Medtech Report India
Medtech Report India
Medtech Report India
Report India
A handbook for Swiss startups
1
This report is created and published by:
swissnex India l Consulate General of Switzerland
#26 Rest House Crescent Road, Bangalore, India 560001
Tel.: +91 80 4941 2000
swissnex India connects Switzerland and India in the fields of science, education, art and
innovation. An initiative of the Swiss State Secretariat for Education, Research and Innovation
(SERI) in association with the Swiss Federal Department of Foreign Affairs, swissnex India is
part of the Consulate General of Switzerland in Bangalore (www.swissnexindia.org).
in association with
http://globalbusinessinroads.com/
GBI works on strategy development, provides technology management and market entry
advisory to international organisations, which includes services like market validation, partner
identification, country representation, business development, technology localisation, piloting,
local business model development, and technology commercialisation. We also manage
programs and develop ecosystems with both global and regional stakeholders. The GBI team,
with a cumulative experience of more than 35 years has designed a technology management
process that focuses on connecting with the right opportunities, hence developing a proactive
strategy where client’s risks are managed well.
In this report, medical technology (medtech) is defined to include medical devices, surgical
and medical instruments, surgical appliances, dental equipment, medical equipment and
wearables. Healthcare sector includes medtech as well.
Million (10^6) is denoted by m and Billion (10^9) by bn.
The information and analyses contained in this document have been prepared by swissnex
India in association with Global Business Inroads (GBI). swissnex India and its partners
assume no responsibility for errors and omissions related to the data, calculations or analysis
contained herein and in no event will swissnex India or its partners be liable for direct,
special, incidental or consequential damages (including, but not limited to, damages for loss
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indirectly from the use of (or failure to use) this report.
Table of Contents
EXECUTIVE SUMMARY 3
5 BUSINESS CONSIDERATIONS 18
5.1 Innovative business models 18
5.2 Adoption 19
5.3 Distribution 20
5.4 Regulation 20
5.5 Good manufacturing practice (GMP) 23
5.6 Intellectual property policy 23
5.7 Where does the Indian market stand – a comparison with China 23
8 MARKET VALIDATION AND ENTRY FOR SWISS MEDTECH AND HEALTHCARE STARTUPS 29
8.1 A personal account of two Swiss medtech startup CxOs 29
9 CONCLUSION 31
10 REFERENCES 32
The Medtech
Market
Potential in India Healthcare status
Growing population, rising income levels and
changing disease profiles call for high quality
Low doctor population
medtech to bridge the gap between demand and
ratio 1:1428
supply of healthcare, making India an extremely
(Switzerland - 1:250)
attractive market.
CHF* 50 billion
market opportunity by 2025.
Medtech sector
growth
(in CHF*)
12% CAGR 50 billion
Healthcare
drivers
Infectious diseases:
‘Make in India’ Tuberculosis kills more than
initiative: 1000 people a day
100% FDI 95% of India resides in Malaria
Medical device endemic regions
incubators, SEZs
10 billion
Non-communicable diseases:
Largest number of diabetics in
2.9 billion the world
Heart disease occurs 10-15
years earlier than in the west
2010 2014 2025
(Projected)
Rapidly growing healthcare sector Medtech sector segmentation: Total sales of 4577.78 million
and import of 3159.12 million
Revenue by disease (80 billion CHF* in 2013) � (TS) TotalSales CHF* (m)
� (I) Imports CHF* (m)
Infectious Diseases 21.35%
Others 33.71%
In-vitro
diagnostic reagents
Sectors by New market
creation
revenue (products, TS: 1429.63
investments) I: 468.76
Manufacturing
20% % Imports : 32.79
(Domestic sales TS: 2459.26 TS: 362.96
and exports, finished
I: 2150.48 I: 280.53
and raw materials) Sales
% Imports : 87.44 % Imports: 77.29
40% 40%
Fast
growing Patient Connected Self and Hospital and
segments aids medical home care laboratory
*1 CHF = 1USD
India’s medtech market was valued at USD 10 bn in 2014 and is expected to touch USD 50
bn mark by 2025. This is in part due to India’s rising income levels, swelling private sector
investment in healthcare, ageing population, growing medical tourism industry, and government
incentives in the medtech space. All these factors make India an extremely attractive market for
international firms.
There is a need to use medtech effectively to address the huge gap between demand and
supply of healthcare services in India. The medtech sector in India is at a nascent stage with
most of the indigenous manufacturing restricted to medical consumables. In fact, imports still
constitute over 75% of the current medtech market. India is looking to improve self-sufficiency
in medtech as a part of the “Make in India” initiative. The rapidly expanding sector presents
immense opportunities to global players.
India is on the cusp of epidemiological transition. There is a big shift in health burden from
communicable to include non-communicable diseases, which in turn is driving key medtech
segments. There is a demand for both cutting-edge precision technologies and for affordable
low technology.
The Indian medtech innovation ecosystem is fast evolving and vibrant with academic research,
venture capital firms, government funding and promising startups developing products
specifically for the Indian market. In many ways, the ecosystem is very reflective of the Swiss
medtech innovation ecosystem.
This report aims to outline the Indian medtech and healthcare scenario. It intends to provide
the reader with a specific overview of the market opportunities, challenges, the innovation
ecosystem and strategies for success with illustrative case studies.
3
1.
Medtech industry in India is growing rapidly, and provides plenty of opportunities for innovative
Swiss medtech startups to contribute. There is a strong disparity between supply and demand.
Demand factors such as a growing population, increasing purchase power and a changing
health profile are driving the need for high quality innovative solutions.
Medtech
Market in 1.1 Medtech Market Analysis
India The Indian market is among top 20 markets globally in terms of market size. In Asia, it is 4th
after China, Japan and South Korea. The medtech sector in India was worth USD 10 bn
in 2014 and is growing at 12% compound annual growth rate (CAGR). In contrast, the
global medtech market is growing annually at the rate of 4.1% (1). The Swiss medtech
market, which has the highest density of medtech related activities, is currently valued at USD
14 bn and growing at a single digit rate. The world’s largest medtech market, the US market,
enjoyed a rapid double-digit growth rate in the last decade, but will see a sluggish 5% growth
rate post 2020 (2). These numbers have sparked immense interest in India from international
medtech firms. A snapshot of the sector is shown in the exhibit below.
Year
4
1.2 An Import Driven Market
At present, the medtech sector is dominated by imported products both as finished
goods and raw material. This is primarily due to lack of a strong regulatory environment
coupled with an inverted duty structure favouring imports. Basic customs duty ranges
from 5-7.5% with up to 4% special additional duty for finished goods and 2.5% basic customs
duty on raw materials and accessories used to manufacture medical devices. High-tech
equipment like MRI, CT Scanners etc constitute a big bulk of the medical devices imported
into the country (3).
Unlike China or USA, India also does not have a preferential purchase policy for domestically
manufactured goods for use in public health infrastructure.
Disposables and
1429.63 468.76 32.79
consumables
In-vitro diagnostic
362.96 280.53 77.29
reagents
Domestic companies largely manufacture low-end products, which serve both the domestic
and international markets. Products manufactured in India are mainly syringes, needles,
catheters, blood collection tubes, medical equipment and medical electronics. Consumables
and disposable segment is the only sector of the Indian medtech industry where the sale of
indigenous products overshoots the sale of imported products. More than 60% of domestically
manufactured goods are exported.
5
Figure 3 Industry profile of medical devices manufacturing in India (4)
6
2.
Medtech sector and the healthcare sector are interdependent. Hence, it becomes imperative
to understand the health status and healthcare delivery status in India. These inform the need
of medtech solutions and product development.
In 2014, India was the 6th largest global market in terms of size and is expected to rank
Setting the in the top 3 by 2025. India accounts for 20% of world’s population and is forecasted to cross
Context: 1.4 bn by 2025, of which 50% will be over or below 30 years. India’s average expenditure on
Healthcare in
healthcare over the last decade has been around 4% GDP. India’s per capita expenditure on
healthcare was USD 75 in 2015, as against USD 420 in China, USD 9403 in the USA and USD
In India, 58% of all healthcare expenditure is out-of-pocket. India has a wide socio-
economic index consisting of people who are able to afford world-class treatment and
those who are pushed deeper into poverty due to healthcare expenditure. In comparison,
Swiss only pay 25% of their health expenditures out of their pocket, a result of higher state
expenditures on public health, advanced social security coverage and more widespread
insurance penetration (5).
Despite advances, health infrastructure is not equitably distributed and overall the infrastructure
is well below WHO guidelines. To drive equitable healthcare, the role and market opportunity
of every segment in healthcare delivery systems is paramount; given the large unmet
needs of the growing population to provide high quality and affordable healthcare.
• Death at Childbirth: India has the highest number of maternal deaths in the world,
accounting for 17% of all the women who died during or after birth (6).
• Infant Mortality: Even though India achieved impressive growth in child survival, 38
out of 1000 children still do not reach the age of one. This is significantly higher than
Brazil, with an infant mortality rate of 15 out of 1000 children and neighbouring countries
such as Bangladesh, with 31 out of 1000 children (7). These numbers underline the
enormous demand in affordable basic healthcare solutions that strengthen mothers
and newborns.
• Shortage of Healthcare Professionals: According to the World Bank, India has only
0.7 physicians per 1000 people, which is half of the global average at 1.5 physicians per
1000 people (5). With this number, India also has a much lower doctor density than China
and Brazil, which are both around 1.9. Switzerland currently has 4 doctors per 1000
inhabitants. Solutions that allow healthcare staff to extend their reach to remote
places (virtual doctors) as well as time efficient medtech solutions are needed.
7
• Shortage of Healthcare Infrastructure: The World Bank estimates that the Indian
government currently spends about 1% of its GDP on public health care. The hospital
resources fall short on the number of people they are expected to serve: India has only 0.7
hospital beds per 1000 people, while other BRIC countries like Brazil and China have 2.3
and 3.8 respectively. Switzerland has 6 beds per 1000 people. Medtech costs 30-40%
of the total investment required to set up a tertiary care hospital and contributes to
20-25% in total healthcare cost to a patient (8). Given this, affordable medtech is a
key determinant in improving the health infrastructure.
Doctors 0.7 1
Table 2
However, these numbers average out the healthcare scenario in India. For e.g. Goa and
Manipur have the lowest infant mortality rate at 11/1000 live births, while Madhya Pradesh has
the highest at 59/1000 live births. Similarly, there are >1.5 doctors in Tamil Nadu and Karnataka
while <0.5 doctors in Bihar, Uttar Pradesh (9). Target regions are distinct depending on the
kind of problem the medtech product addresses.
The contrasts are stark and there is a large urban-rural divide in the supply and demand of
healthcare. While 70% of the Indian population resides in rural areas, majority of the doctors,
pharmacies and hospitals are in cities. The poor infrastructure coupled with a lack of well-
trained medical staff is a huge challenge for rural healthcare delivery. This is in stark contrast
to the cities in the country, where due to the dominance of private healthcare players and the
spending power of the urban middle class, access to the best medical equipment is a given.
There is a huge opportunity for innovative solutions that increase accessibility to
good healthcare.
8
Healthcare is offered through several delivery channels right from grassroot level physicians
including those practicing traditional or indigenous forms of medicine, independent
practitioners with clinics of varying sizes, hospitals and specialty hospitals. Availability is driven
by purchasing power and demographic profile. Apart from special government initiatives on
healthcare (HIV/AIDS, TB, Malaria, vaccinations, etc.), private sector dominates the market.
80% of all out-patient and 60% of all in-patient services are provided by the private sector (10).
Out of the total healthcare spend, the government spend was only one-third (WHO Global
Healthcare Expenditure Database). Government spending continues to be low, resulting in
an increased private sector presence. Recent estimates indicate that around 95% of the
new hospital beds will be added by the private sector (12).
Apart from rise in income, change in social and age demographics, increased awareness,
epidemiological transition, penetration of health insurance, increasing mobile usage and
emergence as a key destination for medical tourism have propelled the demand for healthcare
in India. The industry has growth rate of 10-12%, and with a 12% CAGR, the sector will grow
to USD 250-300 bn by 2025.
9
Figure 6 Healthcare market is pegged at USD 250-300 bn for 2025 (1)
Year
Disease % Revenue
Others 12.61
Oncology 7.74
Gastrology 6.99
Orthopedics 4.99
Neurology 3.50
Dermatology 3.50
Respiratory 3.00
Gynaecology 2.75
Urology 1.37
Table 3
10
3.
Epidemiological transition and changes in demographic profile in parallel are causing a swift
transition in health status. Aside from changes in disease profile and age demographics,
rising incomes, increased health awareness, penetration of health insurance and increasing
demands from medical tourism will push the demand for better healthcare and medtech.
Factors expected to drive growth of the industry are described below:
Key
Drivers for 3.1 Epidemiological Transition
Healthcare
and in turn, The health burden of India has shifted from communicable to include non-communicable
the Medtech diseases. India’s current health status is characterised by high morbidity (incidence
Market
of disease), low mortality (incidence of death) and dual burden of communicable and
non-communicable diseases (NCDs). NCDs include asthma, acute bronchitis, problems
of joints/ bones, hypertension, cardiovascular diseases (CVDs), diabetes, cancer, etc. There
is a pattern of increasing morbidity with age. Chronic NCDs have increased over five-fold
in prevalence in ageing populations especially those over 60 years. Rise in NCDs has not
replaced communicable diseases either (15).
The national health profile for 2015 attributes over 50% death to NCDs (16)
Condition Death %
Cardiovascular diseases 26
Cancer 7
Diabetes 2
Injuries 12
Table 4
11
• Cardiovascular Diseases: Cardiovascular diseases (CVDs) will be the largest cause of
death and disability by 2020 in India. The World Congress of Cardiology estimates that
40 % of deaths in India will be from heart disease. By the year 2020, 2.6 m Indians
are predicted to die due to coronary heart disease which constitutes 54.1 % of all
CVD deaths. Nearly half of these deaths are likely to occur in young and middle aged
individuals (30-69 years). Currently Indians experience CVD deaths at least a decade
earlier than their counterparts in countries with established market economies (20). Heart
disease has reached epidemic proportions with 30 m patients and 200,000 surgeries
being performed (21). One of the key reasons for the grim statistics is late diagnosis
of cardiovascular issues. This is more often than not due to limited access to
diagnostic equipment, qualified cardiologists and preventive care especially in the
rural areas of the country.
• Diabetes: India has the dubious distinction of being both the cardiovascular disease
and the diabetes capital of the world. There were 69.1 m reported cases of diabetes
in 2015 (22). Studies have also shown that the disease sets in at a younger age in the
Indian population. The average age of a diabetic is 40 in India, 10 years younger than in
developed countries (23). In the rural areas where there is limited access to monitoring
equipment, affordable care and trained medical personnel, the disease takes a toll on
entire families. The alarming number of diabetics in the country has led to a scurry
of activity in the local medtech market to manufacture cost effective, easy to use
diabetes monitoring devices and service delivery innovations for early diagnosis.
12
• Bacterial Diseases: Tuberculosis causes around 1000 deaths each day and accounts
for a loss of over 11 m disability adjusted life years (DALYs). Bacterial resistance
is a growing threat due to indiscriminate use of broad spectrum antibiotics (26). It is
estimated that 40% of the Indian population has active or latent tuberculosis (27).
Emergence of immune compromising HIV/AIDS and diabetes could increase the
prevalence. Newer diagnostic methods to ascertain for antibiotic resistance at the
onset and equipment to improve biosafety laboratory infrastructure are required.
Outbreak of typhoid, an acute condition caused by poor sanitation is a reason for high
mortality. The central ministry of health indicates a morbidity rate from 1 to 22 per 1000
people due to typhoid in different parts of India (28). Equipment to improve cold-chain
to improve immunisation are needed. Cold chain is also a requirement for polio,
diphtheria pertussis tetanus vaccines and diluents among others.
• Diarrhoeal Diseases: 1 out of 242 children in India dies from diarrhoea before turning 5
years of age. The incidence is highest in children below 1 year. 15% of pediatric beds in
India treat gastroenteritis (29). Ways to improve vitamin supplementation, safe water
and improved sanitation are unmet needs.
• Parasitic Diseases: Endemic diseases like Kala-azar and Malaria are major public health
problems in the states of Bihar, West Bengal and Uttar Pradesh. The diseases affect the
poorest people and is linked with a weak immune system, poor sanitation and living
conditions. In 2013, 882,000 cases of malaria were reported. Though malarial cases have
almost been halved from 2 m in 2000, emergence of chloroquine resistance and vector
resistance to insecticides has hampered malaria control. India’s National Vector Borne
Disease Control aims to eradicate malaria by 2030 by expanding community based
diagnostic testing and treatment (28, 30).
• Viral Diseases: India accounts for over 2.1 m HIV/AIDS cases with 75,948 new cases
in 2015. Though HIV/AIDS rates have dropped from 24% to 0.26% between 2007-2015,
incidences have been increasing in several states in north and north-east India - Assam,
Tripura, Sikkim. There is a need for quick diagnosis and interventions in medicine
delivery across hostile terrain (31).
From 1.2 bn in 2011, India’s population is set to grow to 1.4 bn by 2025. Declining infant
mortality and increasing life expectancy will augment the demand for healthcare. Even
though the Indian population is currently young – with a median of 26 years – the population
distribution is slowly changing. Indian population over 60 years will contribute to 12.5% of
total population by 2025, which means, a whopping 175 m will be elderly. Estimates by the
UN Population Fund show that 66% or 115 m of the elderly are likely to suffer from at least
one NCD ailment (32).
13
3.3 Rising Income Levels Increases Affordability
Access to affordable healthcare is a major constraint for 59% of households with an annual
income of <USD 3000 per year. Households in the income bracket of USD 3000-7500 is
expected to increase to 37.5% by 2018 (10). This increasing population group, who are
willing to pay for better healthcare services, will be favourable for the industry.
In January 2016, India crossed 1 bn mobile phone subscribers mark. The ubiquitous reach
of mobile phones has made it the most effective way for last mile connect. Of these 302
m had internet connections (33). Cheapest calling rates in the world and increasing internet
penetration are of consequence for tele, e- and mhealth. This translates to an increased
market opportunity for medtech in this segment. Connected devices are currently one of
the top 5 fast-growing segments in medtech in India.
In 2014 only 17% of the Indian population had a health insurance (34). So the ability of
lower income groups to access quality healthcare still remains an impediment. Government
sponsored schemes account for around 80% of the health insurance coverage provided.
The low penetration is set to change as the commercial health insurance policies have been
increasing at 10% CAGR (35). Health checkups which are mandatory for health insurance
will also rise requiring quality medtech to service the demand.
India is currently one of the top three destinations for medical tourism in the world. The medical
tourism industry in India is expected to grow to USD 10.3 bn by the year 2020 from USD
2.8 bn in 2015. Investments in luxury healthcare are growing because of the strong demand
for high quality below-international prices of healthcare. For e.g. ABV is investing USD 78
m for a luxury hospital in Mumbai, Aster Medcity has built a 575-bed hospital in Kolkata,
Fortis has built a 450-bed hospital in Delhi (36). India hosted 240,000 medical tourists in 2013
(37). Highly sought-after treatments in India include bone marrow transplants, cardiac
bypass surgery, eye surgery and hip replacements, all of which require sophisticated
and state-of-the-art medical technology.
14
4.
Technological advancements have expanded the role of medical technologies to play a key
role at all stages of healthcare chain – increasing access, screening, diagnosis, treatment,
reparation and monitoring.
Opportunities
for Medtech
Industry
across the
Healthcare
Spectrum
Figure 7
at each stage of the healthcare chain are given below. These case studies illustrate that
to succeed in India, the focus must be on improving affordability, accessibility, availability
and quality.
Screening: UE LifeScience -
Intelligent Breast Examination iBE
iBE is a low-cost portable, non-invasive, radiation-free FDA approved handheld scanner. iBE
pairs with smartphones through Bluetooth and scanning results appear on the screen. The
emphasis is on affordability with each screening costing just USD 1.5. Operating requirements
are very low so the device can be operated at home, temporary health camp or in a clinic. UE
Lifesciences is backed by Unitus Seed Fund.
15
Treatment: Perfint – Maxio
Maxio is a minimally invasive, image-guided robotic system for interventional oncology
procedures like ablation, drug delivery, biopsy, drainage, fine-needle aspiration, etc. It is
an integrated precision device combining tumour visualization, treatment planning, robotic
navigation and image verification. In 2015, it was used in 1,500 procedures across US,
Germany, Russia and India. Perfint raised USD 11.04 m in series D from Norwest Venture
Partners in 2013.
16
Key takeaways for product development
• Tailoring the product to India, specifically to the market (private or public)/
region (urban or rural, specific state or city) one intends to sell
• Cost differentiation
• High quality at lower prices
• Portable products that can be used at lower levels of health infrastructure
• Products requiring less training (low operational requirement)
• Saleability at early stages of development
• Innovative business models
17
5.
To an outsider, India may seem like a single market with huge volumes, but the reality is
India is not one market, but many. There is a market for high quality, cutting-edge high
precision medical equipment at the upper end of the value chain and for low-technology high
volume products at the lower end of the value chain. Healthcare is evolving dramatically
Business
with advances in IT, data analytics, precision engineering, and genetics. Hence, innovations
in business models, regulation and technology adoption have to be generated to encourage
To succeed in India, innovation cannot be confined to product level technology but supported
by two other pillars of innovation – service delivery and operating models. Companies have
adopted interesting ways to capture, consolidate positions in existing markets and for new
market creation. The following case studies of Thyrocare, GE, Philips and Lybrate illustrate
new, innovative business model ideas:
Sawai Man Singh hospital in Rajasthan is one of Government’s few multispeciality hospitals
serving multitudinous people. Philips India worked with the radiology department of the hos-
pital to set up three Tesla MRI scanners and two 128-slice CT scanners costing USD 4.5 m in
a PPP model where a private player was roped in for funding. The funder gets paid on a per
use basis. The hospital handles 150 cases per day and a high-volume, low margin business
model has been set successfully (40).
18
Lybrate – mHealth
In a country with over 1 bn mobile phone connections and 300 m mobile internet connections,
using mHealth to offer healthcare is a good proposition. Lybrate describes itself as the
‘Facebook of healthcare’. Lybrate is an app which enables users to get credible solutions
or second opinions for their health issues from a pool of trusted doctors on an open-
ended platform. It also provides private consultation with a doctor of their choice. Users can
share their medical reports, pictures, prior medications, or any other record in a one-on-one
discussion with the doctor. Lybrate has over 80,000 doctors from different specialties on its
platform. Patients seek multiple opinions from doctors for free on the open platform, or start
a one-on-one dialogue privately for a fee with doctors. On the open platform, doctors’ replies
are endorsed by other doctors increasing their reputation in the client base.
5.2 Adoption
mHealth platforms like Lybrate present a market opportunity for sensors, devices for remote
monitoring, artificial intelligence and mobile applications that can improve healthcare delivery.
Outlook of healthcare practitioners is key for adoption of new technologies.
In Himachal Pradesh (an Indian state), 90% of healthcare services are provided by the
government. 70% of the region is difficult to access, with mountainous terrain and sub-zero
temperatures most of the time. Healthcare provision is sub-optimal with individuals having
to travel 10-15 km on foot to the nearest healthcare centre. The state has the highest tele-
density of all states in India. Therefore the idea of using mHealth instead of in-person doctor
visits for clinical diagnosis, providing health advice, monitoring compliance for treatment and
exchanging clinical information with patients is appealing.
A study on 592 doctors showed that mHealth tools were accepted as an additional tool but
not as a replacement for interaction with patients. There was a perception that patients would
not readily accept mHealth services. Only 58.8% of participants were open to easily adopting
mHealth services. Concerns ranged from competency of handling personal information, how
mHealth would affect customer base, and whether it would really enhance the effectiveness
of healthcare activities (41).
Medtech companies worldwide are facing increasing competition in the same segment making
product differentiation difficult. Customer experience is a key differentiation factor and
especially influences adoption in India. At Sawai Man Singh hospital, Philips did not only
sell and set-up the instruments but worked with the radiology department to train technicians
and optimized the workflow to increase throughput.
19
5.3 Distribution
A medical device has to pass from the manufacturer through unorganised distributors to
reach hospitals, clinics and laboratories. Challenges in this multi-tier distribution system
include a supplier driven market and lack of information leading to pricing issues for
manufacturers. From the buyer perspective equipment is expensive, training is an issue and
access to cheaper medical devices comes with “no service” which decreases confidence in
buying the medtech product itself.
Instead, refurbished equipment which come at 60% of the cost of a new one are often
preferred. MRIs, X-Rays, ventilators, cath labs are most commonly purchased refurbished
equipment. Approximately, 20% of the overall equipment sold and almost 30% of the sales
in the private sector is refurbished (42). 20% new beds are being added in tier 2/3 cities
(cities with population between 20,000 – 1,00,000) every year. Hence, it becomes important to
provide services across these regions efficiently.
This is now changing with players like Collateral Medical, acting as a pan-India agent to
directly sell to end customers online at transparent prices.
Collateral Medical –
IT-enabled Pan-India Distribution Company
Collateral Medical is a medical device marketing and distribution company headquartered in
Mumbai. They have partnered with global and domestic original equipment manufacturers
(OEMs) leveraging technology – e-commerce portal, internet and mobile technologies to serve
pan-India customers ranging from corporates, NGOs to individual doctor’s clinics. Colmed
mainly targets small hospitals and clinics where demand is very high. By acting as procurement
agents for these smaller customers, Colmed is able to manage inventories and negotiate a
fair price by aggregating small orders. From the medtech manufacturer perspective, products
are quickly brought online as customer offerings and technology dissemination done through
videos, features, etc. The company is growing over 100% each year and has serviced orders
from all of 29 states in India.
5.4 Regulation
Medical devices are largely unregulated except certain classes which are considered
“drugs” and come under the Drugs and Cosmetics Act. Exact information can be found
at Central Drugs Standard Control Organisation (CDSCO) website - http://www.cdsco.
nic.in/. The CDSCO has a separate medical devices and diagnostics division separate
from drugs and cosmetics.
The class of regulated devices are termed “notified medical devices” and the rest are “non-
notified devices”.
20
List of notified medical devices and substances (43)
I.V. Cannulae
Bone Cements
Heart Valves
Orthopedic Implants
Table 5
Devices that don’t fall under the category of “notified device” can be imported to India with
“import and export license” from the Indian distributor. However the distributor or legal
representative in India does need to submit certain documents like device approval from the
country of origin, post marketing data and device master file to the regulatory body.
21
Timeframe (indicative
License (44) Authority
in months)
DGCI/ Directorate
Import General Of Foreign 3
Trade (DGFT)
Marketing/ manufacturing
new device after DGCI 6
satisfactory clinical trials
Table 6
If a notified medical device is marketed in USA, Europe, Japan, Canada or Australia, clinical
study in India is not required. Data from prior clinical trials, post market report and design
document is sufficient to get approval in India.
The Central government can prohibit import or manufacture which have been withdrawn from
markets stated above (43). Application for registration certificate and import license for noti-
fied devices can be filed through Sugam, an online CDSCO portal.
The government is presently trying to introduce greater regulation in the medtech industry
through the National Medical Device Policy (45). The objective is “to strengthen the Make in
India drive in the medical device sector by reducing the dependence on imports and setting
up a strong base for medical devices especially those having critical implications in terms of
affordability and availability for patients”. Some of the salient features of the draft National
Medical Device Policy include:
22
1. Setting up of a National Medical Device Authority (NMDA) an autonomous body under the
Department of Pharmaceuticals. NMDA will be responsible for setting up and managing,
through an appropriate corporate body, medical devices mega parks of approximately
500 hectares and above, of various specializations.
2. Under the guidance of the NMDA, the government will provide incentives to both
Greenfield and Brownfield units for manufacturing in India, interest subsidy and
concessional tariff for fixed periods of time.
3. Setting up an institutional framework of a) medical device testing centers in PPP mode,
b) designating centers of excellence for supporting product development and validation,
c) strengthening the BIS mark akin to CE and FDA, d) setting up of skill development
committees under NMDA and e) setting up of incubation centers.
GMP guidelines are prescribed for companies manufacturing in India. Foreign manufacturers
also need to submit their GMP certificate. Non-compliance leads to cancellation of
manufacturing license. To curb below-par standards of devices, the government has a “whistle
blower” policy and incentivises citizens who bring to attention spurious cases (44).
India complies with the World Trade Organization regulations and, specifically, the Trade
Related Aspects of Intellectual Property Rights Agreement (‘TRIPS’). India has a well-
established statutory, administrative, and judicial frameworks to safeguard IPRs. Patented
inventions (including products) are given 20 years of protection in India. Computer databases
and software programs, which are widely used by the medical devices industry, have been
protected under copyright. Computer programs having technical application to the industry
and computer programs in combination with hardware can now be patented in India. Though
trade secrets and know-how are not protected by any legislation, they are protected under the
common law and through contractual obligations (44).
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5.7 Where does the Indian Market Stand –
a Comparison with China
As a result of China’s economic growth and government’s health reform investments, the
healthcare industry in China has been continuously growing in the past years and this trend
will continue in the coming years. In the table below, some of the significant differentiators
between the Indian and Chinese medtech markets are given.
India China
Although a framework
to establish a regulatory In China, clinical evaluation
authority is in the works, is more robust than clinical
currently medical devices evaluation reports submitted
Regulatory with a CE mark or FDA in Europe and USA for Class
Environment approval are allowed to II/III devices. Pre-existing CER
enter the Indian market. is not sufficient for approvals
Local clinical data is not in China, necessitating local
required, making market clinical data (48).
access easier in India.
Table 7
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6.
India is one of the hotbeds for startups offering huge opportunities. This is reflected in the Global
Startup Ecosystem Ranking where Bangalore was placed #15 on the list. Delhi and Mumbai, two
other India cities, were also featured in the top 20. In comparison, Switzerland did not make it
to the top 20 list. Exit values, VC investment from Bangalore have grown 4 times each (49). The
state of entrepreneurial ecosystem specifically for medtech is described below.
Medtech
Ecosystem in
India 6.1 Investor Interest
Medtech sector is witnessing lot of Foreign Direct Investments (FDI). Between 2000 and
2011, inflows were around USD 36.7 m each year. It has increased to USD 134 m in 2014.
Presently, even the Swiss financial centre and SIX Swiss Exchange are reaching out to 200-
250 pharmaceutical, biotech, healthcare and medtech companies in India for listing on their
platform (50).
Investment
Medtech Company Investors
(USD m)
BPL Medical
Goldman Sachs 20.18
Technologies
Table 8
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6.2 Academic Research and Technology Transfer
Academic research in the medtech sector in India is looking at finding solutions for the local
market needs which are low-cost, less time consuming, point-of-care and easy to transport
given the fragmented nature of healthcare delivery in India. Examples of translational projects
originating from academia supported by Government of India for commercialization of
research discoveries is given below:
Table 9
Technology transfer and academia-industry links are strengthening with applied research being
transferred over to the industry. Below are two case studies of successful academia-industry
collaborations with products innovated for India, but impacting patients all over the world:
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valve has been implanted in over 100,000 patients and is used in Thailand, Nepal, South Africa
and Kenya. Sri Chitra institute has over 130 patents out of which 50 have been commercialised
or are in the process of being converted to technology.
Developing medical technology requires a lot of machines that startups can’t really afford to
buy. Co-creating, co-working spaces, makerspaces, incubators and accelerators provide key
resources for product development, interactions and office infrastructure. India has around 60
Ministry of Science and Technology supported incubators (full list at www.nstedb.com) and
100+ independent incubators. Relevant examples for medtech are given below:
Table 10
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7.
Medtech industry in India is nascent and growing fast. Lessons from other industries are key
to figure out successful formulae to sell in India. More than the best management systems, big
financial resources or big brands, strategies and execution are what matter.
Indian Market behind Maruti-Suzuki. Automobile experts opine that this is due to disconnect of the board
- Lessons
members located in Detroit, Wolfsburg, Tokyo (54). Local presence is invaluable to build
relationships, deeply understand customers and Indian conditions either directly or
The cash payment system developed specifically for India is being used in other
countries like Indonesia and Singapore. Safety features that allow one to track journey,
SOS button, etc. which are now standard features were originally developed for India.
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8.
A good strategy for Swiss entrepreneurs is to visit India to understand the size and nature of
the Indian market, positioning for their product and assessing their value proposition.
swissnex India offers a structured market validation plan for startups visiting India. The 1-3
weeks plan includes meetings with potential customers, collaboration partners, key opinion
Market leaders (KOLs), regulatory and legal experts. swissnex India also promotes technology
Validation showcase through conferences, forums, trade shows and big ticket events. In this period, the
and Entry
startup can hope to
• Understand cost structures of setting operations
for Swiss •
•
Meet experts and validate the product/ service offering for the Indian market
Medtech and
Network with potential customers and collaborators
• Understand IP/ legal issues surrounding the company
Healthcare
Startups swissnex India regularly conducts market validation tours specifically for medtech and
healthcare startups, mentors, investors and other interested Swiss stakeholders. The tailored
program exposes participants to two top startup ecosystems in the world – Bangalore and
Delhi. The tour includes networking with hospitals, experts, startups in India and KOLs. For
our next tour, check www.swissnexindia.org.
Startups ready for India can use swissnex India as a base while they set up their own offices
within India. Support includes a short-term office infrastructure, access to networks and help
with hiring.
Contact: innovation@swissnexindia.org
29
What milestones have you already achieved in India?
“By coming to India, we have seen the need for our solution and the interest of India’s hospitals
to use our product. We are now in contact with two hospitals that are willing to try our solution
for some trials.”
What advice would you give to other startups that are planning to come to India?
“Be open-minded, it’s a huge culture from which we have already learned a lot. Understanding
their problems enables us to design a better solution for their market.”
Thanks to swissnex India, we have access to the startup network in Bangalore. We have now
many essential contacts, ranging from the healthcare sector in India to manufacturing and
software development. Last month, we filed a patent in India to protect our technology in
prevision of marketing in the future.”
What advice would you give to other startups that are planning to come to India?
“I would advise them to go there and feel the atmosphere. India is not a place where you can
just meet people on the internet to put a collaboration together. You need to be present on the
spot and meet and talk directly to the people, to create mutual trust. In this, swissnex India
can really be of help. Moreover, it is indispensable to have a local Indian contact who is able
to communicate with different players on behalf of the startup.”
30
9.
The Indian market is very unique. In India, consumers shop for healthcare. This means there’s
a market for every segment of medtech to enable healthcare delivery. Ideas for the medtech
and healthcare segment are plenty – innovative business models, working directly with clinical
research and hospitals to provide customized solutions, using the population as a base to inform
big data and analytics, developing new products and manufacturing in India.
Conclusion
By 2020, Asia-Pacific will surpass the European Union in terms of size of medtech market, with
majority of the customers beyond the premium segment. Further, individual markets that make
Asia-Pacific are a complicated collection with different political systems, culture and disease
profiles. Doing business in India gives a heady mix of the same extraordinary challenges and
big opportunities, mimicking that of Asia-Pacific market as a whole. Worldwide, healthcare
systems are in great economic stress and are increasingly demanding greater returns on
investment. Innovating for India automatically focuses on maximum value. This learning
translates to helping healthcare systems worldwide with their cost curve, a global opportunity.
31
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