Medical Plastics Data Service November - December 2017

CToabnletoef nts Vol. 25 No. 6 Nov. - Dec. 2017 22 Cover Story • Medical Plastics Market Analysis By Applications - 2014 – 2025 Increasing market size for medical grade plastics has resulted in rise in demand for premium grade plastics .The industry is characterized by continuous technological advancements to produce refined products to …… • Plastics In Medical & Healthcare Sector : Emerging Trends & Applications Bioplastics , Antiseptic For Medical Devices , Micro Injection Moulding, Prosthetics, Wound Care, Spinal Implants , Kink-Resistant Tubing, Bioresorbable Polymers, Medical Device Adhessives, Medical Swabs…………. 27 Industry Awards • Rajv Nath, Forum Coordinator, Association Of Indian Medical Device Industry (AiMeD) Awarded Dynamic Healthcare Entrepreneur Of The Year 2017. The award , adjudged by a jury of eminent personalities associated with Public and Private Heathcare and Government Establishments, highlighted the contribution of a personality who has been able to set up a new mark in the Healthcare Industry with a Unique Philosophy and by following a Distinctive Approach. MEDICAL28 Markets DEVICES • Medical Devices : India Market and Context (Based on Report Prepared By “Sathguru” For in INDIA Assocham) Medical Device Sector representing 9 % of the overall healthcare Industry , is 4th largest in Asia is 36 growing at a CAGR of 16 % . The current shift reflects companies moving up the value chain, building competitiveness through ……… Industry News • Qosina Announces Scott Herskovitz as New President and CEO. • DCGI Issues Classification Of Medical Devices & In Vitro Diagnostics Under Provisions Of Medicall Devices Rules, 2017 • Launch Of KIHT A Major Boost Towards Making India A Global Manufacturing Hub For Medical Devices: AiMeD • India Aims To Ease Import Process For Medical Devices 38 Global Trends • New Materials for Medical Devices • Medical implants drive growing demand for Ultra-High Molecular weight polyethylene Industry Clusters 45 Article Index Article Index : January 2017 to December 2017 . Important Articles published in “Medical Plastics Data Service” during January 2017 to December 2017 20 Did You Know? • About Using Medical Polymers Reduce Hospital-Acquired Infections 44 Events • MEDICAL MANUFACTURING ASIA 2018: Delivering solutions for the future of medtech 44 Event Calender • PLASTINDIA 2018: Feb. 7-12, 2018, Ahmedabad • Medicall 2018 - Hyderabad: February 23-25, 2018 • Medical Fair India 2018: March. 16-18, 2018, Mumbai • K 2019 : October 16 to 23, 2019 Dusseldorf, Germany. • Medical Manufacturing Asia 2018: August 29 - 31, 2018 Nov.-Dec.2017 19

Flashback ?YoDKuindow ? About Using Medical Polymers Reduce Select Article Index Hospital-Acquired Infections Jan. 2000 to Sept. 2005 Hospital Acquired Infections (HAIs) affect millions of people around the world and cost healthcare systems billions. Whether the cause is reduced staffing in hospitals (resulting in • Potential Of Plastics In Medicine less time for healthcare workers to thoroughly disinfect between patient visits), the increas- (January 2000) ing resistance of certain pathogens to current sterilization procedures, or any of a dozen Dr. V. Kalliyana Krishnan other reasons, this problem continues to affect patients needing healthcare. • The Use Of PVC For Critical Medical Catheter Acquired Urinary Tract Infections (CAUTIs) are the single largest cause of hospital Applications (July 2001) acquired infections today. This is because it is common for bacteria biofilms to form on the Dr. CSB Nair, Director, Research & Develop- catheter surface, leading to damage, inflammation and infection via the adjacent tissues. ment, Kerala Biofilms are thin layers of microorganisms, usually protozoa and bacteria, which colonise exposed surfaces of medical devices. • Phthalates In Medical Devices (July 2001) Dr. Leonardo Maghetti, Marketing Manager Antibacterial coatings, whether silver or antibiotic impregnated, are intended to kill the biofilms Of S.I.F.R.A.EST Group, Italy once they have formed, minimising damage to exposed tissue. In practice, however, this approach is ineffective at preventing the growth of bacterial biofilms - existing coated • PVC In The Healthcare Sector (July 2001) catheters on the market have not reduced CAUTIs Abstracted From The Web Site Of The Danish Association DMDA, Www.Dmda.Dk Using Polymers to Reduce Infections • Materials For Medical Devices The use of plastic medical devices helps caregivers to control the HAI problem because of (March - Apr. 2003) features like : cleanliness, sterility, convenience, ease of use, and low cost.There is a need Dr. CSB Nair, Director, Research & Develop- to do more in controlling and reducing infections, and one way to help improve outcomes is ment, Kerala through the use of antimicrobial plastics in the construction of various medical devices. Rather than aiming to kill bacteria, researchers looked to better protect against HAIs by changing • Medical Plastics (May - June 2003) the physical properties of surfaces to make them inhospitable to bacteria. Abstracted From An Article By Mr. Richard Stewart As Published In “Plastics Engineering”. Polymers and, more specifically, the proper selection of such materials for manufacturing of medical devices, will continue to be a factor in helping control hospital-acquired infections, • Present Trends And Future Prospects Of and provide better patient safety, improved healthcare, and reduced operating costs. Plastics In Medical Applications (Nov-Dec 2004) Whether the improvement comes from surface-bound or released antimicrobials in medical Dr. B. Ramaraj, Senior Technical Officer, device plastics; from the use of more resistant polymers; or from better design that allows CIPET, Mysore more effective cleaning and longer useful life of the plastic products, the improved outcomes will be a welcome trend in reduction in the frequency of HAIs .. • Present Trends And Future Prospects Of Plastics In Medical Application In a (Sep-Oct 2004) Nutshell.... Dr. B. Ramaraj, Senior Technical Officer, CIPET, Mysore “Innovation distinguishes between a leader and • Plastics Gain New Importance In Medicine a follower.” At Compamed (Sep-Oct 2004) Mr. Host Giesen, Project Director, Medica 2004 -Steve Jobs • Trend for Miniaturisation in Medical Nov.-Dec. 2017 Technology - Systems and Components for Telemedicine and Point-of-Care Diagnos- tics (Nov-Dec 2005) • Glove Manufacturing (Nov- Dec 2005) Mr. Manan Shah, Rubber Technologist • Medical Device Reprocessing (Nov- Dec 2005) • The Importance Of Proper Material Selec- tion In The Medical Device Development Process (With Special Reference To Thermoplastic Polyurethanes) (Sept – Oct 2005) • Medical & Health Applications of Poly carbonate - (Sept – Oct. 2005) • Silicone Rubber in Medical Application (Sept – Oct. 2005) Mr. Manan Shah, Rubber Technologist 20

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. Special Focus Theme Pavilion on “Medical & Healthcare Plastics” in the “Pastindia 2018” Show. EDITORIAL ADVISORY BOARD Polymers and Plastics play important and critical role for enhancing human life. Dr. TARANG PATEL This is through extremely valuable contribution as an important material for Medical M.B.B.S., M.Ch. (ONCO) Disposables, Medical Device, Pharmaceuticals, Diagnostic Products etc. Cancer & Reconstructive Surgeon I am pleased to inform our readers that, “MEDICAL PLASTICS DATA SERVICE “ Mr. C. BALAGOPAL is associated with conceptualizing and managing a Special Focus “MEDICAL & Director - Enter Technologies Pvt. Ltd. HEALTHCARE PLASTICS KNOWLEDGE PAVILION “ of about 100 sq.m. Chairman - Mobilexion Technologies Pvt. Ltd. area at the forthcoming “PLASTINDIA 2018” event to be held between Feb. 7-12, 2018, in Gandhinagar, Gujarat. Trivandrum This Medical & Healthcare Plastics Knowledge Pavilion will include Informative Dr. DILIP H. RAIKER Posters, Audio-Visuals, Models, Samples, Publications etc highlighting …… Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai • Why Plastics For Healthcare ? • Major Segments Of Plastics in Medical Field i.e. Healthcare, Medicare & Hygiene ING LOUIS C. SUHUURMAN • Medical Applications & Important Developments Formerly Sales Director • Product Gallery in which will display samples of various Medical Polymers and COLPITT B.V., Holland their respective application products. Dr. A.V. RAMANI • Global Trends, Emerging Opportunities with Facts & Figures Group Sr. Vice President (R&D), The TTK Group • Supplier Opportunities Dr. Vinny Sastri The objective is to help existing and potential manufacturers and investors to President, Winovia LLC, U.S.A. diversify and / or branch out into medical plastic and Disposables products. Such platforms contribute significantly towards the growth of the Plastics in the Medical Dr. C.S.B. NAIR & Healthcare Sectors apart from creating positive awareness with the people at Director (R&D), Peninsula Polymers Ltd large. Dr. BHARAT GADHAVI We invite our readers and the Indian Medical Device Industry to visit and CEO, HCG Medisurge Hospitals benefit from this Unique Opportunity . Mr. A.S. ATHALYE As you are already aware, “Plastindia” is the most significant exhibition in the Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai world organized by “Plastindia Foundation” and one of the largest Plastics Exhibition in the Asia Pacific Region. The coming event is expected to be Dr. SUJOY K. GUHA located in 125,000 sq.m. area and will have 2000 Exhibitors including 600 B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. overseas exhibitors. About 200,000 visitors are expected to visit. IIT, Kharagpur This special issue being brought out for the event gives a very good overview on the “MEDICAL PLASTICS” sector with focus on Indian Medical Disposables and Dr. G. S. BHUVANESHWAR Implants Industry alongwith our regular features including Markets, Global Trends, Consultant, Medical Devices – Design, development, Industry News, Forthcoming Events, Product Gallery, Did You Know etc. 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. Nov.-Dec.2017 21

Cover Story Medical Plastics Market Analysis By Application (2014 - 2025) Industry Insights U.S. medical plastics market revenue, 2014 - 2025 (USD Million) The global medical plastics market size was estimated at USD 20.52 billion in 2016. Increasing demand for medical grade plastics owing to superior properties such as overall device weight reduction coupled with the development of premium grade plastics is expected to drive the market growth over the forecast period. The global population has exhibited a sustained growth over the past few years leading to an increasing demand for healthcare devices over the forecast period. The resultant growth of the industry envisages the rise in the demand for premium grade plastics for use in medical devices leading to market growth. The rapid growth of the pharmaceutical industries in the U.S. is advanced products, exemplified by Celanese Corporation and expected to impact the growth of the in the economy, mainly on Dow Chemical Corporation in the introduction of enhanced account of the resultant demand for the product in polyethylene resins marketed under the trade name ELITE. pharmaceutical packaging. In addition, high levels of public healthcare expenditure coupled with government investments Report Coverage & Deliverables in the economy are expected to drive the market growth. Application Insights The market for is expected to be strengthened by the The demand for highly durable products such as PETG and development of advanced products by the manufacturers. ABS owing to ease of sterilization coupled with superior barrier Increase in the functionality of engineered plastics coupled with properties is expected to drive the orthopedic implants packaging the absence of any significant threat to human health is expected segment to grow at a CAGR of 5.3% from 2017 to 2025. In to benefit the market growth. Growing penetration of the product addition, the segment is likely to grow in the wake of growing in the medical device industry is expected to drive the market prevalence of the orthopedic surgeries. growth. The orthopedic soft goods segment exhibits a high demand for Modernization of the European regulations for medical devices PEEK and propylene plastics. due to high strength coupled with is likely to be a key factor affecting the industry growth in the superior resistance against adverse environmental conditions. region. Medical and IVD devices are the most regulated products In addition, the demand for the product is expected to grow in that are marketed in the Europe region with regulations specified the wake of rising efforts of the orthopedic goods manufacturers under the directive (93/42/EEC and 98/79/EC). The presence towards the reduction in the overall weight of the products. of such stringent regulations is expected to limit the market growth in the region. The demand for high strength materials such as ABS for heel & finger protection, finger & toe splints, and leg splints is expected Medical waste incineration with plastics such as PVC release to register growth over the next eight years. In addition, the use various hazards chemicals such as dioxins and mercury which of ABS for the products is facilitated by easier availability coupled can cause serious public health effects including cancer, birth with the superior impact resistance. defects, infertility, endometriosis, and immune system impairment. As a result, the industry is expected to witness a The use of plastics in wound care is niche application segment growing rejection of such products with high levels of product due to high quality sterilized product requirements and is replacement. expected to reach USD 1,089.8 million by 2025 due to superior performance such as absorption of wound exudates and aid in Increasing demand for various surgical procedures including blood clotting in severe wounds. The market for wound care breast augmentation, nose jobs, liposuction, eyelid surgery and plastics is expected to exhibit high levels of R&D carried out by face and neck lifts up is expected to drive demand for surgical key manufacturers instruments, which in turn is likely to have a positive impact on the industry growth. Technological advancements in the knee Improved flexibility, high transparency, and resistance to the and hip implant surgeries is expected to have a positive impact electromagnetic waves offered by engineering plastic materials on the industry growth is expected to drive demand for use in biopharma devices over the forecast period. In addition, the demand for the product in The industry is characterized by continuous technological vials, prefilled syringes, biopharma delivery device subsystems, advancements to produce refined products to gain the market and cartridges is expected to drive the market growth. share. The companies resort to the introduction of technologically 22 Nov.-Dec. 2017

Cover Story in myriad applications. The market exhibits a high volume of raw material procurement from the manufacturers located in Asia Regional Insights Pacific. Germany was one of the major markets for medical plastics in The companies in the industry operate their businesses through Europe accounting over for 16.0% of the total market in 2016 strategic tie-ups with the medical device and component and expected to reach 17.9% by 2025. Increasing aging manufacturing companies which result in an ensured demand population and rising occurrence of chronic diseases in the for the product by the manufacturers. In addition, a number of country has resulted in an increased healthcare expenditure players provide price discounts in a bid to attract the consumers leading to market growth. and increase the annual revenues. The industry in Asia Pacific is expected to grow at a CAGR of The market in Asia Pacific is expected to grow at a CAGR of 6.6% from 2017 to 2025 on account of the increasing applications 6.6% from 2017 to 2025 on account of the increasing applications of plastics in wound care, packaging, and mobility aid among scope of the product in wound care, packaging, and mobility aid others. Furthermore, the increasing demand for high quality among others. Furthermore, the increasing demand for high medical devices and components by hospitals in major quality medical devices and components by hospitals in major economies such as China, India, Singapore is likely to drive economies such as China, India, Singapore is likely to drive growth. growth. The market in India is expected to witness high growth owing to The market in India is expected to witness high growth owing to the increased government efforts to improve public health the increased government efforts to improve public health conditions. In addition, the increasing private participation in the conditions. In addition, the increasing private participation in the healthcare industry is expected to increase the demand for high healthcare industry is expected to increase the demand for high quality healthcare devices and components in the country. quality healthcare devices and components in the country. The industry in Central & South America is projected to witness The Central & South America medical plastics industry is a growth of 4.5% during the forecast years, driven primarily by projected to witness a growth of 4.5% during the forecast years, the increasing consumption of the products in key applications driven primarily by the increasing consumption of the products such wound care, denture base materials, and disposable in key applications such wound care, denture base materials, components. The industry is likely to grow on account of and disposable components. The industry is likely to grow on economic development in Brazil and Argentina. account of economic development in Brazil and Argentina. Competitive Insights (Ref: https://www.grandviewresearch.com/industry-analysis/ medical-plastics-market) The industry is highly competitive with the presence of a number of companies across the major economies. Key players are involved in the production of various grades of plastics for use 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 23 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 Nov.-Dec.2017

Cover Story Plastics In Medical & Healthcare Sector Emerging Trends & Applications Bioplastics Used in the Medical Field many components in general designed with challenging geometries or with high precision requirements. The biodegradability of bioplastics combined with the sustainability of their resources, make them a great candidate Low-Density Polymer Lightens the Load of in the medical field. Prosthetic Hand Whether for artificial eyes or modern implants, several materials The polymer’s light weight and self-lubrication play important have been used in the medical field. But, a material that benignly role in the hand’s design. disappears in the body would be a panacea. With the emergence of biodegradable and bio-absorbable polymers, temporary Researchers at the University of Southampton, UK, have chosen prostheses, tissue engineering, and drug delivery vehicles began low-density thermopolymer to create various parts of the next to rise. generation of its innovative Southampton-Remedi prosthetic hand, which has been developed over several decades. Bioplastics, particularly PLA, are biodegradable materials with Continued development and improvements on the hand have organic base which brings about a sustainable resource. Another been the subject of several PhD programs over the years. The important aspect of bioplastics is their biocompatibility which newest version is a low-mass, sensor-rich artificial hand designed makes them usable in biomedical applications. Also, they are to be a highly functional, adaptive prosthesis. bio-absorbable which makes them more ideal in tissue engineering. PLA is made from lactic acid which is produced by Electroactive Material for Wound Healing bacterial fermentation of sugars. PLA is widely used in tissue engineering, due to its physical and chemical properties, to This technology uses electrical activity to facilitate the wound- construct the scaffold. Although PLA presents a decent level of healing process while protecting the wound. The bandage is satisfaction in tissue engineering applications, its properties need made of an electroactive material that is stimulated by the heat to be enhanced to meet ideal requirements of tissue engineering. of the body and the pressure of cell growth, thus no external power source is required. Fillers and Coatings offer slow-release Antiseptic for Medical Devices An electroactive device is applied to an external wound site. This method utilizes generated low-level electrical stimulation Many medical devices are subject to colonisation by bacteria. to promote the wound-healing process while simultaneously In some instances, the body’s immune system can effectively protecting it from infection. The material is fabricated from eradicate these microbes, with few or no symptoms for the polyvinylidene fluoride, or PVDF, a thermoplastic fluoropolymer individual. that is highly piezoelectric when poled. The fabrication method of the electroactive material is based on a previous Langley Conventional means of preventing and treating device-related invention of an apparatus that is used to electrospin highly infections frequently involve the use of topical or systemic aligned polymer fiber material. A description of the fabrication antibiotics. However, antibiotics are under acute threat by the method can be found in the technology opportunity evolution of resistance among pathogenic bacteria, and there announcement titled, “NASA Langley’s Highly Electrospun Fibers are ever more urgent calls to reduce antibiotic use in order to and Mats,” which is available on NASA Langley’s Technology preserve the dwindling supplies of effective drugs for life-or-death Gateway. situations. PEEK Polymer for Spinal Implant Device Micro Injection Moulding For Silicone Parts PEEK is an attractive alternative to titanium for spinal implants The continuous growth of minimally invasive surgical procedures, because it shares similar modulus to bone, and its radio the increasing demand of high precision medical devices and transparency allows for easy visualization in X-rays, said Solvay the latest advanced manufacturing technological developments in a press release. The polymer is also inert, which means it are leading towards a new trend of small and precise silicone does not interact with human tissue. While this quality supports components manufactured under new micro-techniques that biocompatibility, it means that PEEK does not naturally lend itself conventional injection moulding processes are unable to achieve. to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva PEEK polymer. Micro Injection Moulded Parts Kink-Resistant Tubing In smaller medical devices The new micro injection technologies allow the precise manufacturing of silicone parts weighing only a few milligrams Today’s implantable medical devices require bio-friendly (a range of 10 milligrams is generally used to define the border), silicone that keeps fluids flowing even when space is tight. components with strict tolerances (for example for high precision valves) and for conventional injected parts having some particular Nov.-Dec. 2017 or critical micro structured zones (for example thin section membranes) Silicone micromoulded components are increasingly used in minimally invasive surgical devices, in small and precise fluid control activities (valves, septums and seals), in devices fitted with microsensors, in precision overmoulding operations and in 24

Cover Story compliant materials—are now reliably bonded in production lines with predictable and controlled medical adhesives. Combining highly biocompatible silicone with the elasticity and durability of nylon creates a class of durable, crush- and kink- Applications resistant tubing that’s ideal for today’s small yet highly complex medical devices. Adhesives can be categorized into the following segments : • Structural: adhesives with defined load bearing properties, That’s because small is the name of the game when it comes to today’s implantable medical devices, and tubing has to shrink typically chemically curing, resulting in high strength bonds to fit them. The challenge is that silicone – the most for the most demanding applications. biocompatible, durable and flexible material for tubing – tends • Non-structural: adhesives for uses other than load bearing, to kink when produced in small sizes. typically physically curing (solvent/water evaporation, hot melt), for light-duty or cosmetic applications. The solution is reinforced tubing, which allows significant Pressure Sensitive: adhesives generally for temporary reduction of the bend radius of small silicone tubes. This opens applications, cured through the application of pressure between up design possibilities for long-term implantable devices, two surfaces, primary application—skin-based. drainage tubes and tubes that resist collapse under higher vacuum pressures. Medical Swabs Bioresorbable Polymers Swabs are one of the most commonly used single-use devices in the medical industry. Some of the typical applications for bioabsorable polymers include sutures, rods, plates, screws, and scaffolds for tissue Polyester Tipped Swabs engineering Polyester is a synthetic spun fiber made from a polymer. Originally introduced into the realm of medical diagnostics by What are bioresorbable polymers? DuPont under the brand name Dacron®, it is now manufactured by others and no longer carries a brand name. Polyester fiber Bioresorbable polymers are materials that are absorbed in the has been tested and validated for use in specimen collection in body after performing the desired therapeutic function. Implants microbiology, rapid test diagnostics and PCR analysis. produced with bioresorbable polymers are decomposed in the body by natural degradation pathways into water and carbon Polyester tipped swabs boast excellent collection and release dioxide. There are two kinds of bioresorbable materials, properties and, while somewhat more costly than cotton or rayon, biopolymers which are naturally derived and biopolyesters which are not absorbent and boast superior release properties. Puritan are synthetically produced. Biopolyesters include for example purchases only the finest grade spun polyester fibers which are polylactide (PLA) poly lactide-co-D, L lactide (PLDL,) poly lactide- then produced to our specification of finish and other co-glycolide (PLGA,) poly lactide-co-caprolactone (PLCL,) poly characteristics to assure reliable performance, every time. caprolactone (PCL) poly dioxanone (PDO,) and poly lactide-co- trimethylene carbonate (PL-TMC). These biopolyesters are Foam Tipped Swabs available as either amorphous or semi-crystalline polymers which Medical grade polyurethane foam has been found to be an provide a range in mechanical strength and degradation profile. excellent tip material for diagnostics. Foam is produced in a Bioresorbable polymers provide the possibility to customize the range of porosities in sheet form. Common configuration for use level of crystallinity, hydrophilicity, molecular weight, and in tipped applicators is 100 ppi (pores per inch). degradation profile of the polymers to further improve mechanical properties and biocompatibility. Puritan specifies thickness, width and porosity of the material purchased from a U.S. manufacturer for incorporation in medical Medical Device Adhesives devices. Other properties are specified as well, such as absorbency (hydrophilic being very absorbent and hydrophobic Medical devices require careful consideration when choosing being not absorbent), open or closed cell, conductive or electro- adhesives. From design of the base part to the application static dissipative, even colored. For chemical resistance, method to the final intended use, many factors can affect the polyethylene foam is chosen. Your intended use dictates which success of an adhesive joint. Prudent and conscious design foam tipped swabs will work best. choices are key factors in determining the success of any medical product. Hydrogel Coating produces more comfortable, enhanced medical elastomers Adhesives can offer many merits over designing with fasteners. They can provide cost reduction in many cases, and offer another Catheters, intravenous lines and other types of surgical tubing choice to increase flexibility in design. They can be pre-tested are a medical necessity for managing a wide range of diseases. by vendors to confirm their compliance with ISO 10993 or USP But a patient’s experience with such devices is rarely a I to VI and be used to bond and seal between parts. These comfortable one. factors can assist in passing biocompatibility testing of the completed device. Overall, their applications are broad and their Now engineers at Massachusetts Institute of Technology (MIT) use in the medical field will only grow as both device variety and have designed a gel-like material that can be coated onto adhesive technologies advance in the years to come. standard plastic or rubber devices, providing a softer, more slippery exterior that can significantly ease a patient’s discomfort. From silicones and epoxies to acrylic-based adhesives, the world The coating can even be tailored to monitor and treat signs of of medical adhesives is broad in its choices and applications. infection. As novel medical treatments and technologies have come forth, medical adhesives have flourished, integrating themselves into The hydrogel coating can be embedded with compounds to the designs of many medical devices. Components with materials sense, for example, inflammatory molecules. Drugs can also be that once provided difficulty—catheters, disposables, other incorporated into and slowly released from the hydrogel coating, Nov.-Dec.2017 25

Cover Story to treat inflammation in the body. References : https://www.medicalplasticsnews.com/news/opinion/friend-of- the-earth/ https://www.med-technews.com/news/cleaning-up-fillers-and- coatings-offer-slow-release-antiseptic/ https://www.medicalplasticsnews.com/news/its-a-small-world- the-move-from-silicone-to-micro-moulding/ https://www.medicaldesignbriefs.com/component/content/ article/1106-mdb/tech-briefs/27841-low-density-polymer- lightens-the-load-of-prosthetic-hand https://www.plasticstoday.com/medical/solvay-s-peek- polymer-gets-nod-spinal-implant-device/181484498757812 http://www.medicaldesignandoutsourcing.com/make-kink- resistant-tubing-work-smaller-medical-devices/ https://www.medicalplasticsnews.com/news/opinion/ disappearing-world/ https://www.mpo-mag.com/contents/view_online-exclusives/ 2017-11-02/medical-device-adhesives-specifications-and- failure-modes/ https://blog.puritanmedproducts.com/medical-swabs-how-to- choose https://www.materialstoday.com/polymers-soft-materials/news/ hydrogel-coating-enhanced-medical-elastomers/ 26 Nov.-Dec. 2017

Industry Awards Rajiv Nath Awarded Dynamic Healthcare Entrepreneur Of The Year 2017 At Pharma Leadership Awards 2017 Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AIMED) and Joint MD of Hindustan Syringes and Medical Devices Ltd (HMD) Rajiv Nath, Forum Coordinator of Association of sector like addressing 70% import dependency, lack Indian Medical Device Industry (AIMED) and Joint of trust in Indian medical device, reliance on 3rd MD of Hindustan Syringes and Medical Devices Ltd country regulations, incomplete regulations dis- (HMD) was voted winner of the Healthcare Dy- couraging investments, need for promoting volun- namic Entrepreneur of the Year 2017 category. He tary ICMED certification, respect for Indian medi- was awarded at the prestigious 10th Pharmaceu- cal devices, ethics in manufacturing and healthcare tical Leadership Summit & Pharma Leaders Power and patient friendly pricing. Brand Healthcare Leadership Awards 2017 orga- nized by Network 7 Media Group recently in He also shared his vision to position India among Mumbai. the top 5 manufacturing global hubs of medical devices and place India in the top 5 list of medical He was honoured for his achievements in the field value travel destinations globally. of healthcare entrepreneurship. His eminence, and Nath said “I am very happy to receive this award dynamic leadership to drive innovations and con- as it validates the contribution and efforts made tributions in medical devices for healthcare has by us at HMD and at AIMED and AISNMA to better helped India to carve out a niche for itself in the the healthcare sector of the country. I have always global map. He has demonstrated remarkable and been motivated by my father to follow sincere and exceptional performances in setting the agenda fair business values. This award is an appreciation and road maps for the future healthcare by setting of the hard work and dedication we have made to- an exemplary entrepreneurial competency and wards transforming the healthcare sector in India. leadership in the healthcare industry. I thank the teams of all three organisations who were always behind me, supporting my vision and He has driven with passion in building HMD as working relentlessly to meet our common goal.” most prominent player in India and abroad in the manufacturing and supply of syringes, needles, I.V. “Pharma leaders Power Brand Awards are the most cannulas, safety I.V. cannulas, surgical blades, safety prestigious annual industry awards that acknowl- scalpels, scalpvein sets, non-reusable syringes, edge and honour individuals and organizations for blood collection tubes and blood collection systems their accomplishments using healthcare innova- etc.etc. tions to deliver the best value in achieving specific goals and objectives,” said Satya Brahma, Chairman The award was adjudged by a jury of eminent per- and Editor-In-Chief of Network 7 Media Group. sonalities associated with public and private healthcare, government establishments and Recently Rajiv Nath was in the news for leading healthcare consultancies. The award highlighted the bold unprecedented step to self-regulate the the contribution of a personality who has been able Max Trade Margins of syringes and needles to to set up a new mark in the healthcare industry maximum 75% in AISNMA, the All India Syringes with a unique philosophy and by following a and Needles Manufacturers Association to address distinctive approach. the criticism on excessive Max Retail Prices of Syringes and Needles. On the occasion, Nath also gave a presentation on “Quality in Healthcare and Making Ethical choices” (Ref : http://pharmabiz.com/ highlighting serious issues of Indian healthcare ArticleDetails.aspx?aid=106375&sid=12) Nov.-Dec.2017 27

Markets Medical Devices : India Market and Context ( abstracted from report prepared by “Sathguru” for “Assocham India ) Innovation Adoption for Expanded Clinical petitive advantage for several drugs. There has been an unmet Possibilities & Making-in-India need for novel drug delivery mechanisms to improve medication adherence, drug absorption including less frequent dosing, Medical device sector represents 9% of the overall Indian extended-release formulations, easy administration and targeted healthcare industry5. Indian medical device market is the 4th larg- delivery and device innovation has helped address some of these est in Asia and under top 20 in the world. It was valued at $4.2 priorities. Self-injecting insulin pens are a pertinent example of Billion in 2014 and is growing at a CAGR of 16% over the period drug companies leveraging device innovation. The recent Epipen of five years6. There are several contributing growth factors such pricing controversy in the US also highlights how proprietary de- as high volume demand, epidemiological transition, growing GDP; vices have been used tactically for competitive advantage by drug and government efforts such as Make-in-India, 100% FDI, medi- companies even in the case of highly established drugs. At the cal parks and shared infrastructure facilities buoyed by modest other end, integration of drugs for various objectives has allowed private sector investment. device companies also to provide more clinically attractive solu- tions and seek growth opportunities. One of the older examples The industry is at the cusp of a major transitionary phase. The would be the case of drug eluting stents that now dominate highly import dependent industry (more than 70% by value) has markets globally. We have outlined below some of the popular gained significant attention for the potential it holds to contribute areas of innovation for drug device combinations: to ‘Making in India’. Contrastingly, there are about 800 medical device manufacturers in India, but hardly 10% generate a turn- A. Vascular: drug-eluting stents, coated vascular over in excess of Rs.600 Million, creating a wide stratification in prostheses indigenous manufacturing landscape. Most indigenous manufac- turers have historically focused on consumables and disposables. High incidence of cardiac ailments, coronary artery disease in particular, has paved way for minimally invasive solutions offered The current shift reflects Indian companies moving up the value by drug-eluting stents. They combine the polymer and drug to chain steadily. They are building competitiveness through indig- achieve coronary revascularization and at the same time deliver enous innovation, absorption of acquiring synergistic and sophis- anti-proliferative drug at the target. ticated technologies from global sources and strategic partner- ships. On the other end, MNC’s are now seeking to grow beyond B. Drug delivery: transdermal patches, inhalers, the high end of the market and establish presence in the low drug pumps value segment. They are exploring possibilities such as setting up their own facility (3M in Pune, Becton Dickinson in Haryana), In India, drug pumps, insulin in particular, has seen an unprec- acquiring local manufacturers (Philips Medical System’s acquisi- edented demand, owing to 65 million diabetic patients. Insulin tion of Alpha X-Ray Technologies), developing cost efficient so- pumps have been in use for a considerable time, but the new lutions relevant to the Indian context (GE’s low cost warmer) and pumps are being designed to be smarter, smaller and program- even introducing products from Chinese acquisitions in India mable, to detect insulin level and systemically release it. While (Orthopedic devices – Stryker and Medtronic). insulin pumps are wearable, implantable pumps for direct CNS delivery are also being developed. However, the segment still struggles with fundamental problems such as an inverted duty structure that often favors importers Simultaneously, innovations in nanotechnology has enabled over manufacturers and slow regulatory reform. Public health targeted drug delivery reducing off-target toxicity and dosage procurement channels for innovative devices have also been quantity. Antibody-based delivery and similar technologies in underdeveloped and call for attention. particular will make delivery of large molecule drugs easy and convenient. Despite the above challenges, devices represent the segment where greater change is expected in the next five to ten years. C. Orthopedic: Bone implants/cements We discuss below pervasive innovation trends observed across segments of devices and glimpses from the evolving the Indian The new generation of bone implants are not only bio absorb- landscape. able but also contain pellets of antibiotic drugs to be delivered at the site of the morbidity. Recent FDA approvals and clearer regu- Pervasive Innovation Trends across Device lations have escalated the development of combination products Categories and consecutively research has transpired beyond USA. Combi- nation products has seen convergence of pharma and devices 1. Drug Device Combinations – The Convergent Opportunity industries to co-develop products. This also presents an oppor- Drug device combinations offer attractive growth opportunity for tunity for CDMO’s in India to grow and offer novel solutions to both drug and device companies. Device innovation is emerging address this unmet need. as preferred lifecycle management strategy and source of com- Large pharma players have been actively involved in technology development like Sun Pharma’s Levulan Kerastick for treating actinic keratosis or Dr. Reddy’s Zembrace SymTouch pen to treat acute migraines. India’s strong pharma industry offers ripe collaboration opportunities for device companies to co-create value and seek growth opportunities. 28 Nov.-Dec. 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. • 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 : 29 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] Nov.-Dec.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 AN ISO 13485-2012 PRE USED SYRINGE CE certified Company MANUFACTURING EQUIPMENT Manufacturer & Exporter of Medical Disposable Devices & Surgical Moulds : 2, 3, 5, 10ml Products Syringe Printing Machine : 2/3, 5, 10ml Range of Products : Syringe 4 Parts Assembly Machine : • Infusion Set 2/3, 5, 10ml • Blood Administration Set • Measure Volume Set Contact : 7895648113 • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry [email protected] • Respiratory Exerciser • Twin Bore Nasal Oxygen Set Nov.-Dec. 2017 • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp Contact Yogesh Patel M. : +91 98241 21383 MEDICARE 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 : [email protected] Website : www.medicaredevices.com 30









Nov.-Dec.2017 35

Industry News Qosina Announces Scott Herskovitz as New President & CEO Ronkonkoma, NY,USA,January 3, 2018—Qosina Corp. is powerhouse that it is today and a trusted partner to our pleased to announce the appointment of Scott Herskovitz to customers, distributors and vendors. Stuart is a leader of great president and chief executive officer, effective immediately. As integrity, character and intellect. I look forward to building on the president and CEO, Scott will have responsibility for development Qosina foundation and taking the company to the next level by and execution of the company’s strategic plan. helping our customers find, order and receive quality medical components quickly and accurately.” “I am very excited about the future of Qosina and look forward to continued positive growth under Scott’s leadership,” said Founded in 1980, Qosina is a leading global supplier of OEM Qosina Chairman of the Board Stuart Herskovitz. “Scott’s single-use components to the medical and pharmaceutical experience, strategic thinking and proven ability to deliver results industries. Qosina’s philosophy is to address its customers’ need make him the perfect person for this role. His vision and to reduce time-to-market by providing thousands of stock communication style will bring a new level of engagement and components. The company’s vast catalog features more than performance from the employees. I enthusiastically welcome 5,000 products shown in full-scale illustrations on a one- Scott as Qosina’s new leader.” centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification Prior to his promotion topresident and CEO, Scott worked in of existing molds, and new product design and development. business development, served as vice president of marketing, Qosina isISO 9001, ISO 13485 and ISO 14001 registered, and and later, vice president of sales and marketing at Qosina. operates in a 95,000 square-foot facility with an ISO Class 8 “I am thrilled and honored to take on the role of president and Clean Room. visit www.qosina.com or call +1 (631) 242-3000. CEO of Qosina,” said Scott Herskovitz. “Stuart Herskovitz had a vision 38 years ago of what he wanted the Qosina brand to Contact : Qosina Corporation, Rachelle Morrow be. He worked hard to build the company into the global +1 (631) 242-3000, [email protected] DCGI Issues Classification Of Medical Devices Cardiovascular Catheter, Cerebrospinal Catheter, Atherectomy & In Vitro Diagnostics coronary Catheter, to name only a few, have been listed in the high risk Class D category. The Drugs Controller General of India (DCGI) has issued classification of medical devices and in vitro diagnostic medical Vein Ablation device, Thermal Ablation device, Uterine balloon devices under the provisions of the Medical Devices Rules, 2017. therapy devices, RF Conducte MR steerable electrode catheter, Bone cement, Bifurcation Stent, Vena Cava Filter Sets, Central These Rules will be applicable to substances used for in vitro Venous Catheters, Introducer Sheath, Carotid Filter System, diagnosis and surgical dressings, surgical bandages, surgical Hemodialysis Catheter (Long Term), Percuataneous staples, surgical sutures, ligatures, blood and blood component Intravascular Long Term Catheter, Implanted Subcutaneous collection bag with or without anticoagulant covered under sub- Intravascular Port & Catheter, Subcutaneous Intraspinal Port & clause (i); substances including mechanical contraceptives Catheter, Coronary Dilation Catheter, Diagnostic Radiology (condoms, intrauterine devices, tubal rings), disinfectants and Catheters, Micro-catheter, Tympanostomy Tube, Anastomosis insecticides notified under sub-clause (ii); and devices notified Bypass Tube, etc have been listed in the moderate to high risk from time to time under sub-clause (iv), of clause (b) of section Class C category. 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). Fiberoptic Oximeter Catheter, A-V Shunt or Fistula Adapter, As per the Rules, medical devices other than in vitro diagnostic Forceps endoscopic, Vessel Dialator for percutaneous medical devices will be classified on the basis of parameters Catheterization, Tracheobronchial Suction Catheter, Cervical specified in part I of the first schedule, namely low risk as Class Drain, Rectal Balloon, Vial Adapter, Nasopharyngeal Catheter/ A; low to moderate risk as Class B; moderate to high risk as Nasophar yngeal, Esophageal obturator, Suction Tip and Class C; and high risk as Class D. In vitro diagnostic medical Catheter, Arterial Catheter, Cholangiography Catheter, Umblical devices will be classified on the basis of parameters specified in Artery Catheter, Flow Directed Catheter, Endoscopic Ligation part II of the First Schedule, namely low risk as Class A; low to Devices, Dialysate Tubing and Connector, Colon Tube, moderate risk as Class B; moderate to high risk as Class C; and Connecting Tube, Decompression Tube, Biopsy Needle Kit, high risk as Class D. Mammary Biopsy Needle, Cholangiography Needle, Epidural Needle, etc have been included in the Class B category. Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Nasopharyngeal Catheter/Nasophar yngeal, Y-Connector as an rules made thereunder. In this connection, in exercise of the accessory to perfusion sets, Surgical Dressings, Umbilical powers conferred under sub-rule (3) of rule 4 of Medical Devices occlusion device, Bolster Suture, Alcohol Swabs, etc have been Rules, 2017, the DCGI has classified the medical devices and included in the Class A category. in vitro diagnostic medical devices, based on the intended use of the device, risk associated with the device and other (Ref: http://www.pharmabiz.com NewsDetails.aspx?aid=105268&sid=1) parameters specified in the First Schedule. ************************************************************************************ As per the classification issued by the DCGI, Radiofrequency Launch Of KIHT A Major Boost Towards Making Ablation Device, Percutaneous Conduction Tissue Ablation, India A Global Manufacturing Hub For Medical Coronary stent, Bioresorbable Vascular Scaffold (BVS) System, Devices: AiMeD Angiographic Guide Wire, Cardiac Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and The recently launched Kalam Institute of Health Technology Control, RETRIEVAL SNARE, Cardiac Thermodilution Catheter, (KIHT), India’s first institute dedicated to medical technology located at Andhra Pradesh MedTech Zone (AMTZ), 36 Nov.-Dec. 2017

Industry News Malakondaiah - Principal Secretary (HM&FW), Govt. of Andhra Pradesh; Dr.Renu Swarup - Senior Advisor, DBT & MD, BIRAC; Visakhapatnam, will prove to be a major boost towards making Rajiv Agarwal - Joint Secretary, Department of Industrial Policy India a global manufacturing hub for medical devices, according & Promotion (DIPP), Govt. of India; Dr. Swati Basu - Scientific to the Association of Indian Medical Device Industry (AiMeD), Secretary, Office of Principal Scientific Adviser to Govt. of India; an association of medical devices manufacturers in the country. Rajiv Nath - Forum Coordinator, AIMED; Prof. B. Ravi - Institute Chair Professor, IIT Bombay, Mumbai; Prof. Balaram Bhargava Named after India’s 11th President Dr APJ Abdul Kalam, KIHT - Executive Director, School of International Bio-Design, AIIMS, has been set up with the aim to identify critical gaps in medical New Delhi and Dr. Jitendar Sharma - Managing Director & technology and suggest the government to do focused spending CEO, AMTZ, Visakhapatnam as Executive Director. on such areas and help bridge the gap between academic research and industrial market access, by auctioning of patents (Ref : http://pharmabiz.com NewsDetails.aspx?aid=105451&sid=1) and prototypes available with government funded academic research institutions. ************************************************************************************* Rajiv Nath, Forum Coordinator, AiMED said “We are extremely India Aims To Ease Import Process For Medical happy that the 1st Governing Body meet of KIHT is a major step Devices towards making India a global manufacturing hub for medical device sector and to build a robust system for innovation in the Medical device and IVD imports to India should not be held up medical devices sector in the country.” at ports because of “slight confusions” over product names, pending applications during mergers and acquisitions, or shelf- AiMeD is also on KIHT’s Governing Board and will spearhead life issues if the importers have valid registration certificates and and coordinate the indigenous development of medical devices. import licenses, according to the Central Drugs Standard Control In the first Governing Body meeting held in Delhi recently, KIHT Organization. CDSCO issued notice to port offices in response has been identified as nodal point for medical technology to complaints that products were being inappropriately withheld program support cell for national biopharma mission; KIHT has for those reasons. been accepted as the facilitator for DBT/BIRAC funded innovations for helping them with certifications; and there was U.S. device makers, meanwhile, continue to push back against an approval accorded for technology e-auction. India’s new price controls on certain devices that resulted in sharp decreases in their average prices, and say some may KIHT is being guided by stalwarts of the scientific community pull their products from the Indian market. like Dr. R. Chidambram, Principal Scientific Advisor to Government of India as president and the Governing Body (Ref : https://www.fdanews.com/articles/184376-india-aims-to-ease- members include: Prof. Vijay Raghavan - Secretary Department import-process-for-medical-devices) of Biotechnology (DBT) as chairperson; Dr Poonam Contact Addrss : Operon Strategist, 37 Office 10, Third Floor, MSR Capital, Morwadi Road, Pimpri, Pune : 411018. Phone : (020) 65283428, 9028043428. E Mail : [email protected], [email protected] Nov.-Dec.2017

Global Trends New Materials for Medical Devices New for old : Spike (Flemina) According to Ineos Styrolution. demand shifts towards new solutions. healthcare application providers are torn in two directions when it comes to working with new materials. Ineos Styrolution has proven that styrenics make ideal materials for a range of healthcare applications – and the company is Healthcare application providers are torn in two directions when constantly growing the number of dedicated solutions for the it comes to working with new materials. On the one hand, they healthcare sector. Today, Ineos Styrolution is aiming at would like to build superior devices to existing ones – or all new developing the first all-styrenics IV set. Being a dedicated applications that cannot be realised with existing materials. On supplier for styrenic polymers in the healthcare industry, the the other hand, every new material requires lengthy approval company is bundling its styrenics IV activities within its global processes. healthcare team, led by Alexander Silvestre. As a result, new materials should provide a significant new value Styrenics provide several properties resulting in a higher proposition to justify the investment in new applications and efficiency and lower cycle times. These may be key for an devices. application provider. The key benefits of styrenics include • easily bonded to other materials Two main factors drive the value proposition of a new material • a low density resulting in more output in the healthcare industry. • excellent flowability and processability • high flow grades The first factor is related to the actual physical and chemical • lower processing temperatures properties of the new material. These properties decide if a • limited to no pre-drying product is capable of serving a defined purpose. Details are listed in technical data sheets. For styrenic materials, for Styrenics provide the additional benefit of clean incineration after example, the data sheet may contain dozens of mechanical, use. thermal, rheological and other properties. Overall, it can be said that the Ineos Styrolution materials such An important material property for many materials in the medical as Styrolux and Styroflex show properties that are well balanced industry is the chemical resistance against drug media. Residual making them ideal solutions for IV sets. In addition to the above monomer and additive release into the media needs to be kept list of properties, the materials show an excellent behaviour in to a minimum, and low adsorption and absorption of targeted drug absorption tests, in particular in comparison to traditionally drugs are very important drivers when selecting new materials. used materials. This includes, for example, a very low absorption Styrenic materials traditionally show a very good performance rate for insulin and overall low absorption values for typical drug in this area and Styrolux, an Ineos Styrolution SBC material, molecules. excels with a strong resistance against drug media. Ineos Styrolution has a strong presence in this field, with solutions such as In addition to the material properties, application providers also pay attention to the ease-of-use of working with a certain material. • MABS (Terlux), SMMA (NAS) and MBS (Zylar), highly ‘Ease-of-use’ describes a long list of criteria that may be different transparent materials for connectors from material to material and from application provider to application provider. The list ranges from processability of the • dedicated Styrolux grades, specifically designed for the use material all the way to services provided by the material provider. in drip chambers in IV sets It includes topics like product quality, availability of the material (eg. long-term availability and early notification of change, reliable • the above mentioned Novodur HD M203FC G3 for demanding deliveries), logistical aspects and many more criteria. Global applications like spikes and applications requiring structural application providers may have additional requirements such stability as sourcing across different regions at identical quality. • Polystyrene and ABS solutions for roller clamps All-styrenic IV set In addition to these existing materials, Ineos Styrolution is Healthcare application providers constantly look for alternatives currently working on material solutions for the flexible parts of for commonly used materials. Having alternative solutions at the IV set. hand does not only allow exploring new properties or new functionalities. They also provide a safety net if tighter regulations • Materials for tubing are under development using SBC (styrene-butadiene block copolymer) based solutions (see references 3 and 4). Important properties for good tubing materials include a high transparency for visual inspection, good resistance against kinking during bending to ensure continuous drug feeding and good resilience. The recent integration of the K-Resin business into Ineos Styrolution’s market leading styrenic portfolio leverages both companies’ respective strong technical heritages to create new and innovative customer solutions for medical applications. • Materials for IV bags require film featuring a good puncture resistance, good transparency and they must be able to be sterilised. The materials also need to feature a defined shelf life, which is due to high barrier properties. Another aspect is the need for regulatory approved stabilisation and additive (eg. waxes) packages. First developments have been reported 38 Nov.-Dec. 2017

Global Trends (see reference 5). Ongoing research show that it is crucial to “Our development team is closely linked not only to state-of- combine puncture resistance with high temperature resistance the-art technology to develop and produce innovative styrenics and certain barrier properties (provided by polyolefins and based materials, we are also in close contact with leading medical cycloolefins). OEMs, thanks to the global presence of our healthcare team. They constantly provide us with valuable insights into the Norbert Niessner, global head of research and development/ industry’s needs.” intellectual property at Ineos Styrolution, summarises the ongoing efforts. (Ref : https://www.medicalplasticsnews.com/news/matter-of- substance/) Medical implants drive growing demand for ultra-high molecular weight polyethylene Demand for ultra-high molecular weight polyethylene (UHMWPE) with WWII, and it continues to be a popular application. for the fabrication of orthopedic and cardiovascular implants is UHMWPE-based hard ballistic fibers are used in helmets and driving growth for the material in global markets, according to a body armor, while soft ballistic fibers are used in vests to protect report from Technavio (London). The study projects a compound soldiers from the impact of knives and bullets. annual growth rate of more than 9% during the 2017 to 2021 forecast period. A newer application involves rechargeable batteries, where UHMWPE is widely used as a separator. Demand is especially UHMWPE is an odorless, tasteless and nontoxic polyethylene high in North America, according to Technavio. Separators made (PE). It has all the characteristics of high-density PE, but with from UHMWPE offer a microporous texture, small aperture and the added advantage of being resistant to acids, alkalis and other enhanced rejection rate, which are crucial for the performance organic solvents, according to Technavio. UHMWPE is available of batteries in the automotive industry in North America. in many shapes and forms, making it suitable for a range of applications, but the medical segment is one of the primary For a free sample report or to purchase the full study, go to the markets, accounting for almost 30% of market share in 2016. Technavio website. The other leading applications are protective apparel and gear and rechargeable batteries. https://www.plasticstoday.com/medical/medical-implants-drive- growing-demand-ultra-high-molecular-weight-polyethylene/ 124849842957645 UHMWPE-based implants have gained popularity in applications 39 such as orthopedic and cardiovascular implants, notes the report, because of the material’s long life span and tensile strength. In cardiovascular devices, UHMWPE fibers are gradually replacing polyethylene terephthalate fibers owing to their small size and flexibility, explains Mohd Shakeel Iqbal, a lead plastics, polymers and elastomers research analyst at Technavio. “The types of UHMWPE-based cardiovascular implants are cardiac stents, pacing devices and structural cardiac implants. In addition, the advances in medical technologies, increasing healthcare investments, an aging population and [growing] disposable income” are driving demand for UHMWPE in medical applications, said Iqbal. The material has a long history of use in protective gear starting Nov.-Dec.2017

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] 40 Nov.-Dec. 2017

Press Release 4th Manufacturing Process for Medical Technology Exhibition and Conference 29 - 31 Aug 2018 Marina Bay Stands • Singapore MEDICAL MANUFACTURING ASIA 2018: chain for the medical, healthcare, medical manufacturing and Delivering solutions for the future of medtech medtech sectors. Jointly organised by SPETA (Singapore Preci- sion Engineering and Technology Association) and Messe • Mark your calendar for the 4th Manufacturing Processes Düsseldorf Asia, the exhibition is modelled after the No.1 global for Medical Technology Exhibition and Conference from trade fair in the medtech sector, COMPAMED, held in Düsseldorf, 29-31 Aug Germany. 12 Jan 2018 – Innovative medical technology is an increasingly The 4th edition of MEDICAL MANUFACTURING ASIA is fast important driver for delivering efficiencies in the global healthcare gaining traction as the region’s leading specialist trade exhibition system. Through advances in medical technology, precision en- for the medtech and medical manufacturing sectors. Following gineering, micro-manufacturing processes, and IT, medical de- the success of the 2016 edition, the exhibition welcomed 200 vices and solutions have become more sophisticated, accurate companies from 18 countries, and 5,420 trade visitors from 52 and effective. As a specialist exhibition on manufacturing pro- countries. For booth space booking and more information on cesses for medical technology, the 4th edition of MEDICAL MANU- MEDICAL MANUFACTURING ASIA 2018, please visit FACTURING ASIA will focus on new manufacturing technology www.medmanufacturing-asia.com. and automation which play vital roles in driving innovation and operations. The upcoming edition will highlight companies that About Messe Düsseldorf Asia cover the spectrum of additive manufacturing or 3D printing tech- Messe Düsseldorf Asia is a subsidiary of Messe Düsseldorf in nologies, imaging and diagnostic imaging solutions, as well as Germany, one of the world’s leading trade fair organisers, re- nano manufacturing and automated solutions. sponsible for organising more than 20 global No. 1 exhibitions in various industries including medicine and health, specifically As Singapore continues to grow its medtech presence on the MEDICA, COMPAMED and REHACARE INTERNATIONAL held world stage, with a sizeable number of complex scientific instru- in Düsseldorf, Germany. With extensive expertise in organising ments already designed and manufactured here, the 3-day exhi- trade fairs in Southeast Asia, Messe Düsseldorf Asia has devel- bition strongly reflects Singapore’s focus on moving upstream to oped a portfolio of numerous trade fairs in the region since 1995. not just production but also value engineering. For companies keen on engaging global medtech companies and see Singapore For more information on the exhibition, please contact : as an ideal base to develop products for the Asian region, MEDI- CAL MANUFACTURING ASIA 2018 provides a highly relevant Exhibitor Contact : Press Contact : springboard. Daphne Yeo Melvin Chye MEDICAL MANUFACTURING ASIA 2018 comes against a dy- namic backdrop which sees the Asia Pacific medtech market Senior Project Manager Marketing & Communications expected to surpass the European Union by 2020 as the world’s second largest medtech market after the United States1, while Executive on the global front, the medtech sector is expected to grow 5% or more annually through to 2022, to reach nearly US$530 billion2. Tel: (65) 6332 9682 Tel: (65) 6332 9652 With Singapore’s positioning as Asia’s top location for medtech [email protected] [email protected] and home to over 30 globally-recognised medtech companies, MEDICAL MANUFACTURING ASIA 2018 continues to attract a Events Calender highly international exhibitor base coming mainly from Asia and Europe and a trade visitor base that is predominantly represented • PLASTINDIA 2018 : by the medical devices and instruments, medical and healthcare, 10th International Plastics Exhibition, Conference & and electrical and electronic sectors from around the region. Convention Date: Feb. 7-12, 2018. Complementing the exhibition is the half-day forum on High-tech- Venue: Gandhinagar – Ahmedabad, Gujarat, India. nology for Medical Devices where exhibitors will present and share latest developments and trends on the global and domestic fronts • Medical Fair India : and market opportunities for medtech products from Europe. 24th International Exhibition And Conference Organised by IVAM Microtechnology Network, the German-based Date: March 16-18, 2018. international association has an extensive membership with com- Venue: Goregaon (East), Mumbai panies in the fields of microtechnology, nanotechnology, advanced materials, and photonics. • Medical Manufacturing Asia 2018 4th Manufacturing Processes for Medical Technology MEDICAL MANUFACTURING ASIA 2018 is also synergistically Exhibition and Conference co-located with the region’s leading medical and healthcare ex- Date : August 29 – 31, 2018 hibition, MEDICAL FAIR ASIA – thus providing an end-to-end Venue : Marina Bay Sands Singapore solutions and business sourcing platform across the entire value • K 2019 Nov.-Dec.2017 The World’s No. 1 Trade Fair for Plastics and Rubber Date : October 16 - 23, 2019 Venue : Dusseldofr, Germany 41

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 Nov.-Dec. 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] Nov.-Dec.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 Nov.-Dec. 2017

January 2017 to December 2017 Column Content Column Content November-December 2017 Global Trends • Medical Packaging - Global Market Scenario Cover Story • Medical Plastics Market Analysis By Applications - 2014 Industry News • Now, MRP must on medical devices – 2025 • Health ministry issues draft guidance document on • Plastics In Medical & Healthcare Sector : Emerging “Essential principles for safety and performance of Trends & Applications medical devices” Industry Awards • Rajv Nath, Forum Coordinator, Association Of Indian • Covestro results buoyed by high PU, polycarbonates Medical Device Industry (AiMeD) Awarded Dynamic demand Healthcare Entrepreneur Of The Year 2017. • Health ministry releases draft list of devices & in vitro Markets • Medical Devices : India Market and Context (Based on diagnostics along with risk-based classifications Report Prepared By “Sathguru” For Assocham) • India’s 1st medical tech institute, Kalam Institute of Health Industry News • Qosina Announces Scott Herskovitz as New President Technology at AMTZ gets 100% financial support from and CEO. DBT • DCGI Issues Classification Of Medical Devices & In Vitro Product Gallery • Dip-Molded Plastisol Y Connectors Diagnostics Under Provisions Of Medicall Devices Rules, Did You Know? • About The “Medical Grade “ Polymer Dilemma 2017 May - June 2017 • Launch Of KIHT A Major Boost Towards Making India A Cover Story • Medical Polymers Processing – Selecting Right Materi- Global Manufacturing Hub For Medical Devices: AiMeD als & Manufacturing Systems • India Aims To Ease Import Process For Medical Devices Materials • Compatibility of Thermoplastic Polyurethanes with Drugs Global Trends • New Materials for Medical Devices for IV Sets • Medical implants drive growing demand for Ultra-High Manufacturing • Designing and Manufacturing of Molds for Medical Molecular weight polyethylene Industry Clusters Components Did You Know ? • About Using Medical Polymers Reduce Hospital Technology • Syringe Plungers Can Contribute to Patient Safety -Acquired Infections Global Trends • Healthcare Plastics Recycling Project: A Success September - October 2017 • Trends Pushing Solid Growth in Global Market for Cover Story • Medical Device Industry In India – A Sunrise Industry Medical Plastics Industry Clusters • Favourable Ecosystem Lifts Med Device Manufacturing Industry News • Tekni-Plex Announces $15 Million Investment in New In Gujarat Regulations • Update on European Regulations for Medical Devices China Manufacturing Facility Global Trends • US Medical Device Makers Call For Trade Action Against • AMTZ Partners With GMDN Agency For Identification India • Medical Plastics Market worth 21.06 Billion USD by 2022 Of Medical Devices Industry News • Manufacturers Welcome Price Cap On Medical Devices • Gujarat Registers Maximum Number Of 170 Medical • Gujarat FDCATo Tie Up With NIPER Ahmedabad To Train Devices Units In The Country Under CLAA Scheme Inspectors For Detecting SAE Of Medical Devices • MTaI Puts Forward Key Recommendations To Govt For • HLL Takes Over Tech For Production Of 3 Medical More Enabling Environment For Medical Devices Indus- try In India Devices • Gujarat FDCA Writes To Health Ministry To Accelerate Process of Setting Up Much Awaited Medical Device • NIPER To Team Up With Cos Furthering Make In India Testing Lab At Vadodara Product Gallery • Qosina Introduces New 2018 Catalog Product Gallery • ‘Male And Female Connectors And Caps, Low Dose Did You Know ? • About Advanced Medical Polymer For Treating Diabetic Patients Syringes, Spikes, Adapters And Y Connectors’ • New Tuohyborst Adapters Did You Know? • Why “PEEK” Offers Success For The Manufacture Of Medical Parts March - April 2017 July - August 2017 Cover Story • ASEAN Medical Devices & Plastics Sectors : Immense Market Potential Cover Story • Challenges Of Selecting Right Supplier For Medical Materials Polymers Manufacturing • Developing Drug / Device Combination Products : Concept to Commissioning Technology • New Innovations - Expanding horizons for Thermoplas- Snippets tic Elastomers in Medical Applications • Packaging Testing for Medical Devices Product Gallery • Dilators and Introducer Sheaths • Emerging Market of Platinum Cured Silicone Products Global Trends • Global Medical Disposables Market to Reach US$193.9 in Medical Industries Bn by 2018 • Conair Introduces New Cutter for Medical Tubing • Medical Polymers Market to exceed $24bn by 2024 • RecentAdvances in Plastics Technology for Medical Care • Asia-Pacific Reprocessed Medical Devices Market Will Nov.-Dec.2017 Hit at a CAGR of 15.7% by 2017 to 2027 Industry News • Med Devices Import up 16.8%, Export By 25.7% During 2012-16 45

January 2017 to December 2017 Column Content Column Content • DCGI begins registration of notified bodies to carry out Industry News • Conference Theme : “Manufacturing Medical Devices in Quality India : Growth Opportunities” audit of mfg sites of Class A & Class B medical devices • Speakers’ Introduction • 10% price hike cap on most medical devices • Presentation Abstracts • Exhibitors’ Profile • CDSCO to go online for all services in six months • List & Profile of Advertisers • Student Programme: Career Opportunity Presentations, Did You Know? • About Drug / Device Combination Products & ASEAN Poster Presentations & Paper Presentation Competitions Markets • Technology Display Show 2017 • Roadmap for Indian Medical Device Industry January - February 2017 • Indian Medical Device Industry to Develop Into A Global Cover Story : Event Highlights Manufacturing Hub • 14th National Conference & Technology Exhibition on • AiMeD & Invest India sign a momentous MoU aimed at “Indian Medical Devices & Plastics Disposables/ Implants making India a global manufacturing hub for medical Industry 2017” supported by major leading industry devices and components associations as well as Government, Regulatory, Export • Advanced Process Validation For Medical Device Promotion and Research Organizations.14th National Manufacturers Conference & Technology Exhibition on “Indian Medical Devices & Plastics Disposables/ Implants Industry 2017” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. 46 Nov.-Dec. 2017