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MEDICAL DEVICES
Presented By:
Rushikesh . S. Markad
Management Scholar: 15PMM542
Department Of Pharmaceutical
Management,
...
FLOW OF PRESENTATION
 Healthcare Sector In India
 Medical Device
 Difference between Drug & Device
 Device Classificat...
Earlier Scenario of Healthcare Sector in India
Healthcare Sector- Present Scenario
Source: Industry Report, Healthcare: India, The Economist Intelligence Unit, July 2014...
Growth Pattern in Healthcare sector- India
0
20
40
60
80
100
120
140
160
2012 2013 2014 2015 2016 2017
US$Billion
FY
98
11...
Revenue Split
Hospitals
Meical Equipment and
Supplies
Medical Insurance
Diagnostics
Pharmaceuticals
71%
9%
4%
3%
13%
Sourc...
Medical Device
Definition
 As per Schedule M-III
Medical tool which does not achieve its primary intended action
in or on the human body...
Sector split
 Orthopedic Implants & Prosthetics
 Cardiovascular
 Neurovascular
 Dental
 Life Science Tools & Services...
Segmentation By Application- India
Source: Global marketing Emergo group Inc.
Segmentation By Revenue- India
Other medical &
Therapeutic Devices
Spinal Devices
Cardiovascular
Devices
Neuromodulation
D...
DIFFERENCE
 Based on Chemistry &
Pharmacology
 Safety & Efficacy
 Clinical Trials
 Local and Systemic Toxicity
 Long ...
Device classification
CLASS RISK LEVEL EXAMPLE
A Low Risk Surgical retractors / tongue
depressors
B Low-moderate Risk Hypo...
Global Scenario of Medical Device
Market
0
100
200
300
400
500
2011 2012 2013 2018
UDbillion
FY
Market Size
• Indian Medic...
GLOBAL MEDICAL DEVICE MARKET
USA
Western Europe
Middle/East Africa
Eastern Europe
Asia/ Pacific
Asia/Pacific
24%
Western E...
• US
• JAPAN
• GERMANY
• ITALY
• FRANCE
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
USA(US
$120)
Japan( US
$ 31.5)
BRIC( US
...
Process Flow of Rise of Emerging
Markets
MNC’s define the market and enter with
high quality, usually imported devices not...
TOP 10 MEDICAL DEVICE
MANUFACTURERS
Name of Company Revenue(In $US
BN)
Market Cap($US BN)
Johnson & Johnson 28.7 294.2
Gen...
Mergers & acquisitions
2011 2012
 Number of deals 443 330
 Total deals (with values disclosed)
 Number of deals 191 141...
Mergers & acquisitions
ACQUIRER TARGET DEAL VALUE (£ mn)
Johnson & Johnson Synthes Gmbh 12745
Hologic Inc. Gen- probe Inc....
US MARKET
• Valued at more than US$ 60 Billion
• Accounts for 20% of global industry by production
• World’s largest Medic...
Sector Breakdown of Deals
General Equipments &
supplies
Patient monitoring
equipment & therapies
Life Sciences tools &
Ser...
INDIA
Medical Device Market By
Segmentation
Column1
Medical and Diagnostic
Equipments
Medical Implants
Medical Disposables
and S...
Factors Affecting Medical Device Industry
Medical
Device
Industry
Local
Market
Sentiment
s
Economic
based
factors
Unmet
cl...
FACTS
 Market size- $ 7.9 US billion
 Contributes only 6% of India’s US $ 40 billion healthcare
sector
 It is growing a...
Growth of Medical Device Industry
0
2
4
6
8
10
12
2012 2013 2014 2015 2016 2017
US$Billion
FY
5.1
5.9
6.8
7.9
9.2
10.7
Sou...
Top Players
• 3 M
• India Medtronic
• Johnson & Johnson
• Becton Dickinson
• Abbott Vascular
• Bausch & Lomb
• Baxter
• Zi...
Regulation In Medical Devices
Regulation In Medical Devices
• India had no regulations for medical devices in place prior to
2005.
• The import, manufac...
Regulation In Medical Devices
• CLAA will adopt to regulatory Standards of Bureau Of Indian
Standards (BIS) and Internatio...
Regulation In Medical Devices- US
Classification according to 21 CFR 860 which is a part of
Medical Device Amendments of 1...
List of Notified Medical Devices
 Disposable Hypodermic Syringes
 Disposable Hypodermic Needles
 Disposable Perfusion S...
Growth Drivers & Restraints
Drivers:
• Expanding Healthcare
Sector
• Changing Demographic
profile
• Booming economy
• Agei...
Current Scenario
• Medical Device and NPPA
• Amendment of D & C Act
• Regulated Medical Devices sector
• Role of Governmen...
SWOT Analysis
• FDI
• Increased
JV
• Regulations
• Monopoly of
MNC’s
• Low per
capita
expenditure
• Unaware
rural market
•...
Conclusion
• Medical Technology companies are accelerating their
Investments in emerging markets and India is a prime
targ...
Medical device Industry 2015
Medical device Industry 2015
Medical device Industry 2015
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Medical device Industry 2015

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A complete scenario of Medical Device Industry Of USA and India as well as of some major players. The presentation also highlights the Rules and regulations with respect to the devices and also SWOT analysis of emerging markets

Published in: Healthcare
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Medical device Industry 2015

  1. 1. MEDICAL DEVICES Presented By: Rushikesh . S. Markad Management Scholar: 15PMM542 Department Of Pharmaceutical Management, NIPER, Mohali.
  2. 2. FLOW OF PRESENTATION  Healthcare Sector In India  Medical Device  Difference between Drug & Device  Device Classification  Medical Devices – Global Scenario  US medical Device Market  Indian Medical Device Market  Regulations  Current Scenario In India  SWOT Analysis  Conclusion
  3. 3. Earlier Scenario of Healthcare Sector in India
  4. 4. Healthcare Sector- Present Scenario Source: Industry Report, Healthcare: India, The Economist Intelligence Unit, July 2014 $ 96.3 US billion 1 Bed/1050 Per capita $ 61 US 71% share in healthcare expenditure 0.7 Doctor/1000 33% share of govt. in healthcare 4%
  5. 5. Growth Pattern in Healthcare sector- India 0 20 40 60 80 100 120 140 160 2012 2013 2014 2015 2016 2017 US$Billion FY 98 113 129 Source: RNCOS •Healthcare Sector in India is growing at a CAGR of 10-11%
  6. 6. Revenue Split Hospitals Meical Equipment and Supplies Medical Insurance Diagnostics Pharmaceuticals 71% 9% 4% 3% 13% Source: India Brand Equity Foundation, November 2011
  7. 7. Medical Device
  8. 8. Definition  As per Schedule M-III Medical tool which does not achieve its primary intended action in or on the human body by Pharmacological, Immunological or Metabolic means  An instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions and does not achieve its purposes through chemical action within or on the body  Medicinal products covered under D&C act will not fall under schedule M-III  In case there is uncertainty about whether the product falls under drug or medical device category regulators will consider mode of action
  9. 9. Sector split  Orthopedic Implants & Prosthetics  Cardiovascular  Neurovascular  Dental  Life Science Tools & Services  Patient Monitoring Equipment & Therapies  Disposable Equipment & Supplies  General Equipment & Supplies  In Vitro Diagnostics, Supplies & Equipment  Ophthalmic Goods, Optical Instruments & Lenses
  10. 10. Segmentation By Application- India Source: Global marketing Emergo group Inc.
  11. 11. Segmentation By Revenue- India Other medical & Therapeutic Devices Spinal Devices Cardiovascular Devices Neuromodulation Devices Diabetes Devices Urology Devices Surgical Technology 22% 18% 10% 5% 3% 3% 6%
  12. 12. DIFFERENCE  Based on Chemistry & Pharmacology  Safety & Efficacy  Clinical Trials  Local and Systemic Toxicity  Long Product Life Cycle  Drug Interaction  Large Population  Less user interaction  Based on Engineering  Safety & Performance  Clinical Evaluation  Biocompatibility  Short Product Life Cycle  Device Malfunction  Limited Population  Significant user interaction DRUG DEVICE
  13. 13. Device classification CLASS RISK LEVEL EXAMPLE A Low Risk Surgical retractors / 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 •As per Risk levels and Intended use •Classified in accordance with Annexure-IX of Schedule M-III provided by Drug Technical Advisory Board (DTAB)
  14. 14. Global Scenario of Medical Device Market 0 100 200 300 400 500 2011 2012 2013 2018 UDbillion FY Market Size • Indian Medical Device Market is growing at almost twice rate than Global market
  15. 15. GLOBAL MEDICAL DEVICE MARKET USA Western Europe Middle/East Africa Eastern Europe Asia/ Pacific Asia/Pacific 24% Western Europe 24% Source: EPSICOM USA 45% Eastern Europe 4% Middle/East Africa 3%
  16. 16. • US • JAPAN • GERMANY • ITALY • FRANCE 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% USA(US $120) Japan( US $ 31.5) BRIC( US $ 26.28) Germany( US $ 23.38) MarketShare market Share Major Players
  17. 17. Process Flow of Rise of Emerging Markets MNC’s define the market and enter with high quality, usually imported devices not available locally Local companies identify the opportunity and reverse engineer/adapt to local requirements and get prepared to compete with MNC’s Survival of the Fittest Step I Step II Step III
  18. 18. TOP 10 MEDICAL DEVICE MANUFACTURERS Name of Company Revenue(In $US BN) Market Cap($US BN) Johnson & Johnson 28.7 294.2 General Electric Co. 18.1 243.6 Medtronic Inc. 17.1 61.2 Siemens AG 17 92.2 Baxter International Inc. 16.4 38.7 Fresenius Medical Care AG & Co. KGAA 15.2 21.1 Koninklike Phillips 11.8 26.1 Cardinal Health Inc. 11.0 25.1 Novartis AG 10.7 227.5 Covidien plc 10.4 40.1
  19. 19. Mergers & acquisitions 2011 2012  Number of deals 443 330  Total deals (with values disclosed)  Number of deals 191 141  Transaction value (£m) 28,293 28,820  Average deal size (£m) 148 204  Deals less than £500m (with values disclosed)  Number of deals 181 133  Transaction value (£m) 10,370 7,393  Average deal size (£m) 57 56
  20. 20. Mergers & acquisitions ACQUIRER TARGET DEAL VALUE (£ mn) Johnson & Johnson Synthes Gmbh 12745 Hologic Inc. Gen- probe Inc. 2388 Agilent Technologies Dako 1390 Boston Scientific Corporation Cameron Health 869 Asclepius Zoll Medical Corporation 1367 EQT Parteners AB BSN Medical Gmbh 1452 Fujifilm Holdings Corp. Sonosite 624 Thermo Fisher Scientific One Lambda 592 Linde Inc Air Products & Chemicals 487
  21. 21. US MARKET • Valued at more than US$ 60 Billion • Accounts for 20% of global industry by production • World’s largest Medical device market and accounts for 45% of global market by sales • In 2013 US have spend 18% of its GDP on healthcare which is more than any other country • Domestic consumption- 40% • >6000 medical device manufacturers • Current Issue: 2.3% medical device tax under affordable care act in 2010
  22. 22. Sector Breakdown of Deals General Equipments & supplies Patient monitoring equipment & therapies Life Sciences tools & Services Disposable Equipment and Supplies Orthopaedic Implants & prostheticsIn vitro diagnostics, supplies& Equipment 14% 18% 17% 12% 13% 6% 4% 6% 7% 3%
  23. 23. INDIA
  24. 24. Medical Device Market By Segmentation Column1 Medical and Diagnostic Equipments Medical Implants Medical Disposables and Supplies 56% 25% 19% Source: RNCOS
  25. 25. Factors Affecting Medical Device Industry Medical Device Industry Local Market Sentiment s Economic based factors Unmet clinical needs due to technology mismatch Regulatory Environme nt Healthcare Providers Reimburse ment Policies
  26. 26. FACTS  Market size- $ 7.9 US billion  Contributes only 6% of India’s US $ 40 billion healthcare sector  It is growing at a faster annual rate of 15% than 10-12 % growth seen in the Healthcare sector in its entirety  >14,000 different products types, as per the Global Medical Device Nomenclature (GMDN)  Ranks 4th in Asia and 20th in the world  70% of the medical devices are met by imports
  27. 27. Growth of Medical Device Industry 0 2 4 6 8 10 12 2012 2013 2014 2015 2016 2017 US$Billion FY 5.1 5.9 6.8 7.9 9.2 10.7 Source: RNCOS • Growth of Medical Sector alone is higher than the entire Healthcare sector in India
  28. 28. Top Players • 3 M • India Medtronic • Johnson & Johnson • Becton Dickinson • Abbott Vascular • Bausch & Lomb • Baxter • Zimmer India • Edwards Life Sciences • St. Jude Medical
  29. 29. Regulation In Medical Devices
  30. 30. Regulation In Medical Devices • India had no regulations for medical devices in place prior to 2005. • The import, manufacturing, distribution and sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945). • Controls and inspections are carried out by the CDSCO, state drug controllers and central/state laboratories. • CLAA- Branch of CDSCO ( Major regulatory body) • All medical devices will undergo conformity assessment procedures to ensure compliance with quality and safety standards before they are allowed to Indian markets
  31. 31. Regulation In Medical Devices • CLAA will adopt to regulatory Standards of Bureau Of Indian Standards (BIS) and International Organization of Standards (ISO) specification for quality management • For Class A devices- Manufacturers may perform their own conformity assessment procedures • For B, C, D – CLAA in consultation with BIS publish list of notified bodies authorized to perform conformity assessment • Imported Medical devices that are already approved in US/or and EU Union or that have been deemed equivalent to CE mark and FDA approved device will be allowed on Indian market without undergoing separate conformity assessment procedure
  32. 32. Regulation In Medical Devices- US Classification according to 21 CFR 860 which is a part of Medical Device Amendments of 1976 and safe medical device act of 1990 Class I: General Control Eg: Elastic Bandages, Examination gloves Class II: General control with Special control Eg: Infusion pumps, surgical drapes Class III: General controls and premarket approvals Eg: Implantable pacemakers, pulse generator, HIV diagnostic tests, Heart valves
  33. 33. List of Notified Medical Devices  Disposable Hypodermic Syringes  Disposable Hypodermic Needles  Disposable Perfusion Sets  In vitro Diagnostic Devices for HIV, HbsAg and HCV  Cardiac Stents  Drug Eluting Stents  Catheters  Intra Ocular Lenses  I.V. Cannulae  Bone Cements  Heart Valves  Scalp Vein Set  Orthopedic Implants  Internal Prosthetic Replacements
  34. 34. Growth Drivers & Restraints Drivers: • Expanding Healthcare Sector • Changing Demographic profile • Booming economy • Ageing population • Increase in outsourcing • Increased prevalence of Lifestyle Diseases • Telemedicine Restraints: • Reliance on Import • Lack of access to technology • Regulatory system • High capital requirement • Lack of Government interest • Less expenditure by Government in healthcare sector as compared with other nations
  35. 35. Current Scenario • Medical Device and NPPA • Amendment of D & C Act • Regulated Medical Devices sector • Role of Government  Regulatory Control  Make In India  Foreign Direct Investment  Education of Medical Devices  Medical Device Parks  National Centre of Medical Devices
  36. 36. SWOT Analysis • FDI • Increased JV • Regulations • Monopoly of MNC’s • Low per capita expenditure • Unaware rural market • Huge Market • Growing Private hospital Sector Strength Weakness OpportunityThreats
  37. 37. Conclusion • Medical Technology companies are accelerating their Investments in emerging markets and India is a prime target because of its growing population, growing middle class and improving healthcare infrastructure • Till date most Medtech multinationals have pursued a conservative business strategy and operating model in India focused on delivering their existing offering to the premium segment of the market • But now the playing field is becoming more competitive and companies in search of growth need to move beyond the traditional model

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