MEDICAL DEVICES : SECTOR ANALYSIS

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MEDICAL DEVICES : SECTOR ANALYSIS

  1. 1. NIPER Ahmedabad Medical Devices in India a brief report Presented Jointly by NIPER-Ahmedabad and Frost and Sullivan
  2. 2. NIPER Ahmedabad Origin and Objectives Commissioned by the Department of Pharmaceuticals NIPER Ahmedabad undertook the study of the sector Objectives: Understand the sector, its issues and promote the sector To develop sector specific infrastructure Incubator, industry cluster and requisite research facilities at new NIPERs To develop and train human resources required for the growth of this sector. Acknowledgement: FICCI and Frost & Sullivan
  3. 3. MEDICAL DEVICES SECTOR  A medical device is defined as any healthcare product that achieves its primary intended purpose not through chemical action or by being metabolized.  Medical devices include electro-medical equipment and related software, furniture, supplies and consumables, cardiovascular and neurological products, opthalmological implants, orthopaedic appliances, prosthetics and diagnostic kits, reagents, and equipment.  Medical devices - crucial role in a healthcare. Used for diagnosis, therapy and patient monitoring.  Difficulties in Segmentation  Growth in pharmaceutical and healthcare sectors in INDIA in the recent years. Medical devices and Diagnostics set for a vibrant growth in near future.
  4. 4. NIPER Ahmedabad Focus on Implants
  5. 5. Avenues - Products  Material Science and Biomaterials  Cardiovascular & Diabetes Pacemakers, Defibrillators, Drug-eluting stents, Catheters, Valves  Orthopaedics Joint replacement: Plates, Nails, Dynamic Hip Screw, limb deformity correction devices, casting materials  Ophthalmology Intra ocular lens (IOL), Viscoelastics (OVDs)  Oncology Radio Guided Neuro Surgery Newer range of genetic diagnostic kits and reagents  Neurology Treatment of stroke. Coiling of aneurysms; angioplasty and stenting of carotid  Diagnostics and Imaging Radiology, Ultrasound, CT, MRI, X-ray etc. MD in the field of Cardiac imaging, CT Colongraphy, Digital X-ray, Molecular Imaging, MRI, Musculoskeletal, Nuclear, Ultrasound,
  6. 6. FACTS AND FIGURES  The global medical devices market : estimated USD 220 billion in 2008  Equipment: 40-50% [ophthalmic, dental, imaging and other medical equipment] Medical disposables: 25-30% Implants: 20-25% 160 180 200 220 240 2004 2005 2006 2007 2008 USDBillions YEAR CAGR: 4.5%
  7. 7. NIPER Ahmedabad Regional Market Share North America 44% Europe 32% Asia Pacific 18% Rest of World 6% GLOBAL MARKET SHARE
  8. 8. Indian Medical Devices Market 1600 1800 2000 2200 2400 2600 2800 3000 2006 2007 2008 USDMillions YEAR CAGR: 15%
  9. 9. INDIA – Facts and Figures regarding the Medical Device Market  The fastest growing Medical Devices market - Rs. 12,000 cr.  Growth Rate - 15% annually for next 5-6 years  Market Segments –  Equipment: 50-55% [ophthalmic, dental, imaging and other medical equipment] Medical disposables: 25-30% Implants: 20-25%
  10. 10. INDIA: IMPORT v/s EXPORT
  11. 11. SWOT ANALYSIS OF MEDICAL DEVICE INDUSTRY  Strengths-  Potentially Huge market with growing urban middle class population  Growing private hospital sector aiming to attract health tourists  Success in Pharma and other paramedical areas  Weaknesses-  Low per capita expenditure  Developing government policies and infrastructure  Untapped rural markets  Excessive dependency on imports  Academic knowhow is not well developed in this sector  Support system from R & D not available  Opportunities-  Overseas companies investing in India to set up R & D units  Increasing Joint ventures and agreements  Overseas aid assisted projects to improve healthcare infrastructure  Regulations to improve market for domestic manufacturers.  Threats-  Regulation policies may slow down the development of the market  Unorganized market for medical disposables  Lack of regulations, specifications - leading to spurious products.
  12. 12. NIPER Ahmedabad Regulation and Safety CLASS RISK LEVEL DEVICE EXAMPLES A Low Risk Thermometers / tongue depressors B Low-moderate Risk Hypodermic Needles / suction equipment C Moderate-high Risk Lung ventilator / bone fixation plate D High Risk Heart valves / implantable defibrillator
  13. 13. GROWTH DRIVERS  Booming economy  Increasing healthcare expenditure  Changing demographic profile  Increasing incidence of life style diseases  Ophthalmology  Cancer  Cardiovascular diseases  Hypertension, diabetes and renal diseases  Neurological and psychiatric disorders and addictions  Increasing number of medical tourists  Proliferation of hospitals  Government programes and support  Outsourcing / relocating of medical devices manufacturing by western MNCs  User friendly and handy devices  Telemedicine
  14. 14. INDIA: IMPORT v/s EXPORT
  15. 15. Issues and Challenges  India’s dependency on imports for supply of medical devices  Regulatory environment – Reliable & Consistent  Low level of healthcare insurance  Low levels of healthcare facilities and awareness especially in rural areas.
  16. 16. NIPER Ahmedabad SUMMARY AND RECOMMENDATIONS SUMMARY AND RECOMMENDATIONS  Medical devices sector – Rapidly growing  Highly diverse products  Inter-disciplinary approaches  Segments:  Medical-dental-surgical equipment  Implantable devices  Plastic disposables  Our focus of this report is implants  Our recommendations follows
  17. 17. NIPER Ahmedabad RECOMMENDATIONS - INDUSTRY SUMMARY AND RECOMMENDATIONS – INDUSTRY Patent awareness, early licensing, ambulatory and office based products, combination products, material sciences and newer materials, alloys and biodegradable materials are some of the trends a company needs to strategize. Product liability, insurance, and cost-conscious market are other facts companies cannot ignore.
  18. 18. NIPER Ahmedabad RECOMMENDATIONS - INDUSTRY Industry: Highly technology driven and regulated industry. Needs to understand market dynamics Strict regulation Competition from Europe and China Recommendations:  Technology is the key in this sector.  Develop technology based liaison-joint ventures  SMEs: Cluster - consortium for R & D & testing.  Develop R & D base  R & D support from Government: BiPP, SBIRI, TDB, Cluster programs, Assistance for patents.  Trading - Manufacturing - Product Development
  19. 19. NIPER Ahmedabad RECOMMENDATIONS - GOVERNMENT Recommendations for Government:  Ignored by Government  Completely unregulated until 2006  No government research institute Specific recommendations.  Incentive to encourage manufacturing of imported products  The largest segment - equipment imported. This segment requires special attention, strategy than implants  Develop institutional support  Incubators and Cluster development  Attention to Human resource development  Variety of testing facilities required –Material & Biological testings  Special packages for SMEs -access to sector specific infrastructure and facility  Health insurance structure and coverage  “Life saving” - duty-free: discourages manufacturing.
  20. 20. Need to set up NCMD Involved in Product Development & Testing facilities Having R & D infrastructure for this sector Human Resource development & Training Consultancy and facilitation With NIPERs – NIPER Ahmedabad National Centre for Medical Devices
  21. 21. Recommendations for NCMD - NIPERs Interfacing with Engineering, Medical and Pharma sectors. Should be well-aligned with Pharma Academic Centres:  Meet the Technological and Regulatory demands of MD industry.  Introduction of relevant MD related courses (including market and business analysis, basic engineering, electronics, material sciences and biomaterials, testing and evaluation etc.).  Interdisciplinary and combinatory research projects - to work in interdisciplinary groups Testing facility for devices:  Establishing a testing facility  Testing models for efficacy and quality control studies Pre-clinical and Clinical studies for Medical Devices:  Pre-clinical/clinical studies for MD (class 2B and III) as per regulatory guidelines.  For training the personnel and providing necessary facility for the SMEs.
  22. 22. NIPER Ahmedabad Thank you!
  23. 23. Resources  The information in this report is derived from several sources:  Published industry reports  Several financial analysis report  Websites of regulatory agencies like USFDA  International Trade Centre  Statistical Outline of India,  DCGI and CDSCO, ICMR, Ministry of Health and Family Welfare  Various industry associations  Director General of Foreign Trade  Press news items and websites of various companies. In addition, site visits to research institutes like CDRI, IITs, attendance at national and international conferences, and interviews with several industry executives, consultants, association office bearers and regulators have contributed to the compilation of information. The compiled information has been analyzed by a team of experts and recommendation have been developed based on the opinion formed by the team.
  24. 24. NIPER-Ahmedabad Thank you Acknowledgement: Support from Department of Pharmaceuticals Government of India However, opinion and views expressed are not necessarily subscribed by either the Department of Pharmaceuticals or the Government of India
  25. 25. NIPER Ahmedabad MEDICAL DEVICES: CAPACITY BUILDING Blueprint for NIPER Ahmedabad
  26. 26. NIPER Ahmedabad RECOMMENDATIONS - Government Recommendations for Government:  Ignored by Government for R & D support  No government research institute  Completely unregulated until 2006 Specific recommendations.  Develop institutional support for R & D  Incubators and Cluster development  Attention to Human resource development  Variety of testing facilities required –Material & Biological testings and Clinical evaluation  Access to proven technology sourcing and technology transfer mechanism  Special packages for SMEs -access to sector specific infrastructure and facility,
  27. 27. Capacity Building - Avenues  Product Development & Testing  Incubator, Cluster Development  HR and Training
  28. 28. Product Development and Testing HR and Training Incubator and Cluster Development Capacity Building - Avenues
  29. 29. Cluster - formation Key-factor for success Medical Devices…
  30. 30. Incubator and Cluster Projects  Department of Pharmaceuticals and Govt. of Gujarat have agreed to jointly develop Medical Device Cluster in and around Ahmedabad  50 acre cluster will have Common Facility Centre  Proximity and access to NIPER-Ahmedabad specializing in Medical Device –Implants in terms of training, product development and testing facilities
  31. 31. Product Development and Testing HR and Training Incubator and Cluster Development Capacity Building - Avenues
  32. 32. Need to set up NCMD Involved in Product Development & Testing facilities Having R & D infrastructure for this sector Human Resource development & Training Consultancy and facilitation With NIPERs – NIPER Ahmedabad National Centre for Medical Devices
  33. 33. Product Development and Testing HR and Training Incubator and Cluster Development Capacity Building - Avenues
  34. 34. National Centre on Medical Devices at NIPER-Ahmedabad R & D Facilities and Product Development:  Interdepartmental state-of-art facilities for R & D in Medical Devices.  Facilities and expertise will include basic engineering, electronics, metal, polymer and material sciences and biomaterials, software development, product development and evaluation etc.  Interdisciplinary and combinatory research projects - to work in interdisciplinary groups  Access to faculty for consultation, joint technology development and evaluation Testing facility for devices:  Establishing a testing facility – chemical, physical, material and biological  Pharmacological Testing models for efficacy, toxicity and quality control studies Pre-clinical and Clinical studies for Medical Devices:  Pre-clinical/clinical studies for MD (class 2B and III) as per regulatory guidelines.
  35. 35. Product Development and Testing HR and Training Incubator and Cluster Development Capacity Building - Avenues
  36. 36. No. Course Description Remarks 1 Bioengineerin g Biomaterials, Biomechanics, Bioinformatics, Bio- transport, Telemetry, Imaging, Anatomy & Physiology BITS, Pilani, BE degree 2 Technical Cardiac, Neuro, Medical Imaging, etc. Diploma courses at Paramedical institutes 3 Biomedical Engineering Biochemistry, Anatomy & Physiology, Instrumentation, Control theory BE degree at several engineering colleges 4 Biomedical Technology Instrumentation and Methodology, clinical biology, molecular and cell biology Diploma and Degree courses at University post graduate level 5 Instrumentati on & control BE degree at several engineering colleges NEED to generate skilled manpower with both technical as well as pharmacy based understanding and training. COURSES CURRENTLY AVAILABLE
  37. 37. Current status and HR Gaps Serious lacuna in terms of availability of skilled manpower. Being a multidisciplinary field, currently the industry employs people of various backgrounds. Our academia needs to develop interdisciplinary approach. No dedicated academic courses either short term or long term available in India.
  38. 38. Recommendations for NIPERs Interfacing with Engineering, Medical and Pharmaceutical sciences. Academic Centres:  Meet the Technological and Regulatory demands of MD industry.  Introduction of relevant MD related courses (including market and business analysis, basic engineering, electronics, material sciences and biomaterials, testing and evaluation etc.).  Interdisciplinary and combinatory research projects - to work in interdisciplinary groups Training in Testing of devices:  Short term certificate/diploma courses for MD testing and regulations Training in Pre-clinical and Clinical studies for Medical Devices:  Short term certificate/diploma courses for preclinical and clinical product development studies Training in Marketing, Regulation and Quality  For training the personnel in business, marketing, regulation and quality.
  39. 39. NIPER Ahmedabad Thank you!
  40. 40. NIPER-Ahmedabad Thank you

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