Leveraging AI for Enhanced Quality Assurance in Medical Device Manufacturing

Tushar Khinvasara *

Medical Device and Pharmaceutical Manufacturing, USA.

Stephanie Ness

Diplomatische Akademie, Austria.

Abhishek Shankar

Indian Institute of Technology, Madras, India.

*Author to whom correspondence should be addressed.


Abstract

The medical device sector adheres to strict regulatory frameworks, requiring precise adherence to quality assurance (QA) processes during the production process. Conventional quality assurance (QA) approaches, although successful, sometimes require substantial time and resource allocations, resulting in possible obstacles and higher expenses. The emergence of Artificial Intelligence (AI) in recent years has completely transformed quality assurance (QA) methods in different sectors, providing unparalleled prospects for improved productivity, precision, and scalability. This research examines the possibility of using AI technologies to enhance quality assurance processes in the manufacturing of medical devices. Manufacturers may improve product quality and streamline production workflows by utilising AI techniques like machine learning, computer vision, and natural language processing to automate and optimize important QA procedures. Artificial intelligence systems can analyse large amounts of data to find abnormalities, uncover flaws, and anticipate any problems in real-time. This allows for proactive intervention and reduces the chances of non-compliance hazards. In addition, AI-powered QA systems provide adaptive learning capabilities, constantly enhancing performance through feedback and adapting to changing regulatory needs. The incorporation of artificial intelligence (AI) into current quality management systems enables smooth and efficient sharing of data and compatibility, promoting a comprehensive approach to quality control throughout the whole production process.

Keywords: Quality enhanced AI, quality assurance, artificial intelligence


How to Cite

Khinvasara, T., Ness , S., & Shankar , A. (2024). Leveraging AI for Enhanced Quality Assurance in Medical Device Manufacturing. Asian Journal of Research in Computer Science, 17(6), 13–35. https://doi.org/10.9734/ajrcos/2024/v17i6454

Downloads

Download data is not yet available.

References

Board, Defense Innovation AI principles: Recommendations on the ethical use of artificial intelligence by the department of defense: Supporting document. United States Department of Defense; 2019.

Buchanan B. Artificial Intelligence in Finance. 2019;1–50. Available:https://doi.org/10.5281/zenodo.2612537

Charniak E. Introduction to artificial intelligence. Pearson Education India; 1985.

Ghadge A, Er Kara M, Moradlou H, Goswami M. The impact of Industry 4.0 implementation on supply chains. Journal of Manufacturing Technology Management. 2020;31(4):669–686 Available:https://doi.org/10.1108/JMTM-10-2019-0368

Gupta D, Victor HC, De Albuquerque A, Khanna, Purnima Lala Mehta. (eds) Smart sensors for industrial internet of things. Springer International Publishing, Springer Cham; 2021 Available: https://doi.org/10.1007/978-3-030-52624-5

IFR. Available:https://ifr.org/ifr-press-releases/news/record-2.7-million-robots-work-in-factories-around- the-globe

Ivanov SH, Webster C. Adoption of robots, artificial intelligence and service automation by travel, tourism and hospitality companies – a cost-benefit analysis. Prepared for the international scientific conference. Contemporary Tourism – Traditions and Innovations, Sofia University. October 2017;19-21, Available at SSRN: https://ssrn.com/abstract=3007577

Kalyanakrishnan S, Panicker RA, Natarajan S, Rao S Opportunities and challenges for artificial intelligence in India. In: Proceedings of the 2018 AAAI/ACM conference on AI, ethics, and society. 2018;164–170.

Kubassova O, Shaikh F, Melus C, Mahler M. History, current status, and future directions of artificial intelligence. In: Precision medicine and artificial intelligence. Academic Press. 2021;1–38. Available https://doi.org/10.1016/B978-0-12-820239-5.00002-4

Lee LW, Dabirian A, McCarthy IP, Kietzmann J. Making sense of text: Artificial intelligence-enabled content analysis. European Journal of Marketing. 2020;54(3):615–644 Available: https://doi.org/10.1108/EJM-02-2019-0219

Luckin R, Holmes W, Griffiths M, Forcier LB Intelligence Unleashed: An argument for AI in Education. Pearson Education, London; 2016. Available:https://www.pearson.com/corporate/about-pearson/what-we-do/innovation/smarter-digital-tools/intelligence-unleashed.html

Osuizugbo IC, Alabi AS. Built environment professionals perceptions of the application of artificial intelligence in construction industry. Covenant J Res Built Environ. 2021;1–19 Available:https://www.researchgate.net/profile/Innocent-Osuizugbo/publication/357769049_Built_Environment_Professionals’_Perceptions_of_the_Appl ication_of_Artificial_Intelligence_in_Construction_Industry/links/61dea47a3a192d2c8af51b00/Built-Environment-Professionals-Perceptions-of-the-Application-of-Artificial-Intelligence-in- Construction-Industry.pdf

Rouhiainen L. Artificial intelligence: 101 things you must know today about our future. Lasse Rouhiainen; 2018.

ISBN 1982048808

Vempati SS. India and the artificial intelligence revolution, vol 1. Carnegie Endowment for International Peace. India; 2016.

Andonov S, Marija CB. Calibration for industry 4.0 metrology: Touchless calibration. J Phys Conf Ser. 2018;1065.

Aswal DK. Quality infrastructure of India and its importance for inclusive national growth. Mapan. 2020;35.

Aswal DK. Introduction: Metrology for all people for all time, in Metrology for inclusive growth of India. Springer: Singapore; 2020.

Azizi A. Applications of artificial intelligence techniques in industry 4.0. Berlin: Springer; 2019.

Bécue A, Praça I, Gama J. Artificial intelligence, cyber-threats and Industry 4.0: Challenges and opportunities. Artif Intell Rev. 2021;54.

Benitez R, Ramirez C, Vazquez JA. Sensors calibration for Metrology 4.0, in 2019 II workshop on metrology for industry 4.0 and IoT (MetroInd4. 0&IoT). IEEE; 2019.

Castelo-Branco I, Cruz-Jesus F, Oliveira T. Assessing industry 4.0 readiness in manufacturing: Evidence for the European Union. Comput Ind. 2019;107.

Clark J. Self-calibration and performance control of MEMS with applications for IoT. Sensors. 2018;18.

Compare M, Baraldi P, Zio E. Challenges to IoT-enabled predictive maintenance for industry 4.0. IEEE Internet Things J. 2019;7.

Dal M, et al. The effects of artificial intelligence, robotics, and industry 4.0 technologies. Insights from the Healthcare sector, in Proceedings of the first European Conference on the impact of Artificial Intelligence and Robotics; 2019.

Dopico M, et al. A vision of industry 4.0 from an artificial intelligence point of view, in Proceedings on the international conference on artificial intelligence (ICAI). The Steering Committee of The World Congress in Computer Science, Computer Engineering and Applied Computing (WorldComp); 2016.

Garg N, et al. Significance and implications of digital transformation in metrology in India. Measurement: Sensors. 2021;18.

Gómez-Robledo L, et al. Using the mobile phone as Munsell soil-colour sensor: An experiment under controlled illumination conditions. Comput Electron Agric. 2013;99.

Haenlein M, Kaplan A. A brief history of artificial intelligence: On the past, present, and future of artificial intelligence. Calif Manag Rev. 2019;61.

Hernavs J, et al. Deep learning in industry 4.0–brief overview. J Prod Eng. 2018;21.

Horváth D, Szabó RZ. Driving forces and barriers of Industry 4.0: Do multinational and small and medium-sized companies have equal opportunities? Technol Forecast Soc Chang. 2019;146.

Hsu CC, Tsaih RH, Yen DC. The evolving role of IT departments in digital transformation. Sustainability. 2018;10.

Hu F, et al. Flaw-detected coating sensors applied in aircraft R&M, in 2009 annual reliability and maintainability symposium. IEEE; 2009.

Ren L, Zhang L, Zhao C. Cloud manufacturing platform: Operating paradigm, functional requirements, and architecture design, in ASME Int. Manufacturing Science and Engineering Conf. collocated with the 41st North American Manufacturing Research Conf; 2013.

Wang XW, Industry 4.0: Road to the future industry of German manufacturing industry 2025 (Diagram). Beijing (in Chinese): China Machine Press; 2015.

Winnig LW. GE’s big bet on data and analytics. MIT Sloan Manag. Rev. 2016;57.

Yang T. Predix: The stage pillar of Industrial Internet. China Ind. Rev. 2015;10.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices; 2019 Available:https://eur-lex.europa.eu/eli/reg/2017/745 (Accessed on 15 November 2022)

European Commission—Growth—Regulatory Policy—NANDO Available:https://ec.europa.eu/growth/toolsdatabases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=3 (Accessed on 17 October 2022)

EUROPA—European Commission—Growth—Regulatory Policy – NANDO Available:https://ec.europa.eu/growth/toolsdatabases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 (Accessed on 17October 2022)

US Food and Drug Administration Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. Available: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices (Accessed on 20 October 2022)

EUDAMED Database—EUDAMED Available:https://ec.europa.eu/tools/eudamed/#/screen/home (Accessed on 15 November 2022)

Artificial intelligence act: A welcomed initiative, but ban on remote biometric identification in public space is Necessary|European data protection supervisor. Available:https://edps.europa.eu/press-publications/press-news/press-releases/2021/artificial-intelligence- act-welcomed-initiative (Accessed on 22 November 2022)

Floridi L. The European legislation on AI: A brief analysis of its philosophical approach. Philos Technol. 2021;34.

Jeon B, et al. The architecture development of Industry 4.0 compliant smart machine tool system (SMTS). J Intell Manuf. 2020;31.

Jia F, et al. Deep neural networks: A promising tool for fault characteristic mining and intelligent diagnosis of rotating machinery with massive data. Mech Syst Signal Process. 2016;72.

Kalsoom T, et al. Advances in sensor technologies in the era of smart factory and industry 4.0. Sensors. 2020;20.

Khanzode KCA, Sarode RD. Advantages and disadvantages of artificial intelligence and machine learning: A literature review. Int J Lib Inf Sci (IJLIS). 2020;9.

Khemani D. A perspective on AI research in India. AI Mag. 2012;33.

Kinkel S, Baumgartner M, Cherubini E. Prerequisites for the adoption of AI technologies in manufacturing–evidence from a worldwide sample of manufacturing companies. Technovation. 2022;110.

Landaluce H, et al. A review of IoT sensing applications and challenges using RFID and wireless sensor networks. Sensors. 2020;20.

Leal-Junior A, et al. Application of additive layer manufacturing technique on the development of high sensitive fiber Bragg grating temperature sensors. Sensors. 2018;18.

Lebosse C, et al. Modeling and evaluation of low-cost force sensors. IEEE Trans Robot. 2011;27.

Lee J, et al. Industrial Artificial Intelligence for industry 4.0-based manufacturing systems. Manuf Lett. 2018;18.

Lee J, et al. High-performance gas sensor array for indoor air quality monitoring: The role of Au nanoparticles on WO 3, SnO2, and NiO-based gas sensors. J Mater Chem A. 2021;9.

Lee, S, et al. A transparent bending-insensitive pressure sensor. Nat Nanotechnol. 2016;11.

Lewis GD, Merken P, Vandewal M. Enhanced accuracy of CMOS smart temperature sensors by nonlinear curvature correction. Sensors. 2018;18.

Makridakis S. The forthcoming artificial intelligence (AI) revolution: Its impact on society and firms. Futures. 2017;90.

Malali AB, Gopalakrishnan S. Application of artificial intelligence and its powered technologies in the Indian banking and financial industry: An overview. IOSR J Humanit Soc Sci. 2020;25.

Malhi A, Yan R, Gao RX. Prognosis of defect propagation based on recurrent neural networks. IEEE Trans Instrum Meas; 2011;60.

Malik G, Tayal DK, Vij S. An analysis of the role of artificial intelligence in education and teaching, in Recent findings in intelligent computing techniques. Springer: Singapore; 2019.

Marda V. Artificial intelligence policy in India: A framework for engaging the limits of data- driven decision-making. Philos Trans R Soc A Math Phys Eng Sci. 2018;376.

Mhlanga D. Artificial intelligence in the industry 4.0, and its impact on poverty, innovation, infrastructure development, and the sustainable development goals: Lessons from emerging economies? Sustainability. 2021;13.

Mogali S. Artificial intelligence and its applications in libraries, in Conference: Bilingual international conference on information technology: Yesterday, today and tomorrow. At Defence Scientific Information and Documentation Centre, Ministry of Defence Delhi; 2014.

Moheimani R, et al. Mathematical model and experimental design of nanocomposite proximity sensors. IEEE Access. 2020;8.

Peres RS, et al. Industrial artificial intelligence in industry 4.0-systematic review, challenges and outlook. IEEE Access. 2020;8.

Sakai O, et al. In-vacuum active colour sensor and wireless communication across a vacuum- air interface. Sci Rep. 2021;11.

Robert C, Moy C, Wang CX. Reinforcement learning approaches and evaluation criteria for opportunistic spectrum access. In: IEEE International Conference on Communications (ICC), IEEE; 2014.

Agrawal R, Srikant R. Fast algorithms for mining association rules. In: Proceedings of the 20th International Conference on Very Large Data Bases, VLDB; 1994.

Larcheveque JMHD, et al. Semantic clustering. Google Patents; 2016.

Liu NN, Zhao M, Yang Q. Probabilistic latent preference analysis for collaborative filtering. In: Proceedings of the 18th ACM Conference on Information and Knowledge Management, ACM; 2009.

Zhao X, Zhang W, Wang J. Interactive collaborative filtering. In: Proceedings of the 22nd ACM International Conference on Information and Knowledge Management, ACM; 2013.

Amirian P, Lang T, Loggerenberg F. Big Data in Healthcare: Extracting Knowledge from Point-of-Care Machines. Cham: Springer; 2017.

Bollinger T. Assoziationsregeln – analyse eines data mining verfahrens. Informatik-Spektrum. 1996;19.

Chatterjee S, Hadi AS. Regression Analysis by Example. New York: Wiley; 2015.

Dhanachandra N, Manglem K, Chanu YJ. Image segmentation using K-means clustering algorithm and subtractive clustering algorithm. Procedia Comput. Sci. 2015;54.

Gluchowski P, Chamoni P. Analytische Informationssysteme: Business Intelligence- Technologien und -Anwendungen. Berlin/Heidelberg: Springer Imprint/Springer Gabler; 2016.

Gong S. A collaborative filtering recommendation algorithm based on user clustering and item clustering. JSW. 2010;5.

Goodfellow I. Deep Learning. Cambridge: MIT Press; 2016.

Kim N. Load profile extraction by mean-shift clustering with sample Pearson correlation coefficient distance. Energies. 2018;11.

Michalski RS, Carbonell JG, Mitchell TM. Machine Learning: An Artificial Intelligence Approach. Berlin: Business Media; 2013.

Sutton RS, Barto AG. Reinforcement Learning: An Introduction. Cambridge: MIT Press; 2018.

Casadesus-Masanell R, Ricart JE. How to design a winning business model. Harvard Business Review [Internet]; 2011 Jan 1 [cited 2020 Jan 8]. Available: https://hbr.org/2011/01/how-to-design-a- winning-business-model

Baima G, Forliano C, Santoro G, Vrontis D. Intellectual capital and business model: A systematic literature review to explore their linkages. J Intellect Cap; 2020. Available: https://doi.org/10.1108/JIC-02-2020-0055

Secinaro S, Calandra D, Secinaro A, Muthurangu V, Biancone P. Artificial Intelligence for healthcare with a business, management and accounting, decision sciences, and health professions focus [Internet]. Zenodo; 2021 [cited 2021 Mar 7] Available:https://zenodo.org/record/4587618#.YEScpl1KiWh

Jacoby WG. Electoral inquiry section Loess: A nonparametric, graphical tool for depicting relationships between variables q. In; 2000.

Kumar S, Kumar S. Collaboration in research productivity in oil seed research institutes of India. In: Proceedings of fourth international conference on webometrics, informetrics and scientometrics. 2008;28–1.

London School of Economics. 3: Key measures of academic influence [Internet]. Impact of social sciences; 2010 [cited 2021 Jan 13]. Available:https://blogs.lse.ac.uk/impactofsocialsciences/the-handbook/chapter-3-key-measures-of-academic-influence

Oxford University Press. Oxford English Dictionary [Internet]; 2020. Available: https://www.oed.com

Wartena C, Brussee R. Topic detection by clustering keywords. In: 2008 19th International Workshop on Database and Expert Systems Applications. 2008;54–8.

Redondo T, Sandoval AM. Text Analytics: The convergence of big data and artificial intelligence. Int J Interact Multimed Artif Intell. 2016;3. Available:https://www.ijimai.org/journal/bibcite/reference/2540

Kalis B, Collier M, Fu R. 10 Promising AI Applications in Health Care; 2018;5.

Kayyali B, Knott D, Van Kuiken S. The ‘big data’ revolution in US healthcare [Internet]. McKinsey and Company; 2013 [cited 2020 Aug 14]. Available:https://healthcare.mckinsey.com/big-data- revolution-us-healthcare

Use of telemedicine and virtual care for remote treatment in response to COVID-19 pandemic. J Med Syst; 2020;44.

Agrawal A, Gans JS, Goldfarb A. Exploring the impact of artificial intelligence: Prediction versus judgment. Inf Econ Policy. 2019;1.

Ahmed MA, Alkhamis TM. Simulation optimization for an emergency department healthcare unit in Kuwait. Eur J Oper Res. 2009;198.

Aisyah M, Cockcroft S. A snapshot of data quality issues in Indonesian community health. Int J Netw Virtual Organ. 2014;14.

Aria M, Cuccurullo C. Bibliometrix: An R-tool for comprehensive science mapping analysis. J Informetr. 2017;11.

Baig MM, et al. A systematic review of wearable patient monitoring systems—current challenges and opportunities for clinical adoption. J Med Syst. 2017;41.

Bennett CC, Hauser K. Artificial intelligence framework for simulating clinical decision- making: A Markov decision process approach. Artif Intell Med. 2013;57.

Bert F, et al. HIV screening in pregnant women: A systematic review of cost-effectiveness studies. Int J Health Plann Manag. 2018;33.

Biancone P, et al. Management of open innovation in healthcare for cost accounting using EHR. J Open Innov Technol Market Complex. 2019;5.

Biancone PP, et al. Data quality methods and applications in health care system: A systematic literature review. Int J Bus Manag. 2019;14.

Burton RJ, et al. Using artificial intelligence to reduce diagnostic workload without compromising detection of urinary tract infections. BMC Med Inform Decis Mak. 2019;19.

Calandra D, Favareto M. Artificial Intelligence to fight COVID-19 outbreak impact: An overview. Eur J Soc Impact Circ Econ; 2020;1.

Carter D. How real is the impact of artificial intelligence? Bus Inf Surv. 2018;35.

Chakradhar S. Predictable response: Finding optimal drugs and doses using artificial intelligence. Nat Med. 2017;23.

Chen G, Xiao L. Selecting publication keywords for domain analysis in bibliometrics: A comparison of three methods. J Informet. 2016;10.

Chen X, et al. A comparative quantitative study of utilizing artificial intelligence on electronic health records in the USA and China during 2008–2017. BMC Med Inform Decis Mak. 2018;18.

Choudhury A, Asan O. Role of artificial intelligence in patient safety outcomes: Systematic literature review. JMIR Med Inform. 2020;8.

Cho BJ, et al. Classification of cervical neoplasms on colposcopic photography using deep learning. Sci Rep. 2020;10.

Choudhury A, Renjilian E, O Asan. Use of machine learning in geriatric clinical care for chronic diseases: A systematic literature review. JAMIA Open. 2020;3.

Collins GS, Moons KGM. Reporting of artificial intelligence prediction models. Lancet. 2019;393.

Connelly TM, et al. The 100 most influential manuscripts in robotic surgery: A bibliometric analysis. J Robot Surg. 2020;14.

Davenport T, Kalakota R. The potential for artificial intelligence in healthcare. Future Healthc J. 2019;6.

Doyle OM, Leavitt N, Rigg JA. Finding undiagnosed patients with hepatitis C infection: An application of artificial intelligence to patient claims data. Sci Rep. 2020;10.

Dumay J, Cai L. A review and critique of content analysis as a methodology for inquiring into IC disclosure. J Intellect Cap. 2014;15.

Dumay J, Guthrie J, Puntillo P. IC and public sector: A structured literature review. J Intellect Cap. 2015;16.

Elango B, Rajendran D. Authorship trends and collaboration pattern in the marine sciences literature: A scientometric Study. Int J Inf Dissem Technol. 2012;1.

Engqvist L, Frommen JG. The h-index and self-citations. Trends Ecol Evol. 2008;23.

Falagas ME, et al. Comparison of PubMed, Scopus, Web of Science, and Google Scholar: Strengths and weaknesses. FASEB J. 2007;22.

Fleming N. How artificial intelligence is changing drug discovery. Nature. 2018;557.

Forina M, Armanino C, Raggio V. Clustering with dendrograms on interpretation variables. Anal Chim Acta. 2002;454.

Forliano C, Bernardi P, Yahiaoui D. Entrepreneurial universities: A bibliometric analysis within the business and management domains. Technol Forecast Soc Change. 2021;1.

Gatto A, Drago C. A taxonomy of energy resilience. Energy Policy. 2020;136.

Gu D, et al. Visualizing the intellectual structure and evolution of electronic health and telemedicine research. Int J Med Inform. 2019;130.

Guo J, Li B. The application of medical artificial intelligence technology in rural areas of developing countries. Health Equity. 2018;2.

Guo Y, et al. Artificial intelligence in health care: Bibliometric analysis. J Med Internet Res; 2020. 22.

Haleem A, Javaid M, Khan IH. Current status and applications of Artificial Intelligence (AI) in medical field: An overview. Curr Med Res Pract. 2019;9.

Hao T, et al. A bibliometric analysis of text mining in medical research. Soft Comput. 2018;22.

Hoff T. Deskilling and adaptation among primary care physicians using two work innovations. Health Care Manag Rev. 2011;36.

Huang Y, et al. Rehabilitation using virtual reality technology: A bibliometric analysis, 1996– 2015. Scientometrics. 2016;109.

Hussain AA, et al. AI Techniques for COVID-19. IEEE Access. 2020;8.

Jiang F, et al. Artificial intelligence in healthcare: Past, present and future. Stroke Vasc Neurol. 2017;2.

Junquera B, Mitre M. Value of bibliometric analysis for research policy: A case study of Spanish research into innovation and technology management. Scientometrics. 2007;71.

Khan G, Wood J. Information technology management domain: Emerging themes and keyword analysis. Scientometrics. 2015;9.

Levitt JM, Thelwall M. Alphabetization and the skewing of first authorship towards last names early in the alphabet. J Informet. 2013;7.

Levy Y, Ellis TJ. A systems approach to conduct an effective literature review in support of information systems research. Inf Sci Int J Emerg Transdiscipl. 2006; 9.

Liao H, et al. A bibliometric analysis and visualization of medical big data research. Sustainability. 2018;10.

Liberati A, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. Plos Med. 2009;6.

Lu J. Will medical technology deskill doctors? Int Educ Stud. 2016;9.

Mas F, et al. Knowledge translation in the healthcare sector. A structured literature review. Electron J Knowl Manag. 2020;18.

Mas F, et al. From output to outcome measures in the public sector: A structured literature review. Int J Organ Anal. 2019;27.

Mas FD, et al. La performance nel settore pubblico tra misure di out-put e di outcome. Una revisione strutturata della letteratura ejvcbp. 2020;1.

Massaro M, Dumay J, Guthrie J. On the shoulders of giants: Undertaking a structured literature review in accounting. Account Auditing Account J. 2016;29.

Mehta N, Pandit A, Shukla S. Transforming healthcare with big data analytics and artificial intelligence: A systematic mapping study. J Biomed Inform. 2019;1.

Meskò B, et al. Digital health is a cultural transformation of traditional healthcare. Mhealth. 2017;3.

Novak D, Riener R. Control strategies and artificial intelligence in rehabilitation robotics. AI Mag. 2015;36.

Panch T, Szolovits P, Atun R. Artificial intelligence, machine learning and health systems. J Glob Health. 2018;8.

Paul J, Criado AR. The art of writing literature review: What do we know and what do we need to know? Int Bus Rev. 2020;29.

National Manufacturing Strategy Advisory Committee (NMSAC), Strategy Advisory Center of the Chinese Academy of Engineering (SACCAE). Intelligent Manufacturing. Publishing House of Electronics Industry, Beijing (in Chinese); 2016

Miao W. Speech at the National Meeting to Exchange Pilot and Demonstration Experiences on Intelligent Manufacturing (in Chinese); 2016 Available:http://mt.sohu.com/20160728/n461524353.shtml

Drath R, Horch A. Industrie 4.0: hit or hype? IEEE Ind. Electron. Mag; 2014;8.

Evans PC, Annunziata M. Industrial Internet: Pushing the Boundaries of Minds and Machines, in General Electric; 2012.

Ivanov D, Dolgui A, Sokolov B. A dynamic model and an algorithm for short-term supply chain scheduling in the smart factory industry 4.0. Int. J. Prod. Res. 2016;54.

Lasi H, Fettke P, Kemper HG. Industry 4.0. Business Inform. Syst. Eng. 2014;6.

Lee J, Bagheri B, Kao HA. A cyber-physical systems architecture for Industry 4.0-based manufacturing systems. Manuf. Lett. 2015;3.

Li BH, Zhang L, Chai XD. Smart cloud manufacturing (cloud manufacturing 2.0)-a new paradigm and approach of smart manufacturing, in Proc. Int. Intelligent Manufacturing Conf; 2014.

Li BH, L Zhang, Wang SL. Cloud manufacturing: A new service-oriented networked manufacturing model. Comput. Integr. Manuf. Syst. 2010;16.

Li P. Accelerate the construction and application of industrial intelligent cloud platform. High Technol. Ind. 2016;5.

Pan YH. Heading toward artificial intelligence 2.0. Engineering. 2016;2.

Posada J, Toro C, Barandiaran I. Visual computing as a key enabling technology for industrie 4.0 and industrial Internet. IEEE Comput. Graph. Appl. 2015;35.

Kashmer D, Cannon S, Wolf M, Gray J, Hayne W. Ten secrets: A healthcare quality improvement handbook: The Healthcare Lab, Inc; 2018.

Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academies Press; 2001.

Bradley EH, Yuan CT. Quality of care in low- and middle-income settings: What next? Int J Qual Health Care. 2012;24.

Eyob B, et al. Ensuring safe surgical care across resource settings via surgical outcomes data and quality improvement initiatives. Int J Surg. 2019;72.

Garcia-Elorrio E, Schneider EC. Research on health-care quality improvement in low- and middle-income countries: Is it a worthy investment? Int J Qual Health Care. 2012;24.

Hanefeld J, Powell-Jackson T, Balabanova D. Understanding and measuring quality of care: Dealing with complexity. Bull World Health Organ. 2017;95.

Leatherman S, et al. The role of quality improvement in strengthening health systems in developing countries. Int J Qual Health Care. 2010;22.

Magge H, Kiflie A, Nimako K. The Ethiopia healthcare quality initiative: Design and initial lessons learned. Int J Qual Health Care. 2019;31.

Muehlematter UJ, Daniore P, Vokinger KN. Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): A comparative analysis. Lancet Digit Health; 2021;3.

Witten IH. Data mining: Practical machine learning tools and techniques. Cambridge: Morgan Kaufmann; 2016.