Medical devices

India is the 4th largest market for medical devices in Asia, among the top 20 markets globally
THE WORLD OF medical DEVICES

 Welcome everyone! Today, we'll delve into the fascinating world of

medical devices. These instruments play a crucial role in modern
healthcare, assisting in diagnosis, treatment, monitoring, and
prevention of various medical conditions. From simple
thermometers to complex surgical robots, medical devices have
revolutionized the way we approach healthcare, improving patient
outcomes and enhancing the lives of millions worldwide.
WHAT ARE MEDICAL DEVICES

 Instruments used for:

 Diagnosis
 Treatment
 Monitoring
 Prevention of medical conditions
 Examples:
 Stethoscopes
 Thermometers
 Blood pressure cuffs
 Imaging devices (X-ray, MRI)
 Surgical instruments
 Pacemakers
 Artificial limbs
X-ray machine

Electrocardiogram (ECG)

Ultrasound machine

MRI scanner

Pulse oximeter
Robotic surgical arm

3D printed prosthetic limb

Blood pressure monitor

Nebulizer

Glucometer

Defibrillator
CLASSIFICATION OF MEDICAL DEVICES

 Based on risk to patients:

 Class I: Low risk (e.g., bandages, tongue depressors)
 Class II: Moderate risk (e.g., blood pressure cuffs, contact lenses)
 Class III: High risk (e.g., heart valves, pacemakers)
 Exempt: Minimal risk (e.g., non-invasive thermometers, adhesive bandages)
IMPACT OF MEDICAL DEVICES

 Improved diagnosis and treatment

 Enhanced patient outcomes
 Increased life expectancy
 Improved quality of life for individuals with chronic
conditions
 Advancements in minimally invasive procedures
 Reduced healthcare costs associated with longer hospital
stays
THE FUTURE OF MEDICAL DEVICES


The future of medical devices is brimming with exciting possibilities, driven by
advancements in technology and a focus on personalized, preventative, and accessible
healthcare. Here are some key trends shaping the landscape:
 1. Rise of the "smart" devices:
 Internet of Medical Things (IoMT): Devices will be increasingly interconnected,
allowing for real-time data collection, remote patient monitoring, and better care
coordination. Imagine pacemakers transmitting vital signs or insulin pumps automatically
adjusting based on blood sugar levels.
 Artificial Intelligence (AI) integration: AI algorithms will analyze patient data to detect
diseases earlier, predict health risks, and personalize treatment plans. This could involve
AI-powered diagnostics, robotics-assisted surgery, and even drug development.
 2. Focus on personalized and preventative healthcare:
 Wearables and biosensors: Continuous monitoring of vital signs, sleep patterns, and activity levels
will empower individuals to take a more active role in managing their health.
 Digital therapeutics: Software applications and interactive programs will offer non-invasive
treatments and support for various conditions, promoting self-care and behavior modification.
 3D printing: This technology will enable the creation of customized implants, prosthetics, and
even organs, catering to individual needs and improving biocompatibility.
3. Accessibility and affordability:

 Telehealth and remote monitoring: These technologies will expand access to healthcare in remote
areas and for individuals with limited mobility.
 Focus on cost-effectiveness: As healthcare costs rise, there will be a push for devices that are not
only effective but also affordable for patients and healthcare systems.
 Challenges and considerations:
 While the future holds immense promise, ethical considerations regarding data privacy,
cybersecurity, and equitable access to these advancements must be addressed. Additionally,
ensuring regulatory frameworks adapt to the evolving landscape will be crucial.
INDUSTRY SCENERIO

 The size of the Indian medical devices market is estimated

at $11 Bn, and is expected to grow to $50 Bn by 2025 and
the sector has been growing steadily at a CAGR of 15%
over the last 3 years
Major segments (five major segments)

 Consumables & Disposables include needles and syringes, etc

 Diagnostic Imaging includes MRI, X-Ray, Ultrasounds, etc
 Dental Products includes dentures, braces, etc
 Orthopaedics & Prosthetics include knee implants, artificial joints
 Patient Aids include hearing aids and pacemakers, etc
Medical Industry growth drivers

 Growing population
 Life expectancy
 Shifting deasease burden
 Changing preference
 Growing middle class
 Increasing disposable income
 Health insurance
 Rise in medical tourism
 Infrastuctural development
 Govt steps to strengthen the industry
 Cabinet approves medical devices policy 2023 to help sector grow to USD 50 bn in next 5 yrs.
 Under the PLI scheme for medical devices, till now, a total of 26 projects have been approved, with a committed
investment of Rs 1,206 crore and out of this, so far, an investment of Rs.714 Cr has been achieved .
 The National Medical Devices Policy 2023 is to meet the maximum requirements from locally manufactured products
 Setting up of 4 medical device park in the state of Himachal Pradesh ,Madhya Pradesh ,tamil nadu and Uttar Pradesh .
 Under the PLI scheme, total of 14 projects producing 37 products have been commissioned and domestic
manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan,
Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc.
 India and Netherlands sign a Memorandum of Intent to cooperate on medical product regulation, and enhancing the
quality of medical products
 National Policy on Research and Development and Innovation in Pharma MedTech Sector in India
 National Medical policy 2023
 The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical
device sector to meet the public health objectives of access, affordability, quality and innovation. This
sector is expected to realize its full potential, with the strategies viz, building an enabling ecosystem
for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory
framework, providing support in training and capacity building programs and promoting higher
education to foster talent and skilled resources in line with the industry requirements. Encouraging
domestic investments and production of medical devices complements the Government’s
‘Atmanirbhar Bharat’ and ‘Make in India’ programs.
 National Medical Devices Policy, 2023:
 Vision: Accelerated growth path with a patient-centric approach and to emerge as the global leader in
the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding
global market over the next 25 years. Policy is expected to help the Medical Devices Sector grow
from present $11 Bn to $50 Bn by 2030.
 Mission: Policy lays down a roadmap for accelerated growth of the medical devices sector to achieve
the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality
Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.
The six strategies planned under the National Medical policy
2023

1. Regulatory Streamlining
2. Enabling Infrastructure
3. Facilitating R&D and Innovation
4. Attracting Investments in the Sector
5. Human Resources Development
6. Brand Positioning & Awareness Creation
 Scheme for medical devices manufacturing
 The Indian Government has identified the medical devices as a priority sector for the flagship 'Make in India' program
and is committed to strengthen the manufacturing ecosystem. India is the fourth largest medical devices market in Asia.
Currently, the Indian market has high reliance on imports but in recent times the exports have seen a surged. ‘Atma
Nirbhar’ Bharat mission is providing an impetus to India’s vision of becoming a global manufacturing hub for medical
devices. Recent initiatives for instance, The Production Linked Incentive Scheme (PLI) and Promotion of Medical
Devices Parks Scheme, are a testimony to this. These schemes have been cogently constructed to incentivize large-scale
manufacturing and to build required infrastructure for developing manufacturing clusters within India.
 Scheme 1

Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices

1- The Production Linked Incentives Scheme (PLI) Scheme for Medical Devices manufacturing proposes a financial incentive to boost domestic
manufacturing and attract large investment in medical devices segments such as cancer care devices, radiology and imaging devices, anaesthetics
devices, implants etc.
2- Production Linked Incentives to the tune of $ 456 Mn
3- The Scheme is set to create global champions out of India and boost the “Make in India, Make for the World” mandate
 Scheme 2
 Production Linked Incentive Scheme for Pharmaceuticals (PLI 2.0)
 The Production Linked Incentive Scheme aims to enhance India’s manufacturing capabilities by
increasing investment and production in the pharmaceutical and medical devices sectors and
contributing to product diversification to high value goods in the sectors.
 The Scheme intends to create global champions out of India who have the potential to grow and scale
using cutting edge technology and thereby penetrate the global value chains. The Scheme includes a
broad range of product segments ranging from biopharmaceuticals, APIs, and in vitro medical
devices.
 55 Pharma Companies have qualified for the 15,000 Crore PLI Scheme, giving the ""Pharmacy of
the World"" a boost to increase investment & production of Pharmaceuticals & Medical Devices.
 Scheme 3

 Promotion of Medical Device Parks

 Promotion of Medical Device Parks aims to strengthen the infrastructure base and develop a robust
manufacturing ecosystem for medical devices in the domestic market. Grants under the Scheme for
development of world-class standard testing and infrastructure facilities will build momentum for domestic
production and deepen the value chain of Medical Devices in India. Additionally, these are expected to
reduce the cost of manufacturing significantly, leading to better accessibility and affordability of medical
devices in the country.
 The total financial outlay of the scheme is Rs. 400 crore and the tenure of the scheme is from FY 2020-2021
to FY 2024-2025
 Proposal from 16 States/UTs were received under the scheme
 Based on the evaluation, the proposals of State Government of Himachal Pradesh, Tamil Nadu, Madhya
Pradesh and Uttar Pradesh have been given “in-principle” approval under the scheme.
 The scheme reflects the spirit of co-operative federalism where the Central Government and State
Governments will partner to develop the Medial Device parks for better performance of the sector.
 Incentive & Common Indicated Infrastructure
 Incentive
 Outlay of INR 400 crores to provide financial assistance for building common infrastructure for medical devices parks across 4 states.
 Grant per park up to INR 100 Crore or 70% project cost (whichever is less)
 Grants in the North East States and Hilly States (i.e. Himachal Pradesh, Uttarakhand, UT of Jammu & Kashmir and UT of Ladakh), to be
INR 100 Crore or up to 90% of project cost (whichever is less)
 Indicated Common Infrastructure:
 Component Testing Centre/ESDM/PCB/Sensors facility
 Electra-Magnetic Interference & Electra Magnetic Compatibility Centre
 Biomaterial / Biocompatibility /Accelerated Aging Testing Centre
 Medical Grade Moulding/Milling/Injection Moulding/Machining/Tooling Centre
 3D Designing and Printing for Medical-Grade Products.
 Sterilization/ETO/Gamma Centre
 Animal Lab and Toxicity testing Centre
 Radiation Testing Centre
 Radiology Tube/Flat Panel Detectors/MRI Magnets/ Piezo Electrical Crystals/Power Electronics Facility
 Solid waste management/ETP/STP/Electronic Waste management Unit
 Common Warehouse & Logistics (Clearing and Forwarding, Insurance, Transportation. Customs, Weighbridges, etc.) Centre
 Emergency Response Centre/Safety/Hazardous Operations audit Centre
 Centre of Excellence/Technology incubator/ ITI/Training Centres
Medical Industry trends
Major investors
Policies and schemes