IJSOM2023, Volume 10, Issue 2, pp. 117-135ISSN-Print: 2383-1359ISSN-Online: 2383-2525www.ijsom.comModelling and Analysis of Challenges for Industry 4.0 Implementation in Medical DeviceIndustry to Post COVID -19 ScenarioSanjiv Narula a, Anil Kumar *, b, Surya Prakash c, Maheshwar Dwivedy c, Harish Puppalac and Vishal Talwar aa School of Management. BML Munjal University, Gurugram, Haryanab Guildhall School of Business and Law, London Metropolitan University, London, UKc School of Engineering and Technology. BML Munjal University, Gurugram, HaryanaAbstractToday, the health care and medical sector is adopting digital technologies aggressively. However, this adoption also hassignificant challenges, especially during COVID-19. This research aims to identify and categorize the significantchallenges related with application of Industry 4.0 (I4.0) technologies in the medical device industry. An expert-basedsurvey is carried to capture the perception of medical device industry leaders about the challenges associated with theimplementation of digital technologies. Further, interpretive structural modeling (ISM) method was used for an empiricalinvestigation of the hierarchy and interdependencies of identified challenges. The authors have proposed a mind map andconceptual model of hierarchy and interdependencies of challenges associated with the digital transformation of themedical device industry towards I4.0. Industry leaders and policymakers worldwide are defying challenges while thedigital transformation of the organizations post COVID-19. The I4.0 implementation challenges identified and ategorizedin this research may aid as a guide for medical device manufacturing organizations while designing a strategy for I4.0transformation and to make sure that they start on the right -footing. Most of the existing work is focused on theadvantages of I4.0 for managing the organization's post-COVID-19, lacks thoroughness and testing. Owing to theidentified gap, this study intends to empirically identify the critical challenges associated with applying I4.0 technologiesin the medical device manufacturing sector. This study is a pioneer in identifying and categorizing the vital challengesneeded to deal with this critical situation. A potential area of future research can be the validation of the identifiedchallenges with a larger sample size.Keywords: Industry 4.0; Medical device manufacturing; Digital technologies COVID-19; Interpretive structuralmodeling (ISM); Smart factory.1. IntroductionDue to the coronavirus outburst, industrialized operations across the globe are witnessing unforeseen disruption (Mitra etal., 2020; Nicola et al., 2020). The prime focus in the current scenario acclimatizing to the absurdly transformed state ofaffairs (Ranney et al., 2020). The medical sector shows incredible agility to meet the increasing demand for medicaldevices, health care equipment, personal protective equipment (PPEs), and medicines (Spina et al., 2020). The

Healthcare 4.0: Trends, Challenges and BenefitsFull PaperMati Ur RehmanSchool of BusinessSwinburne University of TechnologyMelbourne, AustraliaEmail: [email protected] Eslami AndargoliSchool of BusinessSwinburne University of TechnologyMelbourne, AustraliaEmail: [email protected] PoustiSchool of BusinessSwinburne University of TechnologyMelbourne, AustraliaEmail: [email protected] Fourth Industry Revolution, known as Industry 4.0, refers to the forces that are transformingindustry, including the healthcare industry, where it has been termed Healthcare 4.0. Though laggingother industries in the adoption of new innovative technologies, the healthcare industry is embracingthe potential benefits that arise from new innovative technologies. New trends revealed both in theacademic literature and by industry practice show that researchers and practitioners are becoming moreaware of the benefits technology can bring to an industry as complex as the healthcare industry. Theobject of the study is to identify the challenges, trends and gaps in the existing body of research withregard to Healthcare 4.0. In this study, a systematic literature review on Healthcare 4.0 research paperswas conducted to identify trends, challenges and the perceived benefits that may arise from it. This paperfound that there is a need to conduct more empirical studies in this area. It, further, identified the needto implement practical procedures in the industry to get feedback from patients and healthcareparticipants in order to promote the adoption of new Healthcare 4.0 technologies.Keywords: Health 4.0, Industry 4.0, healthcareAustralasian Conference on Information Systems Rehman, Andargoli & Pousti2019, Perth Western Australia Healthcare 4.05571 INTRODUCTIONIndustry 4.0 is changing all segments of the industry (Pang et al. 2018). Starting mainly with a focus onthe manufacturing sector, it is now affecting other industries, such as healthcare, where it has beencalled Healthcare 4.0 (Chung and Kim 2016). The research was conducted using a systematic literaturereview of healthcare research articles to identify the trends, challenges, and perceived benefits inHealthcare 4.0.The healthcare industry has already experienced several waves of technological change, starting withHealthcare 1.0, where doctors kept patient records manually (Hathaliya et al. 2019). Healthcare 2.0followed, where paper-based manual records were replaced by electronic record (Hathaliya et al. 2019).Healthcare 3.0 advanced to the point where wearable devices were introduced (Hathaliya et al. 2019).The key technological characteristic that individuates Healthcare 4.0 from its predecessors is that a largenumber of devices of varying types communicate with each other (a) to monitor a patient’s health and(b) to conduct other health-related activities driven by Internet of Things (IoT) , Cyber-physical Systems(CPS) and Internet of Services (Chung and Kim 2016). Pang et al. (2018) defines Healthcare 4.0 as acombined application of IOT, artificial intelligence, robotic, and intelligent sensing in healthcare inorder to transform its value chain. It aims at digitising healthcare enterprise and services. Therefore, inthis paper we aim to highlight the implication of this technology for the practice and delivery ofhealthcare services.2 METHODOLOGYThis paper follows the six step approach of Mathiassen et al. (2004) for conducting a systematicliterature review. Firstly, four academic databases, Scopus, Science Direct, PubMed and Web of Sciencewere selected, and then two search categories were used to search them. One focusing on Health andrelated terms, such as ‘Healthcare OR Clinics OR Hospitals OR Pharmacy; and the other focusing onIndustry 4.0 concepts, such as Industry 4.0 OR Healthcare 4.0 OR Care 4.0. Then, after having scannedeach article’s title and abstract, the researchers chose a data set of relevant for a full text review. Then,other relevant articles selected from the reference list of chosen articles in pervious step.The search covered papers published in English to July 2019, which were then filtered according tosteps: (1) duplicates were removed; (2) books, book chapters, and conference papers were eitherremoved or filtered based on their abstract and title; and (3) all the remaining papers were read in detailto identify those papers which focused on Health 4.0. The research process flow is shown in Figure 1

Covid-19 had a significant impact in South Africa. The disease has caused widespread disruption in various areas of the economy. The pandemic devastated several areas, for example, economic growth, social and political life, and the healthcare sector. However, there was a significant improvement in the adoption and use of technology in delivering various services. This improved response to the fourth industrial revolution was registered in the various sectors of the South African economy. Investigate the effects of the COVID-19 crisis on implementing the Fourth Industrial Revolution technologies in South Africa. Identify and discuss areas of the South African economy that have responded strongly to 4IR due to the pandemic. Compulsory sources to peruse: 11.Ojo-Fafore, E., Aigbavboa, C. and Thwala, W., 2021. The impact of the Covid 19 pandemic on the development of the fourth industrial revolution in Southern Africa. Journal of Intellectual Disability-Diagnosis and Treatment. 9(1):56-63. Retrieved from https://www.lifescienceglobal.com/pms/index.php/jiddt/article/view/7190/3884 [Accessed 27 March 2023]. (Google Scholar). 12.Neto, R.D.C.S., Maia, J.S., de Silva Neiva, S., Scalia, M.D. and de Andrade, J.B.S.O., 2020. The fourth industrial revolution and the coronavirus: a new era catalyzed by a virus. Research in Globalization. 2:100024. Retrieved from https://www.sciencedirect.com/science/article/pii/S2590051X20300137 [Accessed 28 March 2023]. (HTML). 13.Adelowotan, M., 2021. Educational Innovations for Coping up with COVID-19 Situation in South African Universities. Eurasian Journal of Educational Research, 95:139-155. Retrieved from https://files.eric.ed.gov/fulltext/EJ1321447.pdf [Accessed 28 March 2023]. (Google Scholar).

Introduction to the Special Section:Convergence of Automation Technology,Biomedical Engineering, and Health InformaticsToward the Healthcare 4.0Zhibo Pang , Senior Member, IEEE, Geng Yang , Member, IEEE, Ridha Khedri, Member, IEEE,and Yuan-Ting Zhang, Fellow, IEEEAbstract—Industry 4.0 is spilling out from manufacturingto healthcare. In this article, we provide a brief history andkey enabling technologies of Industry 4.0, and its revolu-tion in healthcare—Healthcare 4.0—and its reshaping of thelandscape of the entire healthcare value chain. We discussthe shift in the system design paradigm from open, small,and single loop to closed, large, and multiple loops. We pro-vide the example of a Caregiving Home, and discuss emerg-ing research topics and challenges, including healthcare bigdata, automated medical production, healthcare robotics,and human–robot symbiosis. Relevant papers published inthis special section are also presented.Index Terms—Caregiving Home, convergence, Health-care 4.0, healthcare robotics, human–robot symbiosis,Industry 4.0.I. I NTRODUCTIONTHE FOURTH REVOLUTION of industry (Industry 4.0)is reshaping all the segments of industries. Pulled bygrand social challenges, automation technologies are dramat-ically “spilling out” from traditional scenarios, such as factoriesand workshops, to everyday life. The traditional research areasof biomedical engineering and health informatics for the agingThis work was supported in part by Open Foundation of the StateKey Laboratory of Fluid Power and Mechatronic Systems at ZhejiangUniversity under the Grant GZKF-201703, in part by the FundamentalResearch Funds for the Central Universities, in part by the Open Foun-dation of the State Key Laboratory of Fluid Power and Mechatronic Sys-tems, in part by the Science Fund for Creative Research Groups of theNational Natural Science Foundation of China under Grant 51521064, inpart by NSFC-Zhejiang Joint Fund for the Integration of Industrializationand Informatization under Grant U1509204, and in part by the NaturalSciences and Engineering Research Council of Canada (NSERC) underGrant RGPIN 2014-06115. (Corresponding author: Geng Yang.)Z. Pang is with the ABB AB, Corporate Research, V ¨aster ˚as 72178,Sweden (e-mail: [email protected]).G. Yang is with the State Key Laboratory of Fluid Power and Mecha-tronic Systems, School of Mechanical Engineering, Zhejiang University,Hangzhou 310027, China (e-mail: [email protected]).R. Khedri is with the Department of Computing and Software, Facultyof Engineering, McMaster University, Hamilton, ON L8S 4L8, Canada(e-mail: [email protected]).Y.-T. Zhang is with the Department of Mechanical and Biomedical En-gineering, City University of Hong Kong, Hong Kong (e-mail: [email protected]).Digital Object Identifier 10.1109/RBME.2018.2848518population have gained unprecedented interest from the automa-tion industry. The research landscape in both academia and in-dustry is significantly reshaped with the cross-disciplinary syn-ergy of expertise and the deep convergence of automation tech-nology, biomedical engineering, and health informatics. Thistrend has been driving the rapid development of health engi-neering, an emerging interdisciplinary field for the predictive,preventive, precise, and personalized medicine. More powerfultools from process or factory automation, such as distributedcontrol systems and robotics, are penetrating into biomedicineand healthcare applications [1], [2]. For example, research ac-tivities related to robotics for biomedicine and healthcare havebeen largely intensified in the recent years [3], [4].The goal of this special section is threefold: 1) to reviewthe advancement in the convergence of automation technology,biomedical engineering, and health informatics; 2) to identifythe gap between the state-of-the-art of research and industrialdemands; and 3) to envision the directions for future research.The application scenarios can cover single or multiple scenariosof health engineering, such as primary care, preventive care,predictive technologies, hospitalization, home care, and occu-pational health. We focus on the cross-disciplinary approaches,solutions, and initiatives rather than single disciplinary ones.II. I MPACT OF I NDUSTRY 4.0 TO HEALTHCAREA. Industry 4.0 Basics and Key TechnologiesIndustry 4.0 (also sometimes spelled as Industrie 4.0) is avision for a new industrial revolution put forward by the Com-munication Promoters Group of the Industry–Science ResearchAlliance to further enhance Germsany’s manufacturing industry[5]. Several other countries, such as China and India, followedby articulating similar visions. The current advances in the fol-lowing areas trigger the Industry 4.0 vision.Cyber-physical systems (CPS) refers to the area where sys-tems incorporate computation and physical processes. Thesophistication that is reached in harnessing machine controlthrough computing provides unprecedented efficiency in thephysical processes and gives levels of performance neverreached before. As early as the 1970s, we started to designsystems where we embedded the computing driven control into

Industry 4.0 Applications for Medical/Healthcare ServicesShuva Paul 1,* , Muhtasim Riffat 2 , Abrar Yasir 2, Mir Nusrat Mahim 2, Bushra Yasmin Sharnali 2,Intisar Tahmid Naheen 2, Akhlaqur Rahman 3 and Ambarish Kulkarni 4



Citation: Paul, S.; Riffat, M.; Yasir, A.;Mahim, M.N.; Sharnali, B.Y.; Naheen,I.T.; Rahman, A.; Kulkarni, A.Industry 4.0 Applications forMedical/Healthcare Services. J. Sens.Actuator Netw. 2021, 10, 43.https://doi.org/10.3390/jsan10030043Academic Editors: Igor Bisio andClaudio SavaglioReceived: 20 March 2021Accepted: 24 June 2021Published: 30 June 2021Publisher’s Note: MDPI stays neutralwith regard to jurisdictional claims inpublished maps and institutional affil-iations.Copyright: © 2021 by the authors.Licensee MDPI, Basel, Switzerland.This article is an open access articledistributed under the terms andconditions of the Creative CommonsAttribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).1 Georgia Institute of Technology, Atlanta, GA 30332, USA2 Department of Electrical Engineering and Computer Science, North South University,Dhaka 1229, Bangladesh; [email protected] (M.R.); [email protected] (A.Y.);[email protected] (M.N.M.); [email protected] (B.Y.S.);[email protected] (I.T.N.)3 School of Industrial Automation, Engineering Institute of Technology, Melbourne, VIC 3000, Australia;[email protected] School of Engineering, Swinburne University of Technology, Hawthorn, Melbourne, VIC 3122, Australia;[email protected]* Correspondence: [email protected]: At present, the whole world is transitioning to the fourth industrial revolution, or Industry4.0, representing the transition to digital, fully automated environments, and cyber-physical systems.Industry 4.0 comprises many different technologies and innovations, which are being implementedin many different sectors. In this review, we focus on the healthcare or medical domain, wherehealthcare is being revolutionized. The whole ecosystem is moving towards Healthcare 4.0, throughthe application of Industry 4.0 methodologies. Many technical and innovative approaches have hadan impact on moving the sector towards the 4.0 paradigm. We focus on such technologies, includingInternet of Things, Big Data Analytics, blockchain, Cloud Computing, and Artificial Intelligence,implemented in Healthcare 4.0. In this review, we analyze and identify how their applicationsfunction, the currently available state-of-the-art technologies, solutions to current challenges, andinnovative start-ups that have impacted healthcare, with regards to the Industry 4.0 paradigm.Keywords: cloud computing method; artificial intelligence; IoT; blockchain; healthcare 4.0;industry 4.01. IntroductionScience and technology have been advancing in many ways, impacting almost everysector of human life. Advanced electrical power generation, transmission, and distributionsystems (i.e., smart grids), as well as advanced healthcare, education, roading, and trans-portation, and so on, are making daily life more efficient and easy [ 1 ]. The use of MachineLearning (ML) in different sectors has helped to operate multiple interconnected industriesin parallel [ 2– 6]. Industry 4.0, or the fourth industrial revolution, describes the conversionand development of industrial manufacturing through the digitization of new technologies.The idea of the industrial revolution has varied from decade to decade; presently, thereexists global competition between industrial manufacturers. In response, Industry 4.0has added a new dimension where, with the help of new technologies, the industrialmarket has hit a new level, the likes of which has not been seen before. The industrialinternet concept was introduced in 2012 [7 ], with a close-fitting mixture of both digitaland physical worlds adjoining Big Data with the Internet of Things (IoT). This thoughtdescribes many widespread ideas about Industry 4.0. Experts have estimated that around46% [ 8] of the global economy could benefit from the industrial internet. The industrialrevolution can be presented or divided into four revolutions. The first industrial revolution,known as Industry 1.0, began with mechanical efficiency in the late 1800s [ 9 ] and involvedthe manual use of mechanical tools, mostly in the textile industry. The second revolution’s

Healthcare 4.0 Implementation: Opportunities and Challenges in theHealthcare SectorImplementação do Healthcare 4.0: Oportunidades e Desafios no Setor da SaúdeEduardo de Siqueira CorreaORCID: https://orcid.org/ 0000-0001-9757-6660Universidade Nove de Julho, BrasilE-mail: [email protected] Cardoso SátyroORCID: https://orcid.org/ 0000-0002-0201-222XUniversidade Nove de Julho, BrasilE-mail: [email protected] Ferreira da SilvaORCID: https://orcid.org/0000-0001-6482-8729Universidade Nove de Julho, BrasilE-mail: [email protected] Luiz MartensORCID: https://orcid.org/0000-0003-1242-8795Universidade Paulista, BrasilE-mail: [email protected]é Celso ContadorORCID: https://orcid.org/ 0000-0003-4695-3379Universidade Paulista, BrasilE-mail: [email protected] Healthcare 4.0 é a aplicação dos princípios da Indústria 4.0 na área da saúde, permitindo a personalizaçãoem tempo real do atendimento aos pacientes. Embora tenha ganhado relevância nos últimos anos devidoaos benefícios da Indústria 4.0, o conceito ainda é pouco conhecido por profissionais do setor de saúdebrasileiro e internacional. Usando o método de revisão da literatura e pesquisa de levantamento com 26especialistas em Healthcare 4.0, este trabalho tem como objetivo identificar as oportunidades e desafios emprojetos de implementação do Healthcare 4.0 no setor de saúde do Brasil. A relevância deste estudo é aidentificação das principais oportunidades encontradas: tecnologia digital facilita a coleta de dados dospacientes; a implementação estratégica do Healthcare 4.0 pode trazer vantagens competitivas àorganização; e os principais desafios: a necessidade de capacitação digital dos profissionais de saúde parao Healthcare 4.0, e a necessidade de motivar todos os envolvidos para a adoção do Healthcare 4.0,contribuindo para a teoria. A contribuição prática é ajudar os profissionais da área da saúde envolvidos acompreenderem os pontos relevantes para projetos de implementação do Healthcare 4.0 bem-sucedidos.Palavras-chave: Healthcare 4.0; Indústria 4.0; Oportunidades; Redes; Projetos164ABSTRACTHealthcare 4.0 is the application of Industry 4.0 principles in healthcare, enabling real-time personalizationof patient care. Although it has gained relevance in recent years due to the benefits of Industry 4.0, theconcept is still little known by professionals in the Brazilian and international health sector. Using theliterature review method and survey research with 26 experts in Healthcare 4.0, this study aims to identifyopportunities and challenges in Healthcare 4.0 implementation projects in the health sector in Brazil. Therelevance of this study is the identification of the main opportunities found: digital technology facilitatesthe collection of patient data; the strategic implementation of Healthcare 4.0 can bring competitiveadvantages to the organization; and the main challenges: the need for digital training of healthcareprofessionals for Healthcare 4.0, and the need to motivate everyone involved to adopt Healthcare 4.0,contributing to theory. The practical contribution is to help the healthcare professionals involved tounderstand the relevant points for successful Healthcare 4.0 implementation projects.Keywords: Healthcare 4.0; Industry 4.0; Opportunities; Networks; Projects