'Medical Device Asia' May-June 2016 by Worldwide Publications

No.8 No.3 | May-June 2016 | New Delhi

Medical

Manufacturing

Asia

BREAST Robotic Surgery Advantages & Disadvantages UNIQUE HEART SURGERY DEVICE! Show Report! HKTDC HONG KONG INTERNATIONAL MEDICAL DEVICES AND SUPPLIES FAIR

IMPLANT!

HEART ATTACK CARDIAC&ARREST! WEIGHT LOSS DEVICES!

Government of India, Registrar of Newspapers of India (RNI)#: DELENG/2009/30008

highlights Medical Devices & Equipment | Healthcare | Pharmaceutical Journal

STARLED3 NX Surgical led lamp

India’s First Non-Surgical Helpline for Arthritis

MEDICAL MANUFACTURING ASIA 2016

Robotic Surgery

Germany’s injection moulding sector continues to grow

unique heart surgery device

MEDICA 2016 + COMPAMED 2016: Trend barometer of a dynamic market

New TechCenter for high-end medical device developments

“Maker in India” Award 2015

"Tomotherapy” New Hope for Cancer Patients

Heart Disease is Different for Women, but it's Still Deadly

Non-surgical weight loss devices

Heart attack and cardiac arrest difference

Vol.8 No.3 |May-June 2016 | Annual Subscription: India : Rs.2000 / Overseas: US$ 250

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

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, & owned by World-Wide Publications at D-182, Anand Vihar, Delhi-110092 and printed by him at Chandu Press, 63, Patparganj, Delhi-110092. Editor: Sarvjit Kanwar

China Correspondents Ying Wei / Adrian Liu

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.

Healthcare Buzzwords

he “Cloud” versus the “Closet” is a way of defining the two most common ways of managing and sharing software products in a medical practice. The “Closet” is the traditional model where a server is installed, often into an extra closet where the phone system is also kept that runs the Practice Management and/or Electronic Medical Record software on the desktops in the practice. Generally, the practice owns their own software and hardware, and pays for it upfront as a capital expense. In the “Cloud” model, which is rapidly gaining favor, a constant Internet connection allows the server hardware to be kept offsite in the vendor’s data center. The software is paid for on a monthly, operational expense basis, and security, upgrades and

maintenance are all outsourced to the vendor. Acronyms for “Electronic Medical Record” and “Electronic Health Record.” The two terms are generally used interchangeably to describe any software that that documents medical services delivered between providers and patients. An Electronic Health Record on the other hand generally refers to the complete history of a patient’s life and conditions as they visit different providers in different health settings. With the EHR’s focus on health as opposed to medicine, and portability with the patient as opposed to static and office-based, EHR tends to be the “official” term used by the ONC. “Big Data” is a blanket term used to

describe the tremendous amount of raw data that we create as part of our everyday lives. As we become more proficient in capturing, storing, and analyzing these massive data sets – and the increasingly complex tools needed to do so – there is tremendous hope in the ability for industries to glean insights from the mountain of data they already have. Healthcare, with the tremendous amount of data that is already collected and stored in the form of medical records, is considered one of the areas with the most to gain from advances in “Big Data” tools. A Health Insurance Exchange is a controlled marketplace where consumers can compare and purchase health insurance, as well as find out about any subsidies or tax benefits they can take advantage of

to offset the cost of coverage. Each state has the option of setting up their own state-level exchange, or participating in the federally-run exchange. The exchange also sets minimum coverage levels for each state, and mandates that insurance companies disclose actuarial percentages and coverage levels of similar plans so that consumers can make informed decisions about coverage. Health Information Management is the field of study that deals with overseeing and maintaining health care information for a patient population. Although HIM refers to the management of both paperbased and electronic health records, the field increasingly focuses on the storing, securing, and disclosing of electronic data.

Medical Device ASIA | May-June 2016 | 3

STARLED3 NX Surgical led lamp easily and accurately: • ON/OFF function • Light intensity adjustment • DoF - Depth of Field - for a deep light • ENDO - Light for endoscopy ideal for minimal-invasive surgery • SIZE - Light spot diameter adjustment to focus the operating area • SYNC - Function (optional) useful to synchronize controls of the combined lamps: STARLED3 NX double (twin dome configuration) and STARLED3 NX together with STARLED5 NX or STARLED7 NX. STARLED3 NX is available in the following versions:

Ceiling mounted, (Single, double configuration or together with other STARLED3 NX lamps) , Wall mounted, Trolley mounted ( ABPS battery

on demand) . ABPS is a rechargeable battery powered system made by ACEM Medical

Company dedicated to power surgical lamps as by European Directive 93/42/EEC. STARLED3 NX with ABPS has the same STARLED3 NX is a lamp manufactured by ACEM based on the Next generation LED technology, assuring cold light, long life and low

energy consumption. The lamp is suitable for countless applications both for surgery and operating room. It is ideal for diagnosis, dental sector, gynecology, dermatology, general medicine and surgery. STARLED3 NX grants a homogeneous and shadowless light thanks to

its special LED optics created by ACEM Medical Company that directs light beams at best according to the needs. The visual area is perfectly illuminated assuring both excellent visual comfort and working conditions. Its next generation LEDs produce an unparalleled quality of light with a colour temperature (CCT) of 4.500 °K and a colour rendering index (CRI) of 95.

performance and appearance, since the structure containing the battery is within the trolley base. The structure which covers and protects the battery is made of resistant plastic, and its dimensions are: 550 x 340 x 240 mm. The control panel on the structure allows managing all fundamental parameters, such as residual charge, type of power supply, recharge status and electrical power supply presence, amongst others. ABPS:

• has an from so

STARLED3 NX has a light intensity of 130.000 lux with a low energy

electronic control which allows for automatic switch electric power supply to battery power supply that STARLED3 NX can be used as a high performance mobile unit.

consumption of 69W. • is recharged The life cycle of its LEDs is about 50.000 hours. STARLED3 NX is composed by three reflectors that produce a

well-blended and intense cone of light focusable through the automatic adjustment of the light spot diameter. Its slim, practical and compact design makes it perfect for several uses. The lamp is ergonomic, easy to move and to position and suitable for the laminar flows of the operating room. Its ENDO function (light for endoscopy) gives the possibility to use STARLED3 NX for minimal-invasive surgery too. The easy -to-clean shape and material of STARLED3 NX as well as its removable,

sterilizable and easy-to-grip handle assure an excellent cleanliness. Functions are adjusted by its innovative easy-to-read, ergonomic and easy-to-clean I-SENSE® control panel. With a simple touch it can manage 4 | May-June 2016 | Medical Device ASIA

the battery maximum

by an automatic charger and requires no specific maintenance. Its autonomy may vary depending on model, which can be from 12 Ah to 28 Ah with charging time of about 8 hours.

Fore more details, please contact: Acem Medical Company Via della Tecnica 29 40050 Argelato Bologna – ITALY Phone + 39 051 721844 Email: info@acem.it Website: www.acem.it

SBF Launches

India’s First Non-Surgical Helpline for Arthritis

Indian patients suffering from Arthritis or showing any symptoms of joint pain can now avail free consultation by simply dialling an Arthritis helpline, launched for the first time in India by SBF Healthcare.

ccording to recent statistics, Arthritis is rising on an alarming rate and studies have shown that over 180 million people have been affected by it in India alone. Arthritis, especially Osteoarthiritis is the second largest rheumatologic problem and the most frequently occurring joint disease among Indians, especially in women. Speaking on the occasion, Wg Cdr (Dr) VG Vasishta (Retd), Founder & CEO, SBF Healthcare expressed his pleasure & stated “Finally, we have a one stop non-surgical, painless solution to all your queries about arthritis, be it the symptoms or treatment & management. Our aim to launch such a helpline is to ensure that people get the right medical advice, clear misconceptions, learn more about non-invasive and non-surgical treatment

options of this disease.”

cer and other related ailments.

SBF Healthcare, the pioneers of the breakthrough SPMF therapy (Sequentially Programmed Magnetic Field) for Osteoarthritis, Spine ailments and Cancer effectively utilizes radio-frequency magnetic field beams that sensitize and re-create the missing biological stimulus necessary for cellular regeneration of cartilage . This unique technology is a painless and affordable alternative to treating certain types of cancers and effective regeneration of articular cartilage in case of Osteoarthritis, without any side effects. It halts the progress of disease and increases cellular strength and its functionality.

SBF Healthcare will give free consultation to patients through its helpline, about non-invasive and non-surgical, cost effective alternatives for treating Arthritis.

SBF Healthcare is headquartered in Bangalore along with its presence in Mumbai and is equipped with state of the art equipment and a dedicated team of expert consultants who have treated more than 6500 cases of Osteoarthritis, as of today. With this technology SBF Healthcare is able to treat diseases like Arthritis, spinal problems, Can-

Patients can dial on this number 8884149984 to get free consultation by experts for general awareness on arthritis, second opinion, and other treatment possibilities. About SBF Healthcare SBF Healthcare and Research Center (SHRC) Pvt. Ltd. was founded in 2006 by Wing Commander (Dr) V. G. Vasishta (Retd.), professor & head of radiology, who developed this treatment on the basis of the MRI technology soon after his retirement from the Indian Air Force. SBF in India quickly gained popularity as the best healthcare centers in the country for Osteoarthritis treatment and Cancer treatment, owing to unrelenting dedication to excellent medical services and pioneering research in life-saving Osteoarthritis and Cancer medical technologies.

Medical Device ASIA | May-June 2016 | 5

Key exhibitors and industry partners show strong support for

MEDICAL MANUFACTURING ASIA 2016 3rd Manufacturing Processes for Medical Technology Exhibition and Conference sets the stage as the industry’s knowledge-information exchange platform

Established as Asia’s leading exhibition for the medical technology, medical manufacturing processes and related sectors, MEDICAL MANUFACTURING ASIA 2016 – modelled after COMPAMED and jointly organised by SPETA (Singapore Precision Engineering and Technology Association) and Messe Düsseldorf Asia, will bring to the industry the latest advances and an extensive product range from 200 exhibitors across 20 countries. This includes strong representation from national/ country groups from Austria, China, Germany, Italy, Japan, Taiwan, USA and Europe – a group presence led by the IVAM Microtechnology Network. 6 | May-June 2016 | Medical Device ASIA

xhibiting names include, BRUKER SINGAPORE, P3 SRL, RESILIA SRL, HI-TECH MEDICAL, MICRO SYSTEMS TECHNOLOGIES, QOSINA, TOTEX INTERNATIONAL, R + E AUTOMATIONSTECHNIK GMBH, VASCUTEK, STARLIM SPRITZGUSS GMBH, SUNNINGDALE TECH, NIHON DENTO KOUGYO, KAMADA SPRING, ALC TECHNOLOGIES, ALEX CORPORATION, ABRASIVE ENGINEERING, FORMATIVE TECH, LUMBERG ASIA PACIFIC, KIEFEL GMBH, NANOFILM TECHNOLOGIES INTERNATIONAL, PACIFIC ADHESIVE SYSTEMS, RACER TECHNOLOGY, SP MANUFACTURING, VASCUTEK and many more. With the MedTech sectors operating within a highly regulated framework with unique research, design, development and manufacturing considerations, MEDICAL MANUFACTURING ASIA 2016 features a line-up of new materials, substances and components covering MedTech’s upstream and downstream processes. The specialist trade fair will present a converging, knowledge-information exchange platform for the industry and will be staged over three days as it plays host to a series of concurrent events for industry specialists

to gain MedTech insights to the latest developments and best practices across various fields and specialities. Alongside the exhibition, a series of thought leading sessions by leading experts covering various topics will be addressed at MEDICAL MANUFACTURING ASIA 2016 including:

MEDTECH BUSINESS FORUM • Jointly organised by Singapore Institute of Manufacturing Technology (SIMTech) and Messe Düsseldorf Asia • The forum will gather the MedTech industry to review trends in the Asian, European and American markets; to examine how future needs can be addressed • Speakers at the forum include, Mr Steven Koh, Advisor, SPETA, Mr Philip Tay, Research Analyst, Transformational Health, Frost & Sullivan, Mr Abhay B. Bangi, Partner, Transaction Advisory Services, Ernst & Young and Mr John Lim, Lead, MedTech Initiative, Precision Engineering Centre of Innovation (PE COI), SIMTech IVAM FORUM – HIGH-TECH FOR MEDICAL DEVICES • Organised by IVAM

Microtechnology Network, the session will be chaired by Dr. Thomas R. Dietrich, the network’s CEO • Learn from successful case studies from the likes of Microsystems UK, Specialty Coating Systems, Finetech and Z Microsystems • Topics covered to include micro moulding for today’s medical devices, advanced conformal coating technologies for the medical industry, challenges of sensor packaging for medical imaging applications and digitalization in healthcare and disease

To have visitors make the most of their visit to MEDICAL MANUFACTURING ASIA 2016, networking opportunities with some 7,000 new and potential suppliers, customers and business partners from the region will be made more targeted with a complimentary business matching service, available preand during the exhibition. For space bookings and visitor registration to MMA 2016, please visit www.medmanufacturing-asia.com. For more information on MFA 2016, please visit http://www.medicalfair-asia.com

MEDTECH SME WORKSHOP • Organised by APACMed, the workshop will focus on product design & development, IP management, regulatory strategy, clinical trial management, capitalraising, commercialization and distribution/channel management, which will be of deeper relevance to research institutes, start-ups and smaller MedTech R&D or manufacturing businesses Re-enforcing the merits of the co-location with MEDICAL FAIR ASIA (MFA) 2016 – the region’s No. 1 exhibition for the Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies sectors, MEDICAL MANUFACTURING ASIA (MMA) 2016 is well poised to be the gateway for those in the MedTech sectors to reach out to a ready pool and highly targeted audience – through MFA’s exhibitor participation of 1,000 companies from 45 countries and some 15,000 visitors. The synergistic trade fairs in their respective disciplines will also provide an under-one roof experience, represented by the diversified and expansive showing of the latest products, technology and solutions tailored for Asia’s medical and healthcare industry, and an ideal business platform to source, exchange expertise and establish knowledge links, in capturing a bigger market share in the healthcare and MedTech sectors. Medical Device ASIA | May-June 2016 | 7

HKTDC Hong Kong International Medical Devices and Supplies Fair

More than 10,000 Buyers Joined the Fair

The seventh HKTDC Hong Kong International Medical Devices and Supplies Fair concluded its successful three-day run. Organised by the Hong Kong Trade Development Council (HKTDC) and co-organised by the Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA), the fair welcomed more than 10,000 buyers, a slight increase of 1.2 per cent over the previous year. “With the advancement in medical technologies and the global trend of an ageing population, there is immense growth potential in the medical supplies and products market,” said HKTDC Deputy Executive Director Benjamin Chau. “The Medical Fair showcased a wide selection of medical supplies and attracted exhibitors and buyers from all over the world. This year, buyer attendance from such places as the United States, Malaysia, the Philippines, Thailand and Singapore recorded satisfactory growth, an indication of the Asian market’s flourishing demand for medical products and services.”

Strong demand in the silver market The United Nations estimates that, by 2050, there would be 2.1 billion people aged 60 or above, accounting for 25 per cent of the world’s population. This trend has boosted demand for healthcare products tailored to elderly care and rehabilitation and buyers at the Medical Fair were keen to source such products. Eyeing the massive business opportunities related to the silver market, Delta Pyramax Engineering Ltd. from Hong Kong, which previously specialised in the building-related materials business, has extended its scope to include the distribution of medical devices over the past decade. At the fair this year, the company displayed an electric and ergonomic toilet aid from the Netherlands, designed for the elderly and patients with limited mobility. Webby Lau, the company’s Marketing Manager said, “Our company has been participating in the Medical Fair for the past few years. Traffic is good at this year’s fair. We have met many potential customers whose response to elderly products was better than last year. We will continue to explore business cooperation with these new contacts in the hope of establishing long-term relationships with 8 | May-June 2016 | Medical Device ASIA

them.” There is a growing trend of people at an early age being diagnosed with dementia. Hong Kong’s Janley Ltd. showcased its German Memoriana Dementia Room Concept at its debut exhibition this year. This room-setting service can simulate a patient’s home environment in a hospital room with rehabilitation features added to the room’s furnishings. The company’s Managing Director, Jeffrey Tai, said, “There is a growing demand for elderly home care and rehabilitation products. Many local hospitals and elderly homes have come to us and expressed strong interest in our products. We are in talks with a number of new and existing customers to develop business opportunities and we are positive about growth in the elderly medical supplies market.”

Household medical products sought after This year’s Medical Fair welcomed more than 260 exhibitors from 12 countries and regions. Fifteen product zones showcased a variety of healthcare equipment, products and services and provided an important business platform for the healthcare industry. Household medical products and services are becoming more common. Hong Kong exhibitor Illies East Asia Ltd. exhibited its mobile

de u l c n Co

electrocardiograph (ECG) device. By simply placing the device on the user’s finger or chest, it can take an ECG reading in just 30 seconds. The records can also be shared with medical professionals immediately via a mobile app. Sebastian Behler, Illies’s Department Director, Healthcare Technologies, said, “We’ve received strong enquiries from a lot of buyers from different places about this product, including buyers from Hong Kong, the Chinese mainland, India, Malaysia and Ireland. Some of them have bought samples from us. The results are very encouraging and we are positive about the prospects for further business development.” A first-time exhibitor APL Group Pty Ltd. from Australia sells and distributes healthcare and medical equipment in Australia and the Asia Pacific region, with a focus on automated external defibrillators (AEDs). General Manager Julian Cosgrave said the Medical Fair has helped his company explore the Hong Kong and Asia Pacific markets. “Many buyers have expressed keen interest in our products, including those from Hong Kong, India, Pakistan and the Philippines. The fair really opens up business opportunities and increases the industry’s awareness about AEDs.” Mr Cosgrave said the Medical Fair has successfully

brought together a large number of buyers and he was very impressed with the results. He hopes to return to the fair annually to grow the brand’s presence in the region. Also making its debut at the fair was Sweden’s ENTpro AB, a manufacturer and supplier of medical devices sold in Europe, the US and Japan. The company spotlighted a series of devices for people suffering from nasal allergies. These included a nasal rinsing devise and an innovative solution to stop snoring. Peter Ahnblad, Founder of ENTpro AB, said he considered the Medical Fair helpful for companies entering the Asian markets and particularly Hong Kong. He said, “We have received overwhelming responses from retailers and distributors enquiring about our products, including buyers from Hong Kong, Malaysia, Singapore and the Chinese mainland. At least four Hong Kong companies have expressed interest in distributing our products. We will decide on the right partners going forward.” Xiangxue Pharmaceutical Co., Ltd. is a high-tech medical and pharmaceutical company based in Guangzhou, coming to source at the fair. The company specialises in manufacturing Chinese medicine and medical research. Engineer Shi Zhi Wei said the company was actively expanding in the fields of life science and precise medical treatment. They joined the fair to find new products and learn about

the latest market trends. “We are interested in the advanced bone cement exhibited at the Hong Kong Science and Technology Parks Corporation booth,” Mr Shi said. “We also hope to explore cooperation opportunities with The Chinese University of Hong Kong in the research and development of wound dressings. The fair has brought together a selection of advanced medical equipment and products and provided the industry with a great opportunity to exchange ideas.”

demand for elderly products. He said the company had come to the fair to look for different home care and rehabilitation products. “I have found more than 10 suppliers from the Chinese mainland and will be getting more product information and pricing details from them. We will then conduct market research to test the response of consumers. Initial orders may range from several thousand US dollars to US$10,000 for each product. If sales are positive, bigger orders will be made.”

Immense business opportunities in Southeast Asia

To help industry professionals garner market intelligence and expand their business networks, the HKTDC organised a series of

Southeast Asia represents a massive market, and buyer attendance from the region was satisfactory. Concoll Inc. is a medical equipment distributor in the Philippines that provides advanced medical equipment to various government institutions and hospitals in the country. John Barry A. De Jesus, CEO, visited the Medical Fair for the first time this year. “We have found a number of exhibitors from Korea, Hong Kong and the Chinese mainland and talked to them about supplying medical devices such as ECG equipment and video laryngoscopes. I am very positive about placing orders with them.”

seminars, forums and workshops during the Medical Fair to examine topics ranging from the latest industry developments to international regulations for medical devices. The Hospital Authority Convention 2016 was also held alongside the Medical Fair, creating more opportunities for interaction between industry players. The conference was attended by more than 5,000 healthcare professionals. Also held in parallel with the Medical Fair was the Asia Biotech Invest Conference, which offered biotech companies in the Asia Pacific region a platform for cooperation and information exchange.

India’s Biomed Healthtech (P.) Ltd. is an importer and distributor of overseas high quality medical equipment in India. Mukesh Daftary, the company’s President, pointed out that India’s ageing population had boosted the country’s Medical Device ASIA | May-June 2016 | 9

HKTDC Hong Kong International Medical Devices and Supplies Fair SHOW IMPRESSIONS

10 | May-June 2016 | Medical Device ASIA

HKTDC Hong Kong International Medical Devices and Supplies Fair SHOW IMPRESSIONS

Medical Device ASIA | May-June 2016 | 11

Robotic Surgery Advantages &

By Amanda Gaid, 933 Lee Road, Suite 250, Orlando, Florida 32810, amanda@questns.com

Disadvantages

means faster recovery time, lower risks of infection, and less blood loss.

Allows Greater Precision than Traditional Surgery The tiny tools and high quality cameras used for robotic surgeries allow greater precision than many surgeons are able to achieve without the use of these tools. This means a greater success rate for highly sensitive procedures where there is little room to maneuver within the body. Of course, surgeons must be highly skilled and practiced with using surgical robots before this benefit can be seen.

Requires Extensive Training Using surgical robots can be dangerous without plenty of experience and extensive training. One wrong move with the tools can have major consequences for the patient, including perforated organs, nerve damage, and tissue injuries. Training costs time and money, which take those resources away from the other needs of the medical facility. Even the most skilled surgeon may have trouble with robotic surgery, too, as it requires a different type of hand eye coordination.

Very Expensive for the Facility

Surgical robots are becoming more mainstream in most developed nations of the world. Over the past decade in particular, many robots have been introduced into hospitals and other medical facilities. Surgical robots have the potential to do great things for the medical industry, but at this point there are still some clear disadvantages. This page covers a few of the greatest advantages and disadvantages of using robots for surgeries.

Less Invasive Than Traditional Surgery One of the main reasons that hospitals are trying to introduce surgical robots into the mix is that surgical robots can perform less invasive procedures than traditional surgeries allow. The use of tiny tools and cameras allows surgeons to see inside of the body while making only small incisions through which the robots operate. This less invasive approach 12 | May-June 2016 | Medical Device ASIA

At this point in time, surgical robots are still very expensive for medical facilities. There are also costs associated with updating and upgrading the machines as improvements are made. The benefits may outweigh the costs eventually, but the upfront costs are high for medical facilities to get the robots and invest the time into training and optimizing the machines. This makes robotic surgery unrealistic for smaller hospitals and facilities with limited resources.

May Interfere with Medical Billing Since surgical robots are still not used consistently across the board for all procedures, there may be some difficulties with medical billing and insurance coverage when robots are used. Due to the great costs of obtaining the machines, procedures done using robots may also initially cost the hospital more, which may be difficult to pass on fairly to patients. Essentially, doing robotic surgeries may cost the hospital at first and may increase patient bills greatly, until a breakeven point can be achieved. While robotic surgery will most likely help to improve healthcare across the board in the future, the technology is still in early stages. Surgical robots may not be the best choice for every hospital at this early point.

Exclusive Interview!

Luc Provost , CEO B Medical Systems talks to ‘Medical Device ASIA’ during AID & DEVELOPMENT ASIA SUMMIT 2016, Bangkok MDA: What is your company’s presence in public-spirited aid and development strategy at present? LP : B Medical Systems, or formerly Dometic S.à r.l., has been active for many years in providing cold-chain equipment for programs financed by the Vaccine Alliance Gavi. Gavi was created in 2000 with the purpose of improving access to new and underused vaccines for children living in the world’s poorest countries. Based in Geneva, Switzerland, Gavi brings together public and private sectors with the shared goal of creating equal access to vaccines for children, wherever they live.

Luc Provost is CEO of B Medical Systems (a former division of the Dometic group), specialized in the production of medical refrigeration equipment for blood and vaccines. Since Luc joined the group in 2000, he significantly contributed to the company’s strategic planning and to field operations worldwide. Luc Provost holds a university degree in business and management from UCL Mons and in international marketing at the University Laval Quebec. Before joining B Medical Systems, he gained a valuable experience in the industry and the army.

Medical Deivce ASIA (MDA): Please describe your company profile/backgrounder in

nutshell. Luc Provost (LP): B Medical Systems S.à r.l. is a Luxembourg based company with more than 30 years of experience in the medical refrigeration sector. It is a leading manufacturer and distributor of cold-chain equipment for large scale vaccination programs in emerging markets. In the most difficult situations and remote areas in the world, our customers can count on us to ensure the success of their vaccination campaigns - and to help save lives.

As a leading manufacturer and distributor of cold-chain equipment for large scale vaccination programs B Medical Systems has worked together with Gavi in many emerging markets. Over the years, we have built up a vast network of agents and have gained an excellent reputation for quality and efficiency of installation, as well as after sales support. Our expertise in the field also allows us to develop bundled solutions which combine our quality products and cutting edge technology – such as our latest product innovations.

MDA: Can you please elaborate more on your solutions of cold chain equipment for large scale vaccinations programs in emerging markets? Especially your new innovation of a Blood Bank Refrigerator operated by a solar direct driven (SDD) system, which is a life saver in remote regions? LP : The MRB 3000 SDD Blood Bank Refrigerator is the first solar direct driven (SDD) blood bank refrigerator. Solar generators produce mostly more energy than SDD refrigerators consume. But this is not our only SDD product. Our Health Center Kit recognizes the excess of available energy and charges automatically a battery which offers other crucial supplies to the remote health center, such as communication and lighting for over 35 hours and allows to power essential devices operating on direct current. We currently offer a 10 years warranty* on all solar direct drive products, including a data logger. The Data Logger allows real time, worldwide remote monitoring of temperature(s), lid openings & GPS position with data access via the internet on google maps. Such information can be crucial for the quality surveillance of the cold chain and the monitoring of vaccines. Alarms are set for preventive and corrective maintenance for temperature deviations and lid openings and will be sent by text message or email.

MDA: What future trends do you see for the Public-spirited aid and how does your company prepare for the future? We also produce a range of high end medical refrigerators and freezers which are sold to blood transfusion centers, hospitals, pharmaceutical companies and university laboratories in developed markets globally. B Medical Systems provides full assistance and training services to its customers, agents and distributors, including installation, service and maintenance of its products. 14 | May-June 2016 | Medical Device ASIA

LP : We believe that in the future there will be an increasing focus on Total Cost of Ownership (TCO) and sustainability. It is thus our strategy to align our product offer to these challenges.

*This offer is subject to initial installation of the unit by a designated B Medical Systems Service provider and having activated the Data logger on installation (GSM network coverage needed). This has no impact on our existing guarantees for Photovoltaic modules.

MDA: Keeping in view of the ongoing trends and situations, what products would you like to introduce in future? LP : The main focus of our R&D is to further develop our products to achieve utmost reliability and very low need for maintenance or with no need for maintenance at all. We also want to continue thinking out of the box and develop innovative solutions such as the Health Center Kit, which is a unique product on the market today.

MDA: What organisations support you and to what extent in achieving your goals, since you are involved in life saving humanitarian work world-wide. LP: B Medical Systems has a strong distribution network worldwide, which allows us to ensure long lasting relationships with key cold chain stakeholders including WHO, UNICEF and GAVI, as well as local governments. There are many success stories of how our products have helped to save lives. One example is Nigeria where our SDD vaccine refrigerators were installed. In Nigeria, over 40% of under-5-year olds’ deaths are attributable to vaccine preventable diseases. In 2013, the National Primary Health Care Development Agency (NPHCDA) completed a comprehensive cold chain assessment in which they identified the need to transform the vaccine supply chain and to re-design the flow from cold stores to service delivery points and shift to solar-powered systems for cold chain at service delivery points. B Medical Systems supplied 1,565 Units of TCW 2000 SDD refrigerators and icepacks freezers in collaboration with Prezzo Shed Investment Limited who carried out the local components of the contract for transportation, distribution/ delivery, installation and training of health workers. As a result of this change, vaccines are more accessible and potent presently in Nigeria than at any other time. The joint efforts of NPHCDA, the GAVI Alliance, B Medical Systems, Prezzo Shed Investment Limited and other partner in the past years were successful in leading to the recent declaration by WHO on September 25, 2015 “that Nigeria has been officially removed from Polio endemic list” and it is also the first time that Nigeria has stopped the transmission of wild polio virus.

MDA: What was the main motive to attend AIDF ASIA Summit, how did it go for you? Did you achieve your goals? LP: It was a very successful event for us. Being a Gold Sponsor of the Summit allowed us to address a high level audience. It was a good opportunity to present B Medical Systems’ new ownership and our current product offer, in particular our 10 year-warranty for our Solar Direct Drive products, which was received with great interest by the audience.

About B Medical Systems B Medical Systems S.à r.l. is a Luxembourg-based pioneer in the medical equipment industry. The company was founded in 1979 when the World Health Organization approached Electrolux in Vianden to provide a solution to their problems in safely storing and transporting vaccines around the world. Then, Electrolux became Dometic, a division of the Dometic Group. Their recognition grew through their work and the positive results it generated and they have become wellknown for the company’s expertise in Cold Chain and Blood Safety. All the stakeholders of B Medical Systems recognize the company for the work it does, not just for profit, but for the greater good of mankind, saving lives in developing nations and setting standards in developed nations in doing the right thing. In March 2015 Navis Capital Partners took over 100% of the division from the Dometic Group. Since September 1st, 2015 Dometic Medical Systems Division changed its name to B Medical Systems. The name change shows the deep conviction of B Medical Systems team and its shareholders to continuously deploy dedicated solutions in a reliable global partnership. With its worldwide network of distributors, its own Research and Development capability and flexible manufacturing facilities, the company continually strives for excellence in product development, manufacturing and customer service across all of its product lines. The “Medical Systems” division of B Medical Systems S.à r.l. specializes in research, development and the manufacture of professional refrigerators, freezers, storage and solutions for safe blood transport and management. Now, the company is committed to exploring new technologies, increasing the variety of our products and seeking new fields of business. B Medical Systems S.à r.l. is a flexible, innovative and customer-oriented company, which has always been recognized for the excellence and performance of its products. The company has always based its reputation on one rule: “never compromising on standards” to deliver the best performance these programs deserve, for humanity. Over the past few years, B Medical Systems have been supported extensively and passionately by its regional consultants and country partners who dedicate themselves to a cause and have gained credibility in their own right with the regional agencies and country authorities. Medical Device ASIA | May-June 2016 | 15

Germany’s injection moulding sector continues to grow · · ·

Geographical location contributes to strong injection moulding industry Over 2 million tonnes of polymer used in 2015 German economy remains stable compared to EU counterparts

moulding is used, Germany is the largest market in Europe. Major companies such as Bericap (caps and closures), Gerresheimer Wilden (medical products), Röchling (automotive products) and Pöppelmann (automotive and packaging) are all based in Germany. AMI’s Directory of Injection Moulders in Germany demonstrates not only the size of German industry but also its stable growing market in contrast to many other major European countries. Of over 2300 sites listed, more than a hundred sites have been added since our

previous edition. The heart of

2015 and its automotive production was up 3%, despite the

and buyers with a vast amount

ithin Europe the largest injection moulding market is Germany, thanks to the size and scale of its manufacturing industries. Germany saw an

increase of 2% for polymers used in injection moulding in industry’s emissions scandal. German injection moulders have benefited from the weak Euro and the success of its OEMs in export markets. On top of this, lower oil prices helped to strengthen its continuing economic improvement and consumer confidence, which has also contributed to growing demand for packaging and consumer goods. These factors coupled with its proximity to emerging eastern and central European markets means German injection moulders continue to serve both traditional and new geographical regions. Germany clearly represents the largest sector of the European injection moulding industry using just over 2 million tonnes of polymer in 2015. In nearly every segment where injection 16 | May-June 2016 | Medical Device ASIA

the directory is the data on the custom moulders. The directory has been specifically organised so as to provide designers, specifiers of data on the activities of these companies. This information shows that over 80% of companies listed process polypropylene resins (the most widely used material) and over half have some involvement in supplying to the automotive industry. The database also provides the markets served (caps & closures, thin wall containers etc), other services offered (welding, stamping etc) and specific polymers used at each site.

Russian and Australian scientists develop unique heart surgery device

cientists from MISiS National University of Science and Technology and their colleagues from Australia’s Endogene-Globetek medical company have developed a unique device to enhance cardiovascular surgery. From now on, doctors will be able to perform heart bypass surgery without stopping the heart itself. Cardiovascular disorders kill 17 million people annually worldwide or more than any other disease. A stapler like device for mending blood vessels using strong staples makes it possible to quickly and safely restore blood vessels and to considerably reduce the post-operative period. This Russian-Australian invention received an award at the 44th INVENTIONS GENEVA international exhibition. A standard heart bypass surgery lasts four to five hours, with doctors having to stop the heart, and entails lengthy post-operative rehabilitation. Doctors are unable to restart a patient’s heart in 5 percent of all cases. This new stitching instrument allows doctors to operate on the heart while it beats. Instead of sawing the breast bone apart, surgeons can now simply bore two holes through it and put the bypass in place. The entire operation lasts about 60 minutes, and the patient can be discharged on the following day. This innovative stapler uses special resilient nickel titanium (nitinol) reversible shape memory staples. In short, this metal can be deformed and then its original shape restored after abnormal deformations. These staples are inserted inside a cartridge which is then placed inside the polymer-body stapler’s distal end. 18 | May-June 2016 | Medical Device ASIA

“The world has no other device like it. The main advantage is that it reliably patches up the blood vessels in no time. In addition, it is very easy to quickly learn to use the stapler. It can be used during abdominal surgery to patch up blood vessels and other hollow body organs, including aortic aneurisms or during intestinal surgery,” said Sergei Prokoshkin, a professor at pressure metal treatment department of MISiS National University of Science and Technology. It took experts about nine years to perfect the invention, with Russian scientists continuing to upgrade the staples and their Australian counterparts working on the stapler’s body. Pre-clinical tests have already been completed, and this technology has also been patented in Russia and Australia. Clinical tests are scheduled to commence soon.

InventionShare Announces New Socially Responsible

Carbon Reduction Portfolio to Benefit Planet Greg Waite, CEO of InventionShare™, recently announced that the company will actively be seeking new game changing inventions which can be added to the company’s current carbon reduction portfolio in Q2 of 2016. Speaking from its Ottawa offices, Mr. Waite said that InventionShare is always looking for inventions that give companies a competitive advantage or the ability to disrupt a market place as well as inventions that can make a difference to the planet and help in reducing carbon and greenhouse gases. InventionShare currently has three game changing inventions in its inventory that focus on helping to reduce carbon production world-wide: Circuit Seed, 5by5 Wireless and PowerWindings.

ircuit Seed™ is a new family of circuit building blocks for processing analog signals using fully digital components and design flow. Simulation and silicon test results have demonstrated a dramatic reduction in power, better performance and higher accuracy, all with small integrated circuit footprints. The circuit designs are much simpler, reducing product costs with faster development so that less testing is required and there are fewer parts to assemble. Mr. Waite said, “Semiconductor companies are always looking for ways to support manufacturers’ ever increasing demands to make products that are smaller, lighter, faster – products that consume less power, give off less heat and that are easier, quicker and less expensive to design, manufacture and test. They want products with fewer parts that offer higher reliability and lower total product costs. Circuit Seed delivers these competitive advantages and, when you consider that the IoT of the future will have millions of power driven devices, Circuit Seed provides a significant way to reduce manufacturing costs and power consumption world-wide. You are looking at greater than 30% reduction in power requirements for Circuit Seed circuits.” InventionShare’s 5by5 Wireless™ invention provides five times’ greater wireless internet coverage and economical wireless internet connectivity using UHF 300-1000 MHz frequency spectrum. Developed by a team of experienced technology entrepreneurs with many years of experience in wireless communications, the full duplex wireless communications system is a 100% hardware solution. It affords greater data throughput and wireless coverage up to 25 miles (32 km) - for a total circular coverage area of 1,250 square miles or 3,200 square kilometers from one low cost base station. The 5by5 Wireless circuit also can provide full duplex over all spectrum to all wireless communications devices; it is platform agnostic, providing reliable communications support wherever and whenever it is required. The main advantage of 5by5 Wireless is that is uses less power than conventional wireless and, due to the range, one 5by5 Wireless tower can replace 20 to 25 conventional broadcast towers - reducing a huge amount of energy consumption.

Mr. Waite said, “5by5 Wireless provides an amazing amount of wireless coverage while reducing the amount of power used. If you were to figure out that we can supply a 5by5 Wireless solution to the 4.5 billion people still without internet world-wide, and reduce the need for all those power hungry towers that saves literally millions of kilowatts of power annually 5by5 Wireless can have a real impact on the people and the planet by helping to bring the knowledge of the internet while reducing the power to do so.” InventionShare’s third invention is PowerWindings™ - a new power transformer design that reduces the amount of materials found in traditional transformers and/or provides greater efficiency with the same material. Mr. Waite said, “There are transformers in literally millions of products. By integrating PowerWindings’ design into a company’s current manufacturing processes we can reduce the overall amount of materials required, specifically steel and copper. PowerWindings can also reduce the power required to produce the steel and copper components for, literally, millions of products. Using the same materials, especially for the smaller transformers, we can have a large impact on efficiency and reduce power losses for the billions of consumer, business and light industrial products in the market place. “The PowerWindings design process is another socially responsible invention that will definitely change the planet by reducing the overall amount of materials used to create millions of transformers world-wide. Not only can we reduce the material costs to lower the price of the product but when you think of the billions of transformers produced at all levels each year PowerWindings will have a significant effect on the planet in terms of the energy used in the production, mining and manufacturing processes.”

About InventionShare™ InventionShare provides inventors with funding, talent, expert processes to accelerate innovation, patent creation and monetization. Respecting that each of our inventors is the architect and the mastermind behind the invention, we work with our inventors in a professional manner as partners helping them take their inventions to market by partnering with leading corporations. About 5by5 Wireless™ 5by5 Wireless is a patent pending family of inventions that provides a unique solution in delivering internet services to the entire world. Technically it provides full duplex over wireless and high signal strength with very low noise. It is a low cost hardware solution that delivers on the promise of extended range wireless on UHF and on all spectrums and it delivers full duplex to rural, remote, metro, office, smart city, industrial and home applications. About PowerWindings™ InventionShare is currently socializing PowerWindings and looking for partners within the transformer product categories to partner with InventionShare or license these inventions for world-wide or regional markets or for specific product categories within the industry. For more information contact Mr. Keith Taylor at ktaylor@inventionshare.com for more details. For more information, or for information on partnering with InventionShare, contact Kensel Tracy, VP Invention Catalyst at ktracy@inventionshare.com or 613-225-7236 Ext 116 Medical Device ASIA | March-April 2016 | 19

The Lancet Kidney Campaign

launches on World Kidney Day On World Kidney Day (WKD) 2016, The Lancet and the International Society of Nephrology (ISN) are launching an online campaign to raise awareness of acute and chronic kidney diseases and bring together the best available evidence to inform strategies to reduce national, regional and global burden of the disease and its risk factors. The Campaign brings together research and analysis on acute kidney injury (AKI), chronic kidney disease (CKD), and dialysis and transplantation from across The Lancet journals. Also launched recently is a new video in partnership with ISN, including interviews with ISN President Adeera Levin, Past President Giuseppe Remuzzi, and President Elect David Harris. The Campaign will provide monthly updates on advances in nephrology as well as expert commentaries and interviews on key health and policy issues relevant to kidney disease. For the launch, there will also be a commentary on the winner of the Affordable Dialysis Prize. “Despite its devastating effects, kidney disease is not usually part of national health strategies, and does not receive the funding or research attention afforded to other chronic diseases” write the ISN leadership and The Lancet Editor-in- Chief Dr Richard Horton in their joint Comment published recently “It is imperative that evidence is presented to push kidney disease to the forefront of national and global health agendas.” Kidney disease is increasingly recognised as a major public health problem worldwide. About one in ten adults have evidence of CKD, the prevalence of advanced CKD is rising worldwide, and the fastest growth is occurring in low- and middle-income countries. The incidence of AKI has also increased substantially over last 20 years and is an important driver of CKD and kidney failure. Although renal replacement therapies (RRT) are more available in high income countries, namely dialysis and transplantation, access to it is limited in many countries, and as few as 25% of patients requiring RRT globally do not get it. For more information, please visit The Lancet website: http://www.thelancet.com 20 | May-June 2016 | Medical Device ASIA

LightStrike Germ-Zapping Robots

Destroy Superbugs Before They Harm Hospital Patients The new CDC report points to six antibiotic-resistant threats, which include:

Recently, the Centers for Disease Control & Prevention (CDC) issued a report on superbugs and the risk they pose to hospital patients stating that “more work is needed – especially in fighting antibiotic-resistant bacteria.” Hospital acquired infections (HAIs) kill nearly 200 people in the U.S. every day and affect 1 in 25 hospital patients – and these numbers do not include infections acquired at skilled nursing, long-term acute care and outpatient surgery facilities.

enex Disinfection Services recently announced the launch of its new LightStrike™ Germ-Zapping Robots™, a portable disinfection system that destroys antibiotic-resistant bacteria in a four-minute cycle. More than 300 hospitals, long-term acute care, outpatient surgery and skilled nursing facilities use Xenex’s FullSpectrum™ high intensity pulsed xenon light technology to destroy deadly superbugs before they harm patients. Numerous hospitals have reported significant decreases in their infection rates after using Xenex’s Germ-Zapping Robots for room disinfection, and published their infection reduction results in peer-reviewed journals. LightStrike uses pulsed xenon to create broad spectrum, highly intense light covering the entire germicidal spectrum and is the only ultraviolet disinfection technology shown, in multiple peer-reviewed published

studies, to help hospitals reduce infection rates. “Hospitals using Xenex GermZapping Robots have reported and published 50, 70 and 100 percent decreases in their infection rates. More can and should be done to stop the spread of the superbugs that harm patients and hospital employees. Don’t go to a hospital unless your room has been properly disinfected because superbugs can dwell on surfaces for five months just waiting to infect the next patient,” said Morris Miller, CEO of Xenex. “Our xenon light robots destroy germs and bacteria in less than five minutes. Hospitals using our technology have reported and published data on fewer infections and a return on their investment in a matter of months – that’s good news for the patients and the hospital’s bottom line.”

bring down contamination,” said Dr. Mark Stibich, Chief Scientific Officer of Xenex. Designed for speed, effectiveness and ease of use, hospital cleaning staff operate the LightStrike robot without disrupting hospital operations. Without contact or chemicals, the robot eliminates harmful microorganisms safely and effectively. According to Xenex customers, LightStrike can disinfect 30-62 hospital rooms per day, including: patient rooms, operating rooms, equipment rooms, emergency rooms, intensive care units and public areas.

1. Carbapenem-resistant Enterobacteriaceae (CRE); 2. Methicillin-resistant Staphylococcus aureus (MRSA); 3. ESBL-producing Enterobacteriaceae (extended-spectrum ß-lactamases); 4. Vancomycin-resistant Enterococcus (VRE); 5. Multidrug-resistant Pseudomonas aeruginosa; and 6. Multidrug-resistant Acinetobacter. LightStrike robots destroy all of these superbugs, as well as Clostridicum difficile (C.diff) spores, in a four-minute disinfection cycle. In addition to its 20 percent faster cycle time, LightStrike includes patented SureStrike™ technology, which validates bulb ignition and guarantees a proper broad spectrum pulse for every disinfection cycle. Xenex robots also include HAI rate tracking, which correlates use of the robot and the hospital’s own real-time HAI data to track the disinfection program’s effectiveness. Xenex officials believe that LightStrike’s shortened cycle time provides tremendous value to hospitals, especially in the Operating Room environment. “Surgical site infections devastate patients and cause unneeded expense for hospitals. Hospitals using Xenex GermZapping Robots have published studies showing 100 percent and 46 percent decreases in their SSI rates after using Xenex to disinfect their ORs at the end of the day. Our LightStrike robot is so efficient that they can run it in 2-minute cycles in between cases in the OR to further

Proven to Reduce HAI Rates MD Anderson Cancer Center, the Central Texas Veterans Health Care System, Cooley Dickinson Health Care, Trinity Medical Center, Orlando Health South Seminole Hospital and other hospitals have published 14 studies providing evidence of the robot’s efficacy in highly regarded scientific journals that include the American Journal of Infection Control (AJIC), Journal of Infection Prevention, Infection Control & Hospital Epidemiology (ICHE) and BMC Infectious Diseases. About Xenex Disinfection Services Xenex’s patented Full-Spectrum pulsed xenon UV room disinfection system is used for the advanced disinfection of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. The Xenex mission is to save lives and reduce suffering by eliminating the deadly microorganisms that cause HAIs. The company is backed by wellknown investors that include Malin Corporation, Battery Ventures, Targeted Technology Fund II and RK Ventures. For more information, visit www.xenex.com.

Medical Device ASIA | May-June 2016 | 21

MEDICA 2016 + COMPAMED 2016: Trend barometer of a dynamic market

Booking demand confirms a high level of satisfaction with the event’s new schedule

When top decision-makers in the healthcare business meet in Düsseldorf again in the middle of November at the world’s leading medical trade fair, MEDICA 2016, (scheduled date: 14 – 17 November 2016; Monday to Thursday), 5,000 exhibitors from around 70 countries will be presenting themselves once more as partners in unchanged enthusiastic innovation – offering tailored solutions for outpatient and clinical care. According to the European Patent Office, in 2015 no other technological sector submitted as many patent applications worldwide as the field of medical technology. 22 | May-June 2016 | Medical Device ASIA

“

The course of registrations up until now is showing that the incredibly high level of participation seen in the previous year can be expected again, thereby indicating a high level of satisfaction among exhibitors with the new schedule of the event, running from Monday to Thursday,” explains Joachim Schäfer, managing director of Messe Düsseldorf. He is also pleased about the development of the trade fair for medical technology suppliers being held in parallel, COMPAMED. “Here as well, the change of schedule has been positively accepted by the

exhibitors, and the extension of COMPAMED by an additional day has been expressly welcomed. This can also be seen by a high rate of repeat bookings. Once again, we expect a turnout of more than 800 exhibitors in the fully booked COMPAMED halls, 8a and 8b.”

Concerning innovations, the market at the moment is characterised by a special dynamic of important supplier trends. The digitalisation of healthcare is progressing at an unstoppable rate,

and this concerns all fields, outpatient and clinical care, as well as patients and physicians alike. With reference to Germany, the latest enacted E-health Act should ensure that the networking of stakeholders within the scope of the healthcare process is considerably optimised by means of a more effective collection and utilization of patient data – at least this has been stated as its clear goal. The predominant “digital patchwork” up until now pertaining to intrinsically sophisticated, but poorly compatible solutions could now be woven into a better overall system using a better integration of data.

Innovations in focus and great prominence “waiting in the wings” MEDICA 2016 visitors will be able to see for themselves what the digital future in the healthcare sector will be like via the exhibitors’ many innovations as well as the lectures and presentations at the MEDICA CONNECTED HEALTHCARE FORUM (with the MEDICA App COMPETITION) or the MEDICA HEALTH IT FORUM (each in hall 15). In particular, “wearables” and smartphones in combination with special health apps, which can also be used by patients themselves, have the potential of becoming an indispensable element of networked health in the future. Numerous new products relating to this topic have been already presented at the MEDICA 2015, and countless other mobile health applications are currently under development, whereby many focus on cardiovas-

cular diseases, diabetes as well as the remote monitoring of therapies. Here a particularly high level of user potential can be expected in the future with regard to patient numbers. The topic of big data also continues to be a focus of visitors’ interest. At its core, it has to do with compiling and evaluating enormous amounts of patient data in order to be able to gain knowledge with regard to the development of and effective therapy for certain diseases. The MEDICA ECON FORUM will also be dealing with the opportunities and consequences of healthcare digitalisation. The forum (in hall 15), organised as a joint effort between the Techniker Krankenkasse (a German statutory health insurance company) and Messe Düsseldorf, has been firmly established as a platform for health policy dialogue, shown by the confirmations of prominent guests to again attend

this year’s event. Those who have already confirmed their participation include, among others: The Federal Minister of Health, Hermann Gröhe, the NRW Minister of Health, Barbara Steffens, or also Maria Klein-Schmeink, health policy spokeswoman of the Bundestag parliamentary group Alliance 90/ The Green Party (Bündnis 90/Die Grünen).

The third dimension is finding its way into operating theatres Not only bits and bytes are affecting the healthcare business, however. Medical technology also has exciting topics to offer. At the moment, innovations for interventional procedures are seen as particularly important. In the case of modern surgery procedures, an “integrated” approach is in demand. Data deriving from medical imaging flows into the controls of surgical assistance systems. They can even be generated during surgery by imaging systems directly available

Medical Device ASIA | May-June 2016 | 23

in the operating theatre, ensuring that the intervention can take place in a precise and gentle manner. Here, above all, progress in the field of endoscopy and instruments for minimally invasive surgery translate into great benefit. Currently, the third dimension is increasingly finding its way into operating theatres. In the case of so-called 3D laparoscopy systems, there are two image sensors that are precisely aligned with each other at the end of the endoscope, providing the surgeon with a lifelike endoscopic 3D image during the course of minimally invasive surgery.

Conferences directly integrated into the specialist trade fair Such important medical technology trends will not only be represented by exhibitor innovations at the MEDICA, but will also be reflected within the scope of the programmes of the accompanying conferences. For example, these include the MEDICA MEDICINE & SPORTS CONFERENCE, dealing with the use of applications in close proximity to the body and “wearables” for monitoring vital signs, or the MEDICA EDUCATION CONFERENCE. This conference is being organised this year for the third time by the German Society for Internal Medicine (DGIM) and offers participants an excellent op24 | May-June 2016 | Medical Device ASIA

portunity to gather and exchange information on new technologies and their medical use as part of a scientific training event held in parallel to the world’s largest medical trade fair. Of the four conference days, each individual day offers a particular thematic focus. Along with innovations in the field of 3D laparoscopy, among other things, the event will be started off with “New operative techniques during surgery”.

more, the 39th German Hospital Conference as a leading event for the directors and management of German hospitals, the international DiMiMED conference for specialists from the field of disaster and military medicine as well as the MEDICA PHYSIO CONFERENCE will be forming a close content-oriented link to the topics of the specialist trade fair – aimed toward the specific interests of their respective participant target groups.

On the other days, the MEDICA EDUCATION CONFERENCE will be dedicated to imaging and interventional procedures (e.g. magnetic resonance tomography and sonography), future technologies for internal medicine (e.g. remote monitoring in the case of chronic disease) as well as, on the event’s last day, “Diagnostics in the fields of internal medicine, laboratory medicine, toxicology and hygiene”.

Now, and in the future, a central strength of the MEDICA continues to be that it does not just deal with solutions for one individual medical specialist discipline at a time, but that it offers solutions for the complete “workflow” of patient treatment.

With reference to the MEDICA conference programme, further-

The individual focuses of the MEDICA trade fair, which are clearly structured according to hall, include: Electromedicine/medical technology (more than 2,500 exhibitors), laboratory technology/

diagnostics, physiotherapy/orthopaedic technology, commodities and consumables, information and communication technology, medical furniture and specialist furnishings for hospitals and doctors’ offices.

COMPAMED – hotspot for complex high-tech solutions This year, once more in parallel to the MEDICA, the COMPAMED with approx. 800 exhibitors will be taking place for the 25th time. Always scoring top annual results with reference to the number of exhibitors and visitors, it has long since developed into the leading

international marketing communication platform for suppliers of the medical technology industry. Where, at one time, simple parts, components and equipment for technical devices and medical products had primarily been presented, today, COMPAMED is a hotspot for complex high-tech solutions. Here, the microsystem technology solutions for mobile diagnosis, monitoring and therapy systems are particularly in line with the current trend. These include, among others, smart sensors and energy storage systems for use in “wearables”, microtechnology applications for intelligent implants or printed electronics. In addition, the subcontracting and outsourcing of services for all elements of the process chain (R&D, production, supply chain management, quality management, spare parts handling, etc.) are continuing to gain in importance.

With 18,800 visitors last year, the COMPAMED broke its best record so far. A total of 130,000 specialist visitors from around 120 countries toured the MEDICA and COMPAMED in 2015. This unique combination allows MEDICA and COMPAMED to represent the entire process chain and the full range of medical products, devices and instruments. Together, they keep the Düsseldorf trade fair complex (19 halls) fully booked. As in previous years, it will be possible to visit both events with a single ticket.

Opening hours: 10:00 am - 6:30 pm / 14 – 17 November 2016. Medical Device ASIA | May-June 2016 | 25

New TechCenter for high-end medical device developments

he Spang & Brands technology center, which was built in 2014, is now in full operation: “in a few months we will finally integrate R & D to close the performance chain,” explains Friedrich Echterdiek, the company’s Managing Director. Here, in the TechCenter, the strong basis for a successful new product series begins with the initial concept and the prototype, discussed with the customer, and continues with materials suitability tests and mould making, to advance to pilot injection moulding testing. The latest developments from the TechCenter are exhibited during MEDTEC. A complete array of plastic precision parts – technical solutions for medical device technology and pharmaceutical applications – exhibited during MEDTEC, Stuttgart, Germany held this year. The company offers syringes, hollow needles, puncturing membranes, implant parts and components for keyhole surgery, componentry for infusion and blood bags, transfer and connection systems as well as assembled componentry and ready-for-sale systems, whose geometries and characteristics (e.g. rated break points responding to twisting or breaking power) must comply with the highest demands for precision. A specific highlight will be a newly designed CUD – composite unit dose. The highly filigreed parts must not exceed very tight micro-tolerances and must withstand constant load while guaranteeing the required cleanness, hygiene and safety for the use with, on and inside patients. Therefore special plastic compounds are preferred (TPU, TPE, TPV, resomer materials etc.) that can only be processed using high performance moulds. “We have been specialising on precision and cleanroom injection-moulding technology for the medical and pharmaceutical industry for 30 years...,” explains Friedrich Echterdiek, “...especially for certain customer projects, we offer the right solutions, supported by CAD-3D design, MoldFlow analysis and more than 60 fully electric and hydraulic mono- and multi-component injection moulding machines, and we can rely on continuously expanding engineering know-how.” The fully automated and manual assembly and packaging of the parts and the components – from pre-production to just-intime batch sizes, from small series to million-piece batches takes place in cleanrooms of various classifications. Strategically positioned testing stations with 3D measuring technology and visual and tactile control support quality assurance. Conformity with national and international legal regulations for medical components and devices are safeguarded across the entire development of a product – from its prototype to the delivery at the customer’s site. Among several validations, the company has been certified in accordance with ISO 13.485. 26 | May-June 2016 | Medical Device ASIA

CUD – composite unit dose

connector with rated break point

contact lens holder for vitreoretinal surgery

Robotics Lasik Launched in Gurgaon

Nuance Releases Latest Version of Dragon for Mac Medical Speech Recognition Software

Medanta-The Medicity brings the revolutionary FemtoLASIK, the latest and safest in bladeless refractive LASIK treatment to the city

The Medicity, one of India’s largest multi-super specialty institutes located in Gurgaon recently announced the launch of FemtoLASIK, a revolutionary technology and the most advanced LASIK treatment available in the world that enables bladeless refractive treatment. Speaking on the launch, Dr. Naresh Trehan, Chairman and Founder, Medanta said, “At Medanta, it is our constant endeavour to bring the latest medical technologies in the world to Gurgaon and provide the best cure to every patient. The launch of FemtoLASIK showcases our commitment to strengthen our ophthalmology division at the Medicity and provide all encompassing medical treatment under one roof.” FemtoLASIK technology is the most advanced procedure aimed at improving patient’s quality of life by reducing the dependence on glasses. This world renowned LASIK technology is the current state- of-the-art in refractive surgery. It works by altering the shape of the cornea to treat nearsightedness, farsightedness and astigmatism. Dr. Sudipto Pakrasi, Chairman, Institute of Ophthalmology at Medanta - The Medicity said, “FemtoLASIK is bladeless and allows the creation of flaps with diameter and thickness of a wide range. It creates very precise, perfect and smooth corneal flaps to ensure accurate treatment with minimum risk. This is the safest LASIK technology available in the world today.”

Enhanced Speech Recognition Engine and Updated Interface Improves Usability for Clinicians for Better Documentation of Patient Encounters SYDNEY, Australia, March 10, 2016 – Nuance Communications today announced the availability of Dragon® for Mac Medical for India, the latest version of Mac-based speech recognition software for clinicians. Updated with a new, more accurate speech recognition engine and designed with a specialised medical vocabulary, Dragon for Mac Medical assists clinical workflows by allowing clinicians to dictate documentation of patient encounters directly into Mac-based electronic health records (EHR), such as MacPractice, or other systems. This enables clinicians to complete documentation faster, and with greater detail and specificity, leaving more time for patient care. Dragon for Mac Medical features an enhanced speech recognition engine that offers up to 15 percent greater accuracy over the previous version, and supports updated medical vocabularies for more than 90 medical specialties and subspecialties. Dragon for Mac Medical learns a clinician’s unique voice over time and grows even more accurate to assist in capturing important patient details and information. The software also allows clinicians to set up custom words for terminology unique to a location or area of specialty, and create simple dictation commands for multiple lines or formatted lines of text (e.g. “Insert negative ROS.”). “Documentation is an essential part of the healthcare process, but it often requires a significant time investment from clinicians,” said Peter Mahoney, Senior Vice President and General Manager, Dragon and clinical documentation, Nuance. “The latest version of Dragon for Mac Medical improves dictation capabilities and allows clinicians to capture specific medical terminology quickly and accurately – restoring valuable time that is better spent providing care to patients.”

“With this launch, the Institute of Ophthalmology at Medanta is at par with other renowned medical institutions globally.” Dr. Pakrasi added.

Additional new features of Dragon for Mac Medical include:

About Medanta:

• A redesigned interface with a drop-down menu of essential functions for improved usability

Medanta – The Medicity is one of India’s largest multi-super specialty institutes located in Gurgaon, a bustling town in the National Capital Region. Founded by eminent cardiac surgeon, Dr. Naresh Trehan, the institution has been envisioned with the aim of bringing to India the highest standards of medical care along with clinical research, education and training. Medanta is governed under the guiding principles of providing medical services to patients with care, compassion, commitment. Spread across 43 acres, the institute includes a research center, medical and nursing school. It has 1250 beds and over 350 critical care beds with 45 operation theatres catering to over 20 specialties. Medanta houses six centers of excellence which will provide medical intelligentsia, cutting-edge technology and state- of-the-art infrastructure with a well-integrated and comprehensive information system.

• Improved support for built-in microphones for all MacBook, MacBook Air, MacBook Pro, and iMac computers for higher initial accuracy without training • Improved support for additional countries, including Australia, India, New Zealand and Singapore •

Support for OS X El Capitan (10.11) Medical Device ASIA | May-June 2016 | 27

MEDICA EDUCATION CONFERENCE 2016

Experience Tomorrow’s Medicine Today For the third time, the German Association for Internal Medicine (Deutsche Gesellschaft für Innere Medizin, DGIM) is organizing the MEDICA EDUCATION CONFERENCE, together with the Messe Düsseldorf. This conference offers participants a unique opportunity to gather and exchange information about new technologiesand their medical application in the framework of an advanced scientific training course during the world trade fair for medical technology, MEDICA.

The event will keep the motto “Science meets Medical Technology” in 2016, even though there is a new conference president: Professor Dr. Stefan Frantz, Director of the University Hospital and Polyclinic for Internal Medicine in Halle, tookover from Professor Dr. Hendrik Lehnert, President of the University of Lübeck, who has held this position for the past two years. With the focus on individual topic areas each day and a range of different courses, for example on laboratory medicine and emergency medicine, the conference wants to attract interested medical professionals from all specialties – from clinics and practices – and anyone interested in medicine and medical technology in science, research, development and manufacturing. Scientifical lectures offer depth or overview, practical sessions teach expertise that can be used by doctors for the daily care of patients. A core aspect of all events is the reciprocal exchange between doctors and industry representatives in order to highlight the needs of both sides. In addition to the interdisciplinary offerings, the conference also provides an international information and networking platform: the choice of events held in English was increased due to high demand; high-caliber speakers and interlocutors include several from abroad.

28 | May-June 2016 | Medical Device ASIA

Each of the four days of the MEDICA EDUCATION CONFERENCE, taking place from November 14 to 16 in DĂźsseldorf, has an individual thematic focus. On Monday November 14, the focus is New Operative Techniques in Surgery. In addition to innovative techniques and future visions, current standards of surgical methods will be presented in diverse and compact form. Tuesday November 15, 2016, addresses Imaging and Interventional Procedures such as magnetic resonance tomography and sonography. These procedures find application throughout medicine in diagnosis and therapy and are important elements of daily outpatient and inpatient clinical patient care. The third conference day focuses on Internal Medicine: Future Technologies and Remote Patient Management. What does telemedicine mean for chronic diseases such as diabetes? To what extent can digital solutions such as remote monitoring in case of heart failure help to avoid a hospital stay? Experts will ask themselves these and other questions on Wednesday November 16. The scientific program of the eventÂ´s final day looks at Diagnostics in Internal Medicine, Laboratory Medicine, Toxicology, and Hygiene. Goaloriented determination of laboratory parameters, correct interpretation and connection to individual clinical symptoms can be key factors that determine the course of many diseases. In addition, gram-negative and gram-positive pathogens, for example, are an omnipresent, interdisciplinary topic of discussion that will be addressed on November 17, 2016. Day passes can be purchased for the conference. These tickets entitle the visitor to check out MEDICA the same day. Participants thus have the opportunity tobe inspired byfurther innovations in the fields of science and medical technology in the MEDICA trade fair halls. The conference was structured to end at 3:30 pm on all four days. It is just a short walk to the neighboring fair halls where new technological worlds await. For the second time, MEDICA is taking place from Monday to Thursday. You can find further information on the conference at http://www.medicatradefair.com/mec2. Medical Device ASIA | May-June 2016 | 29

Mr. Suresh Vazirani felicitated with the

“Maker in India” Award 2015

by the Lions Club International

a common goal of ‘improving our communities’. From providing instant assistance during sudden disasters to, helping visually challenged people see again or taking over the education of abandoned families, the Lions Club has created a huge impact on society by and large. About Transasia Bio-Medicals Ltd.

Mr. Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd. was felicitated with the ‘Maker In India’ Award 2015 for his outstanding contribution in the field of Indian diagnostics.The award was presented by Mr. Raju V. Manwani, International Director of Lions Club International (2013-15) & Chief Promoter alongwith and Mr. Ajay Arora, Past President, Mumbai SOL. Other prominent people who received this year’s awards are Mr. Devendra Fadnavis, Chief Minister of Maharashtra, Commander Rishabh Kapur and television artists, amongst others.

he SOL Lions Gold Awards held every year, are a tribute to individuals from different walks of life who have made an outstanding contribution to the society. Mr. Vazirani won the ‘Maker in India’ Award for his outstanding efforts in design, innovation and sustainability over last 36 years that has helped place India on the global diagnostic industry map. He was awarded in the Special Category encompassing pioneers from fields as diverse as Sports, Bravery, Business, and Medicine among others. As the ‘Make in India’ wave sweeps the nation, this recognition has come at an apt time and close on the heels of yet another award! Recently Mr. Vazirani was also bestowed with the ‘Pioneer for the Make in India Concept’ Award, 2015 by Dr. Harsh Vardhan - Hon’ble Minister of Science & Technology and Earth Sciences, Govt. of India. On receiving the award, Mr. Vazirani remarked, “I feel a sense of joy and pride, as Transasia succeeds in catering to the global diagnostic needs in over 100 countries through its high quality and affordable products. I am a proud Indian today and grateful to Lions International for this honor.” The Lions Club International is the world’s largest service club organization started in 1917 and has 1.37 million members, working globally towards 30 | May-June 2016 | Medical Device ASIA

Incepted in the year 1979, Transasia Bio-Medicals Ltd., is headquartered in Mumbai, India. It is recognized as India’s Largest In-vitro Diagnostic Company and offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Diabetes Management, Microbiology and Molecular Diagnostics. Infact, Transasia is the first Indian company to manufacture and export sophisticated, state-of-the-art blood analyzers and reagents. Transasia is a part of the global Erba Diagnostics Mannheim GmbH Group. The Erba Transasia Group has spread its footprint across USA, UK, Europe, Turkey and Eastern Europe, Russia and France, by means of various acquisitions – Erba Germany, Erba Czech Republic, Erba Russia, Erba Turkey, Erba France, Erba Diagnostics (USA), Erba Molecular (UK), Diamedix (USA), Delta Biologicals (Italy), ImmunoVision (USA), JAS Diagnostics Inc. (USA) and Drew Scientific (USA). Today, the Erba Transasia Group serves millions across 100 countries. Recently, the Erba - Transasia Group has added another feather to its cap by acquiring Lumora, a UK based patented molecular technology company. This makes the Group, one of the selected few global companies with its own

patented technology for molecular testing. Transasia manufactures and markets equipment and reagents, with an impressive install base of above 50,000 equipments across India. The vast network of more than 180 service engineers, 350+ Sales and Marketing Team, 16 zonal offices, and 350+ Distributors allows us to reach out to customers across the length and breadth of the country. Its foray into indigenous research, has resulted in development of state of the art products and technologies, enabling Transasia’s deliverables to be synonymous with the best in the world. Alliances with international partners like Sysmex Corporation (Japan), Medica (USA) and Diesse(Italy) have ensured that cutting edge technology and solutions is brought to India. Transasia markets, services and supports the Sysmex products and solutions in India. Transasia’s commitment to healthcare has been recognized by various awards and accolades, the latest one from the World Economic Forum which conferred the organization with ‘Global Growth Company Award, 2014’, ‘Most Indigenous Medical Equipment Devices Company’, ‘Pioneer for the Make in India Concept’ Award, by the Hon’ble Minister of Science & Technology & Earth Sciences, Government of India and recently was bestowed with the ‘Maker in India’ Award 2015. With a vision of being recognized as a ‘local for global’ organization, Transasia continues to provide doctors and patients with reliable, affordable and innovative Medical Diagnostic Systems.

MARK YOUR CALENDAR! 1 Sep 2016

MEDICINE + SPORTS CONFERENCE ASIA Marina Bay Sands ∙ Singapore

MEDICAL FAIR ASIA to host the inaugural edition of the MEDICINE + SPORTS CONFERENCE ASIA in 2016! Organized by Navispace in cooperation with the Sports Medicine Association Singapore (SMAS), Exercise is Medicine Singapore (EiMS), FIMS (International Sports Medicine Association), WT Wearable Technologies and Messe Düsseldorf Asia; the MEDICINE + SPORTS CONFERENCE ASIA will bring together sports medicine experts, healthcare providers, physicians, fitness trainers and industry players from around the world to discuss innovations in sports medicine and pertinent healthcare challenges specific to Asia and the Southeast Asian region. The conference is based on the MEDICA MEDICINE + SPORTS CONFERENCE that has been experiencing great success for three consecutive years and is part of MEDICA, the largest medical tradeshow in the world. As per its European equivalent, the first MEDICINE + SPORTS CONFERENCE ASIA, will be held in conjunction with a Messe Düsseldorf trademark event; MEDICAL FAIR ASIA. Similarly the two conferences are also built on the main objective of having an interdisciplinary exchange between international sports medicine experts, professional athletes, the sporting goods and healthcare industry. In a global sports medicine market that is shifting towards Asia and is experiencing accelerated growth, the MEDICINE + SPORTS CONFERENCE’s Asian premiere comes at an opportune time to address some of the key factors that are driving this sector. For one, population growth in the world’s most populous countries China and India constitute to sport related injuries of 5% in China and 3.8% in India. This is a key factor that drives the Asia Pacific Sports Medicine market which is growing at a CAGR of 6.96 % and is expected to be worth US$ 3.95 billion by the end of 2019. At the same time in the developed Southeast Asian countries, ageing populations will develop much faster than in Europe and the US and see a total percentage increase of 430% by 2050 – the highest growth in Asia, which overall will be made up of 27% percent elderly population in 2050; coupled with an increased adoption of modern lifestyle habits and rapid economic growth in the Southeast Asia region, resulting in more noncommunicable diseases that amount to 62 % of all deaths across the regions, with more conditions such as heart and respiratory disease, osteoporosis, obesity, depression and type-2 diabetes being noted. This creates increased demands for healthcare services and immense pressure on the healthcare systems. In Singapore alone the health care expenditure is projected to reach SGD$12 billion by 2020. The MEDICINE + SPORTS CONFERENCE ASIA will facilitate the right dialogue and networking platform for discussions and development of solutions. Attendees of the conference will be able to join in as eminent speakers from the industry will share on main topics such as physical

activity as a key to disease prevention, defining health and fitness guidelines, creating the right activity programs for athletes and non-athletes, vital data and performance monitoring, digital systems in elite and recreational sports as well as new digital solutions such as new activity trackers, monitoring devices and other health gadgets that are emerging every day and continue to produce great investment potentials. MEDICINE + SPORTS CONFERENCE ASIA | Program 10.00 a.m. OPENING KEYNOTE 10.30 a.m. SESSION 1 Exercise Medicine – The Role of Physical Activity in Healthcare 11.45 a.m. SESSION 2 Activity Program for Individual Needs 14.00 p.m. SESSION 3 Vital Data and Performance Monitoring 15.45 p.m. SESSION 4 Digital Systems in Elite and Recreational Sports

A Preview Of One Of the Distinguished Key Note Speakers Dr Ben Tan, BBM, PBM • MBBS (Singapore), MSpMed (Australia), FAMS (SpMed) • Designated Workplace Doctor (Compressed Air Works) Sports Physician • Chief, Department of Sports Medicine, Changi General Hospital • Senior Consultant, Changi Sports Medicine Centre • Senior Consultant, Singapore Sports Medicine Centre Dr Tan’s original research covers sports medicine and sports science, and has been published in international peer-reviewed journals and presented at international conferences. He is also the author of the books, “The Complete Introduction to Laser Racing,” and “Fight the Fat – What You Must Know and Do to Lose Weight,” and “Run for Your Life! – the Complete Marathon Guide.” Apart from sports injuries, Dr Tan’s areas of interest also include musculoskeletal sonography, extracorporeal shock wave therapy (ESWT), physical activity promotion, weight management, gait analysis, and performance enhancement.

MEDICAL FAIR ASIA

11th International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies 31 Aug – 2 Sep 2016 Marina Bay Sands, Singapore Open for Booth Space Bookings at www.medicalfair-asia.com

Medical Device ASIA | May-June 2016 | 31

Pharmaceutical tablet production goes mobile

with award-winning technology from GEA

ConsiGma™ 25 continuous line installed at Pfizer’s facility in Groton, Connecticut.

Pfizer combines GEA’s continuous processing technology with G-CON portable cleanroom PODs for the manufacture of drug tablets anytime, anywhere.

flexible and configurable continuous pharmaceutical tablet processing technology developed by GEA has won an international award as part of a groundbreaking mobile manufacturing platform developed in collaboration with Pfizer and G-CON. The prototype Portable, Continuous, Miniature and Modular (PCMM) manufacturing platform, now operational at Pfizer’s facility in Groton, Connecticut, scooped Pfizer the International Society for Pharmaceutical Engineering (ISPE)’s 2016 Facility of the Year Award (FOYA) for Equipment Innovation. Conceived, designed and built through a future-facing initiative between the three partners, the PCMM technology has at its center GEA’s state-ofthe-art miniaturized and mobile ConsiGma™ continuous oral solid dosage (OSD) pharmaceutical processing technology. Configurable for either, direct blending and compression of powder streams into tablets, or for wet granulation, drying, milling and tableting, the ConsiGma™ system features a new vertical in-line powder blender. Five process analytical technologies (PATs) have been integrated into the system to continuously monitor and control all process and quality parameters, and ensure minimal losses in the event that production needs to be stopped or process parameters need to be changed. G-CON has designed and constructed a modular, prefabricated, and highly maneuverable POD® system that can rapidly be set up around the equipment to provide a GMP-compliant cleanroom environment. 32 | May-June 2016 | Medical Device ASIA

The PCMM technology represents a completely self-contained and mobile continuous manufacturing system that can be transported to geographical areas of need, and installed within days to produce as much or as little drug as required, whether for product development, clinical trials manufacture or commercial production. When production is no longer required the unit can just as easily be disassembled and transported to another site. This agile concept for continuous manufacturing could feasibly make huge, purpose-built production plants a thing of the past, significantly reducing capital expenditure and operational redundancy. And with industry driving to reduce costs, increase quality and focus on patient-centric manufacturing, GEA believes that PCMM manufacturing will become the industry standard platform for processing OSD therapeutics. “We are delighted that the PCMM solution received this prestigious award from the global pharmaceu-

tical engineering society represented by the ISPE,” comments Frans K. A. Maas, Vice President, Application Center (APC) Pharma Solids at GEA. “The consortium of Pfizer, G-CON and GEA have been working successfully on this groundbreaking manufacturing innovation, now in operation in Groton. We’re convinced that this platform, based on GEA’s ConsiGma™ continuous manufacturing technology, provides significant benefits to both the generic and the ethical industry segments when compared with more traditional batch technologies, and is in line with FDA’s guidelines for future solids manufacturing innovations.” “We are proud to have been part of this award-winning collaboration in manufacturing technology, engineering and design, which we believe will change the face of OSD drug manufacture globally,“ comments H. McCoy Knight, Vice President APC Pharma North America. “As a leading innovator of manufacturing concepts, analytical technologies and processing equipment design, GEA will continue to play a major role in the drive to develop OSD manufacturing technologies and solutions for efficient, cost-effective and patientcentric manufacturing.”

Immunochemical Methods & Trends - Dr. Abhipsa Dharia, Sr. Manager- Medical Affairs, Transasia BioMedicals Ltd.

All immunochemical methods are based on a highly specific and sensitive reaction between an antigen and an antibody. Immunochemistry offers simple, rapid, robust yet sensitive, and in most cases, easily automated methods which are applicable to routine analyses in clinical laboratories. Immunochemical methods do not usually require extensive sample preparation. Infact, most methods are based on simple photo, fluoro, or luminometric detection. Immunochemical methods have rapidly replaced chromatographic techniques in clinical diagnostics, offering fast detection of antibodies associated with specific diseases, disease biomarkers, and hormones. The assays most often used in clinical immunochemistry involve either quantitative or qualitative formats using enzyme linked immunosorbent assays (ELISAs), immunochromatography in the form of lateral-flow devices like dip-sticks and test strips or Western Blot assays used to interpret data from protein analysis with gel electrophoresis. Immunohistochemistry, one of the main diagnostics tools in todayâ&#x20AC;&#x2122;s clinical laboratories, is also based on the principles of antigen-antibody binding. Immunohistochemistry (IHC) detects the presence of critical marker proteins in tissue samples while in situ hybridization (ISH) detects target RNA or DNA sequences. When morphology and routine staining cannot provide all the diagnostic answers, pathologists turn to these advanced staining techniques. Both techniques are commonly used for cancer diagnosis where the presence or absence of particular proteins or sequences help pathologists make an accurate diagnosis and differentiate between disease states that look morphologically similar. IHC uses primary antibodies that bind to the target protein and detection systems that link to the

primary antibody to provide a visual indication of the proteinâ&#x20AC;&#x2122;s presence and location using bright field microscopy. ISH uses probes that bind to the target RNA or DNA sequence. Different detection systems are then used to visualize the presence of the target sequence: FISH uses fluorescent dyes and fluorescent microscopy while CISH uses chromogenic dyes and bright field microscopy. Immunohistochemistry (IHC) is identified as the most lucrative sub segment of the tissue diagnostic market majorly owing to increasing incidences of cancer diagnostic. North America is the leading tissue diagnostic market owing to a rising prevalence of cancer, supportive reimbursement facilities and growing demand for personalized medicines. Europe is expected to be the second most profit generating region owing to rising patient awareness levels, especially in Western European

countries. The emerging economies of Asia Pacific such as India and China are expected to witness lucrative growth over the forecast period owing to increasing geriatric population base, increasing disposable income, rapid innovation in diagnostic testing, rising research funding for cancer and large pool of patients. Transasiaâ&#x20AC;&#x2122;s Immunology systems which include the Elan 30s & Mago 4, allows users to adapt to a changing workload requirement and testing needs. Combined with their extensive test menu kits, these systems can move your lab forward by enhancing efficiency, increasing productivity, and reducing the cost of care. At Transasia are focused on bringing our expertise in personalized medicine to address unmet needs. Ref: - http://www.dbt.univr.it/documenti/Avviso/all/ all226092.pdf - http://www.grandviewresearch.com/industryanalysis/tissue-diagnostics-market

Medical Device ASIA | May-June 2016 | 33

“Tomotherapy” New Hope for Cancer Patients

Dr.Naresh Trehan(Chairman of Heart Institute) at the launch of Tomotherapy in ASTRO conference%2cLeela Ambience

Dr.Tejinder Kataria(Chairperson Department of Radiation & Oncology) at the launch of Tomotherapy in ASTRO conference%2cLeela Ambience

The Medicity, in collaboration with the Association of Radiation Oncologists of India (AROI) hosted the Best of ASTRO India conference. The conference is considered to be the gold standard in the professional education and research in the field of radiation oncology internationally. The conference was attended by the leading Radiation Oncologists1 from around the world and offered a platform to empower them with latest developments in the field for the benefit of the general public.

About ASTRO

Dr. Naresh Trehan, Chairman and Managing Director, Medanta - The Medicity inaugurated the conference and in his address spoke about the role of radiation oncology in cancer treatment. Dr. Trehan said, “It is our endeavor to provide the finest medical care in India, and we therefore strive to propagate the advances in medical care, research and training among the medical fraternity. Treatment of cancer is being made more effective by doctors with super-specialties and advances in equipment, ‘Best of ASTRO’ serves as a platform for knowledge sharing in Radiation Oncology leading to delivery of the best treatment for cancer and also empowering of the patient in defeating cancer.” Talking about the conference Dr. Tejinder Kataria, Chairperson, Medanta Division of Radiation Oncology and Organizing Secretary of Best of ASTRO India added that “The conference was a great success this year. It provided a great opportunity for those who could not attend ASTRO 2015 to review all the important presentations covering the major sites and take back the frontiers of science to their clinics.” While launching Tomotherapy in Medanta, Dr. Trehan underlined the relevance of radiation therapy in Cancer treatment. He added, “Radiation Oncology complements surgery and medication in delivering effective cancer treatment and cure. Recognizing that Tomotherapy offers a whole new, revolutionary treatment modality, Medanta has invested significantly and introduced it to India.” Dr. Tejinder Kataria added – “Tomotherapy is the new hope for cancer patients especially leukaemias, lymphomas, carcinoma breast, carcinoma esophagus, prostrate and peadiatric tumors”. 34 | May-June 2016 | Medical Device ASIA

ASTRO is the premier radiation oncology society in the world, with more than 10,500 members who are physicians, nurses, biologist, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. These medical professionals, found at hospitals, cancer treatment centers and academic research facilities around the globe, make up the radiation therapy treatment teams that are critical in the fight against cancer. Together, these teams, treat more than 1 million cancer patients each year. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research and advocacy. ASTRO provides members with the continuing medical education, health policy analysis, patient information resources and advocacy that they need to succeed in today’s ever-changing health care delivery system.

About Medanta - The Medicity Medanta - The Medicity is one of India’s largest multi-super specialty institutes located in Gurgaon, in the National Capital Region. Founded by eminent cardiac surgeon, Dr. Naresh Trehan, the institution has been envisioned with the aim of bringing to India the highest standards of medical care along with clinical research, education and training. Medanta is governed under the guiding principles of providing medical services to patients with care, compassion, commitment. Spread across 43 acres, the institute includes a research center, medical and nursing school. It has 1250 beds and over 350 critical care beds with 45 operation theatres catering to over 20 specialties. Medanta brings together an outstanding pool of doctors, scientists and clinical researchers to foster collaborative, multidisciplinary investigation, inspiring new ideas and discoveries; and translating scientific advances more swiftly into new ways of diagnosing and treating patients and preventing diseases. A one-of-its-kind facility across the world, Medanta through its research integrates modern and traditional forms of medicine to provide accessible and affordable healthcare.

New Rigel Ventest 800

For Accurate Verification Of Ventilator Performance

igel has extended its range of test instrumentation for biomedical equipment with the introduction of a specialist ventilator tester.

The Rigel VenTest 800 gas flow analyser is ideal for both bench top and field service testing of all commonly available ventilators to verify that the ongoing accuracy and reliability of the equipment remains within the required performance standards.

Precise sensor technology enables the VenTest 800 to accurately measure flow, pressure, temperature, and O2 concentrations bi-directionally and is compatible with 13 gas standards and 7 gas types. The three model range includes a standard VenTest 800 analyser for use with all standard ventilators, including adult, neonatal, paediatric and high frequency equipment, as well as anaesthesia machines and spirometers. In addition, specially adapted models for the testing of vacuum measurements (VenTest 810) and low flow pressures (VenTest 820) are also available. The VenTest 800 incorporates a simple, intuitive user interface and graphics display for ease of operation during testing and calibration settings. As well as an internal memory, at the push of a button, all measured values can be transferred to PC records by USB, RS-232 and optional Ethernet interfaces. Once saved, optional software is available that provides a wide range of graphical analysis capabilities, including real time flow/pressure curves, functional zoom and certification documentation. The Rigel VenTest 800 is the latest addition to the companyâ&#x20AC;&#x2122;s comprehensive range of dedicated biomedical test equipment that also includes electrical safety analysers, vital signs simulators and performance analysers. Details at www.rigelmedical.com/VenTest800 Medical Device ASIA | May-June 2016 | 35

EKF Diagnostics publishes

“Anemia and Hemoglobin Testing” guide

Detailed hematology guide available for free download hematology [3]. “As specialists in this area of POC testing, we have published this guide to share our knowledge and demonstrate our commitment to making blood donation and anemia screening easier, more affordable and more accessible than ever before,” said Katja Lemburg, EKF Diagnostics’ Global Product Manager for Hematology. “Our diagnostic analyzers and tests deliver fast and reliable results for hemoglobin and hematocrit that provide both practitioner and patient with the information they need to make clinical or lifestyle decisions in seconds.”

KF Diagnostics, the global in vitro diagnostics company, announces the publication of its new guide, “Anemia and hemoglobin testing” [1]. Available to download for free from ekfdiagnostics.com, the in-depth hematology guide provides a review of the symptoms and causes of anemia, through to methods for testing hemoglobin and hematocrit, as well as factors that may influence these measurements. Anemia is the most common blood disorder, affecting around 25% of the global population, and can be caused by poor nutrition or various diseases. It is a condition where the number of red blood cells or the availability of hemoglobin falls below the body’s physiological needs. Consequently, hemoglobin and hematocrit are the main blood tests used to diagnose anemia. In addition, pre-donation hemoglobin testing is an integral part of blood donor health assessment in many countries. Since anemia reduces an individuals’ wellbeing,

36 | May-June 2016 | Medical Device ASIA

physical productivity and work performance, timely treatment can restore personal health and raise national productivity levels by as much as 20% in developing countries, as observed by WHO [2]. Notably, Anemia also contributes to 20% of all maternal deaths [2] , meaning that many countries conduct interventions during pregnancy to reduce anemia and its adverse effects. Hemoglobin and hematocrit can be measured by a variety of methodologies. In particular, point-of-care (POC) testing in hematology has continued to grow in popularity; with hemoglobin measurement now the most commonly used parameter in POC

EKF’s range of hemoglobin analyzers includes Hemo Control, which uses the ‘gold standard’ azide methemoglobin method to deliver results from 25 seconds, and DiaSpect Tm, which uses a reagentless cuvette to provide results in just about one second. Its specialist hematocrit analyzer is the UltraCrit Plus which, uniquely, uses ultrasound to measure hematocrit with a high degree of accuracy within 30 seconds. HemataSTAT II is a microhematocrit centrifuge that provides quantitative readings for multiple samples that is perfect for laboratories or even veterinary use. References: 1. http://workshop.fluidbook.com/view er/14091_4ce791664036d9927a1d9ba44bc7a5 af_1450197526/ 2. http://www.who.int/nutrition/topics/ ida/en/ Access date: 24/07/2015 3. Where are we at with point-of-care testing in haematology? Briggs C et al., British Journal of Haematology, 2012, 158, 679-690.

For more information on EKF Diagnostics, please see www. ekfdiagnostics.com.

Missed opportunities to avoid painful shocks at the end of life MANY PATIENTS UNAWARE OF BENEFITS OF DEACTIVATING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR an ongoing basis like a pacemaker does, deactivating the device does not actively hasten death. However, if a patient experiences a dangerous heart rhythm--a common occurrence during the natural course of death from any cause--a deactivated ICD will not intervene to rescue the patient.

any patients who have a common medical device known as an implantable cardioverter defibrillator (ICD) are unaware that the device can be deactivated to prevent painful shocks in their final days of life, according to two studies scheduled for presentation at the American College of Cardiology's 65th Annual Scientific Session.

anymore," said Dilek Yilmaz, M.D., a Ph.D. fellow in cardiology at the Heart and Lung Center of Leiden University Medical Center in the Netherlands and lead author of one of the studies. "If a person is dying of a terminal cancer, for example, the ICD is not going to prolong their life, but it is fairly likely to cause pain in their last hours and prevent them from having a peaceful death."

The Heart Rhythm Society and the European Society of Cardiology have issued recommendations encouraging physicians to inform patients about the benefits of deactivating an ICD when death is near, yet recent studies show that up to 31 percent of people with an ICD receive shocks in their last day of life. Two new studies add further evidence that doctors are not consistently implementing these recommendations, which the authors said may reflect a reticence to engage in difficult discussions about end-of-life decisions.

ICDs are battery-powered, surgically implanted devices used to prevent sudden death in people with certain conditions, such as sustained ventricular tachycardia or fibrillation, that put them at risk for lifethreatening heart rhythms. If the device detects a dangerous heart rhythm, it issues a shock to restore a normal heartbeat. ICDs are extremely common, with 10,000 implanted each month in the United States alone, according to the American Heart Association.

"When you reach the stage of palliative care, sometimes the ICD doesn't have a role in caregiving

The device can be deactivated using a computer in any cardiologist's office, with no need for additional surgical intervention. Because ICDs do not maintain the heart rhythm on

"These shocks are often much more frequent on the patient's last day than any other day of their life," said Silvia del Castillo, M.D., a cardiologist at Hospital Universitario de Fuenlabrada in Madrid and lead author of the second study. "I think it's cruel in many cases to leave the ICD on until the very end, and when doctors don't provide enough information about deactivation or delay that conversation until the final hours, it undercuts the patient's right to make their own decisions." The two studies, conducted independently in the Netherlands and in Spain, revealed similar patterns. Study authors said the situation in the United States is likely to be similar, as well. For the study conducted in Spain, del Castillo and her colleagues surveyed 243 patients with ICDs during clinic visits at three Spanish hospitals. While most respondents showed a high level of understanding about what an ICD is and what it does, far fewer demonstrated a clear understanding of the option to deactivate the ICD or what would happen if it were to be deactivated. Sixty-eight percent assumed shocks were inevitable in the presence of an abnormal heart rhythm, and 21 percent incorrectly believed that deactivation would lead to immediate cardiac arrest. Just 38 percent were aware that they could

decide to deactivate their ICD after consulting with their doctor, and only 37 percent knew that ICD deactivation is ethically appropriate and recommended by major scientific societies. In the study conducted in the Netherlands, Yilmaz and her colleagues surveyed 328 patients with ICDs during a patient educational symposium. Although 73 percent were aware that their ICD could be deactivated, just 12 percent had consulted with their doctors about the matter. Neither of the studies revealed trends in terms of factors such as gender or level of education playing a role. Both study authors attribute the findings to communication gaps and cultural challenges around end-oflife planning. "As doctors, we are focused on healing the patient and saving lives," del Castillo said. "It's hard to talk about death and to explain that this therapy that can save their life now could be harmful to them later. Because we have a hard time talking to patients about this, in the end doctors often make the decision about ICD deactivation alone or with the family, instead of with the person who should be the real decision-maker, the patient." The best time to begin the conversation about ICD deactivation, according to the studies' authors, is around the time when the ICD is being implanted, which is often many years before a patient's death. Then it can be mentioned again during follow-up visits or when someone receives a terminal diagnosis.

Medical Device ASIA | May-June 2016 | 37

New tool to improve blood pressure measurement

cientists at Oxford University have developed a new way of estimating our true underlying blood pressure that overcomes common problems in a clinical setting which can lead to misleading results. Their work is published in the journal Hypertension. Blood pressure measurement is frequently used by medics to understand our health, and dangerously high blood pressure (hypertension) can lead to serious conditions like heart attack or stroke. Blood pressure levels fluctuate throughout the day and can easily change as a result of stress, physical activity and even talking. Readings are usually taken in a doctor's clinic, but these measurements are often different from those taken at home, which are considered to be more reflective of your true underlying blood pressure level.

Study leader Dr James Sheppard said: 'One phenomenon where readings are higher in the clinic than at home is referred to as the 'white coat effect'. This can lead to people being started on blood pressure lowering treatments they do not really need. A reverse effect is also seen -- some patients have lower readings in the clinic than they would in normal life, meaning that they can miss out on treatment that they could potentially benefit from. Understanding and accounting for the scale of these home-clinic differences would improve diagnosis and treatment.' The team therefore analysed data from more than 2000 patients, looking at factors including age, gender, body mass index, alcohol consumption and tobacco use. They also studied a number of 'blood pressure characteristics' from

38 | May-June 2016 | Medical Device ASIA

multiple readings taken in the clinic, including the difference between the first and last readings and the rate of change in blood pressure among others. Data from around 900 patients was used to build a model, identifying factors that affected the difference between home and clinic blood pressure readings. The model was then validated by checking against the data from the other patients in the study. The result is a prediction model that uses three separate blood pressure readings taken in a single consultation and basic patient characteristics to give an adjusted blood pressure reading that is significantly more accurate than existing models for identifying hypertension. Dr Sheppard explained: 'We compared the accuracy of our

model to the current UK NICE guidelines and those in use in the USA, Canada and Europe. It correctly classified 93% of cases, compared to the next best, the NICE guidelines, which correctly classified 78% of patients. 'Correctly classifying people as hypertensive or not is important for patients -- ensuring that those who need treatment get it. Perhaps just as importantly, this approach prevents those patients displaying a white coat effect from being put on treatment which they don't really need. This approach has the potential to save large amounts of money for the NHS by avoiding unnecessary treatment in those with the white coat effect. It may also lead to fewer patients suffering from heart attacks and stroke, by treating patients' blood pressure more effectively.'

Why do sunbathers live longer than those who avoid the sun?

ew research looks into the paradox that women who sunbathe are likely to live longer than those who avoid the sun, even though sunbathers are at an increased risk of developing skin cancer. An analysis of information on 29,518 Swedish women who were followed for 20 years revealed that longer life expectancy among women with active sun exposure habits was related to a decrease in heart disease and noncancer/nonâ&#x20AC;&#x201C; heart disease deaths, causing the relative contribution of death due to cancer to increase. Whether the positive effect of sun exposure demonstrated in this observational study is mediated by vitamin D, another mechanism related to UV

radiation, or by unmeasured bias cannot be determined. New research looks into the paradox that women who sunbathe are likely to live longer than those who avoid the sun, even though sunbathers are at an increased risk of developing skin cancer. An analysis of information on 29,518 Swedish women who were followed for 20 years revealed that longer life expectancy among women with active sun exposure habits was related to a decrease in heart disease and noncancer/nonheart disease deaths, causing the relative contribution of death due to cancer to increase. Whether the

positive effect of sun exposure demonstrated in this observational study is mediated by vitamin D, another mechanism related to UV radiation, or by unmeasured bias cannot be determined. Therefore, additional research is warranted. "We found smokers in the highest sun exposure group were at a similar risk as non-smokers avoiding sun exposure, indicating avoidance of sun exposure to be a risk factor of the same magnitude as smoking," said Dr. Pelle Lindqvist, lead author of the Journal of Internal Medicine study. "Guidelines being too restrictive regarding sun exposure may do more harm than good for health."

Medical Device ASIA | May-June 2016 | 39

OUT FOR BLOOD: FLUID DYNAMICS EXPLAIN HOW QUICKLY A VAMPIRE COULD DRAIN YOUR BLOOD puncture holes with a width of 0.5mm each). Considering the human body has an average of 5 litres of blood and that a vampire might feasibly take 15%, in the study a vampire would drain 0.75 litres of blood, and by their calculations it would take 6.4 minutes to do so. The students presented their findings in a paper for the Journal of Physics Special Topics, a peerreviewed student journal run by the University’s Department of Physics and Astronomy. The student-run journal is designed to give students practical experience of writing, editing, publishing and reviewing scientific papers.

hroughout human history there have been tales of vampires -bloodsucking creatures of folklore that prey on their victims by draining their life essence, usually via the blood. To coincide with the 85th anniversary of Tod Browning's 'Dracula' (1931), students have used fluid dynamics to examine how long it would take for the undead fiend to drain an average human's blood - and have calculated that it would take only 6.4 minutes to drain 15 per cent of the blood from the external carotid artery in a human's neck. Throughout human history there have been tales of vampires – bloodsucking creatures of folklore that prey on their victims by draining their life essence, usually via the blood. To coincide with the 85th anniversary of Tod Browning’s

‘Dracula’ (1931) starring Bela Lugosi, should you (unfortunately) be assailed by a vampire, students from the University of Leicester’s Department of Physics and Astronomy have used fluid dynamics to examine how long it would take for the undead fiend to drain an average human’s blood – and have calculated that it would take only 6.4 minutes to drain 15 per cent of the blood from the external carotid artery in a human’s neck. 15 per cent was used as the benchmark as any more blood loss causes the heart rate to change, while less can be taken without affecting the circulatory system of a human. The aorta, the main artery of the body, splits into five other arteries.

40 | May-June 2016 | Medical Device ASIA

For the purpose of the study the team was concerned with the velocity of blood flowing into only the common carotid artery. They also assumed the five arteries are of even thickness, enabling them to calculate the velocity of blood flowing into the common carotid artery. By examining the average human blood pressure in arteries measured relative to the air pressure, this gave the students the pressure difference. They then worked out average density of blood at room temperature and were able to deduce how much blood would come out of a puncture in a human’s neck (with vampire fangs assumed to leave

Course tutor, Dr Mervyn Roy, a lecturer in the University of Leicester’s Department of Physics and Astronomy, said: “Every year we ask each student to write around 10 short papers for the Journal of Physics Special Topics. It lets the students show off their creative side and apply some of physics they know to the weird, the wonderful, or the everyday.”

Blood and lymphatic capillaries grown for the first time in the lab vessels drain off this fluid. The researchers isolated lymphatic capillary cells from the human dermis. Together with the blood capillaries that were also engineered, this guarantees rapid, efficient vesicular supply of the skin graft. Up to now, this had been a major unsolved problem in molecular tissue biology and regenerative medicine.

esearchers have engineered skin cells for the very first time containing blood and lymphatic capillaries. They succeeded in isolating all the necessary types of skin cells from human skin tissue and engineering a skin graft that is similar to full-thickness skin. Researchers at the University Children's Hospital Zurich and the University of Zurich have engineered skin cells for the very first time containing blood and lymphatic capillaries. They succeeded in isolating all the necessary types of skin cells from human skin tissue and engineering a skin graft that is similar to full-thickness skin. Every year around 11 million people suffer severe burns. The resulting large, deep wounds caused by burning

only heal slowly; this results in lifelong scars. What is needed to reduce this kind of scarring is the grafting of functional full-thickness skin. Only a very limited area of skin can be removed from the individual patient as the surgery, in turn, creates new wounds. Besides conventional skin grafting, another option is to engineer a skin graft in the lab which firstly is composed of the patient's cells and secondly is very similar to natural human skin. Up to now these complex skin grafts didn't contain any blood or lymphatic capillaries, pigmentation, sebaceous glands, hair follicles or nerves. The researchers at the Tissue Biology Research Unit, the research department of the Surgical Clinic and at the Research Centre for

42 | May-June 2016 | Medical Device ASIA

Children at the University Children's Hospital Zurich have been engineering dermo-epidermal skin grafts for some time but now they have succeeded in constructing a more complex organ. "We were able to isolate all the necessary skin cells from a human skin sample and to engineer a skin graft similar to fullthickness skin that contains for the first time blood and lymphatic capillaries too," says Martin Meuli, Head of the Surgical Clinic at the University Children's Hospital Zurich. Fully functional lymphatic capillaries generated for the first time Tissue fluid is excreted from a wound which accumulates in a cavity on the skin's surface and can impede wound healing. Lymphatic

The scientists in the team of Ernst Reichmann, Head of the Tissue Biology Research Unit, were surprised by three findings. The individual lymphatic cells spontaneously arranged themselves into lymphatic capillaries with all the characteristics of lymphatic vessels. In preclinical trials both the human lymphatic capillaries and the blood capillaries engineered in the laboratory connected with those of the laboratory animals. "What's novel is that the lymphatic capillaries collected and transported tissue fluid; hence they were functional," explains Ernst Reichmann and goes on to add, "We assume that skin grafts with lymphatic and blood capillaries will, in future, both prevent the accumulation of tissue fluid and ensure rapid blood supply of the graft." This could markedly improve the healing process and the typical organ structure of this type of skin graft. The first clinical application of these complex skin grafts is scheduled for 2014. They will not, however, contain any blood or lymphatic capillaries as approval has still to be obtained.

New effective treatment for high blood pressure? Removing tiny organ

emoving one of the tiniest organs in the body has shown to provide effective treatment for high blood pressure. The discovery could revolutionize treatment of the world's biggest silent killer. Removing one of the tiniest organs in the body has shown to provide effective treatment for high blood pressure. The discovery, made by University of Bristol researchers and published in Nature Communications, could revolutionise treatment of the world's biggest silent killer. The carotid body -- a small nodule (no larger than a rice grain) found on the side of each carotid artery --

appears to be a major culprit in the development and regulation of high blood pressure. Researchers, led by Professor Julian Paton, found that by removing the carotid body connection to the brain in rodents with high blood pressure, blood pressure fell and remained low. Professor Paton, from Bristol's School of Physiology and Pharmacology, said: "We knew that these tiny organs behaved differently in conditions of hypertension but had absolutely no idea that they contributed so massively to the generation of high blood pressure; this is really most exciting." Normally,

the carotid body acts to regulate the amount of oxygen and carbondioxide in the blood. They are stimulated when oxygen levels fall in your blood as occurs when you hold your breath. This causes a dramatic increase in breathing and blood pressure until blood oxygen levels are restored. This response comes about through a nervous connection between the carotid body and the brain.

work on carotid body research started in the late 1990's and their recent discovery has since led to a human clinical trial at the Bristol Heart Institute of which the results are expected at the end of the year.

Professor Paton commented: "Despite its small size the carotid body has the highest blood flow of any organ in the body. Its influence on blood pressure likely reflects the priority of protecting the brain with enough blood flow." The team's

I am delighted that Bristol was chosen as a site for this important trial."

Professor Paton added: "This is an extremely proud moment for my research team as it is rare that this type of research can so quickly fuel a human clinical trial.

The work was funded by the British Heart Foundation, Cibiem, New York and the National Institutes of Health.

Medical Device ASIA | May-June 2016 | 43

Heart Disease is Different for Women, but it's Still Deadly released study done for the American Heart Association about sex-specific differences in heart disease. She recently talked with The Post about this issue. Q: How are men's and women's hearts different? A: Anatomically, men and women have similar hearts. But physiologically, men and women have different hormones, and blood vessels respond to those hormones. Women have cyclical hormones because of menstruation, pregnancy and menopause. As women get older, especially after menopause, they have more incidents of high blood pressure. They tend to not want to get treated. They tend to want to try lifestyle changes. If, after three months, lifestyle changes don't lower cholesterol and blood pressure, women should not be in denial. They need medication. They need to understand they are at risk of having a heart attack and dying. Q: Men describe an elephant sitting on their chest during a heart attack. What about women?

very year about 610,000 American men and women die from heart disease; that's 1 in every 4 deaths, according to the Centers for Disease Control and Prevention. It's a leading cause of death for both genders.

Roughly two-thirds of women who suddenly die of coronary heart disease never show any advance signs. And that grab-your-chest, crushing, fall-over kind of pain is not what most feel when they have a heart attack.

Volgman, a professor of medicine at Chicago's Rush College of Medicine and medical director of the Rush Heart Center for Women. "They'll have nausea or just not feel well. They have more vague symptoms than men."

Where men and women differ is how they respond to heart disease and how they manifest symptoms.

"Women will describe a discomfort, or they will have pain in their jaws or necks," said Annabelle Santos

As a result, doctors often misdiagnose women, Volgman said. Volgman is a co-author of a recently

44 | May-June 2016 | Medical Device ASIA

A: For women, it's very subtle. They usually have some sensation in their chests. They describe it as heaviness or discomfort. I'll say, "We need to do some testing because of the chest pain." Women get upset, saying they don't have chest pain. They have different perception of pain. They don't like to use the word "pain." Q: What can be done about that? A: We haven't educated women, especially African American and Hispanic women, well enough. So many women are unaware heart disease is the number-one killer. They worry about breast cancer because they hear a lot about that.

That's why we want to put it out there that heart disease is their number-one threat.

Q: What lifestyle changes should women with high blood pressure follow?

If you are worried or have any symptoms in your chest, shortness of breath, pressure in chest, nausea, unexplained fatigue, go to your doctor and get tested for heart disease.

A: Try to get 30 minutes of aerobic exercise a day, five or six days a week. Get a Fitbit or use your phone to see how many steps you are getting in a day. If you are getting 10,000 steps in a day, that's pretty good.

We have a simple blood test now that is sex-specific that is really helpful for women. It's called the Corus CAD test and incorporates age, sex and gene-expression measurements into a single score that indicates any likelihood of obstructive coronary artery disease. Q: Should women start asking for this test during their yearly checkup? A: When you go to the doctor, he or she should assess your symptoms and check risk factors. If you are complaining of symptoms that could trigger thoughts of heart disease, the doctor will get an EKG [electrocardiogram]. Also, specifically ask for the Corus CAD test if you are worried or have symptoms in your chest.

Eating healthy foods, such as fresh fruits and vegetables, is so important. Vitamins, which are so healthy and important, come from fruits and vegetables, not from supplements. A lot of the supplements are processed, so a lot of the vitamins are changed once they are put in supplements. Decrease your saturated fat intake. Decrease sugar and refined carbs. Q: When you talk about family risk factors, what should women look for? A: Learn about your family history. Learn how your father or mother died, or your grandparents. Officially, when we talk about family history, we are talking about men who had heart attacks at less than

55 years of age and women at less than 65 years of age. If the heart attack occurred after that, we don't consider that a family-history risk factor. We can get risk factors from genetic testing, and the cost of genetic testing has markedly decreased so that it's not that expensive to know what your risk factors are. I do this especially with patients with a family history. A patient will say, "My father had a heart attack in his 50s, but he smoked. He was heavy and didn't exercise." These tests help me distinguish patients with family history [who] truly have the risk. Any patients with a family history should have advanced lipid testing [to measure the "bad cholesterol" lipoproteins associated with an increased occurrence of heart attacks and strokes.] Women, especially those of South Asian and African American heritage, have a higher risk for lipoprotein (a).

risks assessed. There are free screenings. The national organization WomenHeart[is] pairing with Burlington Coat Factory to do free screenings. They check blood pressure, cholesterol and glucose to make sure someone isn't diabetic. These are the basic tests when we do heart-healthy screenings. Q: And those specific symptoms for heart disease for women? A: There is a great website, gospreadtheword.com. If people go to that website, it talks about symptoms of heart disease. Go to know your testing options or know your symptoms. It actually asks you what your symptoms are and will give you an idea of what you should do after you answer a few questions.

Q: Should everyone get genetic testing to find out any hidden risk factors? A: Every woman should have her

Medical Device ASIA | May-June 2016 | 45

Stay Happy: Positive Emotions Could Keep Your Heart Healthy

elieve it or not but our emotions play a crucial role in our well-being. A positive mindset can work wonders in helping you deal with various ailments. A recent study has found that people with heart disease may benefit from maintaining positive emotions. The study tracked more than 1,000 patients with coronary heart disease over the course of five years. Patients who reported higher positive psychological states were more likely to be physically active, sleep better and take their heart medications and were also less likely to smoke, compared to patients with lower levels of positive states. "Negative emotions and depression are known to have harmful effects on health, but it is less clear how positive emotions might be healthprotective," said Nancy L Sin,

postdoctoral fellow in the Center for Healthy Aging and in the department of biobehavioural health at Penn State. "We found that positive emotions are associated with a range of longterm health habits, which are important for reducing the risk of future heart problems and death," Sin said.

were associated with less smoking, greater physical activity, better sleep quality and more adherence to medications" at baseline, said the researchers. They found no correlation between positive emotions and alcohol use. The results took into account patients' demographic factors, depressive symptoms and the severity of their heart conditions.

The researchers assessed psychological well-being of participants at baseline and again at a five-year follow-up by asking the participants to rate the extent that they had felt 10 specified positive emotions, including "interested," "proud," "enthusiastic" and "inspired." Physical activity, sleep quality, medication adherence and alcohol and cigarette use were also measured at baseline and again five years later.

Though positive emotions at baseline did not predict changes in health behaviours five years later, increases in positive emotions across the five-year period were associated with improvements in physical activity, sleep quality and medication adherence. There are a number of reasons why positive emotions are linked to optimal health habits, the researchers suggest.

"Higher levels of positive emotions

People with greater positive well-

46 | May-June 2016 | Medical Device ASIA

being may be more motivated and persistent in engaging in healthy behaviours. They might have more confidence in their abilities to maintain routines such as physical activity and sleep hygiene. Positive emotions may also enable people to better adjust their health goals and to proactively cope with stress and setbacks. "Efforts to sustain or enhance positive emotions may be promising for promoting better health behaviours," said researchers. The study is published in the journal Psychosomatic Medicine.

Virtual Heart Prototype To Give Hope To Heart Patients ÂŁ800,000, three-year award supported by the Wellcome Trust, the Department of Health and the British Heart Foundation. The technology could play a vital role in tackling coronary heart disease, which remains the UK's biggest killer. Last year around 48,000 people suffered a heart attack in South Yorkshire alone. This includes around 9,700 people in Barnsley, 11,000 in Doncaster, 9,600 in Rotherham and nearly 17,700 in Sheffield. Doctors currently decide how to treat coronary artery disease by looking at X-ray pictures of the arteries (an angiogram). This involves inserting a tube through the wrist or groin and injecting dye into the arteries to find out where, and how severely, the coronary arteries are diseased.

significance of their disease. This will enable the cardiologist or surgeon to know where to place a bypass graft or stent, without any further tests, so this is a real breakthrough for patients. "The technology will further improve the diagnosis and may reduce the need for some patients to have more invasive tests afterwards. It will also help doctors decide which arteries need treating and even which bits of which arteries, and guide therapy." During the three-year study, the Sheffield research team, led by Dr Julian Gunn, in collaboration with colleagues at the Hospital and the University, will test the system in patients with more complicated heart disease to assess the feasibility of using it on a wider scale.

This is an excellent test, but when the arteries are neither completely normal nor completely blocked up, the results can be open to potential differences of interpretation.

They will also work to improve the accuracy and speed of the software to ensure results are available quickly, so doctors can make prompt decisions about treatment, while patients are in the examination room. Dr Paul Morris, a Specialist Registrar in Cardiology for Sheffield Teaching Hospitals NHS Foundation Trust and a British Heart Foundation Clinical Research Training Fellow, was recently awarded the British Cardiovascular Intervention Society's Young Investigator of the Year 2013 for his work on this project. He is the first doctor from Sheffield to win this award, and beat off stiff competition from hundreds of researchers across the globe to scoop the accolade.

new, award-winning computer system, which assesses heart disease better than the naked eye, could revolutionise the way patients with conditions such angina and heart attack are assessed and treated - saving lives and money.

It is capable of detecting which heart patients need treatment more sensitively and more accurately than the human eye by creating a 3D model of the coronary arteries during an angiogram (see above and below).

The brand new prototype technology has been developed and built by doctors and researchers from Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield.

This reduces the need for further invasive tests and procedures.

Dr Julian Gunn, a Consultant Cardiologist at Sheffield Teaching Hospitals NHS Foundation Trust and a Senior Lecturer at the University of Sheffield's Department of Cardiovascular Science, said: "Heart disease remains one of the world's biggest killers, so weâ&#x20AC;&#x2122;re delighted that the Sheffield team are leading the way with this research.

Now the state-of-the-art software is to be trialled on 100 heart diseases patients from the South Yorkshire area thanks to a

"Any patient with coronary heart disease who has an angiogram can, in the future, have a computerised assessment of the

Medical Device ASIA | May-June 2016 | 47

Non-surgical weight loss devices an interview with Richard Thompson, CEO ReShape Medical

â&#x20AC;&#x153;When should you seek help with weight loss? This is a personal decision that differs from patient to patient. However, I think most people will seek help after attempting to lose weight on their own and having limited or no success.â&#x20AC;?

I believe they will be interested in pursuing products like the intragastric balloon when they begin to get frustrated with diet and exercise programs Please can you give a brief overview of the different types of surgical weight loss procedures? Surgical procedures vary in effectiveness and invasiveness and all come with their own set of complications and lifestyle adjustments. They range from gastric banding that puts a silicone sleeve around the top of the stomach to restrict food intake to sleeve gastrectomies in which a large part of the stomach is surgically removed to bypass surgery where your digestive tract is altered to bypass most of your stomach and a part of your small intestine. These are permanent procedures that are generally chosen by heavier patients whose health is compromised by their size Who is eligible for weight loss surgery? It depends on the individual insurance companies but it is generally performed on patients who have a BMI (body mass index) of 35 to 45 or more. Why is there a need for a nonsurgical weight loss device? Only a very few percent of patients that qualify for weight loss surgery actually choose to have it. It is a last resort and most patients do not see themselves as ready to give up. On the other hand, diet and exercise rarely 48 | May-June 2016 | Medical Device ASIA

work well and patients are looking for some extra help in their quest to lower their weight. A reversible, non-surgical approach has a lot of appeal to these patients. Please can you give an introduction to ReShape Medical’s non-surgical weight loss device? The ReShape Duo® Intragastric Balloon is inserted into the stomach via an endoscopic procedure. The patient is able to go home within a few hours following the procedure and resume their normal life in a few days. The balloon takes up space in the stomach causing the patient to feel full and satisfied after consuming a small meal. Over the six month period that the balloon remains in the stomach, the patient is trained to associate eating small portions with successful weight loss. After the balloon is removed, the patient continues to use this new small portion behavior to retain their weight loss and even to continue to lose. At what stage of development is the device currently? The product is available in the European Union and is in a final pivotal clinical trial in the US. We anticipate that it will be available in the US in 2015 Why do you think there has been a large amount of patient interest in a non-surgical approach to weight loss? Patients want to remain in control over their bodies but they need assistance to successfully lose weight for the long term. They know diet and exercise alone don’t work very well and they don’t want surgery. A non-surgical device that is removed after they lose weight has natural appeal. How safe is the ReShape Duo® Intragastric Balloon in comparison to weight loss surgery? In commercial use to date, the ReShape Duo procedure has a risk profile similar to a diagnostic

endoscopy. Since it is temporary and completely reversible there are no anticipated long term complications. In which countries is the ReShape Duo® Intragastric Balloon currently available? The ReShape Duo® Intragastric Balloon is currently available in the United Kingdom, Spain and Italy.

How do you think the weight loss device market will develop? We believe that there is a lot of pent up demand for a non-surgical product. ReShape is in the lead in bringing our product to the U.S. market but we are still developing our commercialization plans. We have

no doubt that, when it is widely available, there will be considerable interest from both physicians and patients. What are ReShape Medical’s plans for the future? Our focus right now is to successfully conclude our clinical trial in the US and to expand our availability in the European Union. We are beginning to staff up for the release in the US as well. Where can readers find more information? Readers are invited to review our website at www.reshapemedical.com. About Richard Thompson Mr. Thompson has spent over 35 years in the medical device industry. Prior to joining ReShape Medical, he served as the Founder, President and CEO of Luminous Medical Inc, an innovative in-line glucose monitoring company based in Carlsbad, California. Prior to Luminous Medical, Mr. Thompson spent over ten years building Aradigm Corporation, a drug delivery company. He joined Aradigm in 1994 as President, CEO and Chairman of the Board after thirteen years at LifeScan, A Johnson & Johnson Company. Mr. Thompson co-founded LifeScan as a venture backed start-up in 1981. After the acquisition by Johnson & Johnson, he became President of LifeScan in 1991 while building the company to worldwide leadership in its field. Mr. Thompson is currently a member of the board at Intuity Medical Inc. and Asante Solutions Inc. Mr. Thompson holds a BS in Biological Sciences from the University of California, Irvine and an MBA from California Lutheran University.

Medical Device ASIA | May-June 2016 | 49

Heart attack and cardiac arrest difference “People often think that a heart attack is the same thing as a cardiac arrest. This, however, is not true. In order to understand the difference between a heart attack and a cardiac arrest, it is first necessary to understand what happens in both of these processes.” What is a heart attack? The heart is a muscle, and like all muscles it requires an oxygen-rich blood supply. This is provided to the heart by coronary arteries. A heart attack occurs when there is a blockage of the coronary arteries. This is often caused by a blood clot. Such a blockage, if not quickly resolved, can cause parts of heart muscle to begin to die. What is a cardiac arrest? A cardiac arrest is different to a heart attack. In a cardiac arrest the heart actually stops beating; whereas in a heart attack the heart normally continues to beat even though the blood supply to the heart is disrupted. Symptoms of a heart attack and of cardiac arrest In addition to the physiological mechanism being different, the symptoms of a heart attack and a cardiac arrest also vary. Symptoms of a heart attack include: Chest pain – this is often a feeling of tightness in the center of the chest which may last for several minutes and will not decrease upon resting (although the most common symptom of a heart attack, not all patients having a heart attack will experience chest pain) Spreading of chest pain to other areas, most commonly to the arms, jaw, neck, back and abdomen Shortness of breath Coughing Wheezing Feeling or being sick Anxiety 50 | May-June 2016 | Medical Device ASIA

Light-headedness or dizziness Sweating Weakness Palpitations (noticeable heartbeats) Symptoms of a cardiac arrest include: Sudden loss of consciousness/ responsiveness No breathing No pulse The lack of pulse is caused by the heart actually stopping during a cardiac arrest. As a consequence of this, the organs of the body are deprived of blood – this can lead to death. The following warning signs may also occur in the period before a cardiac arrest: Chest pain Shortness of breath Weakness Dizziness Palpitations Nausea Causes of heart attacks and cardiac arrests Cardiac arrests have several potential causes. These include: Ventricular fibrillation – an abnormal heart rhythm (arrhythmia) where the lower chambers of the heart (the ventricles) beat irregularly Ventricular tachycardia Coronary heart disease Changes of the heart structure Pacemaker failure Respiratory arrest Choking Drowning Electrocution Hypothermia Dramatic drop in blood pressure Drug abuse Excessive alcohol consumption An unknown reason A cardiac arrest can also be caused by a heart attack. In fact, according to the British Heart Foundation, the majority of cardiac arrests in the UK are caused by heart attacks. A heart attack itself involves a cut off in the blood supply to part of the

heart muscle. If a large enough portion of the heart is affected, then the heart may stop beating, i.e. a cardiac arrest may occur. But what about heart attacks themselves? What causes them? Well, in contrast to cardiac arrests, heart attacks are generally caused by one main factor – coronary heart disease (CHD). CHD is a condition that is generally caused by fatty deposits building up in the coronary arteries, which provide oxygenated blood to the heart. This is also known as atherosclerosis. Those most at risk of CHD include:

blocks the coronary artery. Summary In summary, there is a difference between a heart attack and a cardiac arrest. A heart attack occurs when the blood supply to part of the heart stops and thus causes a section of the heart muscle to begin to die; whereas a cardiac arrest occurs when the heart stops beating as a whole. There are various symptoms of a heart attack. In contrast, the main symptoms of a cardiac arrest are unconsciousness, lack of breathing and no pulse. Finally, there are many different causes of a cardiac arrest; whereas the main cause of a heart attack is coronary heart disease.

Smokers Those who eat an unhealthy diet – one that is high in saturated fat Those with high blood pressure Those with diabetes Overweight or obese people People who do not exercise frequently Older people, in particularly older men Those with a family history of heart disease People who have been exposed to air pollution, particularly traffic pollution People with CHD may experience a heart attack if a plaque, (a raised patch on the artery wall) splits and causes a blood clot which in turn Medical Device ASIA | May-June 2016 | 51

FDA approves new silicone gel-filled breast implant

he U.S. Food and Drug Administration approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc. The FDA based its approval on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection. In addition, investigators observed fissures (cracks) in the gel of some Natrelle 410 implants. This is a characteristic called gel fracture and is unique to this implant. “It’s important to remember that breast implants are not lifetime

devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.” The silicone gel in the Natrelle 410 implant contains more crosslinking compared to the silicone gel used in Allergan’s previously approved Natrelle implant. This increased cross-linking results in a silicone gel that’s firmer. Crosslinking refers to the bonds that link one silicone chain to another. The clinical significance of this type of silicone gel is not known. Allergan’s studies did not

52 | May-June 2016 | Medical Device ASIA

compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market. Therefore, these implants cannot be directly compared to any previously FDAapproved implant. The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease. Lessons learned from previous postapproval studies on silicone gelfilled breast implants informed the design of post-approval studies for the Natrelle 410. As a condition of approval for the Natrelle 410 breast implants, Allergan must: Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study; Conduct a 10-year study of more

than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications); Conduct five case control studies to evaluate the possible association between the Natrelle 410 implants, as well as other silicone gel-filled breast implants, and five rare diseases—rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma; Evaluate women’s perceptions of the patient labeling; and Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer. Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and styles. They have either smooth or textured shells. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

Certain microbes in the gut could have an impact on metabolism, thereby influencing weight loss

Bacteria find 'key to treating obesity without surgery' W

eight loss after gastric band surgery may be partly caused by changes to microorganisms that live in the gut, say US researchers.

entirely new way to treat the critical problem of obesity.” In the latest study, researchers compared three groups of obese mice on a high-calorie diet.

A study in mice has shown that surgery causes different types of bacteria to colonise the gut. Transferring samples of those bacteria into healthy mice caused them to rapidly lose weight without surgery. But the Harvard University researchers said they could not yet explain the mechanism behind their results. There are differences in the bacteria in the stomachs and intestines of obese people compared with those who are of a normal weight.

One group was given a gastric bypass

And in people who have had gastric bypass operations to help them lose weight, the types of microbes that are found in the gut change. The ability to achieve even some of these effects without surgery would give us an

There was little change in microorganisms present in the mice who had had sham operations, even though the group on the low-calorie diet lost just as much weight as the mice who had had the bypass surgery.

One was given the same fake operation but then fed a lowcalorie diet to promote weight loss

Metabolism impact Researchers then transferred samples from the guts of the three groups of mice into other germ-free mice. Those who received bacteria from the bypass mice, lost a significant amount of weight in two weeks but the others saw no change.

A week later the mice who had undergone the real obesity surgery had different bacteria in their guts, with an increase in types usually seen in lean individuals and a drop in types associated with obesity. Three weeks after surgery they had lost about 30% of their bodyweight, the researchers reported in Science Translational Medicine.

It is not yet clear how the microbes influence weight loss, but one theory is that they have an impact on metabolism. "We need to learn a good deal more about the mechanism by which a microbial population changed by gastric bypass exerts its effects," said study author Dr Lee Kaplan, an associate professor of Medicine at Harvard Medical

One was given a sham operation, and the high-calorie diet

School. "The ability to achieve even some of these effects without surgery would give us an entirely new way to treat the critical problem of obesity, one that could help patients unable or unwilling to have surgery." Co-author Peter Turnbaugh added: "It may not be that we will have a magic pill that will work for everyone who's slightly overweight. "But if we can, at a minimum, provide some alternative to gastric bypass surgery that produces similar effects, it would be a major advance." Prof David Haslam, from the National Obesity Forum, said: "We know the effects of bariatric surgery are not just mechanical and we don't know the full reasons why it works so well, especially in the resolution of diabetes. "There is more to it than meets the eye."

Medical Device ASIA | May-June 2016 | 53

Can Green Tea, Coffee Reduce Stroke Risk? For the study, Kokubo's team collected data on roughly 83,000 men and women, 45 to 74 years old, asking about how much green tea and coffee they drank. Over the course of the study, the researchers kept track of hospital records, death certificates and data about deaths from heart disease and stroke. During an average of 13 years of follow-up, they found that those who had at least one cup of coffee a day lowered their risk for stroke about 20 percent. And, compared to people who rarely drank green tea, people who drank two to three cups a day had a 14 percent lower risk of stroke and people who drank at least four cups lowered their risk by 20 percent.

any people take coffee or tea breaks throughout the day, and that simple act may help them reduce their risk for stroke, Japanese researchers report.

Although it isn't certain why coffee and tea may have this effect, Kokubo thinks it might be due to certain properties in these drinks that keep blood from clotting.

This study of about 83,000 people suggests that drinking green tea or coffee daily might lower stroke risk by about 20 percent, with even more protection against a specific type of stroke.

In addition, green tea contains catechins, which have an antioxidant, anti-inflammatory effect. Some chemicals in coffee, such as chlorogenic acid, may cut the risk of stroke by lowering the chances of developing type 2 diabetes, he explained.

"The regular action of daily drinking [of] green tea and coffee is a benefit in preventing stroke," said lead researcher Dr. Yoshihiro Kokubo, chief doctor in the department of preventive cardiology at the National Cerebral and Cardiovascular Center, in Osaka. "If you cannot readily improve your lifestyle, try to prevent stroke by drinking green tea every day," he said.

Coffee also contains caffeine, which may have an impact on cholesterol levels and blood pressure, and may cause changes in insulin sensitivity, which affects blood sugar, he added. One expert, Dr. Ralph Sacco, past president of the American Heart Association, cautioned that this type of study cannot say for sure that the lower risk of stroke is really the result of drinking coffee or tea.

54 | May-June 2016 | Medical Device ASIA

"Such association studies are still limited in [the] ability to tell whether it is some ingredients in the coffee or tea or some other behavior common to coffee and tea drinkers that is driving the protective effects," said Sacco, chairman of neurology at the University of Miami Miller School of Medicine.

The risk for a type of stroke called a hemorrhagic stroke, in which a blood vessel in the brain bursts and blood floods part of the brain, was cut by 32 percent among those who drank a cup of coffee or two cups of green tea daily. About 13 percent of strokes are hemorrhagic strokes, the researchers noted.

"There have been other studies, however, that have suggested some beneficial effects of coffee and tea on brain health, so the evidence is accumulating that there are some important simple dietary ways we can improve our health," Sacco said.

To be sure their findings related to coffee and tea, Kokubo's group took into account factors such as age, sex, smoking, alcohol, weight, diet and exercise. People who drank green tea were more likely to exercise compared to nondrinkers, they noted.

Government of India, Registrar of Newspapers of India (RNI)#: DELENG/2009/30008