medical devices : sector analysis

NIPERAhmedabad

Medical Devices in Indiaa brief report

Presented Jointly by

NIPER-Ahmedabad and Frost and Sullivan

NIPERAhmedabad

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

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.

NIPERAhmedabad

MEDICAL DEVICES SECTOR

Focus on Implants

Avenues - Products

Material Science and Biomaterials Cardiovascular & Diabetes

Pacemakers, Defibrillators, Drug-eluting stents, Catheters, Valves

OrthopaedicsJoint replacement: Plates, Nails, Dynamic Hip Screw, limb deformity correction devices, casting materials

OphthalmologyIntra ocular lens (IOL), Viscoelastics (OVDs)

OncologyRadio Guided Neuro SurgeryNewer range of genetic diagnostic kits and reagents

NeurologyTreatment of stroke. Coiling of aneurysms; angioplasty and stenting of carotid

Diagnostics and ImagingRadiology, Ultrasound, CT, MRI, X-ray etc. MD in the field of Cardiac imaging, CT Colongraphy, Digital X-

ray, Molecular Imaging, MRI, Musculoskeletal, Nuclear, Ultrasound,

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%

2004 2005 2006 2007 2008160

180

200

220

240

YEAR

US

D B

illi

on

s

CAGR: 4.5%

NIPERAhmedabad

Regional Market Share

North America44%

Europe32%

Asia Pacific18%

Rest of World6%

GLOBAL MARKET SHARE

Indian Medical Devices Market

2006 2007 20081600

1800

2000

2200

2400

2600

2800

3000

YEAR

US

D M

illi

on

sCAGR: 15%

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%

INDIA: IMPORT v/s EXPORT

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.

NIPERAhmedabad

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

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

INDIA: IMPORT v/s EXPORT

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.

NIPERAhmedabad

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

NIPERAhmedabad

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.

NIPERAhmedabad

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

NIPERAhmedabad

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.

Need to set up NCMDInvolved in

Product Development & Testing facilitiesHaving R & D infrastructure for this sectorHuman Resource development & TrainingConsultancy and facilitationWith NIPERs – NIPER Ahmedabad

National Centre for Medical Devices

Recommendations for NCMD - NIPERs

Interfacing with Engineering, Medical and Pharma sectors.

Should be well-aligned with PharmaAcademic 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 studiesPre-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.

NIPERAhmedabad

Thank you!

It is the intention of this report that the

growth witnessed in Pharma sector in past 20

years should be replicated by medical device

and diagnostic sectors in coming 5-7 years,

and India which is net importer will become

exporter, and like generics in pharma will

penetrate regulated market with high-end

products.

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.

NIPER-Ahmedabad

Thank youAcknowledgement: Support from Department of Pharmaceuticals

Government of IndiaHowever, opinion and views expressed are not necessarily subscribed by

either the Department of Pharmaceuticals or the Government of India

NIPERAhmedabad

MEDICAL DEVICES: CAPACITY BUILDING Blueprint for NIPER Ahmedabad

NIPERAhmedabad

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,

Capacity Building - Avenues

Product Development & Testing

Incubator, Cluster Development

HR and Training

Cluster - formation Key-factor for success

Medical Devices…

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

NIPER-A’bad to have Incubator with facilities to house 8-10 start-up companies

Need to set up NCMDInvolved in

Product Development & Testing facilitiesHaving R & D infrastructure for this sectorHuman Resource development & TrainingConsultancy and facilitationWith NIPERs – NIPER Ahmedabad

National Centre for Medical Devices

National Centre on Medical Devices at

NIPER-AhmedabadR & 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.


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 studiesPre-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.

No. Course Description Remarks

1 Bioengineering

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

5Instrumentation & 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

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.

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.).


Training in Testing of devices: Short term certificate/diploma courses for MD testing and

regulationsTraining 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.

NIPERAhmedabad

Thank you!

It is the intention of this report that the

growth witnessed in Pharma sector in past 20

years should be replicated by medical device

and diagnostic sectors in coming 5-7 years,

and India which is net importer will become

exporter, and like generics in pharma will

penetrate regulated market with high-end

products.

NIPER-Ahmedabad

Thank you

medical devices : sector analysis

Documents