Medical Device ASIA (Sept-Oct'14)

SOLED15–F Focusable LED lamp for universal applications

Smartphonebased ECG Takes India

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MEDICA 2014

MEDICAL FAIR ASIA 2014

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MEDICAL MANUFACTURING ASIA 2014 India’s pharma export growth slowest in 15 years

wireless smartphone access for existing blood glucose monitors

3-D printed hands for pediatric patients

medical devices' cybersecurity

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Medical Devices & Equipment | Healthcare | Pharmaceutical Journal

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Vol.6 No.5 |Sept-Oct 2014 | Annual Subscription: Rs.2000

EKF Diagnostics collaborates with MGH to detect treatable cancer mutations in blood samples

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Waldorf Technik re-invents highflex® IML

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Medical Products

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Show Report - MEDICAL MANUFACTURING ASIA 2014

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Show Report - MEDICAL FAIR ASIA 2014

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SOLED15–F - Focusable LED lamp for universal applications

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Frost & Sullivan Applauds MobileHelp

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GE Healthcare and GSK to improve access of diagnostic testing for cancer patients

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MEDICA 2014 preview

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The New FDA Cybersecurity Guidance You Need to Know

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Smartphone-based ECG Takes India by Storm

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Apple Has a Bug to Exterminate from Its HealthKit Apps

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FDA sets guidelines for medical devices’ cybersecurity

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Link between breast implants and cancer under investigation There might be a possible association between breast implants and a form of lymphoma that may develop tumors at a later stage; © panthermedia.net/Lars Zahner

An international research group including Viennese pathologist Lukas Kenner has reviewed cases of possible association between breast implants and a form of lymphoma that may develop tumors at a later stage. The researchers conclude that breast implants can cause a new subtype of the rare yet malignant lymphoma known as ALCL. The research results have been published in the journal Mutation Research.

Worldwide there have been 71 documented cases of patients with anaplastic large cell lymphoma (ALCL) in which researchers suspected breast implants to be the cause. ALCL is normally found in the lymph nodes, as well as in skin, lung, liver and soft tissue, but not usually in the breast.

Cases in which ALCL developed in the breast region almost exclusively involved patients who have had breast surgery. In these cases, ALCL developed around ten years after the operation. The tumors grew in the scar tissue around the implant.

Breast implants are generally safe and studies have found no association between

breast surgery and other forms of cancer. ALCL itself is also an extremely rare occurrence. Among three million breast implants, there are between one and six reported cases of ALCL. ALCL is divided into two subtypes.

In one subtype, the cancerous cells produce an abnormal form of the protein ALK (anaplastic lymphoma kinase). The other type does not express ALK in tumor cells at all. While patients with ALK-positive lymphoma have a better chance of survival, the cancer is considerably more aggressive in ALK-negative cases.

Implant-related ALCL appears to form a third group. The cells do not express ALK, but patients have good survival rates. “This is a previously unrecognized, new subtype of ALCL,” Lukas Kenner explains. “We must now determine the exact causes behind its occurrence.”

The actual reasons why implants can cause lymphoma remain unclear. While some patients were successfully treated with chemotherapy and radiation therapy, the lymphoma in many cases subsided on its own following removal of the implant and the surrounding tissue. An abnormal immune response from the body could therefore be a cause of the cancer. Kenner and his team are now preparing for further studies in which implants and dentures will be examined in other parts of the body.

Lukas Kenner from the Medical University Vienna, the University of Veterinary Medicine, Vienna and the Ludwig Boltzmann Institute for Cancer Research cooperated for this study with scientists from Cambridge, Liverpool, Swansea and Australia. The project was funded by the British organization Leukaemia & Lymphoma Research.

MEDICA.de; Source: Medical University Vienna

Medical Device ASIA | September-October 2014 | 3

EKF Molecular and Massachusetts General Hospital Announce Circulating Tumour Cell Clinical Research Collaboration

Research to confirm clinical utility of PointMan™ and CTC-iChip technologies for non-invasive cancer diagnosis and monitoring PointMan™ provides a reliable and highly sensitive determination of the presence or absence of a mutation in the DNA sequence.

method with which to diagnose, treat and monitor the progress of various cancers. The main difficulty in successfully analysing CTCs has been the ability to detect low level mutations sufficiently and to create assays that are sensitive enough to provide meaningful data; difficulties which PointMan may be able to effectively overcome.

EKF Molecular will design and develop high sensitivity assays which will be utilised by MGH with a view to clinically validating PointMan in the detection of existing and novel mutations, a major step towards the improvement of patient outcomes in the hospital.

EKF Diagnostics, the global diagnostics company, announces that it has entered into a two year research collaboration with Massachusetts General Hospital (MGH), a global leader in successfully bridging innovative science with state-ofthe-art clinical medicine, to develop PointMan™ assays that can effectively detect treatable cancer mutations in blood samples.

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he collaboration agreement has been signed following a detailed evaluation of PointMan DNA enrichment technology

by MGH and will cover a two year long project focussing on lung, breast and skin cancer.

MGH will use PointMan DNA enrichment technology for the detection of genetic variation in circulating tumour cells (CTCs) isolated from a patient’s blood using MGH’s CTC-Chip instrument.

CTCs are shed by primary tumors allowing the cancer to metastasise. CTCs are extremely rare in whole blood and their isolation and characterisation could offer clinicians a routine 4 | September-October 2014 | Medical Device ASIA

Andrew Webb, CEO of EKF Molecular Diagnostics Ltd, commented: “The results of an initial assessment, and now this two year collaboration, moves us even closer to the routine use of blood based tests for cancer rather than a tissue biopsy. The combination of MGH’s CTC-Chip instrument and the easy to use and quick to perform PointMan technology should make this approach to cancer detection and monitoring available, ultimately, to the majority of molecular testing laboratories.”

Dr Daniel A. Haber, Director at Massachusetts General Hospital Cancer Center and Kurt J. Isselbacher, Peter D. Schwartz Professor of Oncology, Harvard Medical School, commented: “We have been studying the sensitivity of DNA enrichment technology as a way to detect and monitor specific mutations in cancers from patients utilising circulating tumour

cells isolated from a simple blood sample. I am hopeful that the combination of such technology with our CTC-Chip technology will have the potential to improve the clinical management of our patients.”

Dr Shyamala Maheswaran, of the Massachusetts General Hospital Cancer Center and Associate Professor of Oncology at Harvard Medical School, who was principal investigator for the collaboration, commented: “This study demonstrated incredible sensitivity for mutations that are relevant to lung cancer, breast cancer and melanoma. During the course of the two-year research collaboration, we will look for other potential target genes associated with these and other cancer types.”

The initial proof of concept data produced by Dr Shyamala Maheswaran’s research team at MGH using PointMan DNA Enrichment assays to detect EGFR sensitizing, as well as resistance (T790M), mutations associated with lung cancer and BRAF V600E associated with melanoma have proved enlightening. These experiments involved spiking as few as 3-10 tumour cells harbouring the appropriate mutations into white blood cells. PointMan enrichment assays reliably detected both T790M and V600E at a frequency of 10 mutant alleles (gene copies) in a background of 10,000 wild type (normal) alleles. Ongoing pilot studies have suggested an even more robust detection sensitivity of three mutant alleles in a background of 30,000 wild-type alleles. v

Advanced Cell Diagnostics and Leica Biosystems Begin

Co-marketing Fully Automated RNA in situ Hybridization Assay represented in over 100 countries.

It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers.

The company is headquartered in Nussloch, Germany. Further information can be found at www.

LeicaBiosystems.com.

Leica Biosystems and Advanced Cell Diagnostics, Inc. (ACD) have announced the co-marketing of ACD’s RNAscope® LS ISH assays with Leica Biosystems’ BOND RX research staining platform*. This agreement provides researchers with an integrated and fully automated ISH solution. The market-leading RNAscope LS reagent kits and ISH probes are available from ACD while the BOND RX instrument and associated reagents are supplied by Leica Biosystems.

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CD’s RNAscope assays represent a major technological advance for in situ RNA detection. For the first time, robust single RNA molecule detection is available for formalinfixed, paraffin-embedded (FFPE) tissue. Since their commercialization three years ago, these assays have been adopted across the globe by major pharma biotech companies and leading research institutions for drug discovery, translational research, and the development of clinical and companion diagnostic tests. The RNAscope LS assays are fully automated on the BOND RX

platform. This open and flexible system automates staining to provide a fast, high-throughput workflow with exceptional consistency and minimal hands-on time.

“Automation is essential for pharma, biotech, translational labs and academic institutions to apply the RNA ISH technology to a wide range of biomarker analysis applications.” said Dr. Yuling Luo, President and CEO of ACD. “We are very pleased to work with Leica Biosystems to expand our automated RNAscope solutions

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in response to the needs of our rapidly growing customer base.”

Dr. David Atkins, VP Advanced Staining at Leica Biosystems added: “Leica is excited to announce the availability of ACD’s RNAscope Assays fully automated on the BOND RX. This is another example of how, with its openness and flexibility, the BOND RX is providing researchers with enhanced tools to help speed-up important discoveries and improve cancer diagnostics”.

About Leica Biosystems Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting.

Leica’s easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is

About Advanced Cell Diagnostics Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity.

RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases. ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com. *For Research Use Only. Not for use in diagnostic procedures.

Learn more about ACD at www.acdbio.com and about RNAscope® Automated Solutions at acdbio. com/products/automated-assays.

Further information about Leica Biosystems can be found at www.LeicaBiosystems.com.

Waldorf Technik re-invents highflex® IML IML automation occupies extremely compact space and still offers this facility at approximately the same invest as systems that due to a restricted budget have merely possessed the capacity to reject the entire batch.

As an optional module for the highflex® IML se-ries, Waldorf Technik has now included entire packaging stations in its programme, with which vetted products can be packaged in transport containers or boxes, practically without human involvement. For many customers, this option may be a good response to the constantly spiral-ling price pressure in the packaging business.

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n time for the Fakuma 2014, the automation specialist Waldorf Technik GmbH &Co. KG uses its innovative force to develop entirely new technologies for the production of pack-aging solutions in injection moulding. The classic highflex® IML comes with entirely new features, while barrier coating is set to revo-lutionise the whole field of food packaging.

The modern world of packaging is now incon-ceivable without inmould labelling, as the brilliant printing and cost-efficient flexibility of this decoration method is quite simply too attractive for a variety of print images. Instead of decorating the cup and lid in downstream printing processes, this method involves the insertion of printed foils into the injection moulding tool to create an integrated process in just one operating step and to deliver an attractively decorated cup or lid.

Unlike in alternative methods such as offset or silkscreen, post-printing and sleeving, the print image can be switched with practically no setup times, which makes it a particularly inexpensive procedure.

Waldorf Technik has worked assiduously over the last two years to develop and consistently expand its product segment of IML automation. Now the portfolio covers more than five different

standard series to meet an array of customer needs such as reduced invest, stack moulds, extremely compact space, systems for consumer goods packaging and also bulk packs.

Indeed, the traditional flagship at Waldorf Tech-nik, the highflex® IML robot has also been fun-damentally reworked in the second system gen-eration to add a variety of new features, also. For instance, it now occupies 30 % less space than before. The automation system is able to process cups and lids in all IML label geometries.

Furthermore, it is entirely at the discretion of the injection moulder to use the highflex® IML automation for tools with a variety of cavity numbers and cavity intervals – and all this with a mere 20-30 minute setup time between different products. In extreme cases, even the manufacture of products injected from inside and outside is possible using just one highflex® IML automation. This means that the system concept remains unique throughout the world – so far, all other manufacturers of IML systems can only offer restricted flexibility.

And whereas camera monitoring with ejection of individual bad parts has so far substantially in-creased both the size of invest and the system itself, the new highflex®

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The IML method is increasingly winning over admirers in export markets, also. Compared with IML users in central Europe, they appreciate it even more when automation and tools come synchronised in a one-stop solution.

This is why Waldorf Technik has now teamed up with Roth Werkzeugbau GmbH to offer its international customers automation on a double bill with first-class thin-wall tools.

And soon the fanbase will have the opportunity to experience all this at first hand during a variety of events scheduled for this autumn.

A world première will be on show at the Fakuma in Friedrichshafen, for instance: a 100 % circumferentially decorated cup with rounded base edges, manufactured in a process that is simple for the operator and realised using a highflex® IML robot from the standard programme.

Another highlight will be the presentation of bar-rier coating as an industrial method of equipping injection moulding receptacles with unbeatable barrier properties at low cost. The first industrial system with a cycle time of less than four se-conds is already installed on the market; project planning for systems with up to 64 cavities is also underway with international customers.

What is so special about barrier

coating? This method permits the combination of benefits offered by glass jars (for instance the outstanding gas and water vapour barrier, taste preservation, protection against the migration of outside sub-stances into the food and such like) with the advantages of cost-efficient plastic packaging (un-breakable, does not splinter, stackable, compact space requirements and good for logistics).

For instance, coffee in a capsule form remains fresh and preserves its aroma, even without sophisticated secondary packaging.

Fresh products also keep their attractive look. The shelf life of all kinds of food products is extended significantly compared with current plastic solutions. In turn, this enables food manufacturers to produce substantially more efficient batch sizes, thus saving logistic costs in restocking retail shelves.

Unlike the other methods of manufacturing plas-tic barrier containers available today (e.g.

EVOH deep drawing), barrier coating provides packaging designers with a hitherto unseen level of freedom when it comes to the forms. The coating process fits seamlessly into the container geometries, so even entirely asymmetrical forms and receptacles with ribs or stacking edges can be made into barrier packs with no difficulty at all. And the costs are unbeat-ably low, as the barrier layer is a mere 0.1 mi-crometres and hence comes with practically no material expenditure at all. All this means that the method has a promising future that may well just revolutionise the market of food packaging.

Waldorf Technik develops and builds high-performance automation systems for injection moulding companies worldwide. The core com-petencies centre around projects in the field of packaging and medical consumer items with short cycle times.

Local Industry Welcomes New Manufacturing Solutions to Myanmar Manufacturing Myanmar 2014 opens today in Yangon to bring international manufacturing technology marketplace to local industry players

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showcase of new-inMyanmar manufacturing solutions from well-known international brands opens in Yangon today. With the aim of encouraging greater adoption of new technologies by local manufacturers to improve productivity and increase output, Manufacturing Myanmar 2014 held at the Myanmar Convention Centre (MCC) from today until Saturday 4 October gives local firms the opportunity to source for machinery and equipment, and tap knowledge of international suppliers on how to improve their current operations.

More than 85 exhibitors from 15 countries and regions, including four international pavilions from China Taipei, Germany, Singapore and Thailand, have come together for the first time to create an international business platform and knowledge sharing hub for the local manufacturing industry.

Government, local suppliers and manufacturers alike laud the staging of Manufacturing Myanmar as an indication the manufacturing industry in Myanmar is headed for an era of industrial transformation.

“Ensuring development, attractiveness and competitiveness of the manufacturing industry sits high on the government’s list of priorities. Having taken steps to

implement reform strategies and invest in infrastructure to make Myanmar a favourable location for international manufactures as well as to create a conducive business climate for local production to flourish, the Ministry of Industry welcomes Manufacturing Myanmar as it further value adds to our efforts,” says His Excellency U Maung Myint, Union Minister, Ministry of Industry.

everything is relevant to our business. We are looking forward to be able to meet the regular suppliers for our projects as well as products or technology which will be useful to us. I hope Manufacturing Myanmar 2014 can bring new technologies to inspire, new opportunities to be taken and open doors for the local manufacturing industry to expand internationally.”

“Learning from international best practices is one way to progress and Manufacturing Myanmar presents a universal benchmark for manufacturing, operational and service excellence, factors which are critical to setting the stage for Myanmar’s manufacturing sectors.

With the knowledge base and exposure to new technology Manufacturing Myanmar can bring on board, I am confident that our manufacturing sector will continue its growth and contribute heartily to the economy,” he adds.

Mr. Philip Seah, Director of Assurich Myanmar, who supplies machine and tools technology to the oil and gas, marine, fabrication and manufacturing sector in Myanmar comments on their participation at Manufacturing Myanmar 2014, says, “We have been in Myanmar for two years, and as the industry develops with more joint ventures opening up, we have witnessed an increase in demand for technology across many sectors we supply to. Manufacturing Myanmar is a good platform to introduce good working systems to improve the productivity of Myanmar’s industries. In time, we will begin to see more semi and fully automated production lines. With the increase use of technology also fetches the need for manpower with the correct technical capabilities, as such, we also have set up a new company providing training courses for local engineers and technicians.”

Royal Marine Group, one of Myanmar’s leading engineering service providers for the marine and oil and gas sector will be visiting Manufacturing Myanmar 2014. Mr. Ye’ Wint Kyaw, Sales Engineer of Royal Marine Group says, “The exhibit profile of this event really caught our eye, design soft wares, tools, machinery and welding equipment, almost

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Welding electrode manufacturer YAWATA, who has had a decade long presence in Myanmar comments on the inaugural edition of Manufacturing Myanmar, Mr. Sittiboon Abhinorasaeth, General Manager of YAWATA says, “We have been in Myanmar for almost 10 years supplying to shipbuilding and construction businesses. In the last few years, the market has grown very fast and we have since partnered up with a local agent. We believe that Manufacturing Myanmar is a match-up between user and supplier for both service and goods. From this event, the local manufacturing industry will be able to source for what it needs and learn from what is available abroad in order to satisfy the needs of the domestic consumers.”

In conclusion, Ms. Lindy Wee, Deputy Chief Executive of organiser Singapore Exhibition Services says, “Manufacturing Myanmar will present many viable options for local businesses looking to upgrade existing operations and processes, as well as expand capabilities through investment in technology. We are certainly glad to receive such a warm reception from the local industry and are looking forward to working with the government, and supporting organisations to herald in a new era in Myanmar’s manufacturing industry.”

Paramount Surgimed Ltd launches AroKleen Adult Diapers with ADL for Extra Dry Feeling

Netherlands’ leading medical chair manufacturer Score starts distributing in Asia-Pacific

Score is Netherlands’ leading manufacturer of medical and dental seating. For over 37 years Score has been developing ergonomic chairs and accessories that enable people to work in a healthy way.

Paramount Surgimed Ltd., a leader in Healthcare & Medical Disposables, introduces “AroKleen” Disposable Adult Diapers with (ADL) acquisition distribution layer, wetness indicator and leak proof. The Diapers are user friendly, affordable and highly beneficial to both male and female persons with bladder problems commonly known as Urinary incontinence.

Arokleen Adult Diapers provide affective incontinence management for those who require or prefer an all in one product. The (ADL) acquisition distribution layer, brings feeling of softness and comfort, sanitary and refresh. Arokleen Diapers offer increased absorption and leakage protection by using materials of the highest quality and including super.

The Paramount Unisex, Disposable Aro Kleen Adult Diapers are user friendly and give the user long-lasting comfort and maintain a high standard of hygiene at the same time makes the user feel secure and continue normal daily activities. Paramount Surgimed Limited, as a part of their Corporate Social Responsibility mandate, is working actively with Age-Care India to provide Adult Diapers to needy old age people and help them lead a better quality of life.

AroKleen Adult Diapers are the perfect solution to the problem of urinary incontinence increasing in elderly population both in males and females.

Urinary Incontinence is an involuntary leakage of urine and can occur in all age groups. The usage of Adult Diapers is very vast and not just restricted to senior citizens. Women may need adult diapers during pregnancy sometimes, uterus removal or normal aging post 60. Men may need adult diapers again due to aging, prostrate removal etc. These Diapers are also beneficial for a person with Alzheimer or for a person on a wheelchair who may be unable to reach and use a toilet on time.

The AroKleen Adult Diapers come equipped with a wetness indicator that indicates optimum utilization and indication of correct time for change thus keeping a check on the hygiene and wellbeing of the wearer. The Waist band at the back gives a perfect fit in all positions. Paramount’s state-ofthe-art production facility has the capability of producing very high qualities with smart leak guards. Smart leak guards prevent leakage from sides and a back lamination sheet helps to prevent hypersensitive reaction and allergies.

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Score’s R&D department is constantly developing new and improved hi-quality seating solutions. The famous saddle seats, the Score Jumper ® and Score Amazone ®, are Europeans’ standard in Dental and medical seating.

New branch in Taiwan

Score is experiencing more and more demand for her products from the Asia-Pacific region. Therefore Score recently set-up a branch in Taiwan. This branch is responsible for the sales in the region and operates as a logistic hub to save transport costs and –time to the Asia-Pacific customers. Also the level of service is highly increased by operating in the applicable timezone and in English-, Mandarin- and Japanese language.

Score solely operates with distributors and is currently looking for business partners supplying the dental and medical market in the Asia-Pacific region.

For more information please visit http://www.scorenl.com

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MEDICAL MANUFACTURING ASIA 2014 records strong growth in 2nd instalment, sets focus on 2016 edition

Encompassing a diverse and vibrant marketplace for the rapidly growing medical technology sector, MEDICAL MANUFACTURING ASIA 2014, jointly organised by Singapore Precision Engineering and Tooling Association (SPETA) and Messe Düsseldorf Asia came to a close on 11 September amidst resounding approval from visitors and exhibitors. Powering ahead from its successful inauguration in 2012, the 2nd edition of MEDICAL MANUFACTURING ASIA achieved strong growth, returning with 200 leading exhibiting companies from 20 countries.

With the significant increase in Asia in the number of downstream medical manufacturers and enhanced manufacturing capabilities on the back of global growth in the medical device sector, Asia represents exciting opportunities for companies keen to tap into the region. This increased focus on the region by medtech manufacturers has spurred national pavilion participation from Austria, China, Germany, Japan, and Singapore at MEDICAL MANUFACTURING ASIA 2014, contributing to the increased internationality of the exhibition, drawing 6,218 quality trade visitors, of which 35% came from the region. “We are pleased with the success of MEDICAL MANUFACTURING ASIA 2014. The second edition has not only seen a significant increase 14 | September-October 2014 | Medical Device ASIA

in the number of exhibitors but also a very good mix of Singaporean and international companies.

Visitor numbers have also been very positive, and we are greatly encouraged by the interest shown,” shared Jeremy Fong, Chairman, SPETA. Addressing the challenges of accessing Asian markets, with its differing market characteristics, MEDICAL MANUFACTURING ASIA serves as the central meeting place in Asia for the medical manufacturing industry to enhance capabilities and insights and to establish key business networks, providing the critical launch pad into Asia and particularly, the ASEAN region. Gernot Ringling, Managing Director, Messe Düsseldorf Asia, said “MEDICAL MANUFACTURING ASIA plays a significant role in bringing the latest medical manufacturing processes and technological capabilities to the fore, providing medtech manufacturers the opportunity to discover a suite of manufacturing solutions and develop business connections necessary to grow their business successfully in the region.” Enhanced business opportunities abound at MEDICAL MANUFACTURING ASIA 2014

Committed to advancing the manufacturing capabilities of the medtech industry, MEDICAL MANUFACTURING ASIA 2014 provided the ideal platform for medtech manufacturers and industry players to engage in meaningful trade and collaborative discussions. For Sunningdale Tech, a leading Asian tooling, plastics injection moulding and precision assembly company, MEDICAL MANUFACTURING ASIA 2014 was a very important exhibition to showcase their capabilities. “We’ve had many people come to us with their designs and discussions to mass produce, and we’ve engaged with many interested customers”, said Simon Tan, Senior Vice President. IVAM, a German association of micro technology and micro-nanotechnology companies and the organiser of a medical device symposium at the inaugural edition of MEDICAL MANUFACTURING ASIA, returned to the exhibition this year as a pavilion organiser as it aimed to foster better business relations between Southeast Asian companies and Germany.

“80% of our members produce

show|report products for the medical technology sector, and that is why we are here because we want to support our members to do business in Asia, as well as help Asian companies do business in Germany and Europe,” said Dr Thomas R. Dietrich, Chief Executive Officer. He added, “Our experience this year has been very good, and we have seen plenty of regional Asian visitors, particularly from Japan, China, Taiwan and Korea, making this a good hub for German companies to start their business in Asia.”

Exploring the next evolution of medical manufacturing with co-located conference Further bolstering the medtech experience at the exhibition was the concurrently held MEDICAL MANUFACTURING ASIA 2014 conference, themed ‘Reaching New Horizons in Medical Manufacturing’ which attracted 154 delegates over three days. A renowned panel of 15 international speakers came together to discuss the present and future of additive manufacturing in medical applications, exploring how additive manufacturing is causing a paradigm shift in medical manufacturing with wide-ranging topics covering many aspects including legal and policy implications, established and exciting future applications, clinical trends, new technologies, and the evolution of processes and materials.

Delivering the keynote address was internationally renowned speaker Professor Stuart Williams, Director, Bioficial Organs Program, University of Louisville, USA. “It’s a wonderful opportunity to see the interaction from people all over the world coming to Singapore to learn about the world-class state of the art capabilities here,” he said. Speaking on the exhibition, he added, “This is a great opportunity to explore the many manufacturers and instrument developers at this exhibition – it’s an overwhelming breadth of technology that you see from the medical device manufacturing sector.” The conference culminated in an insightful learning journey which saw delegates embark on visits to two additive manufacturing centres here - the NTU Additive Manufacturing Centre and the NYP Additive Manufacturing Innovation Centre.

Next Edition of MEDICAL MANUFACTURING ASIA The next edition of MEDICAL MANUFACTURING ASIA will take place from 31 August – 2 September 2016 in Singapore.

Trade visitors can expect a bigger and more dynamic exhibition showcasing even more medical technology players and a diverse line-up of regional visitors. -EndFor more information, please visit www.medmanufacturing-asia.com or contact: Zarina Ann Muhammad Marketing Communications Manager Messe Düsseldorf Asia Tel: +65 6332 9624 Email: zarina@mda.com.sg Desmond Cher Senior Marketing Communications Executive Messe Düsseldorf Asia Tel: +65 6332 9652 Email: desmond@mda.com.sg Medical Device ASIA | September-October 2014 | 15

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MEDICAL FAIR ASIA 2014 SETS NEW RECORD IN EXHIBITOR AND VISITOR PARTICIPATION The tenth edition of MEDICAL FAIR ASIA was a sell-out success, reaffirming its position as Asia’s premier medical exhibition. With a 50% increase in exhibiting companies compared to the previous edition in 2012, this year 800 exhibitors from 35 countries showcased the latest medical technologies at Suntec Singapore. Anchoring the international line-up of companies was a recordsetting 15 national and group pavilions from Austria, Canada, China, France, Germany, Hungary, Italy, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, UK and USA.

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ttracting a notable 10,780 trade visitors of which 40% came from outside of Singapore, MEDICAL FAIR ASIA 2014 has proven to be the preferred strategic business and procurement platform for the region’s medical and health care industries. Representing a 20% increase in visitor attendance from the previous edition, this year also attracted a strong line-up of government

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level delegations and hospital management personnel from Hong Kong, India, Malaysia, Philippines, Turkey and Vietnam.

“MEDICAL FAIR ASIA’s continuing and growing importance to the region and beyond has been demonstrated by the success of this year’s exhibition which continues to attract an increasing number of companies looking to do business in Asia as the region’s healthcare sector continues on a robust growth path,” said Gernot Ringling, Managing Director, Messe Düsseldorf Asia.

“The introduction of new initiatives such as the m-Health showcase focusing on ICT innovations and a robust business matching service which saw more than 55% of exhibitors participate in the programme, as well as visits to medical facilities organised as part of the concurrently run Singapore Medical & Healthcare Conference,

have played a significant role in providing value-added touchpoints to the exhibition which we hope to expand for the 2016 edition,” he added.

For German exhibitor specialising in medical packaging - Vereinigte Papierwarenfabriken GmbH, a returning exhibitor who has been participating at MEDICAL FAIR ASIA over the last eight years, according to its Area Sales Manager, Manfred Blunk, the exhibition serves as “a very important exhibition in Asia, and has international appeal.

We have received a lot of good contacts and expect positive results, and we’ll be here again in 2016.”

Echoing this sentiment was Singapore based company, ITS Science & Medical who showcased their modular operating theatre. According to Dennis Tan, Business Development Director, the exhibition was a “very good

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platform for us to advertise our services and products and it’s a great meeting spot for all our customers to come here and visit us and understand this new technology.” The ITS Group is a fully integrated scientific solutions group and was recently awarded the project to design, fabricate and build some twenty modular operating theatres in the upcoming Ng Teng Fong General Hospital.

For JETRO (Japan External Trade Association) and its eleven exhibiting companies, Mr. Yukihide Nakayama, the Japanese pavilion organiser, commented that with its particular focus on Singapore and the Asia market, MEDICAL FAIR ASIA 2014 is the right platform and “we have seen many companies from various countries, particularly from India, Malaysia and Thailand, and have had many successful business meetings here.” m-Health showcase - a successful look into the future of Healthcare

Anticipating the next evolution in healthcare and the industry’s shift to a more patient-centric approach, the m-Health showcase introduced new technologies that included telemedicine, digital and wireless healthcare applications to home-care monitoring devices and breakthrough innovations in rehabilitation. Technical Innovations, a Bulgarian exhibitor within the m-Health showcase introduced an innovative remote assistance system for the elderly and disabled, and was remarkably pleased at the exposure generated. Daniel Tsanov, its Chief Executive Officer said: “This is our first time in Singapore, and we are surprised by the great interest in our products. We have chosen to be here at MEDICAL FAIR ASIA as we believe the Asian market is a big and strategic market and the event provides great opportunities.”

Singapore-based company Neurostyle, manufacturer of neuro rehabilitation and diagnostic medical devices, said Medical Device ASIA | September-October 2014 | 17

show|report that the m-Health platform was a unique showcase and was able to bring “many quality visitors from different countries and definitely met our expectations”, said Dr Johnson Lu, Managing Director.

As for Hippus NV with their handshoe computer mouse which was ergonomically designed in collaboration with a medical university in the Netherlands, the m-Health showcase provided the ideal opportunity to tap into the Singapore and Asian market.

Drs Sjoerd W. Eisma said: “We are really happy to be here and with the number of contacts and new leads we gained from Singapore, China, and the Philippines. We will definitely be back in two years’ time.”

National groups from Canada and Thailand looking to grow its medical sector at the exhibition MEDICAL FAIR ASIA 2014 was delighted to welcome first time representation from Canada with seven participating companies across various sectors; B+H Architects, Covalon Technologies, Leafsprout Technologies, Mobilewellbeing, Nutralab, and Otosim, as well as the Canadian organiser from its Ministry of Economic Development Trade and Employment.

For MobileWellbeing, MEDICAL FAIR ASIA 2014 provided the perfect stage to promote their patient monitoring systems to hospital and homecare health providers in Asia, and they received “many interested parties who have asked for various product demonstrations, and we have gained great experience as a first time participant,” said its President and Chief Executive Officer Rajiv Muradia.

This year also marked strong Thai participation under the auspices of the Thai National Innovation Agency which featured eight outstanding local companies highlighting their latest innovations. According

to Kant Weerakant, Design and Solutions Manager for the National Innovation Agency, Singapore proved to be the right platform to showcase Thai innovations and to promote the made-in-Thailand brand as “the right profile of customers can be found at the exhibition.”

Diverse international representation draws approval from visitors, spurs business opportunities Visiting MEDICAL FAIR ASIA for the first time, Khairil Anuar Khalid, Senior Manager, Faber Group Berhad, commented he was very impressed with the representation of companies, products and services which spanned across four continents. “We also saw a good number of Asian companies exhibiting alongside the European countries. It is truly a convergence point for the medical industry and this will benefit the ASEAN medical sector even further,” he said.

As for Cesar O. Salazar, President, Surgico Phils Inc, who returned to MEDICAL FAIR ASIA 2014 having first visited in 2012, he was very impressed with the latest edition.

“There were many new products and innovations on display. The exhibition floor was buzzing with discussions between exhibitors and visitors and this is truly the place to be for the medical industry.

The organizers have done a good job in organizing a well presented exhibition”, he said.

Exploring new frontiers with co-located conference Held concurrently with MEDICAL FAIR ASIA 2014, the Singapore Medical & Healthcare Conference, themed ‘New Paradigms in Healthcare’, featured speakers showcasing cutting edge advancements in Singapore’s medical and health care arena, ranging from innovations in healthcare funding to next-generation healthcare technology. Presentations included an exploration of Google Glass and its Application to Healthcare and

18 | September-October 2014 | Medical Device ASIA

a look at future possibilities for smart glasses in hospitals. The conference culminated with a facilities tour that presented the 223 delegates with the unique opportunity to go behind the scenes and visit three leading healthcare facilities in Singapore – Fortis Surgical Hospital, Kwong Wai Shiu Hospital and the NUHS Advanced Surgical Training Centre.

Next edition of MEDICAL FAIR ASIA The next edition will take place from 31 August – 2 September 2016 in Singapore. Prior to this, Messe Düsseldorf Asia will organize MEDICAL FAIR THAILAND 2015, the 7th International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies, from 10 to 12 September 2015 in Bangkok, Thailand.

SOLED15–F - Focusable LED lamp for universal applications - SOLED15–F has a round shape that makes it handy and functional both in use and move.

Its easy-to-move structure is suitable for diagnostics, test labs and dental surgery and its easyto-grip removable and sterilizable handle makes it suitable even for critical sanitary applications.

- SOLED15–F is provided with an I-Sense@ touch panel to control all the functions of the lamp:

SOLED15–F is the focusable LED examination light for diagnostics,

minor surgery and universal applications. It can be used for minor precision surgery, intensive care, recovery room, first aid, cosmetic surgery and dental sector. SOLED15–F supplements the Starled Series range of lamps manufactured by ACEM Medical Company. SOLED15–F contains all the advantages of LED technology and is suitable for multi purpose uses thanks to its flexibility.

It assures: • excellent light intensity • IR-free light beam • colour temperature (CCT) of 4.500°K • colour rendering index (CRI) of 95 • long life • low power consumption - SOLED15–F grants a uniform distribution of light and can focus the light beam with a perfect illumination both on the surface and in depth providing the operator with the best working conditions.

- The high technological level combined with the use of highpowered LEDs allow the lamp to have a very linear yield and a negligible performance decay for its entire life duration.

- SOLED15–F has a light intensity of 50.000 Lux (large spot light beam) increasable up to 77.000 lux (small spot light beam) and a low power consumption (24 W).

• ON/OFF • Light intensity adjustment • Light beam focusing This last function makes SOLED15–F particularly suitable for applications in the dental sector, minor surgery, gynecology where a focused and deep illumination is required.

SOLED15–F is available in the

following versions: Ceiling mounted (single or double configuration) , Wall mounted, Trolley mounted ( ABPS battery on demand) ABPS is a new rechargeable battery powered system made by ACEM Medical Company dedicated to power surgical lamps as by European Directive 93/42/EEC SOLED15–F with ABPS supplies efficient light for every condition of use: in humanitarian interventions, in developing regions, in critical regions, in emergency situations, in case of sudden black-outs, where light has great importance but electrical power supply is not available and as a back-up lamp on field hospitals without UPS or power generators.

battery is within the trolley base.

The structure which covers and protects the battery is made of resistant plastic, and its dimensions are: 550 x 340 x 240 mm. The control panel on the structure allows managing all fundamental parameters, such as residual charge, type of power supply, recharge status and electrical power supply presence, amongst others. ABPS has an electronic control which allowts for automatic switch from electric power supply to battery power supply so that SOLED15–F can be used as a high performance mobile unit and 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.

ACEM SpA Medical Company Division Via della Tecnica 29 - 40050 Argelato Bologna – ITALY Ph +39 051 721844 Fax +39 051 721855 info@acem.it www.acem.it/en

SOLED15–F with ABPS has the same

- The LEDs layout gives a visual comfort and produces a uniform, homogeneous and shadowless light.

performance and appearance, since the structure containing the Medical Device ASIA | September-October 2014 | 19

Frost & Sullivan Applauds MobileHelp for its Targeted Supplies for the PERS Market Based on its recent analysis of the personal emergency response systems (PERS) market, Frost & Sullivan recognizes MobileHelp with the 2014 North America Frost & Sullivan Award for Price Performance Value Leadership.

MobileHelp’s leadership in flexibility across in-home and mobile usage directly captures expectations for tech progression in personal emergency response, and exemplifies key demands of US consumers for these solutions.

MobileHelp is at the forefront of convenience and utility in the M-PERS market and offers a simple two product option covering the range of use cases, with a uniform cellular rate plan. MobileHelp has been active in its dedication to broader mobile medical device product goals that augment its core capabilities in emergency response. Frost & Sullivan believes that both its referral branding within facility-to-home care as well as its increasing direct-to-consumer presence will allow it to expand a cost-effective product base across the medical and monitoring spectrum over time.

Primary consumer interest factors in PERS include price, reliability, contract flexibility, and customer experience of the emergency response. MobileHelp has delivered a strong value story for buyers with its simple interface and top-class emergency referral, including robust features and services provided in system pricing for its DUO series.

MobileHelp has been a pioneer in wearable devices with its wristwatch, which greatly reduces product bulk, damage through movement or falls, and issues related to daily forgetfulness of use.

Secondly, the two-step transition between the Classic and DUO product suites allows customers to seamlessly upgrade from 20 | September-October 2014 | Medical Device ASIA

indoor-only to mixed indoor/outdoor use, with no interruption to service.

MobileHelp also focuses on return guarantees, low obligatory service commitment and easy product upgrade, making its solutions very attractive for new buyers that are seeking emergency care support without product risk.

“Mobility is a key component of shifting customer expectations in personal emergency response systems,” said Frost & Sullivan Research Analyst Daniel Ruppar. Providing systems which broaden flexibility, while offering important ease of use, service support, and other high value factors supporting solution purchase decisions are key characteristics of leadership in this important Senior focused market. Each year, Frost & Sullivan presents this award to a company that has developed a product that offers price competitiveness, ease of use, as well as service effectiveness. Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for outstanding achievement in areas such as leadership, technological innovation, customer service, and product development.

About MobileHelp

MobileHelp is America’s leading provider of M-PERS (Mobile-Personal Emergency Response System) technology based in Boca Raton, Florida, and services clients in all 50 states. MobileHelp develops and distributes market-leading products such as Cellular DUO, the first and only fully integrated medical alert system with GSM/GPS technology, which provides an in-home cellular base station and a mobile device to protect customers away from home; and the Cellular Classic system, an in-home, cellularbased Medical Alert System. MobileHelp’s M-PERS devices are integrated with nationwide wireless voice, data and GPS technology to provide real-time medical monitoring services and location tracking for expedited personal emergency assistance. MobileHelp also offers Fall Button™, an automatic fall detection pendant and MobileHelp Connect ™ , an innovative event notification and web portal for customers, families and caregivers. MobileHelp has built a reputation for quality and affordable solutions for personal protection and peace of mind in or away from home and is the first FDA registered mobile medical alert system provider. For sales or more information about MobileHelp, call 1-800-800-1710 or go online to www.MobileHelp.com .

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Contact us: Start the discussion .

Contact: Mireya Espinoza, P: +1-210-247-3870, F: +1-210-348-1003 E: mireya.espinoza@frost.com; MobileHelp: liz.kohler13@gmail.com SOURCE Frost & Sullivan

Outlook for Hepatitis Patients Set to Improve with Development of Accessible Treatments

T

he Intellectual Property and Science Business of Thomson Reuters, the world’s leading source of intelligent information for businesses and professionals, today released a new study in recognition of World Hepatitis Day on Life Sciences Connect , a blog exploring the latest news and trends in Life Sciences and updates on the drug pipeline identifying multiple treatments in development that may serve as potential alternatives to Gilead’s Sovaldi, currently priced in the United States at $84,000 for 12 weeks of treatment -- $1,000 per pill.

Hepatitis is an inflammation of the liver and there are five main hepatitis viruses, referred to as types A, B, C, D and E -- plus types X and G. The five main types are of the greatest concern because of the burden of illness and death they cause and the potential for epidemic outbreaks. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer, killing close to 1.4 million every year according to the World Health Organization (WHO).

In late 2013, Gilead dramatically changed the hepatitis C treatment landscape with the launch of Sovaldi, an effective cure for many when used in combination with ribavirin. However, the high cost of the treatment keeps it out of reach for the majority of the estimated 130-150 million individuals suffering from the disease.

To raise additional awareness for World Hepatitis Day, Life Sciences Connect analysts complied Sovaldi-Innovative, Cost Effective, Unaffordable, utilizing Cortellis™Competitive Intelligence , the pharmaceutical industry’s leading source for drug pipeline, deals, patents, and company content, to evaluate the current outlook of therapies in the pipeline.

The analysis revealed several alternative treatments in various stages of development. This high activity is expected to create competition that will lessen costs of treatment, making it more

affordable and accessible to patients.

The following were among the key treatments found in different stages of development: Developer

Drug & Mechanism of Action

Indications Under

Development Roche mericitabine

a nucleoside analog NS5B polymerase inhibitor

(similar to Sovaldi)

Phase II for Hepatitis

Bristol Myers-Squibb orally available combination

therapies based on the NS5A

inhibitor daclatasvir, the NS3

protease inhibitor asunaprevir and

the non-nucleoside inhibitor of HCV NS5B Phase III Potential launch in 2015 Abbvie dasabuvir (non-nucleoside NS5B polymerase inhibitor)

veruprevir (HCV NS3/4A protease

inhibitor) and ombitasvir (NS5A

inhibitor), boosted by ritonavir

(+/-ribavirin)

Expected launch Q1 2015

The analysis also includes an infographic illustrating significant shifts in the Hepatitis drug market.

“We conducted this study in recognition of World Hepatitis Day to help raise awareness around this potentially devastating disease and spotlight some drugs in development that may help eradicate it,” said Jon BrettHarris , managing director of Thomson Reuters IP & Science.

“One of the largest barriers in treating hepatitis is accessibility, therefore it is critical to identify the key drugs in development that may help make treatment more attainable.”

Medical Device ASIA | September-October 2014 | 21

Migraine is not just another headache

it needs special attention and specific treatment writes Dr. Rajashekar Reddi, Head of Unit and Principal Consultant, Department of Neurology, MAX Hospitals, New Delhi • On Migraine Awareness Week (Sept 7-13), doctors educate people about the debilitating disorder that can jeopardize normal life • Chronic migraine can be controlled by medication and advanced treatment solutions like OnaBotulinum toxin type A

Lack of awareness also means that the society remains indifferent and unsympathetic to the condition of the patients suffering from the neurological disorder.

As we observe the Migraine Awareness Week, neurologists stress that it is important to educate people that ‘migraines are not just another headache’, and they require special attention and treatment to be managed and controlled.

V

eronica (name changed), a school teacher, had been living with a chronic headache disorder for years. Every Monday, she would return from school with a throbbing pain in her head that would continue for two days, deny her sleep, often cause her to vomit, and make her pop painkillers as a matter of routine.

Yet, for years, she or her family did not care to see a doctor, shrugging off the routine pain as just another headache. After 7 years of suffering when pain killers stopped proving any relief, she finally consulted a doctor who diagnosed her with migraine and suggested injections of OnaBotulinum toxin type A, popularly known as Botox, to relieve her pain.

A large number of people, especially in India, continue to suffer from the awful migraine pains that hamper productivity and disrupt normal life, without ever consulting a doctor. More women than men suffer from these intense bouts of pain, and continue to believe them to be just another form of headaches.

We come across patients who have been living with migraine for years.

They keep popping pain-killers regularly to be able to carry on with their lives. Only when the pain becomes unbearable and painkillers too stop having any effect, do patients see a neurologist, if at all.

It is unfortunate that a large part of their lives is spent in pain, many hours of productivity lost, pleasure forsaken, when this can be treated if medical help is taken. At the same time more intake of pain-killers have long-term side effects such as kidney damage as well as damage to the lining of stomach resulting in ulcer.

Invariably, women are more prone to suffer migraine as against men, with as many as 70 per cent of the sufferers being women. It is believed that hormonal ups and downs make women more prone to it. Sometimes the pain can even lead to sensitivity towards light and sound and cause dizziness and nausea.

The headache occurs at least two days a week; it is severe and difficult to bear and often forces the patient to find solace in a dark and solitary room. Till the headache lasts, some people can

22 | September-October 2014 | Medical Device ASIA

neither eat, nor get a sound sleep and even the slightest of sound can irritate them no end. In some people the pain is so excruciating that they feel like pounding their head on the wall. In a large number of cases women keep suffering from the pain without giving it due importance because women have a habit of keeping their own self at the last priority. Many people have no idea that migraine is a different neurological disorder and is not like other forms of headaches.

What is chronic migraine?

Chronic migraine is the term referred to migraine headaches that have lasted more than 3 months.

Migraine headaches result from a combination of blood vessel enlargement and the release of chemicals from nerves that causes the sympathetic nervous system to respond with feelings of nausea, diarrhea, and vomiting. The exact cause of migraine is not yet clearly known.

The pain typically starts with severe ache on one side of the head, and may spread to the entire head later. In some people, the pain may start due to exposure from the sun. Some may have extreme intolerance to heat in general.

Some people may find that stress, tensions or an emotional trauma may trigger their headaches.

Consumption of certain food items is another factor that triggers pain in some people.

What can be done?

Doctors often focus on preventive treatments of migraines to prevent the pain from starting and to keep triggers at bay. This is why an antacid is always prescribed by a doctor treating migraine so as to prevent acidity which is a major

trigger.

Other solutions include medication, nutritional supplements, lifestyle alterations, such as increased exercise, and preventing triggers.

The aim of such measures is to reduce the frequency and duration of migraines, and if possible also its intensity. These steps help in the overall treatment of the problem. Some people find these therapies effective and see radical improvement in their lives. However, in some people traditional methods do not yield results.

For such people OnaBotulinum toxin type A, popularly known as Botox, can be helpful. Approved by the Food & Drug Administration of the USA for prophylaxis in adult patients who suffer headaches on 15 or more days per month, each lasting more than 4 hours, the drug proves of great help in managing the severe pain in many people.

The drug works by temporarily blocking nerve signals that release such chemicals that cause inflammation and pain. Though chronic migraine cannot be cured permanently, OnaBotulinum toxintypeA can significantly decrease the severity and frequency of migraine attacks.

In ideal patients, the drug is administered in prescribed doses at specific sites on patient’s head and neck. The effect of this treatment lasts upto 3 – 6 months and the need for pain preventive and pain relief medication is dramatically reduced resulting in less sideeffects and improved quality of life of patients. The patient might require a lower dose of this in the subsequent sittings. v

Dr Supriya Shidhaye wins award for research Transasia launches Customer – Call Centre by (Hony.) Brig. Dr. Arvind Lal, Padma Shri, Chairman & on novel drug delivery system Managing Director, Dr. Lal Path Labs

Transasia Bio-Medicals Ltd. launched Customer Call Centre on August 8, 2014 at Transasia House, Mumbai.

This was officially inaugurated by the prominent and renowned (Hony.) Brig. Dr. Arvind Lal, Padma Shri, Chairman & Managing Director, Dr. Lal Path Labs.

At the opening function, Dr. Arvind Lal unveiled the plaque through remote access and made the first inaugural call to the centre declaring the Call Centre open. This was followed by the lighting of the auspicious lamp by Mrs. Mala Vazirani, Executive Director - Transasia Bio-Medicals Ltd.

Dr Supriya Shidhaye, a veteran in pharmacy education, has been chosen for the award for the best research by the Indian Pharmaceutical Congress Trust for her project to combine orally disintegrating tablet to treat paediatric asthma.

Dr Supriya, currently the principal of Vivekanand Education Society’s College of Pharmacy in Mumbai, has been selected for national award for the best research project. The award will be conferred to her next month at Pune.

According to her research, the two commonly prescribed prescribed drugs --Theophylline and Levocetirizine dihydrochloride –can be combined as a disintegrating tablet in a particular dosage regimen for the cost effective and patient compliant treatment of paediatric asthma.

“Theophyliine is incorporated as sustained release microcapsules and Levocetirizine dihydrochloride is incorporated as immediate release taste masked component. The novelty of combining orally disintegrating concept with sustained release is to provide benefit in many aspects to the patients. It will provide a benefit of pleasant taste, sustained action along with reduced frequency and convenience of administration. No such formulation of combination of these drugs is available in the market,” she said, adding that she had applied for a patent for the same.

Indian Pharmaceutical Congress Trust awards are given in various categories to honour the professionals in the pharmacy sector.

A Ph.D holder in pharmaceutics, Dr Supriya has been in the profession of pharmacy teaching for over two decades and she has over 40 published papers to her credit. She has been engaged in development of novel drug delivery systems. She is also an expert in stability study guidelines and protocols, validation techniques for dissolution and analytical methods, drug excipient compatibility studies and statistical data evaluation. She received best paper award for poster presentation at 50th IPC and 17th Asian Congress of Pharmaceutical Sciences on `Reorienting pharmacy education: need of today.’

For more details: Dr Supriya Shiadhaye: -022-25543600, email: supriya.shidhaye@vesip.org

With an enviable track record of over 35 years in the Industry, Transasia is a leader in Clinical Diagnostics and provides Total Solutions for Clinical Diagnosis in Biochemistry, Hematology, Immunology, Critical Care, Coagulation and Urine Analysis.

The inauguration of the Transasia Call Centre will add further value to our prompt service delivery. It will open new vistas in customer care. This would facilitate a swifter response time, technical help; prompt handling of customer calls, improved coordination leading to better deliverables, reaching out even to the far-flung areas.

Transasia’s Call Centre will extend its dedicated service to customers regularly between 8.45am – 7.15pm. Call toll free 1800 103 8226.

About Transasia Bio-Medicals Ltd. Incepted in the year 1979, Transasia Bio-Medicals Ltd., is headquartered in Mumbai, India.

It is one of India’s largest In-vitro Diagnostics Company and offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Electrophoresis, Molecular Diagnostics, Diabetes Management and Microbiology. Infact, Transasia is the first Indian company to manufacture and export sophisticated, state of the art blood analyzers and reagents.

Transasia is a part of the global ERBA Diagnostics Mannheim GmbH Group. The ERBA Group has spread its footprint across USA, Europe, Turkey and Eastern Europe, Russia and France, by means of various acquisitions – ERBA Lachema s.r.o.(Czech Republic), ERBA Russia (Russia), ERBA Diagnostics, Inc. (USA), Diamedix Corporation (USA), Delta Biologicals,S.r.l (Italy), ImmunoVision, Inc. (USA), Erba DDS (Turkey), ERBA Diagnostics France (France), JAS Diagnostics Inc. (USA) and Drew Scientific (USA).

Transasia manufactures and markets equipment and reagents, with an impressive install base of above 40,000 equipments across India. Transasia also exports to more than 94 countries in five continents.

The vast network of more than 150 service engineers, 350+ Sales and Marketing Team, 14 zonal offices, and 300+ Distributors allows us to reach out to customers across the length and breadth of the country.

Alliances with international partners like Sysmex Corporation (Japan), Medica (USA), Diesse (Italy), Immco (USA), Helena Bio-sciences (UK), Genprobe (USA), have ensured that cutting edge technology and solutions can be brought to India. Transasia markets, services and supports the Sysmex products and solutions in India. (www.transasia.co.in) With a vision of being recognized as a ‘local for global’ organization, Transasia continues to provide doctors and patients with reliable, affordable and innovative Medical Diagnostic Systems.

Medical Device ASIA | September-October 2014 | 23

Gen Next At The Risk of Hepatitis: Metropolis Metropolis study released on the occasion of ‘World Hepatitis Day 2014’ Metropolis Healthcare Ltd conducted a comprehensive study, ahead of ‘World Hepatitis Day 2014’. The study observed a worrying trend of Hepatitis B & C in major cities of India like Mumbai, Delhi and Chennai.

Hepatitis B is an infectious inflammatory condition of the liver caused due to Hepatitis B virus that spreads through exposure to infectious blood, vaginal fluid, and semen.

years, 3254 samples tested positive with Hepatitis C.

In order to understand the intensity of the disease in Mumbai, Metropolis Healthcare conducted an inclusive survey on 78, 102 samples. Out of the samples studies, 20.28% of the total sample was found positive for Hepatitis B.

At Metropolis, what we believe is what we say and what we say is what we do. Being empathetic to our customers and being committed to their needs is in our DNA. Metropolis has grown to harness a culture that is open, synergistic, progressive and scientific in nature.

HBsAg Screening (January 2012 to December 2013)

We are the Pathology Specialists delivering over 15 million tests a year, catering to more than 10,000 Laboratories, Hospitals, Nursing homes and 2,00,000 Consultants. With 33 years of experience in delivering accurate reports, Metropolis has earned the reputation of being India’s most respected and only multinational chain of diagnostic centres with presence in UAE, Sri Lanka, South Africa, Kenya, Mauritius and Ghana.

Note: (The above mentioned statistical data is just a representation from Metropolis point of view and cannot be considered as or indicative of National statistical data *) ABOUT METROPOLIS HEALTHCARE LTD.

Driven to make a difference, our wide network includes 105 state-of-art Laboratories across India with over 700 collection centres, processing over 4500 varieties of tests and supported by an efficient team of more than 3000 people. Equipped with cutting edge technology, innovative work equipment, expansive logistics network and rigorous processes, Metropolis ensures and delivers precision and accuracy in every single test; each time, every time.

The survey unveils the worrying trend of Hepatitis B in kid’s population of Mumbai, over 32.74% of children identified with the symptoms of Hepatitis B. Second maximum samples for the Hepatitis B belonged to 20 to 40 years. Since the younger age group is a sexually active group, and given the fact that Hepatitis B is a silent disease; the chances of infection spread are high. The disease can remain undiagnosed for years together, until the associated symptoms get pronounced. Also, the fact that this is the economically productive age group the economic loss to the country because of the disease is undisputable.

A significant finding of the survey also reported 17.97% of the total sample was found Hepatitis C positive. Hepatitis C Virus (HCV) is leading cause of chronic liver disease worldwide which may ultimately lead to liver cirrhosis or fibrosis or hepatocellular carcinoma.

HCV Total (January 2012 to December 2013)

In the last 10 years, Metropolis has expanded into new service lines like Clinical Trials, Hospital Lab Management, Home Health Services, Preventive Health Check-ups and Corporate & Wellness Solutions. Metropolis is at the forefront in adopting cutting edge technologies and services that contribute new revenue streams and has positioned the company on the pedestal it is today.

Today, we are one of the few laboratories that has received the CAP (College of American Pathologists), accreditation, the global gold standard in Laboratory Accreditation. 12 of our laboratories in India has received the NABL Accreditation (National Accreditation Board for testing and Calibration Laboratories). In addition, the central laboratory in Mumbai also adheres to CLIA (Clinical Laboratory Improvement Amendments) program and also follows the guidelines laid by GCP and GLP. Our unit in South Africa is accredited by SANAS (South African National Accreditation System is the only accreditation body approved by South African Government).

Metropolis has been awarded numerous accolades like the ‘Best Diagnostic Company of the year’ by Modern Medicare in 2006 and ‘Best Diagnostic Company of the Year’ in 2010 by Frost & Sullivan. Metropolis was also bestowed with ‘Best IT Integration in Customer Service Management’ at the e-Health World Expo 2011. Metropolis was also honoured with the ‘Quality Brand Award’ by NEHRDO in 2012. Metropolis won the ‘CMO Asia Award’ for Best IT practices in Healthcare in 2012.

The maximum positive samples for Hepatitis C belonged to the age group of 20 to 30 years. HCV is spread most commonly through unintentional exposure to infected blood. This was followed by a fairly substantial number of kids examined during the survey showed the symptoms of HCV positive. Out of 10,534 the tested sample in the age group of 0 to 10 24 | September-October 2014 | Medical Device ASIA

Metropolis Healthcare is led by Ameera Shah, Managing Director & CEO. An International & National Award winners, she was conferred with ‘The Young entrepreneur of the Year Award’ by GE in 2006 and ‘The Young Achiever of the Year Award’ at the CMO Asia Awards in 2011. She was also the recipient of the prestigious ‘Young Entrepreneur of the Year Award’ in 2011 organised by Entrepreneur India and Bloomberg. She has been honoured with ‘Women Leadership award’ at the World Women Leadership and Congress awards 2014. Recently she has been chosen as one of the most respected leaders under 40 years by Economic Times & Spencer Stuart (2014).

GE Healthcare and GSK to improve access of diagnostic testing for cancer patients a subscription-based service.

our clinical, technical and quality

develops. The first Clarient certified

These laboratories will be operated

management expertise to credential

laboratories are expected to start

by GE Healthcare, as per the terms

laboratory partners worldwide.

operations in different countries in

of the partnership.

"This global network of high-quality

early 2015.

diagnostic capability can be

G

The deal will allow GE to develop a

leveraged with confidence by all

GSK oncology companion

broader laboratory and data analytics

pharmaceutical companies in search

diagnostics and disease strategy

service that will enable better

of rigorously standardised oncology

head Jonathan Pan said: "Through

efficiency in the healthcare MARKET

diagnostic services and data."

this agreement, we hope to better

related to oncology precision

E Healthcare subsidiary Clarient Diagnostic Services has entered a

partnership with GlaxoSmithKline (GSK) to improve access to diagnostic testing for cancer

address the variability in access and The deal will see Clarient use GSK's

quality of diagnostic testing which is

clinical laboratory, pathology and

a common problem seen with

"The commercial testing

genomics expertise to certify

targeted oncology therapies and

infrastructure created through this

laboratories and generate diagnostic

related companion diagnostics

collaboration will enable advanced

data on metastatic melanoma

globally.

diagnostic solutions that should

patients.

medicine.

patients.

improve how patient care is delivered, where the certified

Initially, laboratory testing will be

infrastructure created through this

Under the deal, a network of clinical

laboratories are operational."

focused on more than 70 mutations

collaboration will enable advanced

relevant to melanoma, including

diagnostic solutions that should

Clarient Diagnostic Services CEO

BRAF V600E and V600K, and will be

improve how patient care is

Cindy Collins said: "Our arrangement

expanded to other tumour types, as

delivered, where the certified

with GSK will enable us to leverage

the network of clinical laboratories

laboratories are operational."

laboratories will be established to identify genetic mutations associated with different tumour types, and will be made available as

"The commercial testing

Medical Device Asia | September-October 2014 | 25

Aerocrine and Microsoft to test cloudbased remote medical device monitoring minimise exacerbations.

For this pilot project, proof-ofconcept will be conducted in autumn this year, and the data will be collected from Aerocrine devices deployed in Sweden, the UK and US. In the first phase, Microsoft will connect the Aerocrine devices to its secure cloud analytics platform, Microsoft Azure, to show the secure and accurate transmission of telemetry data.

Microsoft Sweden Industry MARKETING development manager Mathias Ekman said: "We are excited to work with Aerocrine on this project as part of the CityNext, Healthier Cities initiative to show the potential of new technology to drive

S

productivity and patient safety as we wedish developer of NIOX

the best possible outcome for the

brand medical devices

Physicians use Aerocrine's devices

Aerocrine has entered into

to measure fractional exhaled nitric

patient."

partnership with US-based

oxide (FeNO), a biomarker for

"A cloud-based solution allowing us

Microsoft for its secure cloud

allergic, airway inflammation which is

to collect data on device perfor-

services that will help transfer device

linked with asthma.

mance in real-time helps us to be

telemetry data.

more proactive in our customer Aerocrine CEO Scott Myers said:

support and ensure that our NIOX

The device's telemetry data will be

"The ability to collect vital telemetry

devices help the physicians deliver

transmitted from physician and

data from deployed devices has

the best possible outcome for the

company sites in Sweden, the UK

been a key objective of ours.

patient."

"A cloud-based solution allowing us

With the FeNO-testing device,

to collect data on device perfor-

physician can accurately identify the

The Swedish firm intends to use this

mance in real-time helps us to be

patients, the type of medication they

information to deploy its field

more proactive in our customer

should receive, as well as monitor

resources for customer service and

support and ensure that our NIOX

the patients' progress helping them

sales support in the future.

devices help the physicians deliver

to maintain adequate control and

and US back to Aerocrine for analysis.

26 | September-October 2014 | Medical Device Asia

move towards a mobile-first and cloud-first world."

Synapse completes enrolment in FDA post-approval trial of NeuRx DPS system in ALS patients

U

S-based Synapse Biomedi cal has completed patient enrolment in its postapproval trial of its NeuRx Diaphragm Pacing System (DPS) system for the treatment of amyotrophic lateral sclerosis (ALS).

and Drug Administration (FDA) specifically for ALS patients.

The system is a four-channel, battery powered neurostimulator with implanted electrodes and it provides electrical stimulation to the muscle and nerves of the diaphragm.

"NeuRx DPS is the only medical device approved by the US FDA specifically for ALS patients."

NeuRx DPS is the only medical device approved by the US Food

This humanitarian device secured approval at the end of 2011 with the demonstration of safety and probable benefit.

The post-approval study, validating the safety, is also intended to help identify the patient population that may benefit most from this therapy.

Synapse Biomedical president and

chief executive officer Anthony Ignagni said: "When we see the impact that this device can have for individual patients, we know that providing this supporting therapy is meaningful for ALS patients.

"Our FDA approval demonstrated the safety of the device and provided evidence of improvements in survival and sleep for these patients.

"It is our mission to make the NeuRx DPS available for the people with this devastating disease and to continue to advance the knowledge base of

how and who to best use it in."

The NeuRx technology was originated at Case Western Reserve University and University Hospitals Case Medical Center (UHCMC) for spinal cord injured patients and further it was developed by Synapse for ALS patients.

UHCMC chair of Surgical Innovation and Synapse Biomedical co-founder Raymond Onders said: "DPS has a proven safe role in maintaining respiration in ALS patients with one of our initial pilot patients using DPS for six years without the need for invasive ventilation."

Medical Device Asia | September-October 2014 | 27

MEDICA 2014 preview: Conference program with many highlights – providers with many innovations “Seeing that in previous years the new forums integrated into the trade fair had been initiated successfully and the internationalisation of the points in the program with many Englishspeaking presentations had been promoted, e.g. through the MEDICA TECH FORUM and the relaunch of the MEDICA HEALTH IT FORUM, this year’s conceptual focus is on the continuation of the live-cell therapy for the conference program started in 2013.” With these words, the trade fair director Joachim Schäfer summarised the crucial changes to the MEDICA 2014 – World Forum for Medicine (12 – 15 November).

The further development of the program particularly concerns the

MEDICA EDUCATION CONFERENCE. For this reason, the German Society for Internal Medicine (DGIM) was acquired as a partner. It has a network of 23,000 members in the fields of science, medicine and health services on a European-wide basis.

The motto of the content orientation of this year’s conference is “Science Meets Medicine” and provides a thematic integration between the conference program and what the trade fair offers. This is because medical advancement is often closely associated with technical developments.

Heart catheters, synthetic joint replacements, modern medical imaging would not be established standards nowadays without

28 | September-October 2014 | Medical Device ASIA

networking technical expertise and medical user knowledge.

The four days of the MEDICA EDUCATION CONFERENCE are dedicated to each area of focus respectively. Planned topics for this include infection and inflammation, telemedicine and robotics, cancer of the intestinal tract, as well as interventional medicine (surgical intervention).

With reference to the MEDICA conference program, other highlights include the 37th German Hospital Conference, as the leading event for the directors and management of German hospitals or also international conferences that were started last year, i.e.

DiMiMED (military medicine) and MEDICA MEDICINE SPORTS +

CONFERENCE (preventive and therapeutic sports medicine).

This year, the MEDICA PHYSIO CONFERENCE, which is organized

by Thieme and the training centre FiHH, is new in this year’s program with treatment-oriented lectures for the professional scene of physiotherapists. The main topic here being focused upon: Pain treatment and sports physiotherapy.

Innovations for the entire treatment process With topical information in connection with MEDICA presentations of the exhibitors and the MEDICA conference program, significant trends also convey numerous forums that

are integrated in the trade fair.

These include MEDICA HEALTH IT FORUM and MEDICA TECH FORUM (developments in the field of high-tech medicine) in addition to, among other things, the MEDICA PHYSIO FORUM (on professional questions of physiotherapists) as well as the MEDICA ECON FORUM, which was successfully initiated by the Messe Düsseldorf and the “Techniker Krankenkasse” (TK, a German health insurance company), on issues regarding benefit assessment and funding of innovations, primarily from the standpoint of patients and those who bear the costs.

In turn, as the world’s largest and leading market platform (again with around 4,600 exhibitors), the MEDICA will be used by medical technology suppliers to present the entire spectrum of new products, services and procedures to raise efficiency and quality in outpatient and in-patient care on almost 116,000 square meters of booked space.

Focuses of the MEDICA trade fair include: Electromedicine/medical technology (more than 2,500 exhibitors), laboratory technology/ diagnostics, physiotherapy/ orthopaedic technology, commodities and consumables, information and communication technology, medical furniture and specialist furnishings for hospitals and doctors’ offices.

A central strength of the MEDICA is that it not only deals with solutions for individual medical specialist disciplines, but for the complete “workflow” of patient treatment.

In reference to product developments, the advancements made, for example, in imaging technologies are impressive. Today, ultrasound devices of the best class offer a resolution and, at the same time, contrast with a penetration depth that would have seemed unimaginable just a few years ago.

There are already some systems that even have built-in “anatomic intelligence” consisting of an integrated database with anatomic structural models. In this way, better balance can be achieved if the transducer does not sit entirely right. Advantages also result in the creation of tomographies. As a result, an image quality is achieved that is even suitable for the high requirements of cardiology.

Automation and digitalisation in the operating theatre As a further crucial trend in light of the innovations of the MEDICA exhibitors, the advancement of digitalization and automation in the operating theatre can be accounted for. Altogether, information and medical technology continue merging with each other more and more. In operating theatres equipped with the state of the art and so-called hybrid operating rooms (with equipment for medical imaging “on the spot”), surgeons can fall back on a continuously growing number of systems that are able to facilitate intervention and patient monitoring in addition to even being able to assist in the process.

imaging and a defined planning and marking of the “target area” before operation. Medical technological equipment in the operating theatre is increasingly networked with one another and can exchange required information among each other or between the hospital operating system for intervention or for creating documentation. The various equipment can be centrally controlled by (touchscreen) panels that are easy to operate.

Marching on:“Wearables” Furthermore there is already a conceptual approach on how data glasses (“Google Glass”) could optimally support surgeons in connecting to patient monitoring systems on the head-up display, showing the most important vital signs.

By the way, wearables: Advancements in the field of sensor systems, material development, energy storage, and chip technology are motors for growth belonging to this diagnosis and communication “all-rounder” used

close to the body. The spectrum of current technology developments ranges from a chip-sensor bandaid to determining specific body parameters by connecting to a smartphone app, all the way to an application for use in the ear that is already ready for market. Thereby, heart frequency, core body temperature and oxygen saturation can be determined.

The Wearable Technologies Show being held in hall 15 communicates to MEDICA visitors a selection of wearables that possess a lot of market potential from a medical perspective.

Together with the supplier trade show, COMPAMED and its more than 700 exhibitors (12 – 14.

November 2014/ halls 8a + 8b), the MEDICA is occupying the entire Düsseldorf fairground. The target audience of both events exclusively include experts in the field.

Opening times: 10:00 am - 6:30 pm, Saturday 10 am - 5:00 pm (MEDICA only).

Systems that are established include those that are computerbased and navigate surgeons very precisely, controlling incision, on the basis of data of medical Medical Device ASIA | September-October 2014 | 29

Vacuum Dispensing of Ignition Coils: Sophisticated Technology Made Affordable

C

oating is one of the most complicated steps in the production process of ignition coils. Many believe it is also the most expensive. As a result, a large number of automotive suppliers hesitate to implement complex machinery to avoid procurement costs.

But there is an alternative to expensive custom-built systems, which has been around for some time now.

A cutting-edge economic solution for small to medium-sized automotive suppliers In addition to its proven vacuum dispensing systems, Scheugenpflug AG offers bespoke equipment modules customised for ignition coil production.

The system is a standardised set of modules which can be combined into a repeat-accurate vacuum production system sizeable to suit any budget.

The production line modules are manufactured in volume production, which gives them a major advantage over custom systems.

THE IDEAL PROCESS A vehicle that starts rain or shine and takes us reliably to our destination?

This is a matter of course for every car or lorry driver, whether air temperature is -40째C on ice and snow or 40째C on sandy roads with wind blowing. To master extreme conditions such as these is a quality standard for the automotive industry, which is a compulsory condition that ignition coil manufacturers must meet in all circumstances. Even the tiniest inhomogeneity, bubble or

cavity will result in a reject during production or in failure in the field.

To guarantee maximum operability of an ignition coil dispensing must be done in a vacuum. However, it does not suffice to merely carry out the dispensing action in a vacuum.

Ideally, the process starts with the proper preparation of the dispensing material.

Custom-built stirring mechanisms, tank degassing and material feed lines, pumps and valves sealed airtight are the minimum requirements to begin with. Dispensers in airtight design and a parametrised vacuum control round off the ultimate vacuum process. Most dispensing materials for potting ignition coils contain jagged fillers for better heat dissipation.

Conventional machines suffer increased wear and tear, which raises costs for spare parts.

Therefore, we use low-wear spare parts instead of expensive ceramic seals and robust pumps and dispensers. When potting ignition coils it is essential to remove all air from the delicate coils of the component. To get rid of even the tiniest bubbles of air deep inside the coiled section of the part air pressure is lowered to about one millibar or less (absolute pressure) during the dispensing process. This is a much lower pressure than in conventional vacuum applications.

A STANDARD SYSTEM WITH MODULAR DESIGN In addition to the proven and compact-sized vacuum systems Scheugenpflug AG offers several production modules optimised for

30 | September-October 2014 | Medical Device Asia

ignition coil encapsulation. Their material preparation units and vacuum chambers are equipped with more efficient pumps. Their double-walled hoses and lines (with a vacuum between the two tube walls) prevent air from diffusing into the dispensing material through the hose wall. Using these highly affordable accessories, every standard vacuum chamber becomes suitable for fine and high vacuum applications. Which means it can be used for filling ignition coils.

This modular plant design concept, which has already been implemented by many renowned automotive suppliers, uses standardised modules which can be flexibly combined with one another.

Since these modules are manufactured in volume production, they show a major advantage over custom-built systems. Thanks to their universal interfaces they can be easily adapted to requirements and retrofitted or converted should the need arise due to newly emerging

production requirements. If the system needs to be modified, the necessary module is added without having to discard existing machinery.

The controls are intuitive and their operation is easy to learn for handling personnel. This saves costs of training and familiarisation. It is an overall economic system which delivers output of highest repeat accuracy and superior process reliability, both in its semi-automated and its fully automated versions.

Scheugenpflug AG recommends consulting with a vacuum dispensing specialist from the planning stage of the system onwards. Many details, such as the design and shape of the substrate, upstream and downstream production processes, curing, etc. have considerable impact on the dispensing process. Therefore, professional analysis combined with mature processing technology and the correct choice of machinery can considerably lower INVESTMENT costs and reduced project planning times.

The New FDA Cybersecurity Guidance You Need to Know

T

he U.S. Food and Drug Administration wants medtech device makers to forearm themselves and their end users against cyber attacks. In a guidance statement, the agency said that although there has been no apparent security breach affecting medical devices, it recommends that medtech manufacturers “consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks.”

Manufacturers can further reduce the vulnerability in their medical devices by having a plan to manage system or software updates, the agency said.

The FDA is worried about:

Malware infections on networkconnected medical devices or computers, smartphones, and tablets used to access patient data; Unsecured or uncontrolled distribution of passwords; Failure to provide timely security software updates and patches among medical devices and networks; And security vulnerabilities in offthe-shelf software designed to prevent unauthorized access to the device or network.

and communicate with stakeholders about vulnerabilities. The agency is planning a public workshop this fall to discuss how government, medical device developers, hospitals, cybersecurity professionals, and other stakeholders can collaborate to improve the cybersecurity of medical devices and protect the public health. It is accepting comments on the guidance at http:// www.regulations.gov.

The industry has not been waiting for FDA to issue the call to arms.

Qmed reported in January that a search engine called Shodan is adept at discovering hard-coded passwords, permitting hackers to gain control of a medical device.

Types of medical devices with known vulnerabilities (based on Shodan searches and a June 13, 2013, Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) report include: Glucose meters; Surgical and anesthesia devices; Fetal heart monitors; Ventilators; Drug infusion pumps; External defibrillators; Patient monitors; And laboratory and analysis equipment.

Other concerns include medical device malfunction; disruption of healthcare services, including treatment interventions; inappropriate access to patient information; or compromised electronic health record data integrity, the agency said inannouncinga public workshop held recently.

The FDA has been working with other federal agencies and the medical device industry to identify Medical Device Asia | September-October 2014 | 31

After Patient Deaths, Thoratec Reinstates Former CEO

of how to use a new controller.

has slowly regained momentum, with an uptick to $27.74 following

The company announced in March

the announcement of Grossman’s

its plans to update labeling and

return.

training materials for the HeartMate II LVAS Pocket System Controller

Burbach left his executive and board

because some patients and

roles but will remain an advisor to

caregivers had trouble with the

the company through the first

process of changing from a primary

quarter of 2016, according to a

system controller to their backup

Thoratec statement.

system controller.

Grossman has worked in the Of these nine cases of death or

healthcare industry for 30 years,

serious injury, eight occurred in

most recently as president and CEO

patients who began using the

of Conceptus, Inc. The Mountain

Pocket Controller after having been

View, CA–women’s health medical

trained on an older model, the EPC

device company’s MARKETvalue

System Controller, according to a

tripled as its sales and profits grew

Qmed report. Two of the deaths

during Grossman’s tenure, Thoratec

involved patients who attempted to

said. Bayer Healthcare LLC pur-

exchange system controllers while

chased Conceptus in 2013.

alone and, contrary to the labeling, without contacting the hospital first.

Thoratec Corp. has replaced CEO Gary Burbach with the man who previously led the company for a decade.

N

ew president and CEO Keith Grossman served in those roles at the Pleasanton, CA–based company from 1996 to 2006, when Burbach took over. The shakeup follows the deaths of four patients

and reduced blood flow or lost consciousness in five others while using the company’s HeartMate II left ventricular assist device. The company and the FDA said the device was not at fault; rather, it was patients’ misunderstanding

32 | September-October 2014 | Medical Device Asia

During Grossman’s previous turn at Thoratec’s helm, the company made

Thoratec announced the release of

advances in the mechanical

an updated version of the Pocket

circulatory support MARKET,

System Controller on September 18.

boosting revenues and market value

The company said it would provide

significantly, the company said.

the latest version free of charge to cardiac centers and patients upon

Grossman has continued to serve

request. The exchange could cost it

on Thoratec’s board since leaving

up to $11 million pretax in the third

the company. From 2007 to 2011,

quarter.

Grossman was a managing director at private equity firm TPG, where he

In August, Thoratec’s STOCK fell to a

initiated and co-led the medical

six-month low of $24.05, after

device venture investing effort, and

having peaked in July at $24.71. It

served as a senior advisor to the firm’s buyout FUND.

Medtronic May Have to Pay a Lot More for Covidien

D

espite recent changes in U.S. tax rules that make corporate tax inversions less lucrative, neither Medtronic nor Covidien appear to be backing away from their $43 billion deal.

The new rules make it more expensive for Medtronic (Fridley, MN) to buy Ireland-based Covidien, potentially requiring Medtronic to borrow MONEY instead of using cash held abroad, according to a Reuters report.

The Treasury Department, for example, is cracking down on many of the FINANCIAL mechanisms— from so-called "hopscotch loans" to STOCK transaction mechanisms— that inverted companies use to access the overseas earnings of foreign subsidiaries of the U.S. company that inverts without paying U.S. tax. It is exactly such financial mechanisms that Medtronic was expected to utilize after merging with Covidien and moving its official headquarters to Ireland.

A Medtronic spokesman declined to comment on the Reuters report, reiterating the company’s initial statement.

"We are studying Treasury’s actions,” said Fernando Vivanco. “We will release our perspective on any potential impact on our pending acquisition of Covidien following our complete review.”

Vivanco declined to comment on how long the corporate review would take.

Covidien did not immediately respond to Qmed’s request for comment on the future of the deal.

However, Covidien CEO Jose Almeida wrote in an SEC filing last week that Medtronic and Covidien are moving toward consummating the deal and are continuing integration planning while evaluating

the new tax rules.

of corporate profits.

President Obama has defined corporations that pursue inversions as “moving their tax residence overseas on paper to avoid paying their fair share in taxes here at home."

Medtronic has an effective tax rate of 18 percent, similar to that of Covidien, according to the Reuters report. Medtronic has said the combined company's tax rate would decline by one or two percentage points.

Reuters quoted unnamed “people familiar with the matter,” who speculated that Covidien may need to lower its asking price and accept more STOCK and less cash to comply with the new rules.

Inversion was supposed free up billions of dollars for Medtronic that company officials say could then be INVESTEDback in the United States.

If the rules had been laws, the corporations’ deal would have allowed Medtronic to walk away unscathed, the Reuters report said.

However, because the U.S. changed the rules, Medtronic could be out $850 million if it abandons the arrangement. That breakup fee would vanish if shareholders of either corporation vote down the deal, the Reuters story said.

The companies had expected the merger to close in late 2014 or early 2015.

Tax inversion deals, which have been termed the “holy grail of tax avoidance” by a number of U.S. politicians, have been picking up recently as a growing number of companies look for ways to reduce their tax burden, Qmed has reported. As many as 25 U.S. companies are considering relocating their headquarters to lowtax destinations, according to the Irish Times.

The corporate tax rate in the United States is 35%—the highest nominal rate in the world, leading a number of companies to look for new domiciles in low-tax nations such as Ireland, the United Kingdom, Switzerland, and the Netherlands.

Medtronic has also pointed out that the U.S. is one of only six OECD countries that impose on its businesses the worldwide taxation Medical Device Asia | September-October 2014 | 33

Smart clothing Device FOURNIER

of BUSINESS CARDS.

Fournier show off his company's Hexoskin smart shirt at the Designers of Things event in San Francisco.

Enter smart clothing, which itself is anything but new. With roots stretching back to NASA’s Human Factors Group in 1985, smart garments have still not become mainstream. Even today, a NASA smart garment—known as ESEWT—looks like something out of a science fiction movie. Developed in collaboration with the Pratt Institute, the University of New Hampshire, and the British firm Rotite, the E-SEWT features an onboard battery and electronics.

The technology could assist astronauts in monitoring the spacecraft and performing emergency procedures while away from the cockpit.

“We'd like this part to disappear into the clothing, so you don't think about it,” said Pierre-Alexander Fournier, chief executive of Hexoskin in an interview with EE Times. “It could be the size of a button, run on a coin cell so you don't need to charge it, and be something you can put in a washing machine.

It is worth pointing out that in the past several decades, many other government-sponsored technologies have become a staple of modern day life. GPS technology was developed in the 1970s by the U.S. Department of Defense. And U.S. government-collected weather data gives millions of consumers access to real-time downloadable weather information and forecasts.

S

smartwatches, headset devices like Google Glass, and other body-worn devices will be with mainstream consumers.

Wearables may need such a transition—because while they were all the rage at CES this year, it remains to be seen how popular

While fitness trackers like the FitBit and the Jawbone have proliferated, their popularity is limited to a relatively narrow demographic.

What’s more, the bulk of wearables developed so far have trouble presenting the data they collect in meaningful ways.

mart clothing could help transition wearables from being a separate device to being one that users naturally wear.

The technology, which is already getting the attention of athletes, features sensors that disappear into clothing.

34 | September-October 2014 | Medical Device Asia

Perhaps NASA’s E-SEWT will ultimately provide the inspiration for smart garments for consumers that could track health metrics, human performance, and other variables.

Sister publication EE Times covers one consumer-facing wearable technology known as Hexoskin that packs two microcontrollers, a Bluetooth radio, A USB controller, memory, and a battery in the packaged roughly the size of a stack

We are not there yet, mostly because of power consumption, which determines the battery size and device form factor.”

The device can gather a range of health metrics including ECG, respiration, temperature, and blood oxygen level. In addition, the technology can come up with an estimate for blood pressure as well.

While the potential is there for this to be an important health monitoring technology for the mainstream, challenges certainly exist. For one thing, there is the gap between the clothing and electronics industries.

“It's like traveling back to the 19th century when you visit [clothing] factories,” said Fournier, in the aforementioned EE Times piece.

The technology is also still expensive. At present, the Hexoskin smart shirt costs $399 with onboard electronics included. But like nearly all electronics, those costs are set to plummet with time, which could make for an array of interesting health- and medical-tracking applications at some indeterminate point in the future. In the meantime, we can see whether the latest generations of smartphones, which include the ability to track users’ activity levels and other health metrics, will have a measurable influence on their user base.

Smartphone-based ECG Takes India

by Storm

A

network of hospitals in India has agreed to use AliveCor Inc.’s smartphone-enabled heart monitor to screen patients across that country for heart arrhythmia and risk of stroke, according to a joint announcement.

Apollo Hospitals will provide patients with the AliveCor heart monitors, which attach to smartphones, as part of its arrhythmia screening and stroke prevention program. The monitor is compatible with iOS and Android mobile devices to wirelessly record, display, store, and transfer heart rate and single-channel electrocardiograms (ECG), according to San Francisco–based AliveCor. Terms of the deal are confidential said AliveCor spokesperson Rebecca Phillips in an email.

“Apollo is our exclusive reseller/ distributor in certain south Asian

countries,” Phillips added. “They are authorized to sell and distribute our product through their channels, which include the pharmacies, physicians and hospitals.”

"We recognize the pioneering work that has been done by AliveCor in the U.S. and also the great value that this technology can bring to patients as we work to address the problems of arrhythmias in India," said Prathap C. Reddy, MD, chair of Apollo Hospitals, in the announcement. "It's extremely important for us to provide access to medical devices that are both clinically proven and cost-effective to help our patients manage their cardiac health.”

Apollo Hospitals operates 51 hospitals, 1,503 pharmacies, 92 primary care and diagnostic clinics, and 100 telemedicine units in 10 countries, according to the announcement.

AliveCor’s smartphone-based heart monitor was used in an Australian study to capture 30–60-second electrocardiogram (ECG) recordings and then wirelessly transmit them to the study's participating cardiologists for interpretation. The researchers reported that previously unknown AF was identified in 1.5 percent of the people screened; all were said to be at high risk of stroke.

AliveCor began working with Practice Fusion—the largest free, cloud-based Electronic Health Record (EHR) community in the United States—in February to enable heart patients to upload data directly from their devices to their EHRs. This uploaded data will be available to physicians and healthcare providers within seconds.

The company said in February that it is also creating a dedicated app for primary care physicians using the

Practice Fusion EHR. This will allow them to collect patient ECGs and request an analysis or "over-read" from licensed technicians or boardcertified cardiologists. This app will also keep track of patients' history over time. AliveCor says the subscription-based program will cost less than the price of a single device, which lists for $199 on the company's website.

The FDA approved the company’s smartphone-based heart monitor in 2012 and allowed it to be sold over the counter earlier this year.

AliveCor makes three versions of its heart monitor. It is available mounted in a case for the iPhone 5 and 5S or for the Samsung Galaxy S4, and with a universal attachment plate to fit other smartphones. The company's free AliveECG app is available in iOS and Android flavors. The app can email or print ECGs, or can save them as PDFs.

Medical Device Asia | September-October 2014 | 35

3-D Imaging Method Unmasks Secrets of the Beating Heart

O

h, my beating heart! One

with a fast, sensitive camera. High-

day, its image may be

speed volume scanning using a

captured in 3-D by a

liquid lens can resolve non-periodic

high-speed microscope designed

phenomena such as irregularly

by German researchers. Max Planck

beating hearts and the flow of

Institute Beating Heart

blood cells.

Scientists at the Max Planck Institute

“These renderings allow us to further

of Molecular Cell Biology and

follow characteristic structures of the

Genetics in Dresden combined

heart throughout the cardiac cycle,�

Selective Plane Illumination Micros-

said Michaela Mickoleit, a PhD

copy (SPIM) and inventive image

student who performed the

processing to reconstruct multi-view

experiments.

movies of the beating heart of a zebrafish.

This technology will allow scientists to observe cardiac contractions and

Each movie covered an individual

the distance between endocardium

plane of the heart. They then used

and myocardium throughout the

the correlations between the

heartbeat. They might achieve better

individual planes to generate a

resolution by manipulating the

synchronized 3D image of the

exposure time and magnification of

beating heart.

the images, enabling views of fine details such as sarcomeres and

Their work may help advance the

filamentous actin.

understanding of heart defects and further experiments on cardiac

The German research is among the

function and development,

latest to use 3D technology for

according to a press release from

medical purposes. In May, research-

the institute. It may also allow for

ers at the MIT Media Lab's Camera

imaging of hearts with arrhythmia.

Culture group said they built a prototype of a glasses-free 3-D TV

The research team stopped the

projector that can improve the

heart from beating by illuminating it

resolution and contrast of conven-

using optogenetics. (Zebrafish

tional video.

embryos can survive several hours

The researchers hope this could

of cardiac arrest.)

make it an attractive transitional technology, cheaper and more

They employed this non-invasive

practical than holographic video, as

technique to gently illuminate the

content producers gradually learn to

fish heart with a thin sheet of light,

harness the potential of

then observed the fluorescence

multiperspective 3-D.

36 | September-October 2014 | Medical Device Asia

Medtronic Hopes to Expand Cardio Biz

M

edtech giants jockeyed for attention to their coronary catheterization products at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting held this week in Washington, D.C., according to a report on bidnessetc.com and company announcements.

Minneapolis-based Medtronic had lots to talk about. The Food and Drug Administration gave 510(k) approval last week to its NC Euphora Noncompliant Balloon Dilatation Catheter for use in heart replacement surgeries. The company received the CE Mark to MARKET the device in Europe in May. Among the new products launched

by Medtronic this year is the the Reveal LINQ, the smallest insertable cardiac monitor now available.

The NC Euphora is inflated with high pressure to ensure that a drugeluting stent inserted to reopen a narrowed artery is fully expanded, aiding transfer of the drug to the artery wall, according to a company statement.

Medtronic also used the conference to tout the results of a study of 305 high-risk patients who received its CoreValve transcatheter aortic valve replacement (TAVR) device. TAVR is indicated for patients who suffer from narrowing of the aortic valve, or aortic stenosis, according to another company statement. It is less invasive than open-heart surgery

to remove and replace an older valve. The company recommends it for patients who cannot withstand open-heart surgery.

“Consistent with the positive oneyear clinical results, all-cause mortality (36.5 percent) and major stroke (5.1 percent) at two years were low for this extreme risk cohort,” the company said.

After two years, the CoreValue demonstrated good blood flow performance, consistent with onemonth and one-year rates, it noted.

The FDA approved the CoreValve on January 17. A Zacks Equity Research blog reported that Medtronic has evidently captured almost 40% of the U.S. MARKET in just two quarters after launching CoreValve in the U.S.

In other news this week, Medtronic announced the launch of its external, wire-free, adhesive heart monitor, the SEEQ Mobile Cardiac Telemetry System. Patients can wear the device for up to 30 days – even in the shower – to help detect and diagnose the cause of irregular heartbeats. Medtronic announced it was acquiring Corventis, Inc., which developed the technology, in June 2014.

The SEEQ system automatically sends cardiac data to the Medtronic Monitoring Center, where cardiographic technicians monitor data around the clock. Patients may also use a trigger button to alert the monitoring center to symptoms, the company said in a statement.

Minneapolis-based Preventice, which Qmed.com reported last week had merged with eCardio (Houston, TX), also makes a patchbased wireless heart monitoring system, the BodyGuardian. Worn on the chest, the BodyGuardian delivers information to a dedicated Samsung smart phone that conveys it to the patient’s physician.

Topping it all off, Medtronic this week was named one of the world's leading companies for sustainability on the Dow Jones Sustainability World Index for the fourth year in a row, according to a Thomson Reuters report. Criteria include economic performance, environmental stewardship and social responsibility.

Not to be outdone, Edwards Lifesciences, Medtronic’s primary competitor in this space, presented five-year trial data for its Sapien transcatheter heart valve at the conference. Inoperable patients who received the company’s Sapien heart valve experienced sustained improvements in heart function and fewer repeat hospitalizations, Edwards (Irvine, CA) said in a statement.

St. Jude Medical (Little Canada, MN) and Boston Scientific Corp. also presented data on their less-invasive heart valves at TCT. However, Medtronic scooped both companies, launching the first U.S. trials for its Evolut R transcatheters on Wednesday, Zacks reported.

Medical Device Asia | September-October 2014 | 37

Apple Has a Bug to Exterminate from Its HealthKit Apps

F

anfare for the iOS 8 debut of Apple’s HealthKit apps fizzled this week when the company announced a software bug would delay the apps’ availability for about two weeks when it would be offered as part of a software update.

Regardless, the iOS 8 operating system debuted September 17.

“We're working quickly to have the bug fixed in a software update and have HealthKit apps available by the end of the month,” a company spokesperson said in an email on Wednesday, Reuters reported.

HealthKit is now being tested by clinicians at Stanford and Duke.

Apple has touted the health–and–

fitness tracking software in HealthKit for its potential to communicate patient health data to hospitals and doctors.

After Apple’s iCloud suffered its own security breach, doubts were cast regarding the security of the HealthKit health-tracking platform.

Apple, however, has banned HealthKit apps from using the iCloud.

After Apple announced the HealthKit delay, several software developers took to Twitter, positing that data management may be causing the problem, according to a report on medcitynews.com. Highprofile organizations, including Stanford and Duke universities, are already working with Apple on

38 | September-October 2014 | Medical Device Asia

HealthKit, according to a previous HealthKit is “already helping top hospitals fight cancer, diabetes,” said Cult of Mac recently. Forbes responded that neither Stanford nor Duke have confirmed that a substantial number of patients are involved in HealthKit trials.

The app works by gathering data from multiple sources and pooling them in a central location so healthcare professionals can analyze health metrics. Regulated medical devices such as glucose monitors, heart and respiratory monitors, and other medical devices, would all connect to Apple’s platform and constantly stream data that patients can make available to healthcare professionals for monitoring

purposes. Apple removed some iOS 8-enabled health and wellness apps that would connect with HealthKit from its app store, including MyFitnessPal and Carrot Fit, Reuters reported.

Electronic health record companies, including Epic, Cerner and Athenahealth, are working with Apple to develop apps to integrate HealthKit with a number of hospitals across the United States, Reuters reported. In June, Qmed.com reported that Apple announced a similar partnership with the Mayo Clinic.

Apple promises on its website that the information transmitted via HealthKit will be private, and controlled by the end user.

A Blood Test for Diagnosing Depression

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method of detecting depression in adults from blood could be the first objective way to diagnose the condition, which affects almost 1 in 10 people in the United States according to the CDC. The test could be truly revolutionary.

While depression has become more widely diagnoses over the past few decades, its diagnosis is often based on vague criteria. WebMD, for instance, notes that doctors look to diagnose the condition by asking patients to self report “sadness or depressed mood most of the day or almost every day” or “loss of enjoyment in things that were once pleasurable.”

Recently Eva Redei, a professor of psychiatry and behavioral sciences at Northwestern University’s Feinberg School of Medicine, has developed a test which could point towards an objective method of detecting depression. In addition, the method could also help improve doctors and mental health

experts ability to identify which type of therapies will work best.

A study supporting the test is underway at Northwestern University’s Feinberg School of Medicine, as researchers have identified nine RNA blood markers that can be used as part of a panel to diagnose the mental disorder.

The study included 32 patients who had been independently diagnosed with depression in a clinical interview, along with 32 nondepressed patients as a control group. The study found the nine RNA blood markers at significantly different levels in the patients diagnosed with depression than in those in the control group.

According to the Anxiety and Depression Association of America, almost 15 million Americans suffer from major depression each year, however diagnosing depression can take anywhere from two to 40 months, resulting in delayed treatments. The hope is that this test

could provide a more timely, accurate manner with which to diagnose the mental condition, accelerating both treatment and therapy.

to be done for Redei and her team.

Researchers plan to continue to test the panel on larger population sizes, as they continue to gather data and refine the method.

“This clearly indicates that you can have a blood-based laboratory test for depression, providing a scientific diagnosis in the same way someone is diagnosed with high blood pressure or high cholesterol,” she said. “This test brings mental health diagnosis into the 21st century and offers the first personalized medicine approach to people suffering from depression.”

The team indicated that the study was supported by grants from the National Institute of Mental Health, and the U.S. National Institute of Health.

Redei previously worked on a different kind of blood test to help diagnose adolescent depression, citing that many of the markers that indicate depression in children were much different than the markers on the adult depression panel. This could eventually pave the way for doctors to test individuals early in childhood, as well as into adulthood for severe depression. Of course there is still a lof research left

Redei is still hopeful that identifying the presence of depression is just the beginning.

Researchers maintain hopeful that the test can not only help identify depression and therapy solutions, but also help distinguish between major depression and bipolar depression.

As we move forward into the realm of mental health discovery, Redei and her team look to establish some of the early building blocks of mental health diagnosis, helping us live healthier lives both physically and mentally.

Medical Device Asia | September-October 2014 | 39

How Nanotubes Could Improve Cancer Diagnostics

U

niversity of Houston researchers are using nanoscience to extract molecules from live cells without killing or damaging the cells. Their method could lead to new possibilities for diagnosing cancer and other diseases.

The scientists used magnetized carbon nanotubes to retrieve molecular information safely from the cells. Nanoengineering allowed them to keep the cells alive and to assess changes in the cells over time, Zhifeng Ren, a physics professor and principal investigator at the university’s Center for Superconductivity, explained in a recent news release.

Ren was lead author of a paper on the breakthrough published this week in the Proceedings of the National Academy of Sciences. His

lab collaborated with that of Paul Chu, founding director of the Texas Center for Superconductivity.

The current research builds on a paper Red’s group published in 2005 in Nature Methods, establishing that magnetized carbon nanotubes can deliver molecular material into cells. Now researchers can move molecules out of cells by magnetically driving them through the cell walls.

The researchers grew the carbon nanotubes with a plasma-enhanced chemical vapor deposition system, enclosing magnetic nickel particles at the tips. Each nanotube had a layer of nickel deposited along the surface to enable it to penetrate a cell wall guided by a magnet.

The magnetized carbon nanotubes acted as the transporter and a

40 | September-October 2014 | Medical Device Asia

polycarbonate filter collected material from cells derived from a human embryonic kidney cancer cell line. It was a “relatively straightforward” method, the researchers said.

The technology allowed the researchers to draw information from a single cell rather than taking an average of many cells. Previous methods, which damaged or killed cells, obscured the specificity of biomarker profiles, challenging researchers and limiting their efficiency, said assistant physics professor Dong Cai. Cai said the new method would be helpful for cancer drug screening and carcinogenesis study.

Scientists will now be able to further study and analyze the biological and chemical processes of the cell, holding out promise for biomedi-

cine, according to Ren. “The individual cells may be different, but you cannot see exactly how they function,” added Chu. Nanoscience is enabling all kinds of medical innovations.Other researchers have shown they can use a designer nanoparticle, which is only a few billionths of a meter, or the size of a few molecules, to attach molecules that perform different functions.

They can also design and fabricate a nanoparticle that contains a number of drugs, a cell-targeting vector, and an imaging component, as well as molecules that improve biocompatibility and uptake.

These precision-engineered nanoparticles may help perform imaging, drug-delivery, and cytotoxicity studies, according to research at Syracuse University.

Shining a Light on Skin Cancer (MMS) device was conceived by

connective tissues, lipids, and cell

referenced against a database of

University of Texas at Austin

nuclei. Pilot clinical trials are

dangerous or benign skin abnormali-

researchers, whose results were

underway for the 3-in-1 device and

ties. Other apps share the photos

published online on August 5 in

FUNDING agencies and start-up

directly with dermatologists, who

Review of Scientific Instruments,

companies have been reached to

provide a rudimentary diagnosis.

from AIP Publishing. The researchers,

help get the device to dermatolo-

from the university’s Cockrell School

gists.

Even present detection tools

of Engineering, say the combined

A

available to dermatologists inspect

light modes improve diagnosing

The American Academy of

potential cancers more superficially than the MMS device.

malignant melanoma and non-

Dermatology reports that one in five

new device could light

melanoma (basal and squamous cell

people will develop skin cancer at

the way to combating the

carcinomas) skin cancers.

some time; by 2015, one in 50 will

Dermoscopes shine light on the skin

develop melanoma. Reducing this

with enough magnification to see

most common form of

cancer in the United States. The skin-

Multiple spectroscopic techniques

rise requires new techniques that

pigment and structures. MMS, on

cancer detection tool combines

enable the instrument to detect

can reach more people, faster.

the other hand, can detect cell

three light modalities into one

changes in cells: diffuse reflectance

device for better detection, thereby

spectroscopic light, for cell changes

Other recent innovations in skin

ments. A dermatologist still must

subjecting only the most likely skin

in tissue microenvironments; laser-

cancer detection have put early

biopsy all potential skin cancers for

abnormalities to biopsy—the next,

induced fluorescence, for altered

diagnosis in the hands of the public,

definitive results. The improvement

more invasive and expensive stage,

tissue matrix, such as with collagen;

more than figuratively. New

in early stage detection, however,

of diagnosis.

and Raman spectroscopy, for

smartphone apps allow users to

could mean substantial reduction in

finding vibrational modes of

photograph suspicious moles and

the nation’s most widely-spread

chemical bonds like those in

have the images algorithmically

cancer.

The multi-modal spectroscopy

changes in tissue microenviron-

Medical Device Asia | September-October 2014 | 41

FDA sets guidelines for medical devices' cybersecurity

T

he Food and Drug Administra tion has released long-awaited guidelines on the cybersecurity of medical devices.

"There is no such thing as a threatproof medical device," said Suzanne Schwartz, director of emergency preparedness at the FDA's Center for Devices and Radiological Health.

"It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks," she said in a statement.

The agency is recommending that manufacturers consider cybersecurity risks as they design and develop medical devices.

Further, companies should give the FDA information about the potential risks they found and what controls they put in place to mitigate them.

The FDA will hold a national

workshop on medical devices and cybersecurity on Oct. 21 and 22.

"Guidelines," for companies covered by the FDA, are in effect rules.

Because the agency has the power to approve or disapprove the release of new medical devices, companies know they must follow its guidance.

While the FDA hasn't had any reports of specific medical devices being targeted by those wanting to do harm, concern over what could happen has been building for some time, because medical devices are increasingly connected to computer networks.

"Many devices are poorly secured and do not require a lot to hack. If there is sufficient incentive to do so, it will happen, causing harm to patients," said Shel Sharma, director of product MARKETING for Cyphort, a threat-detection company.

There are many ways a medical device could be subverted. It used to be that medical devices were stand-alone and relatively untouchable machines, unless someone with intent on harm was in the room with them.

manipulate those devices," he said.

"When it's specialized equipment, especially when it's not connected to the Internet, how do you hack that?" Chris Wysopal, chief technology officer of app security company Veracode.

At a minimum, medical devices should require secure authentication for access, use encrypted communication and make sure that security patches are always added. That will require device manufacturers "to change their mindset and build security from the ground up in the devices," said Sharma.

Speaking at a round-table discussion on medical device security at this fall's Black Hat security conference in Las Vegas, he described one company that used to make anesthesia carts that were all "fiddly dials and knobs interface," with no Internet access.

The company has now moved to an iPad interface that allows wireless access. "Now the hackers can

That's what the FDA is hoping to avoid, by pushing medical device makers to think about possible problems and their solutions before going to MARKET.

The guidance is better late than never, said Chris Petersen, chief technology officer for LogRhythm, a security company. "Many existing medical devices are running commercial or open source operating systems such as Windows or Linux," he said.

New vulnerabilities in these systems are being constantly discovered and patched. That's a problem, because many medical devices were developed "assuming they would never be patched, or patched rarely," he said.

The new FDA guidelines should begin to change that. But for now health care organizations must operate assuming "the adversary is inside now, or will be tomorrow.

They will need to deploy security strategies that address the fact they likely have thousands of insecure, IPenabled devices in their network," Petersen said.

42 | September-October 2014 | Medical Device Asia

Hopkins physician creates 3-D printed hands for pediatric patients pediatric patients.

Johns Hopkins trauma surgeon Albert Chi created custom hands using a low-cost 3-D printer, producing a device that is more child-friendly and affordable than a typical prosthetic, the Baltimore Sun reports. The U.S. Centers for Disease Control and Prevention reported that four in 10,000 children are born with some form of congenital hand loss, and insurance does not always cover pediatric prosthetics, costing patients and their families up to $40,000.

A

s the med tech industry addresses a growing need for devices geared toward children, a Baltimore, MD-based physician is creating 3-D printed hands developed specifically for

Chi produced the prosthetic hands for less than $20, and is working with nonprofit e-NABLE to distribute the devices at a much lower cost.

Children can put on the prosthetic themselves and easily manipulate it with palm muscles, providing a more wearer-friendly model than

traditional devices which typically cover the child's entire forearm, Quinn Cassidy, the mother of one of Chi's patients, told the Sun.

DexCom won FDA approval for a pediatric version of its G4 Platinum continuous glucose monitor for toddlers.

The innovation comes at a critical moment, as federal regulators and devicemakers are pushing for the development of next-generation devices created for pediatric populations. Last year, the FDA handed out $3.5 million in grants to 7 research consortia in September 2013 to spur the creation of pediatric-friendly devices.

Meanwhile, smaller operations and researchers are delving into 3-D printing as a viable therapeutic solution.

The industry took note, and companies like DexCom ($DXCM) and Minnesota-based Smiths Medical are rolling out new products with pediatric populations in mind. Earlier this year, Smiths added tracheostomy tubes for newborns and pediatric patients to its product line, and in February,

In August, Chinese physicians successfully implanted the first 3-D printed vertebrae in a young patient, replacing a section of cancerous vertebrae with a 3-D printed piece created from titanium powder. Last month, British startup Andiamo launched a crowdfunding effort to develop 3-D printed orthotic devices for disabled children.

The company plans to use FUNDS to reduce wait time for pediatric orthotics and test its products in patients to attract future investment.

Medical Device Asia | September-October 2014 | 43

Glooko enables wireless smartphone access for existing blood glucose monitors

and analyze trends has added efficiency within my clinical practice," Dr. Zachary Bloomgarden, an endocrinologist and professor at Mount Sinai Medical Center, said in a statement.

He added that the device ensures "that patients can more seamlessly share their data with me between visits, particularly those at higher risk, including women during pregnancy and poorly controlled patients initiating treatment with insulin. It should also help with patients who are not at high risk but for whom the ability to review home glucose monitoring results will improve adherence to the increasingly complex regimens of modern diabetes management."

The Glooko MeterSync Blue is FDA cleared and HIPAA compliant. The app is available for both iPhone and Android devices. It works with several models of blood glucose monitors from each maker including Accu-Chek, Bayer, Abbott, Nipro, CVS, Walgreens and Rite Aid.

B

lood glucose monitors that work with smartphones aren't new. But taking an existing blood glucose monitor, not designed to work with a smartphone, and enabling it to wirelessly sync up to a smartphone-now that is new.

GLOOKO METERSYNC BLUE-COURTESY OF GLOOKO This is the task that startup Glooko has undertaken--making tens of millions of existing blood glucose monitors transmit wirelessly to

smartphones. The company has launched a small device that plugs into more than 30 existing blood glucose meters that can transmit data wirelessly to a smartphone. Last October, Glooko launched the first version of the device, which required physical attachment via a second connector to the smartphone.

The startup's expectation is that health systems and payers will jump at the chance to collect data on their diabetes patients with the monitors they already have. Dubbed the

44 | September-October 2014 | Medical Device Asia

Glooko MeterSync Blue, the device transmits data wirelessly to a corresponding smartphone app. It does so after each reading, which lets patients view, analyze and annotate their blood glucose readings on their smartphone. The data is then transmitted to the cloud and the Glooko Population Tracker, which allows healthcare providers to identify patients with high or low blood glucose events. The tracker can be used to issue reminders to patients for timely blood glucose data. "Glooko's ability to sync blood glucose data from several meters

The startup recently partnered with the Joslin Institute for Technology Translation at the Joslin Diabetes Center to create a HypoMap to track and predict patients at greatest risk for hypoglycemia. As many as 269,000 U.S. diabetes patients were hospitalized last year due to hypoglycemia, according to Stanford University data cited by the company.

Founded in 2011, Glooko raised $7 million in January in a Series A-1 financing from new investors such as Samsung Venture INVESTMENT and Lifeforce Ventures, as well as existing investors including The Social+Capital Partnership.

Manufacturer buys Singaporean device industry supplier for $195M

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n a diversification bid, Charlotte, NC-based Carlisle Companies purchased Singapore's LHi Technology, a device industry supplier focused on cable manufacturing, for $195 million.

Carlisle CEO David Roberts said the acquisition helps the company "further penetrate the targeted healthcare MARKET by adding scale and technological capabilities while broadening service ranges to our customers in this very attractive market sector. This acquisition also furthers our strategy to diversify the end markets of Carlisle Interconnect Technologies into other higher

margin sectors that reduce our dependence on aerospace for growth," in a statement.

With annual sales topping $100 million, LHi Technology makes leads and cables for ECGs, ultrasound machines, surgical tools and imaging machines, according to its website.

The company operates a 150,000 square foot facility in Shenzhen, China, from which it manufactures and tests its products. The plant also has an external test lab for clients to test their own products.

Mexico, Germany and Japan. The company says its products meet International Organization for Standardization (ISO) standards.

LHi was formerly a portfolio company of international investor 3i Group plc. Its medical device focus will supplement publicly TRADED Carlisle's manufacturing businesses

focused on construction materials, defense, and foodservice, to name a few industries.

In the first half of 2014, Carlisle reported profits of $112.1 million on revenues of $1.51 billion. It has about 11,000 employees in 75 locations around the world.

Singapore-based LHi also has five offices in the U.S., as well as

Medical Device Asia | September-October 2014 | 45

Top VCs nurture consumer pregnancy startups, Glow and BellaBeat

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omen's fertility appmaker Glow raised $17 million to expand upon its launch a year ago, just as at-home pregnancy monitoring player BellaBeat rolled out three new products. Both 1-yearold startups are backed by high-flying tech VCs and are making sophisticated, consumer-friendly products aimed at helping women better manage and monitor their health that circumvent traditional healthcare providers.

Glow's financing was led by Formation 8, a $450 million tech-focused FUND that launched last year.

Peter Thiel's Founders Fund and Andreessen Horowitz.

Thiel is well known as a co-founder of PayPal, while Horowitz was a Netscape co-founder. BellaBeat emerged from well-regarded tech accelerator YCombinator; it got a $4.5 million seed round in May from backers, including SVAngel, CrunchFund, Universal Music Group, Cherubic Ventures and Promus Ventures.

Both startups aim to provide health information to consumers, but it's unclear as yet how they will navigate regulators. Reportedly, Glow has said its app may not need FDA clearance, while BellaBeat received FDA clearance for its smartphone-connected Doppler monitor to listen to the fetal heartbeat.

Glow has an app to track several fertility indicators including menstrual cycle, basal temperature and cervical mucus quality; it also has a day-by-day pregnancy app with tracking and information about mother and fetus. The startup also has a non-profit program that allows couples pursuing pregnancy to pool their pregnancy risk.

Each couple in a group contributes $50 monthly for up to 10 months toward a pool that goes to help pay for fertility treatments for the couples unable to conceive. Ultimately, the startup expects this detailed access to a massive amount of data on conception and pregnancy will allow it to provide better insights into fertility. After its first year, Glow said its users had a total of 25,000 pregnancies since last summer; but about half of its users are actually trying to avoid pregnancy.

"Glow is in a unique position to be a contributor to women's health worldwide. With its data science approach, they're putting together one of the largest fertility studies in human history, which has potential to impact countless women and couples," Joe Lonsdale

46 | September-October 2014 | Medical Device Asia

of Formation 8 said in a statement.

Glow also has ambitions to serve corporations, as well as individuals.

It is offering its service as a benefit employers can offer employees. The startup also hopes its data and analysis might be useful for insurers.

The company's co-founder and CEO Mike Huang told VentureBeat that providing detailed individual data to an insurer could result in better health insurance.

But that expectation runs counter to the ongoing concern that insurers and employers can use access to detailed individual health data to discriminate against them. Huang described the current insurer attitude as, "Don't tell me what you have because if you tell me what you have, I'm not going to help you."

Glow has raised a total of $23 million. It will use the latest financing to advance its big-picture ambitions; "To name a few, we'd like to double down on the product, on our data and research, and on insurance," Huang said in a statement.. Another consumer-focused pregnancy device startup, BellaBeat, rolled out three new products. All are designed to be attractive and appeal to consumers, and are made of wood, as opposed to the metal typically used in medical devices.

They include an updated version of its fetal heartbeat monitor, a wirelessly connected scale and a wearable activity, sleep and stress tracker. That last product comes as either a necklace, bracelet or pendant. And the scale is purported to provide separate weights for mother and fetus.

Founded last year, BellaBeat has sold 35,000 units with 200,000 downloads for its accompanying smartphone app.

The FDA takes steps to strengthen cybersecurity of medical devices

T

o strengthen the safety of medical devices, the U.S. Food and Drug Administration finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software.

As medical devices become more interconnected and interoperable, they can improve the care patients

receive and create efficiencies in the healthcare system.

Some medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.

By carefully considering possible cybersecurity risks while designing medical devices, and having a plan to manage system or software updates, manufacturers can reduce the vulnerability in their medical devices.

“There is no such thing as a threatproof medical device,” said Suzanne Schwartz, M.D., MBA, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health.

“It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from

those risks.” The FDA’s concerns about cybersecurity vulnerabilities include malware infections on network-connected medical devices or computers, smartphones, and tablets used to access patient data; unsecured or uncontrolled distribution of passwords; failure to provide timely security software updates and patches to medical devices and networks; and security vulnerabilities in off-the-shelf software designed to prevent unauthorized access to the device or network.

The FDA has neither an indication that specific devices or systems have been purposely targeted, nor reports that any patients have been harmed as a result of cybersecurity breaches, but remains concerned about device-related cybersecurity vulnerabilities and their potential to adversely impact public health.

The FDA has been working closely with other federal agencies and the

medical device industry to identify and communicate with stakeholders about vulnerabilities.

The agency is planning a public workshop this fall to discuss how government, medical device developers, hospitals, cybersecurity professionals, and other stakeholders can collaborate to improve the cybersecurity of medical devices and protect the public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Medical Device Asia | September-October 2014 | 47

FDA clears glucose monitoring system for use in hospital critical care units

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oday the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared

by FDA for use in these patients.

Blood glucose monitoring systems, also called blood glucose meters, are handheld devices that measure the amount of sugar (glucose) in blood by analyzing a small drop of blood that is placed on a test strip.

After inserting the test strip into the device, the system displays a glucose level reading. Blood glucose measurements are used in the management of many patients in the hospital, including patients requiring insulin to manage blood sugar, and in the assessment of blood glucose levels in newborn babies.

The Nova StatStrip Glucose Hospital Meter System is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients.

variety of health care professionals, such as nurses and technicians, to perform the test at the point-of-care, such as at a patient’s bedside, instead of requiring that the test be performed in a hospital lab (or other lab) that meets the CLIA requirements for high complexity testing.

The CLIA waiver will also allow hospital labs to safely provide blood glucose monitoring to their critically ill patients without having to meet the significant CLIA requirements for high complexity testing.

devices for use in all hospitalized patients.”

“This device provides an important public health resource for critically ill hospitalized patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Devices at the FDA’s Center for Devices and Radiological Health. “It is important for manufacturers of glucose meters used in hospitals to design and test their

Today’s clearance is for indications that include using arterial or venous whole blood from patients in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery. Data supporting this clearance included a study of more

Users of BGMS with manufacturer instructions that do not provide for use with critically ill hospital patients would be subject to the high complexity testing requirements under the Clinical Laboratory Improvement Amendments (CLIA) if such systems were to be used in the critically ill hospital population.

Those requirements include the validation of how well the BGMS worked in that patient population.

The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results, and granted with the clearance “waived” test system status under CLIA. This waived status will allow a broad 48 | September-October 2014 | Medical Device Asia

The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April of 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use with critically ill patients. The device manufacturer submitted a new premarket submission to the FDA seeking clearance of the device with this new indication.

than 1,650 patients with a range of medical conditions, taking various medications, and being treated in a variety of hospital departments, such as cardiac, emergency intensive care, and surgical. Results showed agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all patients types tested.

The Nova StatStrip Glucose Hospital Meter System is manufactured by Nova Biomedical in Waltham, Massachusetts. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample

T

he U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/ or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.

Yeast bloodstream infections are a type of fungal infection—they can lead to severe complications and even death if not treated rapidly.

These yeast pathogens may cause serious bloodstream infections in people with weakened immune systems, including patients undergoing cancer treatment, receiving immunosuppressive therapy following an organ transplant or severely ill patients in intensive care units.

Traditional methods of detecting yeast pathogens in the bloodstream can require up to six days, and even more time to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours.

Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results.

“By testing one blood sample for five yeast pathogens—and getting results within a few hours—physicians can initiate appropriate antifungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

T2Candida incorporates technologies that break the yeast cells apart, releasing the DNA. It then makes many copies of the target DNA, and detects the amplified DNA using magnetic resonance technology. If yeast DNA is found, T2Candida will also presumptively determine the species category to which it belongs, information that helps to guide health care providers to provide appropriate treatment.

The FDA reviewed T2Candida through its de novo classification process, a regulatory pathway for certain novel low- to moderate-risk medical devices. FDA based its review on a clinical study of 1,500 patients, in which T2Candida correctly categorized nearly 100 percent of the negative specimens as negative for the presence of yeast. In a separate clinical study of 300 blood samples with specific concentrations of yeast, T2Candida correctly identified the organism in 84 to 96 percent of the positive specimens. T2Candida is manufactured by T2 Biosystems, Inc. in Lexington, Mass.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Drug resistant bugs on the rise: Malaysia

T

he Malaysian Health Ministry has warned that indiscriminate use of antibiotics must be stopped as antimicrobial resistance could be a major public health SECURITY concern in future. The Ministry further said that overprescription of antibiotics for common ailments resulted in the DEVELOPMENT of antimicrobial resistant strains in the society. Dr Azman Abu Bakar, director of the medical DEVELOPMENT division of the Health Ministry, said, "The medical fraternity must preserve the efficacy of antibiotics and fight antimicrobial resistance by providing prescriptions for antibiotics only when necessary."

Dr Christopher Lee, senior physician, said that there is a substantial increase in resistant strains in Malaysia. He indicated that the levels of resistant Streptococcus pneumonia strains have increased by 18 percent in the last six years, while in case of Acinetobacter baumanii the resistant strains increased by 10 percent. Dr Lee added that the resistance of bacteria strains in the ICU and CCU has gone up by 50-60 percent resulting in the use of fourth generation antibiotics to treat simple illness. These in turn promote antimicrobial resistance, he stated. Dr Lee emphasized,"There has not been many antibiotics discovered in recent years, the US, one of the LEADING countries in drug discovery, has only released two new antibiotics. Things can turn fatal if people become resistant to the antibiotics that we have." -

India’s pharma export growth slowest in 15 years

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he Indian pharmaceutical industry exports will miss the target of USD 25 billion that was set for this fiscal as it witnessed the slowest growth ever in 15 years At 1.2 percent growth, to USD 14.84 billion last fiscal, regulatory issues and the increasing tension with the US over intellectual property rights have resulted in the slump Related Articles Jordan pharma revenue to reach $1 bn by 2015 India to join PIC/S to safeguard drug exports PHARMEXCIL kick starts India-APAC pharma meet Egypt seeking Indian pharma investment Singapore: The Indian pharmaceutical industry exports have registered slowest growth in at least 15 years, a news report explained.

At 1.2 percent growth, to USD 14.84 billion last fiscal, regulatory issues and the increasing tension with the US over intellectual property rights have resulted in the slump. The industry is said to miss the target of USD 25 billion that was set for this fiscal. The government strategy paper had set the target of USD 25 billion for pharma exports during 2014-15. According to the Commerce Ministry data, in 2012-13, the country's pharma exports aggregated USD 14.66 billion. The growth registered in 2013-14 is the slowest in nearly 15 years.

The previous slowest was in 2009-10 when the pharma exports grew by just 5.9 per cent. In calendar year 2000, they grew by 7 per cent. "2013-14 has seen slowdown in growth because of the U.S. raising concerns and due to increase in global competition," Mr PV Appaji, Executive Director, Pharmexcil told PTI. The US accounts for about 25 percent of India's pharma exports but shadowed by regulatory issues, the Indian industry is now facing a turbulent growth period. With further Indian patent process troubles for the industry, reports said that analysts are predicting more slow growth.

Medical Device Asia | September-October 2014 | 49

Singapore scientists find new pattern in immune cell mechanism

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cientists from A*STAR's Bioprocessing Technology Institute (BTI) have identified relationship between two cells which serve human body's natural defence mechanisms against diseases and infections.

Natural killer T (NKT) cells and B cells are two of many immune cell types that work in tandem to help the body fight against foreign infectious agents. NKT cells have very potent functions and are crucial to the immune system despite making up only a small percentage of white blood cells. While scientists have established that NKT cells can promote the production of antibodies by B cells to combat infection, little is known about the effect of B cells on NKT cells until now. Patients with autoimmune disorders have been observed to have drastically reduced numbers of NKT cells.

The study conducted by BTI scientists revealed that autoimmune B cells had altered lipid compositions, causing NKT cells to be over-activated and resulting in their eventual death and depletion in numbers. The scientists further found that removal of a lipid-presenting molecule from B cells resulted in recovery in the numbers of NKT cells. Lipids are a group of naturally occurring molecules that include fats as well as fatty acids. Lipids form part of each cell membrane and allow cells to store energy and mediate cellular responses. Dr Andy Tan, a research scientist at BTI who led the study, said, "Our findings provide an alternative theory to current understanding of how autoimmune B cells affect NKT cells. This will allow new therapeutic strategies to be devised, rectifying NKT cell deficiency in autoimmune patients and improving their health".

Canada bans three Indian API manufacturers

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potex Pharmachem India, Apotex Research and IPCA Laboratories are temporarily banned in Canada for data integrity issues Health Canada has raised its concern on data integrity Related Articles Aus Govt, Apotex sue Sanofi for extending patent Apotex recalls injection on behalf of Hospira Vietnam evicts substandard imported drugs FDA approves generic versions of Plavix Singapore: Health Canada, national health agency, has banned the import of health products from three different companies in India including Apotex Pharmachem India Private Limited (APIPL), Apotex Research Private Limited (ARPL) and IPCA Laboratories after USFDA spotted data integrity issues at their sites.

Health Canada has raised its concern on the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. The agency has not recalled any of the products but has stopped imports as a temporary precautionary measure until it is satisfied of the processes followed at these sites. According to Health Canada, the action would apply to finished products from Apotex and active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA. Health Canada has clarified that certain medically necessary products may be excluded from the action on the condition that they are tested by an independent third party before being released for use or sale.

50 | September-October 2014 | Medical Device Asia

Satish Jindal, BMS India R&D head, to lead US innovation venture

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llied-Bristol Life Sciences, a jointly owned enterprise between Allied Minds and Bristol-Myers Squibb, has appointed Mr Satish Jindal, formerly Vice President of R&D within BristolMyers, to LEAD the company's efforts to identify and foster DEVELOPMENT of biopharmaceutical innovations from top US university research institutions.

Mr Jindal recently headed up Bristol-Myers' research and DEVELOPMENT center in Bangalore, India, that focuses on discovery and early development of drug candidates in several disease areas, including oncology, autoimmune diseases and fibrosis. The center, called Biocon Bristol-Myers Squibb Research & DEVELOPMENT Center (BBRC), has about 575 scientists who have the expertise to conduct drug discovery and early stage drug development, and have successfully delivered several clinical candidates, contributing to the BristolMyers R&D pipeline. Under Mr Jindal's leadership, Allied-Bristol Life Sciences will have access to the scientific expertise from Bristol-Myers and BBRC, as well as the discovery and development resources offered at BBRC. Allied-Bristol Life Sciences currently has more than 100 opportunities under consideration. "We have a unique opportunity to create novel medicines in partnership with Bristol-Myers Squibb," said Mr Jindal, who will be based in Boston. "Through this innovator model of AlliedBristol Life Sciences, we can fill a critical gap that exists in translating highly important scientific discoveries from LEADING academic research institutions." Mr Jindal joined Bristol-Myers Squibb in 2011, and was part of the team that collaborated with Allied Minds to create Allied-Bristol Life Sciences earlier this year.

"Satish Jindal has a strong track record of successfully starting and building biotechnology companies based upon scientific discoveries which can lead to new medicines for the future," said Mr Chris Silva, chief executive officer, Allied Minds. "We are pleased to have him apply his vision and experience towards the success of Allied-Bristol Life Sciences." Allied Minds and Bristol-Myers established Allied-Bristol Life Sciences to work with university researchers to identify discoveries that have promising therapeutic and commercial potential, and to support the research and development needed to take these earlystage opportunities from initial feasibility to pre-clinical candidacy.

Once a program succeeds in identifying a pre-clinical candidate, Bristol-Myers will have the option to acquire the company from AlliedBristol Life Sciences under pre-agreed terms.

Prostate cancer: gentle removal with irreversible electroporation Interview with Professor Michael K. Stehling from the Prostate Center in Offenbach am Main, Germany In many cases, a prostate cancer diagnosis leads to the removal of the entire organ. Several therapies involve a severe outcome such as impotence or incontinence. Yet a surgical intervention doesn’t always eliminate the cancer completely. That’s why physicians debate whether radical measures are actually necessary. After all, prostate cancer grows very slowly.

Prof Michael K. Stehling; © Prostate Center in Offenbach am Main

Compared to prostatectomy or radiation therapy, the NanoKnife® therapy practiced at the Prostate Center in Offenbach am Main removes the tumors in a gentle manner. In this interview with MEDICA.de, Professor Michael K. Stehling explains the advantages of this focal therapy.

skin via the pelvic floor into the prostrate. The electrodes are exactly positioned to where they generate a treatment area that precisely includes the areas of the prostate that contain tumors. To do this, you need to know exactly where the tumors are located of course. Clinical diagnostics play a decisive role in this. The entire IRE intervention as well as monitoring and checkup subsequently take no more than 24 hours.

Which diagnostic procedures were used at the Prostate Center?

Stehling: Diagnostics with focal therapies are more elaborate than with radical therapy options. One essential component of diagnostics at the Prostate Center is magnetic resonance imaging or endorectal MRI. Accuracy is at approximately 85 percent in this case. However, the MRI is only able to illustrate macroscopic tumors, that is to say tumors that are between two to three millimeters in size. If you want to detect microscopic tumors, you can use the so-called transperineal 3D mapping biopsy. This is a systematic biopsy done through the skin of the pelvic floor, where a sample is taken exactly every five millimeters apart. Depending on how many samples are taken, we can put them together again using a special computer program and thus obtain a histological model. With the help of the MRI and the 3D biopsy, we map the relevant tumors or possibly all tumors that are currently in the prostate. These are subsequently removed using the focal IRE method.

Professor Stehling, what was the motivation behind the creation of a center that is exclusively devoted to treating and diagnosing prostate diseases?

Michael K. Stehling: I founded the Prostate Center in 2010 and was motivated by my colleague and friend Professor Ducksoo Kim at the Boston University. The idea was based on our joint work at Harvard Medical School in the nineties. Quite early on, it was clear to us that the existing diagnostic procedures and treatment methods for prostate cancer that are connected with massive side effects were imprecise and uncomfortable and are still today.

What technology is used in the NanoKnife® therapy?

Stehling: The technology behind the NanoKnife® therapy is called irreversible electroporation (IRE). IRE uses very strong electric fields to induce pores in cell membranes. The stronger the electric fields and the higher the pulses that affect the cells, the larger they become. Eventually they no longer close. Water enters the cells until they burst. What’s crucial about this procedure is that it is a non-thermal ablation method. This way only the affected cells are being destroyed. The advantage is that the tissue infrastructure, that being everything else that tissue is composed of such as fibers, the interstitial matrix or basement membranes remain intact. With other thermal ablation methods such as radiofrequency ablation or cryoablation for example, the tissue is melted away. All tissue components are destroyed and the melted tissue lump is then removed via an external removal process. First, this causes the typical pain from the wound healing process and second, significant scarring. Radiation therapy exhibits similar problems. With IRE on the other hand, there is no pain or scarring, because the inflammatory response is not being triggered. This is also called “induced apoptosis“.

Application of the NanoKnife® therapy during an operation; © Prostate Center How is prostate cancer removed?

Stehling: Unlike with prostatectomy, IRE does not require surgical opening of the abdomen or pelvic area. Instead, you insert electrodes through tiny holes in the

Therapy simulation in 2D and 3D. The electrodes embrace the area that includes the tumors in the prostate; © Prostate Center What are the advantages compared with traditional therapeutic measures such as surgery or radiation?

Stehling: There are significantly fewer side effects. In a group of 160 patients, we have treated so far, not one of them exhibits incontinence. What’s more, the percentage of impotence is also less than with other therapies. Oftentimes, impotence is only temporarily. The treatment is also completed within 24 hours.

Patients exhibit no wound pain. After IRE, all other therapeutic measures remain an option. That means, if IRE were to fail, you could still perform surgery or radiation on the patient or treat him with HIFU (high-intensity focus ultrasound). That being said, IRE can also be done in succession as often as you like. This is a major advantage, because after all of the other therapy options, in particular radiation therapy, this is no longer possible or just in a very limited way.

Can you envision NanoKnife® therapy being used in a broad clinical field and replacing treatment options such as surgery and radiation at least in the prostate cancer area?

Stehling: I sincerely hope that NanoKnife® therapy or a similar gentle procedure replaces radical therapy for prostate cancer. The previously performed procedures are extremely bad and often include significant adverse effects. There are considerable recurrence rates begging the question of whether they actually provide the patient with a survival advantage. This is doubtful in many cancer stages and is proven by statistics. I believe NanoKnife® therapy to be an intermediate stage on our way to tumor-cell specific therapy. I am sure that within the next ten years there will be methods that are able to selectively target tumor cells and spare healthy somatic cells. IRE is already selective on a cellular level, but is actually not tumor-cell specific. The ultimate goal has therefore not been completely achieved yet. Yet I believe this is a very important factor, because there is a paradigm shift in cancer treatment at the moment that comes from the U.S. They assume that cancer is a chronic illness. There is still a lot of work ahead of us in this regard.

The interview was conducted by Melanie Günther and translated from German by Elena O’Meara. MEDICA.de

Medical Device ASIA | September-October 2014 | 51

Accutronics Set to Launch Secure CMX Battery Power

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K-based battery firm Accutronics is set to vitalise the medical MARKET this autumn when it launches its next range of batteries at COMPAMED in Dusseldorf. The CMX series will

be launched at a press conference at COMPAMED, the international TRADE fair for high tech medical solutions on 12 November 2014.

The medical MARKET is currently undergoing rapid evolution with the likes of portability and freedom from AC power taking centre stage for doctors and emergency services.

COMPAMED is a fitting location for the CMX launch; a leading TRADE fair for the medical industry. It hosts 700 exhibitors from 40 countries in two exhibition halls taking up 10,000m² of floor space. The event covers the complete spectrum of medical products, from design and development to manufacturing and servicing. Visitors can expect to network with fellow production managers, engineers, designers, researchers and business leaders from across the sector.

Accutronics will be exhibiting in the main hall 8b on stand F30. The UK based battery firm specialises in the design, development and manufacture of smart batteries for industries ranging from medical, defence, industrial and for the portable, handheld MARKET. Accutronics managing director Rob Phillips said, "Without giving too much away, the CMX series launch brings together high-voltage, high-power and smart battery functionality in a package that exceeds the strict regulatory requirements for batteries used in medical devices.

"The medical device MARKET is currently undergoing rapid growth and the CMX series offers tremendous opportunities for OEMs developing devices for life critical applications."

The launch will spark interest from original equipment manufacturers (OEMs) in the medical sector, which is already familiar with similarly innovative launches from Accutronics in the past. Previous products include a credit card sized battery for handheld portable medical devices and a multi-battery system for powering medical carts.

All are part of the customisable Entellion range, which also offers algorithmic security to prevent the use of unauthorised, copycat batteries.

52 | September-October 2014 | Medical Device Asia

TDI Power Releases Two New Products to its Medical Power Portfolio

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DI Power has launched two new products to their medical

portfolio, both are medical and hospital grade devices certified to be used within the patient care area.

The launch took place at HIMSS 2014 in Orlando Florida, MediParc™ and MediPower™.

The products can easily be mounted to hospital mobile equipment, such as computer carts and other portable equipment to expand mobility and increase time of use without the need to recharge.

MediParc™ eliminates the use of power cords, making the charging of carts almost effortless.

The simple act of pushing a cart against the wall activates the charger without the use of a power cord. The wall docking system complies with UL1363A and improves the hospital workflow by removing the need to bend over and manually plug into the wall. MediParc will mount with any existing medical cart or portable equipment and will reduce hospital cost of ownership by increasing the life of the battery and reducing cart downtime.

We spoke to nurses and doctors to better understand their day-today use of Medical Carts and other portable devices. It became clear to us, that not just Medical Carts, but Vital Sign Monitors, Ultrasound Machines, and other medical devices require a more user friendly solution for battery charging. MediParc provides this solution.

MediPower™ next-generation is a fully integrated certified UL60601-1 Mobile Medical Power System. It combines ten+ years of experience in developing reliable and safe medical mobile power, with new product design innovation.

It is the lightest and most advanced power system on the MARKET, at a very competitive price. Its integrated system design provides all the necessary features to add extended battery life to mobile medical devices, and its flexible design makes it configurable to customer specific technologies without added expenses.

The MediPower series of products is reliable taking advantage of TDI Power's robust design, manufacturing, and test processes built on years of power system design for demanding MARKETS

Nanavati Hospital opens renovated cath-lab City’s iconic Dr Balabhai Nanavati Hospital has opened its renovated state-of-the-art new-look Cath-lab, as part of revamping its operations and placing it on par with the top healthcare institutions in the world.

Experts call for early treatment of facial nerve palsy to avoid deformities

Weakness of muscles of the faces, caused by facial nerve problems, should not be neglected, but need to be treated early to avoid deformity of faces, warn experts.

Radiant Life Care Private Limited, which recently took over the operations and management of the hospital, has installed the lab on a priority basis to put Dr. Balabhai Nanavati Hospital – Heart Institute (NHHI), one of the busiest in the City, on full stream with comprehensive facilities.

Radiant chairman Abhay Soi opened the new Cath-lab recently with all the leading cardiologists of the hospital and other top doctors of Dr Balabhai Nanavati Hospital.

“We are introducing the global hospital management best practices and expanding the operations to transform Nanavati into a world class facility.

The Cath-lab is just the first initiative in this direction,” Mr Soi said.

“The lab has state-of-the-art facilities to make it as one of the best in the country. Our lab is one of the busiest in the City and we perform on an average 3000 procedures every year,” said Dr Lekha Pathak.

Dr. Balabhai Nanavati Hospital – Heart Institute is one of the most comprehensive cardiac centers in the city with invasive cardiology, cardiac surgery, non-invasive cardiology and intensive cardiac care unit under one roof.

According to Dr K P Morwani, head of the ENT department of Dr Balabhai Nanavati Hospital, there is a tendency among the people and also the practitioners to neglect, sometimes due to lack of awareness, such symptoms which can lead to huge problems. “Causes of facial nerve weakness are various ranging from infections, trauma, tumors and also congenital (from birth). Correct diagnosis and management depends on a variety of factors. Facial nerve problems when treated early have an excellent potential for good results compared to longstanding problems. Some facial nerve problems require medical treatment but most require surgical treatment.

We have performed the entire range of surgeries for the facial nerve pathologies.

Our results have been more encouraging than many published in literature,” he said.

From August 22, the hospital has organised a three-day Facial Nerve Symposium, first time in the country, to educate the doctors on the importance and procedures.

It also coincided with 100th Temporal Bone Dissection Course. As many as 250 doctors attended the event that has unique live surgeries.

The experts also lamented on the lack of awareness among the ENT specialists across the country about ear infections which become complicated at later stage putting the life of the patients at risk. Most of the difficulties mainly arise because neither the doctors nor the patients know how to handle the situation. Sometimes ear infection can damage tiny bones in the middle ear leading to rare complications in the bone that is located behind the ear i.e. mastoiditis or damage the tissues surrounding the brain and spinal cord i.e. meningitis, Dr Morwani said.

He informed, “Ear infection can also lead to facial nerve problems that cause weakness of the muscles of the face and is very obvious on seeing the subject.

However it is important to notice that problems like facial nerve palsy caused due to complication of ear infection can be successfully treated if diagnosed properly.

Likewise, problem also lies in the fact even established ENT surgeons sometimes fail to relate ear infection to complicated problems like facial palsy, making matter worse for the patients.”

This course basically has been designed and tailor-made to train the doctors on the intricacies of conducting ear surgeries, which is not only a complex procedure but also is an area where hardly few ENT specialist have expertise in, according to Dr. K. T. Patil who was also a faculty of the programme. In fact, Nanavati has the distinction of being the only hospital in the country to conduct 100 ear surgery courses over the span of 16 years that has been delivered in shortest possible time by experts like Dr K P Morwani to sensitise and prepare the ENT surgeons to meet these challenges.

Dr. Narayan Jayshankar, Dr. Rahul Agarwal (Gwaliyar), Dr Sonal Modi (Akola), Dr Satish Jain (Jaipur), Dr Mahadeviya (Banglore), Dr Kirtane (Mumbai), Dr Hans (Delhi), Dr Ammar (Muscut), Dr Dipak Dalmiya (Mumbai), Dr Madhuri Mehta (Hariyana), and Dr Santosh Kakad (AIIMS, Delhi) were also among those to speak at the course.

Medical Device ASIA | September-October 2014 | 53

Gene interacts with stress and leads to heart disease in some people

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The researchers reproduced their findings using data from another study, the Framingham Offspring Cohort; © panthermedia.net/Harry Müller

new genetic finding from Duke Medicine suggests that some people who are prone to hostility, anxiety and depression might also be hard-wired to gain weight when exposed to chronic stress, leading to diabetes and heart disease.

An estimated 13 percent of people, all of whom are Caucasian, might carry the genetic susceptibility, and knowing this could help them reduce heart disease with simple interventions such as a healthy diet, exercise and stress management.

“Genetic susceptibility, psychosocial stress and metabolic factors act in combination to increase the risk of cardiovascular disease,” said Elizabeth Hauser, Ph.D. director of Computational Biology at the Duke Molecular Physiology Institute.

Hauser and colleagues analyzed genome-wide association data from nearly 6,000 people enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA). The MESA study began in 2000 to better understand how heart disease starts, compiling the participants’ genetic makeup as well as physical traits such as hip circumference, body mass index, cholesterol readings, glucose levels, blood pressure and other measures.

In the Duke analysis, the researchers first pinpointed a strong correlation between participants who reported high levels of chronic life stress factors and increased central obesity, as measured by hip circumference.

They then tested genetic variations across the genome to see which ones, in combination with stress, seemed to have the biggest influence on hip circumference. It turns out that variations called single-nucleotide polymorphisms (SNPs) in the EBF1 gene showed a strong relationship with hip circumference, depending on levels of chronic psychosocial stress. What’s more, among those with this particular genotype, hips grew wider as stress levels increased.

“With further analysis, we found a significant pathway from high chronic life stress to wide hip circumference, to high blood glucose and diabetes, to increased cardiovascular disease, notably atherosclerosis,” said Abanish Singh, Ph.D., a researcher in computational biology at Duke and the study’s lead author. “But we found this only in people who were carriers of the EBF1 single-nucleotide polymorphism, and this was limited to participants who were white.”

“These findings suggest that a stress reduction intervention, along with diet and exercise, could reduce the risk of cardiovascular disease and 54 | September-October 2014 | Medical Device ASIA

may be most effective in individuals with this specific genotype,” said Redford Williams, M.D. one of the study’s senior authors and director of Duke’s Behavioral Medicine Research Center.

Further studies will focus on additional genetic factors and why there might be differences in the genetic factors among racial/ethnic groups, including African-Americans, Hispanics and Asians.

“We need to figure out how these genetic factors influence the increased accumulation of fat in the central body and increased blood glucose levels in persons exposed to high life stress and why there are also differences with ethnicity,” Hauser said. “This knowledge could help identify targets for behavioral and drug interventions that could reduce disease risk.”

Concrete policy initiatives

yet to impact the business For the third quarter of Financial Year 2014 ended June 30, 2014, Siemens Ltd. registered an increase in Profit after Tax, which rose to Rs. 13 crores compared to a loss of Rs. 49 crores in Q3 2013. The Company registered New Orders of Rs. 2,744 crores compared to Rs. 2,619 crores in the same period last year. Sales stood at Rs. 2,319 crores in Q3 2014, compared to Rs. 2,588 crores in Q3 2013.

Sunil Mathur, Managing Director and Chief Executive Officer, Siemens Ltd., said, “Overall, the macro-economic situation is still challenging and concrete policy measures will take time to reflect in business.”

BeoCare Expanding Manufacturing Operations BeoCare Group Inc, a leading US manufacturer of medical textiles and consumables used in long term care facilities and hospitals, just closed on the acquisition of a new 42,375 Sq.Ft. warehouse in Hudson, North Carolina. The new facility at 1904 International Boulevard is across the street from the current 82,000 Sq.Ft. manufacturing plant. The new facility will be used for warehousing raw materials and finished product as BeoCare grows its product offering.

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