| Reference: | 1. Abollado, J. R., & Shehab, E. (2018). A systems approach for the definition of lean workflows in global aerospace manufacturing companies. Procedia CIRP, 70, 446-450.
2. Ahmad, R., Kyratsis, Y., & Holmes, A. (2012). When the user is not the chooser: Learning from stakeholder involvement in technology adoption decisions in infection control. Journal of Hospital Infection, 81(3), 163-168.
3. Alam, I. S., Steinberg, I., Vermesh, O., van den Berg, N. S., Rosenthal, E. L., van Dam, G. M., ... & Rogalla, S. (2018). Emerging intraoperative imaging modalities to improve surgical precision. Molecular Imaging and Biology, 20, 705-715.
4. Alburaiesi, M. L. (2020). Using computerized maintenance management system (CMMS) in healthcare equipment maintenance operations. Journal of Environmental Treatment Techniques, 8(4), 1345-1350.
5. Ali, J. T., Mayes, S., Haeberle, H., & Cousins, M. (2017). The MedTech innovation course: Description and initial experiences with a novel collaborative course model. Journal of Entrepreneurship Education, 20(2), 1-9.
6. Altenstetter, C. (2012). Medical device regulation in the European Union, Japan, and the United States: Commonalities, differences, and challenges. Innovation: The European Journal of Social Science Research, 25(4), 362-388.
7. Arias, M., Rojas, E., Aguirre, S., Cornejo, F., Munoz-Gama, J., Sepúlveda, M., & Capurro, D. (2020). Mapping the patient’s journey in healthcare through process mining. International Journal of Environmental Research and Public Health, 17(18), 6586.
8. Ausmed. (2023). Training requirement: Medical device. Ausmed. Retrieved April 16, 2024, from https://www.ausmed.com/organisations/toolbox/training-requirements/medical-device
9. Awad, A., Trenfield, S. J., Pollard, T. D., Ong, J. J., Elbadawi, M., McCoubrey, L. E., ... & Basit, A. W. (2021). Connected healthcare: Improving patient care using digital health technologies. Advanced Drug Delivery Reviews, 178, 113958.
10. Awad, S., Aljuburi, L., Lumsden, R. S., Mpandzou, M., & Marinus, R. (2023). Connected health in US, EU, and China: Opportunities to accelerate regulation of connected health technologies to optimize their role in medicines development. Frontiers in Medicine, 10, 1248912.
11. Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., ... & Phillip, M. (2019). Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the international consensus on time in range. Diabetes Care, 42(8), 1593-1603.
12. Beck, R. W., Riddlesworth, T. D., Ruedy, K., Ahmann, A., Haller, S., Kruger, D., ... & DIAMOND Study Group. (2017). Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: A randomized trial. Annals of Internal Medicine, 167(6), 365-374.
13. Beckers, R., Kwade, Z., & Zanca, F. (2021). The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics. Physica Medica, 83, 1-8.
14. Berelson, B. (1952). Content analysis in communication research. Free Press.
15. Bernard, M., Jubeli, E., Pungente, M. D., & Yagoubi, N. (2018). Biocompatibility of polymer-based biomaterials and medical device–regulations, in vitro screening and risk-management. Biomaterials Science, 6(8), 2025-2053.
16. Beswick, D. M., Kaushik, A., Beinart, D., McGarry, S., Yew, M. K., Kennedy, B. F., & Maria, P. L. S. (2018). Biomedical device innovation methodology: Applications in biophotonics. Journal of Biomedical Optics, 23(2), 021102-021102.
17. Bharadwaj, A., El Sawy, O. A., Pavlou, P. A., & Venkatraman, N. (2013). Digital business strategy: Toward a next generation of insights. MIS Quarterly, 37(2), 471-482.
18. Bhatia, R. (2021). Emerging health technologies and how they can transform healthcare delivery. Journal of Health Management, 23(1), 63-73.
19. Blumenthal, D., & Tavenner, M. (2010). The “meaningful use” regulation for electronic health records. New England Journal of Medicine, 363(6), 501-504.
20. Brass, I., & Mkwashi, A. (2022, November). Risk assessment and classification of medical device software for the Internet of Medical Things: Challenges arising from connected, intelligent medical device. In Proceedings of the 12th International Conference on the Internet of Things (pp. 171-178). IEEE.
21. Bredin, K., & Enberg, C. (2015, June). Sustaining and developing disciplinary expertise in project-based organizations: Balanced and integrated solutions. Project Management Institute.
22. Brugha, R., & Varvasovszky, Z. (2000). Stakeholder analysis: A review. Health Policy and Planning, 15(3), 239-246.
23. Buntin, M. B., Burke, M. F., Hoaglin, M. C., & Blumenthal, D. (2011). The benefits of health information technology: A review of the recent literature shows predominantly positive results. Health Affairs, 30(3), 464-471.
24. Campanella, P., Lovato, E., Marone, C., Fallacara, L., Mancuso, A., Ricciardi, W., & Specchia, M. L. (2016). The impact of electronic health records on healthcare quality: A systematic review and meta-analysis. The European Journal of Public Health, 26(1), 60-64.
25. Campion Jr, T. R., Johnson, S. B., Paxton, E. W., Mushlin, A. I., & Sedrakyan, A. (2014). Implementing unique device identification in electronic health record systems: Organizational, workflow, and technological challenges. Medical Care, 52(1), 26-31.
26. Central Committee on Research Involving Human Subjects (CCMO). (n.d.). What is a medical device? Retrieved February 26, 2025, from https://english.ccmo.nl/investigators/clinical-investigations-with-medical-device/legal-framework-guidances-and-standards-for-clinical-investigations-with-medical-device/what-is-a-medical-device
27. 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.
28. Ciurana, J. (2014). Designing, prototyping and manufacturing medical device: An overview. International Journal of Computer Integrated Manufacturing, 27(10), 901-918.
29. Clarkson, M. E. (1995). A stakeholder framework for analyzing and evaluating corporate social performance. Academy of Management Review, 20(1), 92-117.
30. Conine, T. A., & Hershler, C. (1991). Effectiveness: A neglected dimension in the assessment of rehabilitation device and equipment. International Journal of Rehabilitation Research, 14(2), 117-122.
31. Coulentianos, M. J., Rodriguez-Calero, I., Daly, S. R., Burridge, J., & Sienko, K. H. (2022). Stakeholders, prototypes, and settings of front-end medical device design activities. Journal of Medical Device, 16(3), 031010.
32. Craswell, A., Bennett, K., Dalgliesh, B., Morris-Smith, B., Hanson, J., Flynn, T., & Wallis, M. (2020). The impact of automated medicine dispensing units on nursing workflow: A cross-sectional study. International Journal of Nursing Studies, 111, 103773.
33. Dalgaard, K., Pellumbi, G., Pfeiffer, P., & Reid, T. (2024). What to expect from MedTech in 2024. McKinsey & Company. Retrieved December 28, 2024, from https://www.mckinsey.com/industries/life-sciences/our-insights/what-to-expect-from-medtech-in-2024
34. DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20-33.
35. Donaldson, T., & Preston, L. E. (1995). The stakeholder theory of the corporation: Concepts, evidence, and implications. Academy of Management Review, 20(1), 65-91.
36. Duncan, R. B. (1976). The ambidextrous organization: Designing dual structures for innovation. The Management of Organization, 1(1), 167-188.
37. Eisenhardt, K. M. (1989). Building theories from case study research. Academy of Management Review, 14(4), 532-550.
38. Eisenhardt, K. M., & Graebner, M. E. (2007). Theory building from cases: Opportunities and challenges. Academy of Management Journal, 50(1), 25-32.
39. Elahi, B. (2021). Safety risk management for medical device. Academic Press.
40. Elkington, J. (1997). Cannibals with forks: The triple bottom line of 21st century business. Oxford: Capstone Publishing.
41. European Commission. (2017). Medical device: Definition, classification, and regulation. European Commission. Retrieved February 26, 2025, from https://ec.europa.eu/growth/sectors/medical-device_en
42. Ewertsson, M., Gustafsson, M., Blomberg, K., Holmström, I. K., & Allvin, R. (2015). Use of technical skills and medical device among new registered nurses: A questionnaire study. Nurse Education Today, 35(12), 1169-1174.
43. Fehringer, H., & Stary, C. (2023). User-informed adaptation in IoT home healthcare: Grounding development in empirical evidence. Journal of Theoretical and Applied Electronic Commerce Research, 18(4), 1901-1925.
44. Fiedler, B. A., & David, Y. (2017). Reframing product life cycle for medical device. In Managing Medical Device Within a Regulatory Framework (pp. 3-16). Elsevier.
45. Fitzgerald, M., Kruschwitz, N., Bonnet, D., & Welch, M. (2013). Embracing digital technology: A new strategic imperative. MIT Sloan Management Review.
46. Flavián, C., Ibáñez-Sánchez, S., & Orús, C. (2019). The impact of virtual, augmented and mixed reality technologies on the customer experience. Journal of Business Research, 100, 547-560.
47. Formicola, R., Ragni, F., Mor, M., Bissolotti, L., & Amici, C. (2021, April). Design approach of medical device for regulation compatibility: A robotic rehabilitation case study. In ICT4AWE (pp. 146-153).
48. Freeman, R. E. (1984). Strategic management: A stakeholder approach. Boston, MA: Pitman.
49. Freeman, R. E., Harrison, J. S., Wicks, A. C., Parmar, B. L., & de Colle, S. (2010). Stakeholder theory: The state of the art. Cambridge University Press.
50. Fuller, A., Fan, Z., Day, C., & Barlow, C. (2020). Digital twin: Enabling technologies, challenges and open research. IEEE Access, 8, 108952-108971.
51. Ganjoo, C. (2024). How is the medical device industry changing the healthcare system? BW Healthcare World. Retrieved December 28, 2024, from https://bwhealthcareworld.com/article/how-is-the-medical-device-industry-changing-the-healthcare-system-520587
52. García-Lillo, F., Úbeda-García, M., & Marco-Lajara, B. (2016). Organizational ambidexterity: Exploring the knowledge base. Scientometrics, 107, 1021-1040.
53. Gibson, C. B., & Birkinshaw, J. (2004). The antecedents, consequences, and mediating role of organizational ambidexterity. Academy of Management Journal, 47(2), 209-226.
54. Giraldo, S., la Rotta, D., Nieto-Londoño, C., Vásquez, R. E., & Escudero-Atehortúa, A. (2021). Digital transformation of energy companies: A Columbian case study. Energies, 14(9), 2523.
55. Glenn, B., Francio, V. T., Westerhaus, B. D., Goree, J., Strand, N. H., Sparks, D., & Petersen, E. (2024). Accessibility and ease of use in neuromodulation device. Neuromodulation: Technology at the Neural Interface, 27(3), 584-588.
56. Gold, M. H. (2007). Lasers and light sources for the removal of unwanted hair. Clinics in Dermatology, 25(5), 443-453.
57. Goldfarb, A., & Tucker, C. (2019). Digital economics. Journal of Economic Literature, 57(1), 3-43.
58. Gong, C., & Ribiere, V. (2021). Developing a unified definition of digital transformation. Technovation, 102, 102217.
59. Gopal, G., Suter-Crazzolara, C., Toldo, L., & Eberhardt, W. (2019). Digital transformation in healthcare–architectures of present and future information technologies. Clinical Chemistry and Laboratory Medicine (CCLM), 57(3), 328-335.
60. Graber, F. (2007). Inventing needs: Expertise and water supply in late eighteenth- and early nineteenth-century Paris. The British Journal for the History of Science, 40, 309-330.
61. Gray, J., & Rumpe, B. (2017). Models for the digital transformation. Software & Systems Modeling, 16, 307-308.
62. Greenwood, M., & Van Buren III, H. J. (2010). Trust and stakeholder theory: Trustworthiness in the organisation–stakeholder relationship. Journal of Business Ethics, 95, 425-438.
63. Grewal, D., & Roggeveen, A. L. (2020). Understanding retail experiences and customer journey management. Journal of Retailing, 96(1), 3-8.
64. Halvorsrud, R., Kvale, K., & Følstad, A. (2016). Improving service quality through customer journey analysis. Journal of Service Theory and Practice, 26(6), 840-867.
65. Hanelt, A., Bohnsack, R., Marz, D., & Antunes Marante, C. (2021). A systematic review of the literature on digital transformation: Insights and implications for strategy and organizational change. Journal of Management Studies, 58(5), 1159-1197.
66. Harrison, J. S., Freeman, R. E., & Abreu, M. C. S. D. (2015). Stakeholder theory as an ethical approach to effective management: Applying the theory to multiple contexts. Revista Brasileira de Gestão de Negócios, 17(55), 858-869.
67. Hasani, A., Zegordi, S. H., & Nikbakhsh, E. (2015). Robust closed-loop global supply chain network design under uncertainty: The case of the medical device industry. International Journal of Production Research, 53(5), 1596-1624.
68. Herron, D. M., Marohn, M. J. S. E., & SAGES-MIRA Robotic Surgery Consensus Group. (2008). A consensus document on robotic surgery. Surgical Endoscopy, 22, 313-325.
69. Hickmann, E., Richter, P., & Schlieter, H. (2022). All together now–patient engagement, patient empowerment, and associated terms in personal healthcare. BMC health services research, 22(1), 1116.
70. Hsieh, H. F., & Shannon, S. E. (2005). Three approaches to qualitative content analysis. Qualitative Health Research, 15(9), 1277-1288.
71. Huter, K., Krick, T., Domhoff, D., Seibert, K., Wolf-Ostermann, K., & Rothgang, H. (2020). Effectiveness of digital technologies to support nursing care: results of a scoping review. Journal of multidisciplinary healthcare, 1905-1926.
72. Ibrahimi, O. A., Avram, M. M., Hanke, C. W., Kilmer, S. L., & Anderson, R. R. (2011). Laser hair removal. Dermatologic Therapy, 24(1), 94-107.
73. Jaleel, A., Mahmood, T., Hassan, M. A., Bano, G., & Khurshid, S. K. (2020). Towards medical data interoperability through collaboration of healthcare device. IEEE Access, 8, 132302-132319.
74. Jensen, M. C. (2002). Value maximization, stakeholder theory, and the corporate objective function. Business Ethics Quarterly, 235-256.
75. Jeyarajah, K., & Morrison, B. (2020). A narrative review of the role of robotics in cancer surgery. Digestive Medicine Research, 3.
76. Jiang, F., Jiang, Y., Zhi, H., Dong, Y., Li, H., Ma, S., ... & Wang, Y. (2017). Artificial intelligence in healthcare: past, present and future. Stroke and vascular neurology, 2(4).
77. Jones, T. M., & Wicks, A. C. (1999). Convergent stakeholder theory. Academy of Management Review, 24(2), 206-221.
78. Judy, L. M., Morrow, C., & Seo, N. J. (2023). Development and evaluation of an efficient training program to facilitate the adoption of a novel neurorehabilitation device. Journal of Rehabilitation and Assistive Technologies Engineering, 10, 20556683231158552.
79. Kane, G. C., Palmer, D., Phillips, A. N., Kiron, D., & Buckley, N. (2015). Strategy, not technology, drives digital transformation. MIT Sloan Management Review and Deloitte University Press, 14(1–25).
80. Kang, M., Park, E., Cho, B. H., & Lee, K. S. (2018). Recent patient health monitoring platforms incorporating internet of things-enabled smart device. International Neurourology Journal, 22(Suppl 2), S76.
81. Kannegiesser, M., & Günther, H. O. (2011). An integrated optimization model for managing the global value chain of a chemical commodities manufacturer. Journal of the Operational Research Society, 62(4), 711-721.
82. Kaplan, A. V., Baim, D. S., Smith, J. J., Feigal, D. A., Simons, M., Jefferys, D., ... & Leon, M. B. (2004). Medical device development: From prototype to regulatory approval. Circulation, 109(25), 3068-3072.
83. Kaplan, R. S., & Porter, M. E. (2011). How to solve the cost crisis in health care. Harvard Business Review, 89(9), 46-52.
84. Kohli, R., & Melville, N. P. (2019). Digital innovation: A review and synthesis. Information Systems Journal, 29(1), 200-223.
85. Kotler, P., & Keller, K. L. (2012). Marketing management (14th ed.). Pearson Education.
86. Kramer, D. B., Xu, S., & Kesselheim, A. S. (2012). How does medical device regulation perform in the United States and the European Union? A systematic review. PLOS Medicine, 9(7), e1001276.
87. Kraus, S., Schiavone, F., Pluzhnikova, A., & Invernizzi, A. C. (2021). Digital transformation in healthcare: Analyzing the current state-of-research. Journal of Business Research, 123, 557-567.
88. Krippendorff, K. (1980). Validity in content analysis. In Computerstrategien für die Kommunikationsanalyse (Vol. 69).
89. Kuhr, J. C., Pretzel, J., Vagts, D. A., & Aldred, L. (2009). Integrating humans, device, and events in clinical workflow processes. In Business Process Management Workshops: BPM 2008 International Workshops (pp. 408-415). Springer Berlin Heidelberg.
90. Lacombe, V. G. (2004). Laser hair removal. Facial Plastic Surgery, 20(01), 85-89.
91. Lanfranco, A. R., Castellanos, A. E., Desai, J. P., & Meyers, W. C. (2004). Robotic surgery: A current perspective. Annals of Surgery, 239(1), 14-21.
92. Lang, V. A., & Nalan, D. (2018, April). Combination product patient training: How are patients trained and who conducts the training? In Frontiers in Biomedical Device (Vol. 40789, p. V001T09A003). American Society of Mechanical Engineers.
93. Lasi, H., Fettke, P., Kemper, H. G., Feld, T., & Hoffmann, M. (2014). Industry 4.0. Business & information systems engineering, 6, 239-242.
94. Laurenza, E., Quintano, M., Schiavone, F., & Vrontis, D. (2018). The effect of digital technologies adoption in healthcare industry: A case-based analysis. Business Process Management Journal, 24(5), 1124-1144.
95. Layne, J. E., Jepson, L. H., Carite, A., & Bergenstal, R. M. (2024). 983-P: Long-term improvement in CGM-measured glycemic control in adults with type 2 diabetes not treated with insulin—Real-world data. Diabetes, 73(Supplement_1).
96. Lehne, M., Sass, J., Essenwanger, A., Schepers, J., & Thun, S. (2019). Why digital medicine depends on interoperability. NPJ Digital Medicine, 2(1), 79.
97. Leiting, A. K., De Cuyper, L., & Kauffmann, C. (2022). The Internet of Things and the case of Bosch: Changing business models while staying true to yourself. Technovation, 118, Article 102497.
98. Lemon, K. N., & Verhoef, P. C. (2016). Understanding customer experience throughout the customer journey. Journal of Marketing, 80(6), 69-96.
99. Levkovskyi, B., Betzwieser, B., Löffler, A., & Wittges, H. (2020). Why do organizations change? A literature review on drivers and measures of success for digital transformation. Technovation.
100. Li, J. K., Tang, T., Zong, H., Wu, E. M., Zhao, J., Wu, R. R., ... & Shen, B. R. (2024). Intelligent medicine in focus: The 5 stages of evolution in robot-assisted surgery for prostate cancer in the past 20 years and future implications. Military Medical Research, 11(1), 58.
101. Lin, B., & Wu, S. (2022). Digital transformation in personalized medicine with artificial intelligence and the internet of medical things. Omics: A Journal of Integrative Biology, 26(2), 77-81.
102. Lindsay, M. R., & Lytle, K. (2022). Implementing best practices to redesign workflow and optimize nursing documentation in the electronic health record. Applied Clinical Informatics, 13(03), 711-719.
103. Luo, Y., Hu, Z., & Yu, K. (2018). The impact of the R&D expenditure and patent rights towards operating performance in medical device industry–an empirical study. Revista de Cercetare si Interventie Sociala, 61, 187-197.
104. Mahdi, F., & Ramani, A. (2021). Digital Transformation for MedTech: The time is now. IQVIA MedTech. Retrieved April 9, 2024, from https://www.iqvia.com/-/media/iqvia/pdfs/asia-pacific/white-papers/digital-transformation-for-medtech.pdf
105. Makower, J., Meer, A., & Denend, L. (2010). FDA impact on U.S. medical technology innovation: A survey of over 200. Health Affairs, 29(4), 748-755.
106. Marshall, D. A., Burgos-Liz, L., Pasupathy, K. S., Padula, W. V., IJzerman, M. J., Wong, P. K., ... & Osgood, N. D. (2016). Transforming healthcare delivery: Integrating dynamic simulation modeling and big data in health economics and outcomes research. PharmacoEconomics, 34, 115-126.
107. Mbonihankuye, S., Nkunzimana, A., & Ndagijimana, A. (2019). Healthcare data security technology: HIPAA compliance. Wireless Communications and Mobile Computing, 2019, 1-7.
108. McCarthy, A. D., Sproson, L., Wells, O., & Tindale, W. (2015). Unmet needs: Relevance to medical technology innovation? Journal of Medical Engineering & Technology, 39(7), 382-387.
109. Melnick, E. R., Fong, A., Nath, B., Williams, B., Ratwani, R. M., Goldstein, R., ... & Mete, M. (2021). Analysis of electronic health record use and clinical productivity and their association with physician turnover. JAMA Network Open, 4(10), e2128790-e2128790.
110. Mendes-Soares, H., Raveh-Sadka, T., Azulay, S., Ben-Shlomo, Y., Cohen, Y., Ofek, T., ... & Nelson, H. (2019). Model of personalized postprandial glycemic response to food developed for an Israeli cohort predicts responses in Midwestern American individuals. The American journal of clinical nutrition, 110(1), 63-75.
111. Miclăuş, T., Valla, V., Koukoura, A., Nielsen, A. A., Dahlerup, B., Tsianos, G. I., & Vassiliadis, E. (2020). Impact of design on medical device safety. Therapeutic Innovation & Regulatory Science, 54(4), 839-849.
112. Moorthy, S. A. S. (2013). Lifecycle challenges in long life and regulated industry products. In ICoRD'13: Global Product Development (pp. 833-844). Springer India.
113. Mosch, L., Poncette, A., Spies, C., Weber-Carstens, S., Schieler, M., Krampe, H., & Balzer, F. (2020). Proposal for an implementation framework for digital health technology in the intensive care unit: A qualitative study. Research Square.
114. Muehlburger, M., Kannengiesser, U., Krumay, B., & Stary, C. (2020). A framework for recognizing digital transformation opportunities. In Proceedings of the 28th European Conference on Information Systems (ECIS), An Online AIS Conference, June 15-17, 2020. Retrieved May 6, 2024, from https://aisel.aisnet.org/ecis2020_rp/82
115. Muntés-Mulero, V., Ripolles, O., Gupta, S., Dominiak, J., Willeke, E., Matthews, P., & Somosköi, B. (2019). Agile risk management for multi-cloud software development. IET Software, 13(3), 172-181.
116. Murgia, R. D., Noell, C., Weiss, M., & Weiss, R. (2022). Body contouring for fat and muscle in aesthetics: Review and debate. Clinics in Dermatology, 40(1), 29-34.
117. Najjar, R. (2023). Redefining radiology: a review of artificial intelligence integration in medical imaging. Diagnostics, 13(17), 2760.
118. Nambisan, S., Wright, M., & Feldman, M. (2019). The digital transformation of innovation and entrepreneurship: Progress, challenges, and key themes. Research Policy, 48(8), 103773.
119. Norman, D. A. (2010). Technology first, needs last: The research-product gulf. Interactions, 17(2), 38-42.
120. O’Reilly III, C. A., & Tushman, M. L. (2004). The ambidextrous organization. Harvard Business Review, 82(4), 74-83.
121. O’Reilly III, C. A., & Tushman, M. L. (2008). Ambidexterity as a dynamic capability: Resolving the innovator's dilemma. Research in Organizational Behavior, 28, 185-206.
122. Orihuela-Espina, F., & Sucar, L. E. (2016). Adaptation and customization in virtual rehabilitation. In Virtual Reality Enhanced Robotic Systems for Disability Rehabilitation (pp. 141-163). IGI Global.
123. Ovretveit, J., Keller, C., Hvitfeldt Forsberg, H., Essén, A., Lindblad, S., & Brommels, M. (2013). Continuous innovation: Developing and using a clinical database with new technology for patient-centred care—the case of the Swedish quality register for arthritis. International Journal for Quality in Health Care, 25(2), 118-124.
124. Pamparău, C., & Vatavu, R. D. (2021). FlexiSee: Flexible configuration, customization, and control of mediated and augmented vision for users of smart eyewear device. Multimedia Tools and Applications, 80(20), 30943-30968.
125. Park, Y., Choi, H. R., Shin, J. W., Huh, C. H., & Choi, K. C. (2023). A wearable OLED medical device for enhanced cutaneous wound healing and patient comfort: Revolutionizing dermatology. Journal of Information Display, 1-6.
126. Petrik, D., & Herzwurm, G. (2019, August). iIoT ecosystem development through boundary resources: a Siemens MindSphere case study. In Proceedings of the 2nd ACM SIGSOFT International Workshop on Software-Intensive Business: Start-Ups, Platforms, and Ecosystems (pp. 1-6).
127. Pietzsch, J. B., Shluzas, L. A., Paté-Cornell, M. E., Yock, P. G., & Linehan, J. H. (2009). Stage-gate process for the development of medical device. Journal of Medical Device, 3(2), 021004.
128. Porter, M. E. (1985). Competitive advantage: Creating and sustaining superior performance. Free Press.
129. PrimeKey Solutions AB. (n.d.). The key for security in healthcare and MedTech IoT: Flexibility and scalability. Retrieved April 17, 2024, from https://www.primekey.com/resources/the-key-for-security-in-healthcare-and-medtech-iot-flexibility-and-scalability/
130. Rahayu, S. A., Widianto, S., Defi, I. R., & Abdulah, R. (2021). Role of pharmacists in the interprofessional care team for patients with chronic diseases. Journal of multidisciplinary healthcare, 1701-1710.
131. Ramamurthy, K., Sen, A., & Sinha, A. P. (2008). Data warehousing infusion and organizational effectiveness. IEEE Transactions on Systems, Man, and Cybernetics-Part A: Systems and Humans, 38(4), 976-994.
132. Rammal, D. S., Alomar, M., & Palaian, S. (2024). AI-driven pharmacy practice: Unleashing the revolutionary potential in medication management, pharmacy workflow, and patient care. Pharmacy Practice, 22(2), 1–11.
133. Reddy, K., Gharde, P., Tayade, H., Patil, M., Reddy, L. S., Surya, D., & srivani Reddy, L. (2023). Advancements in robotic surgery: a comprehensive overview of current utilizations and upcoming frontiers. Cureus, 15(12).
134. RegDesk. (2023). The importance of medical device in healthcare. Retrieved December 28, 2024, from https://www.regdesk.co/the-importance-of-medical-device-in-healthcare/
135. Rodbard, D. (2016). Continuous glucose monitoring: A review of successes, challenges, and opportunities. Diabetes Technology & Therapeutics, 18(S2), S2-3.
136. Rogers, D. L. (2016). The digital transformation playbook: Rethink your business for the digital age. Columbia Business School Publishing.
137. Russell, M. (2019). Digital technologies: Supporting and advancing assessment practices in the classroom. In Classroom assessment and educational measurement (pp. 224-242). Routledge.
138. Rutala, W. A., & Weber, D. J. (2013). Disinfection and sterilization: An overview. American Journal of Infection Control, 41(5), S2-S5.
139. Schilling, M. A. (2017). Strategic management of technological innovation. McGraw-Hill.
140. Schneider Electric. (2025) What is EcoStruxure? Retrieved June 9, 2025, from https://www.se.com/ww/en/work/campaign/innovation/overview/
141. Schoville, R. R., & Titler, M. G. (2015). Guiding healthcare technology implementation: A new integrated technology implementation model. CIN: Computers, Informatics, Nursing, 33(3), 99-107.
142. Schwartz, J. G., Kumar, U. N., Azagury, D. E., Brinton, T. J., & Yock, P. G. (2016). Needs-based innovation in cardiovascular medicine: The Stanford Biodesign process. JACC: Basic to Translational Science, 1(6), 541-547.
143. Scott, S. V., & Orlikowski, W. J. (2013). Sociomateriality—Taking the wrong turning? A response to Mutch. Information and Organization, 23(2), 77-80.
144. Shobeiri, S. A. (2019). The innovation of medical device. In The Innovation and Evolution of Medical Device: Vaginal Mesh Kits (pp. 13-60).
145. Sodhro, A. H., Pirbhulal, S., & Sangaiah, A. K. (2018). Convergence of IoT and product lifecycle management in medical healthcare. Future Generation Computer Systems, 86, 380-391.
146. Sorenson, C., & Drummond, M. (2014). Improving medical device regulation: The United States and Europe in perspective. The Milbank Quarterly, 92(1), 114-150.
147. Sturgeon, T., Van Biesebroeck, J., & Gereffi, G. (2008). Value chains, networks, and clusters: Reframing the global automotive industry. Journal of Economic Geography, 8(3), 297-321.
148. Szymczak, C. C., & Walker, D. H. (2003). Boeing–a case study example of enterprise project management from a learning organisation perspective. The Learning Organization, 10(3), 125-137.
149. Tariq, M. U. (2024). Advanced wearable medical device and their role in transformative remote health monitoring. In Transformative Approaches to Patient Literacy and Healthcare Innovation (pp. 308-326). IGI Global.
150. Tettey, F., Parupelli, S. K., & Desai, S. (2024). A review of biomedical device: Classification, regulatory guidelines, human factors, software as a medical device, and cybersecurity. Biomedical Materials & Device, 2(1), 316-341.
151. Threatt, T., Pirtle, C. J., Dzwonkowski, J., & Johnson, K. B. (2020). Using a custom mobile application for change management in an electronic health record implementation. JAMIA Open, 3(1), 37-43.
152. Tolikas, M., Antoniou, A., & Ingber, D. E. (2017). The Wyss Institute: A new model for medical technology innovation and translation across the academic–industrial interface. Bioengineering & Translational Medicine, 2(3), 247-257.
153. Tu, Y.J., & Chang, H.L. (2022). e-Health service based on multi-stakeholder perspectives. Journal of Electronic Business, 24(1), 27–50.
154. Tushman, M. L., & O’Reilly III, C. A. (1996). Ambidextrous organizations: Managing evolutionary and revolutionary change. California Management Review, 38(4), 8-29.
155. Valenta, S., Ribaut, J., Leppla, L., Mielke, J., Teynor, A., Koehly, K., ... & SMILe study team. (2023). Context-specific adaptation of an eHealth-facilitated, integrated care model and tailoring its implementation strategies—a mixed-methods study as a part of the SMILe implementation science project. Frontiers in Health Services, 2, 977564.
156. Verganti, R. (2009). Design driven innovation: Changing the rules of competition by radically innovating what things mean. Harvard Business Press.
157. Verhoef, P. C., Kannan, P. K., & Inman, J. J. (2015). From multi-channel retailing to omni-channel retailing: Introduction to the special issue on multi-channel retailing. Journal of Retailing, 91(2), 174-181.
158. Vial, G. (2019). Understanding digital transformation: A review and a research agenda. The Journal of Strategic Information Systems, 28(2), 118–144.
159. von Schoen-Angerer, T., & Love, J. P. (2023). Equitable access to medicines, vaccines, and medical device. In Global Health Essentials (pp. 327-332). Cham: Springer International Publishing.
160. Vuković, D., Badnjević, A., & Omanović-Mikličanin, E. (2018). Cost effectiveness and increasing accuracy of medical device in legal metrology system: Case study Bosnia and Herzegovina. Inspection of Medical Device: For Regulatory Purposes, 271-289.
161. Waldman, S. A., & Terzic, A. (2019). Healthcare evolves from reactive to proactive. Clinical pharmacology and therapeutics, 105(1), 10.
162. Wang, T., Molassiotis, A., Chung, B. P. M., & Tan, J. Y. (2018). Unmet care needs of advanced cancer patients and their informal caregivers: A systematic review. BMC Palliative Care, 17, 1-29.
163. Warner, K. S., & Wäger, M. (2019). Building dynamic capabilities for digital transformation: An ongoing process of strategic renewal. Long Range Planning, 52(3), 326-349.
164. Weber, R. P. (1990). Basic content analysis (Vol. 49). Sage.
165. Westerman, G., Bonnet, D., & McAfee, A. (2014). Leading digital: Turning technology into business transformation. Harvard Business Review Press.
166. Westerman, G., Calméjane, C., Ferraris, P., et al. (2011). Digital transformation: A roadmap for billion-dollar organizations. MIT Center for Digital Business and Capgemini Consulting.
167. White, M. D., & Marsh, E. E. (2006). Content analysis: A flexible methodology. Library Trends, 55(1), 22-45.
168. World Health Organization. (2021). Standardization of medical device nomenclature. World Health Organization. Retrieved February 26, 2025, from https://apps.who.int/gb/ebwha/pdf_files/EB148/B148_13-en.pdf
169. World Health Organization. (n.d.). Medical device. Retrieved April 17, 2024, from https://www.who.int/health-topics/medical-device#tab=tab_1
170. Woudstra, K., Reuzel, R., Rovers, M., & Tummers, M. (2022). OP65 An overview of participatory approaches, stakeholders, methods, topics and challenges in medical device development: A scoping review. International Journal of Technology Assessment in Health Care, 38(S1), S25-S25.
171. Yang, Q., Al Mamun, A., Hayat, N., Salleh, M. F. M., Jingzu, G., & Zainol, N. R. (2022). Modelling the mass adoption potential of wearable medical device. PLOS One, 17(6), e0269256.
172. Yeh, M. Y., Wu, S. C., & Tung, T. H. (2018). The relation between patient education, patient empowerment and patient satisfaction: A cross-sectional-comparison study. Applied Nursing Research, 39, 11-17.
173. Yin, Robert K. (1984). Case Study Research. Applied Social Research Methods (Vol. 5).
174. Yoda, T. (2016). The effect of collaborative relationship between medical doctors and engineers on the productivity of developing medical device. R&D Management, 46(S1), 193-206.
175. Zamora, E. A. (2016). Value chain analysis: A brief review. Asian Journal of Innovation and Policy, 5(2), 116-128.
176. Zhang, K., Kumar, G., & Skedgel, C. (2021). Towards a new understanding of unmet medical need. Applied Health Economics and Health Policy, 19(6), 785-788. |
