Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
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
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
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
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
2015 trends in global medical device strategy and issues for the supply chain...Tony Freeman
This presentation reviews critical business trends shared by major medical device companies and the implications for their manufacturing supply chain. Consolidation of device OEMs, product line and marketshare changes brought on by accountable care, and OEM desire for larger outsource partners are the dominant themes.
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
2015 trends in global medical device strategy and issues for the supply chain...Tony Freeman
This presentation reviews critical business trends shared by major medical device companies and the implications for their manufacturing supply chain. Consolidation of device OEMs, product line and marketshare changes brought on by accountable care, and OEM desire for larger outsource partners are the dominant themes.
Marketing Strategy for a medical device companysaurabhmalani
This is a marketing strategy for a leading medical device company for a new product launch. This presentation won the Babson Marketing Case Competition - 2012 with prize money of $5000. 16 schools across the globe were competing in this competition.
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Marketing Strategy for Medical Device CompanyAditya Thakur
The marketing strategy won the Annual Babson Marketing Case Competition ($5000 prize money) and involved participation from over 20 Business schools around the globe
Global Trends in Medical Device and Diagnostic OEM Strategy and Implications ...Tony Freeman
Manning Advisors is pleased to announce the publication of its 2017 Global Trends in Medical Device and Diagnostic OEM Strategy and Implications for the Supply Chain. As in past years we looked at the major issues facing medical device OEMs and how those issues drive their relationship with their suppliers.
Our findings this year include:
Medical Device OEMs focusing on improved organic growth
2016 saw major OEMs relying heavily on acquisitions to improve revenues
OEMs see the eventual end of needle-moving acquisitions and are focusing on how to accelerate organic growth
Fee-for-value reimbursement and growing use of informatics are leading to redesign of product suites
The Supply Chain is consolidating around fewer, larger players
The supply chain is also consolidating via acquisitions
OEMs are embracing risk reduction by working with larger supply chain partners
The new threat to existing supply chain companies is the penetration of the market by giant global contract manufacturers like Flextronics and Celestica
Opportunity exists for smaller, nimble players who can assist OEMs in bring product to market more quickly
Opportunity also exists for specialized manufacturers
Feel free to contact me to discuss the issues or to arrange for an onsite presentation to your Board or management team. I look forward to an intriguing discussion.
You may reach me at tfreeman@manningadvisors.com or at (917) 868-0772 directly.
Best regards,
Tony Freeman, Managing Director
Manning Advisors LLC
90 Park Avenue, 17th Floor
New York, NY 10016
MedTele Inc. offers small to mid-size medical device manufacturers the opportunity to introduce new and existing product lines to targeted specialists, hospitals, nursing homes, surgical centers and alternative healthcare facilities through our dedicated, highly experienced Sales and Marketing Services Organization.
For the complete report, get in touch with us at : info@netscribes.com
Abstract:
Netscribes’ latest market research report titled Medical Devices Market in India 2014 captures the technologically driven aspect currently prevailing within the Indian healthcare sector. The booming Indian economy is also witnessing a tremendous surge in the domestic healthcare scenario which, in turn, is leading to perpetual demand for high quality medical products. The demand for high-end, quality devices is especially driven by the private healthcare sector in its efforts to provide sophisticated treatment to patients. However, India lags behind in manufacture of technologically advanced high-end medical equipment, and instead has to rely upon imports from multinationals with extensive service networks. On the other hand, the market for less cost intensive medical supplies and disposable equipment is dominated by domestic manufacturers.
Due to the industry’s dependence on imports, multinationals are showing interest in relocation of manufacturing facilities to India as well as in forging alliances with healthcare sector stakeholders in order to capture greater market share. This brings into focus a key role played by the government that involves taxation and import regulations. The government also takes up several initiatives for the benefit of the market.
Coverage
• Overview of the medical devices market in India and forecasted market size data over 2012 to 2018
• Market Segmentation of medical devices by types
• Overview of the medical devices market in India by types and forecasted market size data over 2012 to 2018
• Snapshot of market segmentation of medical equipment
New and Refurbished Medical Equipment
Regional Demand for Medical Equipment
• Export-import overview of medical devices, value of export-import over 2009-10 to 2012-13 and country-wise value of export-import for 2011-12 and 2012-13
• Qualitative analysis of market drivers, challenges, trends and regulatory measures taken by the government
• Overview of the government bodies and their responsibilities
• Analysis of the competitive landscape and detailed profiles of major players
Why Buy
• Get a clear understanding of the medical devices market in India, how it operates and the various stages of the value chain
• Understand the current market segmentation and future growth potential of the medical devices market in India till 2018 and plan strategies to gain from it
• Strategize marketing, market-entry, market expansion, and other business plans by understanding factors influencing growth in the market
• Understand your competitors’ business structures, strategies and prospects, and respond accordingly
• Make more informed business decisions with the help of insightful recommendations provided to succeed in the Indian medical devices market
Medical Devices & Diagnostics Asia - Balancing Risk & Reward WhitepaperSimranjit Singh
A whitepaper from Quintiles which looks at the growth potential of Asia pacific for medical devices and the approaches to navigate the complex regulatory pathways.
Health Policy Supporting Innovation in Korean Medical Device Sector (July 11,...Sung Yoon Bae
Presented in the AMCHAM Healthcare Innovation Seminar, held in Seoul, Korea on July 11, 2012.
Title: Toward Better Health Policy Supporting Innovation in Korean Medical Device Sector
Date: July 11, 2012
Speaker, Sung Yoon Bae, Professor of Healthcare Management, Inje University, Busan, Korea
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
A case study on Smart medical devices market, which will give an answer to these questions.
Industry snapshot – Market Overview
The market size in India
Market share by Product type/Others Classification (anyone)
Industry structure
Domestic Manufacturing & Export-Import scenario
Key Trends
Key growth drivers
Key challenges
Prevailing government policies
Future outlook
Key investments in the sector (Value of investment and key projects etc...)
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
Organ Preservation Market PPT: Demand, Trends and Business Opportunities 2022-27IMARC Group
The global organ preservation market reached a value of US$ 163.5 Million in 2021. Looking forward, IMARC Group expects the market to reach US$ 242.6 Million by 2027, exhibiting at a CAGR of 6.8% during 2022-2027.
More info:- https://www.imarcgroup.com/organ-preservation-market
Patient Monitoring Devices Global Market estimated to be worth $42,974.9 mill...Vinay Shiva Prasad
The increase in the rate of surgeries and diseased population requires continuous monitoring, increasing demand for portable and remote patient monitoring and increasing funding and investment in patient monitoring are driving the market growth.
Wearable Medical Devices Market PPT: Demand, Trends and Business Opportunitie...IMARC Group
The global wearable medical devices market size reached US$ 23.1 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 73 Billion by 2028, exhibiting a growth rate (CAGR) of 22% during 2023-2028.
More Info:- https://www.imarcgroup.com/wearable-medical-devices-market
Organ Preservation Market Growth, Demand and Challenges of the Key Industry P...IMARC Group
The global organ preservation market size reached US$ 187.9 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 313.4 Million by 2032, exhibiting a growth rate (CAGR) of 5.7% during 2024-2032.
More Info:- https://www.imarcgroup.com/organ-preservation-market
Organ Preservation Market PPT: Demand, Trends and Business Opportunities 2022-27IMARC Group
Looking forward, the organ preservation market value is projected to reach a strong growth during the forecast period (2022-2027).
More info:- https://www.imarcgroup.com/organ-preservation-market
Booming Refurbished Medical Device MarketVikas Gupta
The growth in the refurbished medical device market has been propelled by various drivers and market-enablers, that are transforming the dynamics globally, throwing up a plethora of opportunities for the investors in this segment
The global market for respiratory care device is expected to grow from $ 21,765.7 million in 2021 to $ 33,183.2 million in 2026. The market is expected to grow at a CAGR of 8.8% over the forecast period (2021-2026). Some of the market's key participants are ACOMA, Apex Medical, BMC Medical, Breas Medical, CareFusion Corporation (BD), Chart Industries, Covidien(Medtronic), DeVilbiss Healthcare(Drive Medical), Dräger, Fisher and Paykel Healthcare, GF Health Products, Hamilton Medical, Heyer Medical, Inogen, Invacare, MGC Diagnostics Corporation, Maquet, Masimo Corporation, Nihon Kohden Corporation, Omron Healthcare, PARI Medical Holding GmbH, Philips Respironics, ResMed, SDI Diagnostics, Sysmed, Teleflex, Weinmann, Yuyue Medical. This report intends to identify significant growth areas and to explore relevant market strategies. This in-depth analysis delves into the global market for respiratory care device. The primary goal of this research is to examine the potential growth areas, significant trends, and the market's impact on the industry. The report also reviews the adoption of respiratory care device in both established and emerging markets.
The Indian in vitro diagnostic market - an overviewSchenella Menda
Looking for data on the Indian IVD market? Here is an overview of the market, its segments and a brief description of every segment. I hope you enjoy reading it.
Veterinary Diagnostics Market PPT 2024: Size, Growth, Demand and Forecast til...IMARC Group
The global veterinary diagnostics market size reached US$ 6.6 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 12.6 Billion by 2032, exhibiting a growth rate (CAGR) of 7.3% during 2024-2032.
More Info:- https://www.imarcgroup.com/veterinary-diagnostics-market
India Animal Health Market PPT: Demand, Trends and Business Opportunities 202...IMARC Group
Looking forward, the india animal health market value is projected to reach a strong growth during the forecast period (2022-2027).
More info:- https://www.imarcgroup.com/india-animal-health-market
Mercer Capital's Value Focus: Medical Device Manufacturers | Q1 2014 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
Each issue includes a segment focus, market overview, mergers and acquisitions review, and more.
What is Manpower planning
Need of Manpower planning
Steps of Manpower planning
Methods involved of Manpower planning steps
Operational plans of Manpower planning
Comparison of learning style of four corporate housesVikas Soni
GARDNER’S MULTIPLE INTELLIGENCE
WHAT IS LEARNING STYLE?
BASIC LEARNING STYLES
Field-Dependent and Field Independent Characteristics
Learning Styles: Analytic vs. Global Learners
COMPARISON OF LEARNING STYLE OF FOUR DIFFERENT CORPORATE HOUSES:
CONSULTANCY FIRM
CORE FIRM
MEDICAL DEVICE FIRM
RESEARCH & DEVELOPMENT BASED FIRM
Online marketing- Statics & Strategies 2015Vikas Soni
Global Internet User statics
Indian Internet User statics
What is Online Marketing
Types of Online Marketing
Model to Online Marketing
Marketing Strategies
Advantages and Disadvantages
Challenges
Conclusion
Business Intelligence & Technology_Pharmaceutical BIVikas Soni
An overview of business intelligence introduction, trends, components, approaches, functions, architecture and necessity to any successful business and applications of this BI approach for the better decision making in a pharmaceutical or health industry.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
2. Healthcare Sector in India
What Is Medical Device?
Major Difference Between Drug & Device
Device Classification
Global Scenario Of Medical Device Market
US Medical Device Market
Indian Medical Devices Market
Regulation Of Medical Devices
Current Scenario of Medical Device Industry in India
SWOT Analysis
Conclusion
4. REPORT: 2013
SHARES OF HEALTHCARE EXPENDITURE
71%
9%
13%
4%
3%
HOSPITALS
CAGR>11% (2013-17)
PHARMACEUTICALS
CAGR>12% (2012-20)
MEDICAL DEVICES AND SUPPLIES
CAGR>15% (2012-16)
MEDICAL INSURANCE
CAGR>20% (2008-13)
DIAGNOSTICS
Sources: Business Standard, Hospital Market India by Research on India
5. 9%
A medical device is 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 (which would make it
a drug).
Source: Wikipedia.org
6. A medical device is defined according to Schedule M-III
creates a specific definition of medical devices as separate
from drugs.
Unlike a drug, a medical device is defined as a medical tool
"which does not achieve its primary intended action in or
on the human body by pharmacological, immunological
or metabolic means.”
Medicinal products covered by the Drugs and Cosmetics
Act will not fall under Schedule M-III.
If there is any uncertainty about whether the product falls
under the drug or medical device category of the DCA
under this schedule, regulators will consider the principal
mode of action of the product.
Source: Wikipedia.org
7. DRUG DEVICE
Based on Chemistry &
Pharmacology
Safety and Efficacy
Clinical Trials
Local and Systemic
Toxicity
Long Product Life Cycle
Drug Interactions
Large Population
Based on Engineering
Safety and Performance
Clinical Evaluation
Biocompatibility
Short Product life Cycle
Device Malfunction
Limited Population
8. Medical Devices in India are classified as per their risk levels
and intended use and are divided into different classes
Classification is carried out in accordance with Annexure IX of
Schedule M‐III provided by The Drugs Technical Advisory
Board (DTAB)
9. The global medical device market was worth USD 298 Billion in
2013, which experienced significant growth over the last few years
and is expected to continue, reaching approximately USD 440.5
billion in 2018 with a CAGR of 7.5%
The five largest global markets for medical devices are U.S.,
Japan, Germany, France, and Italy. They account for 13.1% of
global population and 76% of global medical device use.
Conversely, the five most popular countries in the world China,
India, Indonesia, Brazil and Pakistan account for nearly half of the
global population, But they account for only 4.4 per cent of global
medical device use.
US is a global player in the global medical device industry with
nearly 50% shares by sales and nearly 20% of the market shares
by production .
Source: Global Marketing Emergo Group Inc.
14. The U.S. medical device industry, which is valued at more than
$60 billion, is the world’s largest and accounts for nearly 20
percent of the $350 billion global industry, by production
The United States is the world’s largest medical device market,
accounting for nearly 45 percent of the $293 billion global market
by sales
In 2013, the United States spent over 18 percent of its GDP on
healthcare more than any other country
Domestic Consumption = 40%
17 Biggest companies account for 65% of the total revenue
More than 6000 medical device manufacturers
Cardio vascular products form the single largest sector
LATEST ISSUE:2.3% medical device tax on US sales/turnover
for medical device companies.
Source: U.S. International Trade Commission
15. EXPORT OF MEDICAL DEVICES INNOVATIONS OF MEDICAL DEVICES
Source: GTIS DATABASE 2012
16. ETHICON-Women's
Health & Urology, provides a range of
GYNECARE products and solutions for gynecologic surgery
for abnormal uterine bleeding, adhesion prevention, pelvic
floor repair and incontinence. e.g. GynECARETVT
CARDIOVASCULAR CARE-Cardiovascular
Care has been a pioneer in circulatory disease
management and the worldwide leader in the science behind
the diagnosis and treatment of cardiac arrhythmias. E.g.
RADIALSOURCE™
DePuy-
DePuy Joints has products ranging from innovative
orthopedic implants for hip, knee and shoulder replacement to
high technology equipment for computer navigated
surgery. e.g. PFC SIGMA Fixed Bearing Knee System, Delta
Motion.
17. ETHICON ENDO-SURGERY-Markets
advanced medical devices for surgical procedures
that transform patient care by enabling improved patient
outcomes through early detection and treatment, reduced
pain and anxiety and quicker return to normal activity e.g.
ENDOPATH®
LIFESCAN-LifeScan
is dedicated to improve the quality of life of
people with diabetes by developing, manufacturing and
marketing a wide range of blood glucose monitoring
systems and software for use by people with diabetes and
by Healthcare providers. E.G. OneTouch®
18.
19. India’s medical device market is currently the fourth largest
market in Asia with 700 medical device makers, and ranks among
the top 20 in the world
Currently valued at $ 4.4 billion, the Indian medical device and
equipment market is expected to grow to around $ 5.8 billion by
2014 and $ 7.8 billion by 2016, growing at a CAGR of 15.5 per
cent (~2% of the Global MDI)
The Indian medical devices industry forms a very small part of the
total manufacturing industry accounting for only 0.2 percent of all
certified facilities
It is accounting for around 9% of shares in the Indian healthcare
sector, while the Indian Pharmaceutical industry is having 13%
shares in the total healthcare sector of India.
20. IMPORT DOMESTIC PRODUCTION
72%
Source: RNCOS 2012
28%
20.04 GERMANY
18.71 CHINA
17.48 US
10.07 UK
7.25 JAPAN
26.25 OTHERS
21. 19%
MEDICAL AND DIAGNOSTIC EQUIPMENTS
MEDICAL IMPLANTS
MEDICSL DISPOSABLES AND SUPPLIES
Source: RNCOS
56%
25%
23. Expansion of hospital sector
Increase in outsourcing
Rising prevalence of lifestyle diseases
Increase in medical tourism
Spread of telemedicine
Ageing population
Over reliance on imports
Lack of access to technology
Regulatory system
Access to capital
24. 1)
• A strong engineering and information technology industry are
considered to be backbones for the medical technology industry. In
spite of India’s well acknowledged capabilities and global
recognition in these areas, 72 percent of medical devices used in our
country continue to be imported.
2)
• Government appears to have failed to notice that a strong domestic
medical technology industry is vital for meeting its long term needs
of cost effective and sustainable health care needs of the Indian
population across demographics.
3)
• Despite a relatively non conducive manufacturing environment,
several domestic companies have come up in areas such as cardiac
implants, intraocular lenses, orthopedic implants and medical
disposables and have benchmarked themselves to International
norms.
25. 1. 3 M Healthcare
2. India Medtronic
3. Johnson & Johnson
4. Becton Dickinson
5. Abbott Vascular
6. Bausch & Lomb
7. Baxter
8. Zimmer India
9. Edwards Life Sciences
10. St. Jude Medical
11. Stryker
12. Boston Scientific
13. BPL Healthcare India
14. Sushrut Surgicals
15. Trivitron Diagnostics
16. Accurex Biomedical
17. Biopore Surgicals
18. Endomed Technologies
19. Forus Health
20. HD Medical Services
21. Eastern Medikit
22. Harsoria health care
23. Nidhi Meditech System
24. GE Healthcare
25. Philips Medical
26. Wipro Technologies
27. HCL Technologies
27. Trauma-
Bone Plates & Bone Screws
Intramedullary Nailing-
ADLER Atlas Nailing System
Spine-
OneLock™,
a breakthrough in Spine Technology
28. "NIDHILITH" is a intra corporeal pneumatic stone fragmentation device which
fragments the stones in the kidneys, ureters and bladder by direct contact lithotripsy,
under the direct vision endoscopic treatment. This versatile, still simple and users
friendly device proved to provide a most sophisticated and economical method to
achieve the intra corporeal pneumatic lithotripsy.
NIDHI-Uroflow is a fully automatic microprocessor based device with digitally
controlled dip-stick type flow transducer. It is designed to monitor the urinary volume
and flow rate within a urine collection beaker during micturation. NIDHI-UROFLOW
system is quite expedient for very practical day to day flow study.
29. Currently, medical devices are regulated as drugs by the
drug controller general of India (DCGI) of the Central
Drugs Standard Control Organization (CDSCO).
The lack of a drug/device distinction has created
difficulties for foreign companies in the medical device
market.
There is no single list of regulated devices with different
regulations for different devices, and some devices are
not regulated at all.
In certain cases, product registration and manufacturing
standards intended for drugs are applied to the
manufacture of devices.
30. The central licensing approval authority (CLAA), a
branch of the CDSCO, will serve as the main regulatory
body for medical devices.
All medical devices will undergo conformity assessment
procedures to ensure compliance with quality and safety
standards before they are allowed to the Indian market.
The CLAA will adopt the regulatory standards of the
Bureau of Indian Standards (BIS) and International
Organization for Standardization (ISO) specifications
for quality management systems.
31. For Class A devices, manufacturers may perform their own
conformity assessment procedures. However, for Class B, C
and D devices, the CLAA, in consultation with the BIS, will
publish a list of notified bodies authorized to perform
conformity assessment.
All medical devices imported into India are covered by
Schedule M-III and will be subject to its guidelines
Imported medical devices that already have been approved
in the United States and/or European Union, or that have
been deemed equivalent to a CE Mark and FDA-approved
device, will be allowed on the Indian market without
undergoing separate conformity assessment procedures.
32. The classification of medical devices according to 21 CFR 860
which is a part of the Medical Device Amendments of 1976 and
the Safe Medical Devices Act of 1990.
Class I: General controls:
Eg: Elastic Bandages, Examination Gloves
Class II: General controls with special controls:
Eg: Infusion Pumps, And Surgical Drapes
Class III: General controls and premarket approval:
Eg: Implantable Pacemaker, Pulse Generators, HIV Diagnostic
Tests, Automated External Defibrillators, and Heart Valves .
Source: Wikipedia.org
33. The classification of medical devices in the EU is outlined in
Annex IX of the Council Directive 93/42/EEC. There are
basically 4 classes, ranging from low risk to high risk.
Class I (including Is & Im)
Class IIa
Class IIb
Class III
Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of
Conformity issued by a Notified Body.
Certified medical devices should have the CE mark on the
packaging, insert leaflets, etc.
Source: Wikipedia.org
34. The Maharashtra Food and Drug Administration (FDA) has suggested, to
the Drug Controller General of India (DCGI) and the National
Pharmaceutical Pricing Authority (NPPA) that medical devices should be
brought under the Drug Price Control Order (DPCO), to make them
affordable to patients.
Medical devices are notified as drugs under the Drugs and Cosmetics Act,
1940 but are not included under the DPCO. Therefore, the prices of medical
devices cannot be monitored or controlled.
The recommendation comes in the wake of studies conducted by the FDA
which has revealed that manufacturers in connivance with importers,
distributors, and hospitals are fixing the MRP of medical devices arbitrarily.
The study observed that the MRP of a product was set high and the patients
had no bargaining options.
The drug authority believes that under the new DPCO regime, the prices of
these products could be monitored and would also help curb profiteering.
Source: biospectrumindia.com
35. The government is likely to soon permit 100% FDI in brownfield medical devices and equipment
manufacturing projects through the automatic route.
Currently, 100% FDI is allowed in the pharmaceutical sector (including medical devices) in greenfield
projects through automatic route, while Foreign Investment Promotion Board (FIPB) approval is needed
for brownfield investments.
Significantly, of the $5-6 billion-worth medical devices, equipments and technology market in India,
72% is catered to by imports. The government wants to reduce dependence on such imports through
incentives to increase domestic manufacturing. “Foreign investors know that with labour costs in China
going up, it will be cheaper to manufacture medical devices in India and make it a hub for exports to
other parts of South Asia,”
Discussions are on between the ministries of health and commerce on the treatment and regulation of
medical devices under the Drugs and Cosmetics (Amendment) Bill. Once the health ministry comes out
with a negative list of medical devices/equipments/technology that needs to be controlled (via FIPB
approval in brownfield investments), the remaining items can then take advantage of the proposed FDI
norms, they added. Pending parliamentary approval to the Bill, the commerce ministry wants the health
ministry to find a via media – through notification or guidelines – to ensure separate treatment for FDI in
brownfield medical devices/equipment projects.
Source: Business Standard
36. P A Francis
Wednesday, October 08, 2014, 08:00 Hrs [IST]Last week the Union health ministry came out with a notification making labelling
of medical devices mandatory in the country by amending the Drugs & Cosmetics Rules. Although labels of some of these critical
products do contain a few details, many key information is not printed on the packs. With this notification, the labels on the
devices should carry proper name of the medical device, the details necessary for the user to identify the device and its use and the
name and address of the manufacturer. The label should disclose the net quantity in terms of weight, measure, volume, number of
units and the dates of manufacture and expiry. In case of sterile devices the date of sterilisation and details of materials used for the
making such devices should be printed on the label. The label should also mention a distinctive batch number or lot number of the
product besides the manufacturing license number.
It seems that the key objective of making labelling mandatory for medical devices with all the necessary details is to bring the
medical devices sector under the regulatory control of the government. The only regulatory intervention the government did so far
was to place 14 medical devices under Drugs & Cosmetics Act. As this sector remained largely outside the purview of any
comprehensive law, there has been several unfair practices in producing and marketing of medical devices in the country. The
medical devices sector in India is still at a nascent stage with more than 60 per cent of India’s requirement of medical devices and
equipments are being imported as the domestic production is restricted to low technology and disposable items. Whereas the
demand for these life saving products has been growing over the years with a sharp rise in the life style diseases in the country.
Medical devices are life saving products and have to be produced with quality materials as per good manufacturing practices
(GMP) and under all the necessary rules. But, most of the units engaged in the manufacture of medical devices are small and do
not follow GMP voluntarily and there are no specified standards for the materials used. Quality, safety and fair pricing are three
factors that determine the growth of any industry. What has been done by the government last week is not just enough to have a
proper regulatory control on this sector. Apart from laying down standard norms for the materials used for making devices, a
system of price control on these products is extremely necessary. Currently huge profits are made on most of the life saving
devices by the traders, hospital managements and the doctors. As the patients have no say in deciding whether to use a device and
what brand of device to be used, they are subjected to overcharging. This needs to be urgently checked by fixing a system of fair
pricing medical devices as in the case of pharmaceutical products.
Source: Business Standard
37. STRENGTHS
Huge market
Growing private hospital sector
WEAKNESSES
Low per capita expenditure
Developing government policies and infrastructure
Untapped rural markets
Excessive dependency on imports
Support system from R & D not available
OPPORTUNITIES
Overseas companies investing in India
Increasing Joint ventures and agreements
Regulations to improve market for domestic
manufacturers
THREATS
Existing regulation policies
Unorganized market
SWOT
Lack of regulations in Medical disposables and
surgical items leading to spurious products
38. Medical technology (Medtech) companies are
accelerating their investments in emerging markets,
and India is a prime target because of its large
population, growing middle class, and improving
healthcare infrastructure. To date, most Medtech
multinationals have pursued a conservative business
strategy and operating model in India, focused on
delivering their existing offerings to the premium
segments of the market. But the playing field is
becoming far more competitive, and companies in
search of growth need to move beyond the traditional
model.