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
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
1. The document discusses medical devices, their classification, and regulatory approval processes. Medical devices range from simple items like tongue depressors to complex devices like pacemakers.
2. Devices are classified by the US FDA into Class I, II, and III based on risk, with Class III posing the greatest risks. Approval processes vary depending on class, from quality management registration for Class I to premarket approval involving clinical trials for Class III.
3. Key regulatory pathways discussed include 510(k) premarket notification for demonstrating substantial equivalence, and premarket approval involving clinical trials to establish safety and effectiveness for new Class III devices. The regulatory processes aim to ensure the quality, safety and effectiveness of medical devices.
The document provides an overview of clinical trials for medical devices. It discusses definitions of medical devices according to FDA and Indian regulations, and classification of devices into classes based on risk level. The key phases of medical device clinical trials are pilot/feasibility studies and pivotal/confirmatory studies. Other topics covered include premarket notification (510k), investigational device exemption (IDE), premarket approval (PMA), differences between device and drug trials, and the global and Indian medical device markets.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
The document discusses the FDA's regulatory pathways for medical devices. The FDA uses a risk-based classification system to categorize devices as Class I, II, or III based on risk, with Class III devices posing the highest risk. Class I devices face the fewest regulatory requirements while Class III devices require a rigorous premarket approval process. The key pathways are 510(k) clearance for Class II devices and premarket approval (PMA) for Class III devices. The FDA aims to evaluate devices throughout their lifecycle from premarket through postmarket surveillance to ensure safety and effectiveness.
The document discusses key considerations for developing medical devices with a global market strategy in mind. It outlines common mistakes made during development like poor reimbursement planning, lack of human factors research, and unclear regulatory pathways. It emphasizes the importance of bringing together all development disciplines like regulatory, compliance, testing, and reimbursement in a unified strategy from the beginning. Finally, it discusses best practices like working closely with regulatory agencies early, having a platform for evolution, and maintaining strong communication across functions and stakeholders.
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
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.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
This document discusses medical device regulation and classification. It begins by defining medical devices and the purpose of regulation. Devices are classified by invasiveness, duration of use, and anatomical site into Class I, II, and III. Class I devices have the lowest risk, while Class III devices like pacemakers have higher risks. Marketing approval processes vary by class, from general controls for Class I, to 510(k) notifications for Class II that demonstrate substantial equivalence, to stringent Pre-Market Approval (PMA) required for new Class III devices which requires clinical trial data. The document also covers international standards, design control, risk management including failure mode and effect analysis, and risk control methods.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
The document provides guidance for regulatory audits of medical device manufacturers' quality management systems. It discusses the Global Harmonization Task Force (GHTF), which aimed to harmonize medical device regulations internationally. GHTF established 5 study groups, including Study Group 4 which focused on auditing strategies and developed guidance documents. The guidance covers establishing auditing procedures, auditor competencies, and conducting and documenting audits in a harmonized manner. It provides a framework for consistent regulatory audits of medical device quality systems across countries.
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
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.
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
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 discusses medical devices and the regulations around them in India. It provides classifications for medical devices from class A involving lowest risks to class C involving moderate to high risks. Some examples are given for each class. It outlines the regulatory structure in India, noting that the CDSCO is the key regulatory organization. It also discusses the growth of the Indian medical devices market, expected to be worth $11 billion by 2023, and some of the drivers and challenges for the sector. Top medical device companies operating in India are also mentioned.
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
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.
Medical devices are regulated under the Medical Device Rules published in 2017 and effective in 2018 in India. They include any instrument or material intended for human or animal use for diagnosis, treatment or prevention of disease. The Central Drugs Standard Control Organization regulates medical devices and some are notified under the Drugs and Cosmetics Act. There have been efforts to improve regulation of medical devices in India to focus on safety and appropriate use.
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.
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulation updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as knowledge resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulatory updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
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...)
The document discusses medical device regulation in India. It provides definitions of medical devices and outlines the regulatory bodies that govern them, including the Central Drugs Standard Control Organization (CDSCO). It describes the proposed Indian Medical Devices Regulatory Act (IMRDA) and its objectives to establish standards, classify devices by risk, and regulate safety. The regulation of medical devices in India is still developing, with proposals to expand regulation beyond the limited devices currently covered under the Drugs and Cosmetics Act.
Introduction Indian Pharmaceutical market, SWOT analysis, PEST Analysis, Timeline analysis of Sun Pharma, Glaxo Smith Kline, Mankind, CIPLA and Zydus Cadila.
The document is a 297-page report on the infection prevention products and services market in the US. It forecasts that US demand will grow 5.1% annually to reach $21.4 billion by 2015, driven by stricter standards in healthcare facilities to reduce infections. The fastest growing segments will be disinfectants and infection prevention services. The report provides an overview of the market environment, types of infections, relevant products and services, and industry structure.
The Indian medical devices market is growing rapidly due to increasing demand, policy support from the government, and opportunities in exports. The market is expected to increase from $10.36 billion in FY20 to $50 billion by 2025 growing at a CAGR of 37%. Government initiatives such as allowing 100% FDI, production linked incentive schemes, and plans to establish new medical device parks are boosting investment and manufacturing in the industry. Rising healthcare infrastructure in India and amendments to medical device regulations are also driving the growth of the medical devices market.
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
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.
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.
Scientia Med Devices Cardiovascular Fall 08glorikian
The document provides an overview of the cardiovascular medical device market. It discusses definitions and classifications of medical devices, the worldwide medical device market analysis including sizing and segmentation, and focuses on key cardiovascular device segments - stents, cardiac rhythm management, valves, and catheters. The cardiovascular device market is large and growing, driven by an aging population and the increasing prevalence of cardiovascular disease globally. Major players operate in traditional segments like stents and cardiac rhythm management, while emerging markets provide new opportunities for growth.
Automated Feedback in Digital Depression Screening: DISCOVER Trial | The Life...The Lifesciences Magazine
A recent study published in The Lancet Digital Health delves into the effectiveness of automated feedback following internet-based depression screenings.
Yoga Nidra Retreat in Bangalore
Yoga Nidra Retreat in Bangalore
A restful night is key to a healthy lifestyle. The reason behind many health issues that most people have from the modern way of living is nothing but lack of proper sleep. Well, it’s not like they don’t want to sleep, lack of time, an after-effect of day-long stress, and long-term anxiety trigger sleeplessness and thus respective disorders as well.
As per the recent survey, the insomnia percentage in India is above 33%, and the people who are most likely to be impacted with sleep deprivation hover around 52%. These numbers are higher compared to other countries.
Are you one of those populations suffering from sleeplessness and health issues due to lack of proper sleep? If Yes, then you must know that Yoga is the only way to get out of your situation to ensure restful nights after daylong stress and busy working schedules throughout the week.
Besides, even scientific studies prove that frequent consumption of stress-relieving, depression, or sleeping pills is not at all good for health and the brain. In such a scenario, Yoga is the only effective and probably most reliable way to get your sleep on track. Karuna Yoga Vidya Peetham will be on your side as a reliable Weekend Yoga Nidra Retreat in Bangalore.
Yoga Nidra aims at activating the relaxation response and improving the nervous and endocrine system functioning to ensure peaceful nights and active working hours.
Benefits:
An emphasis on some of the more Eastern practices (like yoga nidra, including pranayama, kriyas, mantras).
A peaceful location – the perfect setting for a Yoga Nidra Retreat.
Deepen your yoga practice and take it to the next level.
Retreat Curriculum Details
Practice Relaxation & Preparation for Yogic Sleep
Introduction to the concept and practices of relaxation
Relaxation in daily life
Sequence of relaxation practices
Tension & relaxation exercises
Systematic relaxation exercises
Preparations for Yoga Nidra
Mantra chanting
Introduction to mantra science
Morning prayers & Evening prayers
Surya-namaskar 12 mantras along with bija mantras
Pranayama Practices
Establishment of diaphragmatic breath
Different practices of pranayama
Yoga Nidra philosophy, Lifestyle, & Yoga Ethics
What is Yoga Nidra?
Philosophy of Yoga Nidra
Yoga Ethics
What Makes This Retreat Special
The practice of Yoga Nidra has been secret and imparted to those few yogis who have mastered their sleep. In Indian Mythology, there occurs a unique concept of sleep. We often find even the trinity of the universe Lord Brahma, Vishnu, and Shiva under the domination of sleep.
The course will explore the concept of Yoga Nidra details at theoretical and practical levels. This is designed to assist students of yoga to understand and experience the deeper layers of their personalities.
Type: Yoga Nidra Retreat
Date: 11th Sep 2021
Duration: 2 days
Location: Bangalore outskirt, India.
Food: Vegetarian
Accommodation
Shared Dormitory
Room
50 Hr – Hatha-Vinyasa Yoga Teacher Training Course
50 hours – Hatha-Vinyasa Yoga Teacher Training Course
Course Fee: INR 32,000 for Indian citizens only, for foreigners USD 350.
Yoga Manual (01)
Certificate
Excluded with accommodation and food
Upcoming Batches 50 Hr Non-Residential (Week-Days/Week-End)
Professional Yoga Teacher Training
Our 50 hours Yoga Teachers Training Course Hatha-Vinyasa Yoga Teacher Training Course is beautifully programmed for those enthusiasts who desire to have a professional certificate in the future but can’t afford the time of two months in one slot.
If you have less time or you want to learn slowly, so 50-hour yoga teacher training course in Bangalore can be the perfect yoga course for you, karuna yoga offers a self-paced yoga teacher training course in Bangalore India, and you can join the other half in 1 year of time to complete 200/300 hours Teacher Training Course.
In order to obtain a professional certificate of 200/300 Hour, Teachers Training Course affiliated with Yoga alliance one has to complete the 200 Hours which is usually completed in one or two months of time, we designed this course in such a way that if any participant wants to first get introduced with the way and process of professional yoga teacher training course and have only short time then students can enroll for this yoga course.
Our 50 hours Yoga Teacher Training Course program runs along with our regular student of 200/300-hour Teacher Training Course students in the first phase, upon completion of the course if a student wants to finish remaining their balance of 150/250 hours of Teacher Training Course in the future, then students can continue the course of the second stage of Teacher Training Course to obtain 200/300-hour Teacher Training Course certificate affiliated with Yoga Alliance in order to have a professional certificate.
Our 50 hours can be accepted as continuing education from Yoga Alliance if in the future you want to continue the training from our center. Please make a note while completing 50 hour TTC you will be only provided with a certificate issued by our organization and the certificate will not be affiliated with Yoga Alliance, and only after completion of the second stage of balance 150/250 hours of TTC, which technically becomes 200/300 hours in total of training, we will issue the certificate of 200/300-hour Teacher Training Course.
Karuna Yoga Vidya Peetham is a Registered Yoga teacher training school in Bangalore, India with an affiliation of Yoga Alliance, USA which offers 50 Hour Yoga Teacher Training in Bangalore, India. If you look forward to the course then this is the best choice.
International Certification
Upon successful completion of the course, you will receive a certificate of completion of the 20 hour Hatha Yoga course, that you can count towards your continuing education. Our yoga teacher training courses are accredited by Yoga Alliance USA.
Pre-requisites:
This course is open to all student
📞Call Us 🔼((((8 6 0 7 5 7 5 4 8 3)))🔼 100% Trusted Independent "Call "Girls Service in Kolkata
A nutshell review for Hot "Call "Girls in Kolkata((West Bengal)) . MY experience was superb with them this is the only recommended "Call "Girls service in Kolkata"Call "Girls and again then Russian. so overall my practice was magnificent. The price is also moderate per hour. 0
5 Must-Have’s in ePCR Software for a More PROFITABLE and EFFICIENT EMS, NEM...Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS & NEMT organization, not just certain groups of people or certain departments.
It should benefit EMS crews – making it convenient to enter data and have the tools to increase document accuracy.
It should benefit the back-office by streamlining documentation and billing processes internally and with health facilities.
It should benefit the entire organization by improving workflow efficiency, comply with regulations, reduce costs, and contribute to generating data-driven reports.
To achieve those benefits, ePCR software must have these 5 functions.
Holistic nursing Primacy of nature in the healing process.pptxraima10
HOLISTIC NURSING
Holistic nursing is a way of treating and taking care the patient as a whole body which involves physical, social environment, psychological, cultural and religious beliefs.
Online Live Personal Yoga Training at Home
Home Yoga
Change is Possible!
I am ready to help you, to improve your health, reduce stress and moving towards perfect peace, happiness and joy!
Show you the difference between intentional self-care and unintentional numbing out, so that you can be fully awake for all of your life
Restore your natural physical alignment, because it is critical to your health and well-being
Help you develop a practice of intentional surrender because it brings relief from stress and will improve every aspect of your life
Show you how to take care of yourself because that is the first step toward the connection you are craving with others
Restore your mind-body connection, because decision-making is so much easier when you can hear your own intuition
Home yoga course contents
The private yoga lesson consists of Power Yoga, Dynamic Yoga, Yoga Therapy for different ailments, Yoga for stress management, yoga posture (asana), yogic breathing (pranayama), guided meditation and relaxation. Sometimes the cleansing practices like Vamana Dhouti (vomiting), Jala & Sutra Neti (nasal cleaning), Laghu Sankhaprakshalana (intestine cleansing), vyutkarma & sheetkarma kapalabhati (nasal cleansing), Trataka (eye cleansing) and MSRT (immune system enhancement) are also included depending on the requirement of the participant
If you are looking for a secluded, silent, one-on-one yoga practice with personal care and attention and without any outside disturbances, private yoga lessons are perfect for you. In private yoga lessons, you save your time and energy from traveling to a distance yoga studio and practice yoga from the comfort of your home in a personal ambiance. In private yoga lessons, you learn properly with one-on-one attention from the yoga trainer. The yoga trainer also gets enough time to understand your requirements and customizes the yoga practices accordingly for your maximum health benefit.
If you are suffering from any specific health problems, private yoga lessons are ideal for you. Yoga therapy practices cannot be done in a group, it has to be done always one-on-one basis. Because your problem is different from others. In a group yoga class, the yoga practices are not addressed according to your body conditions & requirements, some of the practices in the group might be harmful to you. Moreover, if the group yoga trainer is not a qualified yoga therapist but only a yoga instructor, he may not know the yoga practices that are useful and harmful to you. Therefore, if you are suffering from any specific health conditions, you require private yoga lessons with one-on-one attention from an experienced yoga therapist for your recovery.
How many people can join in private yoga lessons?
We allow one or, maximum of two people at a time in a private yoga lesson.
Private yoga course contents
The private yoga lesson consists of Power Yoga, Dynamic Yoga, Yoga Therapy for different ailments, Yoga for stress management, yoga post
Reimbursement Bootcamp- Coding, Coverage & Payment lecture by David Farber, K...Levi Shapiro
Presentation by David Farber, King & Spalding LLP, "Reimbursement Bootcamp- Coding, Coverage & Payment". Includes a comparison of FDA and CMS – The Important Differences. Setting Expectations and Understanding Timing. FDA Approval/Clearance vs. CMS (Medicare) Coverage. “Reasonable and Necessary”
CMS coverage determination
(formal or informal);
Focus on health benefits;
Economic data is important;
Superiority endpoint often needed; Focus on Medicare beneficiaries; Public processes; Publishes proposed decisions. Information Considered by CMS. Center for Medicare & Medicaid Services. Clinical evidence (including FDA submissions)
External technology assessments;
Advisory committee recommendations;
Position statements by relevant groups; Expert opinions;
Public comments;
Economic and other cost-effectiveness data;
Other informal opinions. The Basics of Reimbursement
• Coverage
Is the item or service eligible for payment?
• Coding
How is the item or service identified?
• Payment
What are the payment methodologies and amounts?
Medicare Coverage:
Defined Benefit Category
Not Excluded
“Reasonable and necessary for
the diagnosis or treatment
of illness or injury or to improve
the functioning of a malformed
body member.”
— Social Security Act § 1862(a)(1)(A). CMS and Its Contractors Make
Medicare Coverage Decisions
• National Coverage
Determinations (NCDs)
• Local Coverage
Determinations (LCDs)
• Individual Consideration
National Coverage
Determinations (NCD):
National and binding decision by CMS
Coverage and Analysis Group (CAG).
May be requested by anyone
(CMS or external party.)
Public process that generally takes
9-12 months once initiated.
May include certain conditions for coverage (including Coverage with Evidence
Development (CED)). Coverage with Evidence Development (CED). Evidence-based coverage paradigm
that permits CMS to develop
coverage policies for treatments
that are likely to show health benefits
for Medicare beneficiaries but for
which the evidence base is not
sufficiently developed. Two kinds of CED: (1) clinical study
and (2) registry. Local Coverage
Determinations (LCD):
Issued by local Medicare
Administrative Contractors (MACs).
May be requested by anyone
(MAC or external party.)
New formal process in 2019 to
request LCDs.
Limited to particular MAC jurisdiction. Medicare Administrative Contractors. Coding is the “language of
reimbursement.”
Coding operationally links
coverage and payment.
Having a code does not
guarantee reimbursement! TYPE OF CODE, CODING SYSTEM, WHO SETS CODE? WHO USES CODE? Diagnosis, Procedure or Service, Products and Certain Services, Drugs. Current Procedural Terminology (CPT) Codes. Maintained by the AMA CPT Editorial Panel.
Identify medical services furnished by physicians.
5-digit numeric codes with generic descriptors.
Three types of CPT codes. Application process takes at least 15 months for Category I codes, with specific clinical data requirements.
CHAPTER THREE: MUDRA AND BANDHA
Chapter 3 Verse 1 Kundalini is the support of yoga practices
As the serpent (Sheshnaga) upholds the earth and its mountains and woods, so kundalini is the support of all the yoga practices.
Chapter 3 Verse 2 Guru’s grace and opening of the chakras
Indeed, by guru's grace this sleeping kundalini is awakened, then all the lotuses (chakras) and knots (granthis) are opened.
Chapter 3 Verse 3 Sushumna becomes the path of prana and deceives death
Then indeed, sushumna becomes the pathway of prana, mind is free of all connections and death is averted.
Chapter 3 Verse 4 Names of sushumna
Sushumna, shoonya padavi, brahmarandhra, maha patha, shmashan, shambhavi, madhya marga, are all said to be one and the same.
Chapter 3 Verse 5 Sleeping goddess is awakened by mudra
Therefore, the goddess sleeping at the entrance of Brahma’s door should be constantly aroused with all effort by performing mudra thoroughly.
Role of Physiotherapy management in lumbar canal stenosis.Anjali Rana
Lumbar canal stenosis is a narrowing of the spinal canal in the lower back, often causing compression of nerves and resulting in pain, numbness, or weakness in the legs. This condition typically develops gradually, impacting mobility and quality of life, necessitating tailored medical management or surgical intervention for relief.
"NeuroActiv6: Revitalize Your Mind with Youthful Energy and Clarity"Ajay Agnihotri
In today's fast-paced world, maintaining mental clarity and energy can be challenging. The constant demands of work, family, and social commitments often leave us feeling drained and foggy. Enter NeuroActiv6, a revolutionary supplement designed to rejuvenate your mind and restore youthful energy and clarity.
NeuroActiv6 is a brain-boosting supplement that combines a unique blend of natural ingredients known for their cognitive-enhancing properties. This powerful formula is designed to support brain health, improve mental performance, and boost energy levels. Whether you're a busy professional, a student, or someone looking to enhance your cognitive function, NeuroActiv6 offers a range of benefits to help you achieve your goals.
NeuroActiv6 works by providing your brain with the essential nutrients it needs to function at its best. The combination of these powerful ingredients helps reduce brain fog, improve focus and concentration, and increase energy levels. By supporting brain health and enhancing cognitive function, NeuroActiv6 allows you to tackle your day with renewed vigor and mental clarity.
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The Importance of Gratitude in Daily Life.pptxMartaLoveguard
Prezentacja - The Importance of Gratitude in Daily Life
Slide 1: Introduction
Welcome to the presentation on the importance of gratitude in daily life. Today, we'll explore how cultivating gratitude can significantly impact our mental, emotional, and physical well-being.
Slide 2: What is Gratitude?
Gratitude is the practice of acknowledging and appreciating the good things in our lives, big and small. It involves recognizing the positive aspects of our experiences, relationships, and circumstances rather than focusing solely on what's lacking or negative. Cultivating gratitude involves a mindset shift towards abundance and appreciation.
Slide 3: Psychological Benefits
Gratitude plays a crucial role in enhancing mental health by reducing negative emotions such as envy, resentment, and frustration. Research indicates that practicing gratitude promotes more positive emotions like happiness and satisfaction with life. Studies have shown that gratitude can lead to improved overall well-being and a greater sense of fulfillment.
Slide 4: Emotional Resilience
Gratitude fosters emotional resilience by helping individuals cope with stress and adversity more effectively. It encourages a mindset that focuses on solutions and growth rather than dwelling on problems. By finding reasons to be grateful even in challenging times, individuals can develop resilience and maintain a positive outlook.
Slide 5: Social Benefits
Expressing gratitude strengthens relationships by fostering feelings of connection and appreciation. When we show gratitude towards others, it deepens our bonds and encourages reciprocity in kindness and support. Gratitude also enhances empathy and compassion, leading to more meaningful social interactions.
Slide 6: Physical Health Benefits
Gratitude isn't just beneficial for mental and emotional well-being; it also impacts physical health. Research suggests that grateful individuals may experience better sleep, reduced inflammation, and improved immune function. Adopting a grateful mindset can contribute to overall holistic health and well-being.
Slide 7: Cultivating Gratitude
There are practical ways to cultivate gratitude in daily life. Keeping a gratitude journal, where you write down things you're thankful for each day, can help reinforce positive emotions. Additionally, expressing gratitude to others through thank-you notes or verbal appreciation can strengthen relationships and increase overall happiness.
Slide 8: Conclusion
In conclusion, integrating gratitude into our daily routines can lead to profound positive changes in our lives. By focusing on what we are thankful for, we shift our perspective towards abundance and possibilities. Embracing gratitude empowers us to live more fully and joyfully, enhancing both our personal well-being and the quality of our relationships.
BLOOD DONATION ppt For medical students..pptxdarshitam0310
Mention safety measures and potential side effects. Provide tips on how to prepare for donations such as staying hydrated and eating well.This concise format covers the essential aspects of blood donation.
2. FLOW OF PRESENTATION
Healthcare Sector In India
Medical Device
Difference between Drug & Device
Device Classification
Medical Devices – Global Scenario
US medical Device Market
Indian Medical Device Market
Regulations
Current Scenario In India
SWOT Analysis
Conclusion
4. Healthcare Sector- Present Scenario
Source: Industry Report, Healthcare: India, The Economist Intelligence Unit, July 2014
$ 96.3 US
billion
1 Bed/1050
Per capita $ 61 US
71% share in
healthcare
expenditure
0.7
Doctor/1000
33% share of govt. in healthcare
4%
5. Growth Pattern in Healthcare sector- India
0
20
40
60
80
100
120
140
160
2012 2013 2014 2015 2016 2017
US$Billion
FY
98
113
129
Source: RNCOS
•Healthcare Sector in India is growing at a CAGR of 10-11%
6. Revenue Split
Hospitals
Meical Equipment and
Supplies
Medical Insurance
Diagnostics
Pharmaceuticals
71%
9%
4%
3%
13%
Source: India Brand Equity Foundation, November
2011
8. Definition
As per Schedule M-III
Medical tool which does not achieve its primary intended action
in or on the human body by Pharmacological, Immunological
or Metabolic means
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
Medicinal products covered under D&C act will not fall under
schedule M-III
In case there is uncertainty about whether the product falls under
drug or medical device category regulators will consider mode of
action
11. Segmentation By Revenue- India
Other medical &
Therapeutic Devices
Spinal Devices
Cardiovascular
Devices
Neuromodulation
Devices
Diabetes Devices
Urology Devices
Surgical Technology
22%
18%
10%
5%
3% 3%
6%
12. DIFFERENCE
Based on Chemistry &
Pharmacology
Safety & Efficacy
Clinical Trials
Local and Systemic Toxicity
Long Product Life Cycle
Drug Interaction
Large Population
Less user interaction
Based on Engineering
Safety & Performance
Clinical Evaluation
Biocompatibility
Short Product Life Cycle
Device Malfunction
Limited Population
Significant user interaction
DRUG DEVICE
13. Device classification
CLASS RISK LEVEL EXAMPLE
A Low Risk Surgical retractors / tongue
depressors
B Low-moderate Risk Hypodermic Needles /
suction equipment
C Moderate-high Risk Lung ventilator / bone
fixation plate
D High Risk Heart valves / implantable
defibrillator
•As per Risk levels and Intended use
•Classified in accordance with Annexure-IX of Schedule M-III provided by
Drug Technical Advisory Board (DTAB)
14. Global Scenario of Medical Device
Market
0
100
200
300
400
500
2011 2012 2013 2018
UDbillion
FY
Market Size
• Indian Medical Device Market is growing at almost
twice rate than Global market
15. GLOBAL MEDICAL DEVICE MARKET
USA
Western Europe
Middle/East Africa
Eastern Europe
Asia/ Pacific
Asia/Pacific
24%
Western Europe
24%
Source: EPSICOM
USA
45%
Eastern
Europe 4%
Middle/East
Africa 3%
16. • US
• JAPAN
• GERMANY
• ITALY
• FRANCE
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
USA(US
$120)
Japan( US
$ 31.5)
BRIC( US
$ 26.28)
Germany(
US $
23.38)
MarketShare
market Share
Major Players
17. Process Flow of Rise of Emerging
Markets
MNC’s define the market and enter with
high quality, usually imported devices not
available locally
Local companies identify the opportunity
and reverse engineer/adapt to local
requirements and get prepared to
compete with MNC’s
Survival of the Fittest
Step I
Step II
Step III
18. TOP 10 MEDICAL DEVICE
MANUFACTURERS
Name of Company Revenue(In $US
BN)
Market Cap($US BN)
Johnson & Johnson 28.7 294.2
General Electric Co. 18.1 243.6
Medtronic Inc. 17.1 61.2
Siemens AG 17 92.2
Baxter International Inc. 16.4 38.7
Fresenius Medical Care AG & Co. KGAA 15.2 21.1
Koninklike Phillips 11.8 26.1
Cardinal Health Inc. 11.0 25.1
Novartis AG 10.7 227.5
Covidien plc 10.4 40.1
19. Mergers & acquisitions
2011 2012
Number of deals 443 330
Total deals (with values disclosed)
Number of deals 191 141
Transaction value (£m) 28,293 28,820
Average deal size (£m) 148 204
Deals less than £500m (with values disclosed)
Number of deals 181 133
Transaction value (£m) 10,370 7,393
Average deal size (£m) 57 56
20. Mergers & acquisitions
ACQUIRER TARGET DEAL VALUE (£ mn)
Johnson & Johnson Synthes Gmbh 12745
Hologic Inc. Gen- probe Inc. 2388
Agilent Technologies Dako 1390
Boston Scientific
Corporation
Cameron Health 869
Asclepius Zoll Medical Corporation 1367
EQT Parteners AB BSN Medical Gmbh 1452
Fujifilm Holdings Corp. Sonosite 624
Thermo Fisher Scientific One Lambda 592
Linde Inc Air Products & Chemicals 487
21. US MARKET
• Valued at more than US$ 60 Billion
• Accounts for 20% of global industry by production
• World’s largest Medical device market and accounts for 45%
of global market by sales
• In 2013 US have spend 18% of its GDP on healthcare which
is more than any other country
• Domestic consumption- 40%
• >6000 medical device manufacturers
• Current Issue: 2.3% medical device tax under affordable care
act in 2010
24. Medical Device Market By
Segmentation
Column1
Medical and Diagnostic
Equipments
Medical Implants
Medical Disposables
and Supplies
56%
25%
19%
Source: RNCOS
25. Factors Affecting Medical Device Industry
Medical
Device
Industry
Local
Market
Sentiment
s
Economic
based
factors
Unmet
clinical
needs due
to
technology
mismatch
Regulatory
Environme
nt
Healthcare
Providers Reimburse
ment
Policies
26. FACTS
Market size- $ 7.9 US billion
Contributes only 6% of India’s US $ 40 billion healthcare
sector
It is growing at a faster annual rate of 15% than 10-12 %
growth seen in the Healthcare sector in its entirety
>14,000 different products types, as per the Global Medical
Device Nomenclature (GMDN)
Ranks 4th in Asia and 20th in the world
70% of the medical devices are met by imports
28. Growth of Medical Device Industry
0
2
4
6
8
10
12
2012 2013 2014 2015 2016 2017
US$Billion
FY
5.1
5.9
6.8
7.9
9.2
10.7
Source: RNCOS
• Growth of Medical Sector alone is higher than the entire Healthcare sector in
India
29. Top Players
• 3 M
• India Medtronic
• Johnson & Johnson
• Becton Dickinson
• Abbott Vascular
• Bausch & Lomb
• Baxter
• Zimmer India
• Edwards Life Sciences
• St. Jude Medical
31. Regulation In Medical Devices
• India had no regulations for medical devices in place prior to
2005.
• The import, manufacturing, distribution and sale of medical
devices in India are overseen by the Drugs and Cosmetics Act
(1940) and Rules (1945).
• Controls and inspections are carried out by the CDSCO, state
drug controllers and central/state laboratories.
• CLAA- Branch of CDSCO ( Major regulatory body)
• All medical devices will undergo conformity assessment
procedures to ensure compliance with quality and safety
standards before they are allowed to Indian markets
32. Regulation In Medical Devices
• CLAA will adopt to regulatory Standards of Bureau Of Indian
Standards (BIS) and International Organization of Standards
(ISO) specification for quality management
• For Class A devices- Manufacturers may perform their own
conformity assessment procedures
• For B, C, D – CLAA in consultation with BIS publish list of
notified bodies authorized to perform conformity assessment
• Imported Medical devices that are already approved in US/or
and EU Union or that have been deemed equivalent to CE
mark and FDA approved device will be allowed on Indian
market without undergoing separate conformity assessment
procedure
33. Regulation In Medical Devices- US
Classification according to 21 CFR 860 which is a part of
Medical Device Amendments of 1976 and safe medical
device act of 1990
Class I: General Control
Eg: Elastic Bandages, Examination gloves
Class II: General control with Special control
Eg: Infusion pumps, surgical drapes
Class III: General controls and premarket approvals
Eg: Implantable pacemakers, pulse generator, HIV diagnostic
tests, Heart valves
34. List of Notified Medical Devices
Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets
In vitro Diagnostic Devices for HIV, HbsAg and HCV
Cardiac Stents
Drug Eluting Stents
Catheters
Intra Ocular Lenses
I.V. Cannulae
Bone Cements
Heart Valves
Scalp Vein Set
Orthopedic Implants
Internal Prosthetic Replacements
35. Growth Drivers & Restraints
Drivers:
• Expanding Healthcare
Sector
• Changing Demographic
profile
• Booming economy
• Ageing population
• Increase in outsourcing
• Increased prevalence of
Lifestyle Diseases
• Telemedicine
Restraints:
• Reliance on Import
• Lack of access to
technology
• Regulatory system
• High capital requirement
• Lack of Government
interest
• Less expenditure by
Government in
healthcare sector as
compared with other
nations
36. Current Scenario
• Medical Device and NPPA
• Amendment of D & C Act
• Regulated Medical Devices sector
• Role of Government
Regulatory Control
Make In India
Foreign Direct Investment
Education of Medical Devices
Medical Device Parks
National Centre of Medical Devices
38. Conclusion
• Medical Technology companies are accelerating their
Investments in emerging markets and India is a prime
target because of its growing population, growing
middle class and improving healthcare infrastructure
• Till date most Medtech multinationals have pursued a
conservative business strategy and operating model in
India focused on delivering their existing offering to the
premium segment of the market
• But now the playing field is becoming more competitive
and companies in search of growth need to move beyond
the traditional model
Editor's Notes
Medical Equipment and Supplies Report 2013, A Clearwater Healthcare Team Report