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Medical Devices & Equipment | Healthcare | Pharmaceutical Journal Vol.6 No.3 |May-June 2014 | Annual Subscription: Rs.500

Managing Editor Sarvjit

Associate Editor & Public Relations Director Reny

Joint Editors

Vishwapreet Amrita

Production Rakesh

Marketing & Communications Lovleen

Web Editor

Ravindar

Circulation Surekha

Secretary & Legal Advisor Surinder

China Correspondents Ying Wei / Adrian Liu

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STARLED3 NX - Surgical led lamp

8 EKF’s New Lactate Scout+ Analyzer

Editorial Advisory Board

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Alex & Lilly - Netherlands

14 Women are born leaders

alex@vanbienen.net

New Dates for Medica

Andy McCourt - Australia

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Ameera Shah bags ‘World Women Leadership Award’

UK Representative

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Sami Direct Rolls out Vita essentials

Mike Steele, MJ Marketing

20 Heart Rate Monitor watches from Timex

20, Spencer Bridge Road Northampton NN5 5EZ Tel: +44-1604 756 100 Fax: +44-1604-750 910 For advertising, subscribing or to submit a press release, write to : D-182, PR House, Anand Vihar, New Delhi - India. Tel : +91 11 22141542 / 4309 4482 Fax: +91 11 22160635 Email: info@medicaldeviceasia.in Published, Printed and owned by: World-Wide Publications, D-182, PR House, Anand Vihar, New Delhi-110092, India and printed at Technical Press Inc.

26 MEDICA EDUCATION CONFERENCE 2014 30 A supercomputer could change how diseases are treated 32 Broad Range of Products wins the impression at 1st Personalised Medicine & Diagnostics Expo (IVD Japan) 34

India’s ‘statement of intent’ with US FDA

37 Electrophysiology Technology 39 Radiology and Technology 40 Growth of the Medical Tourism Industry

D-182, PR House, Anand Vihar, New Delhi 110092 - India.

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The publisher does not necessarily agree with the views expressed by the

49 World’s smallest, leadless heart pacemaker implanted

contributors, in this issue, nor do accept any responsibility for any errors or interpretation in the publication.

Next Generation Student Microscopes

51 New Innovative Medical Devices 2014 52 Top Medical Technology Innovations

Medical Devices Market in India 2014

Medical devices market in India 2014 captures the technologically driven aspect currently prevailing within the Indian healthcare sector. The booming Indian economy is also witnessing a tremendous surge in the domestic healthcare scenario which, in turn, is leading to perpetual demand for high quality medical products. The demand for high-end, quality devices is especially driven by the private healthcare sector in its efforts to provide sophisticated treatment to patients. However, India lags behind in manufacture of technologically advanced high-end medical equipment, and instead has to rely

upon imports from multinationals with extensive service networks. On the other hand, the market for less cost intensive medical supplies and disposable equipment is dominated by domestic manufacturers. Due to the industry’s dependence on imports, multinationals are showing interest in relocation of manufacturing facilities to India as well as in forging alliances with healthcare sector stakeholders in order to capture greater market share. This brings into focus a key role played by the government that involves taxation and import regulations. The government also takes up several initiatives for the benefit of the market. After a few months of legislative limbo, the Indian government made major moves toward approving

critical changes to laws governing its medical devices. In a regulatory push, the country’s health ministry agreed to examine recommendations of the standing committee on a new amendments bill. The committee’s recommendations were tabled in December 2013, but are now under consideration by the country’s Union Cabinet. The Drugs and Cosmetics Amendment Bill, proposed in 2013, would revolutionize the laws governing medical devices. Under current law--which was passed in 2007--medical devices and equipment are treated as drugs. The new bill would provide separate standards and regulations for medical devices, and cover everything from clinical trials to imports and exports.

Medical Device ASIA | May-June 2014 | 3


Asia’s leading and most influential medical and healthcare exhibition is back!

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ontinuing its proud tradition of show-on-show growth, MEDICAL FAIR ASIA 2014 expands across two exhibition levels as more exhibitors sign up to showcase their latest products and offerings on what is truly a global platform for the medical industry.

Why visit MEDICAL FAIR ASIA 2014? Strong support in the international arena see a host of new and returning nations join a stellar line-up of country pavilions which include Austria, Canada, China, France, Germany, Hungary, Japan, Korea, Malaysia, Netherlands, Singapore, Taiwan, Thailand, UK and USA as they introduce the latest healthcare devices and innovations at MEDICAL FAIR ASIA 2014. At MEDICAL FAIR ASIA 2014, visitors can meet with… • • •

More than 600 exhibitors from over 30 countries 15 national pavilions from across the globe Over 10,000 trade visitors and industry professionals

MEDICAL FAIR ASIA 2014 is THE trade exhibition for you if you are a… • Biologist, Biochemist, Technician • Care Service and Selfhelp Group • Dispensing Chemist, Pharmacist •Health Ministry Official • Hospital Administrator / Executive • Hospital Planner / Turnkey Contractor • Hospital / Polyclinic / Medical Centre • Hospital Technician • Medical Equipment Producer 4 | May-June 2014 | Medical Device ASIA

• Manufacturer • Medical Procurement Agency • Medical Practitioner / Nursing Staff • Medical Trainer / Teaching Staff • Mobile Health Service Provider • Organization for the Disabled • Physiotherapist • Rehabilitation Organization / Nursing Home • Trader / Importer / Wholesaler What can visitors expect to see at MEDICAL FAIR ASIA 2014? • Accident and Emergency Equipment •Building Technology and Services • Catering and Kitchen Equipment • Communication and Information Technology • Dental Equipment and Supplies • Diagnostics• Disinfection and Disposal Systems • Electromedical Equipment • Medical Technology • Fabrics / Laundry • Laboratory Equipment • Medical Furniture and Equipment • Medical Consumables • Ophthalmic Supplies • Pharmaceutical Supplies • Rehabilitation Equipment • Orthopaedic Supplies • Services and Publications

A look back at MEDICAL FAIR ASIA 2012 - A Resounding Success! In 2012, MEDICAL FAIR ASIA played host to 530 exhibitors and welcomed over 8,800 trade visitors from 67 countries, reaffirming its position as the industry’s defining trade fair for Asia and the region. •

98% of visitors found the quality of exhibiting companies to their expectation 94% of visitors felt the range of products and services on offer met their expectations 92% of visitors found the show of importance to their work

For more information on MEDICAL FAIR ASIA 2014, please contact: Katryne Chua (Exhibition Services): Messe Düsseldorf ASIA Tel: (65) 6332 9620 E-mail: katryne@mda.com.sg


STARLED3 NX - Surgical led lamp

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tarled3 NX is a lamp manufactured by ACEM based on the next generation LED technology, assuring cold light, long life and low energy consumption. The lamp is suitable for countless applications both for surgery and operating room. It is ideal for diagnosis, dental sector, gynaecology, dermatology, general medicine and surgery. Starled3 NX grants a homogeneous and shadowless light thanks to its special LED optics created by ACEM Medical Company that directs light beams at best according to the needs. The visual area is perfectly illuminated assuring both excellent visual comfort and working conditions. Its next generation LEDs produce an unparalleled quality of light with a colour temperature (CCT) of 4.500 °K and a colour rendering index (CRI) of 95. STARLED3 NX has a light intensity of 130.000 lux with a low energy consumption of 69W. The life cycle of its LEDs is about 50.000 hours. STARLED3 NX is composed by three reflectors that produce a well-blended and intense cone of light focusable through the automatic adjustment

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of the light spot diameter. Its slim, practical and compact design makes it perfect for several uses. The lamp is ergonomic, easy to move and to position and suitable for the laminar flows of the operating room. Its ENDO function (light for endoscopy) gives the possibility to use STARLED3 NX for minimal-invasive surgery too. The easy -to-clean shape and material of STARLED3 NX as well as its removable, sterilizable and easy-to-grip handle assure an excellent cleanliness. Functions are adjusted by its innovative easy-to-read, ergonomic and easy-to-clean I-SENSE® control panel. With a simple touch it can manage easily and accurately: • ON/OFF • Light intensity adjustment • DoF - Depth of field - for a deep light • ENDO - Light for endoscopy ideal

for minimal-invasive surgery • SIZE - Light spot diameter adjustment to focus the operating area • SYNC - Function (optional) useful to synchronize controls of the combined lamps: STARLED3 NX double (twin dome configuration) and STARLED3 NX together with STARLED5 NX or STARLED7 NX. STARLED3 NX is available in the following versions: Ceiling mounted (Single, double configuration or together with other STARLED NX lamps) , Wall mounted , Trolley mounted (Battery on demand). ACEM SpA Medical Company Division Via della Tecnica 29 - 40050 Argelato, Bologna – ITALY Ph +39 051 721844 Fax +39 051 721855 info@acem.it www.acem.it


EKF’s New Lactate Scout+ Analyzer Delivers Cutting-Edge Benefits in Sports Science EKF has launched a specific product resource website (www.lactatescout.com) housing numerous guides and scientific papers on lactate testing.

EKF’s Lactate Scout+ with hematocrit compensation for highly accurate lactate testing

Uptake of the new handheld Lactate Scout+ device is particularly notable within the sports science market. Testing of lactate is an established parameter for athletic performance diagnostics which confirm optimal individual training regimes and avoid critical overexhaustion. Uniquely, the new Lactate Scout+ analyzer takes the hematocrit (Hct) variations of professional athletes into account to ensure extremely accurate lactate results, even at high or low Hct levels. Other innovative built-in features of the Lactate Scout+ make it an ideal and highly advanced tool for athletic performance assessment. These include an integrated ‘Step Test’ function and Bluetooth™ connectivity, as well as a stop-watch and countdown timer. In addition, Lactate Scout+ Data Link software is available to download free of charge. Data Link makes the transfer of data, from the device to a PC via the integrated Bluetooth interface, a simple task.

“Lactate testing with hematocrit compensation ideal for sports medical health checks”

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ollowing the recent launch of its new Lactate Scout+ analyzer incorporating hematocrit compensation, EKF Diagnostics, the global diagnostics business, is seeing an increasing interest from a broad range of users in both sports and medical science. Consequently,

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Lactate Scout+ is smaller than a cell phone and easy-to-use ‘in the field’ as a training companion for individuals or sports teams. "Lactate Scout delivers quick and accurate lactate measurements during training. This means, I can react immediately, controlling and improving the individual training of sportsmen. Because it is compact, we can take the device with us to all training camps and competitions," said Jirka

Letzin, A-License Swimming Coach, based in Leipzig (Germany). Based on many years of sports medical science, lactate testing has also recently been adopted for use in cardio-fitness and weightreduction programs. F or example, German health insurance providers have started to reimburse sports medical performance and health checks, including lactate tests, before starting to exercise. This is especially recommended for individuals with obesity, Type-2 Diabetes or other chronic diseases. “These checks can not only clarify if a chronically ill patient is able to perform therapeutic exercise, but at the same time determine the appropriate exercise intensities to enable optimal training,” states the German Society of sports medicine and prevention.1 The benefits of rapid and easy lactate testing with hematocrit compensation in both sports and medical science are generating a great deal of interest in Lactate Scout+. “Since its launch in January 2014, the new version of our Lactate Scout+ has generated a significant increase in enquiries from end-users - up 380% compared to the same period in 2013. I believe that this reflects increased awareness of the different applications for lactate, some of which we detail in our new lactate resource website www.lactatescout.com,” commented Katja Lemburg, Product Manager, EKF Diagnostics.


From 2015 on, MEDICA and COMPAMED with new dates from Monday to Thursday

Evenly filled and travel benefits to boot Over the entire duration of the event, a continuously high level of response from the participants can be expected. This makes it easier to plan themes and coordinate with our partners what subject matter is to be focused on.” This year’s MEDICA, World Forum for Medicine, is going to take place from 12 to 15 November 2014 in Düsseldorf. The COMPAMED, High Tech Solutions for Medical Technology, is taking place from 12 to 14 November 2014.

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he world’s largest medical trade fair, MEDICA, and the leading international trade fair for suppliers of the medical technology industry, the COMPAMED, are always going to take place in November on the days running from Monday to Thursday from 2015 on and all days of the event are going to take place parallel to each other in Düsseldorf. This was decided on by the MEDICA Advisory Board according to recommendations made by a working group comprising participants from leading industry associations, exhibitors and Messe Düsseldorf. “In light of the analysis of the market research results on the visitor structure and the number of visitors on days up until this point, the decision is consistent with, and equally oriented to the needs of the exhibitors and the visitors,” explained Joachim Schäfer, managing director of the Messe

Düsseldorf GmbH. He added: “The portion of international visitors and decision-makers, including those from the commercial sector, has continuously risen in recent years with an ever-increasing preference for the days Wednesday and Thursday for the event to take place being away from the weekend.” Joachim Schäfer also mentioned that the concentration of the “normal” working days of the week, Monday to Thursday (instead of Wednesday to Saturday as it has been up until this point), would make it possible in the future for the trade fair halls to be evenly filled on all days, which would incidentally have a positive effect on the hotel booking and traffic situation in and around Düsseldorf. Horst Giesen, Director MEDICA + COMPAMED, cited an additional benefit: “Rescheduling the days of the event is of benefit to the numerous specialist forums integrated into the MEDICA and the accompanying conferences.

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Key programme components include the international MEDICA EDUCATION CONFERENCE, designed by the German Society for Inner Medicine (DGIM) as a medical training event with regard to subject matter, and the 37th German Hospital Conference as a leading event for the management of German hospitals. After their successful premiers in 2013 respectively, the disaster and military medicine conference, DiMiMED, and the MEDICA MEDICINE + SPORTS CONFERENCE for the special needs of sports medicine will also enrich the MEDICA 2014 conference programme once again, being in the English language and therefore attractive to an international audience.

More than half of the approx. 132,000 trade visitors to the MEDICA 2013 were international visitors who had originated from over 120 nations. They collected information from the 4,641 exhibitors from 66 countries on the entire spectrum of new products for qualitatively good and simultaneously efficient medical care, ranging from medical technology and electromedicine, laboratory technology, physiotherapy products and orthopaedic technology all the way to health IT. During this, the COMPAMED 2013 counted 681 exhibitors from 37 countries. They presented to 17,000 visitors a multitude of technological and service-based solutions for use in the MedTech industry – from new materials, components, primary products, packaging and services all the way to complex microsystem and nano technologies. Dates for the MEDICA 2014 in Düsseldorf: 12 – 15/11/2014) Dates for the COMPAMED 2014: 12 – 14/11/2014) Dates for the MEDICA 2015 in Düsseldorf: 16 – 19/11/2015) Dates for the COMPAMED 2015: 16 – 19/11/2015)


FEDERATION OF ROYAL COLLEGES OF PHYSICIANS OF VERNACARE AND NATIONAL UNIVERSITY HOSPITAL THE UK RENEWS GLOBAL PARTNERSHIP WITH SINGAPORE WORK TOGETHER TO IMPLEMENT A PEARSON VUE TO DELIVER SPECIALTY CERTIFICATE NEW APPROACH FOR INFECTION CONTROL EXAMINATIONS

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he Federation of Royal Colleges of Physicians of the United Kingdom has decided to renew its multi-year partnership with Pearson VUE to deliver Speciality Certificate Examinations (SCEs) globally.

The SCEs are a requirement for specialist physicians in the UK and provide an international benchmark for postgraduate medical education. There are 12 specialities, each developed with the relevant UK medical specialist societies. It is the latest in a series of new and renewed global partnerships for computer-based testing leader Pearson VUE, which will continue to be the sole provider of the multiple choice test, divided into two three-hour exams comprising 100 questions. Candidates can sit the test at Pearson VUE’s network of over 5,000 highly secure test centres in 178 countries. Helena Sturridge, Chief Operating Officer, Membership of the Royal Colleges of Physicians of the United Kingdom (MRCPUK), said: “We are delighted to be continuing our relationship with Pearson VUE as they deliver our highquality Speciality Certificate Examinations on an international scale. We chose to renew our partnership because of Pearson VUE’s global presence which means greater accessibility for candidates, highly secure test environments and world-class service.” Bob Whelan, President and CEO, Pearson VUE, said: “This renewal of our partnership with the Federation of Royal Colleges of Physicians of the UK means that we will continue to deliver exams that potentially improve the careers and lives of specialist physicians who have a positive impact on health standards.” About Pearson VUE Pearson VUE (www.pearsonvue.com) is the global leader in computerbased testing for information technology, academic, government and professional testing programmes around the world. Pearson VUE provides a full suite of services from test development to data management, and delivers exams through the world’s most comprehensive and highly secure network of test centres in more than 175 countries. Pearson VUE is a business of Pearson (NYSE: PSO; LSE: PSON), the world's leading learning company. About the Federation of Royal Colleges of Physicians of the United Kingdom The Federation of Royal Colleges of Physicians of the United Kingdom sets internationally recognised standards in medicine. The Federation is a partnership between the Royal College of Physicians of Edinburgh, the Royal College of Physicians and Surgeons of Glasgow and the Royal College of Physicians of London. The colleges work together to deliver the Membership of the Royal Colleges of Physicians of the United Kingdom diploma (MRCP(UK)) and specialty certificate examinations (SCEs.) 12 | May-June 2014 | Medical Device ASIA

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ernacare in conjunction with IDS Medical Systems (idsMED) has secured a significant contract from National University Hospital Singapore (NUH) for the full conversion of its reusable bedpan washer/disinfectant facilities to the groundbreaking Vernacare single use disposable system. Vernacare is the only company to manufacture this total infection control solution that helps hospitals make both financial and environmental costs savings, as well as increase nurse productivity. NUH’s decision to switch systems follows a successful trial conducted across four wards including Short Stay Ward, Cardiothoracic ICU, Oncology and EMD. The bedpan washer/disinfectors and reusable receptacles were removed from these wards and replaced with Vernacare Vortex disposal units and single use receptacles. Feedback on the trial was delivered by staff associated with the trial wards. Nine out of ten respondents were in favour of the Vernacare disposable system and said they would like to continue using it. The Verncare disposable single use system brings a number of financial, environmental, nurse time and infection control benefits. These include helping to reduce instances of hospital acquired infections such as Clostridium difficile and Escherichia coli and eliminating the breakdowns and blockages which may be associated with the use of bedpan washer/ disinfectors. Boosted nurse morale through removal of the environmental hazards associated with bedpan washer/disinfectors was an important factor in NUH’s decision to proceed with the Vernacare system. An Australian study has also shown the effect of the system on productivity and work flows for nursing staff, so their time can be released to care for patients. Following the successful trial NUH worked closely with Vernacare to fully plan the implementation and determine individual ward requirements including staff training plans. Single use disposable systems are used within 94% of UK hospitals and can break the chain of infection by providing a clean product for every use. Single use items, provided new and unused to patients for each use, can be disposed of in the Vortex disposal unit, using cold water. Vernacare’s single use products are manufactured using over-issued clean newspaper and a wax resin to ensure products hold water for up to four hours. No bleach colouring is added, to ensure products are as environmentally friendly as possible. The products are disposed of in the market-leading Vortex disposal unit, using cold water and significantly less energy than traditional bedpan washers. Sarah Bown, Business Development Manager, Vernacare, comments “We are delighted to work with NUH on this important infection control project, this truly has been a team endevaour involving Infection Control, OSS, Nursing teams, Hospital Management and Keppel Engineering. We have worked closely with our local distributor partner idsMED to implement the Verncare single use system at NUH, including full installation, dirty utility room set up and comprehensive staff training across the hospital. idsMED are now on hand to offer dedicated training and support to NUH.”


Woman|Personality

‘Women are born leaders’ - Dr. Vanita Arora a leaf from. In a traumatic accident, she lost her husband in 1994 in just nine months of her marriage. It dealt a crippling blow to Dr Arora, but she picked up the pieces and gave the difficult situation a tough fight. With the unflinching support of her family, she pulled out all stops coming her way, both professional and personal, to achieve a feat hard to match. The upheaval and personal strife she went through make her more humane and considerate towards her patients.

Women are born leaders’ believes Dr Vanita Arora, who broke into the male bastion and successfully created her niche in the field of Cardiac Electrophysiology. At a time when only men dominated the field, Dr Arora did not hesitate from taking the road less travelled, and with her steeled determination she has come a long way. That she is the only woman Electrophysiologist in India speaks volumes about her penchant for doing something ‘extraordinary’ and makes her stand out of the crowd. Dr Arora is a Senior Consultant Cardiac Electrophysiologist & Interventional Cardiologist with Max Super Speciality Hospital, Saket. She is also Associate Director & Head, Cardiac Electrophysiology Lab and Arrhythmia Services. Dr Arora earned her M.B.B.S. degree from Dayanand Medical College & Hospital, Ludhiana, and pursued M.D. in Internal Medicine from the same institute. After joining Escorts in 1995, she did her DNB Cardiology from there, which led to National Board certification. Having begun her career with KEM Hospital, Mumbai in 1994, Dr Arora

moved to Delhi the following year to work with the premier Escorts Heart Institute & Research Centre. In her 15-year-long stint with Escorts, she became a part of a pioneering team to start 3D mapping programme at the heart institute. She takes pride in being the first consultant, thereupon, to have handled an independent case involving the technology. Prior to joining Max Group in 2009, she had been with Apollo Hospital, New Delhi. Coming from a family of doctors -- her father is the oldest practicing physician in Punjab and both her brothers are doctors in the US, Dr Arora says presence of a few women in the field of cardiology fueled her desire to take it up for specialization. Her urge to take up challenges, however, did not rest there. She went on to hone her skills in cardiac electrophysiology, hitherto a domain in India in which only her male counterparts had a say in. She now proudly shares the domain space with 50 male doctors in the country. Dr Arora has not only set a precedent for other women doctors to follow, but also has laid down an example in her personal life that many can take

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Implantation of biventricular pacemaker is Dr Arora’s forte. She performed more than 200 implantations in 2012. Besides, dealing with patients of syncope, a condition in which a person loses consciousness intermittently, is one of her another specialties. She runs Pacemaker and Sycope clinics at Max Hospital. To arm herself with the best of knowledge and techniques in her areas of interest, Dr Arora underwent important fellowships and training in top-notch global institutes. She trained herself for Advanced 3D Mapping at Innoheart Singapore National Heart Center, Singapore. She has been awarded fellowships from University Hospital Leipzigerstr, Magdeburg, Germany in Biventricular Pacemaker Implantation, and University of Wisconsin Medical School, Milwaukee, USA, in Electrophysiology & Complex Arrhythmias. The two of her role models Dr Angelo Auricchio and Dr Jasbir Sra, from the respective institutes and icons in their own spheres, left an indelible imprint on her profession. In a career spanning about two decades, she has to her credit more than 900 Radiofrequency Ablations, 1000 Permanent Pacemaker Implantations, around 400 Biventricular Pacemaker Implantations and 40 3D Mapping Radiofrequency Ablation of the Complex Arrhythmias.

She also contributes to esteemed publications, both national and international, by way of her articles and reviews. She has presented over 50 papers in national and international conferences. Dr Arora is the editor of Asia Pacific Heart Rhythm Society’s newsletter, Editorial Secretary of Indian Heart Journal, and Editor of Cardiological Society of India, Delhi Branch. She is also the member of Fellow College of the Asian Pacific Society of Cardiology; Fellow Complex Arrhythmias, Milwaukee, USA; and Biventricular Pacemaker, Magdeburg, Germany. She is also instrumental in conducting various training programmes to enhance the understanding of ECG and Arryhythmias among young cardiologists and physicians in India and abroad. She leads the ECG training course, an initiative of Dept of Electrophysiology & Arrhythmia Services, Max Hospital. She has successfully held training sessions for doctors in Colombo twice, and will soon hold one in Bangladesh. To bring the latest technologies and equipment to India, Dr Arora is actively involved in research studies and works incessantly to solidify the industry-people collaboration. For her seminal contribution to her field, she has been conferred with many prestigious awards. The Cardiological Society of India recently bestowed upon her the ‘Best Case Report Award in Cardiology’ in recognition of her handling of one of the rare cases, wherein she identified the exact location of one extra beat in the patient’s left atrium that caused severe palpitation, and fixed it with a single radiofrequency heat wave. Dr Arora, who says her strength lies in her team for which she chooses members meticulously, is also the recipient of ‘Chikitsa Rattan Award’ for excellence in Medical Science and has been given ‘Distinguished Service Award’ for outstanding contribution in the field of Clinical & Preventive Cardiology by former President of India A P J Abdul Kalam. In her leisure time, she gels up with her friends, goes on a long drive, listens to music, and reads fiction having strong woman characters.


Ameera Shah bags

‘World Women Leadership Award’

Ameera Shah, Managing Director and CEO, Metropolis Healthcare Ltd, was awarded the ‘Exemplary Women Leadership Award’ at the World Women Leadership Congress & Awards 2014. The Exemplary Women Leadership Award recognizes and appreciates women power and work, celebrating their successes and showcasing their excellence in their respective fields. Ameera Shah has been presented with this award in recognition of her outstanding contribution in the field of healthcare and diagnostics. Ms. Shah has been instrumental in shaping Metropolis Healthcare as one of the first multinational chain of diagnostic labs in the emerging markets. The event recently took place in Mumbai & the function was graced by eminent personalities like by Dr. Massouda Jalal, Former Minister of Women, Founding Chairperson, Jalal Foundation and Dr. Indira Parikh, President, FLAME: Foundation for Liberal and Management Education. Some

of the other awardees were Moira Cullen, VP, Global Beverage Design, PepsiCo, Inc., ChristelQuek, Regional Social Business Lead, Samsung Asia, Patricia Pineau, Director Scientific Communication, L’Oréal Research & Innovation, Monica Tata, MD, HBO India, Navita Yadav, CEO, IL&FS Trust Company Ltd. VibhaPadalkar, Executive Director & CFO, HDFC Life and PoonamKaul, Director - Communications, India, Middle East & Africa, Nokia India.

name to attract talent. However, there are positives to all difficulties! Coming with background of overcoming the odds of an unorganized sector, team Metropolis is a bunch of self – starters who believes in knowledge oriented approach that has enabled our success. Today we are amongstthe largest diagnostic players, we take the onus of progressing at a fast pace and creating many more success stories in the future.

The World Women Leadership Awards appreciate the profound role played by women as leader’s, executioners and decision makers, in shaping the future of the sector and who embody the qualities of leadership in displaying active, creative and integrative efforts in achieving the best possible results in the national and global development plans.

About Metropolis Healthcare Ltd:

Speaking on the occasion Ms. Ameera Shah said, “I am highly privileged to receive the recognition and would like to thank my entire team for their dedication, hard work and continuous support towards making the vision come true. Unlike leaership positions in the organized sector being a woman entrepreneur is a very different and unique journey. Each time I am acknowledged with an award, I recall my modest days as an entrepreneur. Initial days of the enterprise where I did everything myself with little support from the small team I had managed t develop at that time. Getting experienced human resource was not possible for a small growing company. In the initial period neither did Metropolis had financial resources nor a brand

Metropolis Healthcare Ltd. was founded by Dr. Sushil Shah in 1981. Metropolis Healthcare is India’s leading multinational chain of 105 diagnostic centers and 700 collection centers across India, Sri Lanka, South Africa and Middle East. It provides around 4500 specialized tests under a single roof ranging from oncology to genetics, molecular biology and immunoassays using best-of-breed and latest diagnostic equipment. Ms. Ameera Shah has won prestigious award in 2nd CMO Asia Award as Young Achiever of the year’2011 & Entrepreneur India - Young Entrepreneur of the year 2011. eHealth World Expo 2011 – has also awarded Metropolis Healthcare Ltd as “Best Jury Award” for ICT enabled diagnostic service provider for the project IT integration of customer service management. Ms. Ameera Shah has recently been awarded by Dream companies to work for awards powered by Bloomberg UTV Women in leadership for the year 2012. In June 2010, Warburg Pincus, a leading global Private equity firm, has invested up to $85 million in Metropolis Healthcare Ltd.

Medical Device ASIA | May-June 2014 | 15


Evolving trends in Hematology Automation

-Kanchan Jeswani, Product Manager-Hematology, Transasia Bio-Medicals Ltd. The CBC count - the most frequently requested clinical laboratory tests is processed accurately in automated hematology analyzers. During the last two decades, automated blood cell counters have undergone a formidable technological evolution owing to the introduction of new physical principles for cellular analysis and the progressive evolution of software. The results have been an improvement in analytic efficiency and an increase in information provided, which, however, require ever more specialized knowledge to best discern the possible clinical applications. Today’s analyzers are able to provide much more information, both quantitative, such as the extended parameters and qualitative ie. suspect flags. Scatterplots and histograms of the real-time data provide an insight regarding abnormal population of cells and disease patterns which can be identified by the hematologist. These advanced features help in reducing manual reviews, thereby improving the turnaround time for the physicians. The correct interpretation of results requires extensive knowledge of the analytic performance of the instruments and the clinical significance of the results reported. Complete Blood Count –The 3D Approach • Traditional parameters of the CBC count and Differential count These are the conventional, essential parameters reported since time immemorial. • Advanced Clinical Parameters The new generation analyzers’ technology have developed advanced clinical parameters to assess their clinical utility and are approved for routine use in almost all cell lineages. Red cells: Response to treatment can be monitored using Reticulocyte Hemoglobin Content and Immature Reticulocyte Fraction to differentiate between classical and functional iron deficiencies, in addition to monitoring of EPO and/or intravenous iron administration. Suspect flags for red cell abnormality are displayed such as red cell agglutinins and fragmented red cells. White cells: New positional parameters such as Immature Granulocytes provide prior information on bacterial inflammation. White cell counts are corrected for the presence of NRBC and the NRBC enumeration is reported with every sample. Suspect flags are identified for left shift, abnormal /atypical lymphocyte ,blast, etc Platelets: Immature Reticulated Platelets (IPF % Immature platelet fraction) distinguish between the causes of thrombocytopenia16 | May-June 2014 | Medical Device ASIA

increased consumption or decreased production. It also predicts the timing of platelet recovery (after transplantation or chemotherapy) thereby preventing unnecessary platelet transfusionsa precious resource and avoids potential infection risk. Suspect flags are generated for giant platelets, platelet clumps and cellular interferences. • Non-reportable research parameters : These parameters have started to emerge as useful tool in predicting the presence of infections (bacterial/viral); neonatal sepsis; malignancy; inflammation and parasites in blood to name a few. The eventual incorporation of a ‘malaria alert’ into all modern analyzers (now available as suspect flags) would allow for an automated and adjuvant diagnostic method in the workup of febrile patients possibly infected with malaria, especially in scenarios with low pre-test probability for the disease. Some of the high end hematology analyzers are equipped with a body fluid mode for reporting red cell counts, total nucleated cell counts and differentials. Rerun/reflex testing is done automatically without user intervention based on decision rules incorporated in the system. These advanced features helps in reducing manual reviews significantly thereby bettering the turnaround time for the physicians and timely care for the patients. Quality Assurance Internal Quality Control and External Quality Assurance Schemes are readily available for conventional parameters. It is good laboratory practice to have accredited External Quality Assessment Schemes (EQAS) for the reportable clinical parameters as well. For a number of parameters,on some

instruments, there is no internal quality control, which brings into question whether these parameters should be used for clinical decision making. It is important to establish reference ranges locally, and sites wishing to utilize these parameters need to ensure that their analyzers are fully optimized and standardized before use. Laboratories with more than one instrument of the same type need to standardize settings between instruments as well on a regular basis. Futuristic Automation Automation is going the modular way with multiple units of hematology analyzers, integrable slidemaker/stainer, digital morphology system,tube sorters, automated ESR systems, HbA1c system linked to the middleware and LIS, making it a true walkaway one lavender top system. Conclusion Automated blood cell counters are becoming more sophisticated and the range of reportable parameters available is ever increasing. There are increasing amounts of data provided, which require specialist knowledge to interpret as well as understand the limitations in the measurement of the parameters. Both hematologists and clinicians need to remain updated with new parameters and interpretations . Good laboratory practice ensures that reliable results of clinically relevant laboratory tests are reported to the clinician. This expanding range of parameters does allow for novel applications and introduces an element of research and development into routine laboratory hematology practice. Transasia Bio-Medicals Ltd. is privileged to offer the entire gamut of hematology automation from Sysmex ranging from 3 PDA to High end 6 part XN series .


Screening of IDA and Thalassemia using Automated Hematology Analyzers

Two Sides of One Coin: Microcytic Hypochromic Anemia Divya Munshi Product Management-Hematology Transasia Bio-Medicals Ltd.

The Indian Anemia Story: In the Indian context, the two most common etiologies for microcytic hypochromic anemia cases are iron deficiency anemia and beta thalassemia (a genetic hemoglobinopathy). As per the WHO estimate, 80% of children, 58% of pregnant women, 30% adults in India are suffering from IDA while 3.3% of Indian population is affected by beta thalassemia. In regions like Punjab, Gujarat, Rajasthan, IDA and beta thalassemia co-exist with the former being prevalent and latter present in 6.5%, 15% and 3% of their population respectively. This makes the task further difficult in the differentiation of borderline IDA and thalassemic cases. Utility of automated RBC indices, for screening and differentiation of IDA and beta- thalassemia: With the advent of automation in hematology, the first line of screening of IDA and thalassemia is possible through Complete Blood Count (CBC). An automated hematology analyzer reports complete RBC count, Hb, MCV, MCH, MCHC which fall low in cases of microcytic anemia. However, the key automated hemogram indices which help in providing first line of differentiation among such cases of IDA and thalassemia are RDW-SD, RDW-CV in combination with MCV, Automated Reticulocyte Counts and IRF (Immature Reticulocyte Counts). Red cell Distribution Width (RDW) is a quantitative measurement of variation in red cell size provided as either Standard Deviation (RDW-SD) or Co-efficient of Variation (RDW-CV). RDW-SD is measured by calculating the width in fl. (femto liter) at a relative height of 20% above baseline of RBC curve. On the other hand, RDW-CV is measured by calculating ratio of 1SD of RBC curve to Mean Corpuscular Volume (MCV).

Calculation of RDW-SD and RDW-CV: Both RDW-CV and RDW-SD reflect the variability in erythrocyte size and thus measure anisocytosis, however each of these parameters has its own clinical utility. RDW-SD is a direct measure across the RBC histogram, hence it is ‘theoretically’ a better and more accurate measure of RBC anisocytosis across the entire spectrum of MCV values. On the other hand, RDW-CV shows better correlation as an indicator of anisocytosis, if the MCV is in the normal range and when the anisocytosis may be difficult to detect e.g early stage of IDA. While most analyzers report, either RDW-SD or RDW-CV, some recent analyzers provide ‘Simultaneous reporting of RDW-SD and RDW-CV’. Simultaneous reporting of these two indices helps in screening and differentiating IDA and thalassemia. Other than RDW, Ret counts and IRF (Immature Reticulocyte Counts) available on high end 5PDA systems and have been identified as a useful adjunct in diagnosis and management of the above mentioned pathological conditions. According to published reports, Ret counts and IRF have been found to be high in cases of beta thalassemia minor and iron deficiency anemia respectively. Classification of Anemia based on RDW-CV and RDW-SD in combination with MCV : Determination of the MCV is routinely used in the classification of normocytic, microcytic and macrocytic anemia. MCV when used in combination with RDW-CV and RDW-SD, serves as the best criteria for the classification of anemia. As the MCV is an arithmetic mean, it may exclude partial microcytosis - even in the reference range. Only in combination with the RDW-CV and RDW SD, it may indicate dimorphic erythrocytes, for example, the initial stages of iron deficiency.

Medical Device ASIA | May-June 2014 | 17


The table below highlights the importance of RDW-CV, RDW-SD and MCV in differentiation and prognosis of various anemic conditions:

The above mentioned two case studies clearly depict low MCV typical of microcytic hypochromic anemia. In case 1, RDW-CV of 20.5% is indicative of red cell anisocytosis consistent with iron deficiency anemia, later confirmed with iron studies. Whereas in case 2, RDW-SD of 25.6% which is below normal indicative of a monotonous red cell population consistent with beta thalassemia minor, later confirmed with Hb electrophoresis. Given the prevalence of IDA and genetic hemoglobinopathies like thalassemia in India, availability of the simultaneous reporting of RDW-CV and RDW-SD on automated hematology analyzers, goes a long way in screening these pathological conditions. Sysmex hematology analyzers (marketed in India by Transasia Bio-Medicals Ltd.) allow a ‘Simultaneous reporting of RDW-SD and RDW-CV’ alongwith various specialized parameters like Reticulocyte and IRF which help in timely diagnosis of hemoglobinopathies. __________________

Case studies: Illustrating the importance of RDW-CV and RDW-SD in differential screening

References: • Shaker, M., et al. J. Pediatr. 2009, 154(1):44-49. An economic analysis of anemia prevention during infancy. • Barbara J Connell. 2012, Hematology Tools to Aid in the Diagnosis and Management of Iron Deficiency Anemia. • Sysmex Lab Info: 2006, -03, ‘Referenzwertbereiche für die Hämatologie: Sysmex X-family’. • L. Thomas. 2005, Labor und Diagnose; TH-Books; 6. Auflage • Noronha JF et.al. 2005, 43(2):195-7. Measurement of reticulocyte and red blood cell indices in patients with iron deficiency anemia and beta-thalassemia minor.

Company PROFILE: Transasia Bio-Medicals Ltd. Incepted in the year 1979, Transasia Bio-Medicals Ltd., is headquartered in Mumbai, India. It is one of India’s largest In- vitro Diagnostics Company and offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Electrophoresis, Molecular Diagnostics, Diabetes Management and Microbiology. Infact, Transasia is the first Indian company to manufacture and export sophisticated, state of the art blood analyzers and reagents. Transasia is a part of the global ERBA Diagnostics Mannheim GmbH Group. The ERBA Group has spread its footprint across USA, Europe, Turkey and Eastern Europe, Russia and France, by means of various acquisitions – ERBA Lachema s.r.o.(Czech Republic), ERBA Russia (Russia), ERBA Diagnostics, Inc. (USA), Diamedix Corporation (USA), Delta Biologicals,S.r.l (Italy), ImmunoVision, Inc. (USA), Erba DDS (Turkey), ERBA Diagnostics France (France), JAS Diagnostics Inc. (USA) and Drew Scientific (USA). Transasia manufactures and markets equipment and reagents, with an impressive install base of around 38,000 equipments across India. Transasia also exports to more than 94 countries in five continents. The vast network of more than 150 service engineers, 350+ Sales and Marketing Team, 14 zonal offices, and 300+ Distributors allows us to reach out to customers across the length and breadth of the country. Alliances with international partners like Sysmex Corporation(Japan), Wako (Japan), Medica (USA), Diesse (Italy), Immco (USA), Vircell (Spain), Helena Bio-sciences (UK), Genprobe (USA), have ensured that cutting edge technology and solutions can be brought to India. Transasia markets, services and supports the Sysmex products and solutions in India. (www.transasia.co.in)

Case1: Iron Deficiency Anemia

Case2: Beta Thalassemia Minor

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With a vision of being recognized as a ‘local for global’ organization, Transasia continues to provide doctors and patients with reliable, affordable and innovative Medical Diagnostic Systems.


Sami Direct, part of world’s leading health science company, Sami Group, continues its commitment in restoring health and wellness to the Indian community

Rolls out Vita essentials® bi-layered multivitamin tablet to combat new age ailments (MVMs) will help in providing a balanced amount of all nutritional components needed to maintain a healthy lifestyle.

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ami Direct, part of the 25 year old Sami Group, world’s largest health science organisation, today launched Vita Essentials®, a premium bilayered Multi-Vitamin tablet aimed at promoting a healthy lifestyle, by offering protection against metabolic stress, poor diet and environmental pollutants. Sami Group is an acknowledged global leader for unlocking the mystery of herbs, extracting the goodness and restoring good health and wellness to the world for over 2 decades. Young Indians are becoming a prey to new age diseases, like heart attacks, bronchial asthma, high BP and diabetes, essentially owing to sedentary lifestyles or high impact workouts with no professional guidance, excessive smoking and drinking, poor diet, overdose of caffeine and colas, hormonal imbalances and many more. Increasingly, orthopaedics and endocrinologists are reporting a rise in the deficiency levels of Vitamin D3 and B12 among the urban young and are showing symptoms that are manifestation of various ailments. However, supplementation with multivitamin multimineral nutrients

Dr Muhammed Majeed, Founder & Chairman, Sami Group said, “We at Sami Direct have taken the responsibility of restoring health and wellness to the community, through innovative research and deep understanding of the market. This new product which is a unique mix of vitamins and mineral complex enhances the development of different profiles as per RDA (Recommended Daily Allowance) is essential to fight new-age diseases and ensure a healthy lifestyle.” “The combination of different release profiles like immediate release (IR) and sustained release (SR) profile can be achieved in a single tablet. More importantly, it contains only vegetarian extracts, thus suitable for all” he added. The first layer of the Vita-essentials® tablet comprises of18 types of ingredients including Ashwagandha extract, Vitamins, Calcium, Bio Perine and others. The second layer has 5 ingredients comprising of Copper, Folic Acid, Carbonyl Iron and other vitamins. Biotin present in the tablet helps to maintain a steady blood sugar level. Vital in filling the dietary gap, Vita Essentials® boosts the immunity functionality of the body and provides antioxidant boost. Most importantly, it has an extended action implying a less amount of dosage for the individual as the components are released base on the needs of the body. The tablet is suited for ages 12 and above and provides the micro-nutrients in a balanced way. Vita Essentials

comes in a pack of 60 tablets per bottle and 10, 0000 tablets have been rolled out through the chain of independent distributors of Sami Direct across India. It is also available for retail purchase online. The bi-layered tablet is based on Ayurveda and made of natural ingredients only (it also includes synthetic ingredients and chemicalsthe sentence has to be framed accordingly). Sami Direct currently has 20 products available in the market for consumers, which includes a range of cosmetics manufactured using natural extracts.

About Sami Direct Sami Direct is one of the world’s largest health science company. Sami Direct offers various nutraceutical products to the consumers. Sami Direct currently has 87 International patents and recognitions to its credit. Sami Direct have their own R & D facility where rigorous research is carried to create safe products. Sami Direct has created a benchmark globally for the nutraceutical products. The product ranges of Sami Direct are approved by FSSAI (Food Standards and Security Act of India).

Medical Device ASIA | May-June 2014 | 19


Heart Rate Monitor watches from Timex Performance measurement is the key to managing workouts and realizing athletic potential. Whether you are a beginner walker, an experienced racer or an elite triathlete, Timex products provide a unique range of features to help everyone meet their individual fitness goals. From versatile activity trackers to advanced download capabilities, Timex provides easy to use solutions at exceptional values. Health Touch Contact Heart Rate Monitors • Place a finger on the bezel ring to see your heart rate. Heart rate displayed in BPM and % of max formats. Target zone with alert and tracks calories burnt • Stopwatch and countdown timer • Daily alarm and Second time zone • Easy to view in low light conditions with INDIGLO night light

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Health Tracker • Automatically records distance, steps and calories burned all day Diet diary will keep track of units or calories consumed daily Daily activity tracker with 7 day memory to review progress Customizable goals chime in halfway and at completion of goal. Workout mode will display elapsed time, distance and exercise pace intensity in real time (slow,mod,fast) One time easy set up with personal setting for accuracy. Stride set up with manual and automatic calibration options for enhanced distance accuracy 24 hour countdown timer with countdown/ stop (CS) and countdown repeat (CR) that can be used for hydration, cooking or time out for kids Three alarms settable for daily/weekday/ weekend/weekly with 5 minute back up 2 time zone settings make travel easy. Easy to view in low light conditions with INDIGLO night light

Health Touch Plus Contact Heart Rate Monitors with Pace and Distance •

No chest strap required, simply place a finger on the bezel ring to see your heart rate

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Heart rate displayed in BPM and % of max formats. Target zone with alert and tracks calories burnt Target zone with alert Distance sensor tracks steps through natural swinging motion of the arm. Workout mode displays distance, steps, average pace and calories burned Simple stride calibration by entering age, weight and height Stopwatch with 7 workout memory Countdown timer Daily Timer 2 time zone settings make travel easy. Easy to view in low light conditions with INDIGLO night light

About Timex Brand Timex Group is the one of the world’s largest watch maker that designs, manufactures and markets innovative timepieces and jewelry globally. Timex was founded in 1854 and has a rich heritage of making the finest timepieces. Timex Group India has a portfolio of several brands spread across various segments from mid-premium to luxury segment with Brands like Timex, Marc Ecko, Salvatore Ferragamo, Versace, Helix and Tarun Tahiliani. The Group has a design centre based out of Milan and a manufacturing base spread across various countries. Over the years, TIMEX Group India Ltd. has grown to become one of the leading brands in the organized watch market. Brand TIMEX is well-known in India for its youth appeal, sporty, fashionable and technologically advanced product offering. TIMEX group also has set standards of high quality watch-making through excellent technology and innovative product development. TIMEX has been a pioneer in inventing several landmark technologies to its credit including the Indiglo®. TIMEX Group has also diversified and has plans of launching a host of international brands within the premium and luxury segments in the country.


Sankara Eye Care Institution bagged the most prestigious IMC Ramkrishna Bajaj National Quality Award • The only eye-speciality, healthcare institution to win this award • Achieved the Performance Excellence Trophy 2013 Expressing his views on the occasion, Dr. R.V. Ramani, Founder, Sankara Eye Care Institutions, said, “One can easily understand the need for quality in a manufacturing or trading industry without which they lose on the competitive advantage. But in a service industry, that too where charity is the mainstay, as in Sankara Eye Care Institutions India, where unmatched quality with high ethical standards is the very DNA of the organisation, recognising and appreciating the excellence at the right time is of greater significance.”

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ankara Eye Care Institutions was recognized for their national excellence in quality health care by the IMC Ramkrishna Bajaj National Quality Performance Excellence Trophy 2013 at their award ceremony, held on March 19, 2014 at Y.B.Chavan Auditorium, Mumbai. Dr.R.V. Ramani, Founder and Managing Trustee of Sankara Eye Care Institutions India received the Award on behalf of Team Sankara, which was presented by Mr. Arun Maira, Member, Planning Commission, Government of India. Sankara was the only healthcare institution amongst others to win the award. The IMC Ramkrishna Bajaj National Quality Award 2013 saw the presence of experts from the industry, including Dr Devi Prasad Shetty, Chairman, Narayan Hridayalaya group of Hospitals; Meenal Kshirsagar, Retired Reader French, University of Mumbai; K K Maheshwari, MD, GRASIM; Dr. Adi Dastur, Obstetrician and Gynacologist; Dr. K B Kushal, DAV regional directorate; Prasad Menon, Tata Quality Management services and Sunil Alagh, SKA advisor on the panel of judges. Sankara Eye Care Institutions has bagged this award, passing through numerous eligibility criteria and rigorous quality & performance evaluation as amongst leading industrialist participants from varied sectors, including Manufacturing, Service, Small Business, Overseas, Education & Health Care.

Sankara Eye Care Institution can be described as an organisation with 37 Years of Track record, having over a million Eye Surgeries to its credit, community eye care as the Thrust activity, also having process and systems in place and a Pan India presence. The recently Inaugurated Bhojraj Chanrai Sankara Eye Hospital in Mumbai is a standing example of Sankara Eye Care Institution’s experience

and expertise, combining the best of infrastructure, and equipment with highly skilled and experienced Human Resource, Medical and Para Medical. “Awards and Recognitions like this are not only great morale boosters for the organisation concerned, but by projecting the same we are able to motivate many more to tread a similar path, concluded Dr.R.V. Ramani. The IMC Ramkrishna Bajaj National Quality Award Trust was instituted jointly by the Indian Merchants’ Chamber and the House of Bajaj in 1995. Over the years, IMC RBNQA has rapidly become a symbol of top-down organizational excellence. The universal standards and best practices embedded in the IMC RBNQA criteria have transformed Indian leaders into accepting the pivitol roles of customers and employees in driving worldclass processes.

About Sankara Eye Care Institutions, India: Sankara Eye Hospitals-India are focused on providing the highest quality & value for money eye care services and have emerged as the most preferred recognized eye care facility. Founded by Dr RV Ramani and Dr Radha Ramani, with the blessings and guidance from the Sankaracharyas of Kanchi, this community oriented Medical Trust works on eliminating avoidable blindness by providing eye care to all socioeconomic sections. Sankara Eye Care-India has been recognized for quality eye care with various Awards over the last decade. The hospital blends expertise, ambience and state of the art equipment to attract patients to utilize its services. The social enterprise uses the revenue from its functioning to support its community eye care activities across India. The new state art of the facility is another initiative towards achieving Sankara Eye Hospitals, India’s 2020 vision.

Medical Device ASIA | May-June 2014 | 21


OSIM India launches ‘uAngel’ The World’s lifestyle Sofa-Transformer full body massage chair

Anetic Aid: A Patient Trolley Inspired by the Challenge of Driving on British Roads

OSIM India, a leading brand for a healthier lifestyle and overall well-being launches the World’s 1st Sofa-Transformer, OSIM uAngel. OSIM uAngel, a lifestyle sofa transforms from a small sofa into a full-body massage chair. With just one touch of a button, it doubles the pleasure of a modern and elegant looking lifestyle sofa. This sofa is petite in size and generous in features. It comes in five colors that will leave you awestruck. OSIM uAngel complements the style and decor of any modern living space with contemporary designs and colours with an exciting sheen of metallic brushed upholstery. Available in a suite of five home-interior colours; Celestial White, Stellar Red & Mystique Grey the OSIM uAngel transforms into a powerful massage lounger delightfully from a small sofa into a full-body massage chair with just a touch of a button. With strong massage from neck down to the toes, the OSIM uAngel presents a suite of 5 professionally designed massage programmes such as Neck & Shoulders- This massage programme helps the body and mind to achieve a heightened sense of alertness using invigorating massage techniques at higher intensities; Lumbar-A popular massage programme to loosen lower back tension, for a healthier, stronger back; Relax-A pampering massage programme to loosen the overall body when it is tired; Energize- A high-energy massage programme designed to charge up the body and mind and De-Stress-This programme targets very busy ladies who typically feel great amount of stress and this massage programme uses low intensity massage technique to gently stimulate the body to keep you healthy and relaxed. Now double your pleasure with your personal spa masseuse, the OSIM uAngel, the World’s 1st Sofa-Transformer to enjoy a full-body massage and the charm of a beautiful home sofa. OSIM uAngel is priced at Rs.1, 50,000 (Octroi extra in Maharashtra) About OSIM India:

OSIM India (A Division of Paramount Surgimed Limited) was established in September 2004, under the guidance of Mr. Shaily Grover, who has been a visionary in the lifestyle and health care field and has over 25 years of experience. OSIM India offers a wide range of Full Body Massage chairs, Foot Massagers, Back Massagers, Hand Held Massagers and Massaging & Toning belts. Under his able leadership, OSIM India has shown a remarkable growth. 22 | May-June 2014 | Medical Device ASIA

Explained CEO Guy Schofield: ‘We all know how awkward it is to manoeuver a large vehicle on our congested British roads, so our concept behind the design of the QA3 v3.0 was to create as compact, manoeuvrable and light weight a product as possible without compromising the size of the patient lying surface. ‘The result has been that when pushing the QA3 with the backrest raised, it is little more than 1.8m long. Indeed the QA3 v3.0 goes lower and is narrower and shorter than nearly all other patient trolleys on the market. The mattress size however, has not been compromised as it covers almost the entire width of the trolley, offering yet another advantage: an almost zero transfer gap. ‘Combine these features with our unique 5th wheel steering mechanism, and you have a trolley that is supremely easy to handle in the tight congested spaces of your average busy hospital.’ Other features to aid staff manipulating the trolley once a patient is on board include a gas assisted backlift and damper assisted Trendelenburg tilt. As well as patient transport, there is a dedicated Emergency version of the QA3 which is X-ray translucent for A&E departments, and also a special Endoscopy version which has a small but significant 100mm increase in its maximum height. Anetic Aid produces – the QA3 Variable Height Patient Trolley, the QA4 Day Surgery Trolley System, the AT4 Tourniquet System and a wide range of operation table accessories and quality stainless steel furniture.


Corporate|Profile

Metropolis Healthcare Ltd.

- a multinational chain of diagnostic centers. practices that work hand-in-glove with our awareness drives and health check up camps. Metropolis’ capability to carry out health checkups and testing across large geographies ensures that companies can be assured of consistent results and our unique loyalty program provides you with even more reasons to get health checkups done. After all in the battle against disease, diagnosis is the first step. Our services include Clinical Laboratory Medicine, Radiology & Imaging, Hospital Laboratory Management, Central Laboratory Services for Clinical Trials, Site Management Organization, Home Health Services, Preventive Health Check ups, Remote Pathology Testing and Public Private Partnership. VISION

Processing over 15 million tests a year, catering to more than 10,000 Laboratories, Hospitals, Nursing homes and 50,000 consultants; and with 31 years of experience delivering accurate reports, Metropolis has also earned the reputation of being India’s only multinational chain of diagnostic centers with presence in the Sri lanka, UAE and Africa. Since its inception in 1981 as a purely Mumbai based laboratory, Metropolis has come a long way. Visionary leadership, strategic associations with other leading laboratories across the country, strict ethical policies and a penchant for technology are some of the reasons Metropolis is India’s largest laboratory chain. ISO, NABL, CAP (College of American Pathologists – For Mumbai Lab) accreditations reiterate our stringent national and international quality standards - imperative in a vital service sector like healthcare. Our network of 70 state-of-art-laboratories across India, UAE, Sri Lanka and South Africa with over 550 collection centers further demonstrates how committed we are to delivering accurate and timely results. We offer 4500 plus routine, specialized and highly specialized investigations that use over 100 different technologies including Biochip and DNA sequencing. Innovations like Home Health enable us to reach you so that going for a check-up in no longer an inconvenience. At Metropolis, we support the global endeavor to fight disease by incorporating cutting-edge technology and 23 | May-June 2014 | Medical Device ASIA

To achieve excellence in diagnostic across emerging markets using our network of automated and accredited laboratories focusing on accuracy, efficiency and unparalleled customer experience and above all a stringent ethical code. MISSION We have clear-cut mission objectives: • To become the most preferred partner for the Government of India with at least 1 lab in each state • To successfully exploit MBPO opportunities in Europe, UK and the USA • To become a place of equal growth opportunities for all employees • To create an organization propelled by knowledge and research • To develop for its members a platform to learn and share knowledge • To share Corporate Social Responsibility

• To become the leading chain of diagnostic centers across India, Sri Lanka and rest of South Asia. • To become among top 3 player in South East Asia, South Africa and Middle East VALUES At Metropolis we ask people to insist – on the latest technology, on ethical practices and on complete satisfaction. Since at Metropolis we believe that people deserve the best and they should never settle for anything less.

THE METROPOLIS – MANAGEMENT TEAM Dr. Sushil Shah is the Chairman and Founder of Metropolis, the organization that gave India its very first referral laboratory in 1981. However, Metropolis happened only after Dr Shah had made a name as chief pathologist in renowned hospitals like Breach Candy, Cumballa Hill, Sir H.N Hospital and Saifee Hospital. He has been associated with India’s best pharmaceutical companies as technical director of Zydus Cadilla and as executive director (Diagnostic Division) of Dr Reddy’s Laboratories Ltd. An alumnus of Grant Medical College, Mumbai, where he completed his MD in Pathology and Bacteriology, he is also a passionate researcher and many of his works, on subjects like tumor malignancies, fetal sex, and detection of Toxoplasma Gondii, have been published. A Research Fellow of the prestigious Cornell Medical Center, New York, he has brought many radical innovations in diagnostic medicine to India. He is also the President of Association of Practicing Pathologist of India (APPI). Dr Sushil Shah had always wanted to introduce in India, a diagnostic service that was medically advanced and of global quality standards. Metropolis is that dream


come true. Dr. G.S.K Velu, Vice Chairman, has over 18 years of experience in the diagnostics and healthcare industry, and has worked in several multinational companies such as Ciba Corn Diagnostics, Chevron Diagnostics etc., in the capacity of Director (South Asia). He completed his graduation in Pharmaceutical Engineering from BITS Pilani and Post Graduated in Business Administration from Loyola Institute of Business Administration (LIBA) Chennai and received his Ph.D in Pharmacology from the University of Calcutta. He is also in the honorary faculty of Sri Ramachandra Hospital and Research Institute (Deemed) University. Dr GSK Velu is the founder and Managing Director of Trivitron - the largest medical device company of Indian origin in the world. The winner of the Rajiv Gandhi Shiromani Award and the Modern Medicare “Entrepreneur of the Year” Award, Dr. GSK Velu is one of the brains behind the Metropolis growth story. His vision of establishing a global laboratory network is coming good at lightening speed. Ms Ameera Shah is the Managing Director and CEO of Metropolis Healthcare Ltd., a multinational chain of diagnostic centers. Under her stewardship, Metropolis has evolved from its single pathology laboratory status in 2002 to a fully integrated multinational chain of 70 diagnostic centers and 500 collection centers across South Asia, Middle East and Africa. Using her deal-making abilities, the company has expanded at a scorching pace in India and has created JV’s in Sri Lanka, UAE and South Africa. Under her leadership, Metropolis has become a well-respected healthcare brand, catering to more than 10,000 laboratories and hospitals and over 50,000 doctors, and processes more than 15 million tests annually.

ment System) to integrate with SAP that ensures US-FDA 21 CFR part 11 and HL-7 compliance. • Experience: A 31 years experience of processing 15 millions tests per year with state of the art automated equipment, Metropolis is well equipped to cater to the requirements of any organization. • Quick Reports: Reports are available through the Web, ensuring daily reporting and quick turnaround time. •Logistics Capability: Trained in-house team of 100 courier boys to facilitate specimen pick-up and report delivery. Alliance with most of the renowned courier companies for domestic and international shipment ensuring minimum transit time. • Quality: Services are provided through full automation, regular calibration and controls, standardized imported reagents, and three levels of authorization before final release of the report.

In the past 10 years, Metropolis has expanded into new service lines like Clinical Research, Hospital Lab Management and Wellness Solutions and is always exploring and adopting cutting edge new technologies and services that contribute new revenue streams and strategically position the company as a leader. Her vision is to change the dynamics of the industry through consolidation and consistent innovation, bringing accessibility, affordability and excellence to diagnostics in emerging markets.

Apart from Referral Laboratory Services, Metropolis has operations in the areas of Radiology / Imaging Services, Management of Hospital Diagnostic Services, Health Check Ups and Preventive Health Services and Clinical Trial services like Central Lab services and SMO services.

Ms. Shah received a degree in Finance from The University of Texas at Austin and has been recently selected as part of the prestigious Owner-President Program at Harvard Business School. Ms Shah has been elected the Secretary of the IAPL (Indian Association of Pathology Laboratories) and is the co-chair of the FICCI health services national committee that drives policy decisions at the Center.

Services offered by Metropolis

She is highly respected in the healthcare world and has been voted by GE/Modern Medicare as “The Young entrepreneur of the Year” in 2006 and in July 2011 by Entrepreneur India and Bloomberg. She was also recognized and awarded “The Young Achiever of the year” at the CMO Asia Awards in 2011. Overview • Facilities: Metropolis is the only chain of laboratories in India with 70 state of the art laboratories, and a presence in 125 cities in India through its network of Franchisees and Collection Centers in India and abroad. The lab is open 24hours/365 days including Sundays. • Infrastructure: Metropolis constantly introduces new technologies and upgrades the existing one to provide accurate reports and fast turn-around time. Metropolis uses Gold Standard techniques ranging from RIA & CLIA to Biochip Analyzer &PCR, and Real Time PCR to DNA sequencing. Metropolis is the first pathology Laboratory in India to develop a comprehensive LIMS (Laboratory Information Manage-

• Referral Pathology & Imaging Services Metropolis caters offers a comprehensive menu of over 4500 tests catering to all groups of the medical fraternity. • Preventive health check ups Metropolis offers a wide range of packages for Preventive healthcare, from pre-employment and annual check ups for monitoring employee health in corporate sector to providing customized packages for all age groups. • Central Laboratory for Clinical Trials Metropolis is used as a centralized testing laboratory facility by well – reputed pharmaceutical companies and Clinical Research

Organizations (CROs) for centric Clinical Trials.

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• Hospital Laboratory Management Services Professional laboratory management of hospitals ensures increased profit margins and better efficiency. In India, Metropolis pioneered the concept of laboratory management, which involves complete planning and management of laboratories inside & outside hospitals. • Remote pathology testing services With the objective of providing international standard services at low costs, Metropolis laboratories are being used as Remote Pathology Testing Centers for Hospitals, Laboratories and Research Institutions in the US, UK and Europe. • Site Management Organisation Metropolis Clinical Research Centre (CRC) provides the pharmaceutical companies/ CROs and Biotech companies with multiple, highly conducive investigation sites for Clinical Trials. • Home Health Services Metropolis provides home health services through which laboratory tests can be done in the comforts of home. The services can be availed with one day prior appointment. Laboratory tests are made easier through this service. Metro Home Health is the ideal home laboratory solution for senior citizens, people with disabilities, people who prefer the privacy of their home and even people who are simply too busy at work. METROPOLIS - ACCREDITATIONS • NABL – Govt. of India (ISO 15189 standards) accredited laboratory. • CAP (College of American Pathologists) accredited laboratory. • NGSP level I Laboratory certification for Glycated hemoglobin. • SANAS accreditation for South African Lab

Medical Device ASIA | May-June 2014 | 24


CARELYTE® - ECTROLYTE ANALYZER

True Vision Computer-Guidance with Ophthalmic Microscopes Combined TrueGuide® technology from TrueVision adapted to provide surgical planning and guidance templates to Leica Microsystems’ ophthalmic microscopes during cataract and refractive surgery

Carewell Biotech Pvt. Ltd. Offers CARELYTE Fully Automated ION selective Electrolyte Analyzer for measuring Sodium (Na+), Potassium (K+), Calcium (Ca), Chloride (Cl), Lithium (Li) & pH in all type of sample like whole blood, serum, plasma or Urine etc. Five different Combinations are available to choose from. CARELYTE is very easy-to-use analyzer provides results within 40 seconds. It works on Two point Calibration, both Cal-A (500ml) & Cal-B (100ml) are available in individual Bottles. All Electrodes have Average life of more than 30 months and carries warranty for one year. Instrument designed for 24x7 uses, with built in thermal printer. Running cost of the Instrument is lowest in the industry and calibrator packs are manufactured in India. Carewell Biotech Pvt. Ltd. (Delhi), Phone : +91-11-41539602, 66402100 Fax: +91-11-66402100; Email: info@carewellindia.com

Meet ‘Medical Device ASIA’

Wetzlar, Germany and Santa Barbara, CA, USA. TrueVision 3D Surgical, a world leader in neuro and ophthalmic 3D surgical visualization and guidance, and Leica Microsystems, a world leader in microscopes and scientific instruments, announced a global agreement to integrate computer guidance technology for cataract and refractive surgery into ophthalmic microscopes. The two companies, whose 2012 alliance resulted in the first 3D integrated microscope for neurosurgery, recently expanded their relationship to incorporate TrueVision’s 3D intelligent visualization into Leica Microsystems’ ophthalmic microscopes. Now, TrueVision and Leica Microsystems will expand their relationship to add computer-guided microsurgery assistance capabilities to ophthalmic microscopes, including the extensively used Leica M822 and Leica M844 models. The new platform, marketed and supported through Leica Microsystems’ distribution channel, will be available in late 2014. “Adding TrueVision’s software guidance applications to our microscopy platform is the next logical step in the expansion of the collaboration between Leica Microsystems and TrueVision,” says Dr. Heinrich Dreyer, Vice President Leica Microsystems, Medical Division. “Patients will benefit from the application for astigmatic correction during cataract surgery, as they have the potential to see better, but only undergo surgery once. The goal is for patients to experience an improvement of their eyesight and a resulting improvement in quality of life.” The collaboration of TrueVision and Leica Microsystems began in 2012 with a focus on neurosurgery. “This expanded collaboration provides templates inside the oculars during cataract surgery,” says Forrest Fleming, CEO of TrueVision 3D Surgical. “The surgeon can use this best-in-class combination based on an individual’s unique surgical plan, to achieve targeted outcomes for astigmatic correction.”

14-16 September 2014, Suntec,Singapore

James Katz, MD of the Midwest Center for Sight, Des Plaines, IL, says, “I have used Leica Microscopes and TrueVision guidance for over a year with great satisfaction. The elegant and efficient integration of these two components will only improve their outstanding utility. This combination is truly beneficial to my practice and my patients.” Medical Device ASIA | May-June 2014 | 25


MEDICA EDUCATION CONFERENCE 2014:

Medicine meets technology – technology meets medicine

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agnosis. Thus, a stent may be used to widen the artery or a blood clot may be “pulled out” during a vascular constriction diagnosis.

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his year’s MEDICA EDUCATION CONFERENCE, part of the industry show MEDICA 2014 in Düsseldorf (November 12th through 15th) is dedicated to the interrelations between medicine and technology. The conference theme is “Medicine meets technology – technology meets medicine”. As an academic conference, the event addresses physicians and medical professionals, scientists, industry representatives, and hospital executives. Numerous symposiums, seminars, and workshops provide professional insights on the latest technology and innovations benefiting patients today. Another important focus will be on the impact of medical research on technological developments. Medical progress is often closely linked to technological innovations. Cardiac catheters, joint replacements, modern imaging techniques – none of these would be possible without the integration of technology and medicine. As part of the world’s leading medicine industry show MEDICA, where approximately 4,500 exhibitors present their latest developments, MEDICA EDUCATION CONFERENCE 2014 brings together international scientists, physicians, medical professionals, hospital sourcing experts, developers, and manufacturers to discuss the mutual impact of technology and medicine. Each of the four conference days is dedicated to one topic: The professional education event, designed by the German Society for Internal Medicine (Deutsche Gesellschaft für Innere Medizin/ DGIM) in cooperation with Messe Düsseldorf GmbH, will focus on infection and inflammation, telemedicine and robotics, gastrointestinal oncology, and interventional medicine, respectively.

Of these, it is especially the topics “telemedicine and robotics” (a thematic addition for the target group to the MEDICA HEALTH IT FORUM) and “interventional medicine” that consider the impact of technological innovations on scientific and medical progress and their role in medicine. Doctors of various specialties will learn about new, faster, more reliable and potentially more cost-efficient ways of patient care based on advanced information technology. The example of robotic surgery illustrates the opportunities of robotics for medicine. Plastic surgeons increasingly rely on computer-assisted surgery for reconstructions. During these highly complex operations, surgeons use computer-generated 3D simulations to faithfully reconstruct damaged facial tissue and other body parts. Technological developments also impact other medical specialties. An increasing number of specialists, including radiologists and cardiologists, also employ “interventional” techniques. They use modern technology such as cardiac catheters not only for diagnosis but also in treatment. More and more often, interventional approaches even allow for direct treatment during di-

“The program for the MEDICA EDUCATION CONFERENCE is designed to bring together all major medical specialties and allow them to benefit mutually in employing the latest technology,” said Professor Dr. med. Hendrik Lehnert, director of the medical clinic I of the University Hospital Schleswig-Holstein (Lübeck), who was named president of the congress by DGIM. This requires an exchange between medicine and industry, Lehnert explained. “In order to benefit from technological advancements, doctors need to know which innovations are available for any particular medical application. And conversely, technology developers must depend on impulses from sciences and the day-to-day work in clinics and medical practice to create new innovations.” MEDICA EDUCATION CONFERENCE 2014 is designed as a four-day, fulltime continued scientific training. As part of the world forum for medical technology MEDICA, the conference is international in scope. Numerous speakers from around the globe have been invited to Düsseldorf to share their knowledge and experiences in an active exchange. Simultaneous translations will allow international guests to participate in many of the sessions. Participants of MEDICA EDUCATION CONFERENCE can also combine their attendance with a visit of the industry show. This strengthens the link between theory and practice. “This degree of international and interdisciplinary interconnection is seldom found in a continued training event of this caliber,” Hendrik Lehnert says. “I am positive that our conference concept delivers a high value to MEDICA visitors, with insights that directly benefit their work in the hospital, medical practice, and laboratory.”

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MEDICAL MANUFACTURING ASIA 2014 returns for 2nd edition, to feature two-day Conference on Additive Manufacturing in Medical Manufacturing

The biennial MEDICAL MANUFACTURING ASIA returns for its 2nd edition from 9 – 11 September 2014 at Suntec Singapore and will feature a twoday conference centred on the topic of Additive Manufacturing (AM), more commonly known as 3D printing. MEDICAL MANUFACTURING ASIA 2014 comes on the back of a standout showing at its inaugural edition in 2012 where it drew 144 exhibitors from 21 countries, with close to 90% of exhibitors affirming their satisfaction at the internationality and quality of visitors present at the trade fair. Following the government’s announcement that S$500 million over 5 years will be invested in a bid to boost Singapore’s advanced manufacturing technologies which include those for 3D printing, the MMA Conference 2014 on Additive Manufacturing proves timely and is set to play a pivotal role in bringing together highlyqualified specialists and industry

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peers as they engage and crossshare the latest developments, new research and medical technology and medical manufacturing applications. Co-organised by Singapore Precision Engineering and Tooling Association (SPETA) and Messe Düsseldorf Asia, and in collaboration with International Enterprise (IE) Singapore and SPRING Singapore, MEDICAL MANUFACTURING ASIA is a perfect alliance of specialist medical trade fair experience with critical precision engineering industry expertise. Held alongside MEDICAL FAIR ASIA, Asia’s leading medical and healthcare event now into its 10th edition, MEDICAL MANUFACTURING ASIA’s exhibitors and visitors alike will have the added opportunity of tapping into a multifaceted marketplace of quality trade professionals and buyers from the Singapore and international medical technology and healthcare sectors. “Co-locating two stellar trade fairs

was a move that simply made sense. The unique quality of both shows are a perfect match, serving not just to enhance brand exposure for all participating exhibitors, but to create an exciting business playground where all parties have the opportunity to establish a strong business presence in the Asian marketplace, gaining a foothold in the fast growing medical and medtech industry”, said SC Koh, Executive Director, SPETA. Elaborating further, he said the colocated events encourages cross collaboration between both sets of delegates as they mutually tap on the pool of expertise present, spurring new ideas and efforts that could give birth to better and more innovative services and solutions. With Singapore poised to be the medical hub in Asia, MEDICAL MANUFACTURING ASIA 2014 looks set to establish itself as the premier trade fair for the rapidly developing medical technology and manufacturing sector for the


region, an industry that has proven resilient in the face of a challenging global economic climate. On the domestic front, MEDICAL MANUFACTURING ASIA continues to enjoy strong industry participation through support from SPETA, IE Singapore and SPRING Singapore, which collectively have galvanised local exhibitor signup and enquiries that have exceeded expectations. Keen to get in on the action, IVAM, an international association headquartered in Germany and comprising of companies and institutes in the field of micro technology, nanotechnology, advanced materials and optics & photonics, makes a starring return to MEDICAL MANUFACTURING ASIA 2014, following closely on its successful participation at the inaugural edition. With a dedicated pavilion, IVAM will pave the way for its partner organisations to leverage on this unique opportunity to showcase the latest product innovations and tap into the increasingly sophisticated medical sector here in Asia. IVAM will be in distinguished company, with returning nations Austria and Germany having confirmed their country pavilion status.

Augmenting MEDICAL MANUFACTURING ASIA’s trade fair and conference is the Global Asia Trade Exchange (GATE) 14 Medical Technology, an IE Singapore initiative, in partnership with SPETA. GATE14 Medical Technology is a premier procurement event that connects global buyers with Singapore’s medical device companies and suppliers whose offerings include end-to-end precision engineering assembly, product design and development, production and assembly, and prototype testing, to supply chain and distribution services. More information on MEDICAL MANUFACTURING ASIA, the 2-day Conference and the GATE 14 Medical Technology are available from www. medmanufacturing-asia.com.

About the Organisers The Singapore Precision Engineering and Tooling Association (www.speta.org/SPETA) is a trade association representing locally registered companies engaged in the manufacturing of moulds and dies, jigs and fixtures, metal stamping, metal castings, plastic and rubber moldings, precision machining, photonic and semi-conductor equipment, aerospace, automotive and medical parts as well as in providing services related to the precision engineering industry. Messe Düsseldorf Asia (www.messe-duesseldorf.de/MDA) is a subsidiary of Messe Düsseldorf in Germany, one of the world’s leading trade fair organisers, responsible for organising more than 20 global No. 1 exhibitions in various industries including medicine and health, specifically MEDICA, COMPAMED, REHACARE INTERNATIONAL and A+A held in Düsseldorf, Germany. With extensive expertise in organising trade fairs in Southeast Asia, Messe Düsseldorf Asia has developed a portfolio of numerous trade fairs in Southeast Asia since 1995.

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A supercomputer could change how diseases are treated

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he medical community has increasingly turned to genetic information to understand, treat and prevent disease in humans; but analyzing information from a single genome can take many months. Now, researchers working with one of the fastest supercomputers in the world are able to get data on 240 complete genomes in only 2 days. The researchers, from the University of Chicago, have published results of their analysis in the journal Bioinformatics. Aptly named Beagle - in reference to the ship that accompanied Charles Darwin on his well-known scientific journey in 1831 - the computer is based at Argonne National Laboratory in Illinois. Housed in the Theory and Computing Sciences building, Beagle supports computation, simulation and data analysis for the biomedical research community. The team notes that the declining cost of producing DNA sequences is resulting in an increase in whole genome sequencing. But this currently brings about a “computational bottleneck” due to the limited power of analyzing several genomes at once. Rather than looking at genomes one at a time, the supercomputer can process many genomes simultaneously. “It

converts whole genome sequencing, which has primarily been used as a research tool, into something that is immediately valuable for patient care,” says first author Megan Puckelwartz. Dr. Elizabeth McNally, the AJ Carlson Professor of Medicine and Human Genetics and director of the Cardiovascular Genetics clinic at the University of Chicago Medicine, says: “This is a resource that can change patient management and, over time, add depth to our understanding of the genetic causes of risk and disease.” WHY IS WHOLE GENOME SEQUENCING SO USEFUL?BEAGLE, A CRAY XE6 SUPERCOMPUTER Beagle is a Cray XE6 supercomputer. It was able to simultaneously analyze 240 full genomes in just 2 days. The team says that because the genome is so extensive, clinical geneticists have opted for exome sequencing, which involves looking closely at less than 2% of the genome, in regions that code for proteins. Although 85% of mutations that cause diseases are located in these regions, the other 15% of clinically important

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mutations come from non-coding regions. Formerly referred to as “junk DNA,” these mutations from non-coding regions are now known to have significance. But analyzing these regions requires sequencing the whole genome. In order to test Beagle, Dr. McNally and colleagues used raw sequencing data from 61 human genomes and analyzed it on the supercomputer. Using only one quarter of Beagle’s total capacity and publicly available software, the team found that it improved accuracy and greatly accelerated speed. Dr. McNally says these improvements reduce the price per genome, adding that “the price for analyzing an entire genome is less than the cost of looking at just a fraction of a genome.” Additionally, the team says this method of analysis will relieve the bottleneck scientists have been experiencing with cheaper and faster genetic sequencing. Findings have ‘immediate medical applications’ Dr. McNally says their findings have medical applications that can immediately be applied at the Cardiovascular Genetics clinic, where they rely on looking at genes from an initial patient and their family members to understand, treat or prevent disease. “We start

genetic testing with the patient, but when we find a significant mutation we have to think about testing the whole family to identify individuals at risk,” she says. Dr. McNally adds: “In 2007, we did our first five-gene panel. Now we order 50 to 70 genes at a time, which usually gets us an answer. At that point, it can be more useful and less expensive to sequence the whole genome.” By studying these genomes in light of patient and family histories, she says they can gain more knowledge about inherited disorders.”By paying close attention to family members with genes that place them at increased risk, but who do not yet show signs of disease, we can investigate early phases of a disorder. In this setting, each patient is a big-data problem,” she adds. MDA Magazine recently reported on a study published in PLOS Genetics that suggested some genetic variants could indicate the presence of rare genetic mutations that have yet to be discovered. The researchers said their discovery may point to a genetic “missing link” that could uncover previously unknown mechanisms behind common diseases.


In mHealth, BOW BOW Devices, Bluetooth Fairy and Selfie Dashboards Rule

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xperts in mHealth tend to throw data at conference audiences to describe the hottest area in the healthcare sector. But at the MD&M Executive Summit in Anaheim, California, one panelist used humor, instead. Experts on mHealth abound in the conference circuit who use available market data to show how the sector is exploding The usual stats are thrown out: Zillions of people will own smartphones by the year 20XX and they will have downloaded innumerable health apps. And by 20YY, the market for mHealth will grow to a gazillion dollars. But at the MD&M Executive Summit at Anaheim, California, Liam Pender, CEO of product design and development company Egret Technologies, took a different tack in describing trends that he believes is shaping the marketplace. Using humor, he talked about what’s powering the mHealth movement.

In other words, they are able to gather information that was previously largely available when you visited the doctor. BLUETOOTH FAIRY And how do these devices do that? Most of these devices are powered by wireless radios. Recently a low-cost wireless radio has been developed called Bluetooth Low Energy. Pender said that he is seeing many device manufacturers add wireless capability by simply fitting their devices with Bluetooth Low Energy. “These are simple, low-cost, ubiquitous,” he said. Egret Technologies worked with Boston University last summer to develop a bionic pancreas that

links a continuous glucose monitor to an infusion pump to an iPhone using Bluetooth Low Energy. More than 30 boys and girls with Type I diabetes were hooked up to such a bionic pancreas, which is not commercially available, Pender said. The device was able to achieve a “significant reduction in nocturnal hypoglycemia,” he said. SELFIE DASHBOARD One of the values of the mHealth movement is that it can empower patients with data about themselves. Drawing on the popular trend of taking pictures of oneself with one’s own smartphone known as a “selfies,” Pender talks of the Selfie Dashboard. He described it as actionable data being presented

to the user on their mobile devices in the manner that fitbit and other wearable devices do. While patients want all their data, doctors are looking for fewer metrics, but ones that are more important from a clinical perspective, Pender said. Ultimately, the value of the BOW BOW devices, the Bluetooth Fairy, and the Selfie Dashboard that are powering the mHealth movement is that they aim to transform healthcare as we know it They aim to improve the quality of care, drive more self-care, and potentially reduce the cost of care. “These technological advances have real clinical and commercial advantages,” Pender said.

BOW BOW DEVICES These aren’t devices that mimic barking dogs. Rather, the acronym stands for body-worn, battery-operated wireless (BOW BOW) devices. And these are all the rage in the mHealth sector right now. These can be anything from the fitbit wearable fitness trackers, to the Nike fuel band, to even heart-rate monitors and fetal monitors that use sensors to gather data automatically and seamlessly from the wearer. “These devices push data from the medical institution to the home,” he said.

Medical Device ASIA | May-June 2014 | 31


Broad Range of Products wins the impression at

1st Personalised Medicine & Diagnostics Expo (IVD Japan) - leaves big impact on Industry - big opportunities at IVD Japan 2014

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aunched in response to huge demands from the industry, Asia’s ONLY Exhibition & Conference specialised in Diagnostics and Testing for Personalised Medicine, 1st Personalised Medicine & Diagnostics Expo (IVD Japan 2014) held concurrently with BIOtech 2014 Japan, Asia’s largest bio event from May 14-16, 2014 at Tokyo Big Sight, Japan. 572 exhibitors from over 20 countries showed a wide range of products and services like Equipment, Reagents, Contract Services, IT, etc. for Diagnostics and Testing for Personalised Medicine, which were attended over by 11,000 industry professionals from the industries such as Lab Technicians/ Technologists, Research Coordinators, Lab Personnel in Clinical Trial Centers, SMOs, CROs, Lab Technicians/Technologists, Research Coordinators, Lab Personnel, Doctors in Medical Institutions, Clinical/-related Researchers in Universities, National/ Public Research Institutes, and Researchers specialized in Drug Discovery, Clinical Research in Pharmaceutical Companies. The Japanese Government is targeting Medical Care as the core of Japan’s growth strategy, and within that strategy, “Personalised Medicine” is chosen as one of the priority areas. A good example of that is the organisation of “Japanese NIH” with launching/preparation budget of approximately USD 2.26 billion, where 2 areas are chosen as priority sectors – Personalised Medicine and Regenerative Medicine. A series of new projects, easing of regulations and a large volume of 32 | May-June 2014 | Medical Device ASIA

subsidies involved, many overseas suppliers are setting their target to Japan and especially to these two fields. Reflecting the market situation, Reed Exhibitions Japan Ltd., the organiser of Asia’s largest bio event (BIOtech 2014 Japan -13th Int’l Bio Technology Exhibition & Conference) has decided to launch “1st Personalised Medicine & Diagnostics Expo (IVD Japan 2014)” concurrently with BIOtech Japan. Featuring the hottest fields in the current Japanese medical

industry - Personalised Medicine and Regenerative Medicine (covered by BIOtech Japan), these 2 shows gathered huge attention of the industry. Various seminars and conferences conducted during the show and leaders from the Bio-Industry participated who discussed various topics like New Growth Strategy -The Future of Medicine Created by Technological Innovation. Course Leader, Ken-ichi Arai, Professor Emeritus, The University of Tokyo / Director, Chairman, SBI Biotech Co.,


Ltd. & Sub-course Leader, Toichi Takenaka, Chairman, Japan Health Sciences Foundation during the key note session emphasised on the need for health care issues. Besides Hiroto Izumi, DirectorGeneral of the Office of Healthcare Policy, Special Advisor to the Prime Minister, Cabinet Secretariat strongly expressed the Health Care policies and development of new Framework for promoting Medical Research and Development in Japan. The size of the Japanese IVD market is a couple of billion dollars. Japan is the second-largest healthcare market in the world in terms of countries. Regionally, it’s third, after the United States and the European Union. Nevertheless, Japan is one of the top IVD markets in the world. Another point worth mentioning is that Japan is trying to transition from a fee-for-service system similar to that in the United States in the 1970s to more of a system it calls DPC [for diagnostic procedure combination], where they’ll pay so much per diagnosis rather than per procedure. The laboratory in the largest hospitals in Japan used to be a profit center. Now it is a cost center, similar to the way it is in the United States.

its business models from a macro level, what made it such a good industry from the very beginning was its ability to create annuityproducing business. Keeping in view of this the highly experienced team at Reed Exhibitions, Japan held the IVD 2014 successfully. Speaking on the healthcare reforms Overseas Director, Reed Exhibitions Ltd, Hajime Suzuki in an interview to Medical Device Asia, emphasized on some key note topics that helps every Japanese like freedom to choose a healthcare plan that meets your needs with portability of insurance that travels with employees anywhere from job to job and especially the cost and quality that harness the entrepreneurship from market

competition to drive down costs and quality up. Further Hajime Suzuki speaking on the Japanese Health Care Industry said “Japan must act quickly to ensure that its health care system can be sustained. It must close the funding gap before it becomes irreconcilable, establish greater control over supply of services and demand for health care, and change incentives to ensure that they promote high-quality, cost-effective treatment. Many of the measures needed address a number of problems simultaneously and may prove instructive for other countries.” The exceptionally good ratings given by all participants were also

reflected by the exhibitors and visitors, who gave the fair top overall ratings. On the exhibitor side, it reached around 90 percent; on the visitor side, it remained at the extraordinarily high level of 98 percent. On the visitor side, the same percentage – 98 percent – said they had achieved their goals for the fair. The exhibitors were almost as positive with over 85 percent saying they had reached their targets for the fair. Additionally, they were extremely pleased with the standard of the visitors to their exhibition stands. v

The next show will be held in 2015 from 13-15 May.

Japanese companies, tend to be very good at putting together highly complex robotic systems. The Western companies, however, seem to be much better at putting together the wet stuff. And frankly, looking at the IVD industry and Medical Device ASIA | May-June 2014 | 33


India’s ‘statement of intent’ with US FDA

Margaret A. Hamburg

On February 10 this year, the first day of the 10-day official trip to India, US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, signed a “Statement of Intent” with the government of India representated by Keshav Desiraju, Secretary, department of Health and Family welfare. Here are the points on which both countries agreed to cooperate: 1. Sharing of information relevant to lack of compliance with accepted current Good Manufacturing Practice, Good Clinical Practice, or Good Laboratory Practice, as appropriate, by manufactures and sponsors of medical product s and manufacturers of cosmetics, in one another’s country, or any other information as mutually decided upon. 2. Engaging collaboratively as observers in medical and cosmetic product and inspections conducted by the other Participant as per specific terms to be agreed and as time and resources allow. 3. Informing the respective regulatory authorities before undertaking inspections, so that host-country inspectors may join inspections as observers.

4. Collaborating in relevant scientific meetings, symposia, seminars, and other appropriate venues that may be organized either in the United States of America or the Republic of India. 5. Facilitating Participants’ holding (in persons or by teleconference) periodic discussions, possibly once every three months, to report and assess progress on current collaborations and implementation of this Statement of Intent, to address concerns and resolve issues leading to strengthening and improving the bilateral relationship, a1nd to identify new areas for collaboration. 6. Facilitating information-sharing between Participants as appropriate and allowable by law, in support of public health and product safety, quality, and effectiveness, as appropriate. 7. Each Participant intends to designate, within sixty calendar days after the

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signing of this Statement of Intent, a primary Point of Contact (POC) for the Participant who will be responsible for facilitating routine and emergency communication. 8. Each Participant is expected to bear all of its respective costs for activities under this Statement of Intent, unless the Participants decide otherwise; in such instances, the Participants intend to prepare a document that sets forth financial and technical responsibilities of each Participant. When alternative funding mechanisms have been decided upon, the Participants intend that the specific activities are to commence only after said

document is approved by the Participants. 9.This Statement of Intent does not create rights or obligations. 10. Cooperation under this Statement of Intent will commence on the date of its signature by both Participants and will continue for a period of five years. This Statement of Intent may be modified at any time by mutual written consent of the Participants. Either Participant may terminate this Statement of Intent through written notice of not less than ninety days to the other Participant. The Participants may also extend this Statement of Intent by exchange of letters for a further period of five years.


Efficacy of Beta-Hydroxybutyrate Chemistry Assay Driving Recognition as the New Standard of Care in Ketosis Testing about and validating the assay,” Mejia added. Benefits of the Stanbio ß-HB assay were recently on display at the Advanced Pediatric Emergency Medicine Assembly in New York, the SEMPA 360 (Society of Emergency Medicine® Physician Assistants) show in New Orleans and the Southeastern Critical Care Summit at the Emory University School of Medicine in Atlanta.

Diagnostic effectiveness is driving the accelerated acceptance of Stanbio Laboratory’s Beta Hydroxybutyrate LiquiColor® reagent in U.S. hospital chemistry laboratories. The assay is used primarily for determining both the presence and degree of ketosis in suspected diabetic ketoacidosis cases. Stanbio’s enzymatic Beta Hydroxybutyrate (ß-HB) assay produces an accurate and quantitative value that is specific to the ß-HB ketone. These performance qualities are making ß-HB the new clinical diagnostic standard of care for ketone testing. Currently, a major U.S. news magazine ranking shows that 15 of the top 25 diabetes and endocrinology hospitals are using a form of Stanbio’s ß-HB assay. In the U.S., more than 900 hospitals have implemented ß-HB testing to better serve their patients. Survey results from a widely

recognized laboratory reporting organization show that adoption of the Stanbio ß-HB chemistry assay is up 200% from 2011 to 2013. In 2011, 9% of surveyed facilities reported using a form of the ß-HB assay for ketone testing. The percentage has grown to 27% in 2013. “We’re happy about the increasing use of ß-HB in hospital labs,” said Stanbio Laboratory General Manager, Gilbert A. Mejia. “This escalating demand is also improving the way we’re presenting the open-channel reagent to healthcare organizations. For example, we’ve recently had widely recognized Ph.D.’s and physician champions help with our internal product training so we can articulate the efficacy of the test more concisely. We’re seeing the benefits of this new approach as more and more hospital organizations are inquiring

Founded in 1960 and headquartered in Boerne, Texas, Stanbio Laboratory manufactures and markets medical testing and diagnostic devices including clinical chemistry, pregnancy, strep A, serology, urinalysis, and point-ofcare hemoglobin tests. Stanbio Laboratory’s Quality System is ISO 13485 registered and its facility operates under USFDA current GMP requirements. Stanbio also offers OEM and private labeling capabilities and distributes products in over 125 countries worldwide. This year the company celebrates its 54th year in business. To find out more about Stanbio, review its news, or learn more about its products, visit www. stanbio.com. EKF Diagnostics Holdings plc is a worldwide manufacturer of near-patient care equipment for the measurement of glucose, lactate, hemoglobin, hematocrit and glycated hemoglobin (HbA1c). It offers its products to the professional clinical and research laboratories, doctors’ offices, sports clinics, and athletic testing sites. The company is headquartered in London, the United Kingdom.

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Scaffold Improves Heart Cell Growth When one’s heart is damaged by a heart attack or other injury, it can’t heal itself very well. This has prompted researchers at Columbia University (New York, NY) and the University of Minho, Portugal, to look for ways to repair the damage. In “Electrically Conductive Chitosan/Carbon Scaffolds for Cardiac Tissue Engineering,” a paper published on Biomacromolecules, the research team reports the results of experiments in growing neonatal rat heart cells on a matrix of chitosan and carbon nanofibers. Building on previous research, the scientists were aware that chitosan, which is derived from the shells of shrimp and other crustaceans, had good enough biocompatibility to serve as a scaffold for growing heart cells, but that chitosan was a poor electrical conductor. Since electrical impulses are what cause a heart to beat, they had to find a solution. Led by Gordana Vunjak-Novakovic, PhD, professor of biomedical engineering and director of the Laboratory for Stem Cells and Tissue Engineering at Columbia, and Ana M. Martins, PhD, Biomaterials, Biodegradables and Biomimetics Research Group, University of Minho, the researchers reasoned that carbon nanofibers could be used as a doping agent in a chitosan matrix. Carbon nanofibers are good conductors and are biocompatible. To this end, they prepared two types of scaffolds for their experiments. These scaffolds were made of chitosan only, and a chitosan/carbon nanofiber composite. In the composite, carbon nanofibers were homogeneously dispersed throughout the chitosan matrix. The researchers say that the composite scaffold was highly porous with fully interconnected pores and had excellent electrical properties. Both scaffolds were seeded with neonatal rat heart cells and cultured for up to 14 days. After 14 days of culturing, the team reports, the pores throughout the scaffold volume were filled with cells. They also saw that the metabolic activity of cells in the chitosan/carbon scaffolds was significantly higher as compared to the cells in the chitosan-only scaffolds. The incorporation of carbon nanofibers also led to increased expression of cardiac-specific genes involved in muscle contraction and electrical coupling. The researchers say that this study demonstrates that the incorporation of carbon nanofibers into porous chitosan scaffolds improved the properties of their cardiac tissue constructs. They presume this improvement was the result of enhanced transmission of electrical signals between the cells.

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J&J’s Cordis won a CE mark for its renal denervation device The company promises further study of the treatment option, which has faced setbacks at Medtronic Add Johnson & Johnson ($JNJ) to the list of companies that are moving ahead with their renal denervation programs in the wake of Medtronic’s ($MDT) major setback in the space earlier this year. The company’s Cordis division said it won CE marking for its Renlane renal denervation system, and doctors in Europe are already using the device to treat drug-resistant hypertension. Cordis said Renlane uses a helical-shaped, irrigated, multi-electrode ablation catheter combined with a multichannel radio-frequency ablation system. It is minimally invasive, performed through a catheter that is inserted through a small groin incision that runs up to the renal arteries through a blood vessel in the leg. Celene Martin, global president of Cordis, said in a statement that the company is “looking forward to gaining more experience with this therapy and making it available to more patients in need of treatment around the world.” Cordis’ success comes in the wake of Medtronic’s failure in January with its similar Symplicity device, which didn’t meet its efficacy endpoint in a sham-controlled pivotal trial. Medtronic paused its whole renal denervation program as a result, at least until it can learn more about what went wrong during the study. Rival Boston Scientific ($BSX) has said that it wants to move ahead with its related program, but also took a pause to wait for Medtronic’s results. St. Jude Medical ($STJ), whose approach is similar to Medtronic’s and Boston Scientific’s, said it would plow ahead with its program. Covidien ($COV) said it will abandon its renal denervation development program due to slower-than-expected market growth for the hypertension treatment. The company said its decision isn’t connected to Medtronic’s setback and noted it will look for other viable renal denervation treatment options in the future. There are other approaches targeting the marketplace ReCor Medical in California is pursuing a renal denervation program that relies on ultrasound blasts rather than radio-frequency energy to ablate renal nerves and lower blood pressure. Startup Ablative Solutions in Michigan is advancing its own renal denervation program, which uses a device that delivers a precise chemical treatment to the outer layer of the renal arteries (known as perivascular renal denervation).


Electrophysiology Technology Allows Early Disease Diagnosis

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esearchers developed a small analyser that could be able to detect medical conditions by measuring the electrical behaviour of cells. It may well be the minutia of biological cell properties, but the electrophysiological behaviour of our cells determines how effective the cells function, and indeed cellular survival. And the electrolyte balance in cells is often affected in disease conditions. With this in mind, a group of biological engineers based at the University of Surrey in the UK have used electrophysiological principals to develop new technologies to determine the presence of pathophysiology within the cells. The team, led by Professor Michael Hughes, developed a small analyser, which is able to determine the difference between healthy and unhealthy cells by measuring their electrical behaviour. They hope that the device will be able to detect oral cancers and other diseases at an early stage or subclinical presentation. The device, which has been named 3DEP (developed by DEPtech and distributed by Labtech), uses a technique known as dielectrophoresis. The technique works on the

basis that electrical properties of unhealthy cells differ from those of normal ones. The process involves the use of the reader which has been developed by the group, and an inexpensive disposable ‘3-D Well Plate’ chip, which delivers the cell sample for analysis. The aim is to produce a cheap (less than ÂŁ5), effective, accurate and quick diagnostic test that can be used across a wide range of disease states. The reader can deliver a result within approximately 10 seconds, according to the company.

Harnessing technology such as the 3DEP device, which uses well known techniques and the normal physiological state of cells to benchmark against abnormal functions, seems simple in principa,l but highly complex in development. It will be interesting to see how the technology develops.

The research group is currently working in association with the Eastman Dental Institute, the Royal Marsden and Bradford Royal Infirmary to conduct clinical trials to detect oral cancer, and also with the University of California in order to identify stem cells that could be used to repair cellular damage to the brain. There are many common diseases that simply do not currently have a cheap diagnostic test and the developers are hopeful that the 3DEP could be an effective and affordable answer to this problem. The well plates are available in a range of sizes making them flexible for a wide range of cell types and the technology has already been formally launched to the AES Electrophoresis Society and is commercially available. Medical Device ASIA | May-June 2014 | 37


More Than A Third Of Women Have Hot Flashes 10 Years After Menopause

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team of researchers from the Perelman School of Medicine at the University of Pennsylvania has found that moderate to severe hot flashes continue, on average, for nearly 5 years after menopause, and more than a third of women experience moderate/severe hot flashes for 10 years or more after menopause. Current guidelines recommend that hormone therapy, the primary medical treatment for hot flashes, not continue for more than 5 years. However, in the new study published online this week in the journal Menopause, the authors write that “empirical evidence supporting the recommended 3- to 5-year hormone therapy for management of hot flashes is lacking.” Hot flashes are episodes of intense radiating heat experienced by many women around the time of menopause. They can result in discomfort, embarrassment, and disruption of sleep. Changing hormone levels

are believed to cause hot flashes and other menopausal symptoms such as insomnia, fatigue, memory and concentration problems, anxiety, irritability, and joint and muscle pain. In hormone therapy, medications containing female hormones replace the ones the body stops making during menopause. While hormone replacement therapy (HRT) is considered the most effective treatment for hot flashes, it is not appropriate for all women. In addition, concerns about health hazards linked to HRT have made some doctors less likely to prescribe it, or to adhere strictly to recommended duration guidelines.

Obstetrics and Gynecology at Penn Medicine. “While leading non-hormone therapies such as Paxil or Escitalopram may provide some relief of menopausal symptoms for some women, for others, they may not be as effective as hormone-based therapy.”

“Our findings point to the importance of individualized treatments that take into account each woman’s risks and benefits when selecting hormone or non-hormone therapy for menopausal symptoms,” said the study’s lead author, Ellen W. Freeman, PhD, research professor in the department of

In addition, obese white women and African American women (both obese and non-obese) had the greatest risk of moderate/severe hot flashes during the period studied, whereas non-obese white women had the lowest risk. The increased risk of hot flashes in obese women has previous-

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The study evaluated 255 women in the Penn Ovarian Aging Study who reached natural menopause over a 16-year period (1996-2012). The results indicate that 80 percent (203) reported moderate/severe hot flashes, 17 percent (44) had only mild hot flashes, and three percent (8) reported no hot flashes.

ly been associated with lower levels of estradiol (the most potent estrogen produced by women’s bodies) before menopause, but the new finding that non-obese African-American women also have a greater risk of hot flashes remains unexplained. An earlier report from the Study of Women’s Health Across the Nation indicated that African-American women may be more likely to report hot flashes and also have greater symptom sensitivity, suggesting that cultural differences may affect hot flash reporting, but further evidence is needed. The Penn study also found a 34 percent lower risk of hot flashes among women with education beyond high school, a finding that researchers say also calls for additional study. In addition to Freeman, other Penn co-authors are Mary D. Sammel, ScD, from the Center for Clinical Epidemiology and Biostatistics, and Richard J. Sanders.


Radiology and Technology: “Numerous phantom studies have been conducted that prove the advantages of this new CT system”

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adiologists usually do their work after oncologists when it comes to cancer treatment. Yet modern radiology also provides treatments at this point. MDA magazine spoke with Professor Stefan Schönberg, Director of the Institute of Clinical Radiology and Nuclear Medicine at the University Medical Center Mannheim, Germany, about the use of a new computer tomograph and its benefits for patients. MDA: Why is it so hard to conduct evidence-based studies in radiation therapy? Stefan Schönberg: Evidence-based studies that are meant to generate a high level of evidence are generally geared towards the treatment success for patients. This creates problems in traditional – pure diagnostic – radiology. That’s because diagnostic processes are subor-

dinate to clinical decisions, which have an immediate influence on the outcome for patients, so that the contribution of diagnostic radiology is often difficult to determine in terms of outcome. These limitations can only be overcome through a strong and early-specified interdisciplinary integration of radiology into clinical trials. However, with deep integration of modern radiology into trials where clinical treatment decisions are prospectively made based on new functional and quantitative molecular data, there is the chance of generating strong evidence for these procedures. Thanks to the very close clinical, exemplary and practical, formal and infrastructural collaboration created by the Mannheim research campus M2OLIE with clinical academic subjects, radiology and nuclear medicine, respectively, we were already able to largely implement this in our facility. One good example for this is the M2TreatIT process chain defined within the scope of M2OLIE for the diagnosis and treatment of patients with liver cancer. Based on a functional 4D CT and MRT image data set fused before an intervention, patients are specifically treated with the ZEEGO interventional robotic imaging system before a scheduled transarterial chemoembolization. MDA: How does the CT at the research campus differ from other devices? Schönberg: Unlike traditional CT

systems, the Somatom FORCE CT system available at the research campus delivers ultra rapid CT analysis at a tube voltage of just 70 kV. This low tube voltage cannot be used with adult patients in other systems, since the ejection fraction of conventional X-ray tubes is not sufficient in this voltage range. However, aside from a significant reduction in radiation dose with 70 kV exams, this technology also allows an increase in image contrast thanks to an increased presentation of even the tiniest amount of iodinated contrast agents. Thanks to the combination of these two advantages, so-called temporal resolution of dynamic 4D CT perfusion scans to measure microvascular tissue blood flow is clinically applicable in the first place and ethically justifiable due to the dose reduction. MDA: Have you already started a study that is able to prove the advantages of the new CT scan? Schönberg: All patients examined with the Somatom Force are studied in clinical trials based on the establishment of our newly created translational CT center at the Mannheim research campus, which is sponsored by the German Federal Ministry of Education and Research (BMBF). Numerous phantom studies have been conducted that prove the advantages of this new CT system. The focus of our studies are radiation dose reduction, the reduction of iodinated contrast agents that potentially damage the kidneys, as well as an ultra rapid CT to use with children and patients, who are not able to hold their breath during an exam. These topics are incorporated into our current oncological studies on functional microvascular imaging in oncology and therefore into the diagnostic process as defined by the research campus and the inter-

ventional treatment of patients with so-called “oligometastastic“ cancer. MDA: Why is it so difficult to show primary cancer in imaging? Schönberg: During conventional CT scans, which are only performed during a specific timeframe after the contrast agent has been applied, very small primary cancers often show similar density values compared to the surrounding healthy tissue and can thus escape detection. Thanks to the multiple 4D CT perfusion scans done at different times, now you can quantitatively measure the microvascular blood flow in the tissue in addition to the pure density data. Even the tiniest lesions can thus be better detected through this additional multiparametric information on tissue blood flow, tissue blood volume, tissue permeability as well as the transit time of a contrast agent through the tissue. MDA: How is the collaboration with the oncologists? Schönberg: We are very fortunate in that we achieved excellent teamwork between radiology, oncology, radiation therapy, surgery and cardiology in Mannheim. This close collaboration enables us to provide our clinical colleagues with an understanding of functional and molecular procedures that have partially just been developed during the past few years. This ensures that this information can also be used to the patient’s full benefit. This is not just important from a clinical point of view, but it is also an ethical obligation. As radiologists, we learn to truly research the questions that are clinically relevant to our colleagues thanks to this tightly knit cooperative partnership.

Medical Device ASIA | May-June 2014 | 39


Growth of the Medical Tourism Industry

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he countries where medical tourism is being actively promoted include Greece, South Africa, Jordan, India, Malaysia, Philippines and Singapore. India is a recent entrant into medical tourism. According to a study by McKinsey and the Confederation of Indian

Industry, medical tourism in India could become a $1 billion business by 2012. The report predicts that: “By 2014, if medical tourism were to reach 25 per cent of revenues of private up-market players, up to Rs 10,000 crore will be added to the revenues of these players”. The Indian government predicts that India’s $17-billion-ayear health-care industry could grow 13 per cent in each of the next six years, boosted by medical tourism, which industry watchers say is growing at 30 per cent annually. In India, the Apollo group alone has so far treated 95,000

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international patients, many of whom are of Indian origin. Apollo has been a forerunner in medical tourism in India and attracts patients from Southeast Asia, Africa, and the Middle East. The group has tied up with hospitals in Mauritius, Tanzania, Bangladesh and Yemen besides running a hospital in Sri Lanka, and managing a hospital in Dubai. Another corporate group running a chain of hospitals, Escorts, claims it has doubled its number of overseas patients - from 675 in 2000 to nearly 1,200 this year. Recently, the Ruby Hospital in Kolkata signed a contract with the British insurance company, BUPA. The management hopes to get British patients from the queue in the National Health Services soon. Some estimates say that foreigners account for 10 to 12 per cent of all patients in top Mumbai hospitals despite roadblocks like poor aviation connectivity, poor road infrastructure and absence of uniform quality standards.

Analysts say that as many as 150,000 medical tourists came to India last year. However, the current market for medical tourism in India is mainly limited to patients from the Middle East and South Asian economies. Some claim that the industry would flourish even without Western medical tourists. Afro-Asian people spend as much as $20 billion a year on health care outside their countries - Nigerians alone spend an estimated $1 billion a year. Most of this money would be spent in Europe and America, but it is hoped that this would now be increasingly directed to developing countries with advanced facilities. Promotion Of Medical Tourism The key “selling points” of the medical tourism industry are its “cost effectiveness” and its combination with the attractions of tourism. The latter also uses the ploy of selling the “exotica” of the countries involved as well as the packaging of


health care with traditional therapies and treatment methods. Price advantage is, of course, a major selling point. The slogan, thus is, “First World treatment’ at Third World prices”. The cost differential across the board is huge: only a tenth and sometimes even a sixteenth of the cost in the West. Open-heart surgery could cost up to $70,000 in Britain and up to $150,000 in the US; in India’s best hospitals it could cost between $3,000 and $10,000. Knee surgery (on both knees) costs 350,000 rupees ($7,700) in India; in Britain this costs £10,000 ($16,950), more than twice as much. Dental, eye and cosmetic surgeries in Western countries cost three to four times as much as in India.

is utilised. Kerala Ayurveda centres have been established at multiple locations in various metro cities, thus highlighting the advantages of Ayurveda in health management. The health tourism focus has seen Kerala participate in various trade shows and expos wherein the advantages of this traditional form of medicine are showcased. A generic problem with medical tourism is that it reinforces the medicalised view of health care. By promoting the notion that medical services can be bought off the shelf

from the lowest priced provider anywhere in the globe, it also takes away the pressure from the government to provide comprehensive health care to all its citizens. It is a deepening of the whole notion of health care that is being pushed today which emphasises on technology and private enterprise. The important question here is for whom is ‘cost effective’ services to be provided. Clearly the services are “cost effective” for those who can pay and in addition come from countries where medical care costs are exorbitant - because of the fail-

ure of the government to provide affordable medical care. It thus attracts only a small fraction that can pay for medical care and leaves out large sections that are denied medical care but cannot afford to pay. The demand for cost effective specialized care is coming from the developed countries where there has been a decline in public spending and rise in life expectancy and non-communicable diseases that requires specialist services.

The price advantage is however offset today for patients from the developed countries by concerns regarding standards, insurance coverage and other infrastructure. This is where the tourism and medical industries are trying to pool resources, and also putting pressure on the government. We shall turn to their implications later. In India the strong tradition of traditional systems of health care in Kerala, for example, Medical Device ASIA | May-June 2014 | 41


Ovarian Cancer Gene May Point to Early Removal of Ovaries

Women who carry a BRCA1 gene mutation and have their ovaries removed by age 35 appear to dramatically reduce their odds of developing ovarian cancer and dying, a new international study finds. Having this procedure, called oophorectomy, may reduce the odds of dying by age 70 by about 77 percent, researchers say. Women who have BRCA1 or BRCA2 gene mutations are at greater risk of developing breast and/or ovarian cancer. “We have a strong basis to recommend that women who have a BRCA1 mutation really benefit from having an oophorectomy, and they should have it by age 35,” said lead researcher Dr. Steven Narod, a professor of medicine at the University of Toronto, in Canada. Women with BRCA2 mutations can delay surgery until they’re 40, since their risk of ovarian cancer is not as strong, he added. The procedure made news last year when film star Angelina Jolie, a carrier of the BRCA1 mutation, announced plans to have her ovaries removed. Previously, she had

undergone a preventive double mastectomy. Jolie’s mother, actress Marcheline Bertrand, died of ovarian cancer at the age of 56. Study author Narod noted that the benefits of the surgery outweigh the side effects. Those side effects include menopause symptoms, such as hot flashes and sleep disturbances, which can be managed by hormone replacement therapy, he said. Other side effects may include a small increase in the risk for heart disease and possibly memory and thinking problems. Of course, removing the ovaries means not having children, but by 35 the women could have already started a family, Narod said. The real challenge, Narod added, is getting women screened for BRCA mutations. Most women who have these mutations don’t know they have them. “Probably only one in 300 women carry these mutations,” he said. “If we are going to get the full impact, it’s important that more women get tested,” Narod said. But making genetic testing more

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available means lowering the cost from around $1,000 to $100, he added. Narod’s team is currently running pilot programs in Iceland and Bermuda testing every woman who has a mammogram for BRCA mutations as well. Ovarian cancer is often called the “silent killer” because symptoms may not appear until the cancer had spread. In 2013, the U.S. National Cancer Institute estimated that 22,240 women would be diagnosed with the disease that year and 14,030 would die from it. This is why in the United States, as many as 70 percent of women who know they carry BRCA mutations choose to have their ovaries removed, the researchers noted. The report was published Feb. 24 in the Journal of Clinical Oncology. For the study, researchers from North America and Europe used an international registry to identify 5,783 women who carried mutations of the BRCA genes. Among these women, 2,270 did

not have their ovaries removed. Another 2,123 had already had the surgery at the start of the study, and 1,390 women had surgery during the study follow-up period from 1995 to 2011. During an average follow-up of 5.6 years, 186 women developed either ovarian cancer, fallopian tube cancer or peritoneal cancer (cancer of the abdominal lining that covers the uterus), the researchers found. Narod’s group reported that women who had their ovaries removed reduced their risk of ovarian cancer by 80 percent. Among women with a BRCA1 mutation, delaying the surgery until age 40 increased the risk of ovarian cancer by 4 percent and the risk increased 14.2 percent if a woman waited until age 50 before having the operation. For women with the BRCA2 mutation alone, however, the risk of developing ovarian cancer was very low. Among such women in the study, only one developed ovarian cancer. The researchers noted that the lifetime risk of ovarian cancer


among all women -- including those without BRCA mutations -- is only 1.4 percent. During the study, 511 women died: 333 died of breast cancer, 68 from ovarian, fallopian tube or peritoneal cancers, and the rest from other causes. In total, having the ovaries removed reduced the risk of death from any cause by 77 percent. The majority of this reduction comes from the reduced risk of ovarian, fallopian tube, peritoneal and breast cancers, the researchers explained. In a previous study, Narod’s group found that removing the ovaries also reduced the risk of breast cancer by 48 percent in women with a BRCA1 mutation, and the risk of dying from breast cancer by 70 percent in women diagnosed with the disease, according to an Amer-

ican Society of Clinical Oncology news release. Dr. Andrew Menzin, the associate chief of gynecologic oncology at North Shore-LIJ Cancer Institute in Manhasset, N.Y., said the new study “provides strong support for this intervention and can help people decide, in the context of their lives, what to do.” Menzin, who was not involved with the study, said that women with a family history of breast or ovarian cancer should be screened by their primary care doctor. Since genetic testing has not only medical but also other implications -- such as the anxiety it can cause -it should only be done along with genetic counseling to interpret the results, he noted. “It’s a combination of the science of medicine and

the art of medicine,” he said.

Next Generation Student Microscopes – Setting Exemplary Preconditions in Educational Microscopy Working Fast and Efficiently to Achieve Better Results in the Microscopy Classroom

To set exemplary preconditions for students in life science courses, Leica Microsystems continues to enhance the Leica DM100 and Leica DM300 Educational Microscopes. Both microscopes are now equipped with new high performance achromat objectives and ISO labeled plan achromat objectives. There is also a new open monocular tube and an improved optical correction for the binocular tubes. Especially for the Leica DM300, the mechanical stage is now improved with enlarged stage travel. All of the added and improved features of both microscopes are geared to enhance the learning process in the microscopy classroom. They allow students a clearer view on the specimens, so more details can be discovered. Improved field flatness with high

performance objectives The Leica DM100 and Leica DM300 are supplemented with new achromat objectives, featuring an improved field flatness, so that a bigger area of the specimen is in focus. Conforming to ISO 190121:2013, both microscopes can also be equipped with a state-of-the-art set of plan achromat objectives. The international ISO label validates the high performance and quality of these objectives. Visualizing more details with higher contrast Leica Microsystems also enhanced the binocular viewing tubes. The newly corrected binocular tubes enable users to observe the specimen in a higher contrast. For more flexibility in the working process, the Leica microscopes are also provided with a new open monocular tube. This way, students

can swap eyepieces quickly and add some with reticles for measurement if necessary. Working efficiently and saving time Especially for the Leica DM300, Leica Microsystems enhanced the mechanical stage. It features an improved 76 mm x 50 mm stage travel, which can cover two standard microscope slides. The students are now able to scan two slides at the same time and observe every part of the specimens – even if the specimen fills out the whole specimen slide. This makes working with the Leica DM300 more efficient and also time-saving.

improvements will be a welcome enhancement for the increasing demands of the microscopy classroom. The students can now work more efficiently, save time and enhance their learning process”, says Vince Vaccarelli, Educational Product Manager of the Leica Microsystems Industry Division, Buffalo, USA.

For many years, Leica Microsystems has supported students with high quality microscopes to maximize the students’ learning experience. “The DM100 and DM300 Medical Device ASIA | May-June 2014 | 43


Heart at more risk in winters! • •

Intake of too much alcohol can lead to atrial fibrillation, a common form of Arrhythmia Avoid binge eating and focus on eating small quantities at regular intervals - Dr Vanita Arora, Associate Director & Head, Cardiac Electrophysiology Lab and Arrhythmia Services, Max Hospital

“People become more prone to heart attacks in winters. The arteries that arise from the aorta become constricted with the fall in temperatures, as a result of which the heart has to put more effort to pump the blood. This makes the heart stress out and it leads to a heart attack. It is more risky for those who do not have any inkling about pre-existing heart conditions,” says Dr Arora.

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It is important, she says, to keep a constant check on cardiovascular risk factors, and make sure that the winter season brings no harm to your health. he plummeting mercury raises the risk of getting a heart-attack and it is the time when one needs to remain extra cautious.

As viscosity of blood increases with the drop in temperature, the number of cases of heart attacks and other coronary artery diseases increase during winters. The limited awareness about the triggers that lead to heart attack and precautions which can be taken to avoid it during winters is a major cause of worry. Dr Vanita Arora, Associate Director & Head, Cardiac Electrophysiology Lab and Arrhythmia Services, Max Hospital, discusses vulnerability of the heart in order to empower people suffering from cardio vascular diseases with the right kind of prevention, more so during the winter season. 44 | May-June 2014 | Medical Device ASIA

Cholesterol levels fluctuate significantly with the change in the season, which may leave people with borderline high cholesterol with greater cardiovascular risk during the winter months. Apart from managing cholesterol levels, it is crucial that we keep small things in mind and do not stress the heart. Do not ever indulge in overdoing anything and exhausting yourself. Give yourself a break and take frequent rest breaks so that you do not overstress your heart; even if that means alteration in your otherwise intense workout regime. Avoid going for a walk in the morning in extreme chilly days and you can shift your walks in the evening when it is still sunny. People also end up eating more than the normal quantity in winter,

but eating a large meal at one go can put an extra load on your heart. Avoid! It is rather preferable to eat small quantities at regular intervals. Do not over indulge in alcohol, thinking that it will only help you in keeping warm and cozy. Too much of alcohol intake can cause atrial fibrillation, a common irregular heartbeat problem called Arrhythmia that is suffered by millions of people. On consultation of the doctor, one can also keep pills with them and can consume it on confronting breathlessness or chest pain. Pills like Sorbitrate when consumed prevent attacks of chest pain. It helps to buy time to see a doctor. Heart failure leads to most deaths in hypothermia. To keep hypothermia at bay, it is advisable to cover yourself with layers of warm clothes. Besides this, it is advisable to take a bath with warm water only. Also, never ignore any discomfort in chest; severe sweating; pain in neck arms, jaws and shoulders; or shortness of breath. All this might give you a warning signal. Visit a doctor if you come across any of these symptoms. Regular check-ups are always advisable. It will help you pre-empt any big health trouble. It is rightly said that ‘prevention is better than cure’!


FDA Approves Imbruvica to Treat Chronic Lymphocytic Leukemia

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he U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy. CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013. Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy. “Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.” Under the agency’s accelerated approval process, the FDA may approve a drug based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Drugs receiving accelerated approval are usually subject to an agreement to conduct confirmatory trials verifying and describing clinical benefit. Imbruvica for CLL also received priority review and orphan-product designation because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, respectively.

ceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established. The most common side effects observed in the clinical study include low levels of platelets in

the blood (thrombocytopenia), diarrhea, bruising, a decrease in infection-fighting white blood cells (neutropenia), low red blood cells (anemia), upper respiratory tract infection, fatigue, pain in the muscles and bones (musculoskeletal pain), rash, fever (pyrexia), constipation, swelling of tissues (peripheral edema), joint pain (arthralgia), nausea, mouth sores (stomatitis), sinus infection (sinusitis) and dizziness.

The FDA’s accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated participants. On average, participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420 milligram orally administered dose of Imbruvica until the treatment reached unacMedical Device ASIA | May-June 2014 | 45


Medical devices with longer lasting nanoelectronics The debut of cyborgs who are part human and part machine may be a long way off, but researchers say they now may be getting closer. In a study published in ACS’ journal Nano Letters, they report development of a coating that makes nanoelectronics much more stable in conditions mimicking those in the human body. The advance could also aid in the development of very small implanted medical devices for monitoring health and disease. Charles Lieber and colleagues note that nanoelectronic devices with nanowire components have unique abilities to probe and interface with living cells. They are much smaller than most implanted medical devices used today. For example, a pacemaker that regulates the heart is the size of a U.S. 50-cent coin, but nanoelectronics are so small that several hundred such devices would fit in the period at the end of this sentence. Laboratory versions made of silicon nanowires can detect disease biomarkers and even single virus cells, or record heart cells as they beat. Lieber’s team also has integrated nanoelectronics into living tissues in three dimensions - creating a “cyborg tissue.” One obstacle to the practical, long-term use of these devices is that they typically fall apart within weeks or days when implanted. In the current study, the researchers set out to make them much more stable. They found that coating silicon nanowires with a metal oxide shell allowed nanowire devices to last for several months. This was in conditions that mimicked the temperature and composition of the inside of the human body. In preliminary studies, one shell material appears to extend the lifespan of nanoelectronics to about two years.

High-tech glasses help surgeons see cancer cells

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esearchers at Washington University School of Medicine in St. Louis, MO, have developed a way of visualizing cancer cells using high-tech glasses designed to make it easier for surgeons to distinguish between cancerous and healthy tissue. Cancer cells are notoriously difficult to see, even when highly magnified, and the hope is the special glasses will help surgeons remove all of the tumor tissue and avoid leaving behind any stray cancer cells. Viewed through the glasses, cancer cells appear to glow blue under a special light, thanks to a fluorescent marker injected in the tumor that attaches only to cancerous and not to healthy cells. Also, the lighter the shade of blue, the more concentrated the cancer cells are. Dr. Julie Margenthaler, a breast surgeon and associate professor of surgery at Washington University, recently carried out the first operation to use the wearable technology, which has not yet been officially named. She says the technology is still in its early stages and needs to undergo more development and tests, but they are encouraged by the benefits it may offer to patients. She adds: “Imagine what it would mean if these glasses eliminated the need for follow-up surgery and the associated pain, inconvenience and anxiety.” Current tumor surgery often requires further operations. At present, when operating to remove a tumor, surgeons are expected to remove the cancerous tissue and also some neighboring tissue that may or may not include cancer cells. Breast surgeon Dr. Julie Margenthaler uses the high-tech glasses to visualize cancer cells in a patient. Image credit: Robert Boston/Washington University School of Medicine Samples of the tissue are then sent to the lab to be examined under a microscope, and if cancer cells are found, the patient often has to have a second operation to remove more tissue, which is then also sent to the lab. According to Dr. Margenthaler, about 20-25% of breast cancer patients who undergo lumpectomy need to come back for a second operation. In 2012, British researchers writing in the BMJ describe how one fifth of women with breast cancer who choose breast conserving surgery instead of mastectomy eventually need another operation because the first operation fails to remove all of the tumor. If the new wearable technology proves successful, it would eliminate the need for further procedures and reduce stress for patients, as well as save time and money. ‘Goal to make sure no cancer is left behind’ Samuel Achilefu, professor of radiology and biomedical engineering at Washington University led the team that developed the device. In a paper that was published in a November 2013 issue of the Journal of Biomedical Optics, they described how the new technology helped detect tumors as small as 1 mm in diameter. “This technology has great potential for patients and health care professionals,” says Prof. Achilefu. “Our goal is to make sure no cancer is left behind.” Another surgeon, Ryan Fields, an assistant professor of surgery at Washington University, is planning to wear the glasses when he removes a melanoma from a patient later this month. Prof. Achilefu is currently seeking FDA approval for a molecular agent to use with the glasses that specifically targets and stays longer in cancer cells than the one he and his colleagues used in pilot studies on mice, which is already approved by the FDA.

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ew smartphone apps ‘detect epilepsy and improve stroke care’

In these modern times, there is practically a smartphone app for all aspects of life. Now, new research has detailed two new apps that could help people detect epileptic seizures and receive better treatment for stroke. The two new studies will be presented at the American Academy of Neurology’s 66th Annual Meeting in Philadelphia, PA, in April. For the first study that looks at the creation of the epilepsy app, the research team analyzed 67 people with the condition. They were asked questions about their seizures, and the researchers used the most useful questions and answers that could predict an

epileptic seizure in order to create the app.

STROKE APP ‘COULD IMPROVE PATIENT CARE’

The investigators tested the app on 132 individuals with epilepsy in India and Nepal and compared the results with their doctors’ diagnoses.

For the second study, Dr. Claude Nguyen, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues created an app they say could enable doctors to provide more effective care for patients who have suffered acute stroke.

The researchers found that the app was informative in 87% of people, and it complied with doctors’ diagnoses in 96% of these cases. Commenting on the findings, Dr. Victor Patterson, a neurologist from Belfast in the UK and co-author of the study, says: “It can often be difficult to determine whether someone is having an epileptic seizure. This app will help health professionals evaluate and make the diagnosis, especially when doctors are not available.”

Dr. Nguyen says he first thought about a stroke app when he was a fellow at the University of Texas Health Science Center at Houston. He told Medical News Today that as a physician treating acute stroke patients, he needed a tool that would allow him to “accomplish several goals simultaneously.” He wanted to be able to treat the patient in a timely manner, treat them within certain benchmarks and evaluate them for eligibility in clinical trials. “In addition, I often needed to contact research study coordinators or other personnel,” he adds. “I created the app as a way to centralize and streamline these seemingly disparate tasks.” Dr. Nguyen said the app is designed to be used in real-time. He explained that a doctor can enter data about a patient, such as symptom onset time, demographics and

their score on the National Institutes of Health (NIH) Stroke Scale. Using these data, the app can then determine which clinical trials the doctor might consider the patient for. “The app also has a stopwatch feature to track and record treatment times, a phonebook to allow quick contact of study personnel and access to inclusion/exclusion criteria for clinical trials,” he added. Dr. Nguyen said he believes the app will become widely used for stroke care: “On the most basic level, the app can be used as a quality assurance and workflow tool to ensure that practitioners are meeting treatment times for acute stroke. What makes this app novel is that it can help identify patients who are eligible for clinical trials, which is the key toward finding the next stroke treatment.” It seems mobile technology is increasingly being investigated for use in the medical world. Last year, MDA magazine detailing a portable smartphone microscope that is able to detect viruses, while other research reported how smartphone photography could assist with eye disease diagnosis.

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BIOMEDICAL BIG DATA ANALYSIS COMPANY GENALICE RECEIVES A MULTI-MILLION EURO CAPITAL INVESTMENT evaluated and installed by highvolume NGS centers, institutes and companies around the world. Karten states: “We have been greatly encouraged by real-world results which are proving to be the breakthrough that our models had forecast. It is no surprise that some of the early Illumina HiSeq X Ten customers are already users of MAP. We welcome further enquiries from organizations engaged in genomic data analysis so they can see the results for themselves, in their own environment and under their own conditions.

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utch Software Company GENALICE announced that it has reached an agreement on a multi-million euro capital investment from Redbrae, a consortium of US- and UK-based private equity investors. The investment consortium has a strong network in the United States, United Kingdom and Middle East. It has been working with GENALICE for the past year. The successful validation and launch of GENALICE MAP, the company’s groundbreaking DNA data processing solution, formed the basis for the latest financial injection that will provide significant backing to accelerate further product development and distribution. Lead investor Zaheer Sardar, comments: “With the successful validation of GENALICE MAP, we really have found a major game changer in the field of genomics. Big data analysis is a critical problem in this area, and we are delighted to

back a company that has developed an innovative product resulting in greater accuracy, improved speed and lower costs. Our investment will contribute to accelerating this exciting phase of the GENALICE story.” During a 24-hour webcast in December 2013, GENALICE showcased MAP’s robustness and spectacular performance. The product is up to 100 times faster than conventional tools on commodity hardware. Hans Karten, GENALICE’s CEO/CTO, adds: “Our MAP product is based on several technical innovations and is a leap forward for researchers demanding high-quality and cost-effective DNA data processing. With the advent of the $1,000 genome, GENALICE provides a correspondingly lowcost data processing and storage solution, available immediately. We view this as a very positive outcome for users of Illumina X Ten sequencing machines, as GENALICE

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provides a highly efficient IT solution to deal with massive data-file production. For example, GENALICE’s XS model is capable of processing data at a speed that can exceed the maximum throughput of an ultra-high-throughput sequencer; the Illumina X Ten farm, which can process 18,000 full genomes per year. But our sequence alignment and variant calling solution offers so much more than ultra-fast processing of NGS data. GENALICE MAP truly raises NGS data processing and analysis to a new level of performance, with world-beating accuracy, significant storage cost reductions, full compatibility with other pipelines and excellent userfriendliness. GENALICE provides a comprehensive solution to the analysis speed and file-size problem in a single product, so researchers can move straight to the science and concentrate on solving genetic problems.” GENALICE MAP is already being

We would be prepared to discuss evaluation kits for qualified prospects, as we believe the solution will quickly prove its value." About GENALICE GENALICE is a privately owned, innovative software company, based in the Netherlands. It designs and builds groundbreaking software solutions for cost effective and accurate DNA data processing on commodity hardware. Its mission is to save lives and improve the quality of life of people with complex DNA-related diseases, such as cancer. With state of the art technology GENALICE wants to make an important contribution to improved drug development, diagnosis and treatment. For more information please contact: GENALICE B.V. Jos Lunenberg, MSc, MBA Chief Business Officer M +31 6 100 99 773 T +31 88 1221 000 jos.lunenberg@genalice.com www.genalice.com


World's smallest, leadless heart pacemaker implanted

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t's about the size of a large vitamin pill, and, for the first time in Ohio, the smallest heart pacemaker available is being tested at The Ohio State University Wexner Medical Center. Doctors at Ohio State's Richard M. Ross Heart Hospital recently implanted the tiny device in a Columbus woman as part of a global clinical trial to test its safety and effectiveness. Unlike conventional pacemakers, which require a chest incision and electrical leads that run through a vein to the heart, this device is wireless and is threaded through a catheter, then attached directly to the heart

muscle. "With this investigational device, the battery, the pacing electrodes, everything is in a little piece of metal sitting inside the heart. We believe that will eliminate a lot of risk for infection and complications," said Dr. John Hummel, a cardiologist and principal investigator of the trial at Ohio State. If this transcatheter, leadless pacemaker technology works the way doctors hope, they say it could not only benefit patients, but the minimally invasive approach would be more efficient.. "I think this could be a significant development in pacing procedures.

despite medication and other treatments to restore rhythm, so she was eager to be among the first in the United States to participate in this clinical trial.

This could cut our procedure time by more than half," said Dr. Ralph Augostini, a cardiologist at Ohio State. For now, the tiny pacemaker is being tested in people with bradycardia who need single chamber ventricular pacing. Bradycardia is a slow, irregular heart rhythm which prevents the heart from pumping enough blood into the body. This can cause fatigue, dizziness, shortness of breath and fainting. A former librarian, 77-year-old Mary Lou Trejo of Columbus, had been suffering from atrial fibrillation for years. Her heart had slowed,

"The new pacemaker sounded so simple, and I have always thought research is important, so I thought this is a way I could contribute," Trejo said. The trial will enroll 780 patients in 50 centers worldwide. Investigators are expected to report initial results later this year, once the first 60 patients have been followed for three months.

New ultrasound device may add in detecting risk for heart attack, stroke Researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed an ultrasound device that could help identify arterial plaque that is at high risk of breaking off and causing heart attack or stroke. At issue is the plaque that builds up in arteries as we age. Some types of plaque are deemed "vulnerable," meaning that they are more likely to detach from the artery wall and cause heart attack or stroke. "Existing state-of-the-art technologies are capable of determining if plaque is present in the arteries, but can't tell whether it's vulnerable. And that makes it difficult to assess a patient's risk," says Dr. Paul Dayton, co-author of a paper on the new device and professor in the joint biomedical engineering department at NC State and Chapel Hill. "Our goal was to develop something that could effectively identify which plaques are vulnerable." There are two ultrasound techniques that can help identify vulnerable plaques, but both depend on the use of contrast agents called "microbubbles." The first technique is to identify "vasa vasorum" in arteries. These are clusters of small blood vessels that often infiltrate arterial plaque, and which are considered indicators that a plaque is vulnerable. When microbubbles are injected into an artery, they follow the flow of the blood. If vasa vasorum are present, the microbubbles will flow through these blood vessels as well, effectively highlighting them on ultrasound images. The second technique is called molecular imaging, and relies on the use of "targeted" microbubbles. These microbubbles attach themselves to specific molecules that are more likely to be found in vulnerable plaques, making the plaques stand out on ultrasound images. "The problem is that existing intravascular ultrasound technology does not do a very good job in detecting contrast agents," says Dr. Xiaoning Jiang, an NC State associate professor of mechanical and aerospace engineering, an adjunct professor of biomedical engineering and co-author of the paper. "So we've developed a dual-frequency intravascular ultrasound transducer which transmits and receives acoustic signals," Jiang says. "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." The prototype device has performed well in laboratory testing, but the researchers say they are continuing to optimize the technology. They hope to launch pre-clinical studies in the near future. Medical Device ASIA | May-June 2014 | 49


Weight-loss surgery can reduce liver damage:

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tudy shows reversal of earlystage liver fibrosis after bariatric surgery

Bariatric surgery, which is best known for its ability to help patients lose substantial weight, can also result in significant improvement in nonalcoholic fatty liver disease (NAFLD), according to new research presented today at Digestive Disease Week速 (DDW). Researchers at the University of South Florida-Tampa found that bariatric surgery resolved liver inflammation and reversed earlystage liver fibrosis, the thickening and scarring of liver tissue, by reducing fat deposits in the liver. "About 30 percent of the U.S. population suffers from this disease, which is increasing, and more than half are also severely obese," said Michel Murr, MD, lead researcher of the study, professor of surgery and director of Tampa General Hospital and USF Health Bariatric Center. "Our findings suggest that providers should consider bariatric surgery as the treatment of choice for nonalcoholic fatty liver disease in severely obese patients." Dr. Murr and his colleagues suggest that bariatric surgery be considered for patients with a body mass index greater than 35 and obesity-related co-morbidities, or a body mass index of greater than 40. They note that traditional interventions, such as medications, have a low success rate with these patients.

can lead to liver fibrosis and cirrhosis, which can be lifethreatening. After reviewing post-operative biopsies, they found that bariatric surgery resulted in improvements for these patients. In the post-operative biopsies, researchers found that fat deposits on the liver resolved in 70 percent of patients. Inflammation was also improved, with lobular inflammation resolved in 74 percent of patients, chronic portal inflammation resolved in 32 percent, and steatohepatitis resolved in 88 percent. In addition to these improvements, 62 percent of patients with stage two liver fibrosis had an improvement or resolution of the fibrosis. One of three patients with cirrhosis also showed improvement. Dr. Murr noted that these findings on fibrosis reversal apply only to early-stage fibrosis, and not late-stage liver disease. "We are in the midst of an obesity epidemic that can lead to an epidemic of nonalcoholic fatty liver disease," said Dr. Murr. "As a tool in fighting obesity, bariatric surgery could also help prevent the emergence of widespread liver disease."

Researchers compared liver biopsies from 152 patients -- one at the time of the bariatric procedure and a second an average of 29 months afterwards. In examining preoperative biopsies, researchers identified patients with cellular-level manifestations of nonalcoholic fatty liver disease, specifically, fat deposits and inflammation of the liver. These types of liver damage 50 | May-June 2014 | Medical Device ASIA


New Innovative Medical Devices 2014 GE’s Discovery IGS 740 Angiography System Cleared by FDA GE Healthcare received FDA clearance for its Discovery IGS 740, a mobile angiography designed for hybrid operating rooms. The system rides on floor and can position itself in just about any state, moving toand-fro the patient as may be necessary. A spinning laser atop the imaging unit keeps an eye on markers placed along the surgical suite’s ceiling, which provides accurate real-time position information to the device and permits it to return to the exact same state it took previously. The system features a large 41? x 41? (104 cm x 104 cm) detector, bedside controls, and imaging capabilities such as 3D visualization,

live 3D guidance, and needle tracking. Here’s a GE product manager showing off the Discovery IGS 740 at last year’s RSNA:

Sephure, a Handy Suppository Injector, FDA Cleared

FITGuard Mouth Guard to Detect Head Impacts That Lead to Concussions

Sephure, a Handy Suppository Injector, FDA Cleared

While broken bones and torn cartilage are the hallmarks of athletic injuries, in reality undetected concussions are potentially the most dangerous injuries on the field. There are simple tests that can be done on the sidelines to detect a possible concussion, but they require the coach to notice that someone got hit particularly hard. There are already devices that detect impacts to the head, but a new company called Force Impact Technologies has taken a somewhat unique approach and developed a smart sensing mouth guard that will issue warnings when hit to the head is dangerous.

For those not into that sort of thing, rectal suppositories can be a seriously unpleasant necessity of life. It’s normally a digital process (the other kind), which keeps compliance low and embarrassment high. A woman who had to live with having to take rectal suppositories decided to create a device that delivers them with more confidence and greater dignity. The Sephure looks and works similar to a syringe, but dispenses a tablet into the orifice. Unlike vaginal applicators, though, it was designed to prevent the formation of a pocket of air around the medication by venting gasses during administration . This helps to prevent leakage once the suppository melts inside the body and will hopefully lead to greater medication compliance and improved therapeutic effects from the drugs.

The FITGuard has motion sensors built in and an illuminated strip on the front. When the sensors detect an impact of a high enough strength, the strip turns blue following a sub-concussive impact and turns red when it suspects a concussion could have occurred.

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Top Medical Technology Innovations

The MelaFind optical scanner from MELA Sciences.

"By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost," says Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

actually harmless, but has always been impossible to know for sure without an invasive surgical biopsy. Today dermatologists have new help in making the right call — a handheld tool approved by the FDA for multispectral analysis of tissue morphology.

As the regulators, politicians, and corporate executives hash out these details, industry engineers and scientists continue to push through new ideas for improving and managing human health. Every year, industry observers like the Cleveland Clinic and the medical device trade press single out their favorite technology trends. These thought leaders agree that today's best technologies strike a balance between reducing the overall cost of medical care and increasing safety and survival rates—and isn't that what health care reform is all about?

The MelaFind optical scanner is not for definitive diagnosis but rather to provide additional information a doctor can use in determining whether or not to order a biopsy. The goal is to reduce the number of patients left with unnecessary biopsy scars, with the added benefit of eliminating the cost of unnecessary procedures. The MelaFind technology (MELA Sciences, Irvington, NY) uses missile navigation technologies originally paid for the Department of Defense to optically scan the surface of a suspicious lesion at 10 electromagnetic wavelengths. The collected signals are processed using heavyduty algorithms and matched against a registry of 10,000 digital images of melanoma and skin disease.

Here are five emerging technologies to watch in the year ahead. The MelaFind optical scanner from MELA Sciences.

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gainst the backdrop of health care reform and a controversial medical device tax, medical technology companies are focusing more than ever on products that deliver cheaper, faster, more efficient patient care. They are also making inroads with U.S. Food & Drug Administration regulators to re-engineer the complex review and approval process for new medical devices. Many in the industry have long felt overly burdened by what they consider to be an unnecessarily

Cutting Back on Melanoma Biopsies complex approval process. Critics claim it impedes innovation and delays the availability of better health care. To change that perception, the FDA last year announced a new Medical Device Innovation Consortium (MDIC) charged with simplifying the process of designing and testing new technologies. With input from industry, government, and other nonprofit organizations, publicprivate MDIC will prioritize the regulatory science needs of the medical device community and fund projects to streamline the process.

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The ATI Neurostimulator from Autonomic Technologies. Electronic Aspirin

With the most deadly form of skin cancer, melanoma, a huge number of dangerous-looking moles are

The ATI Neurostimulator from Autonomic Technologies.

For people who suffer from migraines, cluster headaches, and


other causes of chronic, excruciating head or facial pain, the "take two aspirins and call me in the morning" method is useless. Doctors have long associated the most severe, chronic forms of headache with the sphenopalatine ganglion (SPG), a facial nerve bundle, but haven't yet found a treatment that works on the SPG long-term. A technology under clinical investigation at Autonomic Technologies, Inc., (Redwood City, CA) is a patient-powered tool for blocking SPG signals at the first sign of a headache. The system involves the permanent implant of a small nerve stimulating device in the upper gum on the side of the head normally affected by headache. The lead tip of the implant connects with the SPG bundle, and when a patient senses the onset of a headache, he or she places a handheld remote controller on the cheek nearest the implant. The resulting signals stimulate the SPG nerves and block the pain-causing neurotransmitters.

ment – but they don't completely remove the need for skin pricks and shots. But there's new skin in this game. Echo Therapeutics (Philadelphia, PA) is developing technologies that would replace the poke with a patch. The company is working on a transdermal biosensor that reads blood analytes through the skin without drawing blood. The technology involves a handheld electric-toothbrush-like device that removes just enough top-layer skin cells to put the patient's blood chemistry within signal range of a patch-borne biosensor. The sensor collects one reading per minute and sends the data wirelessly to a remote monitor, triggering audible alarms when levels go out of the patient's optimal range and tracking glucose levels over time.

The Symphony tCGM biosensor from Echo Therapeutics.

A pillar of health reform is improving access to the best health care for more people. Technology is a costeffective and increasingly potent means to connect clinics in the vast and medically underserved rural regions of the United States with big city medical centers and their specialists. Telemedicine is well established as a tool for triage and assessment in emergencies, but new medical robots go one step further—they can now patrol hospital hallways on more routine rounds, checking on patients in

Needle-Free Diabetes Care Diabetes self-care is a pain—literally. It brings the constant need to draw blood for glucose testing, the need for daily insulin shots and the heightened risk of infection from all that poking. Continuous glucose monitors and insulin pumps are today's best options for automating most of the complicated daily process of blood sugar manage-

The Telemedicine System from InTouch Technologies. Robotic Check-Ups

different rooms and managing their individual charts and vital signs without direct human intervention. The RP-VITA Remote Presence Robot produced jointly by iRobot Corp. and InTouch Health is the first such autonomous navigation remotepresence robot to receive FDA clearance for hospital use. The device is a mobile cart with a twoway video screen and medical monitoring equipment, programmed to maneuver through the busy halls of a hospital. The Sapien transcatheter aortic valve from Edwards Lifesciences. Image: Edwards.com A Valve Job with Heart The Sapien transcatheter aortic valve is a life-saving alternative to open-

heart surgery for patients who need new a new valve but can't endure the rigors of the operation. Manufactured by Edwards Life Sciences (Irvine, CA), the Sapien has been available in Europe for some time but is only now finding its first use in U.S. heart centers—where it is limited only to the frailest patients thus far. The Sapien valve is guided through the femoral artery by catheter from a small incision near the grown or rib cage. The valve material is made of bovine tissue attached to a stainlesssteel stent, which is expanded by inflating a small balloon when correctly placed in the valve space. A simpler procedure that promises dramatically shorter hospitalizations is bound to have a positive effect on the cost of care.

Medical Device ASIA | May-June 2014 | 53


Diagnostic test developed for cryptosporidiosis diarrheal disease

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ioengineers at Rice University and the University of Texas Medical Branch (UTMB) at Galveston have developed a simple, highly sensitive and efficient test for the diarrheal disease cryptosporidiosis that could have great impact on global health. Results from the diagnostic developed by the lab of Rice bioengineer Rebecca Richards-Kortum are read from a paper strip that resembles a pregnancy test. Lines on the strip tell whether samples taken from the stool of a patient contain genetic DNA from the parasite that causes the disease. The research is detailed online in a new paper in the American Chemical Society journal Analytical Chemistry. “Diarrheal illness is a leading cause of global mortality and morbidity,” said Richards-Kortum, director of the Rice 360°: Institute for Global Health Technologies. “Parasites such as cryptosporidium are more common causes of prolonged diarrhea. Current laboratory tests are not sensitive, are time-consuming and require days before results are available. A rapid, affordable, accurate point-of-care test could greatly enhance care for the underserved populations who are most affected by parasites that cause diarrheal illness.” A. Clinton White, director of the

Infectious Disease Division at UTMB, asked Richards-Kortum to help develop a diagnostic test for the parasite. “I’ve been working with cryptosporidium for more than 20 years, so I wanted to combine her expertise in diagnosis with our clinical interest,” he said. “Recent studies in Africa and South Asia by people using sophisticated techniques show this organism is a very common, underappreciated cause of diarrheal disease in underresourced countries.” The parasite is common in the United States, he said, but less than 5 percent of an estimated 750,000 cases are diagnosed every year. In 1993, an outbreak of cryptosporidium in the water supply sickened 400,000 people in Greater Milwaukee, he said. Lead author Zachary Crannell, a graduate student based at Rice’s BioScience Research Collaborative, said the disease, usually transmitted through drinking water, accounts for 20 percent of childhood diarrheal deaths in developing countries. Cryptosporidiosis is also a threat to people with HIV whose immune system is less able to fight it off, he said. “In the most recent global burden-of-disease study, diarrheal disease accounts for the loss of more disability-adjusted life years than any other infectious disease,

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and cryptosporidiosis is the second leading cause of diarrheal illness.” Crannell said. “Anybody, if it’s not treated, can get dehydrated to the point of death. “There’s a lot of new evidence that even with asymptomatic cases or cases for which the symptoms have been resolved, there are long-term growth deficits,” he said. Current specialized tests that depend on microscopic or fluorescent analysis of stool samples or polymerase chain reactions (PCR) that amplify pathogen DNA are considered impractical for deployment in developing countries because of the need for expensive equipment and/or the electricity to operate it. The Rice test depends on recent developments in a recombinase polymerase amplification (RPA) technique that gives similar “gold standard” results to PCR but operates between room and body temperatures. In Rice’s experiments, samples were prepared with a commercial chemical kit that releases all the DNA and RNA in the small amount of stool tested. The purified nucleic acids are then combined with RPA primers and enzymes tuned to amplify the pathogen of interest, Crannell said. “If the pathogen DNA is present, these primers will amplify it billions of times to a level that we can easily detect,” he said. The sample is then flowed over the detection

strip, which provides a positive or negative result. The RPA enzymes are stable in their dried form and can be safely stored at the point of care without refrigeration for up to a year, he said. While current tests might catch the disease in samples with thousands of the pathogens, the Rice technique detects the presence of very few - even one - parasite in a sample. In their experiments, the researchers reported the presence or absence of the disease was correctly identified in 27 of 28 infected and control-group mice and all 21 humans whose stool was tested. Crannell said the method requires little equipment, because the enzymes that amplify DNA work best at or near body temperature. “You don’t need a thermal cycler (used for PCR analysis); you don’t need external heating equipment. You can hold the sample under your armpit, or put it in your pocket,” he said. The research team’s goal is to produce a low-cost diagnostic that may also test for the presence of several other parasites, including giardia, the cause of another intestinal disease. The researchers are working to package the components for use in low-resource settings, Crannell said.



Mda may june2014