Medical Device ASIA - July-August 2014 by Worldwide Publications

Critical Care

Management

medical electronic devices Israeli medical

advances

efficacious business solutions!

Medicine meets

technology

health

care!

e d i t o r i a l

highlights

Medical Devices & Equipment | Healthcare | Pharmaceutical Journal Vol.6 No.4 |July-August 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

Editorial Advisory Board Alex & Lilly - Netherlands

alex@vanbienen.net Andy McCourt - Australia

UK Representative Mike Steele, MJ Marketing

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. D-182, PR House, Anand Vihar, New Delhi 110092 - India. The publisher does not necessarily agree with the views expressed by the contributors, in this issue, nor do accept any responsibility for any errors or interpretation in the publication.

4 Going For Gold With Activeflowbalance 6 Starled7 Nx - New Led Lamp For Operating Room 8 Chem Show Eurasia 2014 10 Software Testing - Medical Electronic Devices & Applications 12 Point Of Care Testing 14 Merck Serono Commits € 2 Million Grant For Fertility 18 Critical Care Management 24 Efficacious Business Solutions! 28 Enhancing Sme Business Ethics In The Healthcare Industry 35 Siemens World’s Longest Lab Automation Track At Thyrocare 36 Medicine Meets Technology – Technology Meets Medicine 38 Medical Manufacturing Asia 2014 41 Paradigm Shift in Syphilis Screening: Need of the Hour 42 Siemens Healthcare India’s First Simultaneous Pet-MRI 46 A Luminous Fabric For Treating New-Born Jaundice 48 Top 10 Israeli Medical Advances To Watch In 2014 50 Multiple-Use Dental Dispenser Devices 51 Regulation On Medical Devices 54 Dr. Roy’s Discovery - A MICROBIOLOGIST FOUND...

Global Endoscopy Devices Market To Grow To $36.9B by 2019 The demand for minimally invasive devices is fueling the growth of the worldwide endoscopy devices market, which is forecast to grow to $36.9 billion by 2019. The global endoscopy devices market is set to grow to $36.9 billion by 2019, according to a new market forecast by Transparency Market Research. In 2012, the market was worth $24.9 billion and is expected to grow at a 6.9% compound annual growth rate between 2013 and 2019. Products included are endoscopes, endoscopic operative devices and endoscopic visualization systems. By virtue of endoscopic procedures involving small incisions through which tubes or rods with camera and specialized instrument are inserted into the body, these devices are minimally invasive. They can be used both for diagnostic and therapeutic/operative purposes. As such endoscopy procedures create less blood loss, reduces the chance for infection while increasing the chances for shorter hospital stays and faster recovery.

Traditional endoscopes that are rigid in nature are most open used in arthroscopy and laparascopic procedures, according to the report, while flexible ones are used in gastrointesitnal, urology and other procedures where rigid endoscopes cannot reach the area of the body that is of interest to the physician. The advent of capsule endoscopy has revolutionized endoscopy procedures. Capsule shaped devices possess built-in camera unit and wireless transmission systems that deliver high quality images to external receiver as they pass through the gastrointestinal tract. Some examples include CheckCap, an Israeli startup that offers noninvasive colon imaging. If

successful, the company will be an alternative to traditional coloscopy that requires extensive prepping of the bowel followed by inserting a a flexible tube with a video camera through a person’s rectum. Another example is Obalon, which is seeking to treat obesity by using intragastric balloons that are introduced through the body using capsule technology. While Check-Cap and Obalon are startups looking to advance endoscopic procedures to the next level, the dominant players, according to the report are: Boston Scientific, Cook Medical, Covidien PLC, Ethicon Endo-Surgery, HOYA Corporation, Intuitive Surgical, Inc. KARL STORZ Endoscopy, Olympus Corporation, and Richard Wolf among others. v

Medical Device ASIA | July-August 2014 | 3

Demag Plastics Group SP. z.o.o. wins gold medal at PlatinumPlast Gala

Going for gold with activeFlowBalance At Plastpol 2014, Demag Plastics Group SP z.o.o. was awarded with a gold medal for the innovative activeFlowBalance technology module, which was integrated into an all-electric IntElect injection moulding machine. The high-tech module was chosen from a pool of products exhibited at the Plastpol trade show in Kielce, Poland, by an independent jury, which was spearheaded by Prof. Joseph Koszkul of the Technical University of Tschenstochau (CzÄ&#x2122;stochowa). Demag Plastics Group was awarded with a PlatinumPlast model for the best technology in the area of injection moulding machines. Dipl.-Ing. Tomasz Tybura, Managing Director of Demag Plastics Group SP. z.o.o. accepted the award with pride. The activeFlowBalance module is designed to balance uneven movements of multi-cavity moulds. It is used on IntElect all-electric machines to prevent the occurrence of negative effects such as flashing, underfilling and mould damage. Demag Plastics Group SP. z.o.o., a subsidiary of Sumitomo (SHI) Demag Plastics Machinery, has been established in the Polish market for injection moulding machines since 2004. As founder and co-owner of the former Demag representation Dematech, Dipl.-Ing. Tomasz Tybura, Managing Director of Demag Plastics Group SP. z.o.o., has been looking after customers with Sumitomo (SHI) Demag machines for years.

At its headquarters in Czestochowa, situated about 230 km from Warsaw, Demag Plastics Group SP. z.o.o. also offers customer instruction and training

4 | July-August 2014 | Medical Device ASIA

seminars as well as machine presentations, mould acceptance processes and customer trials. A team of thirteen Demag Plastic Group employees is working for Tomasz Tybura in Poland. Sales engineers and service staff are mainly active at the three largest centres of the Polish plastics processing industry in Silesia, Warsaw/Lodz and Bydgoszcz/Poznan.

STARLED7 NX - NEW LED lamp for operating room electrical curves typical of LEDs to remain unaltered over the time but maintaining a long life cycle (about 50.000 hours).

STARLED7 NX is the operating lamp granting the best working conditions to surgeons and medical staff. The new NX series of our STARLED lamps meets the highest quality standard requirements. STARLED7 NX produces a perfect IR-free light, with an excellent colour temperature and low consumption suitable for every situation. The Made in Italy design grants visual comfort, practicality of use and compatibility with laminar flows. STARLED7 NX boasts an excellent light quality. The special optics of its LEDs, realized by ACEM, generates a shadowless, clear and homogeneous light assuring visual comfort and best working conditions both for the surgeon and for the medical staff. Thanks to its NeXt generation LEDs, the lamp can produce a perfect illumination under every condition generating a IR-free light, an excellent colour temperature and a practically endless life cycle at low consumptions. The lamp is composed by 57 next generation LEDs circularly placed and splitted into 7 reflectors (with 7 LEDs each one) and other 8 LEDs radially positioned around the handle. STARLED7 NX produces a high illumination level of 160.000 lux. The colour rendering index of 95 and the colour temperature of 4.500 °K allow to reproduce the exact chromatic scale of the colours of the human body. The lamp is provided with ACRIS, the innovative system realized by ACEM that ensures, by the use of a microprocessor, the control of

STARLED7 NX assures: • High quality illumination level for each kind of surgery • Colour temperature representing the contrast of the surgical area perfectly • Colour rendering index of 95 (CRI) • Clear luminosity at 160.000 lux • Colour temperature of 4.500 °K • Ergonomics for an extraordinary simplicity of use and easy positioning for the medical team • Exceptional duration with easier management and low consumptions STARLED7 NX is provided with: • ACRIS, a smart system created by ACEM • A special system to adjust the light field dimension without mechanical parts through an optical-electronic management • A revolutionary I – SENSE® control system • An innovative LIGHT – UP system that, thanks to the special light beams coming from the upper part of the lamp, assures adjustable illumination levels according to the different use and particularly suitable for minimal invasive surgery. FOCUSED AND AMBIENT LIGHT In order to achieve a correct illumination according to the different needs STARLED7 NX can produce a FOCUSED and AMBIENT light. Thanks to the special optics realized by ACEM, the light field focusing system adjusts the light spot diameter accurately assuring an excellent sharpness of details in the operating area. The light field dimension adjustment without mechanical parts is possible through an optical-electronic management that grants a steady, homogeneous, shadowless and reliable illumination of the operating field in every situation particularly suitable for deep cavities. AMBIENT light is managed by the LIGHT-UP system, a technology created by ACEM that produces adaptable

6 | July-August 2014 | Medical Device ASIA

andadjustable illumination levels according to the different uses thanks to the special light beams coming from the upper part of the lamp. This light allows to visualize the operating field as well as the surrounding environment clearly and is particularly suitable for minimal invasive surgery and for the preparation and treatment during the operation, monitoring of the patient and microscope operations. Ergonomic, practical functional design

monitors offered by ACEM. STARLED7 NX functions are managed by the handy, digital and easy-to-read I–SENSE® control panel positioned on the cardanic structure and adjusting: • • • • •

and

Comfortable and light to move, thanks to its central handle, STARLED7 NX is practical also for the medical team who can move it from the lateral handles assuring stability and constant illumination even during the movement. STARLED7 NX has been manufactured with a smooth and resistant material that makes cleaning quick, easy and complete. On demand, the removable and sterilizable central handle can house a video camera shooting the surgical operations accurately (the video camera can be placed on a separate arm alternatively). The lamp shape assures visual comfort and is particularly suitable for laminar flows in the operating room. The design is practical, functional and ergonomic. Thanks to AVSM system (Acem – Video – System – Management) STARLED7 NX is compatible with all the cameras and

•

ON/OFF function Light intensity SIZE - Light spot diameter dimension (light beam focusing) ENDO - Light for endoscopy DOF - Depth of field – for a full visualization of the operating field and deep cavities SYNC – (optional) Mode to synchronize controls among the combined lamps: STARLED7 NX double (twin dome configuration) and STARLED7 NX with STARLED5 NX or STARLED3 NX. The SYNC mode grants simplicity of use saving time and giving the possibility of being managed by a single operator. The precise and easy-to-read I–SENSE® system is functional, simple and easy to clean.

The optional remote control is useful to manage all the functions of the lamp from a remote position offering the end-user better efficacy and practicity. For more information: ACEM Medical Company Via della Tecnica 29 40050 Argelato – Bologna – ITALY Tel + 39 051 721844 info@acem.it www.acem.it

Largest Chemicals Industry Gathering in Eurasia:

6th International Chemicals Industry Group Exhibition Chem Show Eurasia 2014 Chem Show Eurasia 2014, with its three main headings as “Chemicals, Laboratory and Technology”, is preparing to bring together the global giants of the chemical sector professionals for the sixth time in Istanbul Expo Center between October 16- 18 2014.

Cosmetics & Home Care Ingredients Special Zone

Cosmetics & Home Care Ingredients Special Zone will offer 12 m2 and 15 m2 Shell Scheme Stand options and gather all Cosmetics, Home Care and Fragrance Ingredients, Manufacturers and Suppliers in the same zone in Hall 10. Pharmaist “Pharmaceutical Ingredients and Technologies” Concept

hem Show Eurasia 2014 which is expected to draw over 10,000 professional visitors, is introducing the “Pharmaceuticals Ingredients and Technologies Concept” Pharmaist and the Cosmetics & Home Care Ingredients Special Zone for the first time in order to exceed the expectations of the local and international pharmaceuticals industry as well as to increase the raw material and technology resources and inform the industry about the green chemicals and green technologies used for creating new products in the Personal Care and Home Care Industries that are growing rapidly in Turkey. Sector’s leading organization Chem Show Eurasia, which is organized biennially and in which participants and visitors access “Everything About Chemistry”, proved once again that it is the largest chemical industry exhibition in its “Region”

with its visitor and participant statistics of 2012. Chem Show Eurasia 2012 Statistics

Turkchem Chem Show Eurasia 2012 brought together a total of 15,481 industry professionals including 1,613 international visitors from 66 countries under the same roof for 4 days at 25,000 m2 exhibition space with the participation of over 1,000 exhibitor company and company representatives, 326 direct exhibitors including 155 international companies from 13 countries. Chem Show Eurasia 2014 Projections

Considering the high level of interest from the industry since the last months of 2013, Chem Show Eurasia 2014 is expected to host over 350 exhibitor companies and company representatives and over 10,000 local and international visitors during the 3 day event.

8 | July-August 2014 | Medical Device ASIA

The exhibitor profile of Chem Show Eurasia includes companies that manufactures and sells specified chemicals for many different sectors. Many of the exhibiting companies already have the ingredients and raw materials that target the Pharmaceuticals industry in their product lines. The visitor profile of Chem Show Eurasia is very interested in Pharmaceuticals Ingredients and Technologies.

10 Iranian Exhibitors and 60m2 Malaysia Pavilion with over 10 Malaysian Exhibitors. Matchmaking Event and Workshop Presentations

Chem Show Eurasia will also host a “Matchmaking Event” at the specially designated area where companies will have a chance to register online and meet the other companies of their choice one on one. Representatives from our exhibitor companies and leading academicians will be conducting Workshop Presentations at the Workshop Area where industry members will have the opportunity to learn about the new products, Technologies and developments in the industry. Online Registration is now open Get your free online registration www.chemshoweurasia.com

China, Iran and Malaysia Pavilions at Chem Show Eurasia 2014

Do not miss the chance to take your place among the Global Giants of the Chemistry Sector in “Chem

Chem Show Eurasia 2014 will be featuring a 540 m2 China Pavilion with over 55 Chinese Exhibitors, 153 m2 Iran Pavilion with over

For exhibiting details and to make a stand reservation please contact our Sales Department via sales@ artkim.com.tr

SOFTWARE TESTING - MEDICAL ELECTRONIC DEVICES AND APPLICATIONS QuEdge Software Solutions Pvt Ltd, based in Bangalore India was formed almost a decade ago managed under its flagship company MicroGenesis TechSoft Pvt Ltd.

ith strong SDLC background, QuEdge was set up with a vision to meet the much needed demand of clients desirous of developing quality software products.

At QuEdge, we bring together a rich combination of testing tools, mature process and intense team expertise to deliver services that span end-to-end testing requirements for companies in Product Development as well as Service Delivery. Our testing services are uniquely designed to meet client needs. Through our consulting and customized solutions, we help organizations achieve their quality goals by partnering with them to develop an effective software testing strategy. Driven by a team of industry experts who draw their experience from years of software development and testing expertise across technologies in varied environments, QuEdge services top notch clients including Fortune 500 companies. The team works closely with clients to determine their software testing goals and challenges to deliver timely, commercially viable and quality solutions. There is a rapidly growing demand for medical electronic devices and application software’s in the global market. Delivering innovation through software allows features to be built more quickly into the product and enables competitive differentiation. Today medical electronic devices / equipment’s are increasingly packaged with critical software that is used to direct equipment. An application that fails can pose a risk to patient safety, disrupt your business processes and demand magnified financial costs to fix it.

Test validation is guaranteed to help improve code robustness, efficiency, stability, performance, and product readiness of the software to market. As an integral part of the software development life cycle process, test validation is a continual process, beginning early in the development cycle and critical to device innovation. Software validation has become a critical process before releasing product to the market. A minor bug in the software can be a dangerous and costly affair due to the involvement of human lives! Medical electronic devices involve complexities in its internal functioning and performance and this involves functional and performance testing of device. This also involves performance of the software or communication with other medical equipment’s / instruments, processors etc. New releases to the market, communication with multiple and external devices, adaptability of device to different operating systems, different languages for export market, etc., are some of the many challenges software development teams face. Independent validation and verification done by an exclusive test team will help ensure the products released to market will minimize market withdrawal risk. QuEdge understands the intricacies of medical devices testing due to its vast experience and has a dedicated team established over eight years in medical domain testing of various devices, implants and clinical applications. QuEdge forayed into specialization in Health care as one of the focused domains eight years ago. Over the last eight years QuEdge has been servicing clients in health

10 | July-August 2014 | Medical Device ASIA

care and particularly to mention an International leader in medical devices company in Europe as a testimonial reference. QuEdge and its flagship company MicroGenesis have worked with German companies like MBRDI (Mercedes Benz Research Development Institute), Siemens, Airbus etc. We value commitment and have cultural experience. QuEdge is versatile and has experience in executing end-end testing, ensuring accuracy of data and performance of software with inter-related processors etc., testing different processors with implant combinations on multiple operating system, communication with external devices, mobile applications, control system / software of medical implants and diagnostic instruments, end-end functionality testing of medical implants and diagnostic devices, clinical application software’s are some of the services executed in testing. Germany is one of the leading global players in Health care. Software is a vital catalyst for health care Industry. With an improved Software Development Process, Automation and a trusted Partner Ecosystem in place we believe Germany is poised for a sterling growth in the world market. There are many small and mid-sized companies in Germany thriving in the market for its wallet share, racing against project deadlines to roll out products to market. An experienced and trusted Automation Partner can bring relief to their Product development initiatives. Established with a reputation of having handled many International companies, we help customers bring out products to market quicker than before. For more details please visit our website www.quedge.com and contact at info@quedge.com

Point of care testing

Demand is increasing for point of care (POC) diagnostic testing, particularly for tests that help foster clinical decision-making within 30 minutes or less - By David Stein

David Stein, PhD, is Global CEO of the Point of Care (POC) Business Unit, Siemens Healthcare. He is responsible for long-term global strategy and business planning, strategic marketing, product and brand management and product development for all existing and new POC products and solutions.

aboratory-quality test results (once only obtained via the central lab) are now available directly in doctor’s surgeries, out-patient clinics and within hospital departments. Thus it’s no surprise to see a significant expansion of POC testing utilization in critical care and chronic disease management situations, says Dr David Stein. In critical care environments, POC tests are helping physicians to make life-saving decisions within minutes, not hours. The ability to quickly and accurately assess troponin levels, measure pleural fluid pH levels, or rule out pulmonary embolism are just a fraction of the critical care tests now available that can be conducted near the patient. Another example is lactate testing for lactic acidosis (or abnormally high acidity in the blood). Frequently seen in critically ill patients, lactic acidosis has a number of potential causes, including shock, diabetes, liver disease and sepsis. Although generally considered a nonspecific biomarker, knowing lactate levels early in a patient’s presentation can provide valuable information and open a critical window for intervention when treatment is most likely to be successful. Lactate testing at the point of care can be particularly useful in intensive care and the emergency room, where the presentation of symptoms may be inconclusive. For chronic disease management, POC tests are helping to save valuable time by consolidating patients’ visits,

12 | July-August 2014 | Medical Device ASIA

because physicians can now immediately review results and discuss necessary adjustments to treatment plans for a number of chronic diseases, such as diabetes, hypertension and cardiovascular conditions. Notably, in-office diabetes testing is expanding. While historically, HbA1c testing has been commonly used to manage diabetes patients, more recently the medical community has recognized its clinical utility in the disease’s diagnosis, with convenience cited as a significant patient advantage. For example, HbA1c testing can be conducted at any time and requires no patient preparation, unlike fasting plasma glucose (FPG) measurements, where it’s necessary to fast at least eight hours prior to testing. Also, only a single measurement is needed during HbA1c testing, as opposed to blood glucose testing, which involves serial blood draws over several hours. Recognizing the value to physicians and patients, Siemens recently made its DCA HbA1c test kit (#: 10698915. Not available in all countries), which has been used for years as an in-office tool for monitoring diabetics, available as an aid to diagnose diabetes and identify people at risk of developing diabetes. As POC testing continues to evolve, physicians and POC coordinators are helping us identify additional areas where it can be applied,

including chemistry, immunoassay, haematology and, in particular, coagulation testing. The ability to quickly deliver lab-accurate PT/ INR results to clinics and physician offices is an important component of optimal patient care, and we plan to offer a new and innovative handheld device later this year to help address this need. But the value of laboratoryquality POC testing goes beyond clinical application. The growing prevalence of health networks – comprised of hospitals, clinics and physician offices – increases the need for standardization of test results across different locations. For example, a urine test result needs to correlate across multiple sites within the health network, regardless of whether the test was administered via a portable device in the physician’s office, semiautomated device in the clinic, or on a hospital’s fully automated analyzer in the core laboratory. We also anticipate more demand for smaller, easier-to-use devices that provide seamless connectivity throughout hospitals and health networks. Clinicians and POC coordinators will increasingly want to work in a POC Ecosystem—an environment that enables the ability to remotely access and monitor patient status simply, quickly and securely while centrally managing multiple devices to help standardize procedures, facilitate compliance and improve risk management. v

Merck Serono Commits € 2 million to the Grant for Fertility Innovation (GFI) for 2014/15 • Investment reflects company’s ongoing commitment to innovation in Fertility research • Globally, nine projects receive funding from this grant cycle

erck Serono, the biopharmaceutical division of Merck, Germany, announced its strong support of the Grant for Fertility Innovation (GFI) fund with grants totaling up to € 2 million for the years 2014 / 2015. The announcement was made during the 30th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) currently taking place in Munich. Launched in 2009, the GFI is dedicated to transforming innovative translational fertility research projects into concrete health solutions to improve the outcomes of assisted reproductive technologies (ART). In the last five years, approximately 640 applications to GFI were received from over 50 countries around the world; of these applications, nine projects from eight countries were awarded a grant for a total of € 2 million. “The Grant for Fertility Innovation is reflective of our broad, ongoing commitment to advancing scientific knowledge that can be translated into meaningful solutions for patients in need,” said Dr. Steven Hildemann, Global Chief Medical Officer and Head of Global Medical and Safety at Merck Serono. “The GFI enables the novel ideas that exist among forward-thinking fertility researchers from around the world, accelerating our collective ability to positively impact the final outcome of patients undergoing assisted reproductive technology treatments.” 14 | July-August 2014 | Medical Device ASIA

About Merck Serono

Focusing our expertise to make a difference At Merck Serono, we have an enduring commitment and focus in our specialist therapeutic areas of oncology, neurodegenerative diseases, fertility and endocrinology, along with rheumatology as an emerging area of expertise. We also provide a portfolio of cardiometabolic care and general medicine products, especially in emerging markets where patient need remains high. Around the world, teams of dedicated employees work to discover, develop, manufacture and commercialize our prescription medicines, available in over 150 countries. We are internationally recognized as a biotechnology leader, with innovative and successful products along with a promising development pipeline. Our expertise in both biotechnology and pharmaceutical chemistry, combined with a profound understanding of disease in our focus therapeutic areas, enables us to take a flexible approach to finding the right compound to treat a specific disease. The capability to develop and manufacture new molecular entities of either type with equal success allows Merck Serono to exploit the full potential of the biological and chemical spheres at every stage of the drug development process. We truly believe that our focused expertise can make a real difference to people living with serious diseases. Not everything we do leads to a breakthrough, but we never lose sight of the human need that motivates us.

Yasuyoshi Namiki works in our R&D laboratory for liquid crystals in Atsugi, Japan.

Our cutting-edge capabilities in the application of physical-technical innovations have made us a preferred supplier for many industries. Yasuyoshi Namiki works in our R&D laboratory for liquid crystals in Atsugi, Japan.

Patinal速 evaporation materials are needed in many optical instruments

Patinal速 Evaporation Materials from Merck KGaA Darmstadt Germany, are used on many glass surfaces in optical instrumentents as they are used in cameras e. g. for Prisma surfaces. Evaporants are special materials suitable for Physical Vapour Deposition (PVD). These evaporants are inorganic materials with defined optical, electrical and physical properties and are used for Anti-reflective Coatings Sunglasses/ UV-Protection, Decorative Coatings, Antireflective Coatings (Camera Lenses), Filters (Optical Instruments), Dielectric Mirrors (Laser), Dichroic Beam Splitters, Polarizers etc.

Medical Device ASIA | July-August 2014 | 15

Chemicals from Merck ensure reliable analysis in research and production

Specialty chemicals from Merck are important components of the process chain from drug development to industrial production. They ensure reliable analysis in research and dependable production processes. Expertise in chemistry and customercentric innovations have made us a successful supplier to the pharmaceutical, cosmetics, food, plastics, coatings, printing and display industries. We find answers to challenges in environmental protection, production safety and product protection. Our goal is to further expand our expertise in regulated markets and in markets with high barriers to entry. The success is based on a long tradition. We offer a broad portfolio of laboratory chemicals in a range of product grades including the relevant certificates of analysis, thus ensuring consistent and comparable results. We focus on customer needs in a variety of sectors such as the pharmaceutical industry. We offer products and solutions using the latest technological expertise in chemical and biotechnological processes. For example, the Pigments business develops and manufactures innovative effect pigments for use in coatings, packaging and product design. Not only decorative, but also security-relevant aspects, for example brand and anti-counterfeit protection, are important here.

Merck offers chemicals for high-tech applications and laboratory

From pipe dreams to big business - organic semiconductors for the electronics industry. MerckÂ´s chemicals business comprises two divisions offering basics and high-tech products: Liquid crystals for displays; effect pigments for industry and cosmetics; analytical reagents and test kits, as well as products and services along the entire process chain of the pharmaceutical and biotech industry.

16 | July-August 2014 | Medical Device ASIA

Critical Care Management Through Remote Monitoring Solutions With barely 800 critical care interventionists providing care for 1.2 billion people in India, Tele ICU’s are increasingly becoming the lifeline of many hospitals. Remote monitoring helps to meet this shortfall by allowing critical care specialists to monitor and direct treatment of patients in suburban hospitals that typically do not have the same expertise available.

rue to being a land of diversity, our country also exhibits one of the richest economic and social diversities. There are Tier 1 cities such as Bengaluru, Chennai, Hyderabad, Mumbai and Delhi, which have the maximum number of 'super qualified' physicians and nurses and intensive care units with state-of-theart facilities. In most of such centers, the standards of care are high and outcomes are comparable to those seen in ICUs of the developed world. However, over 75 per cent of our population seeks healthcare and more so critical care in smaller towns and villages. Many of these 'smaller hospitals and nursing homes' do have mediocre facilities and are usually run by doctors and nurses who are not as highly qualified or experienced as those in the Tier I cities. But emergencies in patients remain the same...and this leads to a disparity in the quality and standards of ICU care delivered. This story is the same in any other emerging geography. In the case of Indonesia with close to 9000 inhabited islands, the standards of ICU care at a hospital in Jakarta is very different than that in the one in say Makassar or Banda Aceh. It is therefore not unreasonable to believe that the solution discussed below has a universal relevance for emerging markets and not that for India alone. Intensive care units are the places where the sickest patients are housed in a hospital. These are the units where monitoring and care are needed on a 24/7 basis. Over 50% of all hospital deaths occur in an ICU and the cost of healthcare rises exponentially when patients stay longer in an ICU. The longer a patient remains in an ICU, the greater are the chances of cross infection, complications and death. Although bed side care providers are physically present in an ICU, the number of times they can physically attend to each patient and the extent of continuous monitoring that can happen

18 | July-August 2014 | Medical Device ASIA

to each patient is limited. Most of these limitations are due to the inability to physically move from patient to patient and monitor them and provide the required care. In summary, even when physicians and nurses are continuously present within an ICU premises, the actual number of times they can “round on” patients in a given day/shift are limited. The presence of multiple “high acuity” patients within an ICU causes physical care to be concentrated on these patients while the other patients with a lesser acuity level may in fact receive less than the prescribed standard of care. These inabilities which crop up due to manual and physical care giving, can be mitigated to a large extent by having someone qualified monitor these patients from a remote location. The remote monitoring complements the physical activities that happen within an ICU and ensure that patients are being monitored continuously on a 24/7 basis. Any deviations in the conditions of patients can be readily picked up by remote monitoring and actions can be initiated promptly, thereby preempting possible hazardous complications. Many studies have been conducted which have conclusively proven that both patient mortality and average Length of Stay (LOS) are significantly lower in intensive care units that are complemented by a system of remote monitoring. Philips IntelliSpace Consultative Critical Care (ICCC) is a cutting edge tele solution that enables transformation of clinical care in an intensive care setting. Using the ICCC solution, one can now

monitor multiple intensive care units from a central command center that may be located in a geographically separated area. The state of the art hardware and software products that are provided as part of the solution enable clinicians connect to and monitor multiple intensive care units from a central location. Trained Intensivists and intensive care nurses stationed at the command center can monitor the patients in the peripheral ICUs on a 24/7 basis. The solution enables the establishment of a “hub-and-spoke” model where the central command center acts as the hub and the peripheral ICUs act as the spokes. The central command center has multiple “monitoring stations”. Each monitoring station has a high end computer system connected to an array of high resolution computer monitors. Clinical data (coming in from patient monitors / ventilators/ infusion pumps connected to the patient) of patients admitted to the peripheral ICUs is displayed as a “dash board view”, enabling continuous monitoring of vital data and lab values. The monitoring nurse/Intensivists can also triage into the bedside electronic health record system to either view more details than can be seen on the summary screen, or, to place orders for medications and labs. In addition, there is a near-real time display of the wave forms coming in form bed side patient monitors and an ability to start a 2- way audio-video conference with the bedside care provider (doctor/nurse). The high fidelity optics characterizing the audio-video system enables the command

A typical view of a Control Operating Room in a Command Center (Tertiary Level Hospital) center Intensivists/nurse to observe patients in real time. The camera located at the bedside can be controlled from the command center, to enable such actions as panning, zooming and focusing on specific aspects at the bedside. The 2-way audio enables the command center Intensivists/nurse communicate with the bed side care provider, thereby providing valuable instructions concerning the management of the patient. Notwithstanding this, technological developments enables communications even in regions which are band-width constrained. As a complete, holistic solution, ICCC provides all information that is necessary for Intensivists to effectively triage, assess, observe and manage patients in the peripheral intensive care unit and also enables high quality standards-based care to be effectively delivered to the peripheral unit from the central command center. Another important advantage of ICCC is the ability to extend specialist care to areas where such specialization is not readily available. A tertiary care referral hospital situated in the heart of a large metropolis may have many highly qualified and experienced Intensivists and trained nurses on in its staff. A smaller hospital located in a tier II or tier II city, may in fact have an ICU to care for critically ill patients, but not the qualified staff as are available in large centers. When these smaller centers can link up to the larger centers through ICCC solution, high quality specialized care and standard medical advice and guidance can reach the patients in the smaller centers. The qualified specialists sitting in a command center can effectively guide and advise less qualified care givers functioning at peripheral smaller hospitals. The patients who get treated in such units benefit from the expert care and the smaller hospitals can enhance their credibility in being able to provide high quality care for their patients at affordable costs. This can in fact result in a business model where larger hospitals can extend their reach into smaller cities and towns by partnering with local hospitals located in these areas.

India is a country which is very much representative of many other countries in the developing world of growth markets. There is a large concentration of extremely qualified and high standard specialist care in the Tier I cities of the country. However, these serve a meager population. A large percentage of the population (>75%) seeks healthcare in the Tier II and Tier III cities and towns where healthcare facilities aren’t as developed. An important aspect in improving the lives of people living in these towns is to bring the specialized care from the places where it is available to these places without having to move the specialists to the location! The Philips ICCC is tailormade to address this challenge and hence is an extremely relevant concept for these markets in terms of forward thinking in healthcare. On the forward path, one could expect Big data and Analytics to be integrated to this solution which would help bring in intelligence in terms of predictions through Clinical Decision support systems as also population analysis and management. The future is wide open !!!!! We, Philips, in India have been promoting this concept over the last 24 months. We have met with a fair degree of success. We do have hospitals in places like Tiruchirapalli, Karimnagar, Srirangam, Chengalpattu etc. connected to corporate hospitals in Tier 1 cities and being consulted. I am relating below a real-life incident of how this solution can help save life under demanding circumstances The place was the command center of Intele ICU located at Chennai. The situation was a bit chaotic in the command center. There were around 10 patients being monitored in two ICUs located in two small towns of Tamil Nadu, about 100 to 400 KM from Chennai respectively. The consultant on call in the command center had just worked up a new patient admitted to a Hospital in Trichy. The patient was a victim of head injury and owing to the

very low GCS (Glassgow Coma Scale) score at admission, it was decided that the anesthetist in the ICU would intubate the patient and electively ventilate the patient. It was around 11:30 AM in the morning. The patient who was admitted around 10 AM was sedated, intubated and put on ventilator. All of a sudden a message was sent from the bedside nurse that the patient on ventilator was “agitated” and turning violent in bed. She requested an order for more sedatives. Normally on such instances, the consultant would have added an order for additional sedatives. However in this case, the monitoring consultant decided to turn the camera on the patient to get a hang of what exactly was happening. It was a major shock when we found on the camera that the endotracheal tube of the patient was completely blocked by a small column of blood. The agitation was mainly because the patient was in hypoxia and his brain was not receiving enough oxygen owing to a blocked endotracheal tube. The ventilator was pumping harder than normal trying to overcome the “block”. The moment we identified this problem, the consultant from the command center alerted the bed side nurse to rush to the patient’s bedside and perform a prompt suctioning of the endotracheal tube. Shocked as she was at this, the nurse rushed to the bedside and started the suction apparatus. Within 3 minutes, the tube was cleared of blood and debris and the patient at once became calm without needing more sedatives. Had the doctor not identified a blocked tube, and had he like any other day promptly responded to the nurse fulfilling her request for more sedatives, we would have probably lost the patient secondary to hypoxia. A simple video assessment saved the day for this patient. Needless to say, IntelliSpace Consultative Critical Care (ICCC) solution conceived and developed by Philips is a true example of purposeful innovation in medical technology. It is meaningful in the light of the healthcare scenario in India and other emerging geographies, and when implemented widely, can result in a positive clinical transformation in the accessibility, quality and practice standards of critical care medicine.

Medical Device ASIA | July-August 2014 | 19

ERBA Diagnostics Mannheim GmbH instrumentation for autoimmune and infectious diseases. Diamedix Corporation (USA)- US FDA approved, it manufactures In-vitro diagnostic kits marketed in conjunction with its MAGO® series instruments for use in clinical and hospital laboratories. Diamedix offers autoimmune and infectious disease test kits of high quality, with containers and customized racks. JAS Diagnostics Inc. (USA) Manufacturer of clinical chemistry reagents with sales in USA, Latin America, Africa and Asia. Many of its diagnostic chemistry reagents, are manufactured with in house R&D.JAS Diagnostics provides the laboratories with of state of the art, single vial, liquid stable reagents.

RBA Diagnostics Mannheim GmbH, located in Germany is a leading player in the global In-vitro Diagnostic Industry. ERBA Mannheim is ISO 9001:2008 & ISO13485 certified organisation. It has set a benchmark in delivering excellence thorugh world-class quality and technology at affordable rates and with unmatched standards of customer satisfaction. ERBA Mannheim provides a comprehensive portfolio in different specialties including clinical chemistry, immunology, hematology, coagulation, critical care, urine analysis, diabetes monitoring, autoimmune & infectious disease monitoring and microbiology. With an aim to meet the medical needs of doctors and patients worldwide, the ERBA Group has spread its wings through its eleven subsidaries across eight countries:Transasia Bio-Medicals Ltd. (India)- Established in 1979, it is a name to reckon in the Indian clinical diagnostics sector, providing end to end solutions across all laboratory segments. ERBA Diagnostics, Inc. (USA)- Fully integrated In-vitro diagnostics company that develops, manufactures and distributes proprietary diagnostic reagents, test kits and

20 | July-August 2014 | Medical Device ASIA

Drew Scientific (USA)- Caters to the field of diabetes management, hematology and clinical chemistry. Its HPLC based HbA1c systems are renowned for their high performance. ImmunoVision, Inc. (USA)- Based in Arkansas, USA, it develops and manufactures a range of antibodies & antigens for use in diagnostic reagents. Delta Biologicals, s.r.l. (Italy)Manufactures the MAGO® range of instruments and distributes In-vitro in Italy and other international markets. ERBA DDS Diagnostics (Turkey)Established in 1993, the company develops, produces and markets, In-vitro diagnostic products in biochemistry, hematology and urine analysis. ERBA Lachema s.r.o (Czech Republic)- A company with 40 years tradition in the development, manufacturing and sale of products for urine analysis, clinical chemistry, microbiology & hematology.

ERBA Rus (Russia)- A fast growing marketing company, offering sales and after-sales service to its customers in product ranges in urine analysis, clinical chemistry, microbiology and hematology. ERBA Diagnostic (France)The company specializes in conception, design, development and manufacturing of automated analyzers and reagents in clinical chemistry, hemostasis and immunology. Constantly striving to better its best and innovating to serve customers better is one of the key growth drivers at Erba Mannheim. With a dedicated team of experts the ERBA Group has created an impressive track record of successful projects. A team of over 100 R&D personnel, spread across manufacturing facilities in four continents in USA (Miami), Italy (Rome), France (Montpellier), Czech Republic (Brno), India (Mumbai) and Turkey (Istanbul) are constantly working to bring out products with appropriate technology and features to meet the changing customer needs of both the developed and the developing markets. With a commitment to provide ‘Total Solutions in Clinical Diagnosis’, each of the ERBA Group companies strive to create a healthier world!

Medical Devices & Supplies Fair Attracts over 9,600 Buyers Record 240 Exhibitors Take Part in Three-Day Fair

The fifth edition of the HKTDC Hong Kong International Medical Devices and Supplies Fair ended today, attracting more than 9,600 buyers over the fair’s three days. That’s up 17 per cent over the previous year. This year’s fair showcased the offerings of 240 exhibitors from 14 countries and regions, up nine per cent over last year, and a new exhibitor record for the show. Driving Demand “The advancement in medical technology and techniques, as well as the world’s aging population, is driving demand for medical devices and supplies,” said HKTDC Deputy Executive Director Benjamin Chau, who noted that the Rehabilitation and Elderly Care Products zone was among the fair highlights. The HKTDC, he added, organised 36 buying missions from 24 countries and regions, welcoming over 1,200 buying mission members to Hong Kong. Strong Buyer Traffic Hong Kong exhibitor Joe Tam, Providence Enterprise’s Senior Operation Manager, R&D (Electronics) Department, said visitor traffic was good and so was the buyer response. “Buyers are interested in household medical

and healthcare products, and they have asked for in-depth details about product features, prices and cooperation opportunities. Some Middle Eastern and Australian buyers have even shown interest in visiting our factories on the Chinese mainland.” Mr Tam expected overall sales this year to rise from 10 per cent to 20 per cent.

Spain’s Emergencia 2000 SA is an importer of emergency chairs, health monitors and other products. Company CEO Julian Rodriguez Fernandez said he had found four potential suppliers with the help of the HKTDC’s business-matching team and was satisfied with the results.

Tay Eng Hean, Head, China/Hong Kong, at Singapore’s White Rock Medical Company, a first-time exhibitor, was also pleased with the fair. White Rock, which specialises in high-tech medical supplies, featured its patented Alter G AntiGravity Treadmill at the fair. “The response has been very positive, and we are in talks with buyers from the Chinese mainland and Europe,” said Mr Tay.

The Hospital Authority Convention, held alongside the medical fair, attracted 4,500 medical professionals from around the world. Convention participants brought additional business and networking opportunities for exhibitors.

Medical Technology The fair featured a number of seminars, with industry experts discussing topics ranging from medical device technology to market development and trends. Exhibitor Forums were also held, allowing companies to demonstrate their products and answer buyer enquiries.

The Hong Kong International Medical Devices and Supplies Fair was organised by the Hong Kong Trade Development Council and the Hong Kong Medical and Healthcare Device Industries Association.

Tomas Petrusek, Senior Purchasing Manager of the Czech Republic’s Promedica Praha Group, was a first-time fair participant. “I am particularly interested in breathing circuits and laparoscopes supplied by two potential suppliers. I’ll ask for their quotations and samples, and then test these medical devices at hospitals before confirming my orders.” Business-Matching Success Medical Device ASIA | July-August 2014 | 21

Credihealth Organizes Blood Donation Camp As A Part Of Credi Blood Donors Campaign

redihealth, the leading online healthcare information services provider, organized a Blood Donation Camp on the occasion of World Blood Donation Day as a part of their Credi Blood Donors campaign. The World Blood Donor Day, sanctioned by World Health Organization, is held every year on June 14 to raise awareness of the need for safe blood and blood products, and to thank blood donors for their voluntary blood donation. The day also coincides with the birthday of Nobel Laureate Karl Landsteiner (born: 14 June, 1868), a noted Austrian biologist and physician, who was the father of the current system of ABO Blood Grouping. Credihealth has launched a platform “Credi Blood Donors” where healthy enthusiastic individuals can register to donate blood. The users are required to fill in the details given on the Credihealth blog and get registered as donor. Hospitals, clinics or people can notify Credihealth of their blood needs, following which Credihealth will contact its Credi donors. According to District Aids Prevention Control Unit (DAPCU), more than 55% people desist from blood donation camps owing to wrong notions like possibility of weakness or HIV, etc. Credihealth has started the campaign to get rid of such notions and is targeting people from the 18-50 years of age group. The company aims to be the go-to destination for credible information and feedback on healthcare with an association with top doctors and hospitals. Every year India requires millions of units of blood, and there is a huge shortage. Having sufficient quantities of this valuable resource can save many lives – of road accident victims and trauma patients, patients suffering from dengue, treat thalassemia, and support patients undergoing major surgeries and complicated pregnancy cases. Credihealth and Select City Walk, 22 | July-August 2014 | Medical Device ASIA

Saket in association with Rotary Blood Bank New Delhi joined hands to make more people aware of how blood donation has a positive impact on improving the overall well-being of the Indian Society. Commenting on the campaign, Mr Ravi Virmani, Co-Founder, Credihealth India, said, “Our research statistics tell us that every day India requires 38,000 blood units and unfortunately, we do not have adequate blood units’ supply to fulfil this requirement. Hence Credihealth organized a Blood Donation Camp in partnership with Rotary Blood Bank, and Select Citywalk Mall as the venue partner on the occasion of World Blood Donor Day on Saturday, 14th June 2014. Credihealth has taken this initiative to spread awareness regarding the benefits of blood donation and spread the message that it is a completely safe procedure.” On the occasion Mrs Sonu Singh, Manager, Motivation and Camp Operations, Rotary Blood Bank said, “The World Blood Donor Day, sanctioned by World Health Organization, is held every year on June 14 to raise awareness of the need for safe blood and blood products, and to thank blood donors for their voluntary blood donation. For the blood donation camp organized by Credihealth in partnership with Rotary Blood Bank we were able to get more than 100 units were donated by enthusiastic youth till late evening. The aim was to generate awareness and to motivate citizens to donate blood voluntarily, so that the shortage

is overcome. Regular, Voluntary Blood Donors are the single most important source of blood as they have fewer blood borne infections amongst them.” Developed with latest technology, patients can log onto www. credihealth.com and get access to reliable healthcare information including consultation and appointments with top doctors and hospitals. Credihealth mobile application is available on mobile platforms like android and iPhone. The mobile app helps users to have quick and instant connectivity with doctors. The company is offering its services in Delhi, Gurgaon, Noida, and opening up shortly in other metropolitan cities. Credihealth is planning to expand its services to the rest of India within the next few months. About Credihealth

Credihealth.com is the premier destination for booking doctor appointments online in India for both domestic and international patients. Credihealth helps Indian and International consumers make informed decisions on Indian healthcare providers. Credihealth provides the most reliable, comprehensive, updated and validated information on the user’s healthcare needs.

Philips and Salesforce.com Announce a Strategic Alliance to Deliver Cloud-based Healthcare Information Technology In a move to accelerate the transformation of the healthcare industry, Royal Philips (NYSE: PHG AEX: PHIA) and salesforce.com (NYSE: CRM) today announced a strategic alliance to deliver an open, cloud-based healthcare platform, leveraging Philips’ leading positions in medical technology, clinical applications and clinical informatics and salesforce. com’s leadership in enterprise cloud computing, innovation and customer engagement. Patient relationship management will be at the center of the envisioned platform, allowing caregivers to collaborate closely in support of their patients. The platform will enable medical device and data interoperability -- the collection of data and subsequent analysis to enhance clinical decision making by professionals and enabling patients to take a more active role in managing their personal health.

The collaboration has already resulted in two clinical applications to be launched on the new platform later this summer[i]: “Philips eCareCoordinator” and “Philips eCareCompanion”. These care collaboration applications will allow the care team to monitor patients with chronic conditions in their homes and will facilitate Philips’ Hospital to Home clinical programs, such as Banner iCare™, being piloted at Banner Health, a pioneer accountable care organization in Arizona, USA . Similar telehealth-based care delivery models for hospitals utilizing the Philips eICU program were shown to reduce mortality by 26 percent and length of stay by 20 percent in a recent large, multi-center study[ii]. “With this strategic alliance, Philips is making great strides to deliver realtime, digital healthcare solutions,” said Frans van Houten, Chief Executive Officer of Royal Philips . “Healthcare data exists in many different forms and in many different systems today. Together with salesforce.com , we have a tremendous opportunity to reshape and optimize the way healthcare is delivered and provide better access to data across the continuum of care.” “We have entered a new transformative era for healthcare, and technology is enabling the industry to connect to, care for and engage with patients and each other in a profound new way,” said Marc Benioff, chairman and CEO, salesforce.com. “Together with Philips , we are creating an open health platform and ecosystem to benefit everyone that cares about one of the most important issues of our time.” Philips and salesforce.com envision that apps will cover the continuum of care: from self-care and prevention, to diagnosis and treatment through recovery and wellness. The envisioned platform, based on the Salesforce1 Platform, will enable collaboration and workflow, as well as integration of data from multiple sources worldwide, including electronic medical records, diagnostic and treatment information obtained through Philips’ imaging equipment, monitoring equipment, personal devices and technologies like Apple’s HealthKit. Moreover, the cloud-based platform

is designed to be highly scalable with built-in privacy and data security. By combining the data, the platform will allow for analysis that will enhance decision making by professionals and engage patients. Both Philips and Salesforce.com foresee that the platform, will utilize Philips’ clinical data stores and medical device interoperability. It is intended to be open to developers and is expected to result in a vibrant ecosystem of partners creating applications. As a result, the envisioned platform has the potential to transform both professional healthcare delivery and continuous personal health management.

About Royal Philips: Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands , Philips posted 2013 sales of EUR 23.3 billion and employs approximately 112,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter . About salesforce.com Salesforce.com is the world’s largest provider of customer relationship management (CRM) software. For more information about salesforce.com (NYSE:CRM), visit: www. salesforce.com Any unreleased services or features referenced in this or other press releases or public statements are not currently available and may not be delivered on time or at all. Customers who purchase salesforce.com applications should make their purchase decisions based upon features that are currently available. Salesforce.com has headquarters in San Francisco , with offices in Europe and Asia , and trades on the New York Stock Exchange under the ticker symbol “CRM.” For more information please visit http://salesforce.com , or call 1-800-NO-SOFTWARE. “Safe harbor” statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, including statements relating to future products and features. The achievement or success of the matters covered by such forward-looking statements involves risks, uncertainties and assumptions. If any such risks or uncertainties materialize, or if any of the assumptions prove incorrect, the company’s results could differ materially from the results expressed or implied by the forward-looking statements we make. Further information on factors that could affect the company’s financial and other results is included in the reports on Forms 10-K, 10-Q and 8-K and in other filings we make with the Securities and Exchange Commission from time to time, including the company’s most recent Form 10-K. These documents are available on the SEC Filings section of the Investor Information section of the company’s website at www.salesforce.com/investor . Salesforce.com, inc. assumes no obligation and does not intend to update these forward-looking statements, except as required by law. [i] Not yet available for sale; 510(k) pending in the USA [ii] A Multicenter Study of ICU Telemedicine Reengineering of Adult Critical Care. Lilly et al. CHEST. 2014. Vol. 145, No. 3. March. 500-507 1 A Multicenter Study of ICU Telemedicine Reengineering of Adult Critical Care. Lilly et al. CHEST. 2014. Vol. 145, No. 3. March. 500-507

Medical Device ASIA | July-August 2014 | 23

Efficacious Business Solutions! The market in Europe, with its statutory social security systems, is a huge one for all medical devices. Regarding product liability obligations, Europe can also be a risky region for all manufacturers and importers of products. Since the EU has always been oriented to consumer protection and free trade in the domestic market, product surveillance has been intensive. Defective products can cause several civil actions against the manufacturer or importer itself. In these lawsuits, which can be different with regard to civil procedure in each of the EU Member States, the plaintiff can demand compensation for both damages and immaterial damage. Faced with lawsuits resulting from product liability obligations, liability insurance is an integral part of the procedure and should be common for every medical device manufacturer or importer.

roduct liability law as an integral part of modern consumer protection is an often-underestimated risk to NonEuropean manufacturers entering the European market. Every country usually has its own tort law, of which product liability is a part. The EU was the first legal corporation to stipulate a harmonized standard in product liability law, established for its Member States with Council Directive 85/374/EEC of 25 July 1985 on the approximation of laws, regulations and administrative provisions of the Member States concerning liability for defective products (Product Liability Directive).

suppliers of medical devices must comply to avoid civil actions and prosecution.

Furthermore, Council Directive 92/59/EEC of 29 June 1992 on general product safety (European Product Safety Directive) and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Devices Directive) stipulate a legislative framework with which manufacturers and

• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD)

There is not just one medical device directive that has to be taken into consideration when talking about medical safety regulations in the EC; there are three: • Council Directive 93/42/ EEC of 14 June 1993 concerning medical devices (MDD) • Council Directive 90/385/ EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)

In addition to the directive and its national harmonization there is a legal system in each of the

24 | July-August 2014 | Medical Device ASIA

Member States to handle noncontractual damages. The directive does not affect national provisions governing contractual or noncontractual liability. These systems are still in use in the Member States and sometimes represent even more risk to industry than the EU’s harmonized standards. Actually - as a consequence of the so called “PIP scandal” in 2012 regarding contaminated breastimplants – the European regulation system is about to change. The European Commission decided to implement a renewed medical device safety system providing an increased protection for users of medical devices and patients. In order to achieve this higher protection level, manufacturers of medical devices will be exposed to even stronger obligations. Besides, demand for manufacturers is made by the European Commission to conclude mandatory product liability insurances as a condition for the distribution of the medical device products within the European market. “Reusch Rechtsanwälte” is a team of lawyers representing European and non-European companies in all matters of liability law, especially product liability issues. Our clients are primarily large and middle-sized industrial businesses, particularly from the medical device industries, automotive supply and mechanical engineering. We offer our clients practical business solutions that provide preemptive protection against the risks of business operations product liability. We support the client’s legal division, as well as the company’s other specialist departments, in identifying and safeguarding against the various risks faced in connection with the entering of the

European market. Since the EC regulations require a manufacturer located outside the European Economic Area to designate a European Authorized Representative as a liaison to the European Competent Authorities, Reusch Rechtsanwälte cooperate closely with the MT Promedt Consulting as an experienced provider of qualified and professional Authorized Representative Services in all European countries. The combined services of Reusch Rechtsanwälte and MT Promedt Consulting will guarantee nonEuropean manufacturers of medical devices full compliance with all EU regulations during the pre- and post-marketing phase in Europe. You can contact Reusch Rechtsanwälte and MT Promedt Consulting at “Medical Fair Asia”, booth number 4H10-2. Further contact details: Reusch Rechtsanwälte Saarbrücken Office, Hochstraße 63, 66115 Saarbrücken Phone +49 (0)681 / 859 160-0, Fax +49 (0)681 / 859 160-11 Berlin Office, Charlottenstraße 68, 10117 Berlin Phone + 49 (0) 30 20 188 376; Fax+ 49 (0) 30 20 188 575 info@reuschlaw.de www.reuschlaw.de MT Promedt Consulting GmbH Altenhofstrasse 80, 66386 St. Ingbert Germany Phone | + 49 6894 581020 Fax |+ 49 6894 581021 mohr@mt-procons.com www.mt-procons.com

ReWalk(TM) Personal Exoskeleton System Approved by FDA for Home Use -Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S. technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials,” he added. “This is truly the beginning of ‘ReWalking’ as a daily reality in the U.S.”

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk. ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

Derek Herrera, a Captain in the U.S. Marine Corps, is a paraplegic trained on the ReWalk Personal System, and will be one of the first Americans to own the ReWalk. “I see this as a milestone for people in my same situation who will now have access to this technology - to experience walking again, and all of the health benefits that come with ReWalking,” Captain Herrera said. The Marine Special Operations Command Foundation (MARSOC Foundation) will be donating the funds for Herrera’s ReWalk system; Herrera works for the Marine Special Operations Command. “It will be incredible for me to regain independence, to use the system to walk and stand on my own,” he added.

ReWalk provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system The FDA has issued a marketing allows independent, controlled clearance for the ReWalk, which walking while mimicking the natural was granted via a rigorous de novo gait patterns of the legs, similar to process that involved multiple that of an able-bodied person. In clinical studies demonstrating safety and effectiveness of the technology. addition to the ability to stand and walk independently, clinical studies “This revolutionary product will have of the ReWalk Rehabilitation system show significant health benefits to an immediate, life-changing impact the user, on both a physiological on individuals with spinal cord and psychological level. injuries,” said Larry Jasinski, CEO of ReWalk Robotics. “For the first time Study data of the ReWalk system individuals with paraplegia will be indicates potential improvements able to take home this exoskeleton

in cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations. “What makes this so exciting is the understanding that, in addition to the psychological benefits realized by ReWalking, consumers are able to improve upon the clinical benefits,” said Jasinski. “Now, with FDA clearance, users will continue to experience these benefits on a daily basis at home.” ReWalk has been tested extensively in the U.S., Europe, and Israel. The ReWalk system is supported by the most published data of all exoskeleton systems in the rehabilitation market, and is used by more people worldwide than all other exoskeleton systems combined. ReWalk was developed by Dr. Amit Goffer, an Israeli inventor who became quadriplegic after an ATV accident in 1997. It was through his own personal experience in utilizing mobility devices for people with spinal cord injury that Dr. Goffer developed the ReWalk. The company offers two products: ReWalk Personal and the ReWalk Rehabilitation wearable robotic systems. The ReWalk Personal System, designed for everyday use by individuals at home and in their communities, is customfit for each user. The system is designed for daily use in a range of environments such as in the home, at work, at social events, indoors as well as outdoors, as well as on different surfaces or terrains. This revolutionary, cutting-edge technology allows users to stand, turn and walk with independent control of the system.

The ReWalk Rehabilitation system is used in the clinical rehabilitation environment, where it provides a valuable means of exercise and therapy as well as a training base for individuals to be certified, enabling them to purchase a Personal system. “The person walks the system, the system does not walk them. The users are in control -- when they want to sit, they sit, when then want to stand and walk, they do so,” said ReWalk inventor Dr. Goffer. “ReWalking is much more than walking,” says Jeff Dykan, ReWalk’s Chairman of the Board. “ReWalk provides paralyzed individuals with the ability to stand and walk, to look someone in the eye, to hug and be hugged. These are simple acts which many of our ReWalkers thought they would never be able to do again,” he added. “When you take that into account in addition to the health benefits, it underscores just how monumental a day this is for the SCI community here in the U.S.” The ReWalk Personal System is available to consumers upon meeting requirements from a medical examination and successful completion of the required training program. The company also offers a comprehensive maintenance and warranty program for the system. About ReWalk Robotics: ReWalk Robotics (formerly Argo Medical Technologies) develops, manufactures and markets wearable robotic exoskeletons for people with lower limb disabilities, such as paraplegia. ReWalk’s mission is to fundamentally change the health and life experiences of individuals with spinal cord injury. Founded in 2001, ReWalk Robotics is a global company with headquarters in the U.S., Germany, and Israel. For more information on ReWalk Robotics and the ReWalk Systems, please visit http://www.rewalk.com.

Medical Device ASIA | July-August 2014 | 25

PLAC Test to Determine Cardiovascular Diseases

etropolis Healthcare Ltd, India’s leading multinational chain of diagnostic centers has become one of the few laboratories in Asia to offer PLAC Test. It is a risk stratification test which identifies the enzyme in the blood vessels. Plac test is a simple blood test that measures the enzyme activity of Lp-PLA2 level in the body. It is a cardiovascularspecific inflammatory marker implicated in the formation of rupture-prone plaque.

enough; a traditional Cholesterol test can miss hidden risks for heart attack. More than 50% of heart attacks occur in patients with normal cholesterol; rather most cardiovascular (CV) events i.e., Heart attack and stroke are caused due to rupture of plaque that is formed by cholesterol deposition in the blood vessels” Said Dr. Rajesh Bendre, head of department – Immunochemistry & special Immunochemistry, Metropolis Healthcare Ltd.

Lp-PLA2 (Lipoprotein-associated phospholipase A2) is a blood vessel enzyme, found to be the second most predictive of heart attack risk, also warns of vulnerable plaque that could erupt like a volcano. The higher the level of Lp-PLA2, the higher the risk of CV events i.e., Heart attack and stroke - even with normal LDL cholesterol. Lp-PLA2 as a biomarker for cardiovascular risk stratification has been endorsed by various guidelines published by the American College of Cardiology Foundation/ America Heart Association, the American Stroke Association, the American Association of clinical endocrinologists in 2010, 2011 and 2012.

In heart diseases, it’s known that an unhealthy lifestyle that includes fatty foods, excess alcohol and smoking dramatically increases the risk of a stroke. This drives up cholesterol levels and increases blood pressure. Blood vessels become clogged with fatty deposits that can dislodge and make their way to the brain, depriving it of vital oxygen. However, doctors acknowledge that a significant number of people fall victim to strokes despite having no obvious risk factors.

“PLAC Test is a simple blood test that assesses your cardiac health. Cholesterol testing alone is not

“Eventually the unstable plaque can rupture, turn into potential lethal clots and debris loose in bloodstream—causing a stroke or a heart attack. PLAC test is second generation enzyme linked immunoassay test, helping doctors with prediction of future strokes and heart attack” says Dr Arvind Joshi, consultant cardiologist.

26 | July-August 2014 | Medical Device ASIA

Metropolis Healthcare Ltd

t Metropolis, what we believe is what we say and what we say is what we do. Being empathetic to our customers and being committed to their needs is in our DNA. Metropolis has grown to harness a culture that is open, synergistic, progressive and scientific in nature. We are the Pathology Specialists delivering over 15 million tests a year, catering to more than 10,000 Laboratories, Hospitals, Nursing homes and 2,00,000 Consultants. With 33 years of experience in delivering accurate reports, Metropolis has earned the reputation of being India’s most respected and only multinational chain of diagnostic centres with presence in UAE, Sri Lanka, South Africa, Kenya, Mauritius and Ghana. Driven to make a difference, our wide network includes 105 stateof-art Laboratories across India with over 700 collection centres, processing over 4500 varieties of tests and supported by an efficient team of more than 3000 people. Equipped with cutting edge technology, innovative work equipment, expansive logistics network and rigorous processes, Metropolis ensures and delivers precision and accuracy in every single test; each time, every time. In the last 10 years, Metropolis has expanded into new service lines like Clinical Trials, Hospital Lab Management, Home Health Services, Preventive Health Checkups and Corporate & Wellness Solutions. Metropolis is at the forefront in adopting cutting edge technologies and services that contribute new revenue streams and has positioned the company on the pedestal it is today. Today, we are one of the few laboratories that has received the CAP (College of American Pathologists), accreditation,

the global gold standard in Laboratory Accreditation. 12 of our laboratories in India has received the NABL Accreditation (National Accreditation Board for testing and Calibration Laboratories). In addition, the central laboratory in Mumbai also adheres to CLIA (Clinical Laboratory Improvement Amendments) program and also follows the guidelines laid by GCP and GLP. Our unit in South Africa is accredited by SANAS (South African National Accreditation System is the only accreditation body approved by South African Government). Metropolis has been awarded numerous accolades like the ‘Best Diagnostic Company of the year’ by Modern Medicare in 2006 and ‘Best Diagnostic Company of the Year’ in 2010 by Frost & Sullivan. Metropolis was also bestowed with ‘Best IT Integration in Customer Service Management’ at the e-Health World Expo 2011. Metropolis was also honoured with the ‘Quality Brand Award’ by NEHRDO in 2012. Metropolis won the ‘CMO Asia Award’ for Best IT practices in Healthcare in 2012. Metropolis Healthcare is led by Ameera Shah, Managing Director & CEO. An International & National Award winners, she was conferred with ‘The Young entrepreneur of the Year Award’ by GE in 2006 and ‘The Young Achiever of the Year Award’ at the CMO Asia Awards in 2011. She was also the recipient of the prestigious ‘Young Entrepreneur of the Year Award’ in 2011 organised by Entrepreneur India and Bloomberg. She has been honoured with ‘Women Leadership award’ at the World Women Leadership and Congress awards 2014. Recently she has been chosen as one of the most respected leaders under 40 years by Economic Times & Spencer Stuart (2014).

Metropolis’s special initiative trains future doctors in Immunohistochemistry Metropolis Healthcare Ltd. through its interactive medical education initiative, Metrospheres has embarked on a unique experience based learning program in Immunohistochemistry (IHC) aimed at creating industry ready doctors and medical practitioners. Through this, Metropolis is imparting special hands on training to PG students (MD / DNB Pathology) & Practicing Pathologists with a focus on better patient outcomes and treatment in oncology, through better trained, educated well equipped pathologists in this new era of evidence based medicine.

HC has far surpassed its initial expectation as an invaluable tool in the correct recognition of tumors. It is now being increasingly sought after for prognosis of tumors and as a justification for initiation of expensive targeted therapy in oncology practice for prediction of response to treatment. The wider application of IHC has increased the demands from a surgical pathologist who no longer restricts to giving a correct label but also actively participates in the subsequent clinical decision making process. The training program imparts in-depth theory and extensive hands - on experience in IHC techniques. Oncology is a critical practice where wrong diagnosis can lead to severe consequences for the patient. Through the Metrospheres IHC module, Metropolis aims to creating a better understanding of this complex subject and troubleshoot problems in Oncosurgical Pathology & Oncohematology. Speaking on the initiative Dr. Kirti Chadha, National Coordinator & HOD, Surgical Pathology said “At Metropolis, we have made it a routine practice to provide an accurate final diagnosis using all available ancillary tests to each one of our patients & with this initiative we have created a platform to bring together practicing & training pathologists to discuss complex IHC markers which have a direct role in targeted therapy & personalized cancer treatment. As technology & science meet at Metropolis we feel it is important to familiarize the next generation with the latest techniques & whole battery of new applications of IHC. We are using molecular morphology of IHC and tissue to set the stage for treatment and further genetic testing for which the patient may be eligible. IHC is far more powerful than it was two or three decades ago, hence, we pathologists need to think about how to incorporate new markers and knowledge into our daily surgical pathology practice. The hands on training will help them to standardize this beautiful test in their own laboratories & hospitals.” The laboratory demonstrations, exercises, discussions, and trouble-shooting sessions focus on: 1) Orientation, overview, principles and perceptual understating of IHC. 2) Clinical & Technical pearls. 3) ASCO / CAP reporting guidelines for ER , PgR & HER2Neu. 4) Role of IHC in Hodgkin & Non Hodgkin Lymphomas 5) Carcinomas Overview especially CUP that is Carcinoma of Unknown Primary. 6) Sarcomas Overview. Medical Device ASIA | July-August 2014 | 27

Enhancing SME Business Ethics in the Healthcare Industry Trade Development Advisor for Market Access and Compliance with the US Department of Commerce, who oversees the multi-year APEC project. “The medical device sector has unique needs in the area of business practices. This is driven by its high levels of interactions with healthcare professionals,” continued Ms Costa.

he relationship between healthcare companies and physicians is complex, presenting potential conflicts of interest that require oversight. Biopharmaceutical and medical device companies operate in a highly competitive market. As a result, some companies may seek an advantage by extending gifts or other inappropriate inducements to healthcare professionals to promote a specific drug or medical equipment. This practice hurts ethical enterprises seeking to grow local operations or engage in cross-border trade. It stifles the ability of small and medium enterprises (SMEs) to invest their limited resources in health innovation. And it can result in higher costs for patients. SMEs most impacted by corruption

More than USD 1 trillion dollars are paid in bribes every year by the private sector, according to the World Bank Institute. Moreover, small and medium enterprises pay a much higher percentage of their annual revenue to bribes than large companies. More than 70 per cent of SMEs in economies transitioning to a market-oriented environment perceived corruption as an impediment to their business. APEC project on SME business ethics

Beginning in 2011, the Asia Pacific Economic Cooperation (APEC) multi-year initiative on Business Ethics for 28 | July-August 2014 | Medical Device ASIA

SMEs has helped small and medium enterprises in the biopharmaceutical and medical device industries develop codes of ethics to self-regulate their business practices. Today, as a result of the APEC initiative, codes of ethics have been adopted and are undergoing implementation by around 60 biopharmaceutical and medical device industry associations and their member companies from 19 economies across the Asia-Pacific, representing more than 14,000 firms. “The medical device and biopharmaceutical sectors were specifically chosen because ethical business practices have a direct and substantial impact on thousands of SMEs, the wellbeing of patients, consumers and innovation,” said Lynn Costa, Senior

Medical device companies employ royalty and consulting arrangements, research grants, and other forms of collaboration with individual physicians to acquire new medical technology. In many cases, physicians may be involved in the company’s development and testing of innovative technologies. Effective delivery of new medical devices and equipment is also highly dependent on demonstrations and product training with healthcare professionals. “As a result, SMEs in the medical device industry require transparent guidelines or codes to govern how they interact with healthcare professionals,” added Ms Costa. APEC developed principles for ethics codes

In 2011, the APEC project convened expert working groups to develop APEC principles for codes of ethics which resulted in the Kuala Lumpur Principles for the medical device sector and the Mexico City Principles for the biopharmaceutical sector. These APEC principles were intended to serve as guidelines to assist industry associations within each APEC economy develop and implement codes of their own.

“We engaged industry experts, regulators, and academics in the biopharmaceutical and medical device sectors across APEC economies to contribute valuable input during the code drafting process,” explained Dato’ Hafsah Hashim, Chief Executive Officer of SME Corporation Malaysia, who co-chaired the expert working group for the medical device sector and helped draft the codes. “We took into account the economic and regulatory situation in participating APEC economies and came up with a code that could be implemented in these economies alongside their regulations and laws,” added Dato’ Hafsah. The codes focus on three key ethical principles—Integrity, Independence and Transparency. For example, an important provision prohibits companies from providing inappropriate inducements to healthcare professionals of any monetary value, including gifts, entertainment, commissions or gratuities. Other provisions include ensuring promotional and marketing materials on drugs or devices are based on scientific evidence and not false information. “Commitment to ethical practices is more than a business strategy,” said Russell Williams, President of Rx&D, Canada’s Research Based Pharmaceutical Companies, who co-chaired the expert working group for the biopharmaceutical sector and helped draft the APEC principles. “As a healthcare industry, we have a responsibility to adhere to the highest ethical standards.” “Self-regulation in this area is essential and we need to involve all stakeholders in its advancement including industry, health care professionals, governments and patients,” he explained. “A commitment to and application of the APEC Principles will greatly benefit us all.” Industry associations adopt ethics codes

In 2012, APEC organized capacity building workshops and mentor teams to assist medical device and biopharmaceutical industry associations in the Asia-Pacific region draft their own codes based on the APEC Principles. The China Pharmaceutical Industry Association (CPIA) was one of the industry groups that attended the workshops. CPIA promoted the implementation of the Mexico City Principles for the pharmaceutical industry in China. “In 2012, we worked together with the China Chamber of Commerce for Import and Export of Medicine and Health Products and the China Pharmaceutical Industry Research and Development Association to develop our codes known as the ‘Pharmaceutical Enterprise Ethical Practices in China’, the Chinese version of the APEC Mexico City Principles,” said Hong Zheng, Executive Chair of the China Pharmaceutical Industry Association. “We jointly launched our codes in 2013 with eight other Chinese pharmaceutical industry associations, together with support from relevant government ministries and departments in China,” added Ms Zheng.

Training SMEs on implementing ethics codes

In 2013, as a critical next step “to bring these codes into life” and ensure SMEs implement the codes, the APEC initiative organized a trainthe-trainer workshop in Malaysia and created a network of over 100 ethics trainers across all 21 APEC economies to help familiarize individual SMEs with codes of ethics aligned with the APEC principles. SME training programs have since been held in Chile, China, Indonesia, Malaysia, Mexico, Singapore, Peru, Philippines, Russia and Viet Nam and several more are planned throughout the region. The Mexican Association of Innovative Medical Devices (AMID) conducted training programs for its companies earlier this year. “The Code was adopted by all 23 member companies of our association and the general managers from the companies gave their written consent and statement to comply with the Code. We consider the ‘tone at the top’ really important to bring everyone on board,” said Andrea PerezFigueroa, Ethics and Compliance Manager for Latin America at Baxter and Head of the Ethics Committee of the Mexican Association of Innovative Medical Devices Industries. “These 23 companies are also united as a common front to fight corruption in the medical device sector in Mexico and we expect the number of companies to keep on growing,” added Ms PerezFigueroa. SMEs benefit from ethics codes

Xian-Janssen Pharmaceutical Ltd is a member of the China Pharmaceutical Industry Association who attended the ethics trainings and has been operating their business in China under the highest level of ethics codes. Since the training program, the company has continued to regularly update their codes.

“We have had many discussions internally in our company and have updated the working process and standards for our employees,” said Tongyan Wang, Vice President of Xian-Janssen Pharmaceutical Ltd. “For example, if our company sponsors a doctor’s research with the aim of collecting more clinical data, there are clear rules that this sponsorship should be regulated by the medical department separately, and not influenced by the marketing and sales department so as to ensure compliance,” explained Ms Wang. AdvaMed, a medical device industry association in the United States, also ensured their code was aligned with APEC’s Kuala Lumpur Principles for the medical device sector. The association provides a robust training program for member companies and online compliance resources to help them implement the code. To date, 67 SMEs have certified that they are complying with the AdvaMed Code of Ethics, which is based on the APEC Principles. “A medical device company that has adopted, implemented and proactively follows a code of ethics aligned with the Kuala Lumpur Principles can openly hold itself as an enterprise abiding by the highest ethical standards,” explained Mr White, AdvaMed’s Senior Executive Vice President and General Counsel, who played an active role in drafting the APEC Kuala Lumpur Principles and sharing best practices with other industry associations in the Asia-Pacific. “This builds a predictable business environment across the region and facilitates regional trade and patient access to advanced medical technologies. It also helps build the confidence required in long-term relationships that is necessary for business expansion and innovative research and collaboration,” concluded Mr White. For more information, please visit: http://businessethics.apec.org

Medical Device ASIA | July-August 2014 | 29

Fit and Fine with OSIM uShape

OSIM Introduces uShape – Full Body Vibration Exerciser

OSIM introduces uSlender Now get in shape with OSIM’s new Tummy Tucker

OSIM

India introduces uShape, a full-body vibration exerciser that helps to burn off calories efficiently. The uShape, also known as whole body exercise vibration training, is designed to achieve a whole body workout with little effort and time, making it perfect for the time-poor urban dwellers. The uShape provides strong vibrations to the whole body with stand sit or hold varying positions such as squat, push up, lunge etc. These strong vibrations cause rapid contractions to all muscles that are being exercised, making it an easier and more effective way to get a full-body workout. This results in increased muscle strength, improved flexibility and improved blood circulation which encourage the body to burn upto 136 Calories in 10 minutes, resulting in an increased metabolism. Moreover, it helps to reduce the appearance of cellulite and also helps in achieving effective shaping and toning of the whole body. Choose from a total of 9 convenient full body work outs (3auto programs X 3 standing position) according to your needs. The 3 auto programs are specially design to tone and shape your body in progressive levels. The uShape offers you the flexibility of customizing your workout the way you want it. Choose from a manual selection of 10 speeds for a high frequency, efficiency calorie-burning workout. Intensify your workout routine with the resistance card system that allow for versatile strength and body conditioning. The sleek, slim and mobile design of the uShape allows you to store it under the bed or sofa when not in use and the wheel caster on the side allows moving it effortlessly to any place around the house. With the remote control in your hands, you can select and customize your workout options easily and conveniently with the touch of a button. Shaping up has just gotten easier with the OSIM uShape, an effective indoor exerciser in the convenience and comfort of your home. OSIM uShape is priced at Rs. 55000/- (Octroi extra in Maharashtra). For further information please log on to www.osim.com

30 | July-August 2014 | Medical Device ASIA

OSIM

India introduces uSlender, the best compact Tummy Tucker that helps tone and trims your tummy to give you that perfect shape. Small and light weight, the sleek uSlender’s Tummy program increases circulation to bring about oxygen to abdominal area, resulting in higher metabolism and faster fat burning, thereby firming and toning the tummy. It also improves body’s digestion process and facilitates excretion and preventing constipation. Not only your Tummy but uSlender also tones up your Butt, Thighs & Lumbar and also helps in ease aches and tensions in muscles. An Amazing Fact:

A high stress level lowers your metabolic rate and causes your body to store more fat. Besides lowering stress levels, uSlender’s massage technology helps to release Natural Endorphins in your body which boost your body’s ability to burn fat and enhance circulation and metabolism rate to prevent build up of fat cells. With the two manual massage options, Twin Power Osimotion and the Dual Kneading in 3 different intensities, you can now customize your massage according to your preference. The OSIM uSlender comes equipped with a built in timer, the auto timer ensures that each massage session runs for 10mins for optimal results. Select and personalize your massage options easily and conveniently with the on board controls.Quit holding your breathe in and loose that little pouch in your tummy with the sleek and compact OSIM uSlender. OSIM uSlender is priced at Rs.10, 900/- (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.

Paramount Surgimed Ltd. launches

Digital Blood Pressure Monitor with an LCD Display Blood Pressure Monitoring just got easier

Paramount Surgimed Ltd. launches AroCare - An Anti Decubitus Mattress

aramount Surgimed Ltd. launches the Digital Blood Pressure Monitor, one of the best ways to now check your blood pressure with no tension of measuring the zigzag turns of the stick instead getting best and the accurate results on your blood pressure levels. The Digital Blood Pressure Monitoring device is an Easy to use monitor with Fuzzy Logic Inflation and controlled Deflation. The device features a large LCD display with easy to read in-progress results and measures systolic and diastolic blood pressure and pulse rates simultaneously and detects and alerts the user to irregular heartbeat. The device comes equipped with the WHO Indicator, provides an instant comparison to standards set by the World Health Organization. The Digital Blood Pressure Monitor comes in 3 variants Talking Digital Blood Pressure Monitor - 60 times memory irregular

Heartbeat Detector; Time and Date Display; Blood Pressure Level classification Indicator; Automatic Power Off Activated After 1 Minutes of Non Use; Measuring Range 0mm Hg ~300mm Hg; Arm circumference: 22~ 30cm; Measuring Accuracy: Within -3mmHg; Weight 430g; Machine Size: Length 146mm x Width 100mm x Height 60mm. Arm Digital Blood Pressure Monitor - 60 Times Memory; Digital

Display System; Automatic Inflation, Automatic Measurement; Accuracy: Within =4mmHg; Automatic Power off activated after 1 minutes of non-use; Measuring Range: 20mmHg -300mmHg; Machine Size: Length 1041mm/Width 154mm/Height 45mm; Cuff Size: Length 520mm/Width 140mm; Weight: 300g.

aramount Surgimed Ltd, a leader in Healthcare & Medical Disposables, introduces AroCare, Anti Decubitus Mattress. The mattress can prevent and cure decubitus for the patients who would turn over by themselves arduously and lie on bed for a long time at home or in hospital. The Mattress applies dry skin and diffusion of body pressure principle to prevent a skin swelling and sore. The AroCare mattress is reasonable priced and convenient to use. It is simple in structure, easy in operation and is better in prevention and cure of bed sores. It’s a perfect instrument of short-term bed ridden patients and family bed for patients. The mattress is composed of the pump and the airbed. Insert respectively the end of two rubber hoses into the two inlets of the airbed at a depth of 8mm. The inlet side of the air bed is the foot side of the patient. The air-pump has the function of changing air and Square inflated bags will undulate after fresh air is pumped, which can cut back the time that patients touch with mattress in the same interface and obtain a massage effect as well. The amount of air or air pressure amount can be controlled by using the pressure controller.

Wrist Digital Blood Pressure Monitor - Simply wrap the cuff around sizes your wrist and press START. In seconds your blood pressure and pulse are displayed on the digital panel; the fully automatic Wrist Blood Pressure Monitor features both Fuzzy Logic Inflation and controlled deflation along with one-button operation; The memory feature recalls up to 60 readings providing date and time stamps; comfortable wrist cuff suitable for 5-1/4” to 7-5/8” wrist circumferences and alarm clock.

With an air inlet join with plastic tube of the air-pump, put the patient on bed, connect power adapter with alternating current 220V and turn on. Air-pump will start working as soon as the light is bright and until the mattress is full of air. It comes in the size: 1900mm×900mm with an endurable weight: 100Kg.

The price of Talking Digital Blood Pressure Monitor is Rs. 4,000/- (Four Thousand) and available across the country through the extensive distributor/dealer network of the Company.

Anti Decubitus Mattress by Paramount Surgimed Ltd. is readily available across the country through the extensive distributor/dealer network of the Company. It is priced at Rs. 8000/. Medical Device ASIA | July-August 2014 | 31

Personality: Mr. Shaily Grover - Managing Director of Paramount Surgimed Ltd. & OSIM India Mr. Shaily Grover, Managing Director of Paramount Surgimed Ltd. & OSIM India an L.L.B Graduate has been a visionary in the lifestyle and health care field. He is Bachelor of Commerce (Honours). Mr. Grover started Paramount Surgimed Ltd. in the year 1993 for trading in Medical Consumables and devices. After which Medical Division in 1994 was started by him, manufacturing & export of surgical blades. Paramount was the first ISO9000 Co. in the field of Medical devices. It was also the first company to get CE mark for its products and the first ISO14000 Company. He then industry Mr. Shaily bring healthy into India. agreement with on February 2,

entered the retail in 2004; it was Grover’s vision to lifestyle products He signed the OSIM International 2004.

Later on, keeping the need for Incontinence products in mind, Paramount Surgimed Ltd. started a state-of-the-art Adult Diaper Plant in December 2011, which made a revolution in the Indian Medical industry being the first manufacturer of Adult Diapers in India. Well this was not just the end instead was the start of his remarkable success in the health and lifestyle industry then inaugurating a state-ofthe-art Under Pads Production line in April 2013 in its Factory in Bhiwadi, Rajasthan. About OSIM India:

With a vision of being a global leader in the Medical industry, PARAMOUNT SURGIMED LTD. came in to existence, within the Grover Group of companies, in 1993. Capitalizing on the rich and diverse 53 years of experience of the group, Paramount Surgimed Ltd. soon became a name that symbolized trust and quality in the medical industry. The Vision of the company is to be a one stop shop for all needs of medical professionals and institutions. The company started with the manufacturing of Surgical Blades and is now a leading supplier of a complete range of disposable and reusable medical products / devices. Paramount Surgimed Ltd. and all its employees share the vision of their 46 year old dynamic Managing Director, Mr. Shaily Grover to be a global leader in the Medical Industry. With over 25 years of experience in the field, and an inspiring leadership and approach, Mr. Grover has ensured that the Group’s reputation amongst its associates is synonymous with top quality, updated technologies, dedicated approach and customer friendliness. Paramount exports to 50 countries and has 80 distributors and 1400 Dealers across India. Our State-of-the-Art production facility compares to any international standard and is accredited with ISO 9000, ISO 14000, cE and US FDA Registration. 32 | July-August 2014 | Medical Device ASIA

Patient Friendly Orthopedic Casting Tape ‘AroCast’ Paramount Surgimed Ltd. unveils AroCast Casting Tape in Exciting Colors

Paramount Surgimed Ltd., a leader in Healthcare & Medical Disposables, introduces AroCast Orthopedic Casting Tape in exciting colors, Blue, Pink, White, Green and Camouflage for patients with fractures. A fracture is a painful affair and can really dampen moods, but Paramount Surgimed gives you a chance to uplift your mood with a Comfortable & Cheerful looking Cast! The AroCast casting tape is made of pure fiber glass and synthetic resin and is better than the existing orthopedic plaster bandages used for casting. The tape is available across the country through the extensive distributor/dealer network of the Company. AroCast orthopedic casting tape effectively hardens and fixes the surface of the cast and it works especially well for Orthopedic Casting, cast bracing, weight bracing, replacement cast, etc. Since AroCast is orthopedic tape made of fibers and resins, it is easy & simple to use, light in weight, vents superbly, is impact resistant, easily applicable to any body area, provides excellent flexibility & moulding, dries fast and is environmentally safe (burns up completely). AroCast orthopedic tape is available in 5 different colors - blue, pink, white, green and camouflage and 4 difference sizes. The price range starts at Rs.570 for 2inch, Rs.650 for 3inch, Rs.790 for 4inch and Rs.895 for 5inch. Grab a copy of

‘Medical Device ASIA’ @

‘Medical Fair ASIA’

9-11 September 2014, Singapore

Tecan offers revolutionary transfer tool for automated Nested LiHa disposable tip handling

ecan has introduced an innovative new consumable device offering increased throughput and capacity for Freedom EVO® workstations. The patent pending Disposable Transfer Tool is designed for use with Tecan’s Nested LiHa disposable tips, and offers fully automated handling of empty tip trays without the need for a gripper. Nested LiHa disposable tips offer increased worktable capacity for tip storage, allowing five trays of 350 μl tips to be stacked on a single SLAS-format carrier position. Until now, this solution has only been available for instruments equipped with a Robotic Manipulator Arm or a MultiChannel Arm™ gripper option to remove empty tip trays. Tecan has overcome this by developing an innovative consumable device – the Disposable Transfer Tool – that allows the Freedom EVO’s Liquid Handling (LiHa) or Air LiHa Arm to pick up and dispose of empty trays. Implementation of the Disposable Transfer Tool is designed to be as easy as possible using Freedom EVOware® (v2.6 SP1 onwards). The only additional hardware required is a 16-position Transfer Tool Holder, which can be quickly and easily filled by hand prior to beginning a series of runs. This elegant solution is particularly suited to smaller Freedom EVO workstations – where workdeck space is limited – boosting capacity without a significant capital investment. It also offers benefits for larger systems, allowing the gripper to perform other operations while the LiHa Arm disposes of empty trays, improving productivity and functionality for high throughput applications. To find out more about Tecan’s Disposable Transfer Tool, visit www. tecan.com/consumables

Transasia participates in First Annual APPI Conference, Mumbai

ransasia Bio-Medicals Ltd. for over 35 years, is recognized for providing the latest technological advances and encouraging knowledge sharing among experts as a part of its commitment to healthcare. It played an active part in the recently concluded First Annual Conference of Association of Practicing Pathologists (APPI) of India held on 14-15 June’14 at Mumbai. The APPI was a confluence of expertise, offering an excellent platform for knowledge sharing. A poster presentation competition was one of the highlights of the conference, offering insights on daily laboratory experiences. The poster that won the first prize was presented by Dr. Harshala Kulkarni from Dr Bhide’s Laboratory under the guidance of Dr. Milind Bhide and his expert team comprising Dr. Harshala Kulkarni, Dr. M G Bhide and Mrs. Deepali Suryavanshi. The poster on ‘Slide Review Criteria on the Sysmex XN-1000 in a Private Laboratory in Mumbai’ highlighted the use of Sysmex XN1000 analyzer (an advanced cell counter) with middleware for seamless automation. Sysmex XN 1000- 6 PDA hematology analyzer is marketed in India through Transasia Bio-Medicals Ltd.

XN-1000: •It offers several new parameters such as immature granulocytes, NRBCs and Ret-He •It has advanced capabilities for data handling •Transmits more than 200 parameters to the host PC for every sample •New features of XN 1000, the Q flags generated by the system and slide review criteria using these feature when incorporated into the middleware successfully brought down the slide review rate to 18.7% with the sensitivity of 81.24% and specificity of 99.89%. Along with APPI, Transasia was also proud to exclusively arrange a panel discussion on ‘Issues in Hematology’ by : • Dr. Joy Mammen, Prof. & Head-Dept. Of Transfusion Medicine & Immuno Hematology, CMC Vellore, • Dr. Anil Handoo, Sr. Consultant & Director Pathology-BLK Super Speciality Hospital, New Delhi and • Dr. Kunal Sehgal, Consulting Hematologist- P.D Hinduja Hospital, Mumbai. The panel discussion was moderated by Dr. Anita Karnik, Director-Dr. Karnik Pathology Laboratory. Eminent pathologists and hematologists from different parts of the region attended the session and gathered expert opinion on the challenges they face in day-to-day operations.

The poster presentation highlighted the following aspects about Sysmex Medical Device ASIA | July-August 2014 | 33

VERNACARE TO EXHIBIT AT 6th INTERNATIONAL INFECTION CONTROL CONFERENCE 1-3 August 2014, Hong Kong Convention and Exhibition Centre, Wanchai, Hong Kong SAR, China

Vernacare is exhibiting with local distributor partner Shun On Healthcare at the 6th International Infection Control Conference (IICC) in Hong Kong. Together, they are sponsoring a ‘lunchtime symposium’ session on 2 August at 12.30pm in Convention Hall AB. The invited speaker is infection control expert Martin Kiernan, from Southport and Ormskirk NHS Trust in the UK. Kiernan will present his paper on “Human waste disposal in clinical settings: a review of the evidence”, during which he will discuss the various methods of human waste disposal worldwide. He will review the latest scientific evidence of the impact on infection control, as well as the positive and negative aspects associated with each method. Visitors to the exhibition can learn about Vernacare’s innovative complete single-use system and award winning products, which have made the company a global leader in human waste management across the healthcare sector. The organization’s innovative single-use system is used in over 90% of hospitals in the UK and in more than 50 countries worldwide. The 6th IICC coincides with the 25th Anniversary of the Hong Kong Infection Control Nurses’ Association. The 6th IICC is scheduled for 1-3 August 2014 at the Hong Kong Convention and Exhibition Centre. Renowned local and overseas speakers will be in attendance to review and share the latest evidence and updates on infection control. Apart from the scientific sessions, the conference also offers satellite symposia and exhibitions for the industry to demonstrate its products and services to healthcare professionals from all over the world. Vernacare is a leading infection control organisation, whose innovative single-use system and award winning products have made it a global leader in human waste management across the healthcare sector. It is the only company to manufacture the complete human waste disposal system, including Vortex disposal unit and a full range of single use products. With over 200 employees across the UK and North America, working alongside our global network of international partners, the Vernacare system is supported by a specialist team who provide the highest standards of educational support, technical assistance and customer care to our varied customer base across over 50 countries worldwide.

34 | July-August 2014 | Medical Device ASIA

About Vernacare Vernacare is a leading infection control organization that helps hospitals deliver cleaner, safer healthcare. With its revolutionary singleuse system and award-winning product portfolio, the company is a global leader in human waste management across the healthcare sector. The organization’s innovative single-use system is used in over 90% of hospitals in the UK and in more than 50 countries worldwide. Helping to reduce the risk of cross infection, the disposable system removes the need for, and concerns over, the effectiveness of washer disinfectors and hand-washing of reusable bedpans and other toileting aids. Saving invaluable nurse time, the system also allows for more productivity, improved working conditions and patient care and acts as a solution for increasing both patient safety and dignity. Using its market-leading Vortex disposal unit, the Vernacare system utilises less water and energy than re-usable systems to dispose of its single use products, reducing clinical waste impact and energy consumption. The system also minimises costs, as it can help reduce expensive HCAIs and cost significantly less to purchase, operate and maintain than alternative re-usable systems. The only company to manufacture the complete human waste disposal system, including Vortex disposal unit and a full range of single use products, Vernacare is the largest manufacturer in the world for human waste disposable items. Each of the 150 million units produced each year are manufactured using over-issued clean newspaper. The company’s significant investment in automation and quality control measures ensures that the quality of its products is consistently of the highest standard.

SIEMENS

SIEMENS INSTALLS WORLD’S LONGEST LAB AUTOMATION TRACK AT THYROCARE  At 93.5 meters, the installation of Siemens Aptio Automation Solution is also India’s first.  With the solution Thyrocare can perform approximately 200,000 tests per day.  A total of 24 immunoassay and 7 chemistry systems are part of this automation solution.

n a significant boost to availability of in-vitro diagnostic testing services in India, the Diagnostics Division of Siemens Healthcare has successfully installed the world’s longest lab automation track at Thyrocare Technologies, Mumbai. The Siemens Aptio Automation installation at Thyrocare is also India’s first lab automation solution.

pensive now.” He further adds, “In 2014 summer, the first phase of the 187 meter long track that we need for our business has been installed.” Sushant Kinra, Head - Diagnostics Division, Siemens Healthcare India, mentions, “Siemens is aware of how our customers’ needs have evolved. Aptio Automation represents our latest innovation and vision on how we can help laboratories keep pace in this challenging environment and address their most pressing business and clinical demands.” Aptio is an adaptable solution that allows for a phased implementation to accommodate both current

and future needs of medium- to very high-volume laboratories. The solution promises to transform laboratory operations by combining Siemens’ industry-leading workflow expertise with peak performance, adaptability and intelligent technology. Aptio Automation’s circular track and modular design ensure adaptability to nearly any lab or testing environment. Aptio Automation also offers connectivity to Siemens’ portfolio of automation-ready analyzers, thus facilitating a multidisciplinary approach to testing. Further, the point-in-space aspiration feature helps streamline workflow by reducing the need to aliquot (or

divide) samples and its puck-based system with RFID enables individual sample routing and tracking, along with STAT prioritization. Additionally, Aptio Automation delivers comprehensive analytics via powerful, centralized information technology, while having the flexibility to provide pre- and post-analytical capabilities. Siemens’ CentraLink Data Management System facilitates efficient sample flow, auto-verification, quick access to samples and proactive quality control (QC). Plus, the CentraLink System can be customized per end user, speeding up system access and supporting error reduction.

The installation at Thyrocare is 93.5 meter long, which is currently the longest in the world. It has 31 instruments (24 Advia Centaur XP Immunoassay systems and 7 Advia 2400 Chemistry systems) docked to the track, 10 rack loading / unloading robots and 5 decappers. Various intelligent features in the solution allow Thyrocare Technologies to perform approximately 200,000 tests per day involving both immunoassay and chemistry. Dr. A Velumani, CEO and Founder, Thyrocare Technologies explains, “Aptio is sleek, dynamic and intelligent automation solution, very ideal for high volume laboratory for pre-analytical, analytical and post-analytical needs. Our floor is more productive and least exMedical Device ASIA | July-August 2014 | 35

MEDICA EDUCATION CONFERENCE 2014:

Medicine meets technology â&#x20AC;&#x201C; technology meets medicine

36 | July-August 2014 | Medical Device ASIA

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

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.”

Medical Device ASIA | July-August 2014 | 37

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 38 | July-August 2014 | Medical Device ASIA

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.

Medical Device ASIA | July-August 2014 | 39

Paradigm Shift in Syphilis Screening: need of the hour transmission or transfusion. Transasia Bio-Medicals Ltd. has been leading the in-vitro diagnostic industry for the last 35 years and has been providing the latest technological advances for precise disease detection. Recently, Transasia has launched ErbaLisa® Syphilis for detection of total antibodies against Treponema pallidum. Since treponemal serology is relatively complex with different profiles seen at different stages of infection and depending on whether treatment has been given or not, detection of total antibodies (IgM, IgG & IgA) helps in screening samples of any type or at any stage of infection. Serum immunoglobulin IgM and IgG antibody responses to T. pallidum have been studied extensively. Anti treponemal IgM antibodies are produced 2 weeks after exposure, followed by IgG antibodies 2 weeks after IgM production.

Kejal Mistry Product Management-Immunology, Transasia Bio-Medicals Ltd.

Syphilis, once known as the Great Pox, continues to challenge clinicians with its nuances in diagnosis and management. Serologic tests are the foundation of syphilis management because Treponema pallidum (TP) cannot be cultured in vitro, and knowledge of their diagnostic limitations is critical for clinicians. The mainstay of diagnosis for Treponema pallidum infections is based on non-treponemal and treponemal serologic tests. Sensitivities of non-treponemal tests vary depending on the type of test and stage of infection, with lower sensitivities in primary syphilis and late syphilis. False-positive test results are associated with viral infections, pregnancy, malignant neoplasms, autoimmune diseases, and advanced age while false negatives are observed due to detection of lipodial antibody detection appearing later during infection.

A recent report suggested that new recombinant antigen-based treponemal IgG and IgM ELISAs are the most sensitive, highly specific treponemal tests, and thus suitable for screening. Transasia’s ErbaLisa® Syphilis utilizes recombinant antigens of TP which ensures higher diagnostic sensitivity & specificity as compared to non-treponemal tests in case of primary, tertiary & congenital syphilis. It also minimizes the cross reactivity with cardiolipin antibodies. Furthermore, the advantages of the ELISA format include the production of objective results, the ability to link ELISA plate readers directly to laboratory computer systems (reducing the potential for errors transcribing results), and the facility for automation. These factors make ErbaLisa® Syphilis attractive for laboratories with large workloads.

Syphilis stages of infection

Commercial ELISA tests have been developed since the World Health Organization recommended the use of a combination of a nontreponemal and treponemal test for screening and diagnostic purposes to minimize the risk of syphilis infection through the route of transfusion: Recommendations:

1. Screening should be performed using a highly sensitive and specific test for treponemal antibodies: either TPHA or enzyme immunoassay (ELISA) 2. In populations where there is a high incidence of syphilis, screening should be performed using a non-treponemal assay: VDRL or RPR In India, syphilis continues to be a major health problem. However, a constant decline in its prevalence has been observed in recent years. In the current scenario, use of treponemal ELISA has become the first choice of preference to screen population with early or very late stage of infection in which non-treponemal tests are negatives. This helps in better treatment management & eradicating the incidence either through

The reversal of traditional syphilis algorithms using treponemal ELISAs for screening has led to uncertainty in clinical management. The CDC encourages clinicians to consider treatment for late latent syphilis in individuals with positive treponemal ELISA results to reduce the chance of progression to tertiary complications. Important considerations with the new syphilis tests are their Positive Predictive Value (PPV) and Negative Predictive Value (NPV), which depends on the disease prevalence in the population tested. Highly sensitive treponemal ELISAs will be beneficial for diagnosis of patients with suspected syphilis and with no prior history, especially in early or late infections with non-reactive, non-treponemal tests. Globally, VDRL & TPHA combination is being increasingly replaced with ELISA tests that detect treponemal IgG or IgG and IgM. The recent commercial availability of ELISA has made it a method of choice for screening, the world over. v Medical Device ASIA | July-August 2014 | 41

Siemens Healthcare delivers India’s first simultaneous PET-MRI

iograph mMR enables healthcare providers to diagnose diseases at a very early stage, monitor progression of disease and to develop a therapy plan precisely fo-cused on the patient

Siemens Healthcare has introduced for the first time in India the path-breaking integrated whole-body molecular MR system with simultaneous acquisition of PET data. The solution is now available at the PET SUITE Indraprastha Apollo Hospital, New Delhi. The PET SUITE features state-of-the-art PET-MRI and ultra HD PET CT under one roof. Brought to India by the House of Diagnostics, a leading medical diagnostics chain in Delhi-NCR, the Siemens Biograph mMR is the world’s first integrated whole-body molecular MR system with si-multaneous acquisition of PET data. This revolutionary system combines a magnetic resonance imaging (MRI) and a positron emission tomography (PET) scanner in one single device which al-lows doctors, to simultaneously see the morphology of internal organs, how these are working, as well as their metabolism, all in a single image. This helps doctors to make more accurate diagnosis by not only seeing where a tumor is in the body, but also identify its behavior. Moreover, it can also display the body reactions to medication administered to the patient. MRI and PET are already well-established imaging techniques in medicine and have been used for a long time to answer important clinical questions. Now, the combination of both technologies in one system has revolutionized the understanding of many diseases including cancer, epilepsy, dementia and cardiac conditions. With the simultaneous acquisition of MR and PET data, this system is designed to provide new opportunities for imaging. While MR provides exquisite morphological and functional details in hu-man tissue, PET goes further to investigate the 42 | July-August 2014 | Medical Device ASIA

human body at the level of cellular activity and me-tabolism. This innovative system also has the potential to be a particularly valuable tool for identify-ing neurological, oncological and cardiac conditions of diseases and in supporting the planning of appropriate therapies. Since MRI does not emit ionizing radiation, Biograph mMR may provide an added benefit with lower-dose imaging. The project would benefit the people of Asia, Middle East and Africa, who visit India for better treatment, apart from India itself where the incidence of cancer is on rise. In addition, the combination of

the two systems will significantly reduce the time needed for an ex-amination compared to when two separate systems are used. In addition, the Biograph mMR solution occupies a lesser area owing to the fact that the MR and PET are combined. “At Siemens Healthcare, our mission is to innovate to advance human health and our Biograph mMR is an ex-cellent example of living this mission. Siemens Healthcare’s innovative portfolio enables our partners to fight the most threatening diseases and also raise the quality and productivity in healthcare,” said Dr. Armin Bruck, Managing Director, Siemens Ltd.

The Top 3 Medical Device Venture Capital Deals of Q2 obstructive pulmonary disorder, raised $42M in Series D financing. The lead investor was Vertex Venture Holdings Ltd, while Windham Venture Partners, two strategic investors, and all of Holaira’s existing venture investors - Advanced Technology Ventures, Morgenthaler Ventures, Split Rock Partners, and Versant Ventures - also participated in the round. The money will be used to fund a randomized lung denervention clinical trial. Inspire Medical Systems, which makes a first-of-its kind implantable medical device to treat obstructive sleep apnea, raised a $40M Series E round. The lead investor was OrbiMed Advisors while new investors Johnson & Johnson Development Corporation and Aperture Venture Partners also participated. The money also came from existing investors such as Kleiner Perkins Caufield & Byers, US Venture Partners, Synergy Life Science Partners, Medtronic, GDN Holdings and TGap Ventures. Inspire Medical was spun out of Medtronic.

Benvenue Medical, which makes devices to treat vertebral compression fractures raised $40M in a Series E round and $24 million in debt from Silicon Valley Bank. InterWest Partners, a new investor led the equity round, while existing investors like Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners - also participated.

ealthcare venture capital funding swung from a decline in the first quarter to a five-quarter high in the second quarter with medical devices accounting for the lion’s share of VC funding. Which were the biggest deals? Venture capital funding had declined to 125 deals and $1.48 billion in the first quarter of the year, but in the second quarter jumped to a five-quarter high with with 161 deals worth $2.71 billion, according to a recent report . CB Insights, a venture capital database which issued the report, also found that medical devices comprised the lion’s share of healthcare VC funding in the second quarter, accounting for 36% of overall deals. Here were the top three medical device deals of the quarter: Holaira, which is developing a catheter-based system to treat chronic Medical Device ASIA | July-August 2014 | 43

A Shortcut to Medical Device Reimbursement in Germany What’s Germany Better at than Soccer?

Germany has more to brag about than a World Cup championship (thanks to a late-game goal that put the nail in Argentina’s coffin in the final). The country is also home to a thriving medical device industry showing impressive strength in all areas ranging from R&D and medtech startups to regulation and market growth. While the eurozone crisis and global recession crippled some countries and brought others to their knees, fiscally conservative Germany has weathered the storm and maintained a growing healthcare sector. A recent law offers medical device manufacturers a pathway for securing more-timely reimbursement for new medical diagnostic and treatment products used in physician offices. During the last seven years, we have provided consulting services to more than 100 different medical device startups. Some of them planned to obtain the CE mark for their product relatively quickly and launch it in Germany. The problem was getting those German Sickness Funds (payers) to provide reimbursement in a timely manner. In a previous article, we discussed a possible reimbursement shortcut for medical devices used in a hospital inpatient setting. A relatively new option is available for securing interim reimbursement for devices that are used outside the hospital in a physician’s office. The problem

According to German law, innovative procedures and devices used in a physician office setting are not reimbursed, unless they have been officially approved following a positive determination by the federal joint committee (G-BA). Unfortunately, the G-BA does not issue a positive determination before the procedure or device has been thoroughly tested and widely used in Germany and the manufacturer has amassed rigorous data demonstrating its value. Obviously, prior to obtaining reimbursement it would be very difficult to reach this threshold, creating a classic catch-22 situation. The solution

According to the recently enacted law for the Restructuring of the Statutory Health Insurance (GKV-Versorgungsstrukturgesetz), instead of denying reimbursement for procedures or devices that do not yet fulfill all of the conditions required to meet the thresh44 | July-August 2014 | Medical Device ASIA

old, the G-BA can now decide to provide funding for a “controlled study.” Within the timeframe of the controlled study, the manufacturer may be able to reach the aforementioned threshold.

The process

Funding for a controlled study may be granted for new medical diagnostic and treatment methods that have the potential to improve upon existing methods.

The application includes the following six sections:

The proposed process is currently under review by the German Ministry of Health and the effective date for the programme will be finalised once it has been published in the Federal Gazette.

A manufacturer of a medical device used in a new medical diagnostic or treatment procedure may apply for a controlled study from the G-BA.

Section I – Administrative Information: name and address of applicant and contact person. Section II – Summary: description of the suggested new medical diagnostic or treatment method, relevant indications, target population, anticipated distribution in

the German market and expected benefits. Section III – Information on the Medical Product: product description and technical instructions, comparable products, regulatory status and available clinical data. Section IV – Potential: the application should demonstrate by means of “meaningful documents,” such as published randomised controlled studies, the potential of the new medical diagnostic or treatment method as an alternative to existing methods. Section V – Key Elements of Proposed Study: This optional section describes the type of suggested study, relevant population, required sample size, appropriate comparative intervention, endpoints, duration and estimated costs.

Completeness of Application: the application itself is free of charge; however, in this section the applicant also signs a letter of intent indicating a willingness to assume a fair share of the costs, such as the overhead associated with the controlled study. The Sickness Funds pay for the provision of the medical procedure. The process also allows the applicant to submit a written request to the G-BA for a fee-based, nonbinding consultation to provide guidance on the preparation of an appropriate application. The guidance should be provided within eight weeks from submission and costs between €500 and €10,000, depending on its complexity. The information provided during the consultation is confidential.

An approval at this stage typically would require evidence demonstrating the potential of the new medical diagnostic or treatment procedure to improve upon currently available methods. For example, it may reduce costs, be less invasive, have fewer potential side effects or eliminate other disadvantages of existing devices. In addition, it should be made clear to the G-BA that the proposed controlled study can generate needed evidence for integration of the new medical diagnostic or treatment procedure into the healthcare system. Study plan

Initial assessment

Section VI – Sponsorship and

an application, the G-BA has to decide whether a controlled study would be appropriate and notify the applicant accordingly.

Within three months of submitting

For the scientific monitoring and evaluation of the controlled study,

the G-BA may commission an independent academic institute. The institute will be responsible for designing the controlled study, which may also include required quality criteria. After the estimated overhead costs of running the controlled study have been assessed, the applicant will need to submit a declaration of financial support and assume the obligation to conclude a funding agreement between the applicant, the G-BA and the involved scientific institute. This agreement, signed prior to initiation of the study, will describe who pays for what, how much and when. Special discounts, which can amount to as much as 70% of the overall costs, may be granted to small and medium-size businesses (based on annual turnover and number of employees) and for new medical diagnostic or treatment procedures aimed at diagnosing or treating rare diseases. Re-assessment

Following a successful controlled study, the G-BA may decide to provide reimbursement for the new medical diagnostic or treatment method. The average duration of the administrative process is estimated at 29 months (excluding the time required for the controlled study). This may appear to be lengthy; however, it allows the company to validate its technology and provide evidence to show that it is using external resources. The generated evidence may also be used when approaching markets outside of Germany. Beyond the chicken-and-egg dilemma

This recent change in the G-BA’s ability to perform more studies, instead of rejecting an application for reimbursement, especially for treatments or diagnostics used in a physician office setting, is good news for the medical technology industry. By providing a solution to the proverbial chicken-and-egg conundrum with which so many companies struggle, Germany has positioned itself as one of the world’s most—if not the most—innovative healthcare markets. Medical Device ASIA | July-August 2014 | 45

A Luminous Fabric for Treating New-Born Jaundice 460 and 490 nm can destroy the bilirubin produced by the deterioration of red blood cells that causes the yellowing of the skin of patients. Until now, newborn jaundice was treated only by placing the babies under luminous lamps. However, the fluorescent or halogen lamps usually have secondary effects. They generate heat, which can cause retina damage and requires that the newborns wear goggles during the treatment sessions. “Our luminous fabric uses the patented technology Lightex used for obtaining woven surfaces of optical fibres with guiding and a uniform distribution of light from a system of connection to LEDs”, explains Pierre Saint Girons, general manager of NeoMedLight. With this innovative Jacquard weaving process, the start-up has created a fabric that combines natural or synthetic fibres with optical fibres treated after weaving to leave the light perpendicular to their warp. Thus, instead of exposing newborns to the light of a stationary lamp, this new luminous fabric creates a sleeping bag that swaddles and treats babies suffering from jaundice.

eoMedLight?, a spin-off of Brochiers Technologies, ?is currently develop ing a luminous sleeping bag for treating jaundice in newborns. The device combines weaving, optic fibres and phototherapy.

NeoMedLight draws its expertise from the textile tradition of the Lyon region. Brochier Technologies has designed a loom that is the only one of its kind, capable of weaving LED optical polymers and treating 18,230 different threads of a single weft on a Jacquard loom. For a year now, NeoMedLight has been developing these optic fibre weaving patents to treat jaundice in newborns. Neonatal jaundice occurs when the liver is not fully developed during the first days of birth. It affects 60 to 90% of newborn babies and can lead to severe neurological disorders for 14% of patients that may result in irreversible damage. Only the exposure of newborns to blue-green light with wavelengths between 46 | July-August 2014 | Medical Device ASIA

This new approach, according to the company, makes it possible to better control light intensity on the skin of babies, with a uniformity ratio of under 1.3. Moreover, thanks to its lack of bulk (less than 1 mm thick), its lightness (less than 500 g/m2) and its flexibility (optical fibres in polymethyl methacrylate with a diameter of 0.5 mm), parents will be able to hold their babies throughout the phototherapy session, which can last between 7 and 22 hours. “Clinical trials are planned in France and Europe as from next year, which will be the year we will market our breakthrough medical device in France,” says Pierre Saint-Girons, who is looking for €2.3 million this year to finance the clinical trial and marketing phases. NeoMedLight is already exploring other medical applications. For example, the use of optical fibre luminous technical fibres could help in treating Crigler–Najjar syndrome, scarring dermatitis, seasonal depression and pain.

What Does the Future Hold for Medtech? (Physicians Will Be More Like Engineers)

hen I was asked to think about how physicians will be affected by the changes in the medtech industry over the next 5–10 years, I initially thought “not much.” The field of medicine is a slow-moving beast with substantial inertia. Physicians tend to be quite conservative when treating patients for a number of reasons. Many physicians practice the way they were trained, which may have been a number of years ago, despite the continuing medical education requirements to maintain state licenses. Moreover, physicians may be liable if a bad outcome results from treatment that deviates too far from the current standard of care, so they may be reluctant jump on the latest trends in treatment, no matter how promising they seem. And the very first oath a future physician takes when entering medical school is Hippocrates’s, promising to “do no harm,” which often means “watchful waiting.” However, several developments in recent years are pushing physicians to become more accepting of change. We are on a reimbursement cycle returning to capitation and bundled payments. Compensating physicians with a lump sum for the entire care of a particular patient, instead of being reimbursed for individual office visits or procedures, is nothing new. The intended incentive for the physician is to make sure patients stay healthy. Theoretically, this would minimize the number of tests or procedures ordered, and therefore the expense of each would not draw from the capitated payment for that patient, which

could decrease the physician’s bottom line. This reimbursement scenario has been tried before with little success for many reasons. But this time around, it might actually work. The tools to enable this are being developed by the medtech industry right now. Consumer Access to Robust Technology The consumer electronics industry has accelerated the miniaturization of the sensors and logic needed to implement widespread remote patient monitoring. With high-volume manufacturing, economies of scale are driving down cost and power consumption for these components. Parallel to this, the broadband infrastructure needed to support connectivity of these devices has evolved into reliable and stable networks. These advances allow average consumers to carry extraordinary functionality on the smartphones in their pockets and with massive computational power easily accessible in the cloud. These consumer devices are already being used for health-related purposes, and major players like Apple, Google, and Samsung, are providing frameworks for developers to create more robust applications that can meet the needs of the healthcare industry. Policy Change Meets Technology Along with these technical advances, policy changes are forcing more transparency in healthcare and providing financial motivation to emphasize practice behaviors that should result in better delivery of care. The 30-day readmission

penalty provision of the Affordable Care Act is aimed at shifting hospital attention toward ensuring patients do well post discharge instead of allowing them to be readmitted should they decompensate. In the past, these readmissions would have brought in more revenue for the hospital, so there was little incentive to prevent patients from returning to the hospital. But now many hospitals are looking toward remote monitoring as a means for ensuring patients remain stable immediately after discharge. And many payers are catching on, seeing the potential for remote monitoring of patients with chronic conditions as a way to decrease overall costs. Preventing one hospital admission can be enough to justify the cost of many systems currently being developed. From the physician’s perspective, we are at the advent of a new era. The elements I mentioned are laying the foundation for physicians to better understand how to take care of patients with chronic conditions between visits. While the technical issues are quickly being worked out, more effort is needed to present the data collected to clinicians effectively and to avoid information overload and alert fatigue. As these issues are addressed and evidence proves the use of remote technologies does indeed improve outcomes and lower costs, adoption will increase. In a recent whitepaper from Honeywell HomMed, data from the Franciscan Alliance ACO in Indiana shows some promise, with the use of a simple telehealth system significantly decreasing their hospitals’ 30-day readmission rates.

My semiconductor background biases me, but in the near future, I see the physician functioning more like a process engineer in a fab when managing patients with chronic conditions. Using the devices developed today, they may watch trend lines for relevant parameters monitored with wearable devices and remote sensors. Between regularly scheduled office visits, the physician will have the opportunity to take action as a parameter approaches a critical threshold— before the patient even begins to feel symptoms—and prevent those initial, unscheduled hospital admissions from ever occurring. Stephanie Kreml, MD, is a principle at Popper and Co., where she develops and implements business strategy for startup companies and new business units in existing companies. She is also a staff physician at Concentra in Austin, TX.

Stephanie Kreml

Medical Device ASIA | July-August 2014 | 47

Top 10 Israeli medical advances to watch in 2014

RAEL21c compiles a list of the 10 most extraordinary medical devices and pharmaceuticals that promise to revolutionize global healthcare.

1. Na-Nose can detect lung cancer from exhaled breath and will be commercialized in a joint venture with Boston-based Alpha Szenszor – after a few more years of development and testing by the US Food and Drug Administration (FDA). Invented by Technion Prof. Hossam Haick, Na-Nose (the “na” is for “nanotechnology”) has been proven in numerous international clinical trials to differentiate between different types and classifications of cancer with up to 95 percent accuracy. 2. Hervana non-hormonal, long-acting contraceptive suppository won a $1 million development grant last year from the Bill & Melinda Gates Foundation. The Gates Foundation is banking on the product’s potential to provide a more accessible, cheaper and socially acceptable family planning option in developing countries, though it would be marketed in the United States and Europe as well.

no-scale virus-traps (“vecoys”) capture and destroy viruses before they can infect cells, offering a huge advance over antiviral medications and even vaccines. Through the MassChallenge startup accelerator program last November, Vecoy’s platform was chosen to be tested in zero-gravity conditions on an upcoming NASA space mission. 4. CartiHeal Agili-C cartilage regeneration solution for knees can regenerate true hyaline cartilage (the most abundant type of cartilage in the human body) after six months, according to clinical results so far. Based on research at Ben-Gurion University of the Negev, the implant has earned the European Union’s CE Mark of approval. Further clinical studies could lead to FDA approval in the coming years. 5. Oramed Pharmaceuticals seeks to change Type 2 diabetes treatment from a daily injection to a daily pill. Its oral insulin capsule recently received patent approval in the EU, and is in Phase 2 clinical trials under an Investigational New Drug application with the FDA. Jerusalem-based Oramed is also moving forward with clinical trials of

3. Vecoy Nanomedicines na48 | July-August 2014 | Medical Device ASIA

a capsule to treat Type 1 diabetes. 6. Premia Spine developed the TOPS (Total Posterior Solution) System, aiming to revolutionize the spinal implant market with an artificial joint in the same way that total hip and total knee replacement systems made hip and knee fusions a thing of the past. TOPS is available already in Austria, Germany, the UK,

Turkey and Israel. An FDA study is now in the follow-up phase. 7. Mapi Pharma recently won US patents for two promising slow-release platforms for drugs to treat multiple sclerosis symptoms and pain. “We believe in two to three years they could be in the final stage of development, and about three years to market,” says Mapi

Pharma president and CEO Ehud Marom. Another slow-release platform for a schizophrenia drug is next in the pipeline. 8. Discover Medical introduced the SomnuSeal mask for CPAP machines – used widely by sufferers of sleep apnea – in Europe. If sales are successful, the US market will be next. Because SomnuSeal is more comfortable than the current masks used with the machine, compliance could be much greater. Plus, the device does not put strain on the heart as the current mask does.

in Europe sometime in 2015. 10. NeuroQuest has started clinical testing in the United States, under the auspices of Harvard Clinical Research Institute, for its groundbreaking blood test to detect early-stage Alzheimer’s disease. Initial trials in Israel showed NeuroQuest’s test – based on research by Prof. Michal Schwartz of the Weizmann Institute of Science – to be 87 percent accurate with an 85% specificity rate in detecting Alzheimer’s and ALS, two common neurodegenerative diseases.

9. Real Imaging is in the midst of European clinical trials of RUTH, its radiation-free, contact-free, inexpensive and advanced imaging system for early detection of breast cancer. The system, which has won patent approvals in several countries, analyzes 3D and infra-red signals emitted from cancerous and benign tissue, generating an objective report that needs no interpretation. Founder and CTO Boaz Arnon presented RUTH at the most recent conference of the Radiological Society of North America. Initial release of the product will likely be

Medical Device ASIA | July-August 2014 | 49

Multiple-Use Dental Dispenser Devices

ultiple-use dental dispensers, also called dental “syringes” are devices used to deliver various dental products including impression materials, adhesives, dental composites , and endodontic (root canal) materials to a treatment site in the mouth. Multiple-use dental dispensers do not include disposable syringes or dental needles (hypodermic syringes) for injection of anesthetics. Importance of Infection Control Manufacturers typically supply multiple-use dental dispensers as pre-filled syringes with disposable tips. The tips are intended to be discarded after each patient use, but the dispensers containing the remaining dental material are stored for reuse. Contamination or infection control issues arise for future patients when

the body or housing of multiple-use dental dispensers comes in contact with a previous patient’s cheek or lips, or when the dispenser is handled by a dental practitioner whose gloves have become contaminated with previous patient’s blood or saliva. According to the Centers for Disease Control and Prevention (CDC), devices that come in contact with mucous membranes, such as are in the mouth, are classified under a “semicritical” infection control category. CDC recommends that once a device in this category (such as a dental dispenser) becomes contaminated, it should be sterilized or subjected to immersion in a high-level chemical disinfectant. However, multiple-use dental dispensers cannot be reprocessed using sterilization (e.g., steam autoclave) or immersion because this

50 | July-August 2014 | Medical Device ASIA

may damage the material contained in the dispensers. Also, the FDA does not believe that these devices, once contaminated, can be adequately disinfected by wiping with a chemical disinfecting solution. Therefore, the FDA recommends disposal of contaminated multiple-use dental dispensers in order to avoid the risk of cross-contamination to future patients. Tips for Dental Practitioners The following information should help dental practitioners reduce the risk of cross-contamination between patients when using multiple-use dental dispensers. DO: Apply disposable barrier sleeves/ wraps over multiple-use dental dispensers before use with each patient.

Use new, uncontaminated gloves when handling multiple-use dental dispensers. Avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s mouth. DO NOT: Reuse the multiple-use dental dispenser if it becomes contaminated. Reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants. Immerse multiple-use dental dispensers in a high level chemical disinfectant. This may damage the dispenser and the material contained in the device. Sterilize multiple-use dental dispensers. This may damage the material contained in the device.

Regulation on medical devices: ‘INNOVATION AND SAFETY ARE THE TWO SIDES OF THE SAME COIN’

evised legislation that creates the right conditions for safe and innovative medical devices is essential,’ according to Neven Mimica, EU Commissioner for Consumer Policy who spoke last week in Brussels about the Commission’s proposed revisions to legislation on medical devices and in-vitro diagnostic medical devices. According to the Commissioner, the proposed revisions succeed in striking the delicate balance between encouraging innovation and protecting patient safety. He noted, ‘Our ambition is to establish a framework ... that is flexible enough to reap the benefits that innovation can bring to patients and for the competiveness of the industry.’ Europe will face major challenges to its healthcare systems in coming years. Across the EU, our population is ageing - it is estimated that, in 2060, there will be twice as many Europeans aged 65 or over as there are now. This demographic change increases the prevalence of chronic disease and heaps intense pressure on healthcare budgets. On the other hand, innovation in medical devices has gained pace in recent years. The move towards remote diagnoses is just one example of the tech revolution sweeping our healthcare services.

pany, the Commission proposed revised regulations on medical devices and in-vitro diagnostic medical devices. The proposals are intended to extend the scope of legislation and provide greater clarity. The revised legislation would be extended to include, for example, implants for aesthetic purposes. The proposals also provide for stronger supervision of independent assessment bodies by national authorities and clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales. Addressing stakeholders and media at a European Policy Centre breakfast briefing in Brussels last week, Commissioner Mimica noted, ‘The European Commission proposal on medical devices reflects the rapid pace of scientific progress as well as the need to preserve the highest level of patient safety.’ The Commissioner insisted that innovation and safety are in fact ‘two sides of the same coin’.

According to Commissioner Mimica, the regulation is also necessary for the EU to adapt to a global market. He noted, ‘I have just returned from China where I discussed the Chinese revised regulatory framework for medical devices and the effect of its implementation on the market access for the European medical devices. When we have in mind that the EU and China together represent over a quarter of the world’s population, it is easy to recognise the enormous potential of this cooperation for the mutual benefit of our consumers and economies.’ The Commissioner elaborated on how negotiations on the Transatlantic Trade and Investment Partnership with the US would also impact this issue of medical devices: ‘I believe that the mutual recognition of quality management system audits can be beneficial for patients and companies on both sides of

the Atlantic ... However, the basis should be global standards under the International Medical Device Regulatory Forum and not a single jurisdiction standards.’ In April 2014, the European Parliament confirmed its proposed amendments to the Commission’s proposed text. However, Member States continue to consider their position on the proposals despite many days of meetings. The Commissioner underlined how eager he is to see movement on the issue - the proposals are now almost two-years old: ‘Further delays would be prejudicial not only patient safety but also to innovation. Swift access to innovative and life-saving technology is an important aspect of public health ... An uncertain and unpredictable framework does not create a favourable environment for the businesses and the investors.’

Although increasingly innovative medical devices have the potential to allow for early disease diagnosis and treatment, keep us healthier for longer and shift care from hospital to home, they bring with them concerns for patient safety. Such anxieties are particularly keenly felt in light of scandals in recent years regarding defective medical products. In late 2012, following the scandal of defective breast implants produced by the French PIP comMedical Device ASIA | July-August 2014 | 51

Automation in ELISA- the preferred choice Better performing assay kits for serology are first introduced usually in ELISA technique. ELISA is easily adaptable, upgradable and the most affordable method for large screening of patients. Automation in ELISA + NAT is preferred for easy & complete screening. by Saurabh Gupta Sr. Manager-Business Development Transasia Bio-Medicals Ltd.

id you know that blood-the most important fluid in the human body is also the most common carrier for infections? Blood donation is the noblest deed one can do, to help a person in need. However, it is utmost essential to ensure safe blood transfer, as patients run the risk of contracting an infection through blood transfusion. Validating that the blood is infection free is a basic mandate for blood banks and all healthcare setups. Advanced screening plays a major role in minimizing horizontal transmission of diseases through blood donation. Nucleic Acid Testing (NAT)- A technique used to detect the bacteria or virus in blood, is becoming a regular practice at reputed blood banks. Current trend in screening of blood bags include NAT+CLIA or NAT+ELISA of which the latter is more cost effective but has the disadvantage of being very tedious & requiring expert technical intervention. ELISA still remains the method of choice due to its reliability and quick results for blood screening .It also helps in improving the performance & maintaining the screening records, thus aiding in accreditation documentation as well. Serological screening of HIV, HBsAg & HCV is commonly done by ELISA. Even malaria and syphilis can be screened by ELISA.

ELISA test typically has various steps (series of incubations, reagent additions and washing) for performing a test which is mostly done manually, with the help of semi-automated ELISA readers and washers. ELISA systems still have a major market share (30%) of the total immunochemistry business in India. The immunoassay platform has, however, dramatically changed in recent years with the development of reduced assay step protocols and reduction in total testing time. New generation fully automated ELISA instrument, are designed to reduce the manual errors and steps for performing these tests. For blood banks, it is very important to source the instruments and reagents from manufacturers who can provide regular supplies and timely after sales support. Automated workflows for these assays offers a host of advantages such as reliable and effective results, shorter sample processing time, large sample load capacity, multiple tests in a single batch, minimization of human errors and cost effectiveness. ELISA is often used to screen a batch of samples of various origins, and adding automation is highly beneficial reducing the dependency on laboratory personnel. Moreover, automation assures accuracy since accurate volumes are dispensed and time is saved in transferring samples and reagents to designated micro-wells. Automation in ELISA Transasia Bio-Medicals Ltd. is recognized as India’s Leading In-vitro Diagnostic Company. For the past 35 years of its existence, Transasia

52 | July-August 2014 | Medical Device ASIA

has been offering the highest quality products with excellent after sales services to meet the needs of healthcare professionals across the globe. Transasia offers complete range of instruments and reagents in the immunology segment for customers wanting to upgrade to automation. An extensive range of EIA automated analyzers supported by a robust team of experts, ensure that we deliver excellence to our customers. Transasia’s Elan 30s is a unique instrument indigenously designed and developed in India for small and medium workload labs offering assorted tests. It is a boon for blood banks where workload is always performed in batches. Elan 30s is a fully automated ELISA strip processor which can perform 6 tests in a single batch for a private laboratory setup where the workload is low. Earlier, many blood banks, weren’t able to afford an automation for a medium workload laboratory owing to the high costs. Now, with the introduction of such system even a 300 – 500 samples workload blood bank can offer ELISA automation. Elan 30s is an ideal automation platform since it has got a single arm for performing all the steps, automatically inbuilt incubators to control temperatures, washers, and readers to analyze

results, with optional barcode reader to track samples, and data storage equipment for a complete automated workflow. The user friendly software helps to easily track the steps being performed during batch process. Mago 4 is another instrument manufactured by Delta Biologicals,Italy and distributed solely in India by Transasia. It is a fully automated 4 plate ELISA processor which can handle a high workload of upto 104 samples, perform 12 different tests in a plate and has the most easy to use software, making it the most ideal choice for fully automated ELISA system for high volume customers. The instrument delivers everything needed to ensure the rigorous, repeatable analysis required in critical applications including immunology, infectious disease, hormone, autoimmune & IFA. It eliminates errors that occur during manual processes, using advanced automation and precise liquid-handling capabilities. Mago 4 provides the flexibility of an open system; as a result, the users are not locked into a single reagent provider. It is ideal for blood banks in private and government sector in India.

Will Budget help local medical device makers?

iven the government’s stated commitment to encouraging manufacturing, it would be interesting to see whether its first Budget addresses an obvious anomaly in how medical devices are taxed. As things stand, the system is skewed heavily in favour of companies that import devices rather than those that manufacture locally. Not surprisingly, about 80% of the medical devices market consists of imported devices, which have added substantially to the cost of healthcare and, hence, to what patients have to shell out.

While the size of India’s medical devices market is over Rs 30,000 crore, domestic device manufacturers say they are struggling in the face of an adverse taxation regime policy. Currently, the import duty on medical devices and instruments is about 10% and many are even duty-free. As the product is imported on a ‘sale in the course of import’ basis, even value-added tax (VAT) is not applicable to these devices. On parts and equipment imported for domestic manufacture of devices, however, there is customs duty plus excise and VAT. This has meant a much higher effective tax on domestically produced products compared to imported finished goods. This has led to dominant MNCs like GE and Siemens establishing factories in China and importing finished goods into India. None of these companies have any manufacturing facilities in India as there is no motivation for the multinationals to

produce locally. “Countries like China, Brazil and Malaysia differentiate between trading and manufacturing companies. Many of them like China also make product registrations very difficult for trading-only companies to encourage local manufacturing. They had an enlightened policy of starting off by allowing only joint ventures so that domestic partners could build their capacity. That has helped China become the world’s largest manufacturer of medical devices in volume,” explained Dr G S K Velu, founder and MD, Trivitron Healthcare, an Indian medical technology company.

Unlike the pharma sector, which has a separate department in the ministry of chemicals and fertilizers, the medical devices market has not found similar support within the government. There is just the health ministry which is more concerned with regulation and quality rather than the sector as an industry. “The medical devices sector has been asking for a separate department for six to seven years with no effect. So our sector is left in Trishanku world,” said Dr Velu.

The tax skew has also meant that MNCs are able to give bigger cuts to get contracts for their imported devices while domestic companies, unable to offer such huge cuts, are unable to compete. The Indian medical technology market is dominated by medical instruments and appliances used in specialties such as ophthalmic, dental and other physiological classes.

Dr Velu pointed out that what China did for its medical device manufacturing sector was what India had done in the 1970s and ‘80s for its pharma sector, which has helped India become a dominant player in the international pharmaceuticals market and aided the growth of domestic pharma companies. Medical Device ASIA | July-August 2014 | 53

Dr. Roy’s Discovery

A MICROBIOLOGIST FOUND THE ORIGIN OF DIABETIC FOOT ULCERS IN INDIA

ndian microbiologist Dr. Sudip Roy from MEDICA Superspecialty Hospital in Kolkata laid the foundation for the successful treatment of diabetic foot ulcers in India. He uncovered the origin of this unusual infection and was able to improve the chances of a cure significantly. “That was a very proud moment in my life. My hypothesis was proven true in practice,” says Dr. Sudip Roy about his discovery. Dr. Roy is a consultant microbiologist and the chairperson of the Infection Control Committee at MEDICA Superspecialty Hospital in Kolkata. Back in 2008, while he was studying to be a microbiologist at the BJ Medical College in Ahmedabad, the now 39-year-old doctor wondered whether gram-negative bacteria might play a greater role in infections in India than was previously assumed. He was surprised that the treatment success of diabetic foot ulcers in the Western hemisphere and in India varied so much despite the same treatment and the same antibiotics.

IDENTIFYING THE REAL ENEMY

Dr. Roy found new evidence for his theory during a qualification course in Atlanta, Georgia, USA. He realized that most of the people there used toilet paper and the environment was drier when it came to personal hygiene. In India, most people clean themselves with water that contains, for example, infectious coliform bacteria (escherichia coli, gram-negative) after a bowel movement. These bacteria flourish in damp conditions. An open wound can therefore become infected relatively quickly. AVOIDING CONTAMINATION

Dr. Roy estimates that the ratio between gram-negative and gram-positive organisms in India is 75:25 to 80:20. He told us about a case in which a woman in rural India developed a severe eye infection after cataract surgery. Medication was not effective. The bacterial culture revealed coliform bacteria. How did they get into her eye? The physician’s research revealed that the woman had regularly bathed in the village’s contaminated pond. Changing her antibiotics healed the infection.

NOT “ALL THE SAME”

In India, the treatment took much longer and often did not heal the ulcers. He suspected the cause of this could be the predominance of gram-negative bacteria on the South Asian subcontinent, whereas gram-positive bacteria are predominant in the West. However, drugs in India also targeted gram-positive bacteria. The actual gram-negative “perpetrators” could not be treated successfully with the previous conventional treatments.

GRAM STAINING OF BACTERIA IS A KEY DIAGNOSTIC TOOL FOR DIABETIC FOOT ULCERS.

Successful Treatment for a Local VIP The case that the microbiologist is particularly proud of is his first one, in 2011, in which he was able to prove his “discovery.” The patient, an influential government official, is well known. The treating physician initially did not want to take the advice of Dr. Roy, who had identified gram-negative bacteria as the cause

54 | July-August 2014 | Medical Device ASIA

of early signs of “diabetic foot” and recommended changing the patient’s medication. The doctor, however, was afraid of the trouble he would be in if the opposite was true and if Dr. Roy’s optimism proved to be unfounded. EVIDENT PROOF

He treated the patient first with the “tried and true” medication. It wasn’t until shortly before an ulcer formed that he followed the microbiologist’s advice. “I was convinced there was no risk. The treatment would be successful,” reflects Dr. Roy. In fact, there was visible improvement after just 36 hours. The infection did not spread, and the swelling had gone down after 72 hours. The patient did not develop an ulcer, and they saved the foot. In many cases, amputation is the only life-saving option when ulcers do not heal and turn gangrenous. As India is on the verge of a diabetes epidemic, a cure for diabetic foot ulcers is essential. The MicroScan autoSCAN-4 System at MEDICA Hospital processes 60 to 70 different samples daily. HOW MODERN LAB SYSTEMS SAVE LIVES

At MEDICA Hospital in Kolkata, eight to 10 patients diagnosed with diabetic foot are successfully treated each month – based on Dr. Roy’s lab results. “We have a success rate of up to 60 percent and can usually save the limb,” reports Roy. The microbiologist makes use of his state-of-the-art laboratory equipment, including Siemens MicroScan® autoSCAN®-4 System that identifies the pathogens and

software that analyzes the results and offers suggestions for the use of suitable drugs. “The patient’s life depends on this. We process 60 to 70 blood, urine, or pus samples every day. We are very happy with these systems and are anticipating a similar system for fungal diseases,” states Roy. SPREADING THE NEWS

The local politician’s case was the big breakthrough. Since then, Dr. Sudip Roy has been explaining his methods in lectures all over the country. He has now convinced his skeptical colleagues in Kolkata, and is sure that his discoveries are relevant for the entire region, including Bangladesh, Nepal, Bhutan, Sri Lanka, and Pakistan, where people’s habits and the climate are similar – and where gram-negative bacteria predominate. Dr. Sudip Roy’s discovery: different antibiotics for diabetic foot treatment.. India is expected to have the most people with diabetes in the world by 2030. BETTER SAFE THAN SORRY

With the prospect of a diabetes epidemic in India, the importance of the work done by Dr. Roy and his 52-member team cannot be overstated. According to a Times of India report, 67 million Indian citizens currently have diabetes and 30 million are pre-diabetic. India is expected to have the most people with diabetes in the world by 2030. Some of the most severe complications include ulcers, gangrene, and tissue necrosis, which often lead to amputation of the foot and ankle if treatment is not focused enough. v