asia’s first monthly magazine on The Enterprise of Healthcare
volume 10 / issue 2 / February 2015 / ` 75 / US $10 / ISSN 0973-8959 eHealth Magazine
FDI Push to ‘Make in India’ Drive Govt approves 100% FDI in Medical Devices Sector
Cardiac Monitoring & Diagnostic Devices
Immunochemistry Analysers & Reagents
Flow Cytometry
Ultrasound Equipment
BD FACSPresto™ Near-Patient CD4 Counter now CE-IVD marked A unique near-patient technology designed for resource-limited settings
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CE marked according to the In Vitro Diagnostic Medical Device Directive 98/79/EC. For In Vitro Diagnostic Use. BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. © 2014 BD 23-16949-00
• Built-in quality controls to check system accuracy, no need for additional costly external controls • On-board reagent QC to check performance • Expanded menu: CD4, %CD4, and Hb in a single test
asia’s first monthly magazine on The Enterprise of Healthcare volume
10
issue
2
february 2015
President: Dr M P Narayanan
Partner publications
Editor-in-Chief: Dr Ravi Gupta
Editorial Team Health Sr Correspondent: Anshuman Ojha education Sr Editor: Shitanshu Shekhar Shukla Project Manager: Seema Gupta governance Sr Assistant Editor: Nirmal Anshu Ranjan Sr Correspondent: Kartik Sharma, Nayana Singh, Souvik Goswami, Gautam Debroy SALES & MARKETING TEAM: Health North: Sapna Choudhary, Mobile: +91-9910998066 West: Douglas Digo Menezes, Mobile: +91-9821580403 South: Vishukumar Hichkad, Mobile: +91-9886404680 Subscription & Circulation Team Manager Subscriptions: +91-8860635832; subscription@elets.in Design Team Creative Head: Pramod Gupta Deputy Art Director: Priyankar Bhargava Sr Graphic Designer: Om Prakash Thakur Sr Web Designer: Shyam Kishore WEB DEVELOPMENT & IT INFRASTRUCTURE Team Lead – Web Development: Ishvinder Singh Sr Executive – IT Infrastructure: Zuber Ahmed Executive – Information Management: Khabirul Islam event team Manager: Nagender Lal Assistant Manager: Vishesh Jaiswal administration Head Administration: Archana Jaiswal Editorial & Marketing Correspondence eHEALTH - Elets Technomedia Pvt Ltd, Stellar IT Park Office No: 7A/7B, 5th Floor, Annexe Building, C-25, Sector 62, Noida, Uttar Pradesh 201301, INDIA. Phone: +91-120-4812600 Fax: +91-120-4812660 Email: info@elets.in ehealth does not neccesarily subscribe to the views expressed in this publication. All views expressed in the magazine are those of the contributors. The magazine is not responsible or accountable for any loss incurred, directly or indirectly as a result of the information provided. ehealth is published by Elets Technomedia Pvt. Ltd in technical collaboration with Centre for Science, Development and Media Studies (CSDMS) Owner, Publisher, Printer - Dr Ravi Gupta, Printed at Vinayak Print Media D - 249, Sec-63, Noida 201 309, UP, INDIA & published from 710 Vasto Mahagun Manor, F-30, Sector - 50, Noida, UP. Editor: Dr Ravi Gupta © All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic and mechanical, including photocopy, or any information storage or retrieval system, without publisher’s permission.
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editorial
India Calling Indian healthcare industry saw numerous trends emerging in 2014 — be it EMR adoption, personal health apps or shifts in the health insurance markets following government intervention. While most of these trends are here to stay as well as accelerate, one can look forward to more such trends meeting the eye in 2015. On account of rapid innovation in Medical technology (MedTech) in the last decade, medical equipment and devices have gone smaller and therefore, smarter. But things do not stop there: now there is an increasing demand for portable medical instruments, including acute ventilators, portable X-ray machines, portable anaesthesia workstations, point-of-care testing equipment and intra-oral scanners, among others. 2015 looks set to see easily portable, battery-powered medical equipment replacing the traditional ones. Personal health applications were a big news in 2014 and it is expected that their adoption will accelerate in 2015. But the mobile hardware side of things are going to be the big news this year, rather than software-focused mHealth apps. From tricorder-like devices that can diagnose ailments with advanced sensors, to improvements on medical monitoring technology like the Fitbit, to cups that track exactly what you are drinking... MedTech will go the democratisation way in 2015. Going a step further, 2015 also promises to bring less controversial innovations to the realm of additive manufacturing. Doctors will, possibly, be seen using 3D printers not only to create customised casts, prosthetics, braces and implants like knee replacements, but also to print off replicas of a patient’s internal organs to practise on before a surgery. Even as we are a little away from being able to fully reconstruct 3D print organs, we can expect some exciting progress on that front over the next 12 months. Until now, the western world has dominated MedTech market, of late, there has been a power shift in the sector, as the Asian market, specifically India, reaching the boom. The CAGR is expected to hit 20 percent by 2020. This will be aided by the fact that 100 percent FDI has been allowed in the medical device sector. Another factor pushing the industry is the rising income level of the Indian middle class: there are hundreds of millions of new patients now seeking healthcare services, creating a significant demand for high-tech devices, such as stents, pacemakers, defibrillators, insulin pumps, etc. The year ahead is destined to see European and North American MedTech OEMs trying to consolidate and escalate their presence in the Indian healthcare market. The trends emerging this year will have significant implications for the domestic market. No matter who gains or loses, at the end of the day, it’s the people who will benefit from the developments.
Dr Ravi Gupta ravi.gupta@elets.in
february / 2015 ehealth.eletsonline.com
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Cover Story Cover Story
FDI Push
FDI Push to 10
February / 2015 february ehealth.eletsonline.com
‘Make in India’ Drive
Cover Story
Foreign investors may now acquire up to 100 percent stake in existing manufacturing units under the automatic route, as well as validly impose non-compete clauses on domestic targets without having to seek prior permission from FIPB, writes Anshuman Ojha of Elets News Network (ENN)
O
ver the past decade, India has emerged as one of the biggest and most competitive destinations for Foreign Direct Investments (FDI). Earlier, India was mostly regarded as a developing country. However, now it is seen as a strategic location for conducting profitable international business. Toeing the Prime Minister Modi’s vision of ‘Make in India’ into reality, the Government
of India and Ministry of Commerce and Industry has allowed 100 percent FDI in manufacture of medical devices under the automatic route. Currently, investment in Greenfield pharmaceutical projects is permitted fully without government intervention. However, though 100 percent FDI is permitted in Brownfield pharmaceutical entities/projects, it is subject to the government approval route and addi-
tional conditions imposed thereon.
Carve-Out Since medical devices are part of the Drugs & Cosmetics Act, 1940 and fall under the Pharmaceutical sector, all the conditions of the FDI policy on the sector, including the condition relating to ‘non-compete clause’, apply on Brownfield investment proposals of medical devices industry. As per Na-
february / 2015 February ehealth.eletsonline.com
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Cover Story
tional Industrial Classification (NIC) Code 2008, sector code of ‘Manufacture of pharmaceuticals, medicinal chemical and botanical products’ is 2100 while sector code of ‘Manufacture of medical and dental instruments and supplies’ is 3250. Medical devices will fall under the category of ‘medical and dental instruments and supplies’. Therefore, drugs and pharmaceuticals and medical devices are two different industrial activities. The condition of ‘non-compete’ was imposed so that the Indian manufacturers can continue manufacturing generic drugs and catering to the needs of the large number of people in the country and in other developing countries who cannot afford branded and patented drugs. This condition is not relevant to ‘medical devices’ industry of the country where the country is substantially import dependent and the sector is adversely impacted because of the lack of adequate capital and required technology. Therefore, the Cabinet approved the following proposal to amend the relevant paragraphs of the extant FDI policy as contained in the consolidated.
FDI Policy Circular 2014 as follows: • FDI up to 100 percent, under the automatic route is permitted for manufacturing of medical devices. The above mentioned conditions will, therefore, not be applicable to Greenfield as well as Brownfield projects of this industry.
100 % FDI in the Medical Device Industry The government has taken a praiseworthy step to promote manufacture of the medical devices in India, but permitting 100 percent FDI is just a start FDI EQUITY INFLOWS in Rs. Crore
200000
100000
0 2000 2002 2004 2006 2008 2010 20122014
Between April 2000 and May 2014, the Medical and surgical sector recieved investments of `4,318.56 Crore versus Drugs and Pharmaceutical that recieved inflows of `60,100.90 Crore in the same period. From April 2000-May 2014, the FDI inflow(in Rs. Cr) towards 60,100.9
4318.56
What does 100 percent FDI mean for the industry? No doubt this will boost the investments in new manufacturing units, less red tape, and potentially more transfer of technology.
12,142.17
Medical device means: • Any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one
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February / 2015 february ehealth.eletsonline.com
or more of the specific purposes of• Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; • Investigation, replacement or modification or support of the anatomy or of a physiological process; • Investigation, replacement or modification or support of the anatomy or of a physiological process; • Supporting or sustaining life; • Disinfection of medical devices; • Control of conception, and which does not achieve its primary intended action in or on the human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by such means; • An accessory to such an instrument, apparatus, appliance, material or other article; • A device which is reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body or animals; • The definition of medical device at Note (2) above would be subject to the amendment in Drugs and Cosmetics Act.
Hospitals & Diagnostic Centers (16%) Medical & Surgical Appliances (6%) Drugs & Pharmaceutical (79%) Source: ENN Research
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Cover Story
“Currently 100 percent FDI is allowed in both Greenfield and Brownfield projects. Within the same category, a distinct new subcategory has been carved out with regard to medical devices. In this age of super specialisation, if medicines and pharma are one aspect, in which India has attained a certain amount of core competence, we still have not achieved that in medical devices, particularly which are to be installed in human body for the purpose of treatment” Union Finance Minister Arun Jaitley
MNCs will no longer have to go to the Foreign Investment Promotion Board (FIPB) for permissions - they had to till now, which was a time-taking affair. No wonder, between April 2000 and May 2014, the Medical and Surgical sector received investments of `4,318.56 crore versus Drugs and Pharmaceutical that received inflows of `60,100.90 crore in the same period. Albeit the Ministry has taken a praiseworthy step to promote manufacture of the medical devices in India, but permitting 100 percent FDI is just a start. As the definition of medical devices under the DCA amendment bill has finally passed, it may differ from the definition provided by the Ministry. This may impact adversely any proposed investment or further investments to be made in this field. Also, making medical devices in India would require a lot more. India does not have the component ecosystem - manufacturing a pacemaker, for instance, would require design, metals, software, lithium battery, an electronic circuitry and electrodes among other components. India may still need to import the electronic circuitry. Importing too many components would pressurize a company’s operating margins and the end-user, hospitals and in turn patients - would perhaps end up paying more. So the government, as a second step to 100 percent FDI, may need to think of a cluster approach where component manufacturers and other ancillary companies get economies of scale. On the other hand the basic duty on imported medical devices is 0-5 percent with nil SAD compared to 10
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percent basic import duty, plus 4 percent SAD on inputs. This results in significant price differential between indigenously manufactured goods and imports, leading to commercial nonviability of most domestically manufactured devices. To promote indigenous manufacturing and to accomplish Prime Minister Modi’s vision of ‘Make in India’, major impediments such as irrational tax structure need to be removed by withdrawing all concessional duty notifications on basic duty and SAD. Unless tax anomalies are removed, manufacturing of medical devices in India will not really take off, with or without FDI. “The government has done the right thing to allow 100 percent FDI in the medical device sector through the automatic route. This would encourage companies to invest in India and make the Indian plants a hub for catering to the global demand. The economies of scale would lead to the reduction in cost of manufacturing and lead to us being competitive in making quality medical devices. Reducing the tariff barrier on the import of raw material inputs for the production of medical
Varun Khanna, Managing Director, BD India.
Dhruv Chaturvedi, MD, Fresenius Medical Care India
devices in India and providing incentives for Made in India products in the public procurement can work favourably for the sector,” said Varun Khanna, Managing Director, BD India. “New initiative taken by the Indian Government will definitely give positive boost to investments and economic activities in India. In current scenario, as per various estimates over 70 percent of the medical devices i.e. about USD 7 billion are imported from foreign countries. This initiative will encourage the local manufacturing for the global medical device companies, which proportionally increase the investment from abroad in healthcare and diagnostic segment and will yield higher Foreign Direct Exchange (FDI). In our country many sufferers of renal failure remain untreated due to low paying power and affordability. This initiative will help reduce the import charges, which will indirectly lower the treatment cost and ultimately have a positive impact on the life of the patients. Medical devices sector in India is poised to grow significantly owing to infrastructure getting better and it will boost further with ample government support in terms of policy and regulation. However, 100 percent FDI is one part of the reform. At the same time further reforms in licensing, infrastructure and location feasibility would be needed for better outcomes. 100 percent FDI will be a quantum leap for benefiting Indian patients and increasing Foreign Direct Exchange,” said Dhruv Chaturvedi, Managing Director, Fresenius Medical Care India.
Cardiac Monitoring & Diagnostic Devices
Future is Quick, Nimble & Surprisingly
Simple
Cardiac monitoring and diagnostic devices manufacturers are facing survival challenges in today’s marketplace while the need for innovative and safe products continues to grow, writes Anshuman Ojha of Elets News Network (ENN)
C
ardiovascular Diseases (CVDs) are the largest cause of deaths globally, around 17.3 million people died from cardiovascular diseases in 2008. This amounts to 30 percent of all deaths. Of these, an estimated 7.3 million were due to coronary heart disease and 6.2 million were due to stroke. Low- and middle-income countries are the largest affected with CVDs. An estimated 80 percent of CVD deaths take place in low- and middleincome countries. By 2030, almost 23.6 million people will die from CVDs, mainly from heart disease and stroke and are projected to be the single leading causes of death. With the number of people suffer-
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February / 2015 ehealth.eletsonline.com
ing from cardiovascular diseases and the condition upswings globally, the demand for cardiovascular devices is growing. Around 30 million people are severely affected by cardiovascular diseases every year. A considerable market growth is expected in the stress testing systems and diagnostics all over the world by the emerging markets.
Cardiac Monitoring & Diagnostic Devices
Market Dynamics
Currently, up to 11 percent of India’s urban population and 3 percent of its rural population over the age of 15 have diabetes
The global cardiac monitoring and diagnostic devices market was valued at US$ 4.06 billion in 2012 and is expected to reach a value of US$ 7 billion in 2019, growing at a CAGR of 9.7 percent from 2013 to 2019. This market comprises of Electrocardiograph (ECG) monitoring systems, ECG stress testing systems, Holter monitoring systems, ECG data monitoring systems, event monitoring systems, cardiovascular monitoring and diagnostic devices and cardiopulmonary stress testing systems. Globally, Event monitors and ECG systems together account for approximately 33 percent of the market and are expected to support the cardiovascular devices industry going forward. On a global scale, projections for cardiac telemetry systems market value indicate nearly 40 percent by 2015 leaving the rest of the market to the event monitors and ECG systems. By end-user, home/emergency is one of the fastest growing segments accounting for US$ 741 million market value by 2016. However, the global market for implantable loop recorders (ILR) will be growing at a faster rate owing to a new technology attracting many customers in the developed region who can afford such devices. Besides, Holter systems is expected to follow the ILR segment in terms of growth rate, due to rising demand for continuous monitoring which gives the physician a better picture of the patient’s condition. The resting ECG dominated the ECG systems market in 2012 owing to high demand for these systems by patients. Cardiologists demand resting ECG systems for its low price than stress ECG systems. Moreover, resting ECG systems is preferable for elder patients and those with high risk of stroke. North America dominated the cardiovascular monitoring and diagnostic devices market in 2012 and is expected to maintain its lead position in the global market till 2019. However, the Asia-Pacific market is estimated to grow at a higher Compounded Annual Growth Rate (CAGR) of 11.9 percent from 2013 to 2019 due to increasing awareness about cardiovascular disorders and monitoring and diagnostic devices. Asia-Pa-
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Cardiac Monitoring & Diagnostic Devices
cific region shows a rapid increase in the incidence rate for coronary artery disease, deep vein thrombosis and peripheral artery disease, which will expedite the demand for cardiovascular monitoring and diagnostic devices. Increased prevalence of cardiovascular and lifestyle diseases are driving the cardiovascular devices market in emerging countries. Lifestyle changes have led to a growing incidence of lifestyle diseases in emerging countries. It has been recently projected that the incidence of cardiovascular disease will increase by 73 percent by 2030 in China. The prevalence of risk factors such as diabetes and obesity is increasing in China, India and Brazil. Dietary changes, undue stress and changes in lifestyle are leading to more cases of diabetes, obesity, hyperlipidemia, smoking and hypertension, which are all major risk factors for developing cardiovascular diseases. India has the highest number of disability adjusted life years (DALYS) lost due to CHD of the emerging economies in the world. The number of DALYS lost in India stands at 20 days per 1,000 people, closely followed by Brazil. DALYS combines the years of potential life lost due to premature death with the years of productive life lost due to disability. The International Diabetes Federation (IDF) estimates that the number of patients with diabetes in India has more than doubled from 19 million in 1995 to 50.7 million in 2010. It is projected to increase to 69.9 million by 2025. Currently, up to 11 percent of India’s urban population and 3 percent of its rural population over the age of 15 have diabetes. Developing countries are also witnessing the fastest growth of obesity. In these countries, the prevalence of obesity has more than tripled. Cardiovascular disease prevalence and the rising incidence of lifestyle disorders are the main factors for the increase in the population pool suffering with cardiovascular diseases, which is a major
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Global Cardiac Monitoring and Diagnostic Devices Market, By Product Type, 2012 Value-wise (USD Million)
3698.7
ECG Systems Holter Monitors Event Monitors Cardiovascular Diagnostics Catheters ECG Management Systems Implantable Loop Recorders
Total
driver for the cardiovascular devices market in the emerging countries. China had the largest cardiovascular devices market in 2010 among the emerging countries, with a total market value of about US$ 1 billion. This value is estimated to reach US$ 1.3 billion in 2017. The cardiovascular devices market in India was the second largest cardiovascular devices market among the emerging countries and was
valued at US$ 476 million in 2010. It is expected to reach US$ 589 million in 2017. The cardiovascular devices market in Brazil in 2010 was worth US$ 490 million and is estimated to reach US$ 759.2 million in 2017. The rise in cardiovascular disease incidence, the increased spending power of the population, the higher penetration of health care insurance products and the increased focus of multinational cardiovascular companies have been the major drivers of the cardiovascular devices market in emerging countries. The market will grow at a healthy pace in the next five years due to the increasing incidence of cardiovascular diseases, technological advancement, rising cost of cardiac disease treatment, and government regulations in favour of cardiac monitoring.
India is growing as an Important Destination for Cardiac Medical Tourism India is gaining importance as a destination for medical tourism and in particular for the treatment of car-
Cardiac Monitoring & Diagnostic Devices
Technology Advancements
diovascular diseases and surgeries. Complex cardiovascular procedures such as cardiac bypass surgery, cardiac valve repair and replacement and minimally invasive cardiac stenting and angioplasty are procedures that are quite easily taken up in various urban hospitals in India at a lower cost than in the West and even other Asian countries. The low cost of treatment, scale and range of treatment options provided in India, the availability of world class infrastructure, proficient English speaking doctors and paramedical staff and the adoption of medical technologies are some of the factors that are facilitating India’s growth as a center for medical tourism. GE Healthcare, Philips Healthcare, Siemens Healthcare, Nihon Kohden, Cardiac Science Corp (now OptoCircuits) and Schiller AG are the leading companies in the global Cardiovascular Monitoring and Diagnostic devices market, with a combined share of more than 60 percent. Other aggressive players include St. Jude Medical,
Higher penetration of health care insurance products and the increased focus of multinational cardiovascular companies have been the major drivers of the cardiovascular devices market in emerging countries Inc, Boston Scientific Corporation, CareFusion Corporation, Spacelabs Healthcare, Inc and Welch Allyn, Inc. The global cardiac diagnostic industry is a diverse and highly competitive market. It is anticipated that demand for cardiac diagnostic products and services will continue to rise providing opportunities for both the existing market participants and the emerging market participants. Manufacturers should look for ways to distinguish themselves in the marketplace by keeping abreast of key market drivers, restraints, and trends that are affecting the market and the economy as a whole. More than ever before, manufacturers are facing survival challenges in today’s marketplace while the need for innovative and safe products continues to grow.
The days of keeping a patient in the hospital for cardiac monitoring are gone. Many patients cannot afford to spend the night in a hospital because the costs are too high. Additionally, most patients have no need to spend the night in a hospital since they are only having their heart monitored. With modern technology, it is possible for doctors to monitor cardiac activity while allowing patients to live their lives in a normal way. There are a variety of advancements made to the cardiac monitor that are highly beneficial to doctors and patients.
Real-Time Activity The problem with old-fashioned cardiac monitoring was that the results had to be downloaded from a mobile machine. A patient would have to wear a monitor for 24 hours and then go into the doctor’s office for the results to be seen. Now, doctors can either schedule the results to be sent or patients can hit a button to send the results. All of the numbers can be seen in real-time, ensuring that cardiac monitoring is done properly.
Wireless There is no need for patients to be strapped to the bed for cardiac monitoring anymore. While patients will still have wires on them and to the machine, nothing has to be plugged in. Many are able to wear a monitor and go to the grocery store and even work so they can proceed through the day as normal. New technology has provided batteries that last longer and are lighter so that patients can have a more productive day – and have their heart monitored outside the hospital walls.
Mobile Mobility is a huge benefit as a result of modern technology. Computer chips have gotten smaller and new materials have been used in order to provide a mobile cardiac monitor. The primary
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Cardiac Monitoring & Diagnostic Devices
Dr Deepak Khurana Director Cardiothoracic and Vascular Surgery, Rockland Hospitals, New Delhi
MICS – A Whole New Branch of Cardiac Surgery Earlier the coronary artery bypass grafting (CABG) surgery was done using cardiopulmonary bypass machine, making the heart still. But nowadays, the trend is to perform the same surgery in a beating heart without using cardiopulmonary bypass machine, using cardiac surface stabiliser. All this leads to lesser complications, faster recovery of the patients after the surgery, it’s economical and lesser hospital stays. Apart from this, earlier a long incision used to be given in chest midline to perform any major Heart Surgery but now small incision or side hole operative technique is used to avoid a long scar and issues of post operative wound healing. This whole new branch of cardiac surgery is called Minimally Invasive Cardiac Surgery (MICS). Further, the technological advancement in the quality of valves available to us now for valve replacement (mostly mitral/aortic) surgery is more durable, long lasting and better performance leading to lesser complications. This makes the surgery more patient friendly and many patients lead a normal life. In the future, technology is being developed to make the diagnosis, assessment and treatment of the heart problems less invasive and more patient friendly but this requires a learning curve and use of technology, which is usually expensive and has high complication rate initially. In more experienced hands it can still be safely used. The third world countries offer a challenge to make the use of technology affordable for the use of masses.
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benefit is that doctors can learn about a patient’s cardiac activity while they do day to day tasks. The secondary benefit is that the data can be sent over a wireless connection so that doctors have more mobility as well. There are many doctors who work in their own practice as well as in a hospital. If they have a patient in the hospital for cardiac monitoring, it would be impossible to spend time at their practice. Now with mobile monitors, doctors can essentially be in two places at once. With the other benefits to the mobile monitors, doctors can get alerted if there is a problem with a patient so they know what location they need to be in.
Alerts Alerts can actually be sent to the doctor when cardiac monitoring shows something that could be troubling. This will ensure that a doctor can call the patient and find out what they are doing or order them to come into the hospital if there are unusual rhythms or a high/low pulse situation. Doctors are able to monitor more patients when they can receive alerts, making it possible for more patients to get a higher level of healthcare.
One-Piece Devices Traditional Mobile cardiac outpatient telemetry (MCOT or MCT) systems have been two-piece systems that contain a receiver and a transmitter. The two-piece equipment contains wires that are attached to leads, which close the circuit from the heart to the receiver to the transmitter. Recent developments in MCT technology have created a one-piece device that can store data for up to thirty days. The one-piece device features a single receiver/recorder. One-piece designs are appealing to patients because they only have to worry
about one piece of equipment, and it is less obtrusive.
Extended Holter Extended Holter, or “patch” technology as it’s commonly known, is a “long term” Holter device and not MCT technology. Though the “patch” does not require wires, it is a two piece technology that requires data to sync to a remote device via Bluetooth technology. Though this “Band-Aid” Style Patch adheres directly to the patient’s chest without wires, it is fairly large at roughly 5 inches long, 2 inches wide and more than an inch thick.
GPS and Accelerometers MCT devices are now integrating GPS technology and accelerometer metrics. These additional measurements enhance the data that the MCT transmits to the cardiologist, which then enhances diagnostic abilities. The GPS feature allows the physician to gather geographic data about where the patient was during different points in the data. The accelerometer provides a picture of the activity that the patient was engaging in at the time of an event. These features provide a broader scope and more detailed evidence that can help cardiologists understand the status of their patients’ heart function. Indian healthcare industry has been witnessing a drastic change regarding the new innovation and technology, which in terms are applied in improving from sector to sector since the past 3-5 years. Cardiovascular industry growth continues to increase with the presence of multiple technologies such as advanced material and software which is featured in most of the devices. International companies tend to innovate, develop new products and to enhance the existing features in cardiovascular devices.
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Exclusive Interview
Uniqueness of Technology There are big price wars in the single-channel and 3-channel ECG market segments, which restrict the entry of feature rich, bigger display and inbuilt interpretation machine. Majority of small nursing homes, diagnostic centers and clinics are not willing to pay extra for advanced features and continue to stick to small display and less features machines, says Anil Srivastava, National Sales Manager-Medical Equipment, Nihon Kohden India Private Limited
T
he most common ECG exam is the standard 12-lead ECG. It is simple to measure, has low burden on the body, and observing the heart from these 12 directions provides a lot of information which has a wide range of clinical applications. However, some areas, especially pathological change in the right ventricle and the posterior wall cannot be observed from the 12-lead ECG. In order to actually measure the right chest (V3R, V4R, V5R) and back (V7, V8, V9) areas, it is necessary to use different electrode positions than the standard 12-lead ECG. In particular, electrodes must also be attached to the patient’s back so that normal suction cup electrodes cannot be used. Also, the patient must be turned over in some cases and in an emergency it is often difficult to use back electrodes. This complicates the exam procedure. As per American Heart Associations (AHA) Guidelines for Right Ventricular Infarction, patients with inferior STEMI & hemodynamic compromise should be assessed with right precordial V4R lead to detect ST segment elevation and an echocardiogram to screen for RV infarction. Also, as per the AHA – True posterior Myocardial Infarction (MI) may be manifested by tall R waves in right precordial leads and ST segment depression in leads V1 through V4 especially when T waves are upright. Repeat ECGs and incorporation of additional leads such as V7 through V9
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are more specific for the detection of posterior infarction. Possibilities of missing MI decreases from 11.6 percent to 3.2 percent drastically by using 18 leads compared to standard 12 lead ECGs. Synthesised 18-Lead ECG with right-sided and posterior precordial leads (V3R-V5R and V7-V9) is useful in the rapid diagnosis of STEMI within 10 minutes of ED arrival especially in the early detection of right ventricular infarction. Synthesised 18-lead ECG uses the 12-lead ECG waveforms to mathematically derive the waveforms of the right chest leads (V3R, V4R, V5R) and back leads (V7, V8, V9). India is undergoing a rapid health transition with rising burden of coronary heart disease (CHD). Among adults over 20 years of age, the estimated prevalence of CHD is around 3-4 per cent in rural areas and 8-10 per cent in urban areas, represent-
ing a two-fold rise in rural areas and a six-fold rise in urban areas between the years 1960 and 2000. Deaths due to acute myocardial infarction (AMI) in South Asians occur at 5-10 years earlier than western population. In 18-lead synthesised ECG measurement procedure is the same as the standard 12-lead ECG but more information can be obtained. 18-lead synthesised ECG is expected to be useful in detecting right side and posterior infarction. ECG diagnosis has not gained momentum among tier-III and rural healthcare facilities due to poor hospital infrastructure, insufficient transport facilities, understaffed hospitals, and a lack of awareness about cardiovascular diseases. There is a big challenge to introduce newer technology like 16 or 18 lead ECG, as market is still growing for 3- 6 channel ECG. There is an urgent need of market upgardation to 12 lead ECG systems.
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Buyers Speak
CAD – A Rising Concern
The demographics of coronary artery disease in India are different as a lot more young people get affected by CAD here. The coronary arteries appear to be diffusely diseased with more calcification in Indian patients Please comment on cardiology market in India vis-ĂĄ-vis the global market. Cardiology market in India is much larger than the markets in the western countries taken individually. In the west, the spectrum of cardiac diseases essentially involves coronary artery disease (CAD), degenerative or ischemic valvular conditions and arrhythmias. There is also a big segment of vascular disease including peripheral artery disease (PAD) and carotid artery disease. In India, the disease spectrum still involves a great number of cases of rheumatic heart disease. However, with increasing number of diabetics, the number of coronary artery disease is increasing. Also, the demographics of CAD in India are different as a lot more young people get affected by CAD here. The coronary arteries appear to be diffusely diseased with more calcification in Indian patients. Economics plays a significant role in decision-making regarding therapeutic options. Bypass surgery is more readily accepted for multivessel disease.
What are your views on government regulation or any other challenges faced while operating in Indian market? In cardiology, there is difficulty in our ability to freely use portable ultrasound machines due to concerns regarding sex determination and feticide. Also, new technologies that are available in
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the west are not freely available here and importing them is difficult due to government regulations.
Please comment on emerging trends and new technologies. In coronary artery disease world, the new trend is to go minimally invasive, which may be more multi-vessel and left main stenting, or minimally invasive bypass surgery.
What are your hospitals’ offerings? We offer a full range of cardiovascular care including the following: Diagnostic work-ECG, transthoracic 2D and 3D echo, transesophagealecho, holter and event monitoring, implantable loop recorder, treadmill stress testing, stress echocardiography and 128 slice CT coronary angiography, and cardiac MRI. Invasive work including diagnostic coronary angiography, FFR, percutaneous coronary intervention: including rotablation, stenting, and chronic total occlusions. Endovascular interventionsaneurysm repair, endovascular stenting, PTA, renal artery stenting, Dr Kiran Saraff Chief of Interventional Cardiologist, Columbia Asia Hospital, Whitefield, Bengaluru
subclavian and visceral artery stenting, carotid artery stenting, coil embolization, venous angioplasty and stenting, AV fistula interventions, endovenous laser ablation, catheter directed thrombolysis of DVT, PE, etc. Implantable pacemakers, ICD and CRT-D. For more information visit: www.india.columbiaasia.com/hospitals/ whitefield
Buyers Speak
CABG - A Mordern Treatment T
otally Coronary Artery Bypass (CABG) surgery is a modern method to treat coronary heart disease. Total CABG is an advanced form of minimally invasive coronary artery bypass surgery, which is performed without harvesting leg vein. The surgery involves, leg veins which are use to bypass the blocked vessels along with one of the arterial conduits which is normally known as Left Internal Mammary Artery (LIMA). But in total arterial revascularization, we do not use any of the left veins, we use artery in place of artery. There are four basic arteries, which are available as conduits in the body, one is left internal mammary artery which is routinely used by everybody, other is right internal
mammary artery and left hand’s radial artery and fourth one is gastroepiploic artery. So performing bypass surgery by using all these conduits instead of leg veins is popularly known as total arterial bypass grafting, and is much more complicated, demanding and expensive procedure. But longevity of such procedures, and grafts is very high and the requirement of second or third procedure is very low in these kinds of patients and this is specially offered to young patients and those who are in their early fifties. It is highly recommended that one should go for total arterial grafting in younger age group. Leg veins, which are commonly used to perform bypass surgery, are made to bear a pressure of 10 to 20 mm of mercury. We put these veins at a place where
Dr Mukesh Goel HOD Cardio Thoracic Vascular Surgery, Asian Institute of Medical Sciences, Faridabad
pressure is much higher, in the coronary artery which is to the tune of 120 to 140 mm of mercury. So by this kind of pressure these conduits, they, degenerate, intima gets thickened and they degenerate within 8 to 10 years because they’re not made to sustain these kinds of pressure. Whereas, arteries are made by nature to sustain a pressure of 120 and 140 mm of mercury so they tend to persist a longer time than the veins. The advantages of total arterial bypass are no leg vein harvesting and consequently no leg wounds, complications and leg swelling. Not all cardiac surgeons are trained to perform this surgery, only handful of cardiac surgeons can perform it. For more information visit: www.aimshospital.co.in
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Company Profile I
Medical Equipment Finance Company Profile
Shriram Equipment Finance Company Ltd (SEFC) is a part of the “SHRIRAM” Conglomerate which has significant presence in financial services. SEFC is a fully owned subsidiary of Shriram Transport Finance Company (STFC) which is India’s largest NBFC with assets under management of over INR 520 billion. SEFC is a leading NBFC in infrastructure equipment lending, having started its operations in October 2010, it has already attained a most prominent position in Construction Equipment Finance space in the country. With a customer base of over 20,000, employee base of over 1200 and Assets under Management of over INR 35 billion, SEFC operates through a wide network of over 165+ branches across India while catering to needs of all classes of customers across the geography of the country. SEFC has launched Medical Equipment Financing business primarily focusing on diagnostic and dentistry equipments. SEFC intends to aggressively finance equipments like X ray machines, CT scan, MRI machines, Ultrasound, Doppler & Monitors, Mammography machines, Dental chairs & lazers, Dental Radiology equipments, cathlabs i.e. to Diagnosis Centres, Nursing Homes, Hospitals as well as individual Doctors and specialists. Having started its operations at 15 key cities spread across the country, SEFC aims to expand into 60+ centres catering to all customers in this segment in next 3 to 4 months. Eventually this business will be operated out at all 165 branches of the company.
Shriram Equipment Finance with its focused approach in industry brings in pronounced advantages for both customers and manufacturers:
Simplified & fastest loan processing
Largest Retail focused company
PAN India Coverage
Superior Product Offering
Shriram Equipment Finance has simplified and efficient deal processing system aided with cutting edge technology support to provide shortest Turn-AroundTime in the country. SEFC conclude finance and duediligence aspects of deal within time that is 50 per cent of industry average TAT.
Understanding the distributed customer profile across geography, the risks associated with the profile and segment, Shriram Equipment Finance is focused to empower small and medium enterprises/Individuals with easy and attractive finance option available at their doorstep. Today SEFC is one of the largest retail segment financer in Construction Equipment segment and same would be replicated for Medical Equipment Finance business as well.
Leveraging Shriram Transport’s presence in more than 650 branches, SEFC has manned its operations at 165+ locations thereby covering entire geography of the country. Having started Medical Equipment Financing in 18 branches currently, intends to spread into all 165 locations across the country.
Shriram Equipment Finance with its superior industry understanding and underwriting skills has evolved product offering in terms of asset selection, Loan-To-Value, tenor and other finance terms flexible that is by far the best in the industry.
Covering all & everywhere
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Shriram Equipment Finance believes and demonstrates financial inclusion of all asset classes/models and customer grades with best in industry product offering. Complete coverage to the matrix of assets and customer grades make Shriram Equipment Finance a comprehensive solution provider in this segment.
February / 2015 ehealth.eletsonline.com
Buyers Speak
Cardiology – Trends and Technology
T
he field of cardiology has undergone rapid changes in the last decade. We have more potent drugs, development of new diagnostic techniques, and evolution of stent technology with more complex coronary anatomy being treated without surgery. New valve therapies for high risk patients have emerged and are likely to evolve further. Stem cells as always have been an area of active debate and research. It can be said that the future looks bright and there is much to look forward to. Recently, there is approval and availability of new antiplatelet drug Prasugel/Ticagrelor used in the treatment of unstable patients and also for those undergoing stent procedures. New drugs like Ivabradine and Ranolazine are being used as add on therapy for angina management. For treatment of irregular heartbeats like atrial fibrillation drug like Dronedarone, which is a new antiarrythmic drug is being used, while Dabigatran an oral anticoagulant is a very exciting addition in stroke and embolism prevention in patients with atrial fibrillation. The latest addition for cholesterol management is a drug called Rosuvastatin, which has shown promising results. Newer drugs which are stronger are undergoing advanced stage clinical trials. In interventional cardiology, various newer modalities for assessment and treatment of the severity of the lesion during angiography have been developed. Procedures like Fractional Flow Reserve, which are used to measure pressure differences across coronary artery block to determine the likelihood that it impedes oxygen delivery to the heart muscle. Another technique which
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Dr Sudhir Vaishnav Senior Interventional Cardiologist, Kohinoor Hospital, Mumbai
is gaining importance is IVUS assisted angioplasty (Intravascular Ultrasound). IVUS guidance may provide with the opportunity to optimize results during the angioplasty procedure and help more accurately select the cases where stenting are required. Newer local drug delivery using Drug Eluting Balloon (DEB) have generated interest lately. DEB is used in patients where Drug Eluting Stent (DES) cannot be delivered or where DES does not perform well. With the advance in technology lately, bioabsorbable stents have been developed because the need for mechanical support for the healing artery is temporary. The advantage of complete biodegradable stent is that the stent would disappear from the treated site reducing or abolishing late stent clotting, improving lesion imaging with CT or MR, facilitation of repeat treatments (surgical or percutaneous) to the same site. Till now management of valvular heart disease was mostly surgical domain, among the valve afflictions valvular mitral regurgitation remains largely the purview of surgery. The Mitra Clip
Device, a metallic clip is used to grasp and approximate the free edges of the two leaflets, has proven relatively safe and effective. Various other devices have been used for the treatment of cardiac conditions like an implantable cardioverter defibrillator or automated implantable cardioverter defibrillator for the treatment of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. Another device used to treat patients with advanced congestive heart failure is a ventricular assist device, which is an electro mechanical circulatory device that is used to partially or completely replace the function of the failing heart. Percutaneous aortic valve replacement using stent based prosthesis has emerged as a promising new option in which surgical aortic valve replacement is considered not to be safe. Lastly, stem cell therapy as applied to cardiology has shown partial progress. A large number of patients with coronary artery disease experience angina with vessels that are not suitable for revascularization. The angina in so called end stage coronary artery disease is refractory to conventional medical therapy. Stem cell therapy may be the answer to problem of left ventricular function recovery following an angioplasty during an ongoing heart attack but needs to be proved conclusively in large scale trials. The future holds bright for cardiac patients with the advance in technology and medicine improving the overall morbidity and mortality along with improvement in the quality of life. For more information visit: www.kohinoorhospitals.in
Flow Cytometry
One Diagnostic Tube Go with the Flow Current trends in flow cytometry are helping to drive increased adoption of this technology in clinical testing, pharmaceutical studies, and basic research in novel areas. Anshuman Ojha of Elets News Network (ENN) has more
F
low cytometry established itself as a valuable research tool several decades ago. It now has become a major asset in the diagnosis, prognosis, and monitoring of many medical disorders in addition to some commercial applications. Flow cytometers were initially large and somewhat cumbersome instruments, but have evolved into table-top, userfriendly, multi-functional ones. Over the years, clinical laboratory scientists have found additional ways to utilize flow cytometry that go well beyond simple particle counting. To-
day’s flow cytometers are used in cell differentiation, chromosome analysis, cellular immunology, clinical hematology, cancer diagnosis, pharmacology, and toxicology, to name a few applications. Though primarily used in monitoring immunocompromised (HIV+) patients and in the diagnosis and prognosis of different blood cancers, their utility has extended into other areas of science and industry. Understanding the science behind flow cytometry helps us to appreciate its usefulness and importance in the clinical laboratory.
Beginning in the 1940s, a number of technological advances in flow cytometry were applied to clinical practices in order to better understand the morphology, kinetics, and structures of various cell types, bacteria, and other microscopic particles. Clinical laboratory application of flow cytometry became particularly relevant with the advent of monoclonal antibodies. With the addition of powerful lasers, highly sensitive photomultiplier tubes (PMTs), and computer technology, the sensitivity and accuracy of crude flow cytometers were greatly improved.
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Flow Cytometry
Global Market
The global flow cytometry market was valued US$ 3.9 billion in 2014, and is expected to reach a value of US$ 5.7 billion by 2018, experiencing a CAGR of 10.3 percent.
North America has the highest share in revenue generated by the current flow cytometry market and is expected to remain the leading revenue generator till 2018 30
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Flow cytometers measure and analyses cells of various characterisations through a light beam that is passed through a suspension of fluid. Several properties of the cell structure and functions can be studied with the help of this technique. The global flow cytometry market was valued US$ 3.9 billion in 2014, and is expected to reach a value of US$ 5.7 billion by 2018, experiencing a CAGR of 10.3 percent. North America has the highest share in revenue generated by the current flow cytometry market and is expected to remain the leading revenue generator till 2018. Geographically, the global flow cytometry market is divided into four regions, North America, Europe, Asia-Pacific, and Rest of the World (RoW). North America and a major part of the European region are saturated markets for this product. North America accounted for the largest share of the global market in 2014. This growth is attributed to a number of factors such as presence of flow cytometry associations in this region, increasing use of flow cytometry techniques in cancer research, rise in investment initiatives by the government, and high quality infrastructure for clinical and laboratory research. The emerging markets including China and India are becoming attractive for the companies engaged in the development and marketing of the products. Various economic developments and growing prevalence of HIV/AIDS, increase in scope of application areas such as drug discovery, stem cell sorting, marine biology, growing number of research initiatives, increasing government support, and growing focus of both international and domestic players are the key factors propelling the demand for flow cytometry products in the Asia-Pacific region. One of the emerging trends in the market is the increase in outsourcing by a large number of drug manufacturers. They outsource the drug discovery and development processes to CROs, which provide a better quality of service and reduce lead time. The major compelling factor of flow cytometry technology is the advancement in the technology such as need for labeling multiple antibodies and multiple image capturing instruments. Comparing to other methods, the flow cytometry technology has many advantages such as accessibility in broader use,
Flow Cytometry
In 2014, the flow cytometry market is estimated at `175 crore. Reagents accounted for 62.3 percent of the flow cytometry market, valued at `109 crore
auto calibration and easy to handle instruments. They have taken over the conventional methods, due to its advantages. Flow cytometry in immunotyping has undergone many changes; this is one of the major applications of flow cytometry. The technology provides detailed quantitative analysis about the cell counts and antigen expression. This technology is very sensitive when compared with the conventional methods. Immunophenotyping is used in the application of haematology. The cytometric analysis is easy in haematology applications due to the hematopoietic distribution system. Key factors restraining the market include high instrument costs and size, lack of awareness among probable users and need for trained personnel. The costs of the instruments vary depending on the size, technology used and present features of the instrument. The flow cytometry technology is becoming popular for research and clinical purposes, yet there is lack of awareness among the users. Most of the users are not aware of the advanced development in the flow cytometry technology and believe that the instruments are space consuming, complex in use and are of high cost, thus affecting the market growth.
Indian Market
A discerning shift in the buying pattern is observed over the last couple of years, with laboratories giving a higher priority to flow cytometry
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In 2014, the flow cytometry market is estimated at `175 crore. The analysers saw sales of 112 units, valued at `66 crore. A discerning shift in the buying pattern is observed over the last couple of years, with laboratories giving a higher priority to flow cytometry. Reagents accounted for 62.3 percent of the flow cytometry market, valued at `109 crore. The National Aids Control Organization (NACO) did not make any procurement of flow cytometer in 2014. The last time it made a purchase was in the year 2010, and it has made procurements only three times in the last eight years. However, despite being an occasional procurer, NACO still remains one of the largest purchasers of the HIV clinical reagents. Indian flow cytometry market continues to be dominated by BD Biosciences, followed by Beckman Coulter. Other aggressive players include Partec, Millipore (acquired by Merck), Amnis Corporation (represented by Imperial life Sciences) and Dako (represented by Suyog Diagnostics).
Flow Cytometry
“Indian flow cytometry market continues to be dominated by BD Biosciences, followed by Beckman Coulter. Other aggressive players include Partec, Millipore (acquired by Merck), Amnis Corporation (represented by Imperial life Sciences) and Dako (represented by Suyog Diagnostics)”
Major Players Becton Dickinson continues to advance instrument systems to make flow cytometry analyzers and cell sorters more powerful, more dependable and easier to use. From easy to use benchtop systems to special order systems to fit your unique needs. Its cell analysers and sorter range includes BD FACS Aria Fusion, BD Accuri C6, BD LSR Fortessa X-20, BD FACSCanto II, and BD Influx, BD FACS JAZZ and BD FACSVerse. Last year BD Biosciences and Jamia Hamdard University has announced FACS e-LEARN – a joint online learning program in cell research and diagnostic for young scientists and researchers. These programs are designed for professionals who are already in a job or a regular academic program. The web module and e-mail support program will be followed by a hands-on experience on flow cytometry instruments and applications. The company has also established Centers of Excellence in flow cytometry through collaborative partnership with several academic institutes of repute. Beckman Coulter delivers comprehensive, innovative system solutions that address the principal steps in today’s diverse laboratory processes. From basic cellular analysis research to advanced cell sorting methods and flow cytometry applications, the company offers flexible solutions that meet evolving needs. Beckman Coulter’s complete range
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Flow Cytometry
of automation and information systems helps you streamline processes for maximum efficiency. From delivery of more timely, accurate and reliable patient test results to the elimination of bottlenecks, our automation and information system solutions empower you to manage lab operations more efficiently and cost-effectively. Its range includes CytoFLEX, Gallios, Navios, FC 500 Series and CyAn ADP Analyzer. MoFlo series includes highspeed, improved sensitivity, and reliable cell sorters with 32 bits and modular feature as per customer’s need. The MoFlo Astrios is the new standard for cell sorting with functionality, speed, and improved sensitivity. It is designed for researchers who desire high productivity with more analytical capability and with biosafety solutions. The ergonomic design of Astrios makes it faster and easier to operate. Merck Millipore’s cellular analysis platforms give you instant access to all facets of cellular phenotypes. From simple and quick cell counts, multidimensional cell health assessments, and sophisticated multiparameter measurements on individual cells, our cell analysis equipment enhances your experiments, delivering more predictive and reliable data than other cell analysis instruments. Amnis imaging flow cytometers are the game-changer in cellular analysis, providing in-depth analysis and detailed imagery of every individual cell and hard to reach subpopulations. The guava easyCyte flow cytometry systems are cost-effective, easy to use and deliver complete and comprehensive cell analysis- right on your benchtop. Muse, is a personalized cell analyser. The company has miniaturised cytometry and packed 3-parameter analysis into a compact, affordable instrument, bringing cell analysis to every benchtop. Amnis, from Imperial Life Sciences, proudly introduces the new Imag-
Most of the users are not aware of the advanced development in the flow cytometry technology and believe that the instruments are space consuming, complex in use and are of high cost, thus affecting the market growth eStreamX tremendous leap forward in cell analysis. Amnis has dedicated 10 years to combining the most advanced technologies in optics, sensors, and image processing to achieve what has never been possible before – a fusion of the analytical power of flow cytometry with the visual detail of imaging. The ImageStreamX quantifies both the intensity and the location of fluorescent probes and can image at incredibly high rates of speed, allowing you to analyse rare subpopulations and highly heterogeneous samples with statistically robust and objective results. By combining the detailed imagery and functional insights of microscopy, the ImageStreamX will rapidly advance your research.
Technological Advancements • Innovation in Instruments A typical flow cytometers are comprised of a fluidic system, an optical system, detection electronics and data acquisition. When a particle
traverses the light, a pulse of scattered or fluorescent light is generated and then analysed. Several independent optical measurements are usually performed per cell and stored on a per cell basis in a computer file. Advances in lasers and detectors have reduced the size and increased the performance of modern flow cytometers. About 20 different measurements can be performed simultaneously on a cell with this approach at rates of up to 100,000 cells per second. A recent development extends the number of measurements to about 50 markers simultaneously by using element labels with ICP mass spectrometric detection rather than optical labels. On-going research aims at matching the MS performance by using full spectral analysis of fluorescence but also at higher levels of multiplexing with surface enhanced Raman labels. Measuring more parameters helps to better differentiate between rare cells and background, resulting in an increase of specificity.
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Flow Cytometry
• Innovation in Reagents Monoclonal antibodies, reactive with cell surface markers and conjugated with fluorescein, were used to measure the lymphocyte populations of B-cells, T-cells and the helper and suppressor cell subsets of T-cells with early flow cytometers. In the meantime more than 300 cellular markers have been assigned a cluster designation (CD number). Antibodies have been complemented with additional affinity reagents such as aptamers, molecular imprints and others. In addition to affinity reagents for proteins, nucleic acid-based assays also provide increased applications in cytometry. Improvements in amplification technology now allow the detection and counting of single RNA molecules in single cells using flow cytometry. • Innovation in Cell Sorting In recent years, the number of applications for separating and analysing bacterial types has increased enormously as a consequence of the improvement in available sorting technology. High-end flow cytometers have the capability to sort cells in real time, based on the analysis approach described above. Analysis rates of up to 100,000 cells per second are possible; special thresholding allows even higher cell throughput by only analysing the easily identified subset of interest. This makes flow cytometric sorters the key choice for further characterisation of single rare cells using genomic single cell technologies after sorting, or for selected populations using proteomic analyses. Fluorescence activated cell sorters have long been based on jet-in-air, elec-
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trostatic droplet deflection designs. Considerable progress has been made in the speed and accuracy of cell sorting. Micro-fluidic flow cytometers have been under development for a number of years and show impressive progress in miniaturising flow cytometric analysis. The parallelisation of flow analysis to comprise simultaneously operating flow analysis and sorting represents an innovative step to increase the processing of individual cells. Cytonome/ ST researchers have demonstrated robust identification of extremely rare target particles. Using Cytonome/ST’s existing parallel detection technology and cross contamination-free sample system, the researchers were able to reliably identify 60 fluorescent target particles within a sample of 640 million non-fluorescent particles in less than one hour. Parallelisation of analysis and sorting overcomes the limitations of single channel processing and allows direct analysis of large sample volumes. • Innovation in Drug Development For several decades, pharmaceutical discovery has been driven by the increasing industrialisation of biological assays. This, coupled with significant improvements in chemical synthesis, has lead to the widespread practice of high throughput screening, whereby assay densities have increased from plates of 96 wells to 384 and 1536 wells. Rapid biochemical assay formats and analysis combined with rapid chemical design and synthesis have revolutionised Quantitative Structure Activity Relationship studies. Taken together with
a concomitant focus on molecular reductionism, driven by advances in genomics technology and sequencing, the result has been an industrial wide focus on target-based discovery. Recently, however, in light of the clear industry wide failure to generate significant New Chemical Entities (NCE), there has been a call to redirect screening technologies away from putative targets and engage in Phenotypic screening and Physiologically Relevant assays. Although phenotypic screening can be interpreted to mean different things, it is generally used to imply an assay for a systemic biological response of a cell or organism. Its definition has come to include the analysis of previously undetected correlated changes that can be increasingly detected and statistically rationalised by analysis of high content data. Highly dimensional data allows investigators to look for and identify nodes, or intersecting points of signal transduction, that occur when a system is perturbed. High content cytometric data and the techniques of rare cell analysis can identify relapsing tumours and, based on the phospho-signalling status of pathways of interest, can guide physicians to a targeted chemotherapy as well as identify potential targets for future drug development. Overall technical advancements being made across the spectrum of hardware, software and ‘wet-ware’ biological tools are making deep and disruptive impacts in many fundamental disciplines within clinical application of cytometry and the whole of drug discovery.
Exclusive Interview
Delivering Innovative Solutions
The new trend in flow cytometry today allows one to analyse multiple parameters simultaneously, says Dharmendra Tripathy, Marketing Manager, BD Biosciences- India
A
cross the past 40 years, BD Biosciences has been honored to be the brand our customers have trusted to facilitate and speed up their work to discover more about life around us and to improve the human conditions using flow cytometry. Our total solutions in flow cytometry continue to keep pace with the accelerating speed of discovery, so they have reliable and consistent results and more flexibility for experiments. The new trend in flow cytometry today allows one to analyse multiple parameters simultaneously—and by adding more colors one can open up a whole new world of information and insight into the research. BD strives to deliver innovative solutions that help make research efforts more efficient and more revealing. From brighter dyes (BD Horizon Brilliant Dyes) and advanced instrumentation with up-to 18 color detection like BD LSR Fortessa X20 that resolve populations of interest to the availability of an expert at just the right time, it all works together to help you get quality data out of every study. In the clinical segment, BD for the first time has come up with an innovative solution of premixed
cocktail BD OneFlow, which brings the standardisation of leukaemia and lymphoma immunophenotyping one step forward. This unique platform is built on the research and validation work of the EuroFlow Consortium on the characterisation of haematological malignancies for improved diagnostic outcomes. This not only maximizes laboratory efficiency but also increases reliability and accuracy of results for better clinical decisions and ultimately patient outcome. In the CD4 monitoring space for HIV, BD has introduced a point-of-care device, BD FACSPresto, a unique nearpatient technology designed for resource-limited settings. With capability to give CD4 count, CD4 percent and Hb from a single drop of blood using a dry reagent cartridge make it a unique proposition, especially when it can do more than
BD FACSPresto
8-10 samples in an hour. With its very small footprint and robust design, BD FACS Presto can be taken to remote places as it houses a battery which allows usage up-to a minimum of six hours without electricity. We are confident that this is an ideal solution for HIV clinicians, path labs, NGOs and health centers that have been referring HIV positives to a central lab or hospital because of high cost of ownership. Now they can not only have their own system but can contribute to the society by giving access of testing and reporting within 20 minutes. Increasing access of CD4 monitoring in India today is the main task and once again BD has lived upto its mission of helping all people live healthy lives. Further, what differentiates BD Biosciences is our knowledgeable and high caliber team of 56 associates who provide information, training, application support, and field services so our customers can achieve optimal performance and productivity. Today, we have more than 900 flow cytometer systems installed in the Indian subcontinent, and we thank our customers for trusting their discoveries to our technologies.
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Buyers Speak
Paediatric Cardiology Services Tell us some of the latest trends in paediatric cardiology that have been adopted by the hospital to offer state-of-the-art paediatric cardiology services? First of all Sahyadri Hospital is equipped with all the necessary as well as latest infrastructure for paediatric cardiology services. The hospital also has the advanced echo machine with paediatric transesophageal probes useful for complex diagnosis. In addition, the cath lab and operation theatre are very much prepared for paediatric cardiac interventions as well as cardiac surgeries. In Sahyadri Hospital we have an experienced team of paediatric cardiac surgeons, paediatric cardiologists and perfusionists that are available round the clock. In addition post operative ICU care is very good at Sahyadri Hospital, which is really very important.
What are the latest techniques for paediatric cardiac surgery that ensure quick recover? Nowadays some of the cardiac defects like ASD, VSD, PDA, PS, AS are corrected with transcatheter interventions resulting in greater successful operations. In these procedures duration of hospital stay is only 2 - 3 days. A lot of patients are demanding such procedures these days. In last year, we have successfully performed more than 100 paediatric cardiac interventions and equal number of surgeries at Sahyadri Hospital. We have successfully performed interventions even on children weighing less than 10 kg. A 2-year-old child, weighing 9 kg was presented to us with recurrent respiratory tract infection. We have tested him on the Echo 14 mm equip-
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disease. This programme is getting a great response and many children have already been operated under this programme. It is especially offering a great aid children belonging to poor families. Now financially weak patients can afford to get treatment in any institute.
What would be your recommendations to the government to promote awareness and extend schemes for this segment? Dr Pankaj Sugaonkar Paediatric Cardiology Sahyadri Speciality Hospital, Pune
ment and diagnosed him with ASD. We successfully performed the ASD device closure on this child and even discharged him within two days after the procedure. On follow up we got to know that the child is free from ASD symptoms and is gaining weight steadily.
What is the percentage of paediatric cardiology patients that come to the hospital and the common condition that is prevalent among them? Incidence of Congenital Heart Disease (CHD) is one percent and its numbers are five percent out of all OPD patients. Now that the government is providing help to patients, the number of cases in OPD is increasing gradually. We are also performing echocardiography in at least 10 patients with CHD daily.
Tell us some trends that support paediatric cardiology surgery and make an affordable option? The government has started a programme to give financial aid to institutes to operate children with congenital heart
Though the government is doing its part by providing financial aid for treatments, but it is not adequate for some of the diseases. For example, smaller babies with TGA the treatment called large VSD still costs significantly. In my opinion government should provide extra help for these diseases so that all children can be treated.
What is your vision for the paediatric cardiology department of the hospital in the coming years? I want to further develop the paediatric cardiology department in our hospital. In the coming years, our aim is to operate even more number of cases and deliver successful results. In addition we also aim to start Foetal Echocardiography Programme so we can diagnose patients in the antenatal phase itself. My aim is to make quality healthcare available, affordable and accountable to all patients with congenital heart disease. With our continual efforts and dedicated care, it will be our collective goal to make this centre a tertiary centre for congenital heart disease patients in India in coming years. For more information visit: www.sahyadrihospital.com
Chemiluminescence
Immunoassay (CLIA) On an Upward Trajectory The future looks bright for immunochemistry industry, with intense R&D activity currently being carried out by small and major companies, and over 500 products in the development pipeline
I
mmunoassays are diagnostic laboratory procedures performed to determine the concentration of several biomolecules that aid in the diagnosis of several disorders. In addition, these assays are used to assess the efficacy of the drugs and to identify the drugs of abuse. The basic principles of immunoassays forms the antigen-antibody interactions in various test samples and are highly sensitive in nature. These assays are carried out across various fields such as biopharmaceuticals, environmental and clinical testing and in various settings such as hospitals, research and development facilities and clinical laboratories. Owing to the increasing demand for efficient as-
says that are highly sensitive and reliable, there has been a continuous evolution of these assays to ensure improved performance. This in turn leads to the continuous technical upgradation in immunoassay platforms or assays. Factors such as rising incidences of infectious diseases coupled with persistent product modifications contribute towards the market growth. In addition, increasing incidences of endocrine disorders (diabetes, thyroid dysfunction), enhanced discovery of biomarkers (cancer and cardiovascular) and introduction of novel drugs leading to increased therapeutic drug monitoring will further augment the market growth.
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Immunochemistry Analysers & Reagents
Indian immunochemistry analysers and reagents market is valued at `1510 crore. The highest contribution to the revenues is from the immunochemistry reagents, accounting for `1313 crore
Indian Market In 2014, the Indian immunochemistry analysers and reagents market is valued at `1510 crore. The highest contribution to the revenues is from the immunochemistry reagents, accounting for `1313 crore. The product segment is further categorized into six major immunoassay instruments namely chemiluminescence immunoassay (CLIA) analyzers, immuno fluorescence (IFA) analyzers, enzyme immunoassay (EIA) analyzers, radioimmunoassay (RIA) analyzers, enzyme linked fluorescent assay (ELFA) systems and multiplexed assay systems. These instruments are classified on the basis of immunochemical methods used for detection and measurement. For instance, RIA analyzers involve the use of radioisotopes while IFA analyzers use fluorescent substances. The immunoassay instruments market is witnessing a rapid pace of technological innovation coupled with diverse applications due to increasing demand for novel assay platforms with enhanced capabilities. The use of CLIA analyzers is increasing rapidly owing to benefi-
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cial features such as high sensitivity and accuracy in detection of analytes in the test sample. These instruments accounted for largest percent share (27%) of the global market in the year 2013 and are expected to grow rapidly in the forthcoming years. In addition, ELFA systems and IFA systems constitute the other promising immunoassay platforms. Immunochemistry instruments find varied applications such as in endocrinology, oncology, cardiology, therapeutic drug monitoring, infectious disease testing and drugs of abuse testing. Owing to the wide range of applications, there is a demand for robust assay technologies thereby generating a lucrative growth potential for development and commercialization of immunoassay instruments. The market growth is significant due to the high demand for automation of procedures in laboratories and diagnostic centres. Automation is already in place in the laboratories of developed nations, but is in high demand in India. However, the cost of automated random access analyzers is still high for Indian market. The shift towards lifestyle diseases, increasing demand for non-invasive diagnostic tools, identification of novel biomarkers and advent of new parameters like vitamin D, B12, cancer diagnosis
Immunochemistry Analysers & Reagents
are opening new vistas for the immunochemistry industry. Moreover, increasing healthcare spending and government initiatives will propel the immunoassay market. Vendors are continually expanding their product lines to fit varying end-user needs. For example, manufacturers are developing analyzers to meet end-user budgets, test volumes, desired breadth of test panels, and levels of automation. Additionally, many analyzers are modular for expansion as desired. Facing a high degree of competition, manufacturers are also shortening product cycles with new launches or adding value on existing installs. The future looks bright for immunochemistry industry, with intense research and development activity currently being carried out by small and major companies, and over 500 products are in the development pipeline. However, the immunochemistry diagnostic market will face increasing competition from other diagnostic technologies and so, future growth will depend on the availability of more clinical evidence to prove effectiveness of immunochemistry tests. The increasing competition from other technologies will also require market participants to differentiate their products to remain competitive.
Global Market The immunochemistry market, which includes revenues from the sales of analysers, reagents, and automation for standalone immunoassay and clinical chemistry analyzers, as well as integrated immunochemistry analyzers, represents 40 percent of the global IVD market. In 2014, sales are expected to reach US$ 21.25 billion, based on estimated 7 percent CAGR. In terms of technology trends, the market is increas-
ingly seeing the entry of chemiluminescence immunoassay (CLIA) analyzers, which are replacing older versions. Smaller labs still opt for immuno fluorescence (IFA) analyzers or semi-automated CLIA systems. Enzyme-linked immunosorbent assay (ELISA) systems and open systems are exhibiting some growth because of their open platform capabilities and larger test menu and affordability. IFA and CLIA analyzers tend to be more expensive, which works in favor of ELISA systems. Frost & Sullivan, however, estimates that ELISA systems will eventually experience erosion because of their lack of sensitivity and low specificities, especially as most laboratories are now consolidating and converting to high throughput systems. As a result, many vendors are using this opportunity to offer immunoassay or standalone clinical chemistry systems for a high discounted price. Demand for immunochemistry systems seems to work negatively for vendors. Because of this, the retention of the install base is crucial. Some strategies adopted by vendors include offering large discounts/upgrades, adding automation capabilities to existing modules, and having long reagent rental contracts. Frost & Sullivan’s install base analysis reveals that a few open system platforms are declining in their install base, leading to rapid transition to either an IFA or a CLIA analyzers. According to College of American Pathologists (CAP) product data, an estimated 184,136 immunochemistry analysers were installed globally in 2013, and recurring consumable sales are a strong factor to segment growth. Only about 17 percent of these analyzers are installed in the United States, confirming rapid adoption patterns in
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Immunochemistry Analysers & Reagents
emerging and rest of the world countries like China, India, and Japan, where there is an untapped opportunity in rural and hospital markets that lack basic diagnostic laboratory infrastructure. Major vendors are Roche Diagnostics, Siemens Healthcare Diagnostics, and Abbott Diagnostics. Other aggressive players include Beckman Coulter, Thermo Fisher, Alere, Agappe Diagnostics, Inova Diagnostics, bioMĂŠrieux, DiaSorin (Representing Trivitron Healthcare), Bio-Rad, IDS, Ortho-Clinical Diagnostics, Transasia, Snibe, Tosoh Bioscience, Arkray, CPC Diagnostics, and Imperial Life Science. The market is also seeing the influx of many newer companies from Canada, Japan, China and Europe. The market has undergone a massive change from a handful of participants offering only ELISA, CLIA, radioimmunoassay (RIA), and IFA as well as multiparametric assays such as microarrays, flow cytometry-based platforms, recombinant immunoassays, and indirect immunofluorescence assays (IFA).
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Road Ahead One of the key challenges when building on install base is the high cost associated with transition. Even when dissatisfied, most lab managers endure outdated instruments to avoid resource-intensive issues, such as the purchase process, staff retraining, protocol standardization, and data management system reevaluation. As labs consolidate, the immunochemistry analyzer market relies on instrument replacements to generate the needed revenue. Nearly all manufacturers rely on key strategies, such as offering replacements for old clinical chemistry and immunochemistry systems or acquiring clients from other vendors. Competition is stiffening as most vendors face difficulties increasing their customer base. The future will see CLIA as a growing analyzer segment with tremendous focus on areas, such as infectious disease testing and autoimmune and oncology segments. The market is moving toward multi-parametric assays, and many companies are exploring the use of multiplex technologies using protein and peptide arrays for autoimmune diagnostics.
Company profile
User-friendly Digital Control Panel for Oxygen The fully automated Digital Control Panel for Oxygen / Nitrous is in sync with changing Technology with the aim to meet the variegated requirements of clients • The Oxygen Control Panel shall be of microprocessor based digital display type. Pressure reduction shall be in two stages. Panel shall be integrated with pressure gauges inside panel on downstream of pressure regulator. Panel shall be fitted with standby line regulator. Line regulators shall have pressure relief mechanism for testing and servicing purpose. • The panel shall be fully automatic and shall switch over from “Bank in Use” to “Reserve Bank” without fluctuation in delivery line pressure, and without the need of external electrical power. After the switch–over, the “Reserve Bank” shall become the “Bank in Use” and the “Bank in Use” shall become the “Reserve Bank”. The control panel will be powered by a microprocessor. The unit shall be compact and enclosed in NEMA 1 enclosure. • A microprocessor circuit board assembly shall provide a relay output to give indication when or just before the manifold switches from one bank of cylinders to another. The switch over shall be mechanically controlled, not electrically. • To avoid excess pressure being supplied to the distribution system, a pneumatically relief valve for the line regulator shall be incorporated. An intermediate pressure relief valve shall be installed between the high-pressure regulators and the line delivery regulators. • The control panel incorporates six coloured LEDs – three for the left bank and three for the right bank – green for bank in use, amber for bank ready and red for bank empty. Both, the left and
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right bank pressures, and the main line pressure, should be displayed on the front door of the cabinet by means of LED’s. All pressure transducers, micro switches, and display LEDs shall be pre-wired to an internal microprocessor circuit board. • All components inside the control panel like pressure regulators, piping and control switching equipment shall be cleaned for oxygen service and installed inside the cabinet to minimise tampering with the regulators or switch settings. • The control panel should be made to provide heavy duty with a flow capacity of over as per requirement of the hospital. • Panel shall be compatible for interfacing with the Information Management System. (optional) Fully / semi automatic control panel oxygen / nitrous oxide system Control panel have two first stage regulators, each capable of delivering 120 psig outlet pressure. The first stage regulator connected to the second stage regulator, which will deliver an outlet pressure of 60 psig. The first two regulators, meant for first stage, will be capable of switchover system incorporated from “Running” to “Reserve” bank due to differential pressure. The control panel provides for two individual content contact pressure gauges to indicate the cylinder pressure in the two wings of the manifold and common pressure gauges to indicate the delivery / line pressure. Control panel have audio alarm for bank changeover. The control panel has built in signal lamp indications for changeover. Control panel covered with suitable cover indicating the respective services.
Exclusive Interview
Managing Quality Control in PoC
We are seeing an increasing amount of patient testing being carried out at the bedside, says David Hunter, Global Manager, Randox Quality Control
C
linical diagnostics is constantly evolving with new breakthroughs bringing earlier and more accurate diagnosis. Traditionally, all or the vast majority of diagnostics tests were conducted in the clinical laboratory. We are now seeing an increasing amount of patient testing being carried out at the bedside or the point-of-care (PoC). The benefits of PoC testing are clear: convenience, ease of use and rapid results clearly enable faster medical diagnosis. However, these benefits are only true if we are certain the results are accurate and reliable. Ensuring this is the primary function of internal quality control (IQC), however IQC in PoC testing can be a tricky one to manage. In the laboratory we would expect good IQC procedures to be well established. However, for most non-laboratorians conducting PoC testing, IQC is an unknown territory. Laboratory managers are ultimately responsible for managing IQC in the point-of-care setting but many struggle to find effective IQC solutions, which are suitable for multiple locations and operators unfamiliar with IQC. How do laboratory managers monitor results in remote sites? How can results be monitored from a variety of PoC users and devices? And, how do you ensure this process is both cost-effective and efficient? Online data management can provide a good solution, helping overcome all of the above issues by facilitating the monitoring of PoC
results anywhere as internet access is available, at any time. Every PoC device throughout the clinical setting should be registered on the data management software. Results can be entered in a variety of ways: on PCs, laptops, tablets or smartphones, and once this is done the software will automatically accept or reject the results based on the performance of the control. This offers PoC users a simple and effective way to ensure that their PoC device is ‘in control’ and that the results produced are reliable. Results from multiple analysers are stored together in the software making it convenient for lab managers to review results. Just by logging onto the software, the laboratory manager can review and compare results from all PoC devices around the hospital or even across multiple sites. This provides lab managers with a comprehensive overview of test performance across the entire clinical setting, without even
having to leave their desk. This gives a long term view of how each device is performing, helping lab managers to identify any maintenance issues or training needs of the operators. Some of the available online data management platforms offer different levels of user access. This means that PoC device operators will have their own unique log-in ID and can have restricted access to the software’s functionality. For example, users can only enter results, not edit or delete them. This enables lab managers to track individual users, helping them to identify operators who perhaps need more training. Many of the software packages available will calculate internal statistics such as the mean and CV, displaying graphs showing trends in IQC data. In addition, a peer-group functionality gives the laboratory visibility of results produced by other users globally using the same PoC devices. The cost-effectiveness and efficiency of monitoring POCT devices using online software is perhaps the most important benefit as some software providers offer unlimited multiple instrument registrations free of charge. This means that a laboratory can register all of their PoC devices on one license. With the right online datamanagement system in place ensuring effective monitoring of internal quality control, both in and out of the laboratory, could get a whole lot easier. Review the marketplace to ensure you find a platform to suit your laboratory’s needs.
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Ultrasound Equipment
Sonography: What does the Future Hold? T
echnological advancements in the field of imaging have made ultrasound ownership cost-effective solutions to providing quality patient care in a private practice. The ultrasound market is moving towards solutions that manage patient comfort and safety more effectively. As the ultrasound equipment has become more sophisticated, users have become increasingly specialized and skilled in how to manage the system. Here is a look at the advancements in the industry and trends for the future.
Market Dynamics The global ultrasound equipment market is expected to reach US$ 6.2 billion by 2019 at CAGR of 5.1 percent from 2014 to 2019. In 2014, Europe accounted for the largest share of the market, followed by North America. However, the AsiaPacific market is expected to grow at the highest CAGR of 5.5 percent from 2014 to 2019. This high growth can be attributed to rapidly increasing aging population, growing focus of multinational companies on emerging markets, improving and modernizing healthcare infrastructure, government initiatives to have advanced imaging systems at public healthcare facilities, and high incidences of cancer cases in this region. Factors such as development of technologically advanced ultrasound devices; rapid growth in aging population with high risk of target diseases; rising incidences of cardiovascular diseases and cancer cases; growing demand for minimally invasive treatment procedures; and increasing public-private funds and grants are driving the growth of the global ultrasound market. However, factors such
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Ultrasound Equipment
as technological limitations of ultrasound, dearth of skilled and experienced sonographers, and unfavorable healthcare reforms in US have been hampering the growth of this market. Major players in the ultrasound market are GE Healthcare, Philips Healthcare, Siemens, Fujifilm SonoSite, Samsung Electronics, Esaote, Mindray Medical, Trivitron, and Toshiba Corporation.
New Systems The growth of the ultrasound market can be seen in the host of systems released in 2014: • GE has announced the commercial availability of its Logiq e ultrasound system in the United States. The system features a programmable probe with buttons that allow for simple, fast, precise use of portable ultrasound at the point-of-care. The new transducer allows for premium imaging capabilities in a compact format for patients in a wide variety of settings. • Phillips has launched its Affiniti ultrasound system at the European Society of Cardiology (ESC) Congress 2014. The intuitive, easy-to-use system meets the needs of physicians who are challenged with treating large volumes of patients. The U.S. launch for Affiniti is slated for 2015. • In July, Esaote received U.S. Food and Drug Administration (FDA) clearance for MyLab Six, an affordable, compact ultrasound system that improves ergonomics for sonographers scanning in a seated position. It can be configured with a complete suite of applications. • Samsung Electronics America announced its first premium ultrasound system, the Samsung UGEO WS80A, which received FDA clearance late last year. The system combines imaging innovations and 5-D technologies to deliver fast, easy, accurate ultrasound images for OB/GYN applications.
Developing New Techniques Ultrasound systems under development are continuing to push the limits of ultrasound use in medicine. For example, a new system developed by researchers at North Carolina State University and the University of North Carolina at Chapel Hill demonstrated the ability to identify arterial plaque that is at a high risk of rupturing and causing heart attack or stroke. “We have developed a dual-frequency intravascular ultrasound transducer, which transmits and receives acoustic signals. Operating on two frequencies allows us to do everything the existing intravascular ultrasound devices can do, but also makes it much easier for us to detect the contrast agents — or microbubbles — used for molecular imaging and vasa vasorum detection,” said Xiaoning Jiang, Ph.D., an NC State University associate professor of mechanical and aerospace engineering, adjunct professor of biomedical engineering and co-author of the paper. Researchers hope to launch preclinical studies with the device in the near future. Other research is showing how ultrasound techniques could be used in areas of medicine commonly dominated by other imaging modalities.
The study, “Detection and Impact of Subclinical Coronary and Carotid Atherosclerosis on Cardiovascular Risk Prediction and Reclassification in Asymptomatic U.S. Adults: Insights from the High Risk Plaque Bioimage Study,” presented at the American College of Cardiology (ACC) 2014 meeting, demonstrated how a new ultrasonic scanning technique for the carotid arteries revealed who is at high risk of being hit by a blood clot.
Outlook As the market and demand for ultrasound grows, vendors are finding ways to ensure the systems are efficient in day-to-day practice. One advancement that could be coming to many physician offices in the near future is robotic-assisted ultrasound. Two Mount Sinai research studies published in the August 2014, issue of the Journal of the American College of Cardiology (ACC): Cardiovascular Imaging showed the potential of telerobotic medicine. One study used a computer to perform a robotassisted trans-Atlantic ultrasound examination on a person in Boston, and the other showed that video econsultation, coupled with remote robot-assisted echocardiogram, dramatically reduces the waiting time for a diagnosis faced by heart failure patients in rural communities. “The two studies give us a glimpse of what to expect in the near future, a patient-friendly imaging technology at your doorstep,” said Jagat Narula, M.D., Ph.D., senior author of both research studies who serves as Director of the Cardiovascular Imaging Center and Associate Dean of Global Research at Icahn School of Medicine at Mount Sinai. The researchers said that in the future, on-demand virtual robotic ultrasound could be used in a wide variety of clinical setting collaborations, including in-hospital or emergency room patient imaging studies, community screenings or even within war zones.
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Exclusive Interview
Next Generation Ultrasound
Ultrasound systems are increasingly being used for guided procedures that extends focus on improving not only patient safety, but also providing cost-effective care, says Pavan Behl, Director & General Manager India & Middle East, Fujifilm SonoSite India Private Limited
T
he medical imaging technology has gone through significant advancements over years. The portability factor, on one hand has facilitated point-of-care (PoC) ultrasound for quality healthcare and on other hand; it has become widely adopted tool for non-invasive diagnosis. Around the world, clinicians are thriving to obtain optimum access to patient’s diagnosis while ensuring bedside care and portable ultrasound ensures this PoC, whether the patient is being treated in an emergency department (ED), an operating room (OR), or a critical care unit (CCU). Ultrasound systems are increasingly being used for guided procedures that extends focus on improving not only patient safety, but also providing cost-effective care. It has put the spotlight on efficient diagnosis of emergent disorders with ultrasound at the bedside and error reduction through ultrasound-guidance of needle procedures. Over years, the role of point-ofcare ultrasound systems is changed dramatically owing to high image quality, portability and design & technical advancements. According to New England Journal of Medicine, “With appropriate use, point-of-care ultrasonography can decrease medical errors, provide more efficient real-time diagnosis, and supplement or replace more advanced imaging in
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appropriate situations.” And hence as a medical tool, ultrasound has found vast usage across applications like anesthesiology, cardiology, critical care, emergency medicine, emergency services, endocrinology, internal medicine, musculoskeletal, nursing, orthopedic surgery, primary care, radiology, interventional radiology, sports medicine, military medicine, vascular surgery and veterinary medicine. Ultrasound systems are increasing being used for guided procedures that increases focus on improving not only patient safety but also, providing cost-effective care. It has put the spotlight on efficient diagnosis of emergent disorders with ultrasound at the bedside and error reduction through ultrasound-guidance of needle procedures. Use of ultrasound at the point of care can also significantly improve the safety of such invasive procedures
as regional nerve block injections, central venous catheter (CVC) placement, and fluid drainage, compared to “blind” insertions based on anatomical landmarks. Ultrasound guidance also increases the effectiveness of paracentesis, a challenging procedure to perform using the blind technique. A large body of compelling clinical evidence has demonstrated that use of ultrasound at the point-of-care can safely aid time-critical decisions and procedures in the Emergency Department (Jain, Stead & Decker, 2008). Employing ultrasound at the bedside can also reduce medical errors, provide more efficient real-time diagnosis, and in certain clinical scenarios, can supplement or replace more expensive imaging modalities, such as computed tomography (CT), sparing patients exposure to ionising radiation (Moore & Copel, 2011). New research shows that using ultrasound as the first diagnostic test for certain common medical conditions, when appropriate, instead of more expensive imaging methods, such as computed tomography (CT) or magnetic resonance imaging (MRI), while maintaining high standards of care. So, in this ever advancing medical world, point-of-care ultrasound today is being established as a medical tool with varied applications and is not merely a tool for radiologists anymore for primary diagnosis.
Buyers Speak
Emerging trends in Ultrasound Imaging With the advancements in technology, ultrasound equipment is becoming a necessary and affordable entity in healthcare centres across the country On emerging trend and new technologies
Share your comments on ultrasound equipment market in India vis-Ă -vis the global market. Radiology has become the backbone of healthcare centers due to developments and advances in the technology including the advancements in ultrasound technology. As one of the most noninvasive, cheap, rapid, with real-time imaging and availability, the ultrasound machines have become one of the most common and essential diagnostic tools in a hospital or diagnostic center. The market of ultrasound machines is, therefore, increasing constantly as ever with simultaneous increase in the number of manufacturers in the past few years. Even old companies are offering newer advance techniques like 4D, elastography, fusion imaging and contrast agents that is are further expanding the scope and future of ultrasound equipment. As radiologists are better aware of cross sectional imaging and direct link with the findings of ultrasound than sonographers, the countries, including India, where radiologists operate the machines, it is taking a pace and rapid expansion.
Your current operations in India and your expansion plan. Currently, we are working in primus super speciality hospital and also associated with few other diagnostic centers where we have state-of-the-art USG machines along with the cross sectional modalities. Keeping the load of patients in mind for ultrasound, these are being updated well in advance. Also, we always look forward for the recent
Dr Virendra Jain
Dr Rajat Jain
advances and to implement them into our institution or hospital.
What are your views on the price-sensitive Indian market? Price of the USG equipment is of the utmost importance along with the other technical qualities like resolution. Price is a sensitive issue but probably not at the cost of quality, resolution and recent advancements.
What are your views on government regulation or any other challenges faced while operating the Indian market? The government bodies issue guidelines before allowing the operations of diagnostic tools in a hospital or diagnostic centre. These guidelines, most of the times, have certain tough legal issues in cases of procurement, installation and operation of ultrasound machines for both the company and the operating doctor, that cause an unnecessary anxiety. Since the machine can be misused for many illegal activities, such as female child foeticide, it causes a lot of trouble for the owner in maintaining machine standards and registrations.
Nowadays, the trend is towards increasing the indications of ultrasounds with more frequent use for diagnostic purposes. Although it will not be a surprise if it is being used by surgeons and physicians on outpatient basis as the technique not just involves diagnostic purposes but also the guided interventions, ECHOs, transesophageal sonography, endoluminal and endocavitary imaging and Doppler. With advances in elastography, fusion imaging, ultrasound contrast agents and 4D imaging technology, the market of ultrasound equipment is repidly increasing fastest not just in major centers but also in the peripheral setups at district and village level.
What are your Hospital’s offerings? At present our hospital offers a decent USG machine with colour Doppler and 3D facilities which serves most of the purposes but we would always like to upgrade it whenever we have more funds. To conclude, USG is an integral part of a hospital and diagnostic centers and have immense potential to expand its utilities if misuse can be checked.
The authors are Head of the Department of Radiodiagnosis, Primus Super Specialty Hospital, New Delhi For more information visit: www.primushospital.com
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Exclusive Interview
Innovations in Medical Device Outsourcing The rising demand for quality medical products and healthcare services are the primary factor driving the growth of the global medical devices outsourcing market, says Vasant G Shah,Vice President and Head, Medical Electronics, Tata Elxsi
M
edical device domain is well known for its ability to adapt to other disciplines of knowledge, which is indeed the reason for its rapid progress. This rapid progress is putting tremendous pressure on Medical Device Manufacturers (MDM). Global demands for innovative and affordable medical products are at the pinnacle now, which is driven in part by an aging population and the needs of emerging market. The challenge for the MDMs is how to seize these business opportunities while complying with more stringent regulatory requirements, surging operational costs and an increasingly complex supply chain. The rising demand for quality medical products and healthcare services are the primary factor driving the growth of the global medical devices outsourcing market. It is important to realize that outsourcing has moved away from mere cost savings, which was the traditional de facto factor for outsourcing, towards value addition or enabling companies to focus on core functions. Outsourcing is done so that tasks that are laborious, repetitive or less technical in nature can be delegated to external agencies such that quality time can be invested on core areas which will help in maintaining competitive by realizing the
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benefits of low labor, better quality and improved innovation. The global medical devices outsourcing market is broadly categorized into the applications and services submarkets. The medical product outsourcing market encompasses Class I, II, and III types of medical devices complying with FDA standards, while the medical services outsourcing market encompasses designing, validation, prototyping, verification, and other regulatory consulting activities. This
US$ 300 billion industry is growing because of the increasing demand of outsourcing across markets. Such demand has fueled innovation in medical technology development and is expected to rise from a value USD 21.1 billion in 2012 to USD 40.8 billion in 2018, registering a CAGR of 11.6 percent in the forecast of 2012 to 2018, according to Persistence Market Research. Medical devices industry has witnessed some of the breakthrough technological advancements delivering ef-
Exclusive Interview
ficient treatment with a reduced time to market and cost at the same time. Some of the recent innovations are: • Robotic surgery – It has observed tremendous development over the past decade. Nowadays doctors can perform unassisted robotic surgery that has been rated as better than an above-average human surgeon. Robotic surgery is mainly performed for specialized open surgeries for rectifying major organs of the body including heart, brain, kidney, lungs and liver. • Micro and nano medical devices - The advent of manufacturing techniques that enable fabrication at the micrometer-scale and below provides unique opportunity for medical device applications. Miniaturization enables enhanced sensitivity, accuracy, and reduced analysis time in diagnostic applications, higher precision, efficacy, and minimized invasiveness in therapeutic applications, and provides the potential for lower costs and broader access to healthcare. • Wearable medical devices – It helps in real time tracking of the
physical condition of a patient round the clock. Traditional wearable devices helps in tracking sweat, monitoring sleep, counting calories, measuring steps, or charting runs. Advanced waterproof wearable devices also helps tracking glucose levels of diabetic patient needing consistent care while allowing the subject to have a normal life. • Microfluidic drug delivery - Traditionally, the use of microfluidic devices has been confined to the laboratory, particularly been employed for drug discovery applications or DNA analysis. However, with the advent of more cost-effective manufacturing techniques, microfluidic devices are being increasingly used as portable diagnostic tools to test blood samples for such electrolytes as sodium and potassium and to create arrays for measuring hematocrit/ hemoglobin, blood gases, coagulation, drug screening, and cardiac markers. Portable microfluidic devices are at the forefront of pointof-care and in-the-field testing
applications that allow patients with chronic medical conditions to monitor themselves at home. • Neuroengineering - Neural engineering is an inherently new discipline that coalesces engineering, physics and neuroscience for the design and development of brain– computer interface systems, cognitive computers and neural prosthetics. This technology helps in advanced treatment in Braincontrolled spinal interface development and for the advancement of neural interface for assistance and augmentation. • Cognitive computing- Cognitive computing marks a new age in transforming healthcare by enabling to produce better trained and skilled doctors and scientists. Cognitive computing is a platform that not only retains and transmits information but actually learns on its own, being inspired by the human brain. • Big Data-Big data is also playing a crucial role in transforming healthcare by allowing quick data analysis on huge sets of data generated by daily monitoring of a patient. The ability to use big data to identify waste in the healthcare system can also lower the cost of healthcare across the board.
Focus on Emerging Markets Emerging market dynamics play a major role in the success of medical device manufacturers. The challenges are different in emerging economies where customers are both extremely price conscious and demanding. In this scenario, a growing number of companies realize that they must reinvent their traditional approaches to product development. Outsourcing is a key factor in designing for the emerging market, which will enable the organizations to focus on their innovative ways while the outsourcing partner can address the needs of the emerging market.
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Case Study
An advanced Patient
Monitoring System to Enhance Patient Care
Nikil Rao, Country Manager of Dräger India, tells Elets New Network about Infinity® Omega Plus patient monitoring systems, which not just brings patient care and patient information system closer but also helps to reduce workplace complexity and support building of efficient care processes Emerging technologies in patient monitoring segment The future of patient monitoring is clearly based on IT integration, data access and capture from across hospitals, and remote access from any point within the hospital or across the globe. The protocol based standardised charting solutions save on time and effort of the care giver, recording the information flawlessly for future access and meaningful interpretation for clinical as well as costs evaluations. Today’s technologies talk about information access at bedside bringing together vital signs, information from HIS/CIS, laboratory results, radiology images, etc., at acute point of-care to accelerate clinical decisionmaking, improve care delivery and facilitate consultation between clinicians. Patient monitors should be standardised, scalable and mobile across all care units, thus enabling flexibility in staff utilization and reducing training time. Scalability of patient monitors accommodate all acuity levels and patient types within and across departments, upgrades and expands
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with ease, supports the sharing of assets, helps build a tailored solution as the demands grow – smoothly and without redundancy. Standardisation, scalability and mobility also saves time preparing patients for transport and for their return, monitoring same parameters in transit as at the bedside, optimises staff and equipment utilisation. Thereby increases patient safety and productivity. Patient monitors should have device Integration to consolidate monitoring – and therapy information – for a better view of patient’s care state at a single point, providing a more complete view of decision-relevant patient data, supporting rapid treatment and generating more comprehensive chart-ready documents, automatically. They should be IT enabled and open a pathway between patient monitoring and hospital IT systems which delivers highest performance, builds on existing, non-proprietary hospital infrastructure , offers literally infinite connectivity through open architectural design, connects effortlessly across multiple sites and finally allows system growth through
a partnership between hospital IT department and medical equipment supplier’s professional services.
The success story of “Bristol Royal Infirmary” Quantifying the quality of care Healthcare costs a lot of money – and critical care is where a significant percentage is spent. That’s why healthcare managers are scrutinising that particular part of the business. As a result, hospital intensive care units are being pressured to provide evidence of the quality of care they offer. Today’s ICUs are under a financial microscope. According to Dr Tim Gould, a visionary Intensivist and Critical Care Consultant at the Bristol Royal Infirmary (BRI) in Bristol, England, “The government is starting to want to see value for money. Also, many intensive care organisations in different countries now have to come up with quality outcome measures that can be used to quantify how good an ICU is in terms of value. One measure is mortality, but the government also wants to see metrics regarding
Case Study
patient safety and quality of care.” Long realising the value of research, Dr Gould wanted to be able to look at certain patient groups to see if various steps the ICU was taking – or not taking – had an effect on outcomes. He also realised that it’s virtually impossible to do that kind of research on paper.
Moving away from paper In 2005, the BRI needed to replace outdated patient monitors in its General ICU. Dr Gould, who then was Clinical Director of General Intensive Care, wanted to add a clinical information system within that replacement cycle because he was interested in taking the first step in replacing paper-based charting. He also wanted to be able to automatically collect information for research from devices such as patient monitors, ventilators, lab and fluid management systems, as well as manually collected data on medication, intervention and assessments. The BRI asked Dräger to install Infinity Omega Plus patient monitoring systems in the 16-bed General ICU. The solution included an electronic charting system, the precursor of the Innovian clinical information system. Innovian replaced the ICU’s manual charting, which consisted of a big A3 paper chart at the foot of every bed – one per day, per patient. So if a patient had a four-week stay, for example, the records were spread across 28 individual charts. Using that data for research was virtually impossible. Now, Innovian automatically gathers data from bedside devices, including patient monitors and ventilators. “We’re documenting more data than ever before and we don’t have to worry about capturing that data. In addition, the system automatically calculates patient scores to evaluate the severity of illnesses,” says Dr Gould. Manual patient scoring is typically time consuming and very often is not done in clinical routine because it requires so much time.
“We’re documenting more data than ever before and we don’t have to worry about capturing that data. In addition, the system automatically calculates patient scores to evaluate the severity of illnesses,” says Dr Gould Comprehensive data capture In 2008, Dr Gould transitioned out of his position as Clinical Director of General Intensive Care to devote more of his time to research. He set up a critical care research group and is supported by three dedicated research nurses. The mission of Dr Gould’s group is to prove that the BRI ICU complies with certain factors that have been set up as benchmarks of quality – such as care bundles for pneumonia patients based on evidence that certain treatments benefit patients. “Although we do these things in our everyday practice, we still need to substantiate our observations with data. Innovian’s data capture is incredibly comprehensive and efficient. The database capability makes it very easy to generate reports describing our compliance with a particular treatment strategy. You can look at various groups of patients and see how well you do against national averages. It’s a good way of confirming that our strategies, treatments and processes deliver good quality results,” says Dr Gould. The BRI participates in audit activities for intensive care that take
place all over the UK – which measure quality, outcomes and cost effectiveness. Based on data over the last 16 years, the BRI consistently ranks in the top echelon of hospitals.
Configurability is key The BRI was able to use a patient data management system as a springboard for research because the platform can be configured. “The configurability of Innovian has allowed us to adapt the system to the specific needs of the unit – which is in essence why we went with the Dräger product over any else’s,” states Zoë Evans, RN, Clinical Information Systems Manager at the BRI, who was instrumental in configuring Innovian for the ICU. Evans was also responsible for transitioning the staff from a manual to an electronic workflow. “A lot of nurses had never used a computer at all, so that was the big challenge. Nurses want the traditional way of caring for patients at the bedside, but their role is becoming more and more technical. So we had to ensure we provided them with the right tools to facilitate that kind of change.” Now, nurses are learning that they actually have more time to care for their patients. Since data capture happens automatically, the nurses are now free to spend more time caring for patients. Innovian has allowed us to shift our focus and be more patient-centric. Evans also configured Innovian to combine documentation for admission and discharge, so for the first time in the hospital’s history, doctors and nurses are documenting on the same screen. “There was a lot of duplication between what the doctors and nurses were writing. Now that duplication is eliminated. Two years after going electronic, clinicians look at the system as a computer and not a paper chart. Now that our clinicians are using Innovian, I don’t think they would ever go back to paper,” further adds Evans.
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Case Study
Electronic prescribing helps increase patient safety Dr Gould and his team have configured Innovian to include parameters of the drugs typically prescribed for ICU patients. While Innovian was not designed to check drug interactions, Dr Gould states, “The fact that Innovian lists the drugs in a pull-down menu format where they are written correctly with the appropriate dosage has improved the quality of our prescribing – compared with it being my handwriting on a paper form.” Innovian is web-based, so the staff can access the system from anywhere in the hospital – and even beyond. “If you’re on call from home in the middle of the night and need to look at something that’s not quite right with a patient, you can have all the relevant information on hand to help with the decision making,” says Dr Gould. Innovian also makes archived data easily accessible to physicians. “During a morning ward round, I can look at an event that happened overnight. Or if a patient has outstanding problems, I can review the archives to see their medical history. Very comprehensive data is available to describe those kinds of episodes, so I can get a clear picture of what went on long after the event,” says Dr Gould. Another advantage this webbased solution provides is that very detailed information can go back to the pharmacy regarding the way the ICU is using drugs and the amount of drugs it is using, so reordering and stocking of drugs from day-to-day can be optimised. Because of this database capacity, the ICU can generate very detailed information about what it actually costs to treat a patient.
Learning from history Dr Gould believes that anyone who is running an intensive care unit has a responsibility to run as safe and as good a unit as possible. “Being able to look back at the activity in your unit using the database is very pow-
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erful because you have a very good description of what you’re doing on a day-to-day, week-to-week, month-tomonth basis with patients and their outcomes. You can target specific disease groups and look at those in detail,” he says. Essentially, what Dr Gould is trying to achieve is more standardised care for every patient. Dr Gloud continues, “By ensuring that you have standardised, best-practice care for every patient, you will improve the overall quality of outcomes for patients. If you use a clinical information system such as Innovian to its full potential, it can allow you to improve the quality of care that you deliver to your patients.” The dual-screen Infinity Omega solution combines an Infinity Delta vital signs monitor with a medicalgrade workstation that brings networked information – such as clinical applications, lab values and DICOM images – to the point-of-care. Innovian is a web-based clinical information system that can gather data from bedside devices in critical care and perioperative care environments “If you use a clinical information system such as Innovian to its full potential, it can allow you to improve the quality of care that you deliver to your patients.” Dr Tim Gould, Intensivist and Consultant, Bristol Royal Infirmary
“Since data capture happens automatically, the nurses are free to spend more time caring for patients. Innovian has allowed us to shift our focus and be more patient-centric.” Zoë Evans, RN, Clinical Information Systems Manager, Bristol Royal Infirmary
Infinity Omega Plus: Infinity Omega + Innovian
and documents care-related activities. This allows the ICU to compare patient status by analyzing vital signs and lab values together with patient care activities that physicians and nurses provide. The Challenge: Hospitals today are under an increasing pressure to quantify the care they deliver. The Solution: Implement the Innovian clinical information system in conjunction with Infinity Omega patient monitoring solution; configure IT solution as a springboard to create research that helps the ICU address quality, safety and costs.
The Results: • Generates the research data necessary to satisfy governmental requirements for quantifying the quality of care • Saves time spent on documentation, enabling clinicians to focus more on their patients • Provides quick and easy access to current and archived patient data, even remotely
Bristol Royal Infirmary With roots tracing back to 1735, the Bristol Royal Infirmary is a teaching hospital with close links to Bristol University. It is part of the University Hospitals Bristol NHS Foundation Trust, a dynamic and thriving group of hospitals in the heart of Bristol, England that also includes the Bristol Heart Institute (BHI). University Hospitals Bristol is a leading international centre for healthcare research and education and has a strong reputation for innovative research and development. The BRI provides acute medicine and surgery, critical care, trauma, orthopedic, and accident and emergency services to the population of the southern part of Bristol (approximately 2.3 million). It also provides the centre for cardio-thoracic services. Infinity and Innovian are registered trademarks of Dräger.
Government Desk
AYUSH Ministry seeks hike in Budgetary Allocation for 2015-16
Cashless Treatment in Private Hospitals
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he United States Food and Drug Administration (FDA) has approved EnteroMedic’s VBLOC vagal blocking therapy, delivered via the Maestro System, which is the first medical device approved for obesity treatment that targets the nerve pathway between the brain and the stomach. The device acts by sending an electrical pulse to block vagal nerve signals involved in controlling feelings of hunger and fullness. The Maestro System is approved for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 35 to 45 kg/m2 with one or more obesity-related health condition and who have failed to lose weight in a supervised weight management program within the past five years. “This is a novel device that interrupts signals from the stomach to the brain that are believed to be involved with stomach emptying and feelings of fullness,” said Martin Binks, PhD, FTOS, Secretary/Treasurer of The Obesity Society (TOS) and Associate Professor of Nutritional Sciences at Texas Tech University. “In clinical trials the device resulted in a clinically meaningful weight loss of 8.5 percent after one year and the FDA determined this was an appropriate risk-benefit profile to approve the device for clinical use.” The FDA has requested the company collect additional safety and efficacy over five years. “We’re encouraged that FDA is willing to continue to consider adding important and innovative new options to the treatment toolbox,” said Dr. Binks. “In addition to the five FDA-approved anti-obesity drugs now available, these novel treatment options can give additional choices to individuals with obesity who have found little success with diet and exercise alone. Medical devices can be part of comprehensive, individualized obesity treatment plan for some patients.” The Obesity Society is encouraged by the many recent actions FDA has undertaken to approve anti-obesity treatments and hopes to see continued positive momentum. “For the first time in history, we see a glimpse of the future for obesity treatment - the potential to treat the disease with a full spectrum of tools,” said Dr. Binks.
ccording to a press release, State government staff and above the poverty line (APL) families can get cashless treatment in private hospitals from January 20, 2015.
Chief Minister Siddaramaiah will launch the schemes and a mobile app that will show the rates fixed by various hospitals for semi-private and private wards, on this day. While government employees will get cashless treatment in 124 empanelled hospitals under the Jyothi Sanjeevini scheme without any cap, APL families will get subsidised treatment under Rajiv Arogya Bhagya (RAB) up to `1.5 lakh in 110 empanelled hospitals. “Under the RAB, there are differential rates for general, semi-private and private wards. While beneficiaries opting for treatment in general wards will get 70 percent reimbursement of the cost, those who choose semi-private and private wards will get reimbursements up to 50 percent”, said Health Minister U.T. Khader.
Himachal Pradesh to get three Medical Colleges
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ddressing a gathering at Patlandar village in Hamirpur district, Himachal Pradesh Chief Minister Virbhadra Singh said the state would open three medical colleges and one of them would be located in Hamirpur district. “The state government has decided to open three medical colleges and one of them would be opened in Hamirpur for which a provision of `190 crore has been made”, he added.
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Case Study
Remedinet Technologies
Technology partner for Tamil Nadu Government Health Insurance Scheme
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he economically weaker sections of the Indian society often find it difficult to afford quality healthcare. Indian population living below the poverty line does not have necessary financial means to avail quality healthcare services. According to various studies, India has abysmal record on health care spending and one of the world’s poorest populations. India is home to the largest number of poor with one-third of the world’s 1.2 billion extreme poor living here. With 4 percent of GDP expenditure on healthcare, India ranks among the bottom five countries with the lowest public health spending globally. With a view to provide affordable treatment to economically backward sections in Tamil Nadu, the Government of Tamil Nadu has introduced a scheme called the “Chief Minister’s Comprehensive Health Insurance Scheme”. Members of families whose collective annual income is less than Rs. 72,000 are eligible to avail benefits under this scheme. The scheme currently covers 1.32 crore families in Tamil Nadu, where beneficiaries can get cashless treatment across 800+ hospitals for a set of pre-defined medical conditions. Each member is issued a card by the government, which can be used to avail medical treatment at any of the participating hospitals. This scheme is entirely cashless, and the premium is paid by the Government of Tamil Nadu on behalf of the beneficiaries to the Insurance Company.
Client Brief To make this scheme a success, there was a need to address the following issues relating to the current claim settlement process: • Health insurance adjudication process involved a lot of paper exchange - starting with patients filing in forms at the time
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• •
•
•
of admission and ending with insurance companies and TPAs sending hard copy records of the amount settled at the time of discharge. Reams of paper were required for collecting relevant data which was then keyed into computers for maintaining records. Physical copies of the data collected were preserved in warehouses for reference. If there were any discrepancies or the patient had to go for an interim enhancement, the entire cycle of physical data collection to tying it and storing it electronically was repeated. Inaccuracies on the part of data operator in keying the data on the system resulted in rejection of the claims or duplication of the entire process. The back and forth transmission of information, through emails, faxes and courier of physical copies, elongated the duration of the claim settlement cycle substantially.
To make the process accurate, hassle free and paperless for its intended beneficiaries, a strong technology support was required for transferring the entire process of claim settlement from offline to online. With a view to manage the entire process of capturing and transmitting data in the claim settlement process electronically, the government roped in Remedinet Technologies as their partner for providing software solutions and the relevant IT infrastructure support.
Impact Remedinet Technologies provided end-to-end technology support for making this scheme paperless. Their solutions made the data gathering exercise structured and accurate. The ways in which Remedinet solutions
Case Study
have enhanced the overall efficiency in the administration of this scheme are mentioned below: • As all patient records were maintained electronically, the time involved in the claim settlement process was reduced drastically. Remedinet made it possible to close up to 400,000 claims per year from 2012 by improving the claim settlement turnaround time. • The time spent in feeding the data and then taking a print out for processing the request was curtailed by half. • Accuracies in maintaining records improved exponentially as the manual process of filling forms was done away with. • A transparent dashboard showed all relevant details for monitoring the claim settlement process. • Real time monitoring of claims made it possible for hospitals, TPAs and insurance company to expedite the settlement process by identifying the stage at which the process was held. • Automation of various caps for different medical conditions made it simpler to process the requests. • Need for warehouses to store the physical copies of the records done away with. • Complete disaster recovery mechanism to make all the records accessible with minimum downtime. • Maintaining almost 1 Terabyte of data every month for the scheme thereby saving tones of papers which would otherwise be
Assured delivery of all crucial information to various participants in the claim settlement process used for storing data. • The gigantic volume of transactions being managed with a response time of less than five seconds. • Assured delivery of all crucial information to various participants in the claim settlement process. • Faster claim settlement process resulted in minimizing the waiting time for patients. • Patients could access their hospital records through a simple and easy to use member portal. • Archive of treatment history made it possible for patients to refer this information for further treatment without actually furnishing the report copies. Remedinet solutions have been the technology backbone for this scheme. To make the government healthcare schemes beneficial for the target group, it is imperative to embrace latest technology. With the central government planning to introduce universal healthcare scheme, Remedinet solutions can go a long way in ensuring the success of such initiatives.
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Hospital News
Apollo Hospitals to Invest `1,500 Crore
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pollo Hospitals Enterprises Limited (AHEL) plans to add another 2,000 beds over the next two financial years, at a cost of around `1,500 crore. Prathap C Reddy, Founder and Executive Chairman, informs that AHEL would be also be adding another 1,000 beds by the end of the current financial year. AHEL is considering the private equity (PE) route to raise money for the expansion. However, the management did not clarify whether it would be AHEL or the holding company which would be raising the money. “The firm’s plans on fund-raising are yet to be finalised,” adds Reddy. As of September 2014, the company has 54 hospitals with 9,091 beds. It also runs one of the largest pharmacy retail chains (1,717 stores). In the past, the company has attracted some of the major PE investors including Malaysian wealth fund Khazanah, which currently holds 10.85 per cent share in the hospital chain.
CDC invests US$ 48 million in Narayana Health
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K’s CDC has invested US$ 48 million in Narayana Hrudayalaya Hospital chains in India. The hospital will use the funds to expand affordable treatment in Eastern, Central and Western regions of the country. In return of its investment, CDC will receive a small minority stake in Narayana Hrudayalaya Hospital chains. “Our long-term capital and strategic support can help Narayana Health Hospital chains build on the success that it has had in using innovation. It will also boost the hospital’s world-class healthcare standards and eventually benefit patients from lower and middle income group,” said Srini Nagarajan, CDC’s Head, South Asia. “We want to transform the way
healthcare is delivered across the world. To achieve our goal, we have partnered with CDC since they are also interested in long-term societal transformation,” said Dr Shetty, Founder, Narayana Health. MISC noted that it has placed their medical equipment and supplies on the government’s electronic ordering system GSA Advantage, as a GSA Schedule 65 IIA contract holder. The firm is authorized to supply products such as IV Pumps, oxygen concentrators, pulse oximeters, urinary catheters, disposable or reusable hospital clothing and many other products to governmental agencies.
Tata Steel to Fund an Eye Care Hospital in Odisha
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ata Steel will fund about `42 crore to set up a 100-bed super specialty eye care hospital at Samarjhola village in Ganjam district, Odisha. An agreement to this effect was signed between the company and Sankara Eye Hospital, which states that Tata Steel will extend financial assistance of up to `42.3 crore for required infrastructure and construction of the proposed hospital to be built over 4.5 acre of land. The healthcare unit is expected to become operational by early 2016. Comprehensive eye care, investigations and outpatient treatment, low vision clinic, contact lens clinic, special clinic for children, daycare options, micro-phaco
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cataract surgeries for spectacle-free vision and glaucoma services are some of the facilities to be available at the hospital. “The company would continue to assist
and supplement the efforts of the State Government to upgrade and improve the healthcare infrastructure in Odisha,” said Arun Misra, Vice President, Tata Steel.
Hospital News
Moga Civil Hospital to be Made 130-bed Facility
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unjab Health Minister Surjit Kumar Jyani and Punjab Agriculture Minister Tota Singh jointly laid the foundation stone of the new building of the maternity ward at Dr Mathura Dass Pahwa civil hospital. Earlier, both ministers laid two foundation stones of the new buildings of primary health centres at Dharamkot and Kot-Ise-Khan towns also. Addressing the gathering at Moga hospital, Jyani said that the Punjab government has also decided to upgrade the Moga hospital from 100 to 130 beds and this process will be completed by next month. “All buildings of the Moga, Dharamkot and Kot-Ise-Khan hospitals will be completed in the next four months and the government has granted `9.40 crore for completing these projects. The new office for senior medical officer and chief medical officer and new toilets will built in all wards of the hospital,” said the minister. The minister also directed the doctors to prescribe only generic
medicines available in the hospitals and, if a medicine is not available in the hospital, they should prescribe only salt names. Jyani promised to the people of all medical facilities and said that medicines are available at the moment in all hospitals across the state. He directed the health officials that the drive against adulteration should be continued across the state.
Wockhardt Hospitals opens first Cardiac Clinic in Bardoli
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community based service for cardiac patients has been launched in Bardoli by Wockhardt Hospitals. According to the hospital, the one-stop service for new patients with heart problems uses the very latest cardiology equipment to assess and diagnose in an efficient and effective way, helping to cut down on waiting times to see a specialist. The hospital it will bring in expert cardiologists into the town every Thursday and on second and fourth Sundays between 12pm and 2pm. “This new service allows us to bring expert lifesaving cardiac care directly into the communities in and around Bardoli for the first time. Along with expert care, we are also cutting down on the amount of travelling for our patients,” said Dr Kalpesh Malik, cardiologist at Wockhardt Hospitals.
Narayana Health acquires Howrah’s Westbank Hospital
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arayana Health has acquired Westbank Hospital in Howrah, West Bengal, for `150 crore. This is the second acquisition by Narayana Health Group in West Bengal this year after it acquired Jubilant’s hospital business in Barasat & Berhampore in March. The acquisition of Westbank Hospital includes the management of the 150 bed Westbank Hospital Unit-I and 240 bed Westbank Hospital Unit-II, in Howrah. Post this, Narayana Health will offer comprehensive cancer care facilities at Westbank, in addi-
tion to the upgrade of the other tertiary care specialties there. Bangalore-based Narayana Health, which operates a chain of multispecialty and super-
specialty hospitals in the country, started with a 300 bed hospital in 2001. It had already been managing the Cardiac Centre at Westbank Unit-II since 2012. With this addition, the Narayana Health network has grown to 29 hospitals across 17 cities in India with a combined bed strength of around 7,500. “In addition to retaining the current employee strength of close to 700, we will strategically strengthen it further,” said Ashutosh Raghuvanshi, vice-chairman, MD & Group CEO, Narayana Health.
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International News
FDA approves Roche’s Blood Screening Assay
Bertech to sell Lung Cancer Test
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oche has received approval from the US Food and Drug Administration (FDA) for its cobas TaqScreen MPX Test, v2.0 for simultaneous detection and identification of HIV, HCV, and HBV in donations of human whole blood and blood components, including source plasma. The test is a qualitative in vitro test to detect Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma. “Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale. By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment,” said Roland Diggelmann, COO, Roche Diagnostics. The test has been developed for use in the screening donations of human whole blood and blood components in pools of six samples and source plasma donations in pools of up to96 samples. Through using multi-dye PCR technology, the test simultaneously detects and separates individual specimens for HIV, HCV and HBV. The test works on the fully automated cobas s 201 system that allows signal detection in four separate channels, facilitating simultaneous monitoring of three viral targets and a full-process internal control. The menu of the cobas s 201 system includes tests for West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV), in addition to HIV, HCV and HBV. The cobas TaqScreen MPX Test, v2.0, along with CE mark, has also obtained approvals in Canada, Brazil, China and India.
MISC received US$ 2 Million Contract
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edical Equipment Solutions (MISC) has received a US Naval supply contract, valued at US$ 2 million. As part of the deal, the company will supply mobile imaging services for Department of Defense (US Navy), for a period of five years. “This contract continues to validate our decision to operate as Certified Woman Owned Small Business, (WOSB 8-A) and encourages us to continue to grow and support governmental operations throughout the world. We can service well beyond the federal level
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lobal Cancer Diagnostics Inc. has announced the signing of a license agreement with Bertech Diagnostics of Edmonton, Alberta. This agreement enables Bertech to sell The Lung Cancer Test in Canada. With this partnership, The Lung Cancer Test will continue its rapid expansion for use by current and former smokers. The Lung Cancer Test was introduced to the US marketplace in late 2014. The Lung Cancer Test is recommended for annual screening for lung cancer in current and former smokers. The test has been clinically proven to detect lung cancer in its early stages. With early detection comes early treatment and higher survival rates. Bertech is addressing the need for patient-friendly, accurate and inexpensive diagnostic tests in Canada. They are located in Edmonton, Canada and will utilize partnerships with laboratories throughout Canada to provide the test. All required clinical and validation studies have been completed with excellent results. The test detects the presence of the required biomarkers that are proven effective in the early detection of lung cancer. The test is now available in all US states. The Lung Cancer Test is intended for use in the highrisk patient population, which includes current and former smokers over the age of 50. Global Cancer Diagnostics announced that The Lung Cancer Test was available for purchase beginning late last year.
to numerous state and municipal governments throughout the country as they will be able to secure quality medical equipment and supplies from a vetted government contractor while being assured of receiving the same level of service and quality,” said Maria Sandra Pineda, President and CEO, Medical Equipment Solutions. MISC noted that it has placed their medical equipment and supplies on the government’s electronic ordering system GSA Advantage, as a GSA Schedule 65 IIA contract holder. The firm is authorized to supply products such as IV Pumps, oxygen concentrators, pulse oximeters, urinary catheters, disposable or reusable hospital clothing and many other products to governmental agencies.
International News
FDA approves First Medical Device for Obesity Treatment
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he United States Food and Drug Administration (FDA) has approved EnteroMedic’s VBLOC vagal blocking therapy, delivered via the Maestro System, which is the first medical device approved for obesity treatment that targets the nerve pathway between the brain and the stomach. The device acts by sending an electrical pulse to block vagal nerve signals involved in controlling feelings of hunger and fullness. The Maestro System is approved for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 35 to 45 kg/m2 with one or more obesity-related health condition and who have failed to lose weight in a supervised weight management program within the past five years. “This is a novel device that interrupts signals from the stomach to the brain that are believed to be involved with stomach emptying and feelings of fullness,” said Martin Binks, PhD, FTOS, Secretary/Treasurer of The Obesity Society (TOS) and Associate Professor of Nutritional Sciences at Texas Tech University. “In clinical trials the device resulted in a clinically meaningful weight loss of 8.5 percent after one year and the FDA determined this was an appropriate risk-benefit profile to approve the device for clinical use.”
The FDA has requested the company collect additional safety and efficacy over five years. “We’re encouraged that FDA is willing to continue to consider adding important and innovative new options to the treatment toolbox,” said Dr. Binks. “In addition to the five FDA-approved anti-obesity drugs now available, these novel treatment options can give additional choices to individuals with obesity who have found little success with diet and exercise alone. Medical devices can be part of comprehensive, individualized obesity treatment plan for some patients.” The Obesity Society is encouraged by the many recent actions FDA has undertaken to approve anti-obesity treatments and hopes to see continued positive momentum. “For the first time in history, we see a glimpse of the future for obesity treatment - the potential to treat the disease with a full spectrum of tools,” said Dr. Binks.
Ostar introduces Cellular Telehealth BP Monitoring System
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S-based telehealth solutions company Ostar Healthcare Technology has introduced its cellular telehealth blood pressure monitoring system. Launched in North American market, Ostar Cellular P201 Remote TeleHealth Blood Pressure Gateway System will help in reduction of 30 day readmission rates for heart patients, specifically Congestive Heart Failure (CHF). Ostar Healthcare Technology CEO Doug Hemenway said: “This North American launch of Ostar Cellular P201 brings forth another market first, a unique cell enabled health device with a combined data gateway approach. “All Ostar products reinforce Ostar’s commitment to advanced remote monitoring, reducing 30 Day Readmission Rates, in line with (CMS) edicts, improving patient outcomes, avoiding unnecessary costs, as required by Accountable Care
Act (PPACA).” The monitoring system includes cellular device with combined mHealth Personal Dashboard app, which transmits relevant data to population health management systems, wellness platforms, EMR’s and HIE’s across the globe. Ostar noted that the P201 Remote Cellular TeleHealth Blood Pressure Gateway System is the first Cellular P Series to be released. Ostar Healthcare Technology COO Paul Markham said: “Given the current transformation of healthcare in the US, this simple cellular enabled, insurance card enabled, remote teleHealth solution, has the potential to positively impact advanced chronic disease management outcomes.”
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National News
Trivitron Healthcare and IMD signs a Joint Venture
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he Trivitron Healthcare has announced a joint venture with the IMD group, Italy. A MoU was signed for the joint venture in the name of Kiran IMD X Ray Private Ltd, to design/develop and manufacture a variety of X-ray equipment and accessories based out of its facilities in Chennai and Mumbai in India, and Bergamo in Italy. Trivitron healthcare holds 60 percent share while IMD group holds 40 percent share in the joint venture. The collaboration aims to reach `100 crore revenue within three years of its operations with X-ray monobloc, X-ray generators, high-frequency X-ray machines, mobile and full room DR, digital OPG and mobile cathlab manufacturing in India. Dr GSK Velu, Founder and Managing Director of Trivitron Group of companies said, “The venture is in line with Trivitron’s philosophy of making state-of-the-art technology accessible and affordable, to the larger section of population.” Aliberti, the CEO of IMD Group of Companies expressed, “Bringing Trivitron and IMD’s expertise and network together will ensure more comprehensive product offerings in the most cost-effective basis.” The joint venture between Kiran and IMD ensures these high technology products will now be manufactured in India, therefore making those accessible and affordable to a larger section of population with special emphasis to emerging markets like South and South East Asia, Middle East and Africa, Eastern Europe and Latin America. Apart from manufacturing products like high-end C-arm, DR, high-frequency X-ray machines, mobile cathlab and digital OPG etc., the venture will also produce monoblocs/generators to be supplied to other X-ray manufacturers across the world using Kiran’s global network. MISC noted that it has placed their medical equipment and supplies on the government’s electronic ordering system GSA Advantage, as a GSA Schedule 65 IIA contract holder. The firm is authorized to supply products such as IV Pumps, oxygen concentrators, pulse oximeters, urinary catheters, disposable or reusable hospital clothing and many other products to governmental agencies.
Cura Healthcare ties up with Oxford Instruments
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URA has announced partnership with Oxford Instruments Healthcare, part of the service division of Oxford Instruments Plc, UK. The company plans to enter tier II and III markets with high-end MRI imaging equipment. It plans to make India a hub for spare parts and accessories for emerging markets and will provide affordable service support and spare parts support that will make product life cycle cost viable for a long term. The partnership is expected to augment Cura’s plans to reach a turnover of `500 crore in three years, a company release stated.
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Medtronic completes acquisition of Covidien
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edtronic plc has successfully completed the previously announced acquisition of Covidien plc. Under the terms of the acquisition agreement, Medtronic and Covidien are now combined under Medtronic. Shares of Medtronic are expected to begin trading on the New York Stock Exchange (NYSE) under the symbol “MDT”. “The culmination of this acquisition marks a significant milestone in our industry. We can now bring together the extensive and innovative capabilities of both Medtronic and Covidien with an underlying objective to solve healthcare’s biggest challenge – expanding access and improving clinical outcomes, while lowering costs,” said Omar Ishrak, Chairman and CEO, Medtronic. He further adds, “This is an exciting day for our employees as we officially join forces to pursue our shared commitment to addressing universal healthcare needs and accelerating Medtronic’s three fundamental strategies of therapy innovation, globalisation and economic value.” Medtronic has its principal executive offices in Ireland, where both the companies have a longstanding presence. The company’s operational headquarters will continue to be based in Minneapolis. Medtronic has a comprehensive product portfolio, a diversified growth profile and broad geographic reach, with more than 85,000 employees in more than 160 countries.
Product Showcase
Critical Care Ventilator for Infants, Children and Adults
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8800 is a critical care ventilator for infants, children and adults. It has comprehensive functionality, a user-friendly design, and is full of high-quality, reliable treatment options for the clinician makes it a state of art & up to date ventilator. In addition to conventional ventilation modes, V8800 also offers BIVENT and PRVC, automatic tube compensation, NIV ventilation, synchronized nebuIizer, inspiratory and expiratory hold, manual inspiration and smart suction are all standard features. With 15�TFT LCD touch screen and a simple intuitive interface, the user can easily set up the ventilation parameters. Screen can be rotated 180 degrees and adjusted UP/DOWN for enhanced view with comfort. V8800 display waveforms and loops, and with a waveform freeze function cursor can be used to measure waveform values. Loop references can be saved. Lungmaneuvers allow determination of LIP and UIP with volume delivered at P1 and P2. Graphic trend of monitored parameters and optional EtCO2 monitoring provide clinicians with complete information. Using the side rails on the machine, the user can add-on modules as needed, such as a humidifier or carbon dioxide monitoring module. Easily removable and autoclavable exhalation valve module to keep,
maintenance costs low built-in battery eliminates the need to worry about power interruptions. An optional internal battery is also available, and an intelligent alarm system reinforces safe use of the machine. The compressor is quiet and medical grade with facility to go to stand by in presence of high pressure inlet air source and activates automatically when inlet drops are not available. The trolley is very sturdy and offers integrated two outlets for connection of humidifier and nebuliser. V8800 has passed all highest quality standards as such and is just not limited to US FDA, CE & IEC standards. For any further enquiry, you may contact us at:
Devdutt Bhatia Founder & CEO Rohanika Electronics & Medical Systems 103 FF, Pocket L Market, SaritaVihar, New Delhi – 110076 Tel: +91-11-2694 7874 / +91-11-9212791770 Fax: + 91-11-2694 3129
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th 4 4th Annual Annual
March March 11, 11, 2015, 2015, Hotel Hotel Royal Royal Plaza, Plaza, New New Delhi Delhi
CONFERENCE CONFERENCE AWARDS AWARDS EXPO EXPO
Product Launch
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hrough thirty five years of its existence, Transasia Bio-Medicals Ltd. has led the Indian In-vitro Diagnostic Industry, in offering quality products and services. With an aim to provide innovations that aid in timely and accurate diagnosis, Transasia regularly introduces innovative and most advanced technology based on the requirements of the customers. The last few years, have seen a rampant growth in the Indian preventive and curative healthcare industry. There are an estimated 50,000 clinical labs in cities, towns, district, villages and remote areas, which gives an indication of the huge patient base and the need to provide quality, dependable and timely diagnostic services. Among others, the most common coagulation tests performed include PT, aPTT and D Dimer. The customer requirement is neatly classified into small, medium clinical labs and (component separation) blood banks. While in some labs, there is a need to perform PT, aPTT, fibrinogen and D Dimer, others such as blood banks routinely perform fibrinogen and Factor VIII. A set of customers specialized in coagulopathy, do perform certain rare parameters. However, not all systems in the market are equipped to cater to these requirements. Additionally, not having small reagent pack sizes for D Dimer and unavailability of timely service in remote areas are issues that need immediate attention. In a step towards resolution of critical issues mentioned above and cater to diverse but pertinent customer needs, Transasia recently launched two advanced coagulation analysers, ECL 105 – Single Channel and ECL 412 – Four Channel. Both these analysers use an innovative technology thereby giving most accurate/precise results at extremely affordable costs. Key features of both the instruments include:
Hardware • Easy-to-operate LCD touch screen graphical display • Built-in incubator for cuvette • Facility for reagent incubation through magnetic stirring of reagents. Especially beneficial for mixing silica or latex based reagents as they require constant stirring to keep the particulate matter suspended in solution • Inbuilt robust thermal printer • Easy connectivity through USB ports, Ethernet ports and RFID detection facility • Storage of data and coagulation clotting curves is
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ECL 105/412: The Latest Revolution in Coagulation Analyzers possible on an external drive • Test menu includes comprehensive range of tests from clotting to chromogenic* and immunologic tests (*only onECL 412) • Light scattering principle is used for performing the assays- Clotting (640 nm), Chromogenic (405 nm) and D Dimer (800 nm)
Software • Intuitive, user-friendly, with minimal simple logical inputs in programming tests, multi-standard calibration, plotting multilevel QC points and running tests • Proven technology of coagulation curve in percentage light scatter for clot detection The ERBA ECL 105/ 412 performs the most comprehensive coagulation tests in semi-automated systems. The tests such as Fibrinogen, Factors assays, Lupus anticoagulant, Protein C , Protein S, AT III* and D Dimer are programmed and can be performed with minimum effort (*only on ECL 412) The QC plotting has been programmed keeping in mind the accreditation requirement of laboratory. Multilevel QC for each test is possible, a feature still rare in many single and four channel analysers. With all its advanced features, ERBA ECL 105/ 412 is equipped to perform complete range of hemostasis tests and give its end-users the freedom to choose the test of their choice.
KNOWLEDGE
EXCHANGE, GOA Higher Education