Medical Plastics Data Service Magazine March - April 2016

Table of

Contents Vol. 24

No. 2

Mar. - Apr. 2016

22 Cover Story

• Indian Medical Device Industry: Integrating Market, Technology, Innovation and Ecosystem - Dr. Jitendar Sharma, Head, Division of Healthcare Technology & Director, WHO Centre for Medical Devices, NHSRC, Ministry of Health & Family Welfare Govt. of India. Advisor (Health) to the Hon’ble Chief Minister of Andhra Pradesh.

Implementation of “IC-MED” in organization as well as for tracking adverse events will help to improve product credibility and profits......

• Important Announcements: - “IC-MED” - QCI-AIMED Voluntary Initiative On Medical Devices - Delinking Medical Devices From Pharmaceuticals And Revision Of Schedule MIII - BIS Certification For Medical Devices

26 Markets • Southeast Asia: Region On The Rise For The Medtech Industry - Asia–Pacific region accounts for half of the world’s population. MedTech market in Asia-Pacific is expected to reach US$133 billion by 2020, outstripping the European Union as the secondlargest MedTech market in the world....

27 Materials • Thermoplastic Polyurethanes: Enabling Innovative Competitive Technologies Through Advanced Materials.

- Dr. Pallavi Kulkarni, Technical Manager, Lubrizol LifeSciences The versatility and tailorability of thermoplastic polyurethanes has become an essential tool in the design engineer’s toolbox. TPUs have successfully replaced PVC for certain device applications where regulations prohibit the use of plasticizers.....

40 Product Gallery • Needleless Injection Site With A Non-Disconnect Male Luer Lock From Qosina

28 Global Trends • Medical Plastics Packaging Trends Keep Expanding

38 Industry News • IMDI 2016 Welcomes Govt Industry Friendly Measures Towards Growth Of Device Sector • CDSCO To Grant Online Registration Certificate, Renewal Of License For Import Of Medical Device Soon • Medical Plastics Market By Type, By Application And By Region - Forecast To 2020

20 Did You Know?

• About Effect of Medical Device Quality Performance on Business Performance

41 Events • Medicall 2016, 15th Edition: July 22 – 24, 2016, Chennai.

16th Edition: Sept. 09 – 11, 2016, Delhi.

• Medical Manufacturing Asia: Aug. 31st – Sept. 2nd, 2016.

• K 2016: Oct. 19 – 26, 2016.

• Medical Fair India 2017 : April 06-08, 2017 Mar. - Apr. 2016

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Flashback November 2003 From Editor’s Desk Dear Readers, “MEDICAL PLASTICS DATA SERVICE” is once again happy to announce a very important event: Seminar on “Medical Plastics : Materials, Applications And Processing For Medical Plastic Devices And Pharmaceuticals Industries” in co-operation with Popular Plastics & Packaging. To be held on January 24, 2004 at Ahmedabad, the Medical Plastics Industry will benefit from the leaders of the industry from all parts of the country including Mumbai, Delhi, Trivandrum etc. This issue covers more information about the Seminar.

This issue also covers the regular columns like Quality , Industry News , Global Trends , etc.

MEDICAL PLASTICS DATA SERVICE wishes “A VERY HAPPY AND PROSPEROUS 2004” to all our readers.

CONTENTS • Cover Story Specialise or Grow - Mr. Leendert Santema, CBI Consultant The Indian Medical Device Industry has not only been going Global but as per the CBI consultant on medical devices Mr Leendert Santeme, the industry is healthy enough to compete on the European market. As explained In the lead article in this issue by Mr Leen Santema, The European medical devices sector is clearly on the look-out for cheaper production countries and there is a definite shift going on at the moment. That means there is some very interesting opportunities for exporters from India.

• Announcement Seminar On Medical Plastics • Quality Medical Device Packaging requirements for Quality Certification of Medical Devices • Global Trends North American Medical Device Plastics Market to reach nearly 2.9 bn pounds by 2008 • Industry News - Stents: Quality Control is a Must - UL India offers safety certification for equipment vendors - New cobalt stent implanted in three cardiac patients in Hyderabad • Did You Know ?

About The Importance of Keeping Premixed IV Bags Covered in their Plastic Overwraps • Events - MEDICA/ComPaMED 2003 : Report - HOSPIMedica INDIA 2004 - Seminar on Medical Plastics • mediNETForum Networking Opportunities • Events Calendar

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Did You Know ?

?

About Effect of Medical Device Quality Performance on Business Performance A company’s quality performance can affect its business performance in multiple ways. For example, quality issues or the lack of them can enhance or impair market reputation; quality failures or failure prevention efforts affect costs; and the impact of quality on customer satisfaction can alter revenues. In extreme cases, quality issues can force the removal of a device, or a company, from the market.

The industry’s transformational growth and innovation have placed new burdens on quality systems. Evidence of this includes an increase in serious patient adverse events reported to the U.S. Food and Drug Administration (FDA) - those resulting in hospitalization, disability, or death - which is about twice as fast as the increase in the overall medical device market.

Quality issues rightly concern every stakeholder in the medical device value chain, from manufacturers and regulators to payors, doctors, and patients. Media attention has increased, and investors have severely punished some companies with quality issues. In the past decade, an average of one company per year has seen a 10 percent drop in share price after a single, major quality event.

The medical device industry is approaching a tip-ping point where the increasing likelihood of a quality event, the rising costs of such events, and the public nature of quality performance will force companies to focus on quality and reliability throughout product design, manufacturing, and marketing.

The good news is that companies in a wide range of industries have developed approaches that help them build quality into processes at every step of the value chain - from design and manufacturing to sales and service - which will lower costs over the long term.

Ref.: (http://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/ public%20sector/regulatory%20excellence/ the_business_case_for_medical_device_quality.ashx )

In a Nutshell....

JOHN LASSETER, PIXAR

Mar. - Apr. 2016

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.

ASSOCIATE EDITORS Mr. Rahil Engineer, B.E. (Biomedical Eng.) Ms. Bishuna Singh, B.E. (Biomedical Eng.)

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.)

Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India.

Dr. J. V. Tyagi Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.

However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

Mar. - Apr. 2016

Editor’s Desk

From the

The last two months have been very eventful for Indian Medical Device Industry with many important announcements both by Industry Association as well as Government and regulatory bodies.

To start with, the 13th National Conference and Technology Show Exhibition on Indian Medical Devices & Plastics Disposables /Implants Industry 2016 concluded on Feb. 12, 2016 was a great success. With highest ever participation by the stakeholders of the Indian Industry , it was lauded by all for the mission of creating an effective platform of interaction between Medical Device Industry and Technology / Service / Materials providers. A detailed report on the Conference and Exhibition is included in this issue.

As a “Key Note Speaker”, Dr. Jitendar Sharma, Head, HCT, Ministry of Health & Family Welfare, through his unique vibrant presentation, elaborated on major issues of importance to the Industry, namely – Quality, Infrastructure, Cost Reduction, Compliance and Reporting. He explained various Government initiatives for the benefit of Medical Device Industry which are highlighted in the abstract of his presentation covered in this issue. Dr Sharma appealed the Industry to “implement “IC-MED” & track adverse events for Credibility & Profits”.

“Indian Certification of Medical Devices Scheme (ICMED)” – country’s first indigenous quality assurance system for medical devices was launched on 15th March, 2016 in New Delhi in the presence of top representatives from government, healthcare industry and quality council fraternity.”

As per Mr. Rajiv Nath, Forum Coordinator, AIMED &Chairman, Technical Committee, QCI-AIMED Voluntary Initiative on Medical Devices, “The Scheme is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness in the systems and in due course will also bring respect to Brand India for those carrying this certificate”.

Another very important development was regarding delinking of Medical Devices from Pharmaceuticals. Through a notification, Ministry of Health & Family Welfare, issued draft rules to amend the Drugs and Cosmetics Rules by revising Schedule MIII. Regarding purchase of Medical Devices by Ministry Of Defense, The Director General – acquisition, Ministry Of Defense issued a notification formally accepting BIS 13485 as equivalent to US FDA and CE for QMS Compliance.

The “Did You Know” column in this issue briefly explains the effect of Medical Device Quality Performance on Business Performance. Quoting a Mckinsey report, it explains, “The medical device industry is approaching a tip-ping point where the increasing likelihood of a quality event, the rising costs of such events, and the public nature of quality performance will force companies to focus on quality and reliability throughout product design, manufacturing, and marketing.”

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Cover Story Indian Medical Device Industry: Integrating Market, Technology, Innovation And Ecosystem

Dr. Jitendar Kumar Sharma Head, Division of Healthcare Technology & Director, WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy, National Health Systems Resource Centre, Ministry of Health & Family Welfare, Govt. of India

Highlights of Presentation made by Dr. Jitendar Kumar Sharma during the 13th National Conference and Technology Display Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016, Ahmedabad.

Dr. Jitendar Sharma started his presentation by giving the overview of Medical Devices Sector. He said, “Medical devices Sector are complex knowledge driven field. It is not like producing microwave or transistor or fridge. It is so knowledge dependent that any lapse in knowledge can lead to adverse events.” He expressed happiness for the fact that the conference was jointly participated

by Universities and Industries. He appreciated the formation of Orthopaedic Implant Manufacturers Association (OIMA) explaining that unless there is a critical mass of people thinking together in the same way, no job can be done. He also mentioned that all the manufacturers will be benefitted by this.

Introducing Division of Healthcare Technology in National Health System Resource Centre which is at NHSRC under ministry of health, he explained that it is the technical secretariat not for regulation but for service delivery and industry promotion. During the presentation he elaborated on major issues of importance to the Indian Medical Device Industry namely – Quality, Infrastructure, Cost Reduction, Compliance and Reporting.

Quality He introduced the new quality assurance scheme, “Indian Certification of Medical Device Scheme (IC-MED)” - a joint initiative of Association of Indian Medical Device Industry (AIMED), Quality Council of India (QCI) & National Accreditation Board for Certification Bodies (NABCB). Explaining more he said that, “This IC-MED mark is a voluntary certification. It is not the replacement to what the regulators do; it is focused quality improvement strategy to improve medical device manufacturing processes. There are many standards in the IC-MED mark right from product manufacture, realization, process to safety to standardization etc.”

He suggested the industry to work together to make “IC-MED mark” a success. He also suggested the industry to have a joint training program so that QCI can offer an orientation program to understand & prepare the company for getting “IC-MED”.

Infrastructure Emphasizing on the importance of Cost Reduction for the industry, Dr. Sharma explained that for both, safety & cost reduction, it is

Dr. Jitendar Kumar Sharma is Head of Healthcare Technology Division and Director of WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy, at National Health Systems Resource Center, the technical support institution under Ministry of Health & Family Welfare, Government of India. He is also Adviser (Health & Medical Technology) to the Hon’ble Chief Minister of Andhra Pradesh and nodal officer for Andhra Med Tech Zone Project. He is a key designer and coordinator of several health technology programs in India and a faculty for courses on health technology policy & assessment in several countries. He is referred as the “Med Tech Man of India” for his contributions to the field of medical technology policy & programs.

He earlier served at Sri Sathya Sai Institute of Higher Medical Sciences, later as consultant to World Bank and then as Consultant to the World Health Organization, Geneva. He is Clinical Faculty at University of Adelaide, Australia and program director for Health Technology Assessment (HTA) fellowships in India. He has been an adviser at Health Technology Innovation Centre, IIT Madras and serves as faculty for National Accreditation Board for Hospitals (NABH) in India for Medical Devices. He has contributed through several research papers, seven books on health technologies & assessments, and six compendiums on technical specifications for medical technologies and has been contributor to several reports on health technologies by International agencies including WHO.

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Mar. - Apr. 2016

Cover Story essential to have right quality of infrastructure. Explaining the need for Medical Device Testing Laboratories in India, Dr. Sharma mentioned that two such laboratories are under process of implementation and will be in operation shortly- one in Noida for testing of electrical & electronic devices and second in Vadodara for biomaterials and implants testing.

He explained the quality of such laboratories abroad and emphasized the need for certified Medical Device Testing Labs.

In order to guide the industry, Dr. Sharma informed that Division of Healthcare Technology has prepared reports on establishing and operationalising medical devices testing laboratories. The reports have been made available at the WHO website as well.

Medical Device Parks In India Dr. Sharma informed that two Medical Device Industry parks are announced in India. He explained at length the benefits of such parks and mentioned that it will reduce the cost of manufacturing and make the indigenous products economical and affordable. In particular he informed that Govt. of Andhra Pradesh has decided to establish country’s first Medical Technology Manufacturing Park at Vishakhapatnam. The creation of such as park is based on the fact that medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufactures to invest upon. A park with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40%-50%. Currently, due to lack of such centrally located sharable facilities, either manufacturers do not undertake production of technologies requiring them or send their products abroad for process up-gradation and value addition.

While the park would have all such facilities in-house to reduce manufacturing process costs, the Andhra Med Tech Zone at Visakhapatnam would be located in an area which is well connected with Railways, Roadways, Waterways and Airways with near presence of Industrial Corridors, Port and Harbor to reduce logistical costs. The park will provide for all capital intensive common manufacturing facilities required by medical device manufacturers and modern state of art 100-150 independent manufacturing units, each of a built-in ready to use area of 1 to 2 acres.

Materiovigilance Program He explained the materiovigilance program designed on the line of Pharmacovigilance for medical devices. He further mentioned that 10 institutions are identified for reporting of adverse events.

He emphasized the need of having a medical device safety officer in each company who can get feedback of adverse events from market so that necessary improvements can be made at product level which would help improve product credibility and profits.

Innovation Emphasizing on the need for innovation, Dr. Sharma introduced the National Health Innovation Portal which carries out evaluation of the innovative medical technology innovation and provides report on whether the innovation is suitable to public health needs.

The evaluation is carried out by Division of HCT and then approved by a committee appointed by Ministry consisting of distinguished scientists as members which makes recommendation for uptake of innovative technologies. Dr. Sharma also explained the Mar. - Apr. 2016

proposed ‘Auction Program’ by government under which patents and prototypes that have been invented at research institutions would be auctioned to the industry thereby leading to transfer of manufacturing rights. Revenue thus generated could be shared with the institutions for carrying out further research and could also be used for supporting medium and small scale manufacturers obtain necessary quality certifications for their products.

Summarizing his presentation, Dr. Sharma strongly suggested the industry to appoint an officer for implementation of “IC-MED” in organization as well as for tracking adverse events. He mentioned that doing this voluntarily will help the industrial progress in a major way. He reiterated that the Govt. will create testing labs as well as Med Tech manufacturing parks which will provide manufacturing space with common facilities at substantially low cost. He also repeated his appeal to the industry to share knowledge on the National Health Innovation Portal.

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Indian Certification Of Medical Devices Scheme (ICMED) (ICMED)” – country’s first indigenous quality assurance system for medical devices was launched in New Delhi.

“ICMED”- a first home developed international class certification scheme for medical devices in the country is the joint initiative of Association of Indian Medical Device Industry (AIMED) and Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). “ICMED” is aimed at enhancing patient safety, to provide enhanced consumer protection along with product credentials to manufacturers for instilling confidence among buyers and users.

For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification and eliminate the malpractices of sub-standard or fraudulent certification or quality audits.“The scheme fills a big regulatory vacuum in quality certification space for medical devices in the country & will enhance the co-mpetitiveness and profitability of Indian medical device industry,” said Dr. V. K. Subburaj, Secretary, Dept. of Pharma, GoI .

“The Scheme is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness and in due course will also bring respect to Brand India for those carrying this certificate,” said Mr. Rajiv Nath, Forum Coordinator, AIMED &Chairman, Technical Committee, QCIAIMED Voluntary Initiative on Medical Devices.

The Certification Scheme being launched has presently two options for certification, one ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ for low risk medical devices and other ‘ICMED 13485 (An ISO 13485 Plus additional requirements) for medium and higher risk devices. A third level, which would additionally prescribe medical device specifications developed by NHSRC, Ministry of Health and Family Welfare is still under development and would be launched later.

According to Dr. M. K. Bhan, former Secretary to the Govt. of India, Dept. of Biotech, Ministry of Science & Tech., for a country like India, the twin challenge is to ensure availability of quality healthcare products at reasonable cost In this direction, the launch of “ICMED” is a significant collaborative initiative & will ensure realization of these objectives”. “QCI is happy to lend a helping hand to the medical device industry to showcase its strength in terms of meeting the highest international standards. It would contribute to the success of govt’s flagship Make in India program,”said Mr. Adil Zainul, Chairman, QCI.

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“NABCB is accrediting certification and inspection bodies and its accreditation programmes are internationally equivalent placing it on par with European and American accreditation bodies. This equivalence would help facilitate acceptance of “ICMED” certification in overseas market,”said Mr.Anil Jauhri, CEO, NABCB. The manufacturers would need to approach any one of the certification bodies approved by QCI under the Scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which would accredit these certifying bodies as per applicable international standards. The certification scheme is open to both indigenous and foreign manufacturers .

“ICMED” is the fructification of a MoU signed between QCI and AIMED on 30 Oct 2014 to fill the regulatory vacuum in quality certification space for medical devices in the country. The scheme has been developed involving various stakeholders with a Steering Committee chaired by Dr. M.K. Bhan, supported by a Technical Committee and a Certification Committee constituted for this purpose. More than twenty govt. and non-govt. organizations participated in various committees.

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Cover Story Amendment Of Drug Rule 76 To Delink Medical Devices From Pharmaceutical And Revision Of Schedule MIII And Its Alignment With IS/ISO 13485 Notified In the notification dated March 29, 2016, Ministry of Health and Family Welfare (Dept. of Health and Family Welfare) has issued draft rules to amend the Drugs and Cosmetics Rules, 1945 for which objections and suggestions are invited.

The words Schedule M and Schedule M III are replaced by Schedule M relating to pharmaceuticals products and Schedule M-III relating to Medical Devices and In-Vitro Diagnostics.

The Highlights Of The Draft Rules Are: • The provisions of this schedule shall be applicable to manufacturers of finished Devices, in-vitro Diagnostics, mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers and ligatures, blood and blood components (collection bags, intended for human or animal use and manufactured in India).

• Finished Devices means any Device or accessory to any

Device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.

• In-vitro Diagnostic means in-vitro diagnostics referred in this Schedule including diagnostic kits and reagents that fall under sub-clause (i) of clause (b) of section 3 of Drugs and Cosmetics Act, 1940.

• Medical Device referred in this Schedule means Devices that are notified under clause (iv) of sub-section (b) of section 3 of Drugs and Cosmetics Act, 1940.

• Regarding the work environment condition the Schedule has specified requirements for the following products: Cardiac Stents/ Drug Eluting Stent, Heart Valve, Intra Ocular Lenses, Bone Cements, Internal Prosthetic Replacement, Orthopedic Implants and Catheters/ I V Cannulae/ Scalp Vein Set. The detailed report is available at (http://www.cdsco.nic.in/ writereaddata/GSR%20357(E)%20dated%2029_03_2016.pdf)

Medical Devices With BIS Certification Is In Vogue With The “Make-In-India” Policy: DGAFMS, Ministry Of Defence • BIS 13485 certification is accepted equivalent to US FDA and CE for QMS Compliance.

• Formal recognition by Defence, not to keep USA FDA as exclusionary.

The Director, General-acquisition, Ministry of Defence has intimated that for technologically sensitive products or devices on which the life of the patient depends, it is the endeavor to procure the best product available globally which satisfy stringent norms for the device quality and patient safety. In the large interest of the patient and to administer or provide the best available treatment modalities, the equipment are required to be either USFDA or European CE or BIS certified. The item may be certified by any of the above certification agencies and not mandatorily by USFDA or European CE.

www.medicalplasticsindia.com

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS, DIAGNOSTICS AND PHARMACEUTICAL INDUSTRY

Published Since 1994 Medical Plastics Data Service, analyses data related to Medical Devices Technology and Markets from hundreds of sources.....distills it into meaningful information and insight to help your business succeed in today’s rapidly changing market place.

Mar. - Apr. 2016

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Markets Southeast Asia: Region On The Rise For The MedTech Industry Asia–Pacific region accounts for half of the world’s population. In recent times, there has been an increasing need for better access to modern MedTech in tandem with the growing demand for healthcare due to demographic shifts in income, population, disease burdens, and general awareness of health issues.

Supported by topical findings by McKinsey & Company, the prevalent demand for Medical Technology in Asia–Pacific is in proportion to the region’s growing silver population which will top 857 million come 2050. According to Medical Device and Diagnostic Industry, the trend is reflected in receipts as the MedTech market in Asia-Pacific is expected to reach US$133 billion by 2020, outstripping the European Union as the second-largest MedTech market in the world.

Echoed by Dr. Thomas Roland Dietrich, Chief Executive Officer of the IVAM Microtechnology Network, he shared that within ASEAN, there are numerous opportunity gaps to be filled in meeting the healthcare needs of its increasing population.

Government-led investment programs are channels to tap on for ASEAN nations to match up to European standards. Dr. Thomas also commented that, “the global move towards mobile diagnostics is important for ASEAN countries too, as it means heightened market potential for local and foreign MedTech companies looking to venture into the region.”

Asia-Pacific-The Fastest-Growing Market For Medical Plastics The Asia-Pacific region is the fastest-growing market of medical plastics, in terms of value and volume. High economic growth rate, growing manufacturing industries, cheap labor, increasing medical plastics patents, expansion, and global shift of consumption and production capacity from the developed markets to the emerging markets are few factors leading to the growth of medical plastics in this region.

China dominates the medical plastics market in Asia-Pacific. The growing middle class and the aging population, increasing purchasing power of people, improvement in living standards and demand for medical devices, technology upgradation in hospitals, requirements for higher quality products, and the development of China’s western regions are the major reasons that are driving the medical devices market in China.

The study has been conducted with various industry experts globally & sources have been divided in 3 categories: by company type; by designation; and by region. The by company type category states the company’s position in the market, that is Tier 1, Tier 2, or Tier 3. By designation refers to the position that the primary expert holds in the specific industry, and is divided in 3 subcategories:C-Level(CXO’s), Director Level, & Others managers, analysts, R&D experts, etc.) By region involves the Asia-Pacific, North America & Europe medical plastics markets for this study.

The report also provides company profiles & competitive strategies adopted by the major market players, such as Phillips-Medisize Corporation, Freudenberg Medical, Nolato AB, Röchling Engineering Plastics, West Pharmaceutical Services, Inc., Parker Hannifin Corporation, MedPlast Inc., GW Plastics, etc.

(Ref: http://www.kptv.com/story/31307337/medical-plastics-market-bytype-by-application-and-by-region-forecast-to-2020)

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Asia’s Leading Trade Fair for the Manufacturing Processes and Medical Technology Sectors Returns 22 March 2016 Returning for its third edition, the biennial MEDICAL MANUFACTURING ASIA 2016 – jointly organised by SPETA (Singapore Precision Engineering and Technology Association) and Messe Düsseldorf Asia, and modelled after the No. 1 global trade fair in the MedTech sector, COMPAMED, will be staged at The Sands Expo & Convention Centre (Marina Bay Sands, Singapore) from 31 August to 2 September 2016.

Well aligning to the trends of Asia’s budding MedTech sector, the industry-defining MEDICAL MANUFACTURING ASIA (MMA) 2016 will showcase an expansive range of products covering the upstream and downstream processes in MedTech sectors, including new materials, components, intermediate products, packaging and services, to micro and nanotechnology, testing systems and services, as well as materials, substance and components for medical technology, presented by over 200 established exhibitors from across the world.

The exhibition’s multifaceted line-up, tailored for the industry, will also feature a complimentary pre-event business matching service that would make face-to-face connections with some 7,000 industry specialists expected at the exhibition more targeted, as well as a concurrently held MEDTech Business Forum. Co-organised by Singapore Institute of Manufacturing Technology (SIMTech) and Messe Düsseldorf Asia, this forum will review trends in the Asian, European and American MedTech markets; examine how future needs can be addressed; and cover the pivotal roles that industry associations play in addressing the changing landscape.

Co-located with MEDICAL FAIR ASIA (MFA) 2016 – the No. 1 medical and healthcare exhibition in Southeast Asia with a focus on the equipment and supplies for the hospital, diagnostic, pharmaceutical, medical and rehabilitation sectors, MEDICAL MANUFACTURING ASIA 2016 is well set to be the regional gateway and an ideal business platform for exhibitors, buyers and visitors to source, exchange expertise and establish knowledge links, in capturing a bigger market share in the flourishing healthcare and MedTech industries.

Exhibition spaces are filling fast. For more information on MMA 2016, please visit www.medmanufacturing-asia.com. For more information on MFA 2016, please visit http://www.medicalfairasia.com/ Mar. - Apr. 2016

Materials Thermoplastic Polyurethanes: Enabling Innovative Competitive Technologies Through Advanced Materials Dr. Pallavi Kulkarni Technical Manager Lubrizol LifeSciences, U.S.A. Thermoplastic Polyurethanes (TPUs) are a class of polymers with unique physicochemical properties. They are inherently strong like thermoplastics yet flexible like elastomers, making them the most versatile class of polymers. TPUs are composed of soft and hard building blocks and the phase segregated morphology of these building blocks imparts physical properties that cover the entire range of polymers from soft, flexible elastomers to rigid engineered polymers and everything in between. Additionally, the soft and hard blocks can be chemically chosen such that they are biocompatible and biostable, suitable for medical applications.

TPUs are generally made from diisocyanates and diols. The diols can either be of high molecular weight, known as a polyol, or low molecular weight, known as a chain extender. The hard segment is comprised of diisocyanate and chain extenders. The soft segment is predominantly comprised of high molecular weight (~1000 Da – 3000 Da) diol. The hard or high glass transition (Tg) segment gives the polymer its strength while the soft or low glass transition segment imparts the material with flexibility. The thermoplastic polyurethane references to polyurethane that can be processed by common melt processing techniques such as extrusion to produce film, sheet or tubing and injection molding for complex component configurations. Thermoplastic polyurethanes can be classified in many different categories based on the performance of the material which is largely influenced by the building blocks used to produce the polymer. The major categories include those defined by physical aspects, hardness, and the chemical characteristics related to the diisocyanate and by the polyol used to manufacture the polymers. The typical hardness range for TPUs is from 70A elastomeric polymers to 85D engineered polymers.

Softer TPUs (50A-70A) are also commercially available. TPU hardness is generally controlled by adjusting the hard and soft segments ratio. TPU’s are generally plasticizer free but can be manufactured to include one if necessary.

TPUs are also referenced based on the nature of the soft segment or the polyol they are based on, i.e. ether, ester and carbonate.

The soft segment contributes the flexibility to the TPU. Ester are known for their strength and oxidative stability, ethers for low temperature performance and hydrolytic stability and polycarbonates combine the oxidative stability and strength of the Mar. - Apr. 2016

esters and the hydrolytic stability of the ethers. Yet another way of referencing TPU’s is by the type of diisocyanate being used, aliphatic or aromatic. A TPU comprising of a polyether soft segment and an aromatic diisocyanate based hard segment is referred to as “Aromatic Polyether TPU”. The chemical nature of the hard segment also contributes to the overall strength and chemical resistance of the final TPU. Aromatic TPUs are in general stronger and more chemical resistant than their aliphatic versions. This difference can be largely attributed to the ability of aromatic hard segments to organize and form crystalline domains. The percentage crystallinity increases with increase in the hard segment content of the TPU. Special considerations are needed to process TPUs with high crystallinity. Screw design and temperature profiles need to be optimized so as to ensure break down of these crystalline domains.

TPUs can be processed into high precision tubing and other medical c o m p o n e n ts by techniques such as extrusion, injection molding or dip casting. A key requirement before processing TPUs is to ensure that the resin is dried thoroughly, below 0.02% moisture. TPUs are hygroscopic polymers and can absorb up to 3% moisture under normal storage conditions. Moisture, combined with heat while processing can lead to degradation and other undesired characteristics such as air bubbles, rough surface and inconsistent dimensions in the final product. Among various drying techniques available, desiccant drying is the recommended method and is known to efficiently drive moisture from within the pellets. Guidelines to effective screw design and other processing considerations are largely dependent on the type of TPU, but generally do not tend to vary a lot among different families.

TPUs have found wide spread application in medical devices primarily due to its versatility in stiffness, chemical composition, processing and long history of biocompatibility. Over the past several decades TPUs have found applications in vascular, cardiac, neurovascular, urology, orthopedic and many other areas. Selection of a particular grade of TPU is based on the area or region of application inside or outside the body, duration of implantation, and the desired physical properties. The differences in chemistries Continued On p : 39

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Global Trends Medical Plastics Packaging Trends Keep Expanding In terms of the future, experts say medical packaging will be dramatically different by the end of the next decade. Medical device and pharmaceutical packaging will become easier to use, less costly to produce and provide much better protection in the future.

These significant changes in medical packaging in the coming decade will strongly impact the materials used in medical packaging. Many forces in alternative drug delivery methods, advances in interactive medical packaging and possible future legislation to require drug packaging to carry tactile (Braille) information are already laying the groundwork for this transformation.

To start with, the rapidly-changing healthcare industry is continually driving development of alternative drug-delivery systems including oral film, nasal spray and inhalation delivery. Such drug delivery systems significantly impact medical packaging material requirements as the packaging function is shifted from a passive to active one.

Factors driving these changes in medical delivery methods are pharmaceutical companies’ needs to extend the commercial life of patented drugs, the need by physicians to improve patient treatment/compliance, and added benefits that accrue to patients by facilitating drug delivery. Drugs delivered by these alternative technologies - especially those that are biologic based - are typically sensitive to moisture, oxygen and light and thus require high barrier packaging.

For example, pMDIs (pressurized metered dose inhalers) provide diabetes patients with a convenient alternative to the needle injection form of insulin. Aspira, a breath-actuated inhaler commercialized by Medicom, includes an integrated dose-counter, which can record up to 300 individual doses, important for people who have difficulties tracking their medication and can help with patient compliance issues.

In the U.S., the Food and Drug Administ-ration (FDA) is encouraging that each primary package produced s h o u l d carry a r a d i o frequency identification (RFID) tag

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with a unique code. Tags activate packaging line operations, such as labeling, provide data for pedigree records, and help track and trace product through the supply chain to prevent counterfeiting and diversion.

Medical packaging engineers increasingly need to work with formulation chemists to understand the specifics of the compounds they are packaging. A range of sorbents are increasingly used to avert chemical and/or physical degradation from occurring in the pharmaceutical package. These sorbents can be customized to eliminate oxygen from the packaged environment while managing free moisture and maintaining a specific equilibrium relative humidity, critically important to ensuring the integrity of certain new drug compositions.

For formulations used in new dry-powder inhaler systems a moisture-management system is needed to prevent the drug product from becoming hydrated and the particles agglomerating, or clustering together while also avoiding excessive drying that could promote static charge of particles and compromise the performance of the device.

Building further, terminally sterilized packaging harmonization is a technical market driver in medical plastics packaging. The International Organization for Standardization (ISO) has revised ISO11607 “Packaging for Terminally Sterilized Medical Devices,” to harmonize it with the European Committee for Standardization (CEN) EN 868-1, “Packaging Materials and Systems for Medical Devices Which Are to be Sterilized.”

The revised ISO 11607 is divided into two separate sections: “Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems,” and “Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes.” This latest revision takes into consideration the changes and advances in both technology and regulations in the medical device industry.

The Sterilization Packaging Manufacturers Council (SPMC), a section of the Flexible Packaging Association in the U.S., has condensed the complex requirements of the standard and associated guidance document into a two-article series with the first part exploring two critical areas: design inputs and the selection/evaluation of materials. Also analyzed is the design of the sterile barrier system and associated protective packaging, packaging process feasibility evaluation/optimization, and sterile barrier system design feasibility.

The law requires pharmaceutical/biotechnology manufacturers to provide serialized identification on prescription drug products and to produce ePedigrees as part of electronic supply chain records.

Each organization handling the drug at each stage of the supply chain must update the record. This ePedigree will track each drug at the smallest item level with a unique serial number and must be in an electronic format (e.g. RFID or variable bar codes) that is interoperable throughout the supply chain.

(Ref: http://exclusive.multibriefs.com/content/medical-plasticspackaging-trends-keep-expanding/engineering)

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Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

Manufacturer And Exporter Of a wide range Of Medical Devices Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests.

Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc...

The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing.

– Supply of Components for Medical Devices.

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India.

Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

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High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount MAr. - Apr. 2016

Mar. - Apr. 2016

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®

Alpha Medicare and Devices Ltd.

(taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests.

ISO 13485 : 2003 • Exporting our products to almost more than 23 countries.

Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com

0434

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •

Urine Container Adaptors (PP) Regulators / Cord Clamp All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures PP Mucas Container And many other Surgical Medical Components

Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : sanidhya.ent@gmail.com 36

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Industry News IMDI 2016 Welcomes Govt Industry Friendly Measures Towards Growth Of Medical Device Sector competitive technologies through advanced materials like T h e m o p l a s t i c Polyurethanes. One more important feature of the event was special focus workshop on second day which included workshop on ‘Bio-compatibility & Medical Device Testing’ offered by Chennai based leading “GLR Labortory” which was very well received by the industry.

The annual conference for the Indian Medical Devices and Plastics Disposables/ Implants Industry which has been organised since 2001 with close support and co-operation from Association of Indian Medical Device Manufacturers (AIMED) and other leading industry associations in medical devices, pharmaceuticals and plastics sectors is driven with the mission to create a platform for the Indian medical device industry and the technology/product/ service providers with an objective to facilitate an environment of healthy growth.

Speaking on the sidelines of the conference, Gujarat FDCA Commissioner Dr H G Koshia said, “The event is very much relevant for Gujarat as the state has the largest number of licensed medical device companies which are nurtured by Gujarat FDCA with an exemplary approach and has received recognition in the country.

This annual event being organised since 2001 has the sole objective of promoting “Make-In-India” mission focused on medical disposables and implants sub-sectors of Indian medical device industry.”

It has been organised over last 15 years with close involvement and support of the leading industry associations both in medical devices, pharmaceuticals and plastics sectors, government including regulatory agencies, research and academic institutes as well as large number of raw materials, equipments and expert service providers.

Leading polymer companies introduced new products including Lubrizol Advance Materials which highlighted innovative

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Rajiv Nath, forum coordinator, AIMED said the event comes at a time when various industry friendly measures have been taken by the government like reduction in the custom duty rates on the raw materials required to manufacture medical devices that will encourage manufacturing in India.

While Dr. Jitendar Sharma, director, WHO Collaborating Centre for Priority Medical Devices and Health Technology Policy, National Health Systems Resource Centre, ministry of health said that government’s plan to set up medical device parks will bring about quality, compliance and provide cost effectiveness by providing infrastructure to boost medical device manufacturing in India, Dr Kiran Kalia, director, NIPER, Ahmedabad informed that NIPER Ahmedabad as a centre of excellence is all set to provide a conducive environment to nurture innovators and industry to further the vision of quality medical device manufacturing in the country through synergies with the government and other stake holders.

Speaking on the occasion, deputy drugs controller Arvind Kukrety said that medical device industry is complementary to the customized healthcare trends existing globally and in India aimed at patient safety and industry compliant friendly.

The event was well received with support from almost 50 industry experts not only from all parts of the countries but also from foreign countries including USA, Europe, China, Singapore etc for sparing their valuable time and efforts and sharing their

techno-commercial knowledge and vision with about 700 or more delegates over two days. About 35 companies took active participation in the technology show exhibition.

The “Technology Display Show Exhibition” was held in conjunction with this conference. About 40 national and international companies showcased materials, adhesives, new technologies, manufacturing/testing equipments, packaging/sterilization equipments and services for medical device industry. It included leading companies like Lubrizol Life Sciences, Covestro, Shriram Axiall , Maider China , ET Elastomer Germany, Atachi Systems USA, VascuTech Medical USA, among others.

A parallel event held along with the medical device conference and technology exhibition was “2nd National Conference On Safety & Risk Management For Healthcare Professionals” for the benefit of healthcare professionals including doctors, nursing staff as well as technicians face a wide range of occupational injuries and hazards.

This conference was organised to create awareness and devise preventive strategies to minimise these risks.

International and Indian experts from the industry and leading hospitals shared their knowledge and experience on this critical issue of importance to healthcare professionals which included Tim Galekop from TiGaMed Consulting, Belgium, Dr Rajesh Shah, president, Gujarat Chapter, Associations of Surgeons of India, Sumit Marwah, director, Dispoline India Pvt. Ltd, Dr J L Meena, state quality assurance medical officer, commissioner of health, government of Gujarat, Dr. Mahesh Patel, quality and patient safety officer, Apollo Hospitals International Ltd, Ahmedabad.

More than 200 delegates from leading private and govt. hospitals including doctors, nursing staff, infection control and quality control staff participated.

(Ref: http://www.pharmabiz.com/ PrintArticle.aspx?aid=93473&sid=2)

Mar. - Apr. 2016

Industry News CDSCO To Grant Online Registration Certificate, Renewal Of Licence For Import Of Medical Device Soon The Central Drug Standard Control Organisation (CDSCO) is planning to launch an online portal for licensing the import of medical device under SUGAM, an online solution for submission, application and grant of permission for the import of drugs, in compliance with Union health ministry’s initiative of e-governance.

At present the portal only provides benefit for the grant of registration certificates for import of drugs or import license of drugs.

Soon the medical device industry can also avail the benefit of online grant of registration certificate and renewal of licence for the import of medical devices.

Dr. G N Singh, Drug Controller General India (DCGI) says, “We will be launching the portal soon and this initiative will put

the e-governance in place. So that the stakeholders get the licence in time & benefit of the devices are given to the patients on time. We want to reduce the regulatory requirement to the min. There should not be any regulatory hindrance for the industry which is doing so well. So we felt the need of launching the online portal for the medical device sector.”

Online licensing system provides an opportunity for user to apply for licenses through online licensing system. It also provides an option to track the status of application online through an application reference number provided by the system during the submission of application.

User can register themselves online for the user name and password and can

access the portal by logging through valid login credentials to apply for licenses. An online interface for user to submit fresh applications, upload supporting documents, respond to queries from CDSCO officials. The user account lists out all the licenses held by it through the country, licenses issued, suspended and cancelled, details of the facilities for manufacturing at each location, import licenses details, details of the technical staff working at each facility etc.

The applicants who can apply for the licence includes importer, Indian agent, corporate, foreign enterprise holding Indian subsidiary and manufacturing unit.

(Ref: http://pharmabiz.com/ ArticleDetails.aspx?aid=93504&sid=1)

Medical Plastics Market By Type, By Application And Region-Forecast 2020 The global medical plastics market is projected to reach USD 6,978.03 million by 2020, registering a CAGR of 7.12% from 2015 to 2020. The demand for medical plastics is high as they have excellent conductivity, tensile strength, long life span, and thermal stability. The growing demand from the Asia-Pacific region and the increasing application sectors such as implants, dental tools, drug delivery devices, surgical instruments, syringes, disposable medical devices, fuel the demand growth

Thermoplastic Polyurethanes

of medical plastics in the global medical market. Medical plastics are being used as the preferred substitute for traditional glass and metal instruments by major medical device manufacturers and suppliers globally.

Implants And Disposable Medical Devices – Fastest-Growing Application Market For Medical Plastics Medical plastics are used for manufacturing the outer body of the disposable medical devices. High tech (Continued From p: 27)

makes one type of TPU suitable for a certain application but unsuitable for another.

Medical Device industry has grown exponentially in the last decade with an evolving regulatory landscape. Device design engineers are constantly looking to create the next-generation device with advanced polymers and materials that offer an edge over existing materials. The versatility and tailorability of thermoplastic polyurethanes has become an essential tool in the design engineer’s toolbox. TPUs have successfully replaced PVC for certain device applications where regulations prohibit the use of plasticizers. PVC, although a well-established polymer has a contentious history primarily due to disposal issues and extraction of plasticizers in to the body. TPUs are plasticizer free and can be processed using the same equipment with slight modifications in some cases. TPUs have a long history of biocompatibility and biostability, which additionally provides justification for selection as an alternative material. In some other instances, TPUs are being used instead of silicones in next generation devices, thereby providing a competitive edge in the marketplace. Major benefits Mar. - Apr. 2016

polymers are used to create new and improved artificial limbs and plastic disposable delivery devices that have succeeded in reducing the risk of infection to patients. The demand for disposable medical devices is more in the emerging economies as the health care sector in these economies has expanded. Polymers such as polyethylene, polyurethane, PET, PMMA, hydrogels, fluropolymers, and polycarbonate are used in manufacturing of implants.

of using TPUs is the ability to use smaller thin walled tubing, higher flow rate and ability to introduce controls due to higher sensitivity of TPUs. Yet another upcoming area of application for TPU is in drug delivery. Ethylvinyl acetate (EVA) and silicones are the most widely used polymers for drug delivery. However, they are limited in their properties and the kind of drugs they can deliver. TPUs, due to their versatility, can be modified to deliver hydrophobic and hydrophilic drugs and have the ability to design the device either by matrix design or reservoir design. Additionally, drug delivery devices can be manufactured by combining or segmenting different TPUs to deliver both hydrophobic and hydrophilic drugs at the simultaneously in a single device. TPUs soften when inserted in the body, which becomes a key attribute for drug delivery devices like vaginal rings, where the ring needs to be stiff prior to insertion and soften once inserted in the vaginal cavity for patient comfort.

The examples mentioned above showcase the uniqueness, versatility and broad range of applicability of Thermoplastic Polyurethanes.

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Product Gallery Needleless Injection Site With A Non-Disconnect Male Luer Lock From Qosina Gamma sterilization compatible. The non-disconnect male luer lock provides a non-removable connection eliminating the need for bonding.The connector also features a swabbableluer activated female luer lock for aspiration or injection. Qosina offers a variety of injection sites, tubing, and syringes in addition to thousands of stock components. Call or log onto our website to request samples or place an order.

Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis valves, tuohyborst adapters, swabs, and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility.

Ronkonkoma, NY – April 5, 2016–Qosina is pleased to announce the addition of a NEW needleless injection site (#91600), with a non-disconnect male luer lock.Made of a COC (cyclic olefin copolymer) external body, a polycarbonate internal body, and a latex-free silicone valve, the injection siteisEtO and

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Qosina offers low minimums and short lead times. Call our Customer Specialists to request a sample, obtain our latest catalog or place an order via phone +(631) 242-3000, fax +(631)242-3230 or e-mail info@qosina.com.

Visit us at www.qosina.com to see our latest products. Custom sourcing services are available through our extensive network.

Contact: Ryan Edwards, Qosina 2002-Q Orville Drive North, Ronkonkoma, NY 11779, Phone +1 (631) 242-3000. Fax +1 (631) 242-3230 Email: redwards@qosina.com

Mar. - Apr. 2016

Events MEDICAL FAIR INDIA 2016 In Mumbai : Number Of Visitors Exceeds Expectations Medical trade fair reports a 34% increase in supporting programme. A high-calibre professional conference with visitors. the focal themes “Healthcare Branding, Marketing & Business The MEDICAL FAIR INDIA 2016, India’s No. 1 Development” as well as “Innovating India with Healthcare Trade Fair for Hospitals, Health Centres and Clinics, has continued Technology” offered decision makers from the clinic sector, medical its successful development in the growth market India in professionals, dealers and players from industry and health impressive fashion. Over 10,700 professional visitors made their management an ideal forum at which to obtain information on trends and to establish contacts. way to the Bombay Convention & Exhibition Centre in Mumbai during three intensive days of the trade fair. This corresponds to Afzal Kamal, National Head of the leading professional journal for record growth of 34% compared to the previous event in Mumbai. medical personnel in India, Medgate Today, again honoured particularly outstanding companies, hospitals and medical The exhibitor figures also benefited once again from the strong professionals during the 22nd MEDICAL FAIR INDIA. The economic situation in the industry: 512 exhibitors from 16 countries renowned MT India Healthcare Award was presented to 32 presented their product innovations from the fields of medical participating Indian companies and personalities from various technology and health management over an exhibition area of categories. For example, awards went to the best doctors in approx. 6,000 square metres, and unanimously praised a Cardiac Surgery, Surgery, Gynaecology and Oncology, as well as successful trade fair. All relevant Indian companies were to personnel from the Healthcare sector (the Healthcare represented in Mumbai, including numerous market leaders from Personality of the Year), and to renowned companies such as Asia. 298 exhibitors from other countries bear witness to the Hindustan Medical Devices, Ribbel International Ltd. or Spencer growing internationality of the event. In addition to India, the largest India Technologies Ltd. exhibitor nations included China, Malaysia and Taiwan; Germany, Visitors to the trade fair included numerous top decision makers France, Great Britain, Italy, Japan, Korea, Turkey, the UAE as from healthcare as well as renowned personalities such as Prof well as the USA also took part in the trade fair. On the initiative of Dr Wali, Personal Doctor to the Indian President, Secretary the Spectaris and ZVEI associations, Messe Düsseldorf organised General Anjan Bose and Dr Jitendar Sharma, Director NHRSC & an official joint company stand as part of the International Trade Advisor to Chief Minister Andhra Pradesh.

Fair Programme of the Federal Republic of Germany (AMP); this The next MEDICAL FAIR INDIA will be held from 6 to 8 April 2017 significantly facilitated participation in the trade fair for exhibitors, in New Delhi in line with the scheduled rotation. and offered both an optical as well as a price benefit through an Information is available online at: http://www.medicalfair-india.com. attractive uniform image and favourable conditions.

The MEDICAL FAIR INDIA is part of the ‘World of MEDICA´ and Horst Giesen, Global Portfolio Director for the ‘World of MEDICA´ is one of the long-established international medical trade fairs of of the Messe Düsseldorf Group, gave a positive summary of the the Messe Düsseldorf Group – organised in close cooperation 22nd MEDICAL FAIR INDIA: “We did not expect such a volume with the world’s largest medical trade fair MEDICA at the of visitors up to the last day of the trade fair. The new products, Düsseldorf location. many of them from the high-tech sector, found a very positive Information on the other international medical trade fairs of the echo from professional visitors. Given extraordinary growth in the Messe Düsseldorf Group can be found at: http://www.world-ofmedical sector in one of the most populous countries in the world, medica.com . we also expect a strong trade-fair business in future that can also Contact In Germany: Udo Wiemann - Messe Düsseldorf GmbH benefit our European exhi. MEDICAL FAIR INDIA and the globally WiemannU@messe-duesseldorf.de ; P.N:+49(0)2114560-756 leading trade fair MEDICA complement each other”.

Contact In India: Sachin Tyagi - Messe Düsseldorf (I) Pvt. Ltd. The MEDICAL FAIR INDIA was accompanied by an extensive

Email: TyagiS@md-india.com; P.No: +91 (11) 4855 0057

K 2016 Düsseldorf – Driving Force For Innovation And International Business

In October, more than 3,000 businesses from the plastics and rubber industry will again present trend-setting products, processes and practical solutions.

solutions. The most important flagship fair of the industry and all related applications, the K pools central trends and future developments in one venue. It has become established as the innovation and business platform not only for raw material Demographic growth, urbanization, rising energy producers, manufacturers of plastics and rubber machinery and consumption, dwindling resources, climate change – there are a processors, but also for stakeholders from the most important user host of challenges to contend with. The global situation calls for industries. creative minds, innovative technology and high-performance K 2016 has been booked out for months. More than 3,000 materials. From 19 to 26 October 2016, the K 2016 will welcome exhibitors from more than 50 nations will take part. As usual, the the international plastics and rubber industry to its exhibition centre largest group of exhibitors comes from Europe, particularly from in Düsseldorf/Germany. Exhibitors are invited to present their Germany, Italy, Austria, Switzerland, France and Turkey, but there Mar. - Apr. 2016

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Events is also an impressive number of participants from the US. At the same time, the K trade fair is a clear indicator of changes in the global market: over the past few years, the number of Asian companies and the exhibition area that they booked has been rising steadily, and this year, particularly China, Taiwan, India, Japan and South Korea will be impressing visitors with their strong presence. As the K trade fair features a wide abundance of companies from all over the world, the spotlight is not only on the major issues that concern the industry – such as energy, resource and material efficiency – but also on niche segments.

As always, K 2016 will spread across the entire exhibition area at Düsseldorf and exhibitors will present their products and services in all of the venue’s 19 halls with a total area of almost 170,000 m2. The logical structure of halls corresponds to the industry’s core business areas: • Machines and equipment • Raw materials, auxiliaries • Semi-finished products, industrial components and reinforced plastics products • Services K 2016 represents the industry’s complete value-added chain in unparalleled depth and width. This also includes rubber, which plays an important role, despite the fact that this segment is rather small compared to other segments of the plastics industry.

Important user industries however, attach major importance to it and its highly innovative developments. Rubber Road in hall 6 is an indispensible constituent of the K exhibition and is much appreciated and cherished by visitors.

The K trade fair is the benchmark for the industry and its global

market place for innovations. This is where experts from the world of plastics and rubber come to meet, demonstrate the industry’s leading edge and inform visiting experts from the automotive industry, packaging, E+E and communication, construction, medical engineering and the aerospace industry about new and visionary areas of application for plastics and rubber materials.

The impressive number of exhibitors and the quality of the presented products is a testament to the importance of the K and its role as the flagship fair for the entire industry, but it is the visitors who cast the ultimate vote. In October 2013, a total number of 218,000 visitors from more than 100 countries came to Düsseldorf, and organisers of K 2016 expect similar numbers this year. More than half (59%) came from abroad; the largest groups of international visitors came from the Netherlands, India, France, Belgium, the US, Italy and the UK. The experts’ verdict was clear: more than 90% of them were very impressed with the abundance of information, innovations and technical solutions.

With the highest information density in the world, the K trade fair is a business and information platform that looks to the future.

Thanks to its pioneering products and solutions and the high number of research institutes, this event has become a hotspot for visionary impulses and developments. Business and research are working hand in hand to provide visiting experts with an insight into future perspectives and scenarios that will shape the future of the plastics and rubber industry. K 2016 is the place where good ideas turn into good business deals. On 19 October, exhibitors and visitors will again live up to this promise.

More information: www.k-online.com Xing: https://www.xing.com/net/pri4bd1eex/k2013

Medicall, India’s largest B2B Medical Equipment and Hospital Need Exhibition, is promoted by Dr. S Manivannan, promoter director of 800 bedded Kauvery Group of Hospitals.

meet one’s peers, to compare and choose equipment and best of all to refresh the knowledge base in the intellectually stimulating BrainStorm Medicall. A favourite with many International product companies, Medicall has these come repeatedly to widen their dealer and distributor base.

Medicall serves as a marketing platform wherein the equipment companies showcase their products to Hospital owners and decision makers. International companies participate in Medicall to understand & explore the Indian Medical Devices market and to appoint the appropriate dealers and distributors in the region.

The show stoppers of Medicall are its seminars and workshops.

Much care is put into this section to ensure they are not didactic and unidirectional but highly interactive and responsive. The Interactive healthcare Intelligentsia at BrainStorm Medicall dishes out nuggets of wisdom in a nutshell. At Medicall, medicine meets management.

Medicall has maintained its position as the largest and best attended Medical shows in India.

In its 13th edition, Medicall has become a truly international show, with over 700 exhibitors from more than 20 countries and professional visitors exceeding 12,000. Most of the exhibitors substantially increased the size of their stall and showcased more products during the 3 day exhibition. It was a true bazaar for hospital equipment and supplies, ranging from surgical gloves to the most sophisticated medical equipment used worldwide.Medicall shows are held at Chennai, Mumbai, New Delhi, Ahmedabad, Kolkata and Colombo.

In its 10th year, Medicall’s 14th Edition was held at Mumbai Oct 9,10 and 11 2015, the exhibition was highly successful with more than 7000 professional visitors.

The medical fraternity embarks on its annual pilgrimage to Chennai, the Mecca of the medical legion. A perfect getaway to

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A wide range of topics have been discussed over the years. Topics ranging from - Survival Strategies for Small & Medium Hospitals, Hospital Projects, Patient Satisfaction Family owned hospitals to financing of hospitals, lean to six sigma, from marketing to mergers and acquisitions, Workshop on NABH Pre Accreditation entry level for Hospitals, Succession planning, Lean Six Sigma, HR in Hospitals, IT :Workshop in Social Media, SEO and Mobile Apps for Healthcare have been discussed by eminent stalwarts.

Medicall Healthcare innovation awards 2015 had attracted over 200 applicants. Medicall identifies recognizes and rewards innovators in the field of Healthcare much ahead.

The 15th edition of Medicall will be held at Chennai Trade Centre 22, 23 & 24 July & the 16th Edition at New Delhi, Pragati Maidan, 9 , 10 & 11 Sep 2016.

Mar. - Apr. 2016

Events

AN ISO 13485-2012 CE certified Company

Events Calender

Manufacturer & Exporter of Medical Disposable Devices & Surgical Products

• Medicall 2016 15th Edition Date: 22-24 July, 2016 Venue: Chennai.

16th Edition Date: 09-11 Sep, 2016 Venue: Delhi.

Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

• Medical Manufacturing Asia 3rd Manufacturing Processes for Medical Technology Exhibition and Conference Date : 31st August - 2nd September 2016.

Venue : Singapore • K - 2016 The World’s No.1 Trade Fair for Plastics and Rubber Date : 19-26 Oct. 2016.

Venue : Dusseldorf, Germany • Medical Fair India 2017 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi.

Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India.

Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com Mar. - Apr. 2016

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Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE

Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : HINDUSTAN SURGICAL Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, Village - Pithai - 387630.

Ta.: Kathlal, Dist. Kheda, Gujarat.

Email : hindustansurgical@yahoo.com Website : www.hindustansurgical.com Tele/Fax : (O) ++91-25440223 Cell :9824060964

Corresponding Address: HINDUSTAN SURGICAL Hasmukhbhai B. Patel 23, Manav Mandir Bungalows, Taxshilla Colony, Old Aradhana School Circle, B/h Ramannagar, Sukhipura, Maninagar, Ahmedabad - 380008 Email : info@hindustansurgical.com

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

•

I.V. Infusion Sets

•

Blood Administration Sets

•

Scalp Vein Set

•

Urine Collection Bags

•

Ryles / Feeding Tubes

•

Catheters and Tubes

•

Surgical Gloves.

Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 44

Mar. - Apr. 2016

GMP ISO - 9001-2008 Certified Company

Surgical Industry For

SALE In Hyderabad, R. R. District, Telangana.

S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980

IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp

An ISO 9001:2008, 13485:2012 & GMP Certified Company Address

Contact through:

surgicalindustrysale@gmail.com BASIL manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance.

BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc.

• DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products.

BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014.

Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : basilpolymer@gmail.com www.basilpolymers.com Mar. - Apr. 2016

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India.

Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

We are a leading Consulting organization providing an integrated services with focus on project technology :

Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.

F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com

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National Healthcare An ISO 9001 : 2008 Company

Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Injection Moulded Medical Components and Extended Tubes :

PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in

ISO : 13485 : 2012

JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &

CERTIFIED COMPANY

Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc.

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 46

Mar. - Apr. 2016