VALUE ADDITION MODELS FOR MEDICAL DEVICE SUPPLY CHAIN VEDPAL ARYA

Transcription

1 VALUE ADDITION MODELS FOR MEDICAL DEVICE SUPPLY CHAIN VEDPAL ARYA DEPARTMENT OF MECHANICAL ENGINEERING INDIAN INSTITUTE OF TECHNOLOGY DELHI NOVEMBER 2017

2 Indian Institute of Technology Delhi (IITD), New Delhi, 2017

3 VALUE ADDITION MODELS FOR MEDICAL DEVICE SUPPLY CHAIN by VEDPAL ARYA Department of Mechanical Engineering Submitted in fulfilment of the requirements of the degree of Doctor of Philosophy to the INDIAN INSTITUTE OF TECHNOLOGY DELHI NOVEMBER 2017

4 Dedicated to Late Sh. Dalbir Singh My Father

5 CERTIFICATE This is to certify that the thesis entitled Value Addition Models for Medical Device Supply Chain being submitted by Mr. Vedpal Arya to the Indian Institute of Technology Delhi for the award of the degree of Doctor of Philosophy is a record of original research work carried out by him. He has worked under our guidance and supervision and has fulfilled the requirements for the submission of this thesis, which to our knowledge has reached the requisite standard. The results contained in this thesis have not been submitted, in part or full, to any other university or institute for the award of any degree or diploma. Prof. S. G. Deshmukh Department of Mechanical Engineering Indian Institute of Technology Delhi New Delhi , INDIA Prof. Naresh Bhatnagar Department of Mechanical Engineering Indian Institute of Technology Delhi New Delhi , INDIA i

6 ACKNOWLEDGEMENTS To the Great Almighty, the author of knowledge and wisdom, for his abundant love First and foremost, I would like to convey my sincere gratitude to my respected supervisors Prof. S. G. Deshmukh and Prof. Naresh Bhatnagar. Their clarity of vision and ability to convey their thought process made things easier for me. But most importantly, both of them have inspired me to be a better man with highest professional ethics. Their support and confidence in me infused new hope to counter the research problem in a composed way and helped me in developing a perspective to succeed. I am forever grateful for their continued help. I offer my gratitude to Mrs Amita Deshmukh and Dr. Sushma Bhatnagar for their motherly care everytime. They kept me motivated for the goal and inspired me to do better. Their continued support is immense for me. I am also thankful to Prof. A. D. Gupta, Prof. D. Ravi Kumar, Prof. M.S. Kulkarni, Dr. Nomesh Bolia and Dr. Abhijit Majumdar for their constructive comments during the progress of my research work. I am thankful to Dr. Vipul Jain for his support and guidance in research and grateful for his help and moral support. I am grateful to Prof. Prem Vrat for his encouraging and helpful guidelines about the career and every time support. I want to thank Mrs Vrat for her blessings and motivating me to do well. I am thankful to Prof. Kiran Seth for the valuable learnings and advises. It was a great experience to be associated with the Spic Macay. I am thankful to Prof. Naoufel Cheikhrouhou, Swiss Federal Institute of Technology (EPFL), Lausanne, Switzerland and Haute Ecole de Gestion De Geneve, Switzerland for providing an opportunity to work under his mentorship. My thanks to Mr. Guillem Maezo, Mr. Ramesh Roshan Das and other members of Laboratoire de Gestion et Procedes de Production (LGPP), EPFL, Lausanne for their wonderful company. I wish to express my heartfelt appreciation to Col. Pankaj Sharma. He has been a great help in all aspects of my doctoral journey and thanks for many fruitful discussions and help at various junctures that kept me motivated. I am grateful to Col. Anil Yadav, Col Gaurav Singh, Dr. Javed Rizvi, Dr. Kiran Bhat, Dr. Md. Hossein Alaei and Dr. Arun Kumar for making this academic pursuit joyful. The journey of research became easy with the support of Mr. Ashutosh, Mr. Umesh Khandey and Mr Neeraj Bhanot. They not only made it joy-able but also productive. I offer my thankfulness to the ever supportive behaviour of Dr. Gajanan Panchal, Dr. Avinash Samvedi, Dr Amit Upadhyay, Dr Sumit Sakhuja and Dr Umang Soni. They were always there for help. It has been a great journey while working in a multi-disciplinary team at our PE Lab. My special thanks to Mr Manish Chaturvedi for insightful discussions and a wonderful company and Dr Pankaj for the support and help. I am thankful to Dr. Neelanchali Asija, Ms Shweta Singh, Ms Pooja Bhati, Mr Avinash Kumar, Dr. Hemant Chouhan, Mr. Rakesh Bhardwaj, Col. Dharamveer, Brig. Sanjay Prasad, Mr Ashwin Patel, Mr Vinay Patil, Mr Rahul Jain, Ms Ramya Ahuja, Mr Alok, Ms Ayesha, Ms Manisha Bansal and Ms Tarika for their support and well iii

7 wishes. I am thankful to Mr Tulsi Ram, Mr. Vijay Tiwari, Mr Sanjay and Mr Anil for their support. I want to thank Dr. Farukh Faraz, Dr. Abhinav Sood, Dr. Smiti Bhardwaj and Dr. Jitendra Sharan for the constructive discussions. I would like to thank Dr. Prashant Ambad, Dr. Md. Asjad, Dr. Anuj Prakash, Dr. A.C. Shukla, Dr. Divya Pandey, Dr. Pankaj Zine, Dr. Girish Kumar and Dr. Amit Kumar for their good wishes. I want to thank for the support of Dr. Deepak Bhutani, Dr. Madhav Kashid, Mr. Praveen Kumar, Mr. Ashish Dwivedi, Mr. Sitakanta Panda, Mr Hemant Suman, Mr Lakshay Taneja, Mr. Sandip Datta, Dr. Tirumallarao Kotni, Dr Azi Alex and Mr Gopendra. I am thankful to Dr Sourav Sarkar, Dr Arvind Baruah, Mr Girish Verma, Mr Anmol Deepak and other members of our Football Group. I want to thank Dr Kuldeep Dagar, Dr. Mukesh Garg, Mr. Vipul Patel, Mr Rakesh Kumar, Mr Umesh Yadav, Mr. Abhishek Verma, Mr. Ashwani Malik, Mr Chirag, Mr. Vipul Kant Gupta and Mr. Rahul Goyal for their help and well wishes. I also want to thank Mr Jaipal, Mr Rajesh Bhat, Mr. Rajesh (IRD), Mr Sandeep Yadav, Mr Bharat Wadhwa, Mr Gopal Singh, Mr Diwakar, Mr Kirpal Singh Negi, Mr Amol and Mr Jaiprakash for their help. My thankfulness to Mr. Ashok Kumar, Mr. Rajender Kumar and other administrative personnel of IIT Delhi for their support. I am thankful to the staff personnel of the office of Mechanical Engineering Department (IITD) for their help. I want to thank the hostel staff, mess staff and other friends whose names are not in the list but have been supportive in any way. I am thankful to the participants of World Congress for Oral Implantology (WCOI) 2016 for their inputs in conducting a research study. I would like to thank Council of Scientific & Industrial Research (CSIR) and Ministry of Human Resource Development (MHRD) for the financial support during the research. My Special thanks to Mr. Vineet Kumar and Mr Chhayakanta Acharya for their wonderful company during my stay at the hostel. I am thankful to Dr. Gaurav Kumar Singh and his family, Dr Kapil Sharma, Mr Sandeep Baliyan and his family, Mr Shivendra Yadav, Dr Pravin Kumar Mutiyar and his family, Dr. Jai Karan and Mr Manoj Ruhil for their support and standing firmly in all times. I express my deep and sincere gratitude to my family and relatives for their continuous and unparalleled love, help and support. I am forever indebted to my Taya Ji - Sh. Ramdev Shastri and my parents for giving me the opportunities and experiences that have made me who I am. I am grateful to my brother and sister and all my relatives for always being there for me. All of them selflessly encouraged me to explore new directions in life and seek my own destiny. My thanks and best wishes to one and all who helped me during my life. (Vedpal Arya) iv

8 ABSTRACT Medical device industry is highly competitive and fragmented which manufactures devices with highest safety and regulatory compliances. This is accomplished by making use of advanced technologies and sustained investment into research and development leading to manufacturing excellence, thereby making the device safe, reliable and effective for human use. International standards (ISO13485) classify the medical devices into three major categories based on the risk involved; which are high risk e.g. Cardiac Stent, medium risk e.g. Dental Implants and low risk e.g. Catheter. Developing valuable medical devices is a big challenge. This should not only fulfil its intended function safely and effectively but at an affordable cost. India has become a favored destination in medical tourism because of the low cost of treatment and world class care, however, the value added medical device industry has not yet evolved. Value creation in the entire chain can be seen as comprehensive multidisciplinary process. Supply chain of the medical devices is different from other commercial supply chains on many aspects such as product complexity, customization, handling and storage, safety standards & strict regulations. For the value creation process, various factors are identified from the literature and their causal relationship is analyzed. Based on the causal relationship model, inferences are drawn regarding the significant factors. This proposed model is made generic and the factors considered during this study can comply with any medical device. Such an analysis can also help the decision maker to focus on and improve those factors which have greater significance on creating value for the stakeholders. An attempt has been made to predict the value in the whole system based on numerous associated factors at various nodes of the supply chain. The results were compared through different methods. v

9 Medical device manufacturing requires manufacturing with some of the advanced technologies. Technology incorporation in an organization during the development stage depends upon the failures that can result through the existing manufacturing technologies and its associated risks. The study involves analyzing the capability of the manufacturing processes for manufacturing medical device based on the failure rates for a real-life case. Propositions regarding process improvement were made based on the economic viability of the available alternatives. The issue of affordable manufacturing is tackled through collaborative manufacturing. Decision making related aspects of medical device selection are studied in line with the shared decision making. Regulatory and traceability aspects of the medical devices were studied and software architecture for an effective traceability is proposed involving all stakeholders. The study addresses the real-life issues of a medical device supply chain and adds value to regulators, manufacturers, clinicians and patients involving effective decision making. The value addition can be articulated in terms of predicting & quantifying value and thereby validating the model leading to affordable manufacturing through collaboration and a proposed software architecture. Key words: medical device; value creation; affordability; supply chain; regulation; causal relationship models; prediction and analysis; process improvement; multi-criteria decision making vi

10 स र म ड कल ड व इस उद य ग अत यड क प रड स प और डवख ड ह ज उच च म स रक ष और ड य मक अ प ल क स थ उपकरण क ड म ण कर ह उन न प र द य डगडकय और ड र र ड व श क उपय ग करक डवड म ण उत क ष ट क प र प त डकय ज ह, डजसस म व उपय ग क डलए ड व इस क स रडक ष, डवश वस य और प रभ व ब य ज सक ह अ र ष टर य म क (आईएसओ 13485) ड डकत स उपकरण क ज खखम क आ र पर प रम ख श र डणय म वग क कर ह ; उच च ज खखम व ल ज स क ड एक स ट ट, मध यम ज खखम ज स द प रत य र पण और कम ज खखम ज स क थ टर बह म ल य ड डकत स उपकरण क डवक स कर एक बड ह म ड कल ड व इस क अपन क र य स रडक ष और प रभ व ढ ग स सस त क म पर प र कर डहए ड डकत स उप र म कम क म क ल ग और डवश व स तर क द खभ ल क वजह स भ र ड डकत स पय ट म एक पस द द ग व य ब गय ह, ह ल डक व ल य म ड कल ड व इस उद य ग अभ क डवकडस ह ह आ ह स प ण श र खल म व ल य स ज क व य पक बह आय म प रड य क र प म द ख ज सक ह ड डकत स उपकरण क आप ड श र खल उत प द क जडटल, अ क ल, ह डल ग और भ रण, स रक ष म क और सख त ड यम ज स कई पहल ओ पर अन य व डणख क आप ड श र खल र स अलग ह व ल य स ज प रड य क डलए, स डहत य स डवडभन न क रक क पह क गई ह और उ क क ज ल ररल शन ष प क डवश ल षण डकय गर ह क ज ल ररल शन ष प म ल क आ र पर महत वप ण क रक क ब र म अ म लग र गर ह इस श ध म एक ज न ररक म ल प रस त डव ककर गर ह कजसक प रर ग डकस भ ड डकत स उपकरण क कलए ककर ज सकत ह इस रह क डवश ल षण, ड रक क उ क रक पर ध य क ड कर और स र कर म मदद कर सक ह ज डह रक क डलए व ल य बढ न क कलए कज म म द र ह आप ड श र खल क डवडभन न स पर अस ख य ज ड क रक क आ र पर प र डसस टम म व ल य क अ म लग क प रय स डकय गय ह पररण म क कवक न न तर क स त लन क गई ह म ड कल ड व इस ड म ण म क छ उन न क क क स थ डवड म ण क आवश यक ह डवक स क रण क द र एक स गठ म प र द य डगक क आन उन डवफल ओ पर ड भ र कर ह ज व म डवड म ण प र द य डगडकय स स ब ड ज खखम क म ध यम स ह सकत ह इस अध यय म व स तडवक म मल क डवफल दर क आ र पर ड डकत स उपकरण ब क डलए डवड म ण प रड य ओ क क षम क डवश ल षण कर श डमल ह उपलब ध डवकल क आडथ क व यवह य क आ र पर प रड य स र क ब र म प रस त व डकए गए ह सहय ग डवड म ण क जररए सस त डवड म ण क म द द इस श ध म उठ र गर ह म ड कल ड व इस य क स ब ड पहल ओ क श र र य कर कससन म कक ग क स थ अध यय डकय गर ह ड डकत स य उपकरण क डवड य मक और ट र कसर कबकलट पहल ओ क अध यय डकय गय और एक प रभ व टर स डबडलट क डलए स फ टव यर आडक ट क चर क प रस त व ह डजसम सभ कहस स द र क श डमल डकय गय ह vii

11 र ह श ध एक ड डकत स उपकरण आप ड श र खल क व स तडवक म द द क स ब ड कर ह और ड य मक, ड म ओ, ड डकत सक और र डगय क डलए व ल य क बढ त ह म ल यव क भडवष यव ण और म ल य ड रण क कलए प रस त डव स फ टव यर आडक ट क चर क म ध यम स सस त उत प द क डलए इस प रस त कवत म ल क प रर ग डकय ज सक ह viii

12 CONTENTS CERTIFICATE... i ACKNOWLEDGEMENTS... iii ABSTRACT... v LIST OF ABBREVIATIONS AND NOTATIONS USED... xxiii CHAPTER 1: INTRODUCTION Preamble Characterization of medical device supply chain Salient features of medical device supply chain Research Problem Research Objectives Scope of the work Thesis outline... 8 CHAPTER 2: LITERATURE REVIEW Introduction Objectives of literature review Classification of the literature Understanding medical devices Definition Classification Medical Implants Select Medical Devices Studies on various aspects of medical devices ix

13 2.4.1 Manufacturing system aspects Affordability aspects Regulations and traceability aspect Decision making and risk aspect Commercial aspect Clinical aspect Literature on supply chain aspect of medical devices Tools and methods Analysis on real life issues and suggestions stated by the practitioners Issues faced by the clinicians Suggestions stated by the clinicians Research Issues Research Gaps Motivation Research Objectives CHAPTER 3: MODELING AND ANALYSIS OF CAUSAL RELATIONSHIPS Introduction Factors affecting value creation Methodology for critical analysis Statistical analysis Descriptive statistics Independent t test for mean comparison Enablers for value creation in MDSC Barriers limiting value creation in MDSC Integrated model development for understanding causal relationships x

14 3.7.1 Decision-making trial and evaluation laboratory Maximum mean de-entropy algorithm Interpretive structural modelling Results and discussion Analysis of causal relationships between enablers Analysis of causal relationships between barriers Summary CHAPTER 4: PREDICTION MODELING FOR VALUE ESTIMATION IN MEDICAL DEVICE SUPPLY CHAIN Introduction Significance of using Bayesian belief network Methodology Bayesian belief networks Model development Construction of a primary BBN structure Validation of the primary BBN structure Drawing the Bayesian belief network Capturing conditional probabilities Validating the BBN Model Qualitative validation of the model Quantitative validation of the model Results and analysis Comparison of results Bayesian belief network output Response surface methodology xi

15 4.6.3 Artificial neural network Discussion Summary CHAPTER 5: PROCESS IMPROVEMENT IN MANUFACTURING OF MEDICAL DEVICE Introduction Select medical device considered in the study Description of key functional elements Significance of studying process improvement in medical device manufacturing Key processes in manufacturing of select medical device Machining Process Cleaning process Surface modification process Assembly process Packaging process Methodology Failure mode and effect analysis Fuzzy analytic hierarchical process Fuzzy technique for order of preference by similarity to ideal solution Results Analysis Summary CHAPTER 6: AFFORDABLE MANUFACTURING OF MEDICAL DEVICE xii

16 6.1 Introduction Motivation for collaborative manufacturing in medical device sector Methodology Characterizing high technology collaborative networks Issues regarding decision making in HTCN Network formation for collaborative manufacturing Analysis of high technology collaborative network Node level measures Network level measures Case study Summary CHAPTER 7: SHARED DECISION MAKING FOR MEDICAL DEVICE SELECTION Introduction Decision making under multi-criteria Basic decision making aspects Case of shared decision making Methodology Case study Summary CHAPTER 8: REGULATORY AND TRACEABILITY ASPECTS OF MEDICAL DEVICE Introduction Key registries worldwide Traceability in medical device supply chain xiii

17 8.4 Framework and role of the traceability software Benefits of the proposed software Implications at the medical device supply chain level Enforcement/implementation pre-requisite Authenticity check for the proposed software Issues handled through the proposed software Software implications on medical device supply chain Conceptual view of the software architecture Basic operational view among various stake holders Framework for enforcement of proposed software Responsibility matrix for various stake holders in MDSC Representation of various flows in the medical device supply chain ISO Implementation framework Summary CHAPTER 9: DISCUSSION AND CONCLUSIONS Summary of the work Contributions of the research Novelty of the research Utility of the research work Conclusions of the research Possible extensions and limitations REFERENCES APPENDIX: DELPHY STUDY LIST OF PUBLICATIONS BRIEF BIO-DATA OF THE RESEARCHER xiv

18 LIST OF FIGURES Figure No. Title Page No. 1.1 Schematic representation of supply chain for medical device Various types of flow in medical device supply chain Framework for research in Medical Device Supply Chain Classification of literature Classification of medical devices according to risk as per FDA guidelines 2.3 Medical implants: Orthopaedic screws Medical device Cardiac stent Medical device Pacemaker Medical Device: Dental Implant System Text analysis on problem areas stated by the clinicians Text analysis of suggestions stated by the clinicians Research methodology for analysis of the enablers and barriers for value creation 3.2 Causal diagram of enablers affecting value creation in MDSC Digraph plot of enablers affecting value creation in MDSC Causal diagram of barriers affecting value creation in MDSC Diagraph plot of barriers affecting value creation in MDSC Methodology used for assessing value through Bayesian belief network Causal relations between the variables and the states of the variables Causal relationship among various factors creating value in MDSC 4.4 Causal relationship among various variables for a default case Bayesian network design based on expert values on root nodes xv

19 4.6 Sensitivity analysis of factors affecting value creation Flow chart for response surface methodology Contour plot of predicted value for MDSC Contour plot of predicted value for MDSC Response optimization for value in MDSC Basic steps of ANN training Base interpretation of the ANN model Regression plot for artificial neural network Training state for the artificial neural network Performance state for the artificial neural network Comparison of predicted values Various components of a dental implant system manufactured at IIT Delhi 5.2 Key process steps in manufacturing of dental implant system Ten (10) axis controlled CNC Turn-mill for machining of medical implants at PE Lab of IIT Delhi 5.4 Machined components of DIS at PE Lab, IIT Delhi Assembly process of DIS performed at IIT Delhi Packaging operation (post assembly view) Methodology for manufacturing process improvement Intersection between M1 and M Prominent modes of failure per process Prominent modes of failure per process (based on E-RPN) Decision making for manufacturing process improvement Methodology adopted Decision making framework for network formation xvi

20 6.3 (a) Directed network (b) Undirected network Location for manufacturing of DIS at IIT Delhi Dental implant system after machining performed in HTCN License for manufacturing of medical devices at IIT Delhi Prominent processes in manufacturing of medical device in existing network 6.8 Dental implant system during assembly in HTCN Collaborative interactions among the members of HTCN based on matrix M Collaborative relationship among the members of HTCN based on tie strength 7.1 Process flow diagram for dental restoration Process flow diagram for functional restoration using a dental implant Various attributes in decision making for a medical device selection 7.4 Methodology for decision making in medical device selection Membership functions for criteria values Membership functions for importance weights Material and Information flow in medical device supply chain Traceability cum feedback Mechanism for medical device manufacturing, PE Lab, IIT Delhi 8.3 Non-Sterile finally packed CSIR Dental Implant (front view) Non-Sterile finally packed CSIR Dental Implant (rear view) Using RFID for traceability of medical devices Interactions between various stakeholders Basic operational view among various stake holders Framework for enforcement of the proposed software Representation of various type of flows in the medical device supply chain 8.10 ISO 13485: Implementation framework xvii

21 LIST OF TABLES Table No. Title Page No. 1.1 Methodologies for addressing the research objectives Description of enablers for value creation in MDSC Description of barriers limiting value creation in MDSC Group statistics for enablers in value creation of MDSC Group statistics for enablers in value creation of MDSC Group wise comparison for enablers through Independent t test Group wise comparison for barriers through Independent t test List of enablers for value creation in MDSC List of barriers limiting value creation in MDSC Average matrix of enablers affecting value creation of MDSC Total relation matrix of enablers affecting value creation of MDSC Cause and effect analysis of enablers affecting value creation in MDSC 3.12 Result of the MMDE algorithm for threshold value Initial reachability matrix of enablers for MDSC Final reachability matrix of Enablers Results of interpretive structural modelling Average interaction matrix of the barriers limiting value creation Calculating the T matrix of the barriers limiting value creation Prominence and causal degree of barriers limiting value creation Result of the MMDE algorithm for threshold value xix

22 3.20 Initial reachability matrix for ISM implementation Final reachability matrix for ISM implementation Hierarchy set for ISM model Value addition from Chapter Variables affecting value creation and their states Parameters for value creation in medical device and their description 4.3 Causal relationships and logics Influential factors for various variables Variables and their definitions Condition probability table for Manufacturing Processes Conditional Probability Table for Manufacturing Processes Normalized values for variable Manufacturing Process Values of root nodes from expert judgement Target node value by experts Comparison of Target Node Values Result of surveys on ranking of parameters Kendall s W Test What if analysis on target node What-if analysis on Manufacturing Quality Sensitivity of target node to a finding at another node Predicted value using Bayesian belief network Range of parameters used in response surface methodology approach 4.19 Predicted value using response surface methodology xx

23 4.20 Predicted value using artificial neural network Value prediction through different methods Value addition through Chapter Key processes in manufacturing DIS Failure modes per process Consolidated list of modes of failures Fuzzy score for weight vector Calculating weights for various risk factors Fuzzy score for linguistic variables used for various alternatives Comparative linguistic terms used for S, O, D and M Evaluation of experts for various FM (In linguistic variables) Mitigation levels for failure modes Normalized scores for the metrics Distance of Ideal and non-ideal solution Calculation of E-RPN for each failure mode Process volatility based on the failures reported Decision constraints and options for various levels of volatility of processes 5.15 Causes, effect and action plan for various failure modes Value addition through Chapter Various attributes for characterization of HTCN vs TN Various real-life cases of collaborative networks Matrices for directed and undirected networks Enterprise selected in high technology collaborative network xxi

24 6.5 Node level measures in HTCN Network level measures for HTCN Structural equivalence matrix Value addition through Chapter MCDM Techniques and their applications Key studies on medical device decision making Factors affecting selection of DIS Data used to evaluate and justify decision making in implant selection 7.5 Importance weights and aggregate weights of the criteria The performance values of the alternatives in form of interval data 7.7 Reference number vector Maximum distances from alternatives to the reference number vector 7.9 Weighted distances to reference point Value addition through Chapter Various registries worldwide for medical devices Role of stakeholders and implications of the software Responsibility matrix for various stake holders in MDSC Value addition through Chapter Snapshot of the research work Tools and methods used in realizing the research objectives xxii

25 LIST OF ABBREVIATIONS AND NOTATIONS USED A AHP AHU ANN ANP B BBN BN C Cc CAD CAM CBCT C Bi C Ci C Di CDSCO CNC CPT Dn D DAC Average matrix Analytic Hierarchy Process Air Handling Unit Artificial Neural Network Analytic Network Process Benefit Related Criteria Bayesian Belief Network Bayesian Network Characteristics matrix Cost Related Criteria Computer Aided Design Computer Aided Manufacturing Cone Beam Computed Tomography Between-ness Centrality of i th Agent Closeness Centrality of i th Agent Centrality of i th Agent Central Drug Standardization and Control Organization Computer Numerical Control Conditional Probability Table Normalized initial direct relation matrix Density Directed Acyclic Graph xxiii

26 DEMATEL DIS FAHP FDA FM FMECA g jk GMP GRA HTCN I ICT ISM ISO k K R L M MCDM MCI MDSC MMDE n N Decision Making Trial and Evaluation Lab-oratory Dental Implant System Fuzzy Analytic Hierarchy Process Food and Drug Administration Failure Mode Failure Mode Effect and Criticality Analysis Geodesic path between the agents i and k Good Manufacturing Practices Grey Rational Analysis High Technology Collaborative Network Identity matrix Information and Communication Technology Interpretive Structural Modelling International Organization for Standardization Proportionality constraint Key Role Number of Links Adjacency matrix Multi Criteria Decision Making Medical Council of India Medical Device Supply Chain Maximum Mean De-Entropy Algorithm Number of states Set of agents xxiv

27 NC B NC C NC D p (e H) p (e) PMA R RFID RG R i RPN RSM S SME SNA SOP S R T TFN TN TOPSIS T Th Xi x ij k Between-ness Centralization of the Network Closeness centralization of the Network Degree Centralization of the Network Likelihood of the evidence Prior probability of the evidence Pre-Market Approval Sum of rows Radio Frequency Identification Grey Relational Grade Rank given to object i Risk Priority Number Response Surface Methodology Sum of squared deviations Small and Medium Size Enterprises Social Network Analysis Standard Operating Procedures Supporting Role Total Relation Matrix Triangular Fuzzy Number Traditional Networks Technique for Order Performance by Similarity to Ideal Solution Threshold value Eigen vector centrality of i th node Pairwise effect between the two factors i and j xxv