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.
This document discusses biologics and biosimilars. It defines biologics as biological products made from natural sources like humans, animals or microorganisms that are used to treat or prevent diseases. Biosimilars are highly similar versions of biologics that are approved because they have no clinically meaningful differences. The document outlines key differences between biologics and biosimilars like regulatory pathways and development testing. It also compares biosimilars to generics and discusses important considerations for biosimilar development like immunogenicity, bioequivalence and post-translational modification.
Advantages of Pharma in India, Market Share and Economic Drivers, Structure of Pharma Sector, Evolution of Pharma, Revenue %, Market Share, Porter 5 Force Model, BCG Matrix, Government Policies, Opportunities.
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
Trends & Opportunities for Indian Pharma is a knowledge paper highlighting the upcoming trends and related opportunities in Indian pharmaceuticals industry
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
I have to try to share some knowledge about the Indian health care sector. I have put some data to get more and more knowledge which can easily understand.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
This PPT contains complete analysis of Pharmaceutical Industry including worldwide and nationwide picture, leading organizations, SWOT analysis, Government policies and regulations, challenges and solutions.
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.
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.
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
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
This document provides an overview of biological products as defined by the FDA. It describes biological products as medical products made from sugars, proteins, nucleic acids or complex combinations in living cells or tissues. Examples like vaccines, blood components and monoclonal antibodies are provided. The document highlights how biological products differ from chemically synthesized drugs in being large molecules from natural sources, requiring complex manufacturing processes, and sometimes being heterogeneous or immunogenic. It briefly outlines the process required for a biological product to be licensed by the FDA, including demonstrating consistent manufacturing and clinical safety and efficacy data.
Pharmaceutical Industry Global & Indianprateek_floyd
The document discusses the global pharmaceutical industry. It provides data showing steady growth in global pharmaceutical sales from 2003-2012, with the US market accounting for the largest share. The top 10 pharmaceutical companies are also listed. R&D spending and trends in major markets like the US, Europe, and Japan are examined. Details are also provided about the large and growing pharmaceutical industries in India and their competitive advantages in generics manufacturing.
The memorandum summarizes key provisions of the newly passed FDA Food Safety Modernization Act, including new requirements for food facilities to register with the FDA, develop and implement hazard analysis and preventive control plans, and maintain additional records. It also outlines new enforcement authorities granted to the FDA, such as mandatory recall authority, administrative detention authority, and the ability to suspend a facility's registration. Major rulemakings and guidance documents required by the Act are also discussed.
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
This document outlines a 3-phase marketing strategy for a new cancer treatment. Phase 1 focuses on early adopters to build credibility and reduce concerns about costs. Phase 2 leverages early success through marketing partnerships and publications to influence insurance reimbursement. Phase 3 aims to capture the mass market and replace existing treatments once insurance provides blanket coverage for the new treatment.
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
The document summarizes the Indian medical device market. It finds that the market was worth $5.1 billion in 2012 and is expected to reach $9.2 billion by 2016, growing at a 15.8% CAGR. Currently, 72% of medical devices sold in India are imported, with imports favored due to taxation policies. The market is dominated by multinational companies in high-tech segments, while domestic players cater to lower-tech areas. The top opportunities are in medical and diagnostic equipment, expected to reach $6 billion and grow over 17% by 2017. Key drivers of growth are increasing incomes, insurance coverage, and government support of healthcare. Barriers include low penetration, over-reliance on
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.
Market analysis of medicine segment in health careVartika Bisht
This document provides a market analysis of the medicine segment of the Indian healthcare industry. It notes that the healthcare industry in India has grown at a CAGR of 17% from 2008-2020 and is expected to reach $280 billion by 2020. The pharmaceutical sector is the largest segment, making up 71% of healthcare expenditures. Key drivers of growth include rising incomes, increased health insurance coverage, and government policies supporting the industry. Major players like Dr. Reddy's, Lupin, Cipla, and Aurobindo control over 20% of the domestic pharmaceutical market. The industry faces high competition but low threat of new entrants or substitutes.
The Japanese market for medical devices reached $37.6 billion in 2016 and is expected to grow to $45 billion by 2020, making it the second largest market globally in terms of growth rate. It remains heavily reliant on imports, especially for sophisticated devices. The regulatory agencies overseeing the medical device market in Japan are the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). Devices are classified based on risk into four classes, with Class I having the lowest risk and Class IV the highest. Regulatory approval processes differ depending on the class, ranging from self-declaration for Class I devices to pre-market approval from MHLW for Class III and
This document discusses regulatory affairs for medical devices. It explains that regulatory affairs professionals help medical companies bring products to market by managing regulatory activities. The course prepares students to understand regulations around developing, testing, and commercializing medical devices from agencies like the FDA and in the EU. It covers topics like classifying devices, obtaining approvals, inspections, compliance, quality management systems, and labeling.
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
Critical success factors for a medical device company include developing a strong business plan, securing adequate funding, building a capable team, navigating the FDA approval process, and establishing reimbursement. The business plan should explain the vision and strategy, understand the market and competition, and include financial projections. Funding typically comes from personal investments initially and then venture capital. Assembling the right people with relevant expertise is also crucial. Navigating FDA approval and establishing reimbursement are major hurdles that require understanding regulations which are complex and changing.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
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
The document discusses the medical device industry, noting that it has worldwide sales of $265 billion annually and employs over 350,000 people in the US. It outlines the impact of the current economy on the healthcare industry, including increased costs, decreased funding, and government regulations. The document advocates for strategic sales and marketing planning to guide resource allocation and coordination between departments. It provides elements that should be included in a strategic plan, such as knowledge of the market and competition, and suggests ways marketing and sales can work together, such as developing consultative selling approaches.
Indian pharmaceutical industry aligns with Medical device segment, PharmaBio ...Dr. Subroto Ghoshal, Ph.D
The document discusses the medical device industry in India. It notes that the Indian medical device market ranks among the top 20 globally and is growing at 15% annually. However, nearly 75% of devices used in India are currently imported. The industry is working to develop international-standard regulations to stimulate local innovation and manufacturing. The government is also taking steps to promote the sector, such as potentially regulating prices and bringing medical devices under the department of pharmaceuticals. The future of the industry in India looks promising with opportunities in areas like wireless surgical devices, robotics, and image-guided surgery.
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...)
India Medical Devices Market: Size, Share, and In-Depth Competitive Analysis ...Kumar Satyam
According to TechSci Research report, “India Medical Devices Market Industry Size, Share, Trends, Competition, Opportunity and Forecast, 2019-2029,” the India Medical Devices Market was valued at USD 15.35 billion in 2023 and is anticipated to witness impressive growth in the forecast period, with a Compound Annual Growth Rate (CAGR) of 5.35% through 2029. This growth is driven by various factors, including strategic collaborations and partnerships among leading companies, a growing population, and the increasing demand for advanced healthcare solutions.
Recent Trends
Strategic Collaborations and Partnerships
One of the most significant trends driving the India Medical Devices Market is the increasing number of collaborations and partnerships among leading companies. These alliances aim to merge the expertise of individual companies to strengthen their market position and enhance their product offerings. For instance, partnerships between local manufacturers and international companies bring advanced technologies and manufacturing techniques to the Indian market, fostering innovation and improving product quality.
Browse over XX market data Figures and spread through XX Pages and an in-depth TOC on " India Medical Devices Market.” - https://www.techsciresearch.com/report/india-medical-devices-market/8161.html
This document provides a summary of the global patient monitoring market from 2012-2020. It discusses key market segments such as devices (cardiac, prenatal, etc.), end-users (medical centers, home users), and regions (North America, Europe, Asia Pacific). The global market is expected to reach $XX million by 2020, growing at 5.2% annually. North America currently dominates the market but Asia Pacific is expected to see the fastest growth. Cardiac monitoring accounts for the largest segment currently but remote monitoring is growing the fastest. The report provides market size data and forecasts for each segment.
The document is the annual report of the Government of India's Ministry of Chemicals & Fertilizers Department of Pharmaceuticals for the year 2020-21. It provides an overview of the pharmaceutical and medical devices industry in India. Some key points:
- India is the 3rd largest pharmaceutical producer by volume globally and supplies affordable generic drugs worldwide. It also accounts for 60% of global vaccine production.
- The medical devices industry in India has potential to reach $50 billion by 2025, currently ranking among the top 20 global markets.
- Exports and imports of pharmaceuticals and medical devices in 2019-20 are provided, with exports of medical devices growing and reducing the trade deficit.
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
Organ Preservation Market PPT: Demand, Trends and Business Opportunities 2022-27IMARC Group
The global organ preservation market reached a value of US$ 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
This document provides an overview of the medical device and equipment industry in India. It discusses key aspects of the industry including leading companies, drivers of growth, challenges, and recommendations for the government. The medical device industry in India is valued at $2.5 billion but has significant growth potential. While private and foreign investment is increasing, challenges remain around low penetration, affordability, and developing a robust regulatory system on par with global standards.
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
The document analyzes the medical devices industry globally and in India. It finds that the global market is led by companies like Johnson & Johnson, GE, and Siemens, with North America having the largest share. In India, the medical devices market is the fastest growing and expected to reach Rs. 12,000 crore in size annually growing 15% due to factors like rising incomes and healthcare spending. However, the industry faces challenges like low R&D investment and an unsteady regulatory environment. The conclusion is that the sector has strong growth potential in India if these issues can be addressed.
Infection Surveillance Solutions Market PPT: Growth, Outlook, Demand, Keyplay...IMARC Group
The global infection surveillance solutions market size reached US$ 652.6 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 1,314.8 Million by 2032, exhibiting a growth rate (CAGR) of 7.65% during 2024-2032.
More Info:- https://www.imarcgroup.com/infection-surveillance-solutions-market
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Causes Of Tooth Loss
PERIODONTAL PROBLEMS ( PERIODONTITIS, GINIGIVITIS)
Systemic Causes Of Tooth Loss
1. Diabetes Mellitus
2. Female Sexual Hormones Condition
3. Hyperpituitarism
4. Hyperthyroidism
5. Primary Hyperparathyroidism
6. Osteoporosis
7. Hypophosphatasia
8. Hypophosphatemia
Causes Of Tooth Loss
CARIES/ TOOTH DECAY
Causes Of Tooth Loss
CAUSES OF TOOTH LOSS
Consequence of tooth loss
Anatomic
Loss of ridge volume both height and width
Bone loss :
mandible > maxilla
Posteriorly > anteriorly
Anatomic consequences
Broader mandibular arch with constricting maxilary arch
Attached gingiva is replaced with less keratinised oral mucosa which is more readily traumatized.
Anatomic consequences
Tipping of the adjacent teeth
Supraeruption of the teeth
Traumatic occlusion
Premature occlusal contact
Anatomic Consequences
Anatomic Consequences
Physiologic consequences
Physiologic Consequences
Decreased lip support
Decreased lower facial height
Physiologic Consequences
Physiologic consequences
Education of Patient
Diagnosis, Treatment Planning, Design, Treatment, Sequencing, and Mouth Preparation
Support for Distal Extension Denture Bases
Establishment and Verification of Occlusal Relations and Tooth Arrangements
Initial Placement Procedures
Periodic Recall
Education of Patient
Informing a patient about a health matter to
secure informed consent.
Patient education should begin at the initial
contact with the patient and should continue throughout treatment.
The dentist and the patient share responsibility for the ultimate success of a removable partial denture.
This educational procedure is especially important when the treatment plan and prognosis are discussed with the patient.
Diagnosis, Treatment Planning, Design, Treatment, Sequencing, and Mouth Preparation
Begin with thorough medical and dental histories.
The complete oral examination must include both clinical and radiographic interpretation of:
caries
the condition of existing restorations
periodontal conditions
responses of teeth (especially abutment teeth) and residual ridges to previous stress
The vitality of remaining teeth
Continued…..
Occlusal plan evaluation
Arch form
Evaluation of Occlusal relationship through mounting the diagnostic cast
The dental cast surveyor is an absolute necessity in which patients are being treated with removable partial dentures.
Mouth preparations, in the appropriate sequence, should be oriented toward the goal of
providing adequate support, stability,
retention, and
a harmonious occlusion for the partial denture.
Support for Distal Extension Denture Bases
A base made to fit the anatomic ridge form does not provide adequate support under occlusal loading.
The base may be made to fit the form of the ridge when under function.
Support for Distal Extension Denture Bases
This provides support
A comparative study on uroculturome antimicrobial susceptibility in apparentl...Bhoj Raj Singh
The uroculturome indicates the profile of culturable microbes inhabiting the urinary tract, and it is often required to do a urine culture to find an effective antimicrobial to treat UTIs. This study targeted to understand the profile of culturable pathogens in the urine of apparently healthy (128) and humans with clinical UTIs (161). In urine samples from UTI cases, microbial counts were 1.2×104 ± 6.02×103 colony-forming units (cfu)/ mL, while in urine samples from apparently healthy humans, the average count was 3.33± 1.34×103 cfu/ mL. In eight samples (six from UTI cases and two from apparently healthy people) of urine, Candida (C. albicans 3, C. catenulata 1, C. krusei 1, C. tropicalis 1, C. parapsiplosis 1, C. gulliermondii 1) and Rhizopus species (1) were detected. Candida krusei was detected only in a single urine sample from a healthy person and C. albicans was detected both in urine of healthy and clinical UTI cases. Fungal strains were always detected with one or more types of bacteria. Gram-positive bacteria were more commonly (OR, 1.98; CI99, 1.01-3.87) detected in urine samples of apparently healthy humans, and Gram -ve bacteria (OR, 2.74; CI99, 1.44-5.23) in urines of UTI cases. From urine samples of 161 UTI cases, a total of 90 different types of microbes were detected and, 73 samples had only a single type of bacteria. In contrast, 49, 29, 3, 4, 1, and 2 samples had 2, 3, 4, 5, 6 and 7 types of bacteria, respectively. The most common bacteria detected in urine of UTI cases was Escherichia coli detected in 52 samples, in 20 cases as the single type of bacteria, other 34 types of bacteria were detected in pure form in 53 cases. From 128 urine samples of apparently healthy people, 88 types of microbes were detected either singly or in association with others, from 64 urine samples only a single type of bacteria was detected while 34, 13, 3, 11, 2 and 1 samples yielded 2, 3, 4, 5, 6 and seven types of microbes, respectively. In the urine of apparently healthy humans too, E. coli was the most common bacteria, detected in pure culture from 10 samples followed by Staphylococcus haemolyticus (9), S. intermedius (5), and S. aureus (5), and similar types of bacteria also dominated in cases of mixed occurrence, E. coli was detected in 26, S. aureus in 22 and S. haemolyticus in 19 urine samples, respectively. Gram +ve bacteria isolated from urine samples' irrespective of health status were more often (p, <0.01) resistant than Gram -ve bacteria to ajowan oil, holy basil oil, cinnamaldehyde, and cinnamon oil, but more susceptible to sandalwood oil (p, <0.01). However, for antibiotics, Gram +ve were more often susceptible than Gram -ve bacteria to cephalosporins, doxycycline, and nitrofurantoin. The study concludes that to understand the role of good and bad bacteria in the urinary tract microbiome more targeted studies are needed to discern the isolates at the pathotype level.
Chair and Presenter, Stephen V. Liu, MD, Benjamin Levy, MD, Jessica J. Lin, MD, and Prof. Solange Peters, MD, PhD, prepared useful Practice Aids pertaining to NSCLC for this CME/MOC/NCPD/AAPA/IPCE activity titled “Decoding Biomarker Testing and Targeted Therapy in NSCLC: The Complete Guide for 2024.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/4bBb8fi. CME/MOC/NCPD/AAPA/IPCE credit will be available until July 1, 2025.
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®
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.