Medical Plastics Data Service July - August 2017

CToabnletoef nts Vol. 25 No. 4 July - Aug. 2017 22 Cover Story • Challenges Of Selecting Right Supplier For Medical Polymers Selecting suppliers is an in tegral part of Medical Device Manufacturer’s commitment to offering highest performing product to their customers. Some of the important criteria are ……. 23 Materials • New Innovations - Expanding horizons for Thermoplastic Elastomers in Medical Applications - Mr. Molay Das, Manager, Market Development, Kuraray India Pvt. Ltd. , Within the medical industry, demand is rising for safe and halogen-free polymers used in manufacturing medical products. Many polymer companies are feeling the….. 25 Materials • Emerging Market of Platinum Cured Silicone Products in Medical Industries - Mr. Vinay Pandey, (B- Tech Rubber Technologist), Ami Polymer Pvt. Ltd. Silicones have been playing vital role as a part of product design in medical industries for more than 75 years. They don’t react with Body Organs and finds most suitable for implant devices…... 26 Technolgy Snippets • Conair Introduces New Cutter for Medical Tubing • Recent Advances in Plastics Technology for Medical Care 35 Global Trends • Medical Packaging - Global Market Scenario - Mercy P. Bulsari (Polymer Technologist), Healthcare packaging is essential for protecting the medicines and medical equipment from contamination from air, moisture and dust. The key drivers for the growth are…… 37 Industry News • Now, MRP must on medical devices • Health ministry issues draft guidance document on “Essential principles for safety and performance of medical devices” • Covestro results buoyed by high PU, polycarbonates demand • Health ministry releases draft list of devices & in vitro diagnostics along with risk-based classifications • India’s 1st medical tech institute, Kalam Institute of Health Technology at AMTZ gets 100% financial support from DBT 40 Product Gallery • Dip-Molded Plastisol Y Connectors 20 Did You Know? 46 • About The “Medical Grade “ Polymer Dilemma Events • T-Plas, 2017: Sept. 20 – 23, 2017, Thailand. • Medicall 2017, 18th Edition: Oct. 6 – 8, 2017, Mumbai • Compamed 2017 / Medica 2017: Nov. 13-16, 2017, Dusseldorf Germany • Plastivision Arabia 2017: Dec. 11-14, 2017, UAE • PLASTINDIA 2018: Feb. 7-12, 2018, Ahmedabad • Medical Fair India 2018: March. 16-18, 2018, Mumbai July-Aug.2017 19

Flashback ?YoDKuindow ? Select Article Index About The “Medical Grade “ Polyner Dilemma Sept. 1994 to Jan. 1996 In order to be used in medical devices, polymers must fulfill demanding standards. For plastics manufacturers this means a great deal of investment for products with restricted • Polycarbonate And Medical Industry market potential. The product and performance characteristics for “medical grade” polymers (September 94) are determined at the discretion of the manufacturer, but everybody selling polymers can Modern Plastics International, have their own definition of what a medical grade is, and that can present something of a February 1993 problem. • EVA V/S PVC (May 94) The selection of materials for medical, pharmaceutical or diagnostic applications can be a Mr. A.K. Dutta difficult task. Strict legal stipulations demand that plastics comply with standards applicable for these uses. What is necessary to transform a “standard” polymer into a “medical • PVC In Medical Device Application grade” ? (March 94) Mr. C.R. Blass, Hydro Polymers Ltd., UK Defining and regulation Requirements for materials used, in the manufacture of medical devices, are specified in • Design Aspects For Reusable Engineering various regulatory requirements and directives. They hav to be be safe and effective and Plastics (November 95) not compromise the safety of patients .The requirements for medical devices among other Ms. Amita Shrivastava, B.E. Plastic Technology things,require safety, quality and suitability, toxicity and mutual compatibility with tissues, cells, body fluids and other used materials. The intended use of the medical device must • Product & Process : Use of Engineering always be considered in this process. Plastics As Medical Tubes (November 95) Mr. D. L. Pandya From a legal perspective it is the company that brings the medical device onto the market that is responsible for complying with any applicable regulatory • Thermoplastic Polyurethane And Its requirements, but medical grade polymers have no strict definition, and very often Medical Applications (November 95) such plastics are sold on the basis of their biocompatibility alone. Mr. S. Sridhar Sankar It is estimated that only about three per cent of global plastics production is destined • Engineering Polymers From GE Plastics for healthcare industry. For Medical Application (September 95) Mr. T. Srinivasan, Design Engineer, GE Not every polymer manufacturer will be willing or even able to meet the healthcare OEM’s Plastics India stringent requirements in the medical and pharmaceutical sectors. • Plastics In Medical Applications Informed suppliers can be identified by asking them how their medical grades are (March 95) characterised. Suppliers sometimes will just say their polymer is tested for biocompatibility, Dr. Viren Shah, Consultant Surgeon, which does not guarantee each individual batch is tested. Ahmedabad, Mr. Sanjay Saxena, Assistant Engineer, CIPET, Ahmedabad (Abstracted froman detailed article at the Ref : http://www.eppm.com/ materials/the-medical-grade-polymer-dilemma/ ) • The Selection And Processing Of PVC Compounds For Blood Bags And Other In a Biomedical Applications (May 96) Nutshell.... Dr. C.S.B. Nair, Technical Adviser, Peninsula Polymers Ltd., Trivandrum, Kerala “Logic and analysis can always find fault with innovative ideas. Use these tools • Once Upon A Time There Was PVC but use them warily. If your intuition (May 96) tells you that you have a great idea, Abstrated From An Article By Mr. Robert S then pursue it a little while longer”. Brookman, Ph.D., Vice President, Colorite Plastics, U.S.A. - Paul Sloane, author of The Innovative Leader • PVC Compounds For Medical Devices (May 96) July-Aug.2017 Mr. R. Santhanam, Hydro S&S Industries Ltd, Madras • Polymers For Potentially New Medical Applications (March 96) Dr. V. Kalliyana Krishnan Of Sree Chitra Tirunal Institute For Medical Sciences And Technol- ogy, Trivandrum • Development of polymer Based Biomedi- cal Devices Our Experience And Future Potential (January 96) Dr. R. Sivakumar, Head, Biomedical Technol- ogy Wing, Trivandrum 20

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. As we have been maintaining and emphasizing all the time, a strong supply chain for the Medical Polymers and related products EDITORIAL ADVISORY BOARD and components is essential to support and facilitate Indian Medical Device Industry in order to accelerate the “Make-In-India” process. However, Dr. TARANG PATEL the Industry faces challenges of selecting right supplier for Medical Polymers. M.B.B.S., M.Ch. (ONCO) Selecting suppliers is an integral part of Medical Device Manufacturers’ Cancer & Reconstructive Surgeon commitment to offering highest performing products to their customers. This important aspect is addressed in this issue both by highlighting some Mr. C. BALAGOPAL important criteria for the selection process as well as introducing two Director - Enter Technologies Pvt. Ltd. important material providers with their respective characteristics and Chairman - Mobilexion Technologies Pvt. Ltd. applications. Trivandrum FOCUSED MEDICAL PLASTICS PAVALION @ “PLASTINDIA 2018”. As an humble effort for creating platforms of interaction and creating linkages with Dr. DILIP H. RAIKER Suppliers with the Indian Medical Devices And Plastics Disposables Industry, Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) “Medical Plastics Data Service (MPDS)” has been contributing through various Former Chief Manager(P), CIPET - Chennai activities. On line with the successful effort during “Plastivision India 2017” event held in Mumbai in Jan. 2017, we are happy to be able to support the focused ING LOUIS C. SUHUURMAN “MEDICAL PLASTICS PAVALION @ “PLASTINDIA 2018”, to be held in Feb. Formerly Sales Director 2018, in Gandhinagar, Gujarat. As it is well known, the event “Plastindia” is the COLPITT B.V., Holland most significant exhibition in the world and one of the largest Plastics Exhibition in the Asia Pacific Region. The coming event is expected to be Dr. A.V. RAMANI located in 125,000 sq.m. area and will have 2000 Exhibitors including 600 Group Sr. Vice President (R&D), The TTK Group oversea exhibitors. About 200,000 visitors are expected to visit. Dr. Vinny Sastri The Medical Plastics Pavilion will be a knowledge platform complete with President, Winovia LLC, U.S.A. posters, Audio-Visuals, Models, over 200 samples of medical plastic products and components and the presence of experts. The aim is to help existing and Dr. C.S.B. NAIR potential manufacturers and investors to diversify and / or branch out into medical Director (R&D), Peninsula Polymers Ltd plastic products. It will also have presence of manufacturers / suppliers of materials, components, machineries, technology essential for manufacturing medical plastics Dr. BHARAT GADHAVI products and devices. CEO, HCG Medisurge Hospitals The newly established “Kalam Institute Of Health Technology ( KIHT ), India’s Mr. A.S. ATHALYE first Institute dedicated to medical technology located at “AMTZ”, Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Vishakhapatnam, will identify critical gaps in medical technology and suggest the government to do focused spending to bridge the gap between Academic, Dr. SUJOY K. GUHA Research and Industry. B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Some of the other important aspects covered under this issue includes “Global IIT, Kharagpur Market Scenario for Medical Packaging” Technology Snippets highlighting innovations and developments in Materials and Machinery, Product Gallery, Industry Dr. G. S. BHUVANESHWAR News, as well as the regular “Did You Know” Column and Events Calender. Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. 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: [email protected] 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-54 •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. July-Aug. 2017 21

Cover Story Challenges Of Selecting Right Supplier For Medical Polymers Which material supplier? Medical Device manufacturers face this challenge on ongoing basis. Considerations are many….. Proven history of providing quality, medical-grade polymers that has acceptable lead times, great on-time delivery performance, competitive prices, flexible interested in a true win-win partnership etc etc. Establishing “partnerships” with suppliers is found to be beneficial - Suppliers who can support Device Manufacturer through such partnership. The benefits are increase in manufacturer’s efficiency in terms of time, cost and quality. Medical Polymers have to face many adverse environment of temperature, pressure, movements, sterilization processes, assembly processes including adhesives on and above the obvious requirements of safety, quality and suitability for the respective application. Selecting suppliers is an integral part of Medical Device Manufacturer’s commitment to offering highest performing product to their customers. It is important to see that the selected suppliers are aligned with their quality, technology and business goals. While it may not be possible to select the most appropriate material supplier on the planet, some of the important criteria are……. 1. Commitment to quality 5. Flexibility and Special Services. 2. Product and Market Knowledge 6. Technology And Innovation 3. Financial Stability 7. Value 4. Communication 8. Corporate Responsibility 22 July-Aug.2017

Materials New Innovations - Expanding horizons for Thermoplastic Elastomers in Medical Applications Mr. Molay Das, Manager, Market Development Kuraray India Pvt. Ltd. A glimpse from Molay Das - Kuraray India on how the new The below graph shows the range of properties possible when generation TPE’s finds the way to resolve several safety blending HYBRAR™ with various ratios of PP. and performance issues…. Orthopedic Gels : Within the medical industry, demand is rising for safe and Kuraray’s SEPTON™ is a series of high-performance, halogen-free polymers used in manufacturing medical products. thermoplastic rubbers that are based on Kuraray’s SEEPS Many polymer companies are feeling the need with new materials technology. Styrene Ethylene Ethylene-Propylene Styrene like thermoplastic elastomers (TPEs). For several decades, the (SEEPS) grades are comprised of copolymers with both isoprene medical industry has relied upon styrenic block copolymers and butadiene in the midblock. SEPTON™ 4,000 Series can be (SBCs), a type of TPE, for use in a range of medical products. used to create orthopedic gels. The SEPTON™ 4000 Series TPE process easily, have excellent mechanical properties and provide orthopedic gels with their necessary stability and super elasticity, and possess strong haptic. Their inherent low toxicity soft characteristics giving the products a natural skin-like feel and compliance to medical and food contact regulations make and performance over a broad temperature range. With their TPEs a safe choice for specifying materials for use. low specific gravity and high tear strength characteristics, these products can replace silicone in various applications. Additionally, With more than 30 different types of TPEs with individual product characteristics like lower melt viscosity, excellent low temperature properties, Kuraray offers a diverse portfolios for the medical behavior and superior process-ability at a low shear rate ensure market. These TPEs are safe and non-toxic and offer flexibility enhanced overall process-ability and production efficiency. and performance in the design of medical products where Developed for high-performance products where long lasting superior performance and safety is needed most. stability and compression set are key requirements, SEPTON™ 4000 Series can be used in applications such as cushions for Kuraray’s TPE products, SEPTON™ and HYBRAR™ combine artificial limbs, orthopedic bandages, prostheses and burn plas- the elastic properties of rubber with the benefits of thermoplastics. ters. Their excellent shock absorbing and damping properties Due to this thermoplastic nature, they can be processed into combined with non-allergenic qualities meet the high demands almost any shape. These TPEs have a soft touch and provide in this industry. comfort and durability. 23 Distinguished by their high clarity, non-allergenic characteristics, and easy process ability, SEPTON™ and HYBRAR™ are perfect for applications such as medical tubes and pouches, orthopedic gels, elastic nonwovens and films, patch adhesives, and medical bags. Medical Tubes : As environmental standards increase, medical tubes are now being replaced with polymers such as HYBRAR™ as a cost- effective solution for soft-touch applications. Due to its toughness, transparency, flexibility and physical properties, HYBRAR™ meets many of the new characteristics needed for medical tubing. This TPE has excellent miscibility with polypropylene (PP) and has high affinity to polyolefins and styrenics making it extremely transparent and easy to process. HYBRAR™ blends with PP are soft, transparent, offer good kink resistance, have high-temperature performance and are solvent bondable. In comparison to PVC, Kuraray HYBRAR™ has similar physical properties but lower density. Being halogen and phthalate free, HYBRAR™ meets many of the environmental and safety standards that PVC cannot meet. Moreover, compounds made out of HYBRAR™ and PP have high tensile and excellent impact strength. The polymer structure of HYBRAR™ also ensures relatively good oxygen and moisture permeability compared to other elastomers. July-Aug. 2017

Materials The below graph shows the comparison of tear strength and density of SEPTON™ to Silicone and Urethane Gels. Medical Bags : Patch Adhesives : Kuraray’s SEPTON™ and HYBRAR™ lines are suitable for dry Various products within Kuraray’s SEPTON™ line can be blending in film extrusion processes, most often found in the processed for patch adhesives. The SEPTON™ 4000 Series manufacturing of medical bags. Both TPEs show maximum can be used when there is a need for products with extremely softness and elasticity. Due to their excellent compatibility with high cleanliness. Their well-balanced adhesion and cohesion polyolefins, they allow great flexibility to create film properties force makes patch adhesives with SEPTON™ products easy to that normally cannot be achieved with commodity polyolefin peel off. For the consumer this means better comfort without resins alone. They perform well in high the risk of causing allergies. temperatures, can be sterilized and can be down-gauged due to their improved Medical applications today are becoming more demanding from impact resistance. Furthermore, there both a performance and safety standpoint. This requires is no migration of PVC plasticizer as materials that go beyond standard SBCs that satisfy value added solutions in a variety processing technologies and end use compared to PVC bags. conditions. SBCs continued advancement in extrusion and injection molding process development further drive adoption In the field of flexible packaging films into new application areas. Due to the concerns with Poly-Vinyl made from polyethylene and Chloride (PVC), SBCs offer a safer and more environmentally polypropylene, HYBRAR™ offers friendly alternative with comparable performance. As the market various grades that can be added for continues to evolve, so has technology, with new materials. specific customization. Compared to plastomers or Polyolefin elastomers, Kuraray India is focused on marketing of Kuraray special these materials perform in the lowest concentrations necessary polymers to meet the emerging requirements from Indian market to achieve maximum value. The main advantage is impact in combination with technical supports and excellent services to resistance for down-gauging purposes. Specifically for the customers. polypropylene, HYBRAR™ can reduce the Sealing Initial Temperature (SIT) up to 10 degrees. Elastic Nonwovens and Films : As elastic nonwovens and films continue to grow their presence in the market, so have the needs to maintain optimal cost performance balance. Kuraray’s SEPTON™ 4000 Series is designed for high-perform- ing elasticity making them an excellent solution for many elastic nonwovens and films. For consumers, the main advantage is higher comfort and a decrease in creep resistance. These dis- tinct properties further lead to down-gauging probabilities. Also, significant material savings – as much as 40 percent lower ma- terial usage and 40 percent weight reduction over competitive products – can be achieved while maintaining mechanical prop- erties, compared to other thermoplastic elastomers. Kuraray’s SEPTON™ 4000 series combines the strength of SEBS with the softness expected of SBS and SIS elastomers. 24 July-Aug.2017

Materials Emerging Market of Platinum Cured Silicone Products in Medical Industries Mr. Vinay Pandey (B- Tech Rubber Technologist) Ami Polymer Pvt. Ltd. # +91 8691013936 [email protected] Silicones have been playing vital role as a part of product design • Platinum Silicone Tubings for Drug Delivery and Surgical in medical industries for more than 75 years. Procedure Silicone polymer is having inorganic backbone which is responsible for its inert behaviour with body tissues and cells. They don’t react with Body Organs and finds most suitable for implant devices. There are two types of Silicones - Peroxide Silicones and Platinum Silicones. Peroxide Silicones are less popular among Polymer formulation • Silicones Gels are used as soft skin adhesives and wound designers for medical industries. Basic limitation of peroxide interface. silicone is by-products generation during its manufacturing process which can extract out with contact media. Extract • Silicone coatings for needles element can deteriorate fluid properties. Platinum silicones don’t generate any by-products hence free of any extractable risk which makes it most suitable for medical applications. • Platinum Silicones are leading in qualifying tests mentioned under standard ISO 10993 biological evaluations of medical devices. List of Tests under Biological Evaluation of Medical Devices - ISO 10993 Cytotoxicity Acute systemic Toxicity Genotoxicity Sensitization Subacute Toxicity Hemo- compatibility • Silicones Resins for Human Implants Irritation Pyrogenicity Implantation • Platinum silicone easily meets with tests mentioned under Silicone Gel as Nasal Silicone Implants Figure Silicone Standard Biological Reactivity test In Vitro USP Class 87 and Breast Implant implants USP Class 88 (In Vivo). www.medicalplasticsindia.com • Having higher shelf life and retains transparency for longer time. Silicones are useful in various types of Medical Devices as mentioned below : A) Surface Devices B) External Communicating Devices C) Implant Device • Platinum Silicone Coatings for Surgical Tools July-Aug. 2017 The Only Indian Portal Site On Medical Plastics/ Devices Technology And Trade 25

Technology Snippets Conair Introduces New Cutter for Medical Tubing They can be stretched, rolled, and inserted into a syringe, injected through a small opening into the body and then, once Conair Group offers a new micro planetary cutter for medical in place, can return to its original shape. tubing, called the M-TPC. Stretchable films to monitor cancer patients The cutter features a fully programmable servo-driven cutting Thin, stretchable film, developed at University of Michigan that can head that cuts small-diameter medical tubing that it virtually coil light waves like a Slinky could make monitoring of cancer eliminates the need for secondary, off-line finishing. The knife survivors more effective and less expensive. Film is based on the spins around the circumference of the tubing from 0.08- to 1- same material used for contact lenses (PDMS), twisted and coated inch in outside diameter, cutting without deformation, burning or with nanoparticles of gold to induce reflectivity, then untwisted. It fracturing. provides a simpler, cost effective way to produce circularly polarised light, essential ingredient in process that could provide early warning The M-TPC cutter is the latest in Conair’s MedLine family of of cancer recurrence. More frequent monitoring could enable doctors cleanroom-ready, downstream extrusion equipment for medical to catch cancer recurrence earlier. applications. Conair introduced it at Plastec East, June 13-15 in New York. New hybrid polymers that can regenerate A completely new hybrid polymer that incorporates rigid and soft The M-TPC planetary cutter splits the tubing apart cleanly nano scale compartments, which can be removed and through displacement, without the loss of any material. This regenerated, has been developed by Northwestern University method of cutting never blocks continuous airflow through the scientists. This polymer is capable of contracting and expanding center of the tube, so tube sizing and ovality are not affected, as like muscles and rapidly responding to environmental stimuli. It they can be when using flying-knife cutters, according to Conair. can be used in implantable materials to deliver something and The Conair cutter is mounted on a servo-driven traveling table then chemically regenerated to function again. Other applications that can handle tubing at line speeds up to 100 feet per minute. of interest include the creation of artificial muscles or other life- The unit can make up to 45 cuts a minute. like materials, delivering biomolecules or other chemicals, self- repairing materials and replaceable energy sources. http://www.plasticsnews.com/article/20170628/NEWS/ 170629899/conair-introduces-new-cutter-for-medical-tubing Stretchable polymer for wearable electronics Panasonic has developed a soft, flexible, and stretchable Recent Advances in Plastics Technology for polymer resins films that can stretch more than 2.5 times its Medical Care: Dr Mosongo Moukwa relaxed length and return to its original form without any damage. The film is based on a thermosetting resin with a 3-D cross- New materials & processing techniques will enable linked structure that makes it flexible and stretchable. It healthcare industry to create innovative products outperforms other films by retaining its mechanical properties Medical plastics market will reach a value of $ 6.9 billion by 2020 after repeated deformation. It is also an insulator, adding to its with a compounded annual growth rate in the 7 percent range potential in wearable devices as well as in transparent, between 2015 and 2020. stretchable electrodes. The business drivers in the medical device industry typically Sponge like polymer for spinal injury include evolutionary innovations in product performance and Scientists at the Mayo Clinic have developed a biodegradable speed to market. Polymers have become an integral component polymer grafts designed to repair damaged vertebrae in the in a wide range of medical designs, enabling the next generation spinal column. The polymer adapts itself into the appropriate of implants, single-use devices, and packaging technology, size and shape once implanted in the body. Derived from a among many others. There are a number of advances in polymer dehydrated hydrogel, surgeons would simply plant these and materials science that have opened up endless possibilities capsules into gaps in the spinal cord (resulting from either surgery in medical technology. Here are some of them. or another injury), and our body’s fluids would then activate the polymer, allowing them to expand to the proper proportions. Dissolvable sensor to monitor brain Scientists from Washington University and the University of Endless possibilities Illinois at Urbana Champaign have developed a wireless device There are so many exciting new materials and processing the width of a human hair that can be implanted in the brain and techniques that, alone or in combination, will enable activated by remote control to deliver drugs. These are wireless the healthcare industry to create innovative, next-generation bioresorbable brain sensors capable of measuring intracranial products. They will allow more effective treatments and the pressure and temperature before being absorbed in the body. promise of better patient outcomes. The combination The devices are made of polylactic-coglycolic acid (PLGA) and of plastics and engineering will continue to revolutionise medical silicone. They represent a revolutionary development for care as far as we can see. neuroscientists who can now temporarily monitor intracranial pressure and temperature with accuracy. Once the device is no (Dr Mosongo Moukwa is director of technology at PolyOne, USA, longer needed, the body absorbs it. and was recently an independent consultant based in Chapel Hill, USA, and vice president - technology at Asian Paints Ltd, Implantable elastomeric and shape memory materials Mumbai, India.) Gelest Inc, a materials technology company, has developed a Ref : As published in “ Business Standard and available at new class of elastomers with unprecedented elongation and web link http://www.business-standard.com/content/b2b- shape recovery abilities. The new materials, based on silicone plastics-polymers/recent-advances-in-plastics-technology-for- with different functional groups, approach 5000 percent medical-care-dr-mosongo-moukwa-117011600298_1.html elongation at break, allowing engineers to create microfluidic devices used in ‘in vitro’ diagnostics that can withstand July-Aug.2017 movement, elongation, and distortion, yet still retain functionality. 26



® 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. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 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 : [email protected] : 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 : [email protected] • [email protected] 28 July-Aug.2017

National An ISO & CE certified Company Healthcare AMIGO SURGI CARE PVT. LTD. An ISO 9001 : 2008 Company Manufacturer of Manufacturing & Exports of Disposable Surgical Products Medical Disposables : I.V.CANNULAS / B.T.SETS / I.V.SETS / I.V. Set, B.T. Set, Urine Bag, SURGICAL LATEX GLOVES / CORD Measured volume set, Cord Clamp, Surgical CLAMPS / MEASURE Gloves etc. VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN Injection Moulded Medical Components and Extended Tubes : SET / CANNULA FIXATOR ETC. Only Manufacturer of IV CANNULA in GUJARAT I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Urine Bag Tubes etc. Mobile : 0091-9825057180 Contact : Tel.: 0091-2764-268249 Naresh Patel E-mail : [email protected] 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Website : www.ivcannulaindia.com Plant Address Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. E-mail : [email protected] Website: nationalhealthcare.in AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT July-Aug. 2017 Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 [email protected] 29

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Global Trends Medical Packaging - Global Market Scenario Mercy P. Bulsari (Polymer Technologist) Email: [email protected] +91-7405591482 (Cell) The medical / healthcare industry is one of the largest industries the forecast period. Other product types include pouches, trays, in the world. Healthcare packaging is essential for protecting blister packs, clamshell packs and vials. Stringent government the medicines and medical equipment from contamination from regulations and strict industry standards are expected to further air, moisture and dust. Being a vital industry, as emerging enhance the market demand. Improved strength, barrier economies grow, demand for healthcare packaging will increase, properties and puncture resistance have added to the further strengthening the market. attractiveness of pouches for small to medium sized packages. Multiple compartment trays and clamshell trays are other types The global healthcare packaging market is constantly challenged which are gaining popularity attributed to lower risk of infection with changing trends such as the increased use of disposable spreading and staff errors during the organization of products. medical products, ageing population, rising cost of raw materials, transportation and energy, cost pressures on suppliers, influence By Material of regulations, outsourcing packaging, child-resistant and • Paper tamper-evident packaging. Countries continue to invest in • Plastic healthcare development, and corresponding strong demand is • Paperboard expected for healthcare packaging, allowing for robust market • Others growth. Furthermore, innovations driven by consumer preferences and environmental concerns will create new and exciting opportunities in the healthcare packaging market. The key drivers for the growth of the medical device packaging By Product Global Medical By Region market are the growing healthcare industry. There is an • Trays Device • North America increased demand for such packaging by the medical device • Pouches • Europe manufacturers on a large scale. The packaging industry on the • Bags Packaging • APAC other hand are seen investing heavily on various technological • Clamshell Packs Market • Others advancements. On the basis of product type, pouches • Other contributes the largest to the market, majorly due to its cost- Segmentation effectiveness and infection resistant specification. Cost sensitiveness and falling healthcare costs are hindering the Regional Analysis of Global Medical Device growth of the global medical device packaging market. North- Packaging Market America contributes largely to overall market share. Asian countries, especially India, China are expected to grow Europe is the leading consumer followed closely by North fastest over the forecasted period due to expansion of the America. Major demand in Europe is generated from Western healthcare industry and stricter government and non-government Europe where most of the major consumers such as GE regulations to support healthcare sector. However, North America Healthcare, Phillips and Siemens Healthcare among others are dominates the market due to advancements of medical located. Asia Pacific has emerged as the fastest growing market technology and infrastructure. led by India and China owing to expansion and stricter regulations for medical products industry in the region. The global medical device packaging market size is expected to cross USD 30 Billion at CAGR of approximately 6% by 2022. Growing healthcare industry is expected to drive the medical devices market which in turn affects the medical device packaging demand. However, healthcare cost reduction in the major markets as well as cost sensitiveness due to rising completion in the medical devices market might hamper the market growth. Global Medical Device Packaging Market Segmentation Containers are the dominant product types of medical device 35 packaging and expected to remain the largest segment over July-Aug. 2017

Global Trends Market Size of Medical Device Packaging by Regions (USD Billion) USD Billion 40 35 30 Europe Asia-Pacific ROW 25 20 15 10 5 0 North-America Key Players The key players of the global medical device packaging market include- Amcor Limited, Bemis Company Inc, Chesapeake Limited, E. I. du Pont de Nemours and Company, Klöckner Pentaplast Group, 3M Company, WestRock Company, Mitsubishi Chemical Holdings Corporation, and Oliver-Tolas. Some of the major players in Global Medical Packaging Market include Amcor Limited, Chesapeake Limited, DuPont, Klöckner Pentaplast Group, MeadWestvaco Corporation, Mitsubishi Chemical Holdings Corporation Bemis Company, Inc. (U.S.), West Pharmaceutical Services, Inc. (U.S.). And 3M company among others. Target Audience • Manufactures • Raw Materials Suppliers • Aftermarket supplier • Research Institute / Education Institute • Potential Investors • Key executive (CEO and COO) and strategy growth manager Ref.: https://www.marketresearchfuture.com 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 : [email protected] 36 July-Aug.2017

Industry News Now, MRP Must On Medical Devices Union Minister for Consumer Affairs Ram Vilas Paswan today “On account of implementation of GST from July 1, there may said that medical devices have been brought under the ambit of be instances where the MRP of a pre-packaged commodity is Packaged Commodities Rules. required to be changed,” Paswan said. This will make it obligatory for the display of retail sale of prices In this context, the ministry has allowed manufacturers or packers (MRPs) on the devices with regard to their sale. This will ensure or importers of pre-packaged commodities to declare the uniformity in the quality of devices, their brand and prices. This changed MRPs on the unsold stock prior to July 1, after inclusion had been a long-standing demand of consumers. He said that a of the increased amount of tax due to GST, if any, in addition to committee has been instituted in the Consumer Affairs Ministry the existing MRP for three months July 1 to September 30. to look into complaints with regard to rates following the roll-out of GST. “The declaration of the changed MRP shall be made by way of stamping or putting sticker or online printing,” Paswan added. He said the ministry is keeping a close watch on the prices of commodities that have undergone a change in the GST regime. http://www.tribuneindia.com/news/business/now-mrp-must-on- medical-devices/433335.html Health Ministry Issues Draft Guidance Document On “Essential Principles For Safety And Performance Of Medical Devices” The Union health ministry has issued the draft guidance are grouped in different categories. document on “Essential principles for safety and performance of medical devices”. They are chemical, physical and biological properties; infection and microbial contamination; manufacturing and environmental This document is prepared under the provisions of Rule 6 of properties; devices incorporating a substance considered to be Medical Devices Rules, 2017 to provide binding guidance for a medicinal product or drug; devices incorporating materials of use in the manufacturing of medical devices which are intended biological origin; devices with a diagnostic or measuring function; to be sold in India. This document provides an overview on devices that incorporate software and standalone medical device meeting the essential principles for safety and performance of software; active medical devices and devices connected to them; medical devices. This document does not dictate how a environmental properties; protection against radiation; protection manufacturer should prove that their medical device has met against mechanical risks; protection against the risks posed to the essential principles laid down in this document, hence the patient by supplied energy or substances; protection against providing flexibility to the manufacturers and catering to the risks posed to the patient for devices for self-testing or self- technological advances and changes in the development of new administration or intended by the manufacturer for use by lay medical devices. persons; information supplied by the manufacturer i.e. Label and Instruction for Use; and performance evaluation including This guidance document describes fundamental design and analytical performance and where appropriate, clinical manufacturing requirements, referred to as “Essential Principles evaluation. for Safety and Performance” that, when met, indicate a medical device including in vitro diagnostic (IVD) medical device is safe In addition to the general essential principles as specified in the and performs to its specification. section 4 of this document, above listed additional essential principles for safety and performance which need to be There are seven general requirements of safety and performance considered during the design and manufacturing process are that apply to all medical devices including IVD medical devices further specified separately for medical devices other than IVD as specified in section 4 of this document. There are further medical devices; and IVD medical devices. design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. http://pharmabiz.com/NewsDetails.aspx?aid=103344&sid=1 The design and manufacturing requirements in this document Covestro Results Buoyed By High PU, Polycarbonates Demand German materials supplier Covestro has reported a sharp rise “In the next five years, we anticipate generating a cumulative in year-on-year earnings and sales in the second quarter of 2017, total of •5bn in free operating cash flow,” said CEO and interim thanks to increasing demand for polymer materials. CFO Patrick Thomas. In the three months to 30 June, group sales were up 17.0% at The cash, he added, will be used for bolt-on acquisitions in the •3.5bn, while core volumes were down by over 1%, the company specialties segment, if the opportunity arises. announced 25 July. Referring to the ongoing demand for its products, chief Higher utilisation rates and “robust demand” also helped the commercial officer Markus Steilemann said Covestro would Leverkusen, Germany-based company to increase earnings further invest in its production plants and removing bottlenecks (EBITDA) by 56.5% to •848m in the second quarter. in the polyurethanes and polycarbonates segments. Net income more than doubled with a 110.4% growth to •484m While core volumes in the polyurethanes segment were down during the period. 2.3% year-on-year in the second quarter, the segment’s earnings July-Aug. 2017 37

Industry News Covestro has already announced further expansion at its Shanghai plant to address growing demand, particularly in the grew by 143.9% over the prior-year quarter to •556m, largely APAC region. The expansion will be completed in 2019. due to improved margins. Core volumes in the Coatings, Adhesives, Specialities segment The decline in volumes was attributable primarily to the polyether decreased by 3.0% from the prior-year quarter, mainly as a result polyols product group and constrained product availability in the of volume shifts in the first six months. MDI and TDI product groups. Earnings in the segment was down 19.7% at •114 million To meet the high demand Covestro announced in March that it compared to the same period the previous year. would continue production of the rigid foam precursor MDI in Tarragona, Spain, for the time being. The company is also For the first half results, Covestro said in the first six months of doubling its MDI capacity at its Brunsbüttel plant in northern the year sales grew 20.8% on a 14.4% total increase in selling Germany to around 400,000 tonnes per year by the end of 2018. prices to •7bn. First half earnings were up 61.3% at •1.7bn, The Polycarbonates segment recorded modest growth in core primarily driven by earnings growth in polyurethanes. Free volumes of 0.7% compared with the prior-year quarter. operating cash flow also increased significantly by 68.8% to •530m. While growth was weaker compared to the previous quarter, due to constrained volumes available in Europe, Covestro http://www.plasticsnewseurope.com/article/20170725/PNE/ benefited from its capacity expansion at the Shanghai site, which 170729949/covestro-results-buoyed-by-high-pu- came on stream late 206. polycarbonates-demand The segment’s earnings rose by 3.1% to •197m. Health Ministry Releases Draft List Of Devices & In Vitro Diagnostics Along With Risk-Based Classifications After notifying the Medical Devices Rules 2017, which will come Suction Ablation Catheter System, Fiberoptic Oximeter Catheter, into force in the country from January 1, 2018, the Union health Cardiac Catherization Kit, Balloon for Cerebrovascular ministry has now issued the draft list of medical devices and in Occlusion, Intra-Aortic System Balloon and Control, vitro diagnostics along with their risk-based classifications. Keratoprosthesis, Detachable coils, Bone heterograft, Vena cava clip, Implantable Infusion pump, Glenoid fossa prosthesis, As per the Medical Devices Rules 2017, medical devices other Vascular clip, Vascular embolization device, Intervertebral body than in vitro diagnostic medical devices will be classified on the fusion device, Haemo-Dialyzer System, Implantable cardiac basis of parameters specified in part I of the first schedule, pacemaker including accessories, Drug eluting stent, Vascular namely low risk as Class A; low to moderate risk as Class B; graft/occluders/Cardiac Patches and Implanted intracerebral/ moderate to high risk as Class C; and high risk as Class D. In subcortical stimulator for pain relief, to name only a few, have vitro diagnostic medical devices will be classified on the basis been listed in the high risk Class D category. of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate A-V Shunt or Fistula Adapter, Enternal infusion Pump, to high risk as Class C; and high risk as Class D. Transcervical(Aminosco pe) Endoscope and accessories, Forceps, endoscopic, Anastomotic Microvascular Device, The devices intended for internal or external use in the diagnosis, Angiographic Guide Wire and Accessories, Vessel Dialator for treatment, mitigation or prevention of disease or disorder in percutaneous Catheterization, Angioscope, Aspiration Needle human beings or animals, as may be specified from time to time and Syringe, Tracheobronchial Suction Catheter, Cervical Drain, by the Central government by notification in official Gazette, after Rectal Balloon, Biliary Stone Retrieval Basket, Contact Lens consultation with the Drugs Technical Advisory Board, fall under Bifola and Daily, Blood Administration kits, Biopsy Kit, the definition of drug. The list of 15 devices notified so far in the Tracheostomy Tube/Tracheal Tube, Irrigating Syringes, country include disposable hypodermic syringes; disposable Intravenous Cannula, Vial Adapter, Suprapubic, nondisposable hypodermic needles; disposable perfusion sets; in vitro Cannula and Trocar, Aortic Cannula, Arterial Cannula, Coronary diagnostic devices for HIV, Hbsag and HCV; cardiac stents; drug Artery Cannula, Arthroscopy Drainage Cannula, Lacrimal, eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone Hemodialysis Cannula, Cannula Injection, Uterine Insufflation cements; heart valves; scalp vein set; orthopedic implants; Cannula, Continuous Positive Airway Pressure Nasal Oxygen internal prosthetic replacements; and ablation device. Cannula, Salpngography Catheter, etc have beenl isted in the Class B category. The new Medical Devices Rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical Likewise, Vein Ablation Device, Thermal Ablation Device, Injector bandages, surgical staples, surgical sutures, ligatures, blood Type actuator syringe, Transabdominal (Fetoscope) Aminoscope and blood component collection bag with or without anticoagulant and Accessories, Anastomosis Device for Microvascular covered under sub-clause (i); substances including mechanical Surgery, Anastomosis Device for Gastroenterology Urology Use, contraceptives (condoms, intrauterine devices, tubal rings), Anaesthetic Conduction Kit, Ophthalmic Laser and Accessories, disinfectants and insecticides notified under sub-clause (ii); and Embolic Particles System, Elbow joint humeral (hemi-elbow) devices notified from time to time under sub-clause (iv), of clause metallic uncemented prosthesis, Peritoneal Automatic Delivery (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of System, Implanted Subcutaneous Intravascular Port & Catheter, 1940). Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis, Pacemaker lead adaptor, Surgical Dressings, etc As per the draft list issued by the ministry, Radiofrequency have been listed in the moderate to high risk Class C category. Ablation Device, Percutaneous Conduction Tissue Ablation, 38 July-Aug.2017

Industry News Bolster Suture, Cyclodialysis eye Cannula, Nasopharyngeal included in the Class A category. Catheter/Nasopharyngea l Class A, Umbilical occlusion device, Incontinence Urosheath Device, Pharynscope, etc have been http://www.pharmabiz.com/ NewsDetails.aspx?aid=103045&sid=1 India’s 1st Medical Tech Institute, Kalam Institute Of Health Technology At AMTZ Gets 100% Financial Support From DBT The Kalam Institute of Health Technology (KIHT), India’s first programme includes an investment of USD 125 million from the institute dedicated to medical technology located at Andhra Government of India and an equal contribution as a loan from Pradesh MedTech Zone (AMTZ), Visakhapatnam, has received World Bank and is anticipated to be a game changer for the 100 per cent financial support from the Department of Indian biopharmaceutical and medical devices industry. Biotechnology (DBT). KIHT shall support Department of Bio-technology in areas of Named after India’s 11th President Dr APJ Abdul Kalam, KIHT medical technology. KIHT – a registered society has Dr R has been set up with the aim to identify critical gaps in medical Chidambaram, Principal Scientific Advisor to Government of technology and suggest the government to do focused spending India as its President; Secretary, Department of Bio-technology on such areas and help bridge the gap between academic as Chairperson and Dr. Jitendar Sharma as Executive Director. research and industrial market access, by auctioning of patents It is a first Institute of its kind with Association of Indian Medical and prototypes available with government funded academic Device Industry (AIMED) on its governing board. KIHT is a jewel research institutions. on the crown of AMTZ which is one of the fastest growing Government of India supported projects in Andhra Pradesh. KIHT shall broadly function on Innovation & Market Access, AMTZ has recently received the most Innovative MedTech Zone Enabling Technology Transfer, and Research & Development Award. Support. Located within AMTZ campus, India’s first state-of-the-art Placed within AMTZ, KIHT is amidst direct access to academia medical devices manufacturing park, KIHT will have direct access and industry. KIHT approval comes under the aegis of the launch to academia and industry. of the National Biopharma Mission – an Industry-Academia Collaborative for accelerating discovery research to early http://pharmabiz.com/NewsDetails.aspx?aid=103359&sid=1 development for biopharmaceuticals. The National Biopharma July-Aug. 2017 39

Product Gallery Dip-Molded Plastisol Y Connectors from Qosina Ronkonkoma, NY – August 3, 2017 – complimentary samples and place orders. Qosina stocks a variety of Y connectors Be sure to sign up for our monthly e- manufactured from plastisol, also known newsletter to stay current with our newest as liquid polyvinyl chloride (PVC),a product additions. Our product development material used to make flexible team can work with you to customize a part components. These connectors are to your specifications. Call our customer produced through a dip molding process service specialists to discuss your project rather than traditional injection molding. in detail via phone +1(631) 242-3000 or Plastisol provides exceptional flexibility, is email [email protected]. Class VI approved and BPA- and latex- free.Dip molding is an ideal method for Founded in 1980, Qosina is a worldwide molding connectors as the dipping dies are supplier of thousands of stock OEM cost-effective,allowing for production to be components including bioprocessing easily scaled. accessories,compression fittings, ENFit™ connectors, luers, clamps, clips, check Qosina offers both standard and universal valves, stopcocks, hemostasis valves, plastisol Y connectors.The universal style tuohy borst adapters, swabs, spikes, can be cut to accommodate 3/32 inch, 1/8 syringes and tubing to the medical and inch, 3/16 inch and ¼ inch OD tubes.With 15 different Y pharmaceutical industries. Qosina is based in Ronkonkoma, NY connector configurations from which to choose, sample in a 95,000 square-foot facility with an ISO Class 8 Clean Room assortment kits containing a selection of plastisol connectors, and is ISO 9001, 13485 and 14001 registered. and custom design services available, Qosina canprovide plastisol connectors to meet the requirements ofall types of Contact : Qosina Corporation, Deanna Whelan 2002-Q Orville Drive North, Ronkonkoma, NY 11779 projects. Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 Qosina offers low minimums and short lead times. Log on to Email: [email protected] qosina.com to see pricing, obtain our latest catalog, request 40 July-Aug.2017

ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit • Breathing Circuit • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit • 3 Ball Spirometer • Nasal Canula • Patient ID Belt • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways Nebulizer Compressor • B. P. Meter • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter Life-O-Line Technologist 41 Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 July-Aug. 2017

ISO : 13485 : 2012 We are a leading Consulting organization JIMIT MEDICO providing an integrated services with SURGICALS PVT. LTD. focus on project technology : AN ISO 13485 : 2012 & CERTIFIED COMPANY Quality Management System as per ISO 9001, ISO 13485, Medical Devices Manufacturers & Exporters of CE marking as per MDD/93/42, FDA Disposable Medical Devices 510k, Audit, Documentation, training and c-GMP. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, Sanjay Y .Shah – Owner Promoter HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, M : +91 98240 17850 Dressings etc. Obelis European Specialized in Handling Large Quantity Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest & OEM / Contract Manufacturing Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Tele : +91-79-25835567, +91-79-25834850 Website : www.unikalindia.com E-mail: [email protected] • Web: www.jimitsurgicals.com 42 July-Aug.2017

Manufacturer And Exporter Of a ISO 9001-2000 wide range Of Medical Devices Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Products available with CE marking 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, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Wide Range Of Products : Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound The company Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical manufactures a wide range Cord Clamp etc... of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited 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: [email protected]/[email protected] Website : www.angiplast.com GMP PACK-EQUIP ISO - 9001-2008 Certified Company (Mfg. Packaging Machinery) S. Nath & Co. Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, Excellence in Quality CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Manufacturer & Exporter of Phone : 25855027 (M) 9825380739 Surgical Disposable Products since 1980 Works : IDEAL® 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • Infusion Set • Blood Administration Set 43 • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] July-Aug. 2017

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 Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount 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 : [email protected] [email protected] • Web : www.airwayssurgical.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) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 44 July-Aug.2017

Events Both service providers of medical technology and their suppliers profit from these positive factors. They will present their full range of services and expertise at the N° 1 international industry platform COMPAMED in Düsseldorf from 13 to 16 November 2017. COMPAMED has been a parallel event for the world’s biggest medical trade fair, MEDICA, for 25 years, and has become a portal into the future of medical technology, allowing you to access futuristic technology and make it into reality today, with over 750 exhibitors. Be it product development, production and marketing or the desire for comprehensive solutions: COMPAMED constitutes the starting point for close collaborations between suppliers and their customers. Often, suppliers’ ideas are aired here, and these lay the foundations for huge advances in development in the world of medicine in some cases. Medical technology has undoubtedly become one This can be demonstrated by taking of the most exciting industries in the world. This the example of diagnostic applications is because health is one of the most important for ‘Point-of-Care Testing’. These are analytical procedures for elements of life, above all others. Therefore, patient-proximate and rapid yet favourably priced and advances in diagnostic and therapeutic uncomplicated laboratory diagnostics. The equipment used in procedures are followed with particular interest. diagnostics and treatment must function reliably and The number of applications for patent from automatically for the benefits to be fully exploited. Samples must service providers is keeping pace with these be taken for analysis in precisely defined quantities and then expectations. The European Patent Office has processed and tested. Drugs must be adapted and dosed recorded that more applications for patents come according to the individual disease patterns presented by each from medical technology than any other branch. patient. Microfluidic systems play an important role in this. The All experts agree that the constant market growth development of tiny components and parts to this end has turned of the past few years is set to continue into the out to be highly complex but it does provide the necessary basis future. The true speed of the growth rate cannot for definite progress, for example in the field of ‘lab-on-a-chip’ be precisely estimated as a result of certain technology. economic and political development, as a result of trade protectionism. Alongside acceleration in So if an increasing number of illnesses which, just a few years innovation from service providers and ago, could only be diagnosed with the aid of complex laboratory skyrocketing enthusiasm for and interest in good analyses can now can be detected with the help of credit-card- medical care, superior technology trends also sized mini laboratories, then it is the exhibitors at the provide extra fuel for this boost. Digital COMPAMED trade fair and their skill who are driving these transformation must be mentioned here. All developments. industries have had to come onboard with digital transformation, and also miniaturise components Other innovations for application in wearables should be to elicit better handling and easier application for mentioned here. Wearables are becoming a market that is their products. earning billions worldwide. The best-known wearables are those used for sports watches or fitness wristbands. Microcomputers July-Aug. 2017 for medical applications (i.e. for monitoring important vital signs or monitoring implant function) are also developing at breakneck speed. Be it suitable wireless modules for sharing data, the most delicate of sensors and servos or powerful energy supplies that fit into the smallest spaces – the latest solutions are going to be presented at the COMPAMED trade fair and the most important aspects will be discussed at the two integrated specialist forums. Raw materials and materials are also a big theme at COMPAMED. For the specialist providers of these, foam isn’t just foam. Our trade visitors learn this at COMPAMED. New 45

Events period and under one roof. This coordinated tandem of trade fairs and topics is a one-off event and both events experience varieties (based on polyurethane) are marking new more success as a result of this mutual support. milestones in wound care. They show a high capacity for fluid retention and fluid containment and are thus excellently Therefore the two forums will be making relevant medical suited for use in modern wound dressings. Patients also technology supplier trends subjects of discussion. Thereby, the have good reason to be happy about this: When dressings COMPAMED HIGH-TECH FORUM (Hall 8a) presented by the are changed, the foam can be removed from the wound IVAM association for microtechnology places key focus on easily and without causing pain. microsystem technology, nanotechnology and production technology and process control. The content will focus on smart When it comes to coatings, specialist experts know that sensor solutions, printed electronics, microfluidics and innovative even a few micrometers can effect significant change and laser and photonics applications. The Countries session, on improvement in the functional characteristics of a medical attractive markets, is dedicated to France. product. This applies for for all systems such as catheters or stents that are used within the body. On the one hand, At the COMPAMED SUPPLIERS FORUM held by the specialist this depends on biocompatibility, but ensuring minimal magazine, DeviceMed (Hall 8b), specialists, leading international friction is also a priority. companies and organisations will be talking about current developments throughout the entire process chain which concern The entire value-added chain in medical technology medical technology. Main focal topics this year include: Digitalisation (mobile health, medical apps, medical industry 4.0), The product range at the COMPAMED trade fair (in Halls 8a wearables, 3D printing and regulations. and 8b) includes the following key branches: Components for medical technology (electronics, components, hoses, filters, As in previous years, it will be possible to visit both events with pumps, and valves, among other items), materials/ substances, a single ticket. micro- and nanotechnology, made-to-order manufacturing, electronic manufacturing services (EMS), complex COMPAMED 2017 + MEDICA 2017 takes place from 13 – 16 manufacturing and equipment partnerships (e.g. OEM – Original November. Equipment Manufacturers) as well as packaging and services. Open from 10:00 a.m. to 6:00 p.m. In conjunction with the world’s largest medical trade fair, MEDICA 2017, it will cover the entire medical technology supply chain – https://www.compamed-tradefair.com from individual components to measuring techniques and quality testing through to sterile, packed end products, within one time AN ISO 13485-2012 Events Calender CE certified Company • T-Plas 2017 : A Synergistic Platform With Focused Manufacturer & Exporter of Medical Disposable Devices & Surgical Medical & Healthcare Plastics Pavilion Products Date: Sept. 20 – 23, 2017. Venue: Bangkok, Thailand. Range of Products : • Infusion Set • Medicall 2017 : India’s Largest Hospital Equipment • Blood Administration Set • Measure Volume Set Expo, 18th Edition • Urine Collecting Bag Date: Oct. 6 – 8, 2017. • Urine Collecting Bag - Uro Meatry Venue: Mumbai. • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Compamed 2017 / Medica 2017: The world’s • Oxygen Face Mask • Nebulizer Kit leading trade fair for the medical industry • Vaccum Suck Suction Set Date : November, 13-16, 2017 • Latex Surgical Gloves Venue : Dusseldorf, Germany • Umblical Cord Clamp • 4th PLASTIVISION Arabia 2017 : International Contact Yogesh Patel M. : +91 98241 21383 Plastics, Printing & Packaging Exhibition Date: Dec. 11-14, 2017. MEDICARE DEVICES Venue: Sharjah, UAE. 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, • PLASTINDIA 2018 : 10th International Plastics Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Exhibition, Conference & Convention Website : www.medicaredevices.com Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India. 46 • Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018. Venue: Goregaon (East), Mumbai. July-Aug.2017