Table of
Contents 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• Now, MRP must on medical devices • Health ministry issues draft guidance document on “Essential principles for safety and performance of medical devices” • Covestro results buoyed by high PU, polycarbonates demand • Health ministry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? • About The “Medical Grade “ Polymer Dilemma
46 Events • • • • • •
July-Aug.2017
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
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Flashback Select Article Index
Sept. 1994 to Jan. 1996 • Polycarbonate And Medical Industry (September 94) Modern Plastics International, February 1993
Did You Know ?
?
• EVA V/S PVC (May 94) Mr. A.K. Dutta
About The “Medical Grade “ Polyner Dilemma
• PVC In Medical Device Application (March 94) Mr. C.R. Blass, Hydro Polymers Ltd., UK
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 market potential. The product and performance characteristics for “medical grade” polymers are determined at the discretion of the manufacturer, but everybody selling polymers can have their own definition of what a medical grade is, and that can present something of a problem.
• Design Aspects For Reusable Engineering Plastics (November 95) Ms. Amita Shrivastava, B.E. Plastic Technology • Product & Process : Use of Engineering Plastics As Medical Tubes (November 95) Mr. D. L. Pandya • Thermoplastic Polyurethane And Its Medical Applications (November 95) Mr. S. Sridhar Sankar • Engineering Polymers From GE Plastics For Medical Application (September 95) Mr. T. Srinivasan, Design Engineer, GE Plastics India
The selection of materials for medical, pharmaceutical or diagnostic applications can be a 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 grade” ? Defining and regulation Requirements for materials used, in the manufacture of medical devices, are specified in various regulatory requirements and directives. They hav to be be safe and effective and not compromise the safety of patients .The requirements for medical devices among other 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 always be considered in this process.
• Plastics In Medical Applications (March 95) Dr. Viren Shah, Consultant Surgeon, Ahmedabad, Mr. Sanjay Saxena, Assistant Engineer, CIPET, Ahmedabad
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 requirements, but medical grade polymers have no strict definition, and very often such plastics are sold on the basis of their biocompatibility alone.
• The Selection And Processing Of PVC Compounds For Blood Bags And Other Biomedical Applications (May 96) Dr. C.S.B. Nair, Technical Adviser, Peninsula Polymers Ltd., Trivandrum, Kerala
Not every polymer manufacturer will be willing or even able to meet the healthcare OEM’s stringent requirements in the medical and pharmaceutical sectors.
• Once Upon A Time There Was PVC (May 96) Abstrated From An Article By Mr. Robert S Brookman, Ph.D., Vice President, Colorite Plastics, U.S.A. • PVC Compounds For Medical Devices (May 96) 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 Technology, Trivandrum • Development of polymer Based Biomedical Devices Our Experience And Future Potential (January 96) Dr. R. Sivakumar, Head, Biomedical Technology Wing, Trivandrum
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It is estimated that only about three per cent of global plastics production is destined for healthcare industry.
Informed suppliers can be identified by asking them how their medical grades are characterised. Suppliers sometimes will just say their polymer is tested for biocompatibility, which does not guarantee each individual batch is tested. (Abstracted froman detailed article at the Ref : http://www.eppm.com/ materials/the-medical-grade-polymer-dilemma/ )
In a Nutshell.... “Logic and analysis can always find fault with innovative ideas. Use these tools but use them warily. If your intuition tells you that you have a great idea, then pursue it a little while longer”. - Paul Sloane, author of The Innovative Leader
July-Aug.2017
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.
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. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG 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 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: 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-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.
Editor’s Desk
From the
As we have been maintaining and emphasizing all the time, a strong supply chain for the Medical Polymers and related products and components is essential to support and facilitate Indian Medical Device Industry in order to accelerate the “Make-In-India” process. However, the Industry faces challenges of selecting right supplier for Medical Polymers. Selecting suppliers is an integral part of Medical Device Manufacturers’ commitment to offering highest performing products to their customers. This important aspect is addressed in this issue both by highlighting some important criteria for the selection process as well as introducing two important material providers with their respective characteristics and applications. FOCUSED MEDICAL PLASTICS PAVALION @ “PLASTINDIA 2018”. As an humble effort for creating platforms of interaction and creating linkages with Suppliers with the Indian Medical Devices And Plastics Disposables Industry, “Medical Plastics Data Service (MPDS)” has been contributing through various 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 “MEDICAL PLASTICS PAVALION @ “PLASTINDIA 2018”, to be held in Feb. 2018, in Gandhinagar, Gujarat. As it is well known, the event “Plastindia” is the 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 located in 125,000 sq.m. area and will have 2000 Exhibitors including 600 oversea exhibitors. About 200,000 visitors are expected to visit. The Medical Plastics Pavilion will be a knowledge platform complete with 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 potential manufacturers and investors to diversify and / or branch out into medical plastic products. It will also have presence of manufacturers / suppliers of materials, components, machineries, technology essential for manufacturing medical plastics products and devices. The newly established “Kalam Institute Of Health Technology ( KIHT ), India’s first Institute dedicated to medical technology located at “AMTZ”, Vishakhapatnam, will identify critical gaps in medical technology and suggest the government to do focused spending to bridge the gap between Academic, Research and Industry. Some of the other important aspects covered under this issue includes “Global Market Scenario for Medical Packaging” Technology Snippets highlighting innovations and developments in Materials and Machinery, Product Gallery, Industry News, as well as the regular “Did You Know” Column and Events Calender.
However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.
July-Aug. 2017
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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. 2. 3. 4.
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Commitment to quality Product and Market Knowledge Financial Stability Communication
5. 6. 7. 8.
Flexibility and Special Services. Technology And Innovation Value Corporate Responsibility
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 generation TPE’s finds the way to resolve several safety and performance issues….
The below graph shows the range of properties possible when blending HYBRAR™ with various ratios of PP.
Within the medical industry, demand is rising for safe and halogen-free polymers used in manufacturing medical products. Many polymer companies are feeling the need with new materials like thermoplastic elastomers (TPEs). For several decades, the medical industry has relied upon styrenic block copolymers (SBCs), a type of TPE, for use in a range of medical products. TPE process easily, have excellent mechanical properties and elasticity, and possess strong haptic. Their inherent low toxicity and compliance to medical and food contact regulations make TPEs a safe choice for specifying materials for use. With more than 30 different types of TPEs with individual product properties, Kuraray offers a diverse portfolios for the medical market. These TPEs are safe and non-toxic and offer flexibility and performance in the design of medical products where superior performance and safety is needed most. Kuraray’s TPE products, SEPTON™ and HYBRAR™ combine the elastic properties of rubber with the benefits of thermoplastics. Due to this thermoplastic nature, they can be processed into almost any shape. These TPEs have a soft touch and provide comfort and durability. 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 costeffective 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
Orthopedic Gels : Kuraray’s SEPTON™ is a series of high-performance, thermoplastic rubbers that are based on Kuraray’s SEEPS technology. Styrene Ethylene Ethylene-Propylene Styrene (SEEPS) grades are comprised of copolymers with both isoprene and butadiene in the midblock. SEPTON™ 4,000 Series can be used to create orthopedic gels. The SEPTON™ 4000 Series provide orthopedic gels with their necessary stability and super soft characteristics giving the products a natural skin-like feel and performance over a broad temperature range. With their low specific gravity and high tear strength characteristics, these products can replace silicone in various applications. Additionally, characteristics like lower melt viscosity, excellent low temperature behavior and superior process-ability at a low shear rate ensure enhanced overall process-ability and production efficiency. Developed for high-performance products where long lasting stability and compression set are key requirements, SEPTON™ 4000 Series can be used in applications such as cushions for artificial limbs, orthopedic bandages, prostheses and burn plasters. Their excellent shock absorbing and damping properties combined with non-allergenic qualities meet the high demands in this industry.
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Materials The below graph shows the comparison of tear strength and density of SEPTON™ to Silicone and Urethane Gels.
Medical Bags : Kuraray’s SEPTON™ and HYBRAR™ lines are suitable for dry blending in film extrusion processes, most often found in the manufacturing of medical bags. Both TPEs show maximum softness and elasticity. Due to their excellent compatibility with polyolefins, they allow great flexibility to create film properties that normally cannot be achieved with commodity polyolefin resins alone. They perform well in high temperatures, can be sterilized and can be down-gauged due to their improved impact resistance. Furthermore, there is no migration of PVC plasticizer as compared to PVC bags. In the field of flexible packaging films made from polyethylene and polypropylene, HYBRAR™ offers various grades that can be added for specific customization. Compared to plastomers or Polyolefin elastomers, these materials perform in the lowest concentrations necessary to achieve maximum value. The main advantage is impact resistance for down-gauging purposes. Specifically for 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.
Patch Adhesives : Various products within Kuraray’s SEPTON™ line can be processed for patch adhesives. The SEPTON™ 4000 Series can be used when there is a need for products with extremely high cleanliness. Their well-balanced adhesion and cohesion force makes patch adhesives with SEPTON™ products easy to peel off. For the consumer this means better comfort without the risk of causing allergies. Medical applications today are becoming more demanding from both a performance and safety standpoint. This requires materials that go beyond standard SBCs that satisfy value added solutions in a variety processing technologies and end use conditions. SBCs continued advancement in extrusion and injection molding process development further drive adoption into new application areas. Due to the concerns with Poly-Vinyl Chloride (PVC), SBCs offer a safer and more environmentally friendly alternative with comparable performance. As the market continues to evolve, so has technology, with new materials. Kuraray India is focused on marketing of Kuraray special polymers to meet the emerging requirements from Indian market in combination with technical supports and excellent services to the customers.
Kuraray’s SEPTON™ 4000 Series is designed for high-performing 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 distinct properties further lead to down-gauging probabilities. Also, significant material savings – as much as 40 percent lower material usage and 40 percent weight reduction over competitive products – can be achieved while maintaining mechanical properties, compared to other thermoplastic elastomers. Kuraray’s SEPTON™ 4000 series combines the strength of SEBS with the softness expected of SBS and SIS elastomers.
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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 tech@amipolymer.com Silicones have been playing vital role as a part of product design in medical industries for more than 75 years.
• Platinum Silicone Tubings for Drug Delivery and Surgical 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 designers for medical industries. Basic limitation of peroxide silicone is by-products generation during its manufacturing process which can extract out with contact media. Extract 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.
• Silicones Gels are used as soft skin adhesives and wound interface. • Silicone coatings for needles
List of Tests under Biological Evaluation of Medical Devices - ISO 10993 Cytotoxicity
Acute systemic Toxicity
Genotoxicity
Sensitization
Subacute Toxicity
Hemo- compatibility
Irritation
Pyrogenicity
Implantation
• Platinum silicone easily meets with tests mentioned under Standard Biological Reactivity test In Vitro USP Class 87 and USP Class 88 (In Vivo). • 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
• Silicones Resins for Human Implants
Silicone Gel as Breast Implant
Nasal Silicone Implants
Figure Silicone implants
www.medicalplasticsindia.com
The Only Indian Portal Site On Medical Plastics/ Devices Technology And Trade July-Aug. 2017
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Technology Snippets Conair Introduces New Cutter for Medical Tubing Conair Group offers a new micro planetary cutter for medical tubing, called the M-TPC. The cutter features a fully programmable servo-driven cutting head that cuts small-diameter medical tubing that it virtually eliminates the need for secondary, off-line finishing. The knife spins around the circumference of the tubing from 0.08- to 1inch in outside diameter, cutting without deformation, burning or fracturing. The M-TPC cutter is the latest in Conair’s MedLine family of cleanroom-ready, downstream extrusion equipment for medical applications. Conair introduced it at Plastec East, June 13-15 in New York. The M-TPC planetary cutter splits the tubing apart cleanly through displacement, without the loss of any material. This method of cutting never blocks continuous airflow through the center of the tube, so tube sizing and ovality are not affected, as they can be when using flying-knife cutters, according to Conair. The Conair cutter is mounted on a servo-driven traveling table that can handle tubing at line speeds up to 100 feet per minute. The unit can make up to 45 cuts a minute. http://www.plasticsnews.com/article/20170628/NEWS/ 170629899/conair-introduces-new-cutter-for-medical-tubing
Recent Advances in Plastics Technology for Medical Care: Dr Mosongo Moukwa New materials & processing techniques will enable healthcare industry to create innovative products Medical plastics market will reach a value of $ 6.9 billion by 2020 with a compounded annual growth rate in the 7 percent range between 2015 and 2020. The business drivers in the medical device industry typically include evolutionary innovations in product performance and speed to market. Polymers have become an integral component in a wide range of medical designs, enabling the next generation of implants, single-use devices, and packaging technology, among many others. There are a number of advances in polymer and materials science that have opened up endless possibilities in medical technology. Here are some of them. Dissolvable sensor to monitor brain Scientists from Washington University and the University of Illinois at Urbana Champaign have developed a wireless device the width of a human hair that can be implanted in the brain and activated by remote control to deliver drugs. These are wireless bioresorbable brain sensors capable of measuring intracranial pressure and temperature before being absorbed in the body. The devices are made of polylactic-coglycolic acid (PLGA) and silicone. They represent a revolutionary development for neuroscientists who can now temporarily monitor intracranial pressure and temperature with accuracy. Once the device is no longer needed, the body absorbs it. Implantable elastomeric and shape memory materials Gelest Inc, a materials technology company, has developed a new class of elastomers with unprecedented elongation and shape recovery abilities. The new materials, based on silicone with different functional groups, approach 5000 percent elongation at break, allowing engineers to create microfluidic devices used in ‘in vitro’ diagnostics that can withstand movement, elongation, and distortion, yet still retain functionality.
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They can be stretched, rolled, and inserted into a syringe, injected through a small opening into the body and then, once in place, can return to its original shape. Stretchable films to monitor cancer patients Thin, stretchable film, developed at University of Michigan that can coil light waves like a Slinky could make monitoring of cancer survivors more effective and less expensive. Film is based on the same material used for contact lenses (PDMS), twisted and coated with nanoparticles of gold to induce reflectivity, then untwisted. It provides a simpler, cost effective way to produce circularly polarised light, essential ingredient in process that could provide early warning of cancer recurrence. More frequent monitoring could enable doctors to catch cancer recurrence earlier. New hybrid polymers that can regenerate A completely new hybrid polymer that incorporates rigid and soft nano scale compartments, which can be removed and regenerated, has been developed by Northwestern University scientists. This polymer is capable of contracting and expanding like muscles and rapidly responding to environmental stimuli. It can be used in implantable materials to deliver something and then chemically regenerated to function again. Other applications of interest include the creation of artificial muscles or other lifelike materials, delivering biomolecules or other chemicals, selfrepairing materials and replaceable energy sources. Stretchable polymer for wearable electronics Panasonic has developed a soft, flexible, and stretchable polymer resins films that can stretch more than 2.5 times its relaxed length and return to its original form without any damage. The film is based on a thermosetting resin with a 3-D crosslinked structure that makes it flexible and stretchable. It outperforms other films by retaining its mechanical properties after repeated deformation. It is also an insulator, adding to its potential in wearable devices as well as in transparent, stretchable electrodes. Sponge like polymer for spinal injury Scientists at the Mayo Clinic have developed a biodegradable polymer grafts designed to repair damaged vertebrae in the spinal column. The polymer adapts itself into the appropriate size and shape once implanted in the body. Derived from a dehydrated hydrogel, surgeons would simply plant these capsules into gaps in the spinal cord (resulting from either surgery or another injury), and our body’s fluids would then activate the polymer, allowing them to expand to the proper proportions. Endless possibilities There are so many exciting new materials and processing techniques that, alone or in combination, will enable the healthcare industry to create innovative, next-generation products. They will allow more effective treatments and the promise of better patient outcomes. The combination of plastics and engineering will continue to revolutionise medical care as far as we can see. (Dr Mosongo Moukwa is director of technology at PolyOne, USA, and was recently an independent consultant based in Chapel Hill, USA, and vice president - technology at Asian Paints Ltd, Mumbai, India.) Ref : As published in “ Business Standard and available at web link http://www.business-standard.com/content/b2bplastics-polymers/recent-advances-in-plastics-technology-formedical-care-dr-mosongo-moukwa-117011600298_1.html July-Aug.2017
®
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
: 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 28
July-Aug.2017
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 : 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
An ISO & CE certified Company
AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.
Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.
AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 pawantiwari1978@gmail.com
July-Aug. 2017
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July-Aug.2017
Global Trends
Medical Packaging - Global Market Scenario
Mercy P. Bulsari (Polymer Technologist) Email: mbulsari5@gmail.com +91-7405591482 (Cell) The medical / healthcare industry is one of the largest industries in the world. Healthcare packaging is essential for protecting the medicines and medical equipment from contamination from air, moisture and dust. Being a vital industry, as emerging economies grow, demand for healthcare packaging will increase, further strengthening the market. The global healthcare packaging market is constantly challenged with changing trends such as the increased use of disposable medical products, ageing population, rising cost of raw materials, transportation and energy, cost pressures on suppliers, influence of regulations, outsourcing packaging, child-resistant and tamper-evident packaging. Countries continue to invest in healthcare development, and corresponding strong demand is expected for healthcare packaging, allowing for robust market 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 market are the growing healthcare industry. There is an increased demand for such packaging by the medical device manufacturers on a large scale. The packaging industry on the other hand are seen investing heavily on various technological advancements. On the basis of product type, pouches contributes the largest to the market, majorly due to its costeffectiveness and infection resistant specification. Cost sensitiveness and falling healthcare costs are hindering the growth of the global medical device packaging market. NorthAmerica contributes largely to overall market share. Europe is the leading consumer followed closely by North America. Major demand in Europe is generated from Western Europe where most of the major consumers such as GE Healthcare, Phillips and Siemens Healthcare among others are located. Asia Pacific has emerged as the fastest growing market led by India and China owing to expansion and stricter regulations for medical products industry in the region.
the forecast period. Other product types include pouches, trays, blister packs, clamshell packs and vials. Stringent government regulations and strict industry standards are expected to further enhance the market demand. Improved strength, barrier properties and puncture resistance have added to the attractiveness of pouches for small to medium sized packages. Multiple compartment trays and clamshell trays are other types which are gaining popularity attributed to lower risk of infection spreading and staff errors during the organization of products.
• • • •
• • • • •
By Product Trays Pouches Bags Clamshell Packs Other
By Material Paper Plastic Paperboard Others
Global Medical Device Packaging Market Segmentation
• • • •
By Region North America Europe APAC Others
Regional Analysis of Global Medical Device Packaging Market Asian countries, especially India, China are expected to grow fastest over the forecasted period due to expansion of the healthcare industry and stricter government and non-government regulations to support healthcare sector. However, North America dominates the market due to advancements of medical technology and infrastructure.
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 packaging and expected to remain the largest segment over July-Aug. 2017
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Global Trends
USD Billion
Market Size of Medical Device Packaging by Regions (USD Billion) 40 35 30 25 20 15 10 5 0
North-America
Europe
Asia-Pacific
ROW
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 : sanidhya.ent@gmail.com 36
July-Aug.2017
Industry News Now, MRP Must On Medical Devices Union Minister for Consumer Affairs Ram Vilas Paswan today said that medical devices have been brought under the ambit of Packaged Commodities Rules.
“On account of implementation of GST from July 1, there may be instances where the MRP of a pre-packaged commodity is required to be changed,” Paswan said.
This will make it obligatory for the display of retail sale of prices (MRPs) on the devices with regard to their sale. This will ensure uniformity in the quality of devices, their brand and prices. This had been a long-standing demand of consumers. He said that a committee has been instituted in the Consumer Affairs Ministry to look into complaints with regard to rates following the roll-out of GST.
In this context, the ministry has allowed manufacturers or packers or importers of pre-packaged commodities to declare the changed MRPs on the unsold stock prior to July 1, after inclusion of the increased amount of tax due to GST, if any, in addition to the existing MRP for three months July 1 to September 30.
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-onmedical-devices/433335.html
“The declaration of the changed MRP shall be made by way of stamping or putting sticker or online printing,” Paswan added.
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 document on “Essential principles for safety and performance of medical devices”. This document is prepared under the provisions of Rule 6 of Medical Devices Rules, 2017 to provide binding guidance for use in the manufacturing of medical devices which are intended to be sold in India. This document provides an overview on meeting the essential principles for safety and performance of medical devices. This document does not dictate how a manufacturer should prove that their medical device has met the essential principles laid down in this document, hence providing flexibility to the manufacturers and catering to technological advances and changes in the development of new medical devices. This guidance document describes fundamental design and manufacturing requirements, referred to as “Essential Principles for Safety and Performance” that, when met, indicate a medical device including in vitro diagnostic (IVD) medical device is safe and performs to its specification. There are seven general requirements of safety and performance that apply to all medical devices including IVD medical devices as specified in section 4 of this document. There are further design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. The design and manufacturing requirements in this document
are grouped in different categories. They are chemical, physical and biological properties; infection and microbial contamination; manufacturing and environmental properties; devices incorporating a substance considered to be a medicinal product or drug; devices incorporating materials of biological origin; devices with a diagnostic or measuring function; devices that incorporate software and standalone medical device software; active medical devices and devices connected to them; environmental properties; protection against radiation; protection against mechanical risks; protection against the risks posed to the patient by supplied energy or substances; protection against the risks posed to the patient for devices for self-testing or selfadministration or intended by the manufacturer for use by lay persons; information supplied by the manufacturer i.e. Label and Instruction for Use; and performance evaluation including analytical performance and where appropriate, clinical evaluation. In addition to the general essential principles as specified in the section 4 of this document, above listed additional essential principles for safety and performance which need to be considered during the design and manufacturing process are further specified separately for medical devices other than IVD medical devices; and IVD medical devices. http://pharmabiz.com/NewsDetails.aspx?aid=103344&sid=1
Covestro Results Buoyed By High PU, Polycarbonates Demand German materials supplier Covestro has reported a sharp rise in year-on-year earnings and sales in the second quarter of 2017, thanks to increasing demand for polymer materials.
“In the next five years, we anticipate generating a cumulative total of •5bn in free operating cash flow,” said CEO and interim CFO Patrick Thomas.
In the three months to 30 June, group sales were up 17.0% at •3.5bn, while core volumes were down by over 1%, the company announced 25 July.
The cash, he added, will be used for bolt-on acquisitions in the specialties segment, if the opportunity arises.
Higher utilisation rates and “robust demand” also helped the Leverkusen, Germany-based company to increase earnings (EBITDA) by 56.5% to •848m in the second quarter.
Referring to the ongoing demand for its products, chief commercial officer Markus Steilemann said Covestro would further invest in its production plants and removing bottlenecks in the polyurethanes and polycarbonates segments.
Net income more than doubled with a 110.4% growth to •484m during the period.
While core volumes in the polyurethanes segment were down 2.3% year-on-year in the second quarter, the segment’s earnings
July-Aug. 2017
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Industry News grew by 143.9% over the prior-year quarter to •556m, largely due to improved margins. The decline in volumes was attributable primarily to the polyether polyols product group and constrained product availability in the MDI and TDI product groups. To meet the high demand Covestro announced in March that it would continue production of the rigid foam precursor MDI in Tarragona, Spain, for the time being. The company is also doubling its MDI capacity at its Brunsbüttel plant in northern Germany to around 400,000 tonnes per year by the end of 2018. The Polycarbonates segment recorded modest growth in core volumes of 0.7% compared with the prior-year quarter. While growth was weaker compared to the previous quarter, due to constrained volumes available in Europe, Covestro benefited from its capacity expansion at the Shanghai site, which came on stream late 206. The segment’s earnings rose by 3.1% to •197m.
Covestro has already announced further expansion at its Shanghai plant to address growing demand, particularly in the APAC region. The expansion will be completed in 2019. Core volumes in the Coatings, Adhesives, Specialities segment decreased by 3.0% from the prior-year quarter, mainly as a result of volume shifts in the first six months. Earnings in the segment was down 19.7% at •114 million compared to the same period the previous year. For the first half results, Covestro said in the first six months of the year sales grew 20.8% on a 14.4% total increase in selling prices to •7bn. First half earnings were up 61.3% at •1.7bn, primarily driven by earnings growth in polyurethanes. Free operating cash flow also increased significantly by 68.8% to •530m. http://www.plasticsnewseurope.com/article/20170725/PNE/ 170729949/covestro-results-buoyed-by-high-pupolycarbonates-demand
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 into force in the country from January 1, 2018, the Union health ministry has now issued the draft list of medical devices and in vitro diagnostics along with their risk-based classifications. As per the Medical Devices Rules 2017, medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. The devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central government by notification in official Gazette, after consultation with the Drugs Technical Advisory Board, fall under the definition of drug. The list of 15 devices notified so far in the country include disposable hypodermic syringes; disposable hypodermic needles; disposable perfusion sets; in vitro diagnostic devices for HIV, Hbsag and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone cements; heart valves; scalp vein set; orthopedic implants; internal prosthetic replacements; and ablation device. The new Medical Devices Rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i); substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). As per the draft list issued by the ministry, Radiofrequency Ablation Device, Percutaneous Conduction Tissue Ablation,
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Suction Ablation Catheter System, Fiberoptic Oximeter Catheter, Cardiac Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and Control, Keratoprosthesis, Detachable coils, Bone heterograft, Vena cava clip, Implantable Infusion pump, Glenoid fossa prosthesis, Vascular clip, Vascular embolization device, Intervertebral body fusion device, Haemo-Dialyzer System, Implantable cardiac pacemaker including accessories, Drug eluting stent, Vascular graft/occluders/Cardiac Patches and Implanted intracerebral/ subcortical stimulator for pain relief, to name only a few, have been listed in the high risk Class D category. A-V Shunt or Fistula Adapter, Enternal infusion Pump, Transcervical(Aminosco pe) Endoscope and accessories, Forceps, endoscopic, Anastomotic Microvascular Device, Angiographic Guide Wire and Accessories, Vessel Dialator for percutaneous Catheterization, Angioscope, Aspiration Needle and Syringe, Tracheobronchial Suction Catheter, Cervical Drain, Rectal Balloon, Biliary Stone Retrieval Basket, Contact Lens Bifola and Daily, Blood Administration kits, Biopsy Kit, Tracheostomy Tube/Tracheal Tube, Irrigating Syringes, Intravenous Cannula, Vial Adapter, Suprapubic, nondisposable Cannula and Trocar, Aortic Cannula, Arterial Cannula, Coronary Artery Cannula, Arthroscopy Drainage Cannula, Lacrimal, Hemodialysis Cannula, Cannula Injection, Uterine Insufflation Cannula, Continuous Positive Airway Pressure Nasal Oxygen Cannula, Salpngography Catheter, etc have beenl isted in the Class B category. Likewise, Vein Ablation Device, Thermal Ablation Device, Injector Type actuator syringe, Transabdominal (Fetoscope) Aminoscope and Accessories, Anastomosis Device for Microvascular Surgery, Anastomosis Device for Gastroenterology Urology Use, Anaesthetic Conduction Kit, Ophthalmic Laser and Accessories, Embolic Particles System, Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis, Peritoneal Automatic Delivery System, Implanted Subcutaneous Intravascular Port & Catheter, Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis, Pacemaker lead adaptor, Surgical Dressings, etc have been listed in the moderate to high risk Class C category. July-Aug.2017
Industry News Bolster Suture, Cyclodialysis eye Cannula, Nasopharyngeal Catheter/Nasopharyngea l Class A, Umbilical occlusion device, Incontinence Urosheath Device, Pharynscope, etc have been
included in the Class A category. 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 institute dedicated to medical technology located at Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam, has received 100 per cent financial support from the Department of Biotechnology (DBT). Named after India’s 11th President Dr APJ Abdul Kalam, KIHT has been set up with the aim to identify critical gaps in medical technology and suggest the government to do focused spending on such areas and help bridge the gap between academic research and industrial market access, by auctioning of patents and prototypes available with government funded academic research institutions. KIHT shall broadly function on Innovation & Market Access, Enabling Technology Transfer, and Research & Development Support. Placed within AMTZ, KIHT is amidst direct access to academia and industry. KIHT approval comes under the aegis of the launch of the National Biopharma Mission – an Industry-Academia Collaborative for accelerating discovery research to early development for biopharmaceuticals. The National Biopharma
July-Aug. 2017
programme includes an investment of USD 125 million from the Government of India and an equal contribution as a loan from World Bank and is anticipated to be a game changer for the Indian biopharmaceutical and medical devices industry. KIHT shall support Department of Bio-technology in areas of medical technology. KIHT – a registered society has Dr R Chidambaram, Principal Scientific Advisor to Government of India as its President; Secretary, Department of Bio-technology as Chairperson and Dr. Jitendar Sharma as Executive Director. It is a first Institute of its kind with Association of Indian Medical Device Industry (AIMED) on its governing board. KIHT is a jewel on the crown of AMTZ which is one of the fastest growing Government of India supported projects in Andhra Pradesh. AMTZ has recently received the most Innovative MedTech Zone Award. Located within AMTZ campus, India’s first state-of-the-art medical devices manufacturing park, KIHT will have direct access to academia and industry. http://pharmabiz.com/NewsDetails.aspx?aid=103359&sid=1
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Product Gallery Dip-Molded Plastisol Y Connectors from Qosina Ronkonkoma, NY – August 3, 2017 – Qosina stocks a variety of Y connectors manufactured from plastisol, also known as liquid polyvinyl chloride (PVC),a material used to make flexible components. These connectors are produced through a dip molding process rather than traditional injection molding. Plastisol provides exceptional flexibility, is Class VI approved and BPA- and latexfree.Dip molding is an ideal method for molding connectors as the dipping dies are cost-effective,allowing for production to be easily scaled. Qosina offers both standard and universal plastisol Y connectors.The universal style can be cut to accommodate 3/32 inch, 1/8 inch, 3/16 inch and ¼ inch OD tubes.With 15 different Y connector configurations from which to choose, sample assortment kits containing a selection of plastisol connectors, and custom design services available, Qosina canprovide plastisol connectors to meet the requirements ofall types of projects. Qosina offers low minimums and short lead times. Log on to qosina.com to see pricing, obtain our latest catalog, request
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complimentary samples and place orders. Be sure to sign up for our monthly enewsletter to stay current with our newest product additions. Our product development team can work with you to customize a part to your specifications. Call our customer service specialists to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com. Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories,compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, 13485 and 14001 registered. Contact : Qosina Corporation, Deanna Whelan 2002-Q Orville Drive North, Ronkonkoma, NY 11779 Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 Email: deanna@qosina.com
July-Aug.2017
ISO 9001-2015 ISO 13485-2012 CE WHO GMP
Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter
• • • • • • • • • • •
Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter
Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901
July-Aug. 2017
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ISO : 13485 : 2012
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.
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
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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Tele : +91-79-25835567, +91-79-25834850
E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com July-Aug.2017
Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
Manufacturer And Exporter Of a wide range Of Medical Devices
ISO 9001-2000
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
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
GMP ISO - 9001-2008 Certified Company
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 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 • snathco@hotmail.com July-Aug. 2017
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. 43
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
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
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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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
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 of the most exciting industries in the world. This is because health is one of the most important elements of life, above all others. Therefore, advances in diagnostic and therapeutic procedures are followed with particular interest. The number of applications for patent from service providers is keeping pace with these expectations. The European Patent Office has recorded that more applications for patents come from medical technology than any other branch. All experts agree that the constant market growth of the past few years is set to continue into the future. The true speed of the growth rate cannot be precisely estimated as a result of certain economic and political development, as a result of trade protectionism. Alongside acceleration in innovation from service providers and skyrocketing enthusiasm for and interest in good medical care, superior technology trends also provide extra fuel for this boost. Digital transformation must be mentioned here. All industries have had to come onboard with digital transformation, and also miniaturise components to elicit better handling and easier application for their products.
July-Aug. 2017
This can be demonstrated by taking the example of diagnostic applications for ‘Point-of-Care Testing’. These are analytical procedures for patient-proximate and rapid yet favourably priced and uncomplicated laboratory diagnostics. The equipment used in diagnostics and treatment must function reliably and automatically for the benefits to be fully exploited. Samples must be taken for analysis in precisely defined quantities and then processed and tested. Drugs must be adapted and dosed according to the individual disease patterns presented by each patient. Microfluidic systems play an important role in this. The development of tiny components and parts to this end has turned out to be highly complex but it does provide the necessary basis for definite progress, for example in the field of ‘lab-on-a-chip’ technology. So if an increasing number of illnesses which, just a few years ago, could only be diagnosed with the aid of complex laboratory analyses can now can be detected with the help of credit-cardsized mini laboratories, then it is the exhibitors at the COMPAMED trade fair and their skill who are driving these developments. Other innovations for application in wearables should be mentioned here. Wearables are becoming a market that is earning billions worldwide. The best-known wearables are those used for sports watches or fitness wristbands. Microcomputers 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
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Events varieties (based on polyurethane) are marking new milestones in wound care. They show a high capacity for fluid retention and fluid containment and are thus excellently suited for use in modern wound dressings. Patients also have good reason to be happy about this: When dressings are changed, the foam can be removed from the wound easily and without causing pain. When it comes to coatings, specialist experts know that even a few micrometers can effect significant change and improvement in the functional characteristics of a medical product. This applies for for all systems such as catheters or stents that are used within the body. On the one hand, this depends on biocompatibility, but ensuring minimal friction is also a priority. The entire value-added chain in medical technology The product range at the COMPAMED trade fair (in Halls 8a and 8b) includes the following key branches: Components for medical technology (electronics, components, hoses, filters, pumps, and valves, among other items), materials/ substances, micro- and nanotechnology, made-to-order manufacturing, electronic manufacturing services (EMS), complex manufacturing and equipment partnerships (e.g. OEM – Original Equipment Manufacturers) as well as packaging and services. In conjunction with the world’s largest medical trade fair, MEDICA 2017, it will cover the entire medical technology supply chain – from individual components to measuring techniques and quality testing through to sterile, packed end products, within one time
AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products 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
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
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period and under one roof. This coordinated tandem of trade fairs and topics is a one-off event and both events experience more success as a result of this mutual support. Therefore the two forums will be making relevant medical technology supplier trends subjects of discussion. Thereby, the COMPAMED HIGH-TECH FORUM (Hall 8a) presented by the IVAM association for microtechnology places key focus on microsystem technology, nanotechnology and production technology and process control. The content will focus on smart sensor solutions, printed electronics, microfluidics and innovative laser and photonics applications. The Countries session, on attractive markets, is dedicated to France. At the COMPAMED SUPPLIERS FORUM held by the specialist magazine, DeviceMed (Hall 8b), specialists, leading international companies and organisations will be talking about current developments throughout the entire process chain which concern medical technology. Main focal topics this year include: Digitalisation (mobile health, medical apps, medical industry 4.0), wearables, 3D printing and regulations. As in previous years, it will be possible to visit both events with a single ticket. COMPAMED 2017 + MEDICA 2017 takes place from 13 – 16 November. Open from 10:00 a.m. to 6:00 p.m. https://www.compamed-tradefair.com
Events Calender • T-Plas 2017 : A Synergistic Platform With Focused Medical & Healthcare Plastics Pavilion Date: Sept. 20 – 23, 2017. Venue: Bangkok, Thailand.
• Medicall 2017 : India’s Largest Hospital Equipment Expo, 18th Edition Date: Oct. 6 – 8, 2017. Venue: Mumbai. •
Compamed 2017 / Medica 2017: The world’s leading trade fair for the medical industry Date : November, 13-16, 2017 Venue : Dusseldorf, Germany
• 4th PLASTIVISION Arabia 2017 : International Plastics, Printing & Packaging Exhibition Date: Dec. 11-14, 2017. Venue: Sharjah, UAE.
• PLASTINDIA 2018 : 10th International Plastics Exhibition, Conference & Convention Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India.
• Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018. Venue: Goregaon (East), Mumbai. July-Aug.2017
