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

1. MEDICAL DEVICES
Presented By:
Rushikesh . S. Markad
Management Scholar: 15PMM542
Department Of Pharmaceutical
Management,
NIPER, Mohali.

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. Earlier Scenario of Healthcare Sector in India

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. 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. Revenue Split
Hospitals
Meical Equipment and
Supplies
Medical Insurance
Diagnostics
Pharmaceuticals
71%
9%
4%
3%
13%
Source: India Brand Equity Foundation, November
2011

7. Medical Device

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. 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. Segmentation By Application- India
Source: Global marketing Emergo group Inc.

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. 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. 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. 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. 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. • 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. 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. 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. 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. 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. 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. 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. INDIA

24. Medical Device Market By
Segmentation
Column1
Medical and Diagnostic
Equipments
Medical Implants
Medical Disposables
and Supplies
56%
25%
19%
Source: RNCOS

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. 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

28. 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

29. Top Players
• 3 M
• India Medtronic
• Johnson & Johnson
• Becton Dickinson
• Abbott Vascular
• Bausch & Lomb
• Baxter
• Zimmer India
• Edwards Life Sciences
• St. Jude Medical

30. Regulation In Medical Devices

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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