Polytech.pptx
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The document discusses the medical device industry including key sectors, regulations, and the product development lifecycle. It notes that the global market size for medical devices is approximately $300 billion and lists common device types such as cardiovascular, orthopedic, imaging, and respiratory devices. Regulations for medical devices are outlined for the US, Europe, Japan, and India. The medical device product development lifecycle includes 5 phases from initiation to post-launch assessment. Human factors considerations and emerging areas in devices such as assistive technologies, telemedicine platforms, cardiac implants, and deep brain stimulation are also summarized.
Polytech.pptx
- 1. 0 Medical Device -Engineering and Domain View
- 2. 1 Medical Device development stakeholder
- 3. 2 Medical Devices Market size Approx $ 300 B Cardiovascular devices Ophthalmology devices and equipment Orthopedic devices and equipment Dermatology, cosmetics, and wound Surgical devices and equipment care Vascular devices Urology devices and equipment Imaging equipment Analytical equipment Drug delivery systems Diabetes equipment Patient monitoring equipment Diagnostic equipment and systems equipment Respiratory devices and equipment Sterilization products Dental devices and equipment Women's health devices and equipment Industry Sectors in the Medical Device Industry Regulations Body US - FDA (Food & Drug Administration) & CDRH (Center for Devices and Radiological Health) Europe - BSI, TUV/RH,TUV/SUD, KEMA, etc in Europe Japan - Ministry of Health, Labor and Welfare( MHLW), Pharmaceutical and Food Safety Bureau, Office of Medical Device Control India – Indian FDA
- 4. 3 Initiation Opportunity and Risk Analysis Formulation/Concep t and Feasibility Phase Design and Development/Verifi cation & validation Phase Final validation/Product Launch Preparation Phase Product Launch and Post-Launch Assessment (overall R&D spending of $30 bn in 2007) Initial evaluation of possible development of commercial product Definition of design input based on customer needs and technical requirements Development of product design and of manufacturing process; verification & Validation Final validation of manufacturing process; preparation of product introduction Market introduction of product; continuous improvement Phase I Phase II Phase III Phase IV Phase V Medical Device Product Development Lifecycle Project Definition Acceptance/Concept Charter Initial Design Acceptance/Development Agreement Gat e 1 Final Design Acceptance/Ramp up Readiness Product launch Acceptance/launch Readiness Gat e 4 Gat e 3 Gat e 2 Financial Review Market Analysis Competitive Assessment Early Risk Assessment Legal/IP Analysis & Filings Regulatory & clinical Path Project Plan & Timeline Customer input/VOC Investigational Clinical Evaluation Early Concept Selection Prototype (Performance) Analysis Initiate & Maintain DHF Initial dFMEA IP landscape, review of filings Initial Regulatory Strategy Initial Re-imbursement Strategy Initiate DFM (Tooling, Fixturing) Customer/Manufacturing Prototype Evaluation Product Design Development Design V&V Maintain DHF/DMR & Project Timeline Design Risk Analysis (dFMEA) Patent Review Regulatory Strategy update Regulatory Submission Reimbursement strategy update Supplier Collaboration Initial Process FMEA Detail Producibility Analysis Product Branding DHF/DMR Completion Market Launch Plan dFMEA Update & Review Design O/p = Design I/P Final patent Review with R&D Obtain Regulatory Approval Finalize Reimbursement Strategy Mfg/Ops Scale up Full Process Qualification Clinical Validation Sales Training Physician Training & sales efforts Product improvements Post Market Surveillance Update Reimbursement as needed Process Improvement as needed Update Design Control Docs Quality Audits Post-Launch Clinical Validation Reps Attend Surgical Cases Reimbursement Path Begin Process IQ/OQ/PQ/PPQ Clinical Validation Plan $ 4 bn $ 12 bn $ 8 bn $ 4 bn $ 2 bn
- 5. 4 Initiation Opportunity and Risk Analysis Formulation/Concep t and Feasibility Phase Design and Development/Verifi cation & validation Phase Final validation/Product Launch Preparation Phase Product Launch and Post-Launch Assessment (overall R&D spending of $30 bn in 2007) Initial evaluation of possible development of commercial product Definition of design input based on customer needs and technical requirements Development of product design and of manufacturing process; verification & Validation Final validation of manufacturing process; preparation of product introduction Market introduction of product; continuous improvement Phase I Phase II Phase III Phase IV Phase V Medical Device Product Development Lifecycle Project Definition Acceptance/Concept Charter Initial Design Acceptance/Development Agreement Gat e 1 Final Design Acceptance/Ramp up Readiness Product launch Acceptance/launch Readiness Gat e 4 Gat e 3 Gat e 2 Financial Review Market Analysis Competitive Assessment Early Risk Assessment Legal/IP Analysis & Filings Regulatory & clinical Path Project Plan & Timeline Customer input/VOC Investigational Clinical Evaluation Early Concept Selection Prototype (Performance) Analysis Initiate & Maintain DHF Initial dFMEA IP landscape, review of filings Initial Regulatory Strategy Initial Re-imbursement Strategy Initiate DFM (Tooling, Fixturing) Customer/Manufacturing Prototype Evaluation Product Design Development Design V&V Maintain DHF/DMR & Project Timeline Design Risk Analysis (dFMEA) Patent Review Regulatory Strategy update Regulatory Submission Reimbursement strategy update Supplier Collaboration Initial Process FMEA Detail Producibility Analysis Product Branding DHF/DMR Completion Market Launch Plan dFMEA Update & Review Design O/p = Design I/P Final patent Review with R&D Obtain Regulatory Approval Finalize Reimbursement Strategy Mfg/Ops Scale up Full Process Qualification Clinical Validation Sales Training Physician Training & sales efforts Product improvements Post Market Surveillance Update Reimbursement as needed Process Improvement as needed Update Design Control Docs Quality Audits Post-Launch Clinical Validation Reps Attend Surgical Cases Reimbursement Path Begin Process IQ/OQ/PQ/PPQ Clinical Validation Plan $ 4 bn $ 12 bn $ 8 bn $ 4 bn $ 2 bn Propensity to outsource/offshore Patni Presence Activities Initiated in 2010
- 6. 7 Eco System
- 7. 8 Eco System Benefits New Business Concepts New Product New Strategies to Grow portfolio New Process
- 8. 9 Eco system – Activities Interactive Activities Sessions : Professional events, Forum Road Show, Trade Shows Conference, Meetings
- 10. 11 “ Human factors is a marriage of psychology and engineering : the application of a scientific body of knowledge about human strengths and weaknesses to the design of technology” Human Factors Human Factors Ergonomics Work in Neutral Postures Reduce Excessive Force Everything in Easy Reach Work at Proper Heights Reduce Excessive Motions Minimize Fatigue and Static Load Minimize Pressure Points Provide Clearance Move, Exercise and stretch Maintain an comfortable Environment
- 11. 12 Human Factors of Medical Devices
- 12. 13 Laparoscopic Grasper Project Involves the following aspects: • Reusable and Smooth operation • Parallel jaws gripping technique over V Shaped gripping. • Sleek design with 4 DOFs • Faster time to market Client Benefits/ Key Value Adds B H L l Operation Closed Position Open Position 120 15 degrees 5 mm 16 mm 550
- 14. 15 Concept Assistive Devices Handle Assembly along with contact pressure sensor Electronic module including wireless sensor Nodes+ Accelerometer+3 axis gyros User interface (Bluetooth, USB etc) Rubber Foot including Contact pressure sensor Walking stick Concept Automatic pill dispatcher Motorized Wheel Chair
- 16. 17 17 Patient End-- Telemedicine Center Doctor’s End-- Telemedicine Center Telecom Network Evaluated and recommended Service Provider Developed complete technical solution around H.264+H.323 Developed Application Interface for doctor and patient end Evaluated and selected video conferencing hardware Camera, TV, Network Adaptor Solution Development: Telemedicine Application
- 18. 19 Deep Brain Stimulation DBS .flv
- 20. 21 DBS Surgery
- 21. 22 DBS Programmer DBS Device Deep Brain Stimulation Devices
- 23. 24 Stents .flv Stents Design, Orthopedic Implants Design Surgery .flv
- 24. Company Confidential 25 Thank You