍵字 Medical device  Complex products and systems (CoPS)  ASEAN  Cross-border commercialization  Consumer barriers. 
中文摘要 none
英文摘要 Medical devices, a category of complex products and systems (CoPS), undoubtedly play a pivotal role in the enhancement of human well-being. The demand for such innovations is increasing in conjunction with the dramatic transformation of healthcare systems across the world. A growing number of medical device companies have sought to innovate their products to satisfy such a huge market demand as well as compete with multiple aggressive rivals. Among the potential markets, Association of Southeast Asian Nations (ASEAN), which many international companies have made every effort to penetrate, represents a diverse region with vigorous economic development, healthcare reforms, population expansion, growing per capita income, and dynamic disease profiles. However, due to the exceptional characteristics of medical devices, companies have faced a variety of barriers when striving to commercialize their products. This research aims to identify those barriers from a consumer perspective by conducting literature review and expert interviews. Innovation Resistance Theory sheds meaningful light on the framework of this research with five primary barrier dimensions, each of which consists of four resistance factors. A questionnaire was developed and the collected data was further analyzed by means of DEMATEL method to construct Importance-Solvability Analysis (ISA) and Network Relationship Map (NRM). The findings reveal that Risk Barriers are the most important and Value Barriers are the most solvable. This research also provides managers with optimal pathways to overcome the barriers based on their causal relationships and levels of importance and solvability.
2.1 Medical Device. 5
2.1.1 Definition and Role of Medical Device. 5
2.1.2 Classification of Medical Device. 6
2.1.3 Medical Devices as “Complex Products and Systems” (CoPS). 8
2.2 Medical Device Industry in ASEAN. 9
2.3 Consumer Behavior in ASEAN. 11
2.4 Innovation Resistance Theory. 13
2.4.1 Functional Barriers. 15
2.4.2 Psychological Barriers. 18
3.1 Stakeholder Analysis. 21
3.2 Sample Description and Settings. 22
3.3 Study Design and Methodologies. 24
3.3.1 Content Analysis. 25
3.3.2 Decision Making and Trial Evaluation Laboratory (DEMATEL). 27
3.3.3 Importance-Solvability Analysis (ISA) and Network Relationship Map (NRM). 30 Inportance-solvability analysis (ISA). 30 Network relationship map (NRM). 32
4.1 Content Analysis. 33
4.2 ISA-NRM Models. 36
4.2.1 Primary Dimensions. 39
4.2.2 Usage Barriers. 41
4.2.3 Value Barriers. 43
4.2.4 Risk Barriers. 45
4.2.5 Tradition Barriers. 47
4.2.6 Image Barriers. 49
5.1 Overcoming Barriers to Medical Device Innovation: Suggested Pathways. 52
5.1.1 Primary Dimensions. 52
5.1.2 Usage Barriers. 54
5.1.3 Value Barriers. 56
5.1.4 Risk Barriers. 58
5.1.5 Tradition Barriers. 60
5.1.6 Image Barriers. 61
5.2 Managerial Implications. 63
5.3 Theoretical Implications. 66
5.4 Limitations and Future Research. 67
5.5 Conclusions. 68
參考文獻 Acharya, A. (2014). Constructing a security community in Southeast Asia: ASEAN and the problem of regional order. Routledge.
Antioco, M., & Kleijnen, M. (2010). Consumer adoption of technological innovations: Effects of psychological and functional barriers in a lack of content versus a presence of content situation. European Journal of Marketing, 44(11/12), 1700-1724.
Berelson, B. (1952). Content analysis in communications research.
Bertoli, G. (2013). Bringing You The ASEAN Way. Retrieved from
BMI. (2013). The Business Monitor International (BMI) Survey Retrieved from https://www.bmiresearch.com/medical-devices
Bogner, A., & Menz, W. (2009). The theory-generating expert interview: epistemological interest, forms of knowledge, interaction. Interviewing Experts (pp. 43-80): Springer.
Bredahl, L. (2001). Determinants of consumer attitudes and purchase intentions with regard to genetically modified food–results of a cross-national survey. Journal of consumer policy, 24(1), 23-61.
Callea, G., Armeni, P., Marsilio, M., Jommi, C., & Tarricone, R. (2017). The impact of HTA and procurement practices on the selection and prices of medical devices. Social Science & Medicine, 174, 89-95.
Callea, G., Cavallo, M. C., Tarricone, R., & Torbica, A. (2017). Learning effect and diffusion of innovative medical devices: the case of transcatheter aortic valve implantation in Italy. Journal of Comparative Effectiveness Research, 6(4), 279-292.
Chang, H. H., & Chuang, S. S. (2011). Social capital and individual motivations on knowledge sharing: Participant involvement as a moderator. Information & Management, 48(1), 9-18.
Chatterji, A. K., Fabrizio, K. R., Mitchell, W., & Schulman, K. A. (2008). Physician-industry cooperation in the medical device industry. Health Affairs, 27(6), 1532-1543.
Chen, L. Y. (2013). The quality of mobile shopping system and its impact on purchase intention and performance. International Journal of Managing Information Technology, 5(2), 23.
Chen, P. T., & Kuo, S. C. (2017). Innovation resistance and strategic implications of enterprise social media websites in Taiwan through knowledge sharing perspective. Technological Forecasting and Social Change, 118, 55-69.
Chou, Y. C., Sun, C. C., & Yen, H. Y. (2012). Evaluating the criteria for human resource for science and technology (HRST) based on an integrated fuzzy AHP and fuzzy DEMATEL approach. Applied Soft Computing, 12(1), 64-71.
Ciani, O., Wilcher, B., Blankart, C. R., Hatz, M., Rupel, V. P., Erker, R. S., . . . Taylor, R. S. (2015). Health technology assessment of medical devices: a survey of non-European union agencies. International Journal of Technology Assessment in Health Care, 31(3), 154-165.
Clemes, M. D., Gan, C., & Zhang, D. (2010). Customer switching behaviour in the Chinese retail banking industry. International Journal of Bank Marketing, 28(7), 519-546.
Dalalah, D., Hayajneh, M., & Batieha, F. (2011). A fuzzy multi-criteria decision making model for supplier selection. Expert Systems with Applications, 38(7), 8384-8391.
Donoghoe, N., Gupta, A., Linden, R., Mitra, P., & Morgenstern, I. B. V. (2012). Medical device growth in emerging markets: Lessons from other industries. Retrieved from https://www.library.hbs.edu/index.php/Citations/In-Vivo-The-Business-Medicine-Report
Elizabeth, E. B. (2012). Facebook pages and benefits to brands. The Elon Journal of Undergraduate Research in Communications, 3(2).
FDA. (2014). Classify your medical device. Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
Feldman, M. D., Petersen, A. J., Karliner, L. S., & Tice, J. A. (2008). Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. Journal of General Internal Medicine, 23(1), 57-63.
Fontela, E., & Gabus, A. (1976). The DEMATEL observer, Battelle Geneva Research Center, Geneva, Switzerland. DOI, 10, 0016-3287.
Garcia, R., & Calantone, R. (2002). A critical look at technological innovation typology and innovativeness terminology: a literature review. Journal of Product Innovation Management, 19(2), 110-132.
Gerrard, P., & Barton Cunningham, J. (2004). Consumer switching behavior in the Asian banking market. Journal of Services Marketing, 18(3), 215-223.
Ghorban, Z. S. (2012). Brand attitude, its antecedents and consequences, investigation into smartphone brands in Malaysia. Journal of Business and Management, 2(3), 31-35.
Goffin, K., & New, C. (2001). Customer support and new product development-An exploratory study. International Journal of Operations & Production Management, 21(3), 275-301.
Gupta, S., & Pal, S. (2001). Consumer behaviour–An Indian perspective, text and cases (1/e). New Delhi: Sultan Chand & Sons, 238.
Herbig, P. A., & Day, R. L. (1992). Customer acceptance: the key to successful introductions of innovations. Marketing Intelligence & Planning, 10(1), 4-15.
Hitzler, R. (1994). Wissen und Wesen des Experten: ein Annäherungsversuch-zur Einleitung: Westdt. Verl.
Hobday, M. (1998). Product complexity, innovation and industrial organisation. Research Policy, 26(6), 689-710.
Hobday, M. (2000). The project-based organisation: an ideal form for managing complex products and systems? Research Policy, 29(7), 871-893.
Holsti, O. R. (1969). Content analysis for the social sciences and humanities. Massachusetts: Addison-Westley.
Infodent International (2012). ASEAN medical devices regulation. Retrieved from https://www.infodent.com/magazine/onlinemag
Jefferys, D. (2001). The regulation of medical devices and the role of the Medical Devices Agency. British Journal of Clinical Pharmacology, 52(3), 229-235.
John, A., & Klein, J. (2003). The boycott puzzle: consumer motivations for purchase sacrifice. Management Science, 49(9), 1196-1209.
Kassarjian, H. H., & Kassarjian, W. M. (1988). The impact of regulation on advertising: A content analysis. Journal of Consumer Policy, 11(3), 269-285.
Kleijnen, M., Lee, N., & Wetzels, M. (2009). An exploration of consumer resistance to innovation and its antecedents. Journal of Economic Psychology, 30(3), 344-357.
Klepper, S. (1996). Entry, exit, growth, and innovation over the product life cycle. The American Economic Review, 562-583.
Koh, J., & Kim, Y. G. (2004). Knowledge sharing in virtual communities: an e-business perspective. Expert Systems with Applications, 26(2), 155-166.
Kurabayashi, T., Niimi, Y., & Yatsunami, S. (2013). Understanding ASEAN consumer markets through country-specific questionnaires. Nomura Research Institute, 192, 1-13.
Kushwaha, G. S., & Agrawal, S. R. (2015). An Indian customer surrounding 7P׳ s of service marketing. Journal of Retailing and Consumer Services, 22, 85-95.
Laukkanen, P., Sinkkonen, S., & Laukkanen, T. (2008). Consumer resistance to internet banking: postponers, opponents and rejectors. International Journal of Bank Marketing, 26(6), 440-455.
Laukkanen, T., Sinkkonen, S., & Laukkanen, P. (2009). Communication strategies to overcome functional and psychological resistance to Internet banking. International Journal of Information Management, 29(2), 111-118.
Lee, W. S., Huang, A. Y., Chang, Y. Y., & Cheng, C. M. (2011). Analysis of decision making factors for equity investment by DEMATEL and Analytic Network Process. Expert Systems with Applications, 38(7), 8375-8383.
Lin, C. J., & Wu, W. W. (2008). A causal analytical method for group decision-making under fuzzy environment. Expert Systems with Applications, 34(1), 205-213.
Maisel, W. H. (2004). Medical device regulation: an introduction for the practicing physician. Annals of Internal Medicine, 140(4), 296-302.
Manca, A. (2009). Economic evaluation of medical devices and drugs—same or different? Value in Health, 12(4), 401-401.
Markiewicz, K., van Til, J. A., Steuten, L. M., & IJzerman, M. J. (2016). Commercial viability of medical devices using Headroom and return on investment calculation. Technological Forecasting and Social Change, 112, 338-346.
Marmer, M., Herrmann, B. L., Dogrultan, E., Berman, R., Eesley, C., & Blank, S. (2011). Startup genome report extra: Premature scaling. Startup Genome, 10, 1-56.
Martilla, J. A., & James, J. C. (1977). Importance-performance analysis. The Journal of Marketing, 77-79.
Mas, J. P., & Hsueh, B. (2017). An investor perspective on forming and funding your medical device start-up. Techniques in Vascular and Interventional Radiology.
Pacific Bridge Medical (2017). Retrieved from http://www.pacificbridgemedical.com/
Neuendorf, K. A. (2016). The content analysis guidebook: Sage.
Noor, M. N. M., Sreenivasan, J., & Ismail, H. (2013). Malaysian consumers attitude towards mobile advertising, the role of permission and its impact on purchase intention: a structural equation modeling approach. Asian Social Science, 9(5), 135.
Norris, J., & Peralta, K. (2014). Trends in healthcare investments and exits 2015. Silicon Valley Bank, https://www. svb. com/uploadedFiles/Content/Blogs/Healthcare_Report/healthcare-report-2015. pdf.
Otnes, C., Lowrey, T. M., & Shrum, L. (1997). Toward an understanding of consumer ambivalence. Journal of Consumer Research, 24(1), 80-93.
Øvretveit, J. (2003). The quality of health purchasing. International Journal of Health Care Quality Assurance, 16(3), 116-127.
Park, H., & Kim, Y. K. (2014). The role of social network websites in the consumer–brand relationship. Journal of Retailing and Consumer Services, 21(4), 460-467.
Pauly, M. V., & Burns, L. R. (2008). Price transparency for medical devices. Health Affairs, 27(6), 1544-1553.
Privitera, M. B., Evans, M., & Southee, D. (2017). Human factors in the design of medical devices–Approaches to meeting international standards in the European Union and USA. Applied Ergonomics, 59, 251-263.
Ram, S., & Sheth, J. N. (1989). Consumer resistance to innovations: the marketing problem and its solutions. Journal of Consumer Marketing, 6(2), 5-14.
Reinders, M. J. (2010). Managing consumer resistance to innovations: Rozenberg Publishers.
Richardson I, T. M. (2015). Medical device software process improvement – A perspective from a medical device company. Paper presented at the 8th International Conference on Health Informatics, Lisbon, Portugal.
Rogers, E. M. (2010). Diffusion of innovations: Simon and Schuster.
Salari, N. (2017). Cultural influences on innovation resistance: a conceptual framework. In E. Shiu (Ed.), Research Handbook of Innovation and Creativity for Marketing Management.
Sall, B. (2014). FDA medical device regulation. FDA Regulatory Affairs, 125.
Secretariat, T. A. (2015). ASEAN Medical Device Directive. Retrieved from www.asean.org
Sharma, P., Chung, C. M., Erramilli, M. K., & Sivakumaran, B. (2007). Challenges of marketing to Asian consumers: Exploring the influence of different cultures, life styles and values on consumer behaviour in Asia. Handbook of Research on Asian Business, 125.
Siahaan, M. C., Pangemanan, S. S., & Pandowo, M. (2014). Price, brand equity, and perceived quality on purchase intention of Honda scooter motorcycle in Manado. Jurnal Riset Ekonomi, Manajemen, Bisnis Dan Akuntansi, 2(1).
Spáčil, V., & Teichmannová, A. (2016). Intergenerational analysis of consumer behaviour on the beer market. Procedia-Social and Behavioral Sciences, 220, 487-495.
Stone, R. N., & Grønhaug, K. (1993). Perceived risk: Further considerations for the marketing discipline. European Journal of Marketing, 27(3), 39-50.
Sun, Y., Fang, Y., & Lim, K. H. (2012). Understanding sustained participation in transactional virtual communities. Decision Support Systems, 53(1), 12-22.
Szmigin, I., & Foxall, G. (1998). Three forms of innovation resistance: the case of retail payment methods. Technovation, 18(6), 459-468.
Taiwan, P. (2015). Taiwan health industries outlook - Prospects and challenges. Retrieved from https://www.pwc.tw/en/publications/taiwan-health-industries-outlook.html
Tamura, M., Nagata, H., & Akazawa, K. (2002). Extraction and systems analysis of factors that prevent safety and security by structural models. Paper presented at the SICE 2002. Proceedings of the 41st SICE Annual Conference.
Tzeng, G. H., Chiang, C. H., & Li, C. W. (2007). Evaluating intertwined effects in e-learning programs: A novel hybrid MCDM model based on factor analysis and DEMATEL. Expert Systems with Applications, 32(4), 1028-1044.
Vincent, C. J., Li, Y., & Blandford, A. (2014). Integration of human factors and ergonomics during medical device design and development: It's all about communication. Applied ergonomics, 45(3), 413-419.
Weber, R. P. (1990). Basic content analysis: Sage.
Wong, J., & Kaiyu, R. T. (2013). Handbook of medical device regulatory affairs in Asia: CRC Press.
Yock, P. G., Watkins, F. J., Denend, L., & Kurihara, C. Q. (2015). Biodesign: Cambridge University Press.
Zahid, A. W., & Dastane, O. (2016). Factors affecting purchase intention of South East Asian (SEA) young adults towards global smartphone brands. Asean Marketing Journal, 8(1), 66-84.
  • 同意授權校內瀏覽/列印電子全文服務,於2022-01-01起公開。
  • 同意授權校外瀏覽/列印電子全文服務,於2022-01-01起公開。

  • 如您有疑問,請聯絡圖書館