Medical Device ASIA - November-December 2014 by Worldwide Publications

Vol.6 No. 6 | November-December 2014 | New Delhi

STARLED3 NX The Next Generation LED Lamp at MEDICA

Medical Device Technology Providers beneďŹ t from Strong International Response

EKF Diagnostics

POC hemoglobin

analyzer at Medica 2014

3D printed model of heart totreat patients

e d i t o r i a l

highlights

Medical Devices & Equipment | Healthcare | Pharmaceutical Journal

4 EKF POC hemoglobin analyzer at Medica 2014

Vol.6 No.6 |November-December 2014 | Annual Subscription: Rs.2000

6 The Next Generation Surgical led lamp Managing Editor Sarvjit

Associate Editor & Public Relations Director Reny

Joint Editors

Vishwapreet Amrita

Production Rakesh

Marketing & Communications Lovleen

Web Editor

Ravindar

Circulation Surekha

Secretary & Legal Advisor Surinder

China Correspondents Ying Wei / Adrian Liu

Editorial Advisory Board

12 Show Report: MEDICA and COMPAMED

Alex & Lilly - Netherlands

19 MTA 2015:Asia’s Premier Engineering Event

alex@vanbienen.net Andy McCourt - Australia

20 Hong Kong International Medical Devices and Supplies Fair

UK Representative

23 Surgeons use 3D printed model of heart to treat patients with

Mike Steele, MJ Marketing

20, Spencer Bridge Road Northampton NN5 5EZ Tel: +44-1604 756 100 Fax: +44-1604-750 910

disorders 25 MEDICAL FAIR THAILAND SET FOR FURTHER EXPANSION 28 Medtronic launches wearable cardiac monitor

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33 Top 5 Medical Technology Innovations 35 Better Ways to Rebuild Badly Injured Bones 38 Surgical Robots ‘Push Back’ 44 Wellograph – A Stylish Watch with Basic Fitness Capabilities

Published, Printed and owned by: World-Wide Publications, D-182, PR House, Anand Vihar, New Delhi-110092, India and printed at Technical Press Inc. D-182, PR House, Anand Vihar, New Delhi 110092 - India. The publisher does not necessarily agree with the views expressed by the contributors, in this issue, nor do accept any responsibility for any errors or interpretation in the publication.

46 NEC MultiSync MD212G3 LCD Grayscale Diagnostic Monitor 48 Genteel Lancing Device for Pain-Free Glucose Testing Anywhere on Body 51 Samsung RS80A Ultrasound System Now Available in U.S.

When hearing aid users listen to music, less is more Music hasn’t always been part of the hearing aid design process

use hearing aids is that music can sound distorted, said Croghan, and it’s common for people to remove their hearing aids to listen to music.

The findings suggest that less sophisticated hearing aids might actually be more compatible with listening to music, especially recorded music that has itself been processed to change the way it sounds.

Modern hearing aids use processing called “wide dynamic range compression,” which leaves loud sounds untouched but amplifies softer sounds. This kind of processing is useful for helping people with hearing loss follow a conversation, but it can distort music, which often covers a wider range of volumes than speech.

he type of sound processing that modern hearings aids provide to make speech more understandable for wearers may also make music enjoyment more difficult, according to a new study by the University of Colorado (CU) Boulder.

“Hearing aids have gotten very advanced at processing sounds to make speech more understandable,” said Naomi Croghan, who led the study as a doctoral student at CU-Boulder. “But music is a different animal and hasn’t always been part of the hearing aid design process.” A frequent complaint among people who

Adding to the distortion is the fact that recorded music commonly undergoes its own processing, known as “compression limiting,” which squeezes louder and softer sounds together into a narrower range, increasing the perceived volume. Too much compression limiting can affect the quality of music even for people with normal hearing, Croghan said, but it

compounds the problem for hearing aid users. “The recorded music is processed through multiple layers by the time the person with hearing loss actually hears it,” Croghan said. The research team – which also included Kathryn Arehart and Scholar in Residence James Kates, both in CU-Boulder’s Department of Speech, Language and Hearing Sciences – asked 18 experienced hearing aid users to listen to classical and rock music samples that ranged from being unprocessed to highly processed. The participants also used simulated hearing aids set at a variety of processing levels. Regardless of which music sample the participants listened to, they generally preferred using the hearing aids with the simplest additional processing – essentially devices that just boost the

volume. The participants also tended to prefer less processed music to more processed music. However, the level of processing of the music itself wasn’t as important as the type of hearing aid used for listener enjoyment. “What’s interesting about this is that more is not necessarily better,” Arehart said. “If I am in a noisy restaurant and I want to hear the people at my table, then more processing may be better in order to suppress the background noise. But when listening to music, more processing may actually do more harm than good.” Despite general agreement among study participants that less processing in the hearing aid was better for listening to music, individual preferences varied from person to person. “When it comes to hearing, like a lot of things, the average result does not fit everyone,” Croghan said.

Medical Device ASIA | November-December 2014 | 3

EKF Diagnostics launches POC hemoglobin analyzer at Medica 2014

DiaSpect Tm – immediate hemoglobin results from a hand-held analyzer

EKF Diagnostics, the global diagnostics company, has introduced the DiaSpect TM point of care (POC) hemoglobin analyzer at Medica 2014, 1215th November, Düsseldorf, Germany. Alongside this new product, EKF exhibited a new version of its Hemo Control hemoglobin analyzer, the industry-leading Biosen glucose and lactate analyzer, as well as previewing SensPoint, a new lactate analyzer designed for use in professional medical settings.

Immediate hemoglobin results The new DiaSpect Tm hemoglobin analyzer is a palmsized point of care analyzer that is fast, easy to use and reliable in all climate conditions as it combines laboratory quality performance with unmatched measurement speed and extensive battery life. In addition to its accuracy of result, DiaSpect Tm is extremely robust since it has no moving parts. Furthermore it utilizes reagent-free microcuvettes which are unaffected by humidity, unlike reagent-based systems. These plexiglass microcuvettes also have a long shelf-life of 2.5 years with no need for refrigeration as they can be stored from 0° to 50°C. DiaSpect Tm is portable and lightweight at just 185g and has an extremely long battery life of 40 days of continuous use, or 10,000 tests, due to its integrated rechargeable lithium-ion battery. DiaSpect Tm is factory calibrated against the HiCN reference method in accordance with ICSH and requires no re-calibration or maintenance, as it undertakes an automatic self-check between every measurement. Its ‘always on’ technology also means the analyzer is permanently ready for use. The user simply collects a capillary or venous blood sample of <10 µL in the microcuvette and inserts it directly into the analyzer. Hemoglobin results are delivered in just one second which can then be

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downloaded to a PC via USB or Bluetooth. For more information on the DiaSpect Tm hemoglobin analyzer or EKF Diagnostics, please visit www.ekfdiagnostics.com.

About EKF Diagnostics EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, Separation Technology Inc, DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors. Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement. Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities. Molecular Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics following the acquisition of UK-based 360 Genomics. EKF Molecular Diagnostics’ technology, PointMan™, is capable of detecting mutant genes from tiny biopsy and blood samples and has recently entered a partnership with the world renowned cancer research center at Massachusetts General Hospital, USA. EKF Diagnostics’ strengths lie in its multi-national research and manufacturing facilities, teams of experienced analysts and engineers in Germany, Ireland, USA and the UK, and a board led by some of world’s foremost authorities in medical diagnostics.

STARLED3 NX - The Next Generation Surgical led lamp introduced at MEDICA 2014 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. STARLED3 NX has a light intensity of 130.000 lux with a low energy consumption of 69W. The life cycle of its LEDs is about 50.000 hours. STARLED3 NX is composed by three reflectors that produce a wellblended 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 easyto-grip handle assure an excellent cleanliness.

Functions are adjusted by its innovative easy-to-read, ergonomic and easyto-clean I-SENSE® control panel. With a simple touch it can manage 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 STARLED 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 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. 6 | November-December 2014 | Medical Device ASIA

ABPS:

• has an electronic control which allows for automatic switch from electric power supply to battery power supply so that STARLED3 NX can be used as a high performance mobile unit. • is recharged by an automatic charger and requires no specific maintenance. Its autonomy may vary depending on the battery model, which can be from 12 Ah to 28 Ah with maximum charging time of about 8 hours. For more information, please contact: Acem Medical Company Via della Tecnica 29, 40050 Argelato - Bologna – ITALY Phone + 39 051 721844 • info@acem.it • www.acem.it

Dr. S. A. Merchant- Biography Nowadays life is uncertain and heart attacks are frequent. Heart disease has become common in young adults and securing the hearts and lives of people is an imperative. Dr Merchant has, therefore, come up with a vision to ‘Save a Heart and Lives’ of people. Dr S. A. Merchant has been a Consultant Interventional Cardiologist for more than two decades in Mumbai. He is one of the foundermembers of Lilavati Hospital and has more than 25 years’ experience in interventional cardiology. Dr. Merchant has a long journey of 25 years in developing Interventional Cardiology from its inception in balloon technology to stents & other innovative devices in the non-surgical treatment of heart disease. His dream was to treat the most complex of heart diseases without performing an open heart surgery. With this vision in mind, he retired after 12 years as a lecturer in cardiology at the prestigious KEM & GS Medical College.

Dr. S. A. Merchant Interventional Cardiologist DM (Cardiology) MD (MED), DNB, (Cardiology) FSCAI (USA)

During the initial days in Rouen, France, he worked in animal labs, research and development of devices, clinical trials, and finally used non-surgical balloon stent and preconcert valves in human beings. The journey continued in USA at Mass General Hospital and Harvard Medical School, where he worked with Professor Igor Palacios and learned the art of treating complex heart disease in the Cath Lab, which he calls his ‘temple’. Dr. Merchant has done pioneering work in the field of balloon angioplasty and stents. He is at present, actively involved in soluble stenting complex heart disease, treating multi-vessel coronary artery disease with medicated stent, below-knee drug eluting stent for diabetic foot, TAVI (Transfemoral Aortic Valve Implant). Dr. Merchant has participated in, and presented papers at various national and international conferences in USA, France, Italy, Africa, China, and Dubai. He regularly conducts live angioplasty workshops and lectures in interventional cardiology in India and around the world. Dr Merchant has been awarded the prestigious fellowship of the American Society of Cardiac Angiography and Interventions. Education:

• 1983 - M. B. B. S, Seth GS Medical College & KEM Hospital, Mumbai University, India • 1987 - M.D. in Medicine, Seth GS Medical College & KEM Hospital, Mumbai University, India • 1990 - D.N.B. in Cardiology, New Delhi, India • 1991 - D.M. in Cardiology, Seth GS Medical College & KEM Hospital, Mumbai University, India. • 1992 - Fellowship in Interventional Cardiology, University of Rouen, France. • 1993 - Fellowship in Interventional Cardiology, MGH & Harvard Medical School, USA • 1995 - Consultant Cardiologist, Lilavati Hospital & Research Centre, Mumbai Expertise:

• • • • • •

Cardiac Catheterisation and Angiography Coronary Angioplasty with drug eluting stent Valvuloplasties and TAVI ( Transfemoral Aortic Valve Implant) Carotid, renal and peripheral below knee stenting Permanent pacemaker implant and arrhythmia management Soluble Scaffolding for Complex Coronary Artery Disease

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Shocking cases of alarming increase of heart diseases in young people and its prevention by Dr. S. A. MerchantInterventional Cardiologist

Heart attack is one of the leading killers of both men and women all around the world. But fortunately, today there are excellent treatments for heart attack that can save lives and prevent diabetes & death. At the onset of a heart attack, what is most important is the first 1 hour that is termed “the golden hour” by doctors. The alarming increase in heart attack is also attributed to the hectic lifestyle , longer hours of work, worldwide recession, smoking , unhealthy lifestyle, continuous stress and lack of exercise. Heart attack shows no sign of being under control, but is increasing and even affecting younger and younger people day by day. Dr. S.A. Merchant, Mumbai’s leading Interventional Cardiologist has introduced Innovative and unique devices to combat this disease which has reached epic proportions and has been seen as one of the killer disease in India. Dr. S.A. Merchant has shared some cases studies of patients. Written below are some of the case studies of young people who were diagnosed with heart attack symptoms, and Dr. Merchant has successfully treated the complicated cases. a.

Cardiac Defibrillator implant to prevent sudden death

Snehal Patil: 20 years old girl had symptoms of giddiness and blackout repeatedly. Holter showed Irregular Heart Rhythm at very high rate of 220 beats per minute. Cardiac defibrillator was implanted. She now feels secure since the ICD device will shock her to normal rhythm in case she has fast irregular beating of the heart and prevent sudden death. Great innovation where the patient carries the defibrillator having a size of a coin implanted in the left shoulder to prevent sudden death from life threatening arrhythmias. b.

Case VI - x: 25 years old with massive heart attack Treated with soluble stent

Mr. XYZ: 25 year old male suffered from severe chest pain. His ECG showed ST segment elevation which is an indication of Acute Heart Attack with severely decreased pumping action of heart to 25 % o 2D Echo, PET scan which is an nuclear imaging technique was used to find the viability of the affected muscle of the heart which was followed by angiography which showed 90% of blockage in main artery of heart (LAD) which was immediately treated with new soluble stent which dissolve (vanish) within 12 months giving back the natural look to the artery. How to Prevent Heart Disease • Heart checkup , its risk factor review early in life and at regular intervals • Aspirin • Statins/ anti-oxidants • Stop smoking/ tobacco • Life style modification • Dietary exercise • Yoga • Early detection & control of HT & Diabetes • Control over weight “Plaque rupture leads to sudden death in young Indians. How to prevent this? Would capping the vulnerable plaque with soluble stent prevent sudden death and heart attack in young Indians? Would control on stress, high BP & cholesterol stabilize the plaque & prevent rupture” a big question mark for young Indians dying of Heart attacks.”

Transasia Bio-Medicals Ltd. selected as “Global Growth Company 2014” by World Economic Forum

ransasia Bio-Medicals Ltd., leading Indian In-vitro diagnostic company is proud to announce that it has been selected as ‘Global Growth Company- 2014’ by the World Economic Forum (WEF), a prestigious worldwide body comprising the world’s top corporations and global enterprises. The award was presented to Mr. Suresh Vazirani on the 5th November, 2014 at the India Economic Summit held in New Delhi. After a vigorous and thorough evaluation process, Transasia Bio-Medicals Ltd was selected as one of the most dynamic and high-growth companies and considered to be a trailblazer, shaper and innovator that were committed to improving the state of the world. This award recognizes the strength of Transasia’s ability to become future Global leader. The pool of candidates for this year was exceptionally strong and diverse, making the process all the more difficult and challenging. Transasia was selected on the basis of being one of the fast-growing companies with the potential to become global economic leader. The nominated Global Growth Companies (GGCs) represented a broad cross-section of industry sectors but share a track record of exceeding industry standards in revenue growth, promotion of innovative business practices and demonstration of leadership in corporate citizenship.

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Transasia Bio-Medicals Ltd. being commended as India’s top manufacturer and exporter of diagnostic products to over 100 countries has been proudly reckoned in this cadre. The award function was held during the India Economic Summit organized by WEF along with the Confederation of Indian Industry (CII) for facilitating the forum’s global multi stakeholder community to meet the new government and together define and shape the country’s next phase of transformation. It enabled high-level leaders from the government, civil society and the business sector for an issue-based interaction and

explore how to collectively shape policies for inclusive growth. India’s Finance and Defence Minister Mr. Arun Jaitley inaugurated the summit. Transasia Bio-Medicals Ltd. is synonymous for its quality and precision in the in-vitro segment. It leaves no stone unturned in delivering holistic healthcare solutions providing its patrons with technological advances backed by expertise and experience. The company’s global footprints and its mission is not only being recognized in India but it takes immense pride in being acknowledged by the world’s most prestigious institution – The World Economic Forum.

MEDICA and COMPAMED:

Medical Device Technology Providers benefit from Strong International Response - Tailwinds for Export Business

“The high number of international visitors has provided medical device technology providers as well as their suppliers at MEDICA and COMPAMED with tailwinds for propping up their export business. Those putting their business on a particularly broad footing across country borders find it easier to compensate for an unclear market and safety situation in specific countries,” says Joachim Schäfer, Managing Director at Messe Düsseldorf, summing up events in the halls of the world’s biggest medical trade fair and of the leading international trade fair for suppliers’ products in medical manufacture after four days (12 – 15 November 2014). The 4,831 exhibitors at MEDICA as well as the 724 exhibitors at COMPAMED gave the again almost 130,000 visitors 12 | November-December 2014 | Medical Device ASIA

(2013: 132,000) impressive proof of the benefit of their product innovations and wealth of ideas for high-quality and affordable health care. Approx. 84,000 visitors came from abroad travelling from some 120 countries to Düsseldorf. The average length of stay rose to 2.2 days. Just as important for exhibitors is the visitors’ decisionmaking authority. MEDICA also boasts top scores here. Over 70% of visitors have a say or are decisively involved in purchasing

decisions; add to these another 10% who are involved in a consulting capacity. The latest reports from industry associations underscore just how important MEDICA and COMPAMED are as drivers for suppliers’ international business. 85% of the medical device technology companies in the German Medical Technology Association BVMed polled expect sales to rise over the previous year, driven especially

by dynamic export business. Explaining trends Marcus Kuhlmann, Head of the Medical Technology Association in SPECTARIS, the German Hightech Industry Association, says: “This year we expect turnover at the 1,200 Germany medical technology manufacturers to exceed EUR 25 billion for the first time, with growth abroad developing more strongly than it is on the domestic market. Exports account for 68%”. In view of the trade fair business Kuhlmann emphasises: “MEDICA continues to be an outstanding possibility for companies to present themselves and their products and is therefore a “must”.” Re-Launch of Conference Program bears Fruit To also meet the needs of international visitors in future, MEDICA’s accompanying conference program has been fundamentally restructured over the past two years – now boasting highlights not only for German trade visitors and conferences on very specific topics. The MEDICA EDUCATION CONFERENCE, which was organised by the German Society for Internal Medicine (DGIM) for the first time this year, offered an impressive multi-disciplinary program: 280 events with 350 speakers on four days placed the link between science and medical technology centre stage. Highlights of the programme included events on sonography, latest insights into the treatment of hepatitis C, the introduction of the MiroSurge surgical robotic system as well as lectures on “Medical and Social Freezing”. “Participant

feedback on the quality of topics and speakers was very positive,” says Prof. Dr. Hendrik Lehnert, the President of the MEDICA EDUCATION CONFERENCE. DiMiMED, the International Conference on Disaster and Military Medicine, registered a further increase in participants with high-ranking representatives from the armed forces of over 20 nations. “Military medical services render outstanding performance worldwide under often very difficult conditions. The opportunity to exchange experiences amongst participants and know-how with medical technology manufacturers was boosted significantly at DiMiMED,” said Dr. Christoph Büttner, the Scientific Head of the Conference (Beta Group), summing up. The MEDICA MEDICINE + SPORTS CONFERENCE for sports and preventive medicine also enjoyed growing attendance. Here renowned experts like Prof. Dr.

Tim Meyer, physician to Germany’s national football team, or Prof. Jonathan Clark, medical director of the Red Bull-Stratos project, provided visitors with exciting insights into the latest methods used in performance diagnostics and sports medicine. Aspects that doctors regularly face as routine were not neglected in the English lectures either. Generating great interest was the session on preventing lack of exercise in children. Speaker Dr. Birgit Böhm (Faculty for Sport and Health Sciences /TU Munich) surprised the audience with the insight that specific sports programmes of gaming consoles (when played energetically via controller) can by all means be considered as useful exercise. Newly incorporated into the programme, the MEDICA PHYSIO CONFERENCE addressed not only pain treatment aspects in physiotherapy but also preventive approaches. Among other things, participants learnt about the

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positive effect of weight training on older people and how medical fitness training schemes can improve patient loyalty and extend the service portfolio of doctors’ surgeries. Hospital Conference – Treatment Quality and How it is Financed The 37th German Hospital Conference focused on the future challenges for hospital politics under the general heading of “Best Quality requires a Better Financing”, to name but one subject. Alongside the political debate on the planned hospital reform for 2015, other focal themes included the challenges posed by an ageing population for nursing care management, IT in clinics, quality and hospital planning as well as specialist care for out- patients as a driver for cross-sector cooperation. The 37th German Hospital Conference counted almost 1,800 participants. Cost-Benefit Ratio Must ad Up The discussions held at MEDICA’s well-attended themed Forums – such as the MEDICA HEALTH IT FORUM or the MEDICA CONNECTED HEALTHCARE FORUM – along with 14 | November-December 2014 | Medical Device ASIA

the product innovations displayed by exhibitors can be summed up as follows: the efficiency and easy handling of medical devices and products is becoming a pivotal purchase criterion. “Quality in care and efficiency are becoming more and more important for patients at clinics and doctors’ practices. The numerous innovations and improvements on show at MEDICA make important contributions to this,” explains Hans-Peter Bursig, General Manager of the Electromedical Technology Association in the Electrical and Electronic Manufacturers’ Association (ZVEI). There is demand for products/services of major benefit for specific treatments and ones that simplify processes. And here cost is not so much an issue. This also applies to the

area of ultrasonic imaging, for example, where flexible ultrasonic probes introduced through the oesophagus furnish detailed, closeup images of the heart. Thanks to this new technology, surgeons find it easier to assess the blood flow “live” during heart valve procedures to ensure that the repaired valve or valve replacement works properly. This can reduce the need for additional corrective procedures. Speaking at the MEDICA EDUCATION CONFERENCE, Prof. Dr. Andreas Schuler, board member at the German Association of Ultrasound in Medicine, stressed: “Modern technology, however, does not help patients if it is in the hands of inadequately trained physicians. This is why we recommend everyone working

with ultrasonic devices to obtain qualifications through certified training and continuous medical education.” He went on to say that the qualifications of the treating physicians most definitely had to keep pace with developments in high-tech medicine. COMPAMED – Suppliers as Competent Partners Regularly held in parallel with MEDICA, COMPAMED succeeded in further consolidating its position as the leading international event for suppliers to the medical manufacturing sector, registering in excess of 700 exhibitors for the first time. Companies as well as research institutes presented themselves in Halls 8a and 8b with their high-tech solutions to just under 17,000 visitors as competent partners for development and production in medical device technology. This time the focus was specifically on miniaturised components, functional materials, intuitive control units and highprecision processes designed to make medical products cheaper, safer and more reliable in future. Application examples included mobile analysis, therapy and control devices. Researchers from the Fraunhofer Institute for Ceramic Technologies and Systems IKTS (Dresden) presented a compact device for analysing prostate tissue at COMPAMED. The laboratory apparatus, which has already successfully completed first clinical tests, will ease diagnosis for physicians in future: through an

automated optical analysis based on laser pulses they will be able to diagnose carcinoma reliably within as little as 90 seconds. So far, comparative tissue analyses were far more labour-intensive and therefore also more costly. From 2015 MEDICA and COMPAMED to be held from Monday to Thursday

Thursday and will run concurrently on all four days. The concentration on “normal” week and working days from Monday to Thursday (instead of from Wednesday to Saturday as before) will in future make for an even better distribution of the trade audience on all four days and a more uniform utilization of exhibitors’ presentations and their infrastructure.

From November next year MEDICA and COMPAMED will always be held in Düsseldorf from Monday to

Dates of next MEDICA & COMPAMED in Düsseldorf: 16 – 19 November 2015

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Ultrasonic Systems Launches New Medical Device Coating Systems The Third Generation Prism coating system platform has new options for medical device coating

Drugs that protect organs during transplantation

ltrasonic Systems, Inc. (USI), a leading manufacturer of highperformance ultrasonic spray coating equipment for medical, fuel cell, semiconductor and solar applications announces the release of the third generation of its Prism product line configured with new options for the application of coatings to cylindrical medical devices such as catheters and stents. A rotational axis and holding mechanism is fully integrated into the machine control system and operating software. Additionally a new version of the PMP (precision metering pump) liquid delivery system has been developed to operate at the ultra-low flow rates required for precision medical device coating. USI’s unique and proprietary nozzle-less ultrasonic spray technology is ideal for the thin and uniform application of coatings to medical devices including surgical mesh, stents and other implantable devices as well as the application of coatings to catheters of various types including balloon catheters. The coatings applied include drug eluting coatings, reagents, protective coatings, diagnostic agents and many others. “We are pleased to expand the capabilities of our Prism product line to meet the increasingly demanding requirements of our customers in the medical device industry” said Stuart Erickson, President of Ultrasonic Systems, “We believe that these new features in combination of our nozzle-free ultrasonic spray technology will deliver unparalleled coating performance.” For catheter coating, the Prism is configured with a fully integrated rotational axis and catheter holding mechanism as well as an ultra-low flow PMP liquid delivery system. USI coating systems are industry proven with more than 2,500 systems installed worldwide across multiple market segments. About Ultrasonic Systems

Ultrasonic Systems, Inc. (USI) manufactures high-performance spray coating equipment based on proprietary nozzle-less ultrasonic spray coating technology. USI’s products deliver a superior alternative to conventional air-atomizing or ultrasonic spray nozzle technology for the electronics assembly, semiconductor, fuel cell, medical, and solar markets for customers worldwide. Our team of technical experts is committed to providing the best technical and application support available. For more information, visit: www.ultraspray.com. 18 | November-December 2014 | Medical Device ASIA

rgans can become significantly damaged during transplantation, but a new article published in the British Journal of Surgery offers a protective strategy that could keep them safe and allow them to function optimally after the procedure. When an organ is transplanted from a donor to a recipient, there is a period of time when the organ is deprived of normal blood flow. While this in itself can cause tissue damage, additional damage may also occur when blood flow is restored to the organ due to a high risk of blood clotting. Investigators led by Thierry Hauet, MD, PhD, of the Institut National de la Santé et de la Recherche Médicale (INSERM), the University of Poitiers, and the Centre Hospitalier Universitaire (CHU) de Poitiers, in France, wondered whether anticoagulants or “blood thinners” might help protect transplant organs against these effects. The team tested the potential of fondaparinux in an experimental model of kidney transplantation. Use of the anticoagulant was linked with improved kidney function both immediately after transplantation and several months later. “People die every day from the lack of available organs. This study demonstrates the benefits of anticoagulation therapy using new and original drugs at the time of organ collection,” said Dr. Hauet. “Such therapy could augment the pool of available organs and allow for the safe use of marginal organs, which have characteristics associated with poorer outcomes or come from donors with medical complexities.” Such an anticoagulation strategy could be an important addition to current transplant protocols to limit tissue damage and improve outcomes in patients receiving kidney, liver, pancreas, lung, heart, and other organ transplants.

Specially-Crafted Feature Areas a Focus at MTA2015 MTA2015, Asia’s premier precision engineering industry event, will return from 14 to 17 April next year at the Singapore Expo. With its hallmark showcase of high-value manufacturing capabilities, MTA2015 will highlight manufacturing excellence in industries such as Aerospace, Complex Equipment, Electronics, Energy, Medical Technology and Oil & Gas / Marine & Offshore Engineering. Feature areas to bring technologies to life Aside from the Capabilities Hub which drew strong interest from trade visitors, this upcoming edition will unveil a brand new feature, the Optical Engineering Focus Area. Optical Engineering Focus Area Working with the Optics and Photonics Society of Singapore (OPSS), an area dedicated to products and services in the field of laser and optical engineering will be developed for the event. The focus area will bring together optical engineering technology suppliers from China, Germany and Malaysia.

has evolved with technological advances and manufacturers and suppliers are now looking at how to create and add value to their manufacturing processes,” says Mr. William Lim, Project Director at Singapore Exhibition Services, organiser of MTA2015. “MTA has been moving in tandem with industry trends and the addition of new feature areas will not only provide a premier sourcing platform of the latest stateof-the-art precision engineering technologies and solutions, it will also create a comprehensive and holistic experience for attendees,” he adds.

“The Optics and Photonics Society of Singapore (OPSS) is happy to participate in MTA2015 in the Optical Engineering Focus Area. MTA2015 is a great platform for industry players and companies to come together to share ideas, network and continue our support for each other in the region’s high-value manufacturing industry. Co-located with the icOPEN2015 conference, the industry can also update themselves on latest technologies and trends in optical engineering,” says Professor Anand Asundi, Chairman of OPSS.

Capabilities Hub The Capabilities Hub will once again bring together local parts and component manufacturers and service providers to highlight their manufacturing competencies in the high-value sectors of Oil & Gas, Medical Technology, Aerospace and Complex Equipment. A collaborative effort with the Singapore Institute of Manufacturing Technology (SIMTech), this area will connect local and overseas manufacturers and enhance their ties through networking and collaboration.

“Manufacturing in the Asian region is no longer simply supplying the labour to make many of the products we use today. It

To-date, exhibition stalwarts such as A&ONE Precision Engineering, ACP Metal Finishing, CEI Contract Manufacturing, Eratech, Fujicon

MTA2015 at A Glance: Show:

MTA2015 - The 20th Precision Engineering Industry Event (held alongside MetrologyAsia2015) Incorporating: iAutomation2015, MetalAsia2015, Outsource&SubCon2015, ToolTec2015 Date: 14 – 17 April 2015 (Tuesday - Friday) Venue: Singapore Expo, Halls 3 & 4A Opening Hours: 10.30am to 6pm daily Admission: Business and trade professionals Website: www.mta-asia.com Engineering, Meiban Group, Microcast, Nanotechnology Manufacturing, Onn Wah Precision Machining, PCI, Shine Precision Engineering, SolidMicron Technologies and ST Kinetics Integrated Engineering, have confirmed their participation in this space. MTA2015: High calibre

manufacturing showcase As manufacturing processes become more sophisticated and requirements for advanced research and development grow, MTA2015 is well-placed to provide the links between major industry players and suppliers across the value chain. MetrologyAsia2015: Serving industry’s demands for precise measurements MetrologyAsia2015, an area dedicated to metrology equipment, will cast a spotlight on companies specialising in high-end test and measurement apparatuses and systems. Attendees will be exposed to the latest in metrology

technology and equipment to meet their precision measuring needs. The last edition of MTA saw participation from metrology bigwigs such as Blum Production Metrology, Carl Zeiss, Hexagon Metrology Asia Pacific, Jenoptik South East Asia, Mitutoyo Asia Pacific, Optical Gaging, Renishaw (Singapore) and Wenzel Asia. Knowledge sharing and discussions at MTA2015 icOPEN, now known as the International Conference on Optical and Photonic Engineering, and the PE COI Annual Conference will also return. These two conferences will feature technical and industry experts giving their insights on the latest trends and issues facing the precision engineering industry. MTA2015 will incorporate iAutomation2015, MetalAsia2015, Outsource&SubCon2015 and ToolTec2015, specialised events that cater to the individual needs of Asia’s manufacturing industry.

About Singapore Exhibition Services Pte Ltd Singapore Exhibitions Services organises a portfolio of international tradeshows serving the Communications, Engineering, Machinery and Lifestyle industries. Our events consistently attract a high level of overseas participation with foreign exhibitors accounting for almost 80% of the show floor. We are a member of Allworld Exhibitions Alliance, a global network with over 50 offices worldwide. For more information, please visit www. sesallworld.com.

Medical Device ASIA | November-December 2014 | 19

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

he fifth edition of the HKTDC Hong Kong International Medical Devices and Supplies Fair, attracted more than 9,600 buyers. That’s up 17 per cent over the previous fair. This year’s fair showcased the offerings of 240 exhibitors from 14 countries and regions, up nine per

cent over last year, and a new exhibitor record for the show. Driving Demand “The advancement in medical technology and techniques, as well as the world’s aging population, is driving demand for medical devices and supplies,” said HKTDC Deputy Executive Director Benjamin Chau, who noted that the Rehabilitation and Elderly Care Products zone was among the fair highlights. The HKTDC, he added, organised 36 buying missions from 24 countries and regions, welcoming over 1,200 buying mission members to Hong Kong. Strong Buyer Traffic Hong Kong exhibitor Joe Tam,

20 | November-December 2014 | Medical Device Asia

Providence Enterprise’s Senior Operation Manager, R&D (Electronics) Department, said visitor traffic was good and so was the buyer response. “Buyers are interested in household medical and healthcare products, and they have asked for in-depth details about product features, prices and cooperation opportunities. Some Middle Eastern and Australian buyers have even shown interest in visiting our factories on the Chinese mainland.” Mr Tam expected overall sales this year to rise from 10 per cent to 20 per cent. Tay Eng Hean, Head, China/Hong Kong, at Singapore’s White Rock Medical Company, a first-time exhibitor, was also pleased with the

fair. White Rock, which specialises in high-tech medical supplies, featured its patented Alter G Anti-Gravity Treadmill at the fair. “The response has been very positive, and we are in talks with buyers from the Chinese mainland and Europe,” said Mr Tay. Tomas Petrusek, Senior Purchasing Manager of the Czech Republic’s Promedica Praha Group, was a firsttime fair participant. “I am particularly interested in breathing circuits and laparoscopes supplied by two potential suppliers. I’ll ask for their quotations and samples, and then test these medical devices at hospitals before confirming my orders.”

discussing topics ranging from medical device technology to market development and trends. Exhibitor Forums were also held, allowing companies to demonstrate their products and answer buyer enquiries. The Hospital Authority Convention, held alongside the medical fair, attracted 4,500 medical professionals from around the world. Convention participants brought additional business and networking opportunities for exhibitors. The Hong Kong International Medical Devices and Supplies Fair was organised by the Hong Kong Trade Development Council and the Hong Kong Medical and Healthcare Device Industries Association.

Business-Matching Success Spain’s Emergencia 2000 SA is an importer of emergency chairs, health monitors and other products. Company CEO Julian Rodriguez Fernandez said he had found four potential suppliers with the help of the HKTDC’s business-matching team and was satisfied with the results. Medical Technology The fair featured a number of seminars, with industry experts

Medical Device Asia | November-December 2014 | 21

6th

GENERAL INFORMATION FOR EXHIBITORS/ VISITORS/PRESS Fair Dates 18 May 2015 (Mon) 19 May 2015 (Tue) 20 May 2015 (Wed)

Opening Hours 10am–6pm 9:30am–6pm 9:30am–5pm

EDITION

Buyer Registration Hours 9:30am–5:30pm 9am–5:30pm 9am–3:30pm

Venue : Halls 3F&G, Hong Kong Convention and Exhibition Centre, 1 Expo Drive, Wanchai, Hong Kong Admission : Free admission for trade visitors aged 18 or above only Organiser : Hong Kong Trade Development Council Co-organiser : Hong Kong Medical and Healthcare Device Industries Association

Major Exhibit Categories : • Accident and Emergency Equipment • Building Technology and Hospital Furniture • Chinese Medical Devices • Communication, Systems and Information Technology • Dental Equipment and Supplies • Diagnostics • Electromedical Equipment / Medical Technology • Laboratory Equipment • Medical Components and Materials • Medical Cosmetology • Medical Supplies and Disposables • Physiotherapy / Orthopaedic / Rehabilitation Technology • Medical Textiles • Trade Services and Publications

Visitor Profile : • Child Care Centres & Nurseries • Department stores / Chain stores / Supermarkets / Hypermarkets • Drugstore chains / Pharmacies • Hospitals: Medical & Dental • Importers, Agents, Distributors, Wholesalers & Retailers • Leading Pharmaceutical Companies • Medical Centres, Medical Chains, Clinics, Dental Clinics, School Dental Care • Centre & Chinese Medical Care Centres • Medical Laboratories • Medical Research Institutes, Medical Schools, Dental Schools • Nursing Homes & Elderly Homes • Physiotherapy Clinics • Public Authority: Health Authority & Hospital Authority • Rehabilitation Centres

For more information, please contact: Hong Kong Trade Development Council - Exhibitions Department Unit 13, Expo Galleria, Hong Kong Convention and Exhibition Centre, Wan Chai, Hong Kong Tel: (852) 2584 4333 Fax: (852) 2824 0026 E-mail: exhibitions@hktdc.org

22 | November-December 2014 | Medical Device Asia

Surgeons use 3D printed model of heart to treat patients with disorders

n experimental 3-

various materials, such as plaster or

now to build models of hearts."

emerging technology that is not

dimensional printed model

ceramic, to reveal even the most

Researchers used an inexpensive

approved by the Food and Drug

of the heart may help

complicated structural abnormalities.

plaster composite material to create

Administration. The University's

surgeons treat patients born with

heart models of a 9-month-old girl,

collaborator, the Jump Trading

complicated heart disorders,

"With 3D printing, surgeons can

3-year-old boy and a woman in her

Simulation and Education Center in

according to research presented at

make better decisions before they

20s all of whom had complex

Peoria, made the printer available for

the American Heart Association's

go into the operating room," said

congenital heart defects. After

the study.

Scientific Sessions 2014.

Matthew Bramlet, M.D., study lead

studying the models and traditional

author and assistant professor of

images, surgeons successfully

Most heart surgeons use 2D images

pediatric cardiology and director of

repaired severe heart abnormalities

taken by X-ray, ultrasound and MRI

the Congenital Heart Disease MRI

in all three patients.

for surgical planning. However,

Program at the University of Illinois

these images may not reveal

College of Medicine in Peoria. "The

"You could see that if you make this

complex structural complications in

more prepared they are, the better

compromise here, you could fix this

the heart's chambers that occur

decisions they make, and the fewer

problem, and go from a single-

when heart disease is present at

surprises that they encounter.

ventricle to a two-ventricle repair,"

birth (congenital heart defects), as

Bramlet said. "That is the difference,

opposed to developing later in life

"When you're holding the heart

potentially, between a life expect-

within a structurally normal heart.

model in your hands, it provides a

ancy of two to three decades, to

new dimension of understanding

four, five or six decades."

But with standard 2D images as a

that cannot be attained by 2D or

guide, doctors now can build a

even 3D images. What once was

Researchers caution that this was a

detailed 3D model of the heart from

used to build trucks, we're using

small study and 3D printing is still an Medical Device Asia | November-December 2014 | 23

MEDIX OSAKA

Concurrently held with:

MEDICAL JAPAN 2015

5th Medical Device Development Expo, Feb 4 -6, 2015, INTEX OSAKA, Japan Organised by : Reed Exhibitions Japan Ltd. | Supported by: Union of Kansai Governments

Japan’s MOST POWERFUL medical device exhibition 125% Larger scale with 660 exhibitors and 25,000* visitors! Medical Device Development Expo (MEDIX OSAKA) becomes 125% larger in scale to welcome its 5th edition from February 4 (Wed) to 6 (Fri) in 2015. This year’s MEDIX OSAKA is held inside of MEDICAL JAPAN 2015 which has brand new concept to cover the entire medical/healthcare industry with 7 concurrent exhibitions.* Japan is now the 2nd largest market of medical industry. The most outstanding expansion is in the field of medical device: in Japan over the past decades, total production values reached JPY 2,6 trillion (USD 25 billion).

PIOLAX MEDICAL DEVICES INC., President, Kazutaka Nanaumi

MEDIX OSAKA 2015, the B to B specialised exhibition, gathers latest technologies required to design and manufacture medical devices such as disposable components, OEM, electronic components, imaging, measuring, sensor and optical components, etc. MEDIX OSAKA 2015 attracts a great number of visitors such as medical device manufacturers of syringes, thermometers, artificial organs, catheters, MRI systems, patient monitors, etc. Active business meetings between exhibitor and visitor, such as comparative discussion for new product, technical advice and cost estimation request for purchasng, are conducted everywhere inside venue.

More Sessions available free of charge Preregistration now >>> www.medix-kansai.jp/en/seminar/

MEDIX OSAKA 2015 warmly welcomes visitors who plan to enter medical device industry as well as the leading medical device manufacturers such as TERUMO, OLYMPUS MEDICAL SYSTEMS, TORAY MEDICAL, FUKUDA DENSHI, ASAHI KASEI, etc.

“Elastic” as of pioneer, by applying the cultivated design and processing technology in the development and manufacturing of automotive parts, was advanced to the medical equipment field. Introduction of the example efforts on correspondence and medical engineering collaboration in range from research to development, and the tips of how to continue its growth during 15 years since its market entry. Session No.: MEDIX-1/Date: Feb. 4 [Wed] 10:30-11:30

Match Making System (FREE) accelerates effective business meeting For visitors who search for the idea to develop new product, tips of costsaving, idea of high-value added design, OEM/ODM partner and technical advice, show management will provide them with Buyers Sourcing Catalogue. Visitors only need a quick registration to inform show management about which exhibitor(s) they request for having business meeting(s) with that is picked up from Buyers Sourcing Catalogue. Fixed appointment schedule and exhibitor(s) booth number are announced to the visitors before the show period. Over 2 appointments arranged, get free coupon for lunch to save JPY 1,000!

Highlights of MEDIX OSAKA 2015

Details of Match Making System free of charge Preregistration now >>> www.medix-kansai.jp/sup/

5 Special Zones concentrated exhibits for medical device development

Comprehensive Show MEDICAL JAPAN 2015

- Prototype Manufacturing , Processing Technology Zone - Testing / Measuring / Sensor Zone NEW! - Electronic Components Zone (e.g. Semiconductor, PCBs, EMC, etc.) - OEM Zone (e.g. Medical Device OEM/ODM, etc.) - 3D Printers, CAD, CAM Zone NEW! Leading Medical Device Manufacturers present special session 170 sessions* spoken by industry leaders concentrate working acknowledge and methods such as how to succeed in development of medical equipment in Japan, latest industry trends and forecast. All the hot topics of healthcare & pharmaceutical field can’t be missed.As excerpts, following 2 sessions are informative for strategic business plan: - Approach and growth strategy to medical industry in GE Healthcare

GE Healthcare Japan Co., Ltd. , Chief Technology Officer, Kazuya Hoshino Methods of growth strategy of GE Healthcare with an eye to business overview and future medical needs of GE and GE Healthcare. Introduction of GE Healthcare technology and its future trends that have been used in medical devices as an example of the products manufactured and developed by GE Healthcare. Collaboration possibilities with Japanese companies through open innovation initiatives that GE group of Japan to expand. Session No.: MEDIX-S3/Date: Feb. 6 [Fri] 10:30-11:30 - Way of entry and commercialization of medical device industry for outside players

Maximized synergy effect among 7 healthcare-related shows Infinitive opportunity to develop potential customers MEDICAL JAPAN, consisting of 7 specialised shows* including MEDIX OSKA 2015, is the Japan’s first trade show which covers all the products/services/ technologies for healthcare, clinical testing, diagnostics and medicine. Visitors are expected to be decision makers from medical institutions, clinical trial laboratories, dealers, universities, medical device makers, pharmaceutical/Cosmetic manufacturers, regenerative medicine/cell therapy related companies and health-care facilities. MEDICAL JAPAN 2015 consists of: - 5th MEDICAL DEVICE DEVELOPMENT EXPO OSAKA [MEDIX OSAKA] - 1st [Hospital + Innovation] Expo Japan - 1st Int’l Nursing & Nursing Care Expo - 1st Clinical Laboratory & Diagnostics Expo Japan - 1st Regenerative Medicine Expo & Conference Japan - 1st Int’l Pharmaceutical R&D and Manufacturing Expo/Conference OSAKA - 1st Int’l Pharmaceutical Ingredients Expo/Conference OSAKA

Free invitation for MEDIX OSAKA and MEDICAL JAPAN available Preregistration now >>> www.medical-jpn.jp/en/inv/ Medical Device Development Expo Osaka (MEDIX OSAKA) Show Management Reed Exhibitions Japan Ltd. 18F Shinjuku-Nomura Bldg.,1-26-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-0570, Japan | Website: www.medix-kansai.jp/en/ TEL: +81-3-3349-8519 | FAX: +81-3-3349-8530 | E-mail: medix-k@reedexpo.co.jp (*Total expected figures of all concurrent shows.)

24 | November-December 2014 | Medical Device ASIA

EXABONE® PASTE Orthopaedic Surgery

- Advanced technology leads to unique specifications

MEDICAL FAIR THAILAND SET FOR FURTHER EXPANSION

EXABONE® PASTE is an advanced pure synthetic nano biomaterial replicating the natural mineral phase of healthy human bone. Optimised sticky viscosity allows a complete and easy filling of the defects, assuring a superior contact at the implant interface. The osteostimulative effects of the hydroxyapatite nano particles encourages osteogenesis. The nano surface area is 50 to 100 times greater than traditional synthetic bone graft. The ultra-high molecular surface area attracts and adsorbs the natural bone growth promoters available at the implant site. Requires no mixing and pre-loaded in convenient applicators ready for direct placement into the defect. EXABONE® PASTE is gamma sterilized and is designed for use in a broad range of non-load bearing osseous defects in Orthopaedic surgery such as : spinal surgery (cage filling), osteotomies, bone cavity and defect filling, metaphysical fractures, acetabulum reconstruction etc... EXABONE® PASTE can be mixed with autologous or synthetic bone or bone marrow aspirate. The healing process starts by rapid colonization of the implant from the viable bone at the implant interface filling and replacing the nanostructure. The bone matures to woven bone and consolidates alongside cell mediated implant resorption. EXABONE® PASTE is manufactured by Exabone GmbH, an ISO 13485 certified company headquartered in Switzerland and is CE marked class III by BSI Group, U.K..

MEDICAL FAIR THAILAND, the leading medical and health care event for Thailand and the region will return from 10 – 12 September 2015 in Bangkok, Thailand, and will once again take place at the Queen Sirikit National Convention Centre (QSNCC). With its 7th edition, MEDICAL FAIR THAILAND is set to return bigger and more influential, featuring a 40% increase in exhibition floor space as it expands further with the addition of another exhibition hall. Continuing on its strong growth path, MEDICAL FAIR THAILAND 2015 will play host to over 15 national pavilions, more than 500 international exhibitors coming from over 30 countries, and is expected to draw attendance in excess of 8,000 visitors from 60 countries. In the spotlight at MEDICAL FAIR THAILAND 2015 will be two new, dedicated platforms in the areas of Digital Healthcare and Rehabilitation Care, designed to further engage the dynamic health care industry. Complementing the new showcases will be a suite of co-located conferences, technical seminars and themed workshops presented by key thought leaders and industry experts in their respective fields, involving delegates, visitors and exhibitors in meaningful discussion on the future of health care. Offering global players the ideal business platform to showcase the latest in medical and health care products, solutions and services, the exhibition also serves as a critical meeting point for the industry to keep abreast of new technological improvements for the hospital, diagnostic, pharmaceutical, medical and rehabilitative sectors. For a complete experience of the medical and health care landscape in Thailand, MEDICAL FAIR THAILAND 2015 will facilitate a series of hospital facility tours, taking attendees behind-the-scenes and giving them exclusive insight into one of the world’s top medical tourism destination. Recognising the intrinsic value of networking to exhibitors and visitors alike, MEDICAL FAIR THAILAND 2015 will incorporate a synergistic Business Matching Service that will drive business networking through prescheduled appointments, helping exhibitors and visitors make the right connections as they grow their network and footprint in the region. Space application is now open for MEDICAL FAIR THAILAND 2015. For

more information on the exhibition, please visit www.medicalfair -thailand.com

Medical Device ASIA | November-December 2014 | 25

Boston Scientific ordered to hand over $18.5M in vaginal mesh litigation

he Obtryx sling implant-Courtesy of Boston Scientific Less than a week after Boston Scientific ($BSX) lost its second courtroom battle over vaginal mesh implants, a federal jury ordered the company to pay $18.5 million in damages to four women who claimed the devices caused them constant pain and injuries. Federal court jurors in Charleston, WV, found that Boston Scientific officials failed to adequately warn the women and their doctors about risks related to its Obtryx implants for urinary incontinence. The jury awarded the plaintiffs $18.5 million in damages, including $4 million in punitive damages, Bloomberg reports. The finding comes on the heels of another unfavorable verdict for Boston Scientific, as last week jurors in a Miami federal court found that the Marlborough, MA-based

company's Pinnacle implants for pelvic organ prolapse and stress urinary incontinence were defectively designed and that company officials did not alert doctors and patients about the devices' risks. The panel awarded four women a total of $26.7 million in damages, including three awards of more than $6.7 million, but did not tack on compensatory damages. Boston Scientific said it disagreed with the Miami federal court jury's findings and that it has "strong grounds to overturn the verdict on post-trial motions and on appeal," company spokeswoman Kelly Leadem told Bloomberg in an emailed statement. Meanwhile, Boston Scientific continues to wade through more than 23,000 claims related to its vaginal mesh implants in U.S. state and federal courts, including cases consolidated before U.S. District

26 | November-December 2014 | Medical Device Asia

Judge Joseph Goodwin in West Virginia and 1,700 cases assigned to one judge in Massachusetts state court. The company scored a victory in July when it won the first case to go to trial in Massachusetts state court over a vaginal mesh implant. But in September, the devicemaker lost a battle when a Texas state jury ordered the device giant to pony up $73 million to a woman who claimed chronic pain and injury from Boston Scientific's Obtryx sling implant. A trial judge later reduced the award to $34.6 million. But Boston Scientific is not the only company facing mesh-related woes. Device heavyweights like Johnson & Johnson ($JNJ), C.R. Bard ($BCR) and Endo ($ENDP) are also dealing with claims over vaginal mesh products, waging courtroom battles or opting to settle suits instead. In September, a federal jury in West

Virginia ordered J&J's Ethicon division to hand over $3.27 million to a woman who claimed that the company's transvaginal mesh device caused undue pain and serious side effects. Eager to lay claims to rest, Coloplast in March forked over $16 million to settle lawsuits over vaginal-mesh inserts. Endo followed suit, and said in October that it would add $400 million to its $1.2 billion reserve to resolve claims over vaginal mesh products by its American Medical Systems subsidiary.

Hillary Clinton hedges on the device tax, says nation must weigh pros and cons

n a speech emphasizing the importance of compromise, likely presidential candidate Hillary Clinton said that there may be room for that dirty word in Washington when it comes to repealing the 2.3% medical device tax. That is a key demand of Republicans, not to mention of the device industry. "I'm well aware of your concerns about the 2.3% device tax, and I think you have an argument to make," she told AdvaMed CEO Stephen Ubl during her address at the association's annual med tech conference. "I think it [a decision] has to be made within the context of a larger set of issues that have been raised by the ongoing implementation of the Affordable Care Act." Clinton didn't take a clear position on the issue saying, "we have to look and see what are the pluses and minuses," and "I don't know what the right answer about the tax is." AdvaMed has been a leading proponent of repealing the device

tax, and Ubl stressed its impact on the industry during earlier remarks to the media, saying the excise tax had played out exactly as he had feared. He cited the difficulty that the Internal Revenue Service has had in administering the tax, which raised $913 million in the first half of 2013, or about 75% of what was expected. The House of Representatives has voted to repeal the tax several times, but the initiative has died in the Senate, where it has never come up for a binding vote. However, in March 2013 the Senate voted a bipartisan 79-20 to repeal the tax in a non-binding resolution. This oddity is explained by the peculiar and toxic politics of the Affordable Care Act, which the device tax helps fund.

the market for the first time, purchasing insurance, using services, and yes, of course, medical devices." In addition, she said the the law's incentivization of the quality of care as opposed to its quantity will benefit the med tech sector--although many conference panelists said the trend is toward lower-cost devices at the expense of quality ones when it comes to medical device reimbursement. She also praised the device industry for its contributions to healthcare, saying, "I'm grateful for the many contributions your technology has made to the family and friends I care

deeply about," including former President Bill Clinton, who had a quadruple bypass surgery in 2004. In another industry-friendly punchline, she said, "I'm well aware from my time in the Senate that your industry sometimes faces onerous approval processes for new products." Adding that the underfunding of regulatory agencies is "particularly maddening when it's in America's interest--not just our health, but our economy--to move your innovations through processes as quickly as possible."

Clinton put up a full-throttled defense of the ACA during her speech, saying the industry will "reap the benefits of those millions of newly insured consumers entering

Medical Device Asia | November-December 2014 | 27

Medtronic launches wearable cardiac monitor acquired from Corventis

edtronic ($MDT) launched the wireless, adhesive heart monitor that it acquired when it bought startup Corventis in June reportedly for more than $150 million. The monitor can be worn up to 30 days to detect and diagnose the cause of irregular heartbeats. But the device remains a second-line tool behind the bulky Holter monitor.

The Seeq System "allows us to get the critical arrhythmia recordings we need to make treatment decisions without being burdensome to patients," Ethan Levine an electrophysiologist and director of electrophysiology and arrhythmia services at Arnot Ogden Medical Center in Elmira, NY said in a statement. "Wearing a bulky monitor for more than a couple of days can be a frustrating experience for patients. Because this device is an inconspicuous and easy-to-use adhesive patch, patients are more likely to wear it continuously, allowing for more consistent and comprehensive capturing of data, which enables physicians to make accurate diagnoses and timely treatment plans," he added.

Known as the Seeq Mobile Cardiac Telemetry System, its wearable sensor has a depth of about 0.6 inches. It's water resistant and designed to be worn continuously while exercising, showering or sleeping. In addition to the sensor, it includes a handheld transmitter that sends data to the Medtronic Monitoring Center via Bluetooth technology, which is staffed around the clock by cardiographic technicians to analyze the data. The system also includes a trigger button the patient can push to send data during a particular event. Medtronic said the system is indicated for patients who have experienced symptoms that suggest an irregular heartbeat such as fainting, lightheadedness, vertigo, palpitations or shortness of breath and whose symptoms were not detected by a 24-hour Holter monitor. A standard Holter monitor is much more burdensome for the patient, as it is equipped with a variety of electrodes and monitors. Earlier this year, Medtronic also launched its Linq Insertable Cardiac Monitoring System, which can continuously monitor patients for up to three years. This implantable monitor is designed for patients with less frequent episodes less likely to be detected by short-term monitoring.

28 | November-December 2014 | Medical Device Asia

J&J Innovation's Ken Drazan on the future of med tech

ohnson & Johnson ($JNJ) sits right at the nexus of consumer, medical device, biopharma and diagnostic products. That makes it privy to some of the more interesting developments as these segments increasingly commingle and rely more on information technology and connectivity. Ken Drazan, the head of Johnson & Johnson's Innovation Center in California, sat down with FierceMedicalDevices to muse on the company's interest in med tech. Its regionally focused Innovation Centers are aimed at sourcing early stage innovation and creating unique deals that bring together the resources of Johnson & Johnson, including venture investment from Johnson & Johnson Development Corporation (JJDC) and company incubation at J-Labs. The aim of the whole structure is to keep J&J plugged in to the latest developments--which could potentially provide deal fodder down the line.

products, light manufacturing and healthcare services companies. He started as the head of Johnson & Johnson's Innovation Center in California in March. Innovation in disease management can also be a crucial contribution for med tech, suggests Drazan. "The promise that medical devices can bring is to make the system more intelligent and require fewer costly touches," he said, citing glucose monitors as an example. "In the past, most devices were passive, not constructed to interpret data. But now we're seeing glucometers connected to phones and starting to create a level of intelligence that reduces the burden on the diabetic. I'd like to see that kind of model appear in other chronic diseases like hypertension, glaucoma and chronic musculoskeletal disease," Drazan added.

Med tech hasn't seen the kind of breakthroughs that biopharma has enjoyed in the postgenomics era, Drazan observed. But that's what he'd like to see from med tech startups.

He cited that med tech regions of interest follow J&J's business lines in orthopedics, general surgery and cardiology. In addition, it's also investing in potentially disruptive areas that are outside those core regions, such as neuromodulation, aesthetics and vascular.

"The hope is that they'll develop creative products that have the same impact on disease that some of the breakthroughs we're seeing with drug therapies are having," he said. "That's only possible on the med tech side with surgery. Hopefully, we'll have devices that enable less intrusive surgery and are more normalizing of the patient's life after those intrusive events."

Drazan noted some of JJDC's portfolio companies including NeuroPace, with its implantable antiseizure device, and stealth startup Cala Health, which has a minimally intrusive device for the management of tremor that emerged from the Stanford University Biodesign program.

Drazan was trained as a liver transplant surgeon and he cofounded growth equity firm Bertram Capital Management, which focuses on business services, consumer

JJDC is also an investor in implantable sleep apnea device company Inspire Medical as well as in hydrogel optical inlay company ReVision Optics. On the diagnostics side, its portfolio also includes

30 | November-December 2014 | Medical Device Asia

molecular diagnostics player Biocartis and acute condition diagnostics company Astute Medical. Full disclosure: NeuroPace, Inspire Medical and Astute Medical all made this year's Fierce 15 list from FierceMedicalDevices. But Nevro is likely the firm's highest profile med tech investment just now; it has filed for a $100 million IPO that is slated to go out next week and values the startup at about $400 million. The startup has a spinal cord stimulation system to treat chronic pain in the back and legs for which it has filed a PMA with the FDA and it is looking toward a potential launch in early 2016. Neuromodulation is obviously a major investment theme for JJDC right now. "We are gaining a better understanding of the peripheral and central nervous systems from an anatomical and physical point of view," Drazan said. "Microelectronics are continuing to provide a more intelligent value proposition for patients." Continuous monitoring, which is promised by an ever-increasing number of wearable and connected devices, is also a source of potential leaps forward. "Historically, a patient's biometrics are measured one at a time in a doctor's office. What the sensor market is enabling is continuous monitoring at a very low cost. Measurement and analytics can interpret whether a disease state is present. This brings in a brand-new dimension," said Drazan. "We are at the very beginning of this phase with the easiest measurements. Pulse, blood pressure and hydration status can all be detected at the surface of the skin," he

continued. "With the next wave, there will be deeper measurement in the body. This can be delivered at very low cost, with comfort for the patient and value for the consumer in the aesthetics. It also provides a decision support system that is valuable to the healthcare system." J&J has an interesting angle and familiarity with consumer products. Drazan noted that consumer products, along the lines of the FitBit, are pushing more into the traditional terrain of medical devices and that doctors are also moving more toward a consumer-oriented model. He expects that an appreciation for consumer perspectives with aspects such as a great form factor that's aesthetically pleasing will play more into med tech as consumeroriented medical devices continue to converge. Med tech innovation should be crucial to J&J, particularly since it is its worst performing segment in recent quarterly figures. Medical Device and Diagnostics revenues were down 5.2% in the third quarter from a year earlier to $6.6 billion, which accounted for more than one-third of the total of $18.5 billion. Pharmaceutical revenues grew by 18% to $8.3 billion, while Consumer revenues shrank a bit by 0.6% to $3.6 billion. J&J VP of Finance and CFO Dominic Caruso described J&J's medical device strategy, which he sees as consistent, on the third-quarter call. "We're going to focus on surgery and orthopedics with selective investments in selective growth areas within cardiovascular medicine," he summed up. The company recently divested its lagging OrthoClinical Diagnostics business for more than $4 billion to private equity firm The Carlyle Group. -- Stacy Lawrence

Top 10 heavy on pharma, with sprinkle of devices

he Cleveland Clinic unveiled the wildly popular Top Ten list of medical innovations on the last day of its Medical Innovations Summit on Wednesday, the closing day of the four-day-long conference. The list of breakthrough devices and therapies, in its 9th year at the event, was selected by a panel of Cleveland Clinic physicians and scientists. There were a large number of innovations from pharma with a sprinkling of medical devices here and there. Innovations on the list ranged from vaccines to mosquito derived viruses, to leadless pacemakers. Here is the list, counting down from 10. 10. New Drug for Heart Failure Angiotensin-receptor neprilysin inhibitor, or ARNI, has been granted "fast-track status" by the FDA because of its impressive survival advantage over the ACE inhibitor enalapril, the current "gold standard" for treating patients with heart failure. The unique drug compound represents a paradigm shift in heart failure therapy. The drug, currently called LCZ696, is being developed by Novartis (Basel, Swtizerland) and is expected to be available next year. "It's important to realize that the trial to show efficacy did not run in its completion because the data safety and monitoring board stopped the trial 27 months into the longterm study because there was a mortality advantage," Steven Nissen, department chair, Cardiovascular Medicine, Cleveland Clinic, told the audience. "There were about 20% fewer deaths. This one is going to be on the fast-track from the FDA you will see it in 2015. Unless we're missing something, I'm 99 percent sure this will get approval." 9. Single-Dose Intra-Operative Radiation Therapy for Breast Cancer

Finding and treating breast cancer in its earliest stages can often lead to a cure. For most women with earlystage breast cancer, a lumpectomy is performed, followed by weeks of radiation therapy to reduce the likelihood of recurrence. Intraoperative radiation therapy, or IORT, focuses the radiation on the tumor during surgery as a single-dose, and has proven effective as whole breast radiation. 8. New Drugs for Idiopathic Pulmonary Fibrosis Nearly 80,000 American adults with idiopathic pulmonary fibrosis may breathe easier in 2015 with the recent FDA-approval of two new experimental drugs. Pirfenidone and nintedanib slow the disease progress of the lethal lung disease, which causes scarring of the air sacs. Prior to these developments, there was no known treatment for IPF, in which life expectancy after diagnosis is just three to five years. 7. Leadless Cardiac Pacemaker Since 1958, the technology involved in cardiac pacemakers hasn't changed much. A silver-dollar-sized pulse generator and a thin wire, or lead, inserted through the vein kept the heart beating at a steady pace. Leads, though, can break and crack, and become infection sites in 2% of cases. Vitamin-sized wireless cardiac pacemakers can be implanted directly in the heart without surgery and eliminate malfunction complications and restriction on daily physical activities. St. Jude Medical (St. Paul, Minnesota) is developing the Nanostim pacemaker, which is not yet approved in the U.S., and is currently being tested in the LEADLESS II trial after initial positive results. "What makes this matter to the patients is that the majority of our complications for pacemaker

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surgery both in the short term and in the long term come from the surgical pocket in the lead," said Daniel Cantillon, of the Heart & Vascular Institute of Cleveland Clinic. 6. Checkpoint Inhibitors Cancer kills about 8 million people annually and is difficult to treat, let alone cure. Immune checkpoint inhibitors have allowed physicians to make significantly more progress against advanced cancer than they've achieved in decades. Combined with traditional chemotherapy and radiation treatment, the novel drugs boost the immune system and offer significant, longterm cancer remissions for patients with metastatic melanoma, and there is increasing evidence that they can work on other types of malignancies. 5. Antibody-Drug Conjugates Chemotherapy, the only form of treatment available for treating some cancers, destroys cancer cells and harms healthy cells at the same time. A promising new approach for advanced cancer selectively delivers cytotoxic agents to tumor cells while avoiding normal, healthy tissue. 4. PCSK9 Inhibitors for Cholesterol Reduction Effective statin medications have been used to reduce cholesterol in heart disease patients for over two decades, but some people are intolerant and cannot benefit from them. Several PCSK9 inhibitors, or injectable cholesterol lowering drugs, are in development for those who don't benefit from statins. The FDA is expected to approve the first PCSK9 in 2015 for its ability to significantly lower LDL cholesterol to levels never seen before. PSCK9-inhibitors, being developed by several pharma firms Sanofi (Paris) Amgen (Thousand Oaks, California) and Regeneron (Tarrytown, New

York). 3. Cost-effective, Fast, Painless Blood-Testing The new art of blood collection uses a drop of blood drawn from the fingertip in a virtually painless procedure. Test results are available within hours of the original draw and are estimated to cost as little as 10% of the traditional Medicare reimbursement. Theranos (Palo Alto, California) is developing the test. "The real benefit and potential of this technology is being able to do hundreds of different laboratory tests on a single small specimen of blood that can be obtained relatively painlessly," said Kandice KottkeMarchant Chair, Pathology and Laboratory Medicine Institute. "Because of the cost of this technology, it has the potential of allowing doctors to test earlier in the disease course." 2. Dengue Fever Vaccine One mosquito bite is all it takes. More than 50 to 100 million people in more than 100 countries contract the dengue virus each year. The world's first vaccine has been developed and tested, and is expected to be submitted to regulatory groups in 2015, with commercialization expected later that year. The vaccine is being developed by Sanofi. 1. Mobile Stroke Unit Time lost is brain lost. High-tech ambulances bring the emergency department straight to the patient with stroke symptoms. Using telemedicine, in-hospital stroke neurologists interpret symptoms via broadband video link, while an onboard paramedic, critical care nurse and CT technologist perform neurological evaluation and administer t-PA after stroke detection.

Top 5 Medical Technology Innovations

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

gainst the backdrop of health care reform and a controversial medical device tax, medical technology companies are focusing more than ever on products that deliver cheaper, faster, more efficient patient care. They are also making inroads with U.S. Food & Drug Administration regulators to re-engineer the complex review and approval process for new medical devices. Many in the industry have long felt overly burdened by what they consider to be an unnecessarily complex approval process. Critics claim it impedes innovation and delays the availability of better health care. To change that perception, the FDA last year announced a new Medical Device Innovation Consortium (MDIC) charged with simplifying the process of designing and testing new technologies. With input from industry, government, and other nonprofit organizations, publicprivate MDIC will prioritize the regulatory science needs of the medical device community and fund projects to streamline the process. "By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost," says Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. As the regulators, politicians, and corporate executives hash out these details, industry engineers and

2. Electronic Aspirin

scientists continue to push through new ideas for improving and managing human health. Every year, industry observers like the Cleveland Clinic and the medical device trade press single out their favorite technology trends. These thought leaders agree that today's best technologies strike a balance between reducing the overall cost of medical care and increasing safety and survival ratesâ&#x20AC;&#x201D;and isn't that what health care reform is all about?

Here are five emerging technologies to watch in the year ahead. 1. Cutting Back on Melanoma Biopsies With the most deadly form of skin cancer, melanoma, a huge number of dangerous-looking moles are actually harmless, but has always been impossible to know for sure without an invasive surgical biopsy. Today dermatologists have new help in making the right call â&#x20AC;&#x201D; a handheld

For people who suffer from migraines, cluster headaches, and other causes of chronic, excruciating head or facial pain, the "take two aspirins and call me in the morning" method is useless. Doctors have long associated the most severe, chronic forms of headache with the sphenopalatine ganglion (SPG), a facial nerve bundle, but haven't yet found a treatment that works on the SPG long-term. A technology under clinical investigation at Autonomic Technologies, Inc., (Redwood City, CA) is a patient-powered tool for blocking SPG signals at the first sign of a headache. The system involves the permanent implant of a small

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nerve stimulating device in the upper gum on the side of the head normally affected by headache. The lead tip of the implant connects with the SPG bundle, and when a patient senses the onset of a headache, he or she places a handheld remote controller on the cheek nearest the implant. The resulting signals stimulate the SPG nerves and block the pain-causing neurotransmitters. 3. Needle-Free Diabetes Care Diabetes self-care is a pain—literally. It brings the constant need to draw blood for glucose testing, the need for daily insulin shots and the heightened risk of infection from all that poking. Continuous glucose monitors and insulin pumps are today's best options for automating most of the complicated daily process of blood sugar management – but they don't completely remove the need for skin pricks and shots. But there's new skin in this game. Echo Therapeutics (Philadelphia, PA) is developing technologies that would replace the poke with a patch. The company is working on a transdermal biosensor that reads blood analytes through the skin without drawing blood. The technology involves a handheld electric-toothbrush-like device that removes just enough top-layer skin cells to put the patient's blood chemistry within signal range of a patch-borne biosensor. The sensor collects one reading per minute and sends the data wirelessly to a remote monitor, triggering audible alarms when levels go out of the patient's optimal range and tracking glucose levels over time. 4. Robotic Check-Ups A pillar of health reform is improving access to the best health care for more people. Technology is a cost-

effective and increasingly potent means to connect clinics in the vast and medically underserved rural regions of the United States with big city medical centers and their specialists. Telemedicine is well established as a tool for triage and assessment in emergencies, but new medical robots go one step further—they can now patrol hospital hallways on more routine rounds, checking on patients in different rooms and managing their individual charts and vital signs without direct human intervention. The RP-VITA Remote Presence Robot produced jointly by iRobot Corp. and InTouch Health is the first such autonomous navigation remotepresence robot to receive FDA clearance for hospital use. The device is a mobile cart with a twoway video screen and medical monitoring equipment, programmed to maneuver through the busy halls of a hospital. 5. A Valve Job with Heart The Sapien transcatheter aortic valve is a life-saving alternative to openheart surgery for patients who need new a new valve but can't endure the rigors of the operation. Manufactured by Edwards Life Sciences (Irvine, CA), the Sapien has been available in Europe for some time but is only now finding its first use in U.S. heart centers—where it is limited only to the frailest patients thus far. The Sapien valve is guided through the femoral artery by catheter from a small incision near the grown or rib cage. The valve material is made of bovine tissue attached to a stainless-steel stent, which is expanded by inflating a small balloon when correctly placed in the valve space. A simpler procedure that promises dramatically shorter hospitalizations is bound to have a positive effect on the cost of care.

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Better Ways to Rebuild Badly Injured Bones

ngineers at Georgia Institute of Technology, each focused on different disciplines, are together developing a new technology that will help the body repair traumatic bone injuries more effectively and at lower cost than current methods. The technology involves using a new system to deliver proteins, called growth factors, to the damaged bone. The most widely used growth factor, bone morphogenetic protein-2 (BMP-2), is typically delivered using a collagen sponge that releases large amounts of the drug initially and thus requires large amounts of the growth factor for subsequent delivery. This treatment is costly because a lot of growth factor is required, and there is also the risk of excess growth factor flowing into nearby areas and creating bone formations where it’s not wanted. The new delivery system binds BMP2 with microparticles of the drug heparin, a widely used anticoagulant, and researchers found that the BMP-2 stayed tightly bound to the heparin and was released slowly over time. “We can control things a lot of better,” says Dr. Todd McDevitt, a professor of biomedical engineering at Georgia Tech and Emory University with joint appointment in the George W. Woodruff School of Mechanical Engineering. “[The new delivery system] does two very important things. We can keep BMP2 in a bone defect site more stably. It doesn’t lose activity, and by doing that we can get away with using a lot less.” That also means there isn’t as much excess growth factor that can float away and build unwanted formations. McDevitt believes the collaboration

of his lab with two others has resulted in the work coming together better and more quickly than if the three had not been interacting. “If you want to try something big, you had better start looking beyond just yourself. You can’t do it all. It’s more fun and usually more productive. That’s certainly been the case here,” he says. Researchers bound the most clinically used growth factor, BMP-2, with microparticles of the drug heparin. Source: Georgia Tech One initial challenge was figuring out how much growth factor binding capacity the materials had. “As far as we could tell from the reported literature, people either tried to saturate it or they just didn’t get as much binding. We, meanwhile, got a really high amount of growth factor binding to the materials, more than 100 times we could find in other places. That means we could add more if we need to but it also means maybe we don’t add so much to get a biological response,” McDevitt says.

potent,” he explains. “It was a very pleasant surprise.” McDevitt’s lab is focused mainly on stem cell engineering, particularly how to control stem cells. “One of the big things we have been interested in is what do stem cells make in terms of regenerative types of therapy,” he says. A neighboring lab of Dr. Johnna S. Temenoff has been working with delivery systems for biomaterials, and the two colleagues began talking about what materials might be better to combine with growth factors, like BMP-2, for better delivery to cells. The third lab of Dr. Robert Guldberg focuses on bone repair strategies and has done a lot of work with the delivery of BMP-2

with other types of materials. Moving forward, the team plans to test its work in an in vivo setting that Guldberg’s lab has used. “We have to do a lot of dosing and safety well before clinical studies. If that yields the success we hope, then we will go to one large animal type of study before going to clinical trials,” McDevitt says. The BMP market for use in orthopedics is well over $1 billion, according to McDevitt. “If you can have even a slight improvement in a form that could be easily injectable or mixed or integrated with current delivery platforms, then major impact is very real,” he says

If all the binding space on the material is not used, there will be room to add in more of other important factors for regeneration of different cells, improving, for example, vascularization, he says. “The nice thing is that many times with biomaterials you have to come up with more sophisticated chemistry changes to your materials to enable something like that. Here we don’t have that problem because there is a class of materials that can combine a lot of different growth factors. So we are starting to look at what are some of the comolecules that we can deliver with BMP-2 to make it even more

Researchers bound the most clinically used growth factor, BMP-2, with microparticles of the drug heparin. Medical Device Asia | November-December 2014 | 35

30 Years of Bionic Ears

bout the time 1970s sci-fi spy Jaime Sommers put her cybernetic ear to work as a government eavesdropper on TVâ&#x20AC;&#x2122;s The Bionic Woman, a real-life experimental hearing device was beginning to turn the meaning of deafness on its ear. The cochlear implant, as close as it gets to a true bionic ear, hit the U.S. market following approval by the U.S. Food and Drug Administration in 1984-85. The continually evolving technology doesnâ&#x20AC;&#x2122;t restore better, stronger, faster hearing, but for people with profound deafness, cochlear implants open a world of sound. After 30 years, cochlear implants are still making significant noise in the

medical device world. Today more than 350,000 people who once lived in silence now use implants to understand conversational speech and hear environmental sounds. The Ears Have It Standard hearing aids work by amplifying sound for people with partial hearing loss. For people who are deaf or have profoundly impaired hearing, thatâ&#x20AC;&#x2122;s not enough; their hearing loss is often linked to damage or other abnormalities in the thousands of tiny sensor hair cells that line the snail-shaped inner ear chamber called the cochlea. These hair cells play a crucial role in hearing, converting acoustic waves

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from the outside world into electrical signals that stimulate the auditory nerve. The brain understands these signals as sound. When these sensory cells are severely damaged or absent, sound waves literally fall on deaf ears, even if the rest of the ear is anatomically healthy. Cochlear implants work something like a telephone wired directly to the brain to replace the function of the sensory hairs. A wire connects the implant with a microphone/speech processor behind the ear. Image: MED-EL In a typical implant, a microphone/ speech processor unit is worn semi-discretely behind the outer ear.

It is connected by wire to a signal transmitter attached to the side of the head by a strong magnet housed within a subdermal receiver/ stimulator device anchored to the skull. A length of wire connects the receiver/stimulator to the cochlea, where the electrodes deliver the converted electrical signals to key regions of the auditory nerve. The first device to gain approval was the landmark House 3M cochlear implant, a single-channel device developed by the House Ear Institute of Los Angeles and 3M Company. It helped users perceive nearby sounds and read lips with greater ease, but it was a far cry from real hearing. A multichannel

A wire connects the implant with a microphone/speech processor behind the ear.

alternative approved a year later beginning the current era of research and development. Today the U.S. cochlear implant market is dominated by three highly competitive companies: Advanced Bionics , Valencia, CA; Cochlear Corporation, Sydney, Australia; and MED-EL, Innsbruck, Austria. Each maker has its own formula, but the basic design of a modern system comprises some version of the same components. Echoes of the Past, Signals of the Future In 2013, three cochlear implant pioneers received the top U.S. honor in medical science, the Lasker-DeBakey Clinical Medical Research Award, for their respective contributions to the field. Graeme M. Clark, an emeritus professor at the University of Melbourne, Ingeborg Hochmair, co-founder of MED-EL in Innsbruck, and Blake S. Wilson of Duke University shared the award for their independent contributions to the device we know today.

Their work built on efforts since the 1950s to electronically stimulate the auditory nerve. One of the first significant advances was by California otologist William House, whose simple single-electrode implant helped two test subjects make out sounds from their surroundings. This 1961 prototype evolved into the House/3M implant approved in 1984. Independently in labs in Australia and Austria, Clark and Hochmair – along with her future husband, electrical engineer Erwin Hochmair – developed more sophisticated multichannel devices and experimentally implanted them in the late 1970s. Their common goal was a device that enabled deaf people to comprehend spoken language without reading lips or needing other visual cues. Most hearing experts wrote that off as impossible, but in 1991 Wilson’s continuous interleaved sampling approach to speech processing brought that dream to life, launching today’s commercial market. Carmen A. Puliafito, dean of the University of Southern California’s Keck School of Medicine, summed up the impact of their work in his remarks at the award ceremony. “Fifty years ago, there was no effective treatment for patients with severe hearing loss,” he said. “Today patients with these implants can speak clearly.” Sounds of the Future Technologies recently introduced commercially or advancing through the development pipeline are focused on issues such as speech perception and sound localization. New rugged and waterproof external housings allow wearers to bathe, swim, or play active sports without harming their bionic ears. Work toward a 50-channel hi-fi implant with more strategically placed electrodes is under way to enrich the sound quality of music and speech. FDA-led tests of hybrid implants that combine electronic stimulation and amplification are promising to make cochlear technology available to people with a wider range of hearing disorders. By using two different devices or sound processors to bring patients a broader spectrum of pitches, this technology could make cochlear implant technology an option for candidates with partial hearing loss. Other groups are working to make the already-discrete implant even less obtrusive, using a wirelessly rechargeable low-power signal processing chip and an internal microphone system to do away with the bulky external components. The world may be moving toward thought-controlled limbs, total artificial hearts, and 3-D printed skin, but the cochlear implant is still the only practical mechanical device that replaces one of the five human senses. And unlike real ears that can diminish in performance as we age, cochlear implants just keep getting better Medical Device Asia | November-December 2014 | 37

Surgical Robots ‘Push Back’ The artificial skin stretch will be useful in situations where force feedback is hard or impossible to achieve.

s promising and exciting as the technology is in providing more options for minimally invasive surgical procedures, robotic surgery brings with it challenges that surgeons have never faced before.

Technology because of the university’s renowned expertise in medicine and the potential for haptic interaction to help patients and clinicians do their job better.

The work of Dr. Allison Okamura, associate professor of mechanical engineering at Stanford University and director of Stanford’s CHARM Lab (Collaborative Haptics and Robotics in Medicine), is addressing one important area of concern: How to provide feedback through touch to surgeons controlling a tiny robot from a master console remotely from the patient although generally in the same room.

The surgeon manipulates what amounts to a fancy joystick that controls a tiny robot that can be less than a centimeter in diameter inside the patient’s body. Back then and even now, it’s difficult to provide touch feedback to the surgeon, Okamura says. The human surgeon operating manually can feel and see, but with a teleoperator, information must be passed back to the surgeon sitting at a master console.

Introduced to the field of haptics at a part-time job during graduate school, “I found it very compelling as a form of human-machine interaction that could be useful in a wide variety of applications,” she says. Upon receiving her PhD from Stanford in 2000, she joined Johns Hopkins University in its Engineering Research Center for Computer Integrated Surgical Systems and

“There are challenges on both the surgeon side and the patient side,” she says. “On the patient side, it’s being able to sense what’s happening when you are interacting with an environment like tissues or with pulling a suture. On the surgeon side, it’s how do you provide that feedback in an intuitive, natural, and stable way.” While robotic surgery has been successful

Providing Feedback

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for many procedures, clinicians would like a way to perform other procedures robotically that involves palpations, such as pressing on tissue to search for hard lumps. “That becomes extremely difficult when you are teleoperating a robot,” she says. Because of the work of Okamura and others in both the haptics and teleoperation research communities, great strides have been made. For instance, it’s now known that in providing force feedback to the surgeon, time is of the essence. “We know you can’t have much delay in your control system. That will result in humans receiving force [sensations] too late, their responses too late and then the patient side of the robot moves too late,” Okamura explains. That builds up errors that can make the system oscillate uncontrollably, even 50 milliseconds delay in certain types of systems may be too long. Increasing Feedback Another focus of her lab is figuring out the different kinds of ways to

provide haptics feedback. One, called force feedback, is to determine how much force should be applied to the human operator to communicate how much force is being applied to the environment inside the patient. Another is gripper force feedback, which lets the surgeon know how much force is being applied between the fingers when perhaps tissue is grabbed and pulled to move it aside. Yet another is a relatively new form of feedback, called skin stretch feedback, when some stimulus is provided locally to the skin rather than applying forces to the whole hand or arm. “We locally stretch the skin and that essentially tricks the user into thinking they are feeling forces even though they are only feeling local skin stretch,” says Okamura. “The advantage is that the user gets a lot of the useful haptics sensation but you can increase the amount of feedback without causing instabilities. You can handle larger time delays in the system than with traditional force feedback.” Okamura’s passion for her work comes through loud and clear. “The most fun thing about robotics is to work on robots that can help people and interact with people,” she says. “We can design a system that people can sit down and try,” and her lab does just that, inviting children to the lab to see the handson work involved in science and engineering. “It’s not just something that you sit back and look at it. Whenever we program something new, you get your hands on it and try it and feel it.” At the same time she is rewarded by knowing that she is working on something that can improve human quality of life.

Tracking Protein Function in Living Cells

roteins are molecules in the human body that keep our cellular functions running smoothly, which is essential for good health. When proteins are not functioning correctly, cellular reactions begin to break down and can lead to illness. Good health relies on accurate communication among cells— delivering the right messages at the right time to the right cells. The kinase family of proteins is a critical group because kinase proteins deliver signals that regulate and orchestrate the actions of other proteins. Proper kinase activity maintains health; irregular kinase activity, over time, is linked to cancer and other diseases. Because kinase proteins play such an important role in human health, drug-development companies want to create drugs that either boost or suppress kinase activity. The current standard approach for checking to see how a drug is affecting a kinase protein is to collect and pulverize a cell sample, extract the relevant kinase, and measure its levels. This is a time-consuming process that drives up costs. This problem may soon be eliminated by a new technology developed by Stanford University bioengineers that allows scientists to observe the behavior of these signaling proteins as they “go about their business” inside living cells. Researchers can observe, in real time, how these kinase proteins regulate health or cause disease, with no extraction, pulverizing, or analysis required. "We’ve been able to observe multiple kinases functioning in living cells, which is something no one else has ever seen," states Markus Covert, an associate professor of

bioengineering and leader of the research team. Signaling System Protein signaling is a complex chemical event. The protein consists of a long chain of atoms. Upon arriving at its destination, the kinase delivers its message, instructing the protein to perform a function at a particular location within the cell. If, however, the message is scrambled, cells will function abnormally—for example, with cancer, the communication breakdown errantly instructs cells to multiply.

effectors, while things are happening.” The Stanford researchers believe their new process will speed up the development of new drugs aimed at cancers and other conditions linked to kinase irregularities. They also hope it will expand research possibilities in the field of live, single-cell signaling dynamics. ‘Hopefully researchers will now be able to analyze multiple cell parameters simultaneously and therefore generate more precise pictures of how cells operate,” adds Regot. “For pharmaceutical companies, this represents a novel, biologically relevant way to test the effects of new drugs. Over the long term, I believe this approach will be implemented to rapidly assess heterogeneity, drug sensitivity, and other parameters in patient cells that can be used to treat diseases such as cancer, in a personalized way.”

To track the activity of this signaling system in living cells, kinase substrates were engineered and tagged with a fluorescent protein so they could be tracked inside the cell with regular microscopy tools. Covert’s team spent more than a year perfecting this technique. So far they have successfully tracked five kinases and see no reason why the technology cannot be extended to other kinases, making it a highly useful tool in drug development that can speed up the rate of discovery. Faster Drug Development This new technique will likely allow researchers to observe and compare kinase activity in healthy versus diseased cells, followed by introducing an experimental drug to see how it affects the living cells. “Currently, most of the methods used to interrogate cell physiology depend on killing the cells at a particular time, and then going through time-consuming and expensive procedures to assess protein function,” says post-doc student and team member Sergi Regot. “With our method, we can observe cells under the microscope and analyze the function of key

A team of Stanford bioengineers led by Assistant Professor Markus Covert has invented a way to observe and report on the behavior of kinase proteins.

The circle inside each cell is its nucleus. When bioengineers stimulate the cells to activate the kinases, the nuclear circles darken. Medical Device Asia | November-December 2014 | 39

New technique allows ultrasound to penetrate bone, metal

Using a new technique, “it’s as if the aberrating layer isn’t even there,” says researcher Yun Jing.

esearchers have developed a technique that allows ultrasound to penetrate bone or metal, using customized structures that offset the distortion usually caused by these so-called 'aberrating layers.'

the ultrasound's acoustic field." "These metamaterials could also be used in industrial settings," says Dr. Yun Jing, an assistant professor of mechanical and aerospace engineering at NC State and senior author of the paper.

"We've designed complementary metamaterials that will make it easier for medical professionals to use ultrasound for diagnostic or therapeutic applications, such as monitoring blood flow in the brain or to treat brain tumors," says Tarry Chen Shen, a Ph.D. student at NC State and lead author of a paper on the work. "This has been difficult in the past because the skull distorts

"For example, it would allow you to use ultrasound to detect cracks in airplane wings under the wing's metal 'skin.'" Ultrasound imaging works by emitting high frequency acoustic waves. When those waves bounce off an object, they return to the ultrasound equipment, which translates the waves into an image.

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But some materials, such as bone or metal, have physical characteristics that block or distort ultrasound's acoustic waves. These materials are called aberrating layers. The researchers addressed this problem by designing customized metamaterial structures that take into account the acoustic properties of the aberrating layer and offsetting them. The metamaterial structure uses a series of membranes and small tubes to achieve the desired acoustic characteristics. The researchers have tested the technique using computer simulations and are in the process of

developing and testing a physical prototype. In simulations, only 28 percent of ultrasound wave energy makes it past an aberrating layer of bone when the metamaterial structure is not in place. But with the metamaterial structure, the simulation shows that 88 percent of ultrasound wave energy passes through the aberrating layer. "In effect, it's as if the aberrating layer isn't even there," Jing says. The technique can be used for ultrasound imaging, as well as therapeutically -- such as using ultrasound to apply energy to brain tumors, in order to burn them.

Transcranial ultrasound therapy

recent study provides new information on the limitations and potential new directions for the future development of transcranial ultrasound therapy. Active research is taking place in the field of transcranial ultrasound therapy, which in the future can potentially be applied to the treatment of brain tumors and targeted drug delivery. The therapy modality has already been successfully applied to the treatment of neuropathic pain disorder and essential tremors. A recent study completed at the University of Eastern Finland provides new information on the limitations and potential new directions for the future development of transcranial ultrasound therapy. Active research

is taking place in the field of transcranial ultrasound therapy, which in the future can potentially be applied to the treatment of brain tumours and targeted drug delivery. The therapy modality has already been successfully applied to the treatment of neuropathic pain disorder and essential tremors. The benefits of transcranial ultrasound therapy include minimal invasiveness, as the treatment is delivered to the brain by transmitting ultrasound through the intact skull of the patient. The study focuses on two issues that may potentially limit the applicability of transcranial ultrasound: skull-base heating and formation of standing-waves. Skullbase heating must be taken into account in treatment planning

As the ultrasound beam encounters the skull bone, part of the beam's energy is transferred into the skull as heat. In the study, it was found that the heating of the skull-base during transcranial ultrasound therapy can result in hazardous temperature elevations when the sonications are performed close to the skull-base. Three new methods to counteract this potentially hazardous phenomenon were developed in the study. Standing waves, on the other hand, are formed in the ultrasound field when waves reflect from the surface of the skull bone. During transcranial ultrasound therapy, the ultrasound amplitude can reach higher levels than intended if these reflections are not taken into account during the initial treatment planning. The study

found that the formation of standing waves is greatly reduced when specifically designed large-area ultrasound transducers are used. A numerical method to simulate propagation of ultrasound The study also introduces a model to numerically simulate clinical patient treatments performed with transcranial ultrasound therapy. The predictions produced by the model were compared to observations done in clinical patient trials performed earlier. The predictions were found to be of an adequate accuracy for an initial treatment planning. However, more accurate characterization of the acoustical and thermal parameters involved in transcranial ultrasound therapy.

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Good vibrations: Mediating mood through brain ultrasound

Stuart Hameroff, professor emeritus in the UA's departments of anesthesiology and psychology, is lead author on the first clinical study showing that transcranial ultrasound affects mood.

esearchers have developed a novel technique to affect mood through ultrasound vibrations applied to the brain. Their findings could potentially lead to new treatments for psychological and psychiatric disorders. University of Arizona researchers have found in a recent study that ultrasound waves applied to specific areas of the brain appear able to alter patients' moods. The discovery has led the scientists to conduct further investigations with the hope that this technique could one day be used to treat conditions such as depression and anxiety.

Dr. Stuart Hameroff, professor emeritus of the UA's departments of anesthesiology and psychology and director of the UA's Center for Consciousness Studies, is lead author on the first clinical study of brain ultrasound, which was published in the journal Brain Stimulation. Hameroff became interested in applying ultrasound to the human brain when he read about a study by colleague Jamie Tyler at the Virginia Polytechnic Institute, who found physiological and behavioral effects in animals of ultrasound applied to the scalp, with the waves passing through the skull.

Hameroff knew that ultrasound vibrates in megahertz frequencies at about 10 million vibrations per second, and that microtubules, protein structures inside brain neurons linked to mood and consciousness, also resonate in megahertz frequencies. Hameroff proposed testing ultrasound treatment for mood on human brains. "I said to my anesthesiology colleagues, 'we should try this on chronic pain patient volunteers.'" His colleagues respectfully suggested he try it on himself, first. Hameroff acquiesced. After 15 seconds with an ultrasound

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transducer, a standard ultrasound imaging device, placed against his head, Hameroff felt no effect. "I put it down and said, 'well, that's not going to work,'" he said. "And then about a minute later I started to feel like I'd had a martini." His mood was elevated for the next hour or two, Hameroff said. Aware that his experience could be a placebo effect, an imagined effect derived from his expectation to feel a change, Hameroff set out to properly test the treatment with a clinical trial. With research committee and hospital approval, and patient informed consent, Hameroff and his

colleagues applied transcranial ultrasound to 31 chronic pain patients at The University of Arizona Medical Center-South Campus, in a double blind study in which neither doctor nor subject knew if the ultrasound machine had been switched on or off. Patients reported improvements in mood for up to 40 minutes following treatment with brain ultrasound, compared with no difference in mood when the machine was switched off. The researchers confirmed the patients' subjective reports of increases in positive mood with a Visual Analog Mood Scale, or VAMS, a standardized objective mood scale often used in psychological studies. "Encouraging!" Hameroff remarked. "We're referring to transcranial ultrasound as 'TUS,'" he added. "Which is also the airport code for Tucson." "This was a pilot study which showed safety, and some efficacy, for clinical use of TUS," Hameroff said. "Beause important structures called microtubules in all brain neurons vibrate in the ultrasound range, and help mediate mood and consciousness, TUS may benefit a variety of neurological and psychiatric disorders." The discovery may open the door to a possible range of new applications of ultrasound in medicine.

desirable than existing brain stimulation techniques such as transcranial magnetic stimulation, or TMS. Used to treat clinically depressed patients, TMS can have side effects including what some describe as an unpleasant sensation of magnetic waves moving through the head. After finding promising preliminary results in chronic pain patients, Hameroff and his colleagues set out to discover whether transcranial ultrasound stimulation could improve mood in a larger group of healthy volunteer test subjects. Jay Sanguinetti, a doctoral candidate in the department of psychology and his adviser John Allen, a UA distinguished professor of psychology, were intrigued by Hameroff's idea of testing ultrasound. They conducted a followup study of ultrasound on UA psychology student volunteers, recording vital signs such as heart rate and breath rate, and narrowed down the optimum treatment to 2 megahertz for 30 seconds as the most likely to produce a positive mood change in patients. "With 2 megahertz those who were stimulated with ultrasound reported

feeling 'lighter,' or 'happier;' a little more attentive, a little more focused and a general increase in wellbeing," Sanguinetti said. Allen and Sanguinetti then began a double blind clinical trial to verify the statistical significance of their findings and to rule out any possibility of a placebo effect in their patients. Results of the trials are being analyzed, Sanguinetti said. "What we think is happening is that the ultrasound is making the neurons a little bit more likely to fire in the parts of the brain involved with mood," thus stimulating the brain's electrical activity and possibly

leading to a change in how participants feel, Sanguinetti said. The UA researchers are collaborating with the Silicon Valley-based company Neurotrek, which is developing a device that potentially could target specific regions of the brain with ultrasound bursts. The UA researchers will work with a prototype of the Neurotrek device to test its efficacy and potential applications. Said Sanguinetti: "The idea is that this device will be a wearable unit that noninvasively and safely interfaces with your brain using ultrasound to regulate neural activity."

"We frequently use ultrasound in the operating room for imaging," said Hameroff. "It's safe as long as you avoid excessive exposure and heating." The mechanical waves, harmless at low intensities, penetrate the body's tissues and bones, and an echo effect is used to generate images of anatomical structures such as fetuses in the womb, organs and blood vessels. Additionally, the high-frequency vibrations of ultrasound, which far exceed the range of human hearing and are undetectable when passing through the body, may be more Medical Device Asia | November-December 2014 | 43

Wellograph Review – A Stylish Watch with Basic Fitness Capabilities

takes readings throughout the day. According to Wellograph, it takes a reading every 10 minutes, and if there’s too much motion, it retries after 1 minute until it’s successful. In a day, the Wellograph might pick up over 100 readings of my pulse to get an accurate measurement.

o here’s the Wellograph Sapphire Wellness Watch, first unveiled at CES 2014 earlier this year. When it came out, it was touted as sleek and stylish, and the first tracker with a sapphire screen (which shows in the high price tag). Finally, the people had a choice of a fitness tracker that didn’t look like a toy. As for its fitness capabilities, it’s got a basic set of features, including a motion sensor and heart rate monitor. So does it live up to its name and graph your wellness? Tune in and find out! Cardio: The Wellograph has a basic system of tracking your jogs. There’s a screen on the watch to display distance travelled during a workout. You can choose to show your pace, speed, or calories burned. It’s

a nice feature that helps distract me every once in a while from the pain as my body screams for more oxygen. It updates live by-thesecond, and seems to represent some average of the last few seconds in time. In terms of accuracy, however, the measurements weren’t entirely up to par. For example, one of my runs was measured 7 km on a map, but the watch registered 4.5 km. On another, I ran 2.4 km according to the map, but the watch registered 1.55 km. It seems to consistently underestimate my runs (roughly 66% of the actual distance), but perhaps I just have a long stride length. So like all wrist trackers, this is personalized to the wearer and you’ll have to scale your own workouts to

44 | November-December 2014 | Medical Device Asia

compare accordingly. wellograph 2 Wellograph Review A Stylish Watch with Basic Fitness CapabilitiesHeart Rate Monitor: On the backside of the watch are three green LEDs and a sensor. Setting the watch to Pulse Mode displays a light show where the LEDs fire repeatedly and the sensor actively takes readings. This is fairly accurate in my experience, with a reading that pops out after 10-15 seconds of recording. The downside is that you pretty much have to be completely stationary for it to work. Even walking with my wrist raised and stabilized would set off the vibration detection feature and pause the recording until I stopped moving. A nice feature is that it automatically

Pedometer: The Wellograph works like a charm when I’m walking normally. So if I’m walking along the street and count 50 steps, I can be sure it’ll count 50 with me. When I’m resting, I can wave my hands around and it generally won’t pick it up as a step, but I’ve caught the pedometer clicking upwards from hand motion here and there, especially if it’s a repetitive action. If I pronate/supinate my wrist back and forth, it’ll start picking up steps after about 6 cycles. If I’m at my desk for a morning, it might rack up an extra 200. Overall, it works fairly well and is a fair indication of my amount of activity throughout a day. Hardware: The design is the main strength of this activity tracker. A stylish, sleek, minimalist piece, the Wellograph is appropriate for most social engagements. A stainless steel frame sits on top of the anodized aluminum backing, and the face of the watch is topped by a rounded piece of sapphire crystal. Two large buttons sit on the distal edge of the watch for navigation of menus. These layers all piece together aesthetically, and overall, it looks almost Apple-esque (even the packaging felt pristine). The brown leather strap has a nice

stainless steel clasp that complements the piece well. On the downside, it’s too thick – at 12.5 mm, the watch feels a little chunky, and because it protrudes so much from my wrist, I’ve smacked it off a few walls and the undersides of tables on the first few days of getting used to it. Good thing the face is made of sapphire, or this review may have been all about the scratches it’s picked up. To test out the strength of the sapphire, I took to it with keys, metal nails, and corners of concrete walls, pressing with considerable force. At the end of it all, it was still shiny and smooth as ever with no visible scratches in any light. Quite a frustrating experience trying to destroy something that wouldn’t give. But also so satisfying to see something stay in pristine condition after putting it through a solid roughing. Now for the face itself. The bezels look too large for my liking – especially the top edge, which is almost twice the width of the other three sides. The design of both the analog and digital clock on the LCD feels too plain and out of place with

the hardware. The recent firmware update gives the watch a new face, which I took a liking to immediately. Time, date, and steps taken, are displayed in clean, thin letters. The poor viewing angle needs a mention. There are times when I want to check the time with a quick inconspicuous glance, and while wearing the Wellograph, I’ve noticed on a few occasions that when my hands are in my lap or on the table, I can’t see the time unless I really rotate the face towards me. The total viewing angle in both directions is probably a combined 120 degrees. This isn’t a dealbreaker, as I can compensate by practicing my fake-yawn-and-check-the-time manoeuvre, but its is still a definite annoyance. The Wellograph is advertised with a 7-day charge, and it holds true to that promise. Once I had streamlined the watch into my routine and was not playing with it every 10 minutes, I found myself only needing to dock it to charge on the weekend. Software and App: The Wellograph has undergone three firmware updates and an app update since I’ve received it. Each time the

performance gets a little better, and they’ve just added a new home screen to show the time, which I find cleaner, and which shows more information (steps are now added) than the original two. The app itself is clean, smooth, and intuitive. You can check your activity (step tracking) and your heart data (heart rate monitoring) and scroll between Day, Week, Month, and Overall views. One downside is that the app only allows display of heart rate data over the current week or month. So when it’s Sunday, the previous week’s data is wiped, and I’m left with an empty Week view. At the beginning of the month, the graph also resets and is empty again until a few more days are recorded. It really would be nice to be able to scroll to previous records. The Sessions menu graphs your workouts and shows you how hard you worked over time in an aesthetically-pleasing graph and various stats. I’ve discovered that the app crashes when I try to sync a workout in Lap mode, but the customer service at Wellograph has been quick to reply so far, and they promise an app update to fix the issue in the near future. Medical Device Asia | November-December 2014 | 45

NEC MultiSync MD212G3 LCD Grayscale Diagnostic Monitor

EC has just unveiled its new grayscale diagnostic monitor, the MultiSync MD212G3. The device features a 21.3? LED screen with a 2048 x 1536 (3 megapixels) resolution, as well as a 1,400:1 contrast ratio and a 1,700 cd/mÂ˛ calibrated brightness. The front of the panel is covered with an anti-reflective coating and a front facing sensor makes sure the luminosity levels remain consistent. The screen is pre-calibrated to the DICOM grayscale standard and the accompanying GammaCompMDTM QA software can be used to make sure the monitor stays calibrated throughout its life. The screen tilts, swivels, and pivots, and is height adjustable as well. It has a couple USB ports in the back, as well as DVI-D and DisplayPort inputs. Its estimated price is $4,699 and it comes with a five year warranty.

46 | November-December 2014 | Medical Device Asia

Close-up of the half-inch long multimicroelectrode array showing detailed circuitry leading to each individual electrode. The array is used to stimulate the spinal cord to enable locomotor and bladder function after paralysis.

Electrical Stimuli Induced Bodily Control in Spinal Cord Injuries

atients who have had spinal

A second experiment was also done by the researchers on trained SCI rats that were held by a harness which

cord injuries suffer from not

allowed their lower limbs to touch the ground. A catheter was used to infuse a saline solution into their bladders.

only paralysis of their limbs,

Varying levels of eEmc stimulation were applied to determine the optimal amount for spontaneous release of the

but also from other complications

bladder. The researchers found that the emptying was best when there was a relatively low level of stimulation. This

often including a loss of bladder

study shows great promise for rehabilitation and improving the quality of life for those that suffer from spinal cord

control. In previous experiments, Dr.

injuries.

Edgerton from the University of California, Los Angeles and collaborators at University of Louisville, used electrical stimulation to allow four patients to voluntarily stand and perform simple movements. In a new study, partly funded by the National Institute of Biomedical Imaging and Bioengineering, researchers are using the previous findings to to help identify and optimize ways to use electrical stimulation to bring back bladder control in rats. In the basic protocol, an electrical epidural stimulator is implanted into the spine which allows researchers to control electrical signals. In the study at UCLA, the researchers observed 10 SCI (spinal cord injured) rats that were trained for six weeks with electrical enabling motor control (eEmc) and a group of 5 untrained rats. The rats in the experimental group were trained to empty their bladders while stepping on a treadmill and the rats in the control were not. The group found that the extra sensory input provided by the treadmill training improved bladder response. Detail of a single electrode of a multielectrode array. Medical Device Asia | November-December 2014 | 47

Genteel Lancing Device for Pain-Free Glucose Testing Anywhere on Body

iabetics checking their blood sugar levels usually have to prick their finger to get a sufficient draw for the glucometer to do its job. Some newer glucometers work with smaller blood samples and are

able to take blood from the inside of the arm where there are fewer nerves to cause pain. Now a new device called Genteel can allow patients to take blood samples from just about anywhere on the body with little pain. The device prevents pain by vibrating the skin just before the lance pierces it and by creating a vacuum around the sample site at the moment of penetration. The actual piercing of the skin is done much faster than with traditional devices, taking only .018 of a second for the needle to pop in and out. Additionally, the contact tip has six levels of depth control to accurately set the penetration level to match the location from where the blood is drawn. The Genteel costs $129, a bit high compared to competing device, though it may prove quite valuable for kids and others not used to regular prickly blood draws. It uses standard FDA approved square lancets and works with whatever glucometer youâ&#x20AC;&#x2122;re used to.

48 | November-December 2014 | Medical Device Asia

Leather Doctor’s Bags: Making a Comeback

he medical device world has been advancing at an unprec edented rate, particularly with the relatively recent advent of batteries and microchips, but there are still classic tools in a physician’s possession that have endured the technological revolution and remain off the electrical grid. Most might think of manual stethoscopes or perhaps reflex hammers as the nonelectric mainstays in a physician’s armamentarium, but today I will feature the finest traditional leather product for healthcare providers: the doctor’s handbag. While the days of house calls and rural doctors that practiced as jack-of-all trade practitioners has nearly faded away, the physician’s bag is coming back into favor due to the everexpanding variety of tools that physicians are using today. I reviewed The Donnini leather doctor’s bag, manufactured by Maxwell Scott. Maxwell Scott is a family-run business based in England that creatively combines British design with Italian craftsmanship. Their bags are handcrafted and use high quality Italian leather. Maxwell Scott launched their medical bags due to popular demand, and insists their lifetime guaranteed products improve with every use.

Donnini bag features a lower compartment that zips open. This section was great to store materials that were not needed as often, but that had to stay clean and organized throughout the bag’s rough journeys across town. The bag buckle can be locked, which did not seem terribly practical, but presumably it can dissuade curious hands from accessing tools when the bag is not in your sight. Overall, the bag passed the field test: relatively light weight, very spacious, comfortable handle, and practical arrangement of compartments. It certainly carries a traditional touch to accompany the white coat. Next I used the bag in the hospital. I found that the practicality of the bag varied largely, depending on the medical specialist using the bag. Neurologists were huge fans! They consistently have too many tools to carry around. For example, surgeons

would not use a bag on their way to the operating room, but could use it at their outpatient practices. A plastic surgery attending let me know that she uses a leather bag to carry the equipment she uses after her surgeries to examine, neurologically evaluate, and photograph her patients. Family medicine and internists are in the middle. I found that most physicians could often use a reliable leather doctor’s bag to carry equipment back and forth between practices and from home, a far better solution than jamming a few items into bulging white coat pockets.

you could pass down to the next generation of healthcare provider in the family, this would be the one.

In conclusion, The Donnini leather doctor’s bag was not only surprisingly elegant, but also practical. Indeed, the cost might inhibit some readers from considering this as their next medical equipment purchase, but if you were to have a doctor’s bag that

I got to first use this bag in the field accompanying a doctor who still conducts house calls in rural Pennsylvania Amish communities. The bag provided ample space for an ophthalmoscope, blood pressure cuff, glucometer, physical exam tools, lab kits for drawing blood, wound care items, and a variety of basic medications. I was even able to fit some notebooks and basic reference materials in there too. Making a Comeback The large Medical Device Asia | November-December 2014 | 49

MOCAheart Device Hopes to Help Track Cardiovascular Health

onsumer ECG devices have been around for a few years now, helping to detect cardiac arrhythmias in everyday situations. Now a new device is coming out

via Kickstarter that aims to provide an altogether different assessment of one’s heart and peripheral vascular health. The MOCAheart device measures the person’s heart rate, blood oxygenation, and a special proprietary MOCA INDEX that’s supposedly derived from the velocity of blood moving through the body. Pulse transit time, or the time it takes for a waveform to travel from one part of the body to another, is indicative of a person’s blood pressure. Yet, it has never been used to accurately deduce the blood pressure, but the MOCAheart device doesn’t try to do that. Instead, the device uses the pulse transit time to indicate a reading on the MOCA INDEX that roughly correlates with whether a person’s blood pressure is normal or not.

50 | November-December 2014 | Medical Device Asia

Samsung RS80A Ultrasound System Now Available in U.S.

amsung rs80a Samsung RS80A

Vision™ architecture complemented

Ultrasound System Now

by S-Vue™ transducer performance

Available in U.S.Samsung is

and ClearVision™ sophisticated

releasing in the U.S. its high-end

digital imaging processing, pushing

RS80A ultrasound system. The

the boundaries of ultrasound

device can be used in a variety of

imaging. With innovative advance-

applications and features hybrid

ments, including hybrid

beamforming technology that

beamforming technology, the next-

provides high-resolution visualiza-

generation SDMR and Single Crystal

tion.

Probe technology, the Samsung RS80A delivers consistent and high-

It’s compatible with 14 different

resolution image quality.

probes, which can be purchased separately as needed, and comes

The RS80A provides premium

with a 23? high definition monitor for

performance through a comprehen-

displaying scan data and a tilting

sive 3D technology suite that

13.3? touchscreen that’s used to

features Realistic Vue™. This

interface with the device. The large

advanced feature allows the user to

display can be folded down when

select light source direction to

moving it between rooms to get out

display high-resolution 3D anatomy

of the way of seeing the hallway

with exceptional detail and realistic

ahead.

depth perception. The product also offers a comprehensive selection of

It has a powered lift mechanism that

2D, 3D and 4D transducers and the

raises and lowers the display and

reliability of a solid state drive.

controls, as well as a sleep mode that memorizes the height of the

The RS80A incorporates a high-

panel and raises it back up to where

resolution, 23-inch HD LED display, a

it was once the system is awoken.

13.3-inch tilting tablet touchscreen and a six-way motorized adjustable

Some more details about the RS80A

console. Samsung’s world-

according to the announcement:

renowned display technology further enhances the image clarity

Samsung’s technological innovation

with excellent contrast, resolution

supports the RS80A’s unique S-

and vibrant colors.

Medical Device Asia | November-December 2014 | 51

Speaker Array Focuses Sound on Listener with Hearing Loss, Spares Everyone Else

any people with hearing

letting everyone else in the room

“My array uses individual loud-

it is possible obtain about a 30 per

loss opt out of using

hear things at normal levels.

speaker elements that are specially

cent of speech intelligibility

hearing aids because of

The system consists of loudspeak-

designed first-order acoustic

improvement of the hearing

their discomfort, poor performance,

ers that are accurately phase-shifted

radiators, or phase shift sources,

impaired listeners, while maintaining

or simply compliance. This is

in respect to each other to create a

thus saving cost and improving the

a good audio quality in the zone

probably even more common when

“hot-spot,” while everything around

robustness of the array to variations

where the healthy listeners are sat.

the person is at home and would

is kept at standard volume. There

in the sensitivity of the elements and

like to relax and crank up the TV.

have been similar systems, but the

in the reproduction environment,”

Marcos adds: “This is quite an

Others in the home may not be as

new technology gets rid of a

said Marcos Simón, a PhD researcher

encouraging result, as it confirms

hot about hearing the TV on full

speaker array placed in the back of

from the University’s Institute of

that it is possible to use the array as

volume, a cause for inevitable

the room that has been used to

Sound and Vibration Research.

a complementary aid for the hard of

domestic fights the world over.

cancel out audio waves that

Researchers at University of

approach the healthy listeners from

The operation of the array has been

This means a 70-year old person can

Southampton have developed a

the rear.

tested by performing behavioural

listen to a TV programme normally

experiments in a normal room, and it

without disturbing others around

has been seen that using the device

them.”

speaker system that can focus high volume audio on one person while

From University of Southampton:

52 | November-December 2014 | Medical Device Asia

hearing.

Smart bandage advances patient monitoring technology Smart bandage advances patient monitoring technology

atient monitoring technology is a growing niche within the industry, with big and small operations looking for their cut of the profits. A new device from a team of nurses, engineers and computer scientists takes the trend one step further, monitoring a patient's health through a bandage. As the New Scientist reports, scientists at the National Taiwan University in Taipei are developing "Bioscope," a bandage-like system that tracks a hospital patient's temperature, heart rat, movement and bodily noises and wirelessly transmits the data to a computer. Sensor modules are 3D printed onto the bandage, and can be swapped in and out by a nursing staff depending on each patient's unique needs. The system includes a heart rate monitor that measures electrical activity at the skin surface, a contact thermometer that measures temperature, an accelerometer that monitors physical movement and a contact microphone that picks up on sound patterns from internal organs. Scientists hope that eventually the device could allow physicians to make diagnoses remotely and monitor patients once they've left the hospital, according to the New

Scientist article. The team plans to present its Bioscope system at the UbiComp conference in Seattle. The innovation joins a host of other patient monitoring products under development. Earlier this month, the FDA cleared the first sensor to monitor heart rate, respiratory and movement in a chair. EarlySense's Chair Sensor Solution is placed underneath a chair cushion and tracks a patient's health without any attachment leads or cuffs. A new iOS device, Cue, allows consumers to test their vital signs at home with simple swabs of bodily fluids. The product consists of a small tabletop analyzer and color-coded cartridges that detect biomarkers such as testosterone, inflammation, vitamin D and fertility. Cue is being presold under an Investigational Device Exemption, but has not yet received full regulatory approval.

Corventis for more than $150 million. The acquisition gives the company access to Corventis' two FDA-cleared patient monitoring products, including a peel-and-stick PiiX sensor that measures vital signs and a mobile cardiac telemetry system that transmits data to a wireless receiver worn on a clip or a belt.

Big name companies like Philips Healthcare ($PHG) and Medtronic ($MDT) are also hedging their bets on a profitable patient monitoring market. In February, Philips closed a new patient telemonitoring tech deal with Partners HealthCare, one of the nation's leading healthcare providers. In May, Medtronic announced that it was in the final stages of acquiring medical sensor company

Medical Device Asia | November-December 2014 | 53

Synthetic Platelet-Like Nanoparticles for Rapid Wound Hemostasis

ven though blood has the

other platelets to aggregate. After

platelets. Platelet-like nanoparticles

their hemostatic functions. PLNs

ability to coagulate, severe

some time the nanoparticles that did

(PLNs) exhibit enhanced surface-

offer a nanoscale technology that

bleeding is still difficult to

not stick to the scar are metabolized

binding compared to spherical and

integrates platelet-mimetic biophysi-

control since there are simply too

by the body to preserve the purity

rigid discoidal counterparts and site-

cal and biochemical properties for

few platelets to aggregate quickly

of essence of our precious bodily

selective adhesive and platelet-

potential applications in injectable

enough to plug the wound.

fluids.

aggregatory properties under

synthetic hemostats and vascularly

physiological flow conditions in

targeted payload delivery.

Researchers from University of California Santa Barbara and Case

Our nanoparticles mimic four key

vitro. In vivo studies in a mouse

Western Reserve University have

attributes of platelets, (i) discoidal

model demonstrated that PLNs

developed synthetic platelet-like

morphology, (ii) mechanical

accumulate at the wound site and

nanoparticles that can be injected

flexibility, (iii) biophysically and

induce ~65% reduction in bleeding

near a wound to act like natural

biochemically mediated aggregation,

time, effectively mimicking and

platelets in helping to treat it.

and (iv) heteromultivalent presenta-

improving the hemostatic functions

tion of ligands that mediate

of natural platelets. We show that

These nanoparticles have the same

adhesion to both von Willebrand

both the biochemical and biophysi-

shape and squishiness as our own

Factor and collagen, as well as

cal design parameters of PLNs are

platelets and actually help signal

specific clustering to activated

essential in mimicking platelets and

54 | November-December 2014 | Medical Device Asia