Table of
Contents Vol. 24
No. 6
Nov. - Dec. 2016
23 Cover Story • Medical & Healthcare Plastic Pavilion – The Dedicated Zone In The Biggest Plastics Show A. Medical & Healthcare Plastics Knowledge Platform - Including Posters, Audio-Visuals, Models, Product Samples & Publications. B. Exhibitors’ Profile : Offering Materials, Machinery, Products & Technology
25 Manufacturing • Diversifying Into Medical Device Molding Medical Device molding is much different from other markets because of tight-tolerance, highly regulated and critical nature of components ,….
26 Industry Cluster • Gujarat Medical Device Industry : Moving Up in Value & Technology Chain With the passage of time, as the medical device industry sector became visible, manufacturing of relatively high investment as well as high technology critical care medical device products started getting manufactured in Gujarat with investments ranging from few crores to few hundred crores.
41 Product Gallery • New Multi - Cavity Channel Clips With Guide Wire Slit
28 Global Trends • Healthcare Plastics Recycling • Europe Medical Plastic Market - Trends and Forecast by 2024 • Global Medical Polymers Market Estimated To Register CAGR Of 13% By 2022
34 Industry News • Medical Devices Industry Wants Govt To Create Investor - Friendly Environment • Med. Device Ind. Rules Recommendations Not Incorporated In Draft For New Med. Device Rules • AIDCOC Urges Health Ministry To Empower State Licensing Authorities (SLAs) To Grant License To Critical Medical Devices
18 Did You Know? • About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials
37 Artical Index • Important Articles Published in the Magazine from January - December 2016
42 Press Notes • PLASTINDIA 2018 – Special Preview • Qosina Receives ISO-13485 Certification • Revolutionary Conveying System with Variable Speed Capability from Conair
43 Events Calendar • Plastivision India 2017 : 19-23 January 2017, Mumbai. • Confederation of Indian Industry (CII), Health Tech India : 3-5 February 2017, New Delhi. • 3rd National Conference On Safety And Risk Management For Healthcare Professionals 2017 : 11 February 2017, Ahmedabad. • Meditech Healthcare Asia 2017 : 10-12 February, 2017, Ahmedabad • 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposable / Implants Industry 2017 : March, 2017. Ahmedabad • Medical Fair India 2017 : 06-08 April 2017, New Delhi. Nov. - Dec. 2016
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Flashback July. - Aug. 2004 From Editor’s Desk Dear Readers, The Medical Plastic Industry is passing through a very critical phase because of recent unprecedented price hikes for the Plastic Raw Materials. Both , for medical disposables as well as diagnostic products, plastics is the major and a very important constituent. Even for Pharmaceutical packaging requirements, polymers are major ingredients. For most of the products, more than 75 % of the manufacturing cost is for the Plastic Materials. And hence, these price hikes would significantly affect the Indian Medical Disposables Manufacturing Industry. As per the industry sources, many of the small scale units have either stopped or reduced their operations since even with the increased prices, the availability is also a problem. Moreover, the increased prices and restricted availability has in turn increased the working capital needs of the industry. In one of our previous issues, we had quoted the consultant, writer and former healthcare materials manager Lynn James Everad as “patient care is at risk unless healthcare systems find new ways to reduce their costs. Improving supply chain efficiency would be a giant step in that direction .” The fundamental problem?“Each link in the chain operates solely its best interest with littleor no concern for the overall efficiency of the chain”, Everad noted. We hope, the Industry is able to come out of this challenging situation. And also while trying to maintain the price lines, the quality should not be sacrificed. “HOSPIMedica ASIA 2004” the Southeast Asia’s leading healthcare industry exhibition is an unique opportunity for the Indian Healthcare Industry to widen their business outreach and enter into meaningful collaborations with the regional players in the healthcare business. CONTENTS • Cover Story : - Challenges faced by Indian Medical Disposables Mfrs. • Quality : The European Authorized Representative for CE Certified Medical Devices Manufacturers • Global Trends : Russia : Medical Equipment Market Overview • Industry News : - NASA to collaborate with Indian bio-medical Industry - Manipal introduces laser technology for ENT surgery - Heart Core ties up with Synchron for medical imaging - India's Healthcare is thriving 'privately' - Polar Pharma to make equipment • Did You Know ? - About Failure of the Tracheostomy Tube • Events Calendar
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Did You Know ?
?
About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials FDA’s Center for Devices and Radiological Health (CDRH) has identified “Modernizing biocompatibility and biological risk evaluation of device materials” as one of the CDRH’s top ten regulatory science priorities for FY2017. The regulatory science priorities serve as a guide for making strategic intramural research funding decisions to ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products. To determine the safety profile of implantable or patient-contacting medical devices, it is critical to perform biocompatibility evaluation to assess the risk of adverse events. This helps us understand and address the risks posed by the potential presence of harmful chemicals or immune response triggers such as contaminants, manufacturing materials, residues and byproducts as well as device degradation byproducts. While animal studies have historically been used to predict long-term safety and effectiveness, tests for carcinogenicity, reproductive toxicity and systemic toxicity are expensive, time consuming, use large numbers of animals and sometimes do not provide results that are easily translatable into a human risk assessment. New, less burdensome approaches that are more patient-centric and predictive of realworld device performance are needed to modernize and transform biocompatibility evaluation of medical devices and their materials. The biocompatibility review of device materials could be further enhanced by developing acceptance criteria, which could include multidisciplinary evidence obtained from integrating chemical characterization, computational modeling, device surveillance and emerging risk assessment tools. Modernizing biocompatibility and biological risk evaluation will reduce healthcare costs and patients would have access to safer devices faster. (Ref: More details at : http://www.fda.gov/downloads/MedicalDevices/ ScienceandResearch/UCM521503.pdf)
In a Nutshell.... “Spend eighty percent of your time focusing on the opportunities of tomorrow rather than the problems of yesterday.” - Brian Tracy
Nov. - Dec. 2016
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, Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. 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. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.
Nov. - Dec. 2016
Editor’s Desk
From the
It is a proven fact that collaborations across the disciplines and sectors contribute significantly towards innovation and competitiveness. And that is how use of plastics has revolutionized the field of healthcare making patients safer and procedures simpler. One such activity is the “Medical & Healthcare Plastics” Theme Pavilion at the forthcoming “10th PLASTIVISION INDIA 2017”, globally recognized as one of the largest plastics trade exhibitions in India to be held In Mumbai between Jan 19 to 23, 2017. “The All India Plastics Manufacturers’ Association – AIPMA” through this unique initiative of integrating Plastics & Medical Technology sectors not only contributes immensely towards Hon. Prime Minister’s “Make-In-India” mission but also towards humanity. “MEDICAL PLASTICS DATA SERVICE” is proud to be associated with this noble cause. For the first time in India , such a Theme Pavilion provides a knowledge platform to highlight opportunities in the Medical Plastics Sector through Posters , AudioVisuals, Models, Samples & Publications along with an opportunity to see demonstrations & interactions with Industry Experts covering Materials, Machinery, Products & Technology. This issue focuses on two very important aspects related to Medical Plastics / Materials. While animal studies have historically been used to predict long-term safety and effectiveness, tests for carcinogenicity, reproductive toxicity and systemic toxicity are expensive, time consuming, use large numbers of animals and sometimes do not provide results that are easily translatable into a human risk assessment. And hence, very rightly, CDRH has identified “Modernizing biocompatibility and biological risk evaluation of device materials” as one of the CDRH’s top ten regulatory science priorities for FY2017. The second is related to “Healthcare Plastics Recyling” – about a collaborative multi-hospital recycling project between the Healthcare Plastics Recycling Council (HPRC) and the Plastics Industry Association (PLASTICS) proved to be successful. Understanding the Industry Clusters helps a lot to promote indigenous industry. The article, “Gujarat Medical Device Industry : Moving Up in Value & Technology Chain” gives a very good overview. As mentioned in the article, with the passage of time, as the medical device industry sector became visible, manufacturing of relatively high investment as well as high technology critical care medical device products started getting manufactured in Gujarat with investments ranging from few crores to few hundred crores. This issue also covers regular features like Industry News, Global Trends, Product Profile, Events etc.
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Nov. - Dec. 2016
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Manufacturing Diversifying Into Medical Device Molding Many injection molders currently serving markets that are slumping are beginning to recognize the value of diversification, and the mantra of many has become, “I want to get into medical molding.” It’s easier said than done. The medical industry, while it may look a stable, high-volume segment, is a tough market to enter. The barriers are primarily regulatory, and Good Manufacturing Practices (GMPs), clean rooms, and the high cost of compliance restrict many molders from gaining entry. A major misconception in the molding community is that big money is to be made in medical devices, however, the reality is that the pricing pressures are just as heavy in medical as in automotive or consumer products. While molded components for nearly all markets require quality, on-time delivery, and best cost, meeting those requirements in medical device molding is much different from other markets because of compliance issues. The overall company culture requires a different mindset for employees who need to understand the medical device manufacturing business. Molding medical device or healthcare products tends to require more resources. The goal of the medical part designer should be to provide a part that combines maximum functionality with minimum complexity. Some of the important principles as enlisted below, when overlooked results in increased mold costs, a defective final product, or premature part failure. What Are OEMs Looking For? Because of the tight-tolerance, highly regulated, and critical nature of components manufactured, various factors are being evaluated by OEMs in determining which outsourced manufacturers will be used, including: • • • • •
Product reliability Proven ability to assist in medical device design History of strong performance and financial health Product performance in the marketplace Cost Value-added capabilities, including assembly, packaging, and sterilization, among others • OEMs are looking for manufacturers largely dedicated to medical with full production and clean room capabilities and systems in place to adhere to stringent regulatory and quality requirements
• Regulatory processes • Experience in designing and developing medical devices in a regulated environment • Capabilities across all classes of devices • Certifications: ISO 13485, ISO 9001, etc. • Registrations: U.S. FDA, CDSCO, etc. • Flexibility • Global footprint • Proven track record Medical Component Manufacturing : Some Important Developments Micro-Moulding New medical technologies are driving demand for smaller plastic components and hence micro-injection moulding has evolved as a technology for the mass production of minute - intricate polymer and composite components for medical applications Hot Runner Moulding. Medical products require thin wall components that can be moulded in large volume, to the tightest tolerances and at a very reasonable cost and hence in some cases economics justify hot runner moulds. All Electric Injection Moulding The process is said to offer lowest energy cost, extreme reproducibility, narrow processing window for thin walled component in engineering polymers, prolonged accuracy and instant repeatability, high uptime, smaller short size utilization, low emission, water saving, noiseless environment need, clean room necessity etc. Automation of Medical Device Moulding There are a variety of elements in the molding process that can be automated. Material Handling : Part Removal Mold Setting : In-Line Assembly Process Data Input : Packing / Boxing Quality Control : Production Analysis The Degree to which a project can be automated depends upon: Part Design, Quality Demands, Run Length, Economics Normally, higher levels of quality will justify higher levels of automation.
Challenges For Global Medical Device OEMs Competition Driven Challenges • Keep designing and making innovative products • Keep designing and making new versions of existing products • Do both of the above at reduced cost Contract Manufacturing Partner Eelated Challenges • • • • •
Global designing and manufacturing capabilities Global regulatory capabilities Communication barriers Cultural differences Fluctuating currencies
Nov. - Dec. 2016
Team MPDS
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Industry Cluster Gujarat Medical Device Industry : Moving Up in Value & Technology Chain As is already highlighted in one of the earlier articles, Gujarat State has the largest number of licenced Medical Device companies in India with wide ranging products from common hospital disposables to most critical cardio-vascular devices. History: The industry in Gujarat originated with the I. V. Fluid manufacturing industry in the 1970s followed by manufacturing of common medical disposables products like I.V. Sets as well as catheters like suction and urethral catheters. The manufacturing of these products was facilitated by easy availability of basic plastic materials as well as plastic processing machineries in Gujarat. Gujarat state is already known for strong entrepreneurial characteristics of the people and also the government and bureaucratic system. And hence with the exposure to the new business opportunity, number of small companies manufacturing I.V. sets and related products started coming one after the another. This resulted in Gujarat state companies manufacturing almost 90% of the low end common medical disposables in India. However, these products were not covered under any drug law as well as the entrepreneurs also did not have the back ground and understanding of requirements for medical device sector. With the covering of I.V. sets, needles and some other products under the food and drug control requirements, the medical device industry in Gujarat entered in a transition stage facing many challenges both for the manufacturing as well as quality requirements. Around this time, UNIDO initiated a cluster development program for the pharmaceutical units in Gujarat which was extended to the medical device industry also. This program was carried forward by Foundation of MSME Clusters (FMC). At the suggestion of the Ministry of Small Scale Industries, Government of India, the United Nations Industrial Development Organisation (UNIDO) conceptualized and initiated the process of creating the Foundation for MSME Clusters. Subsequently, the Foundation was legally constituted as a non-government, non-profit registered trust under the auspices of the Entrepreneurship Development Institute of India (EDI), Ahmedabad, in the year 2005. Gujarat Medical Device Industry Cluster Support Program By UNIDO : A Unique Success Story. The SME Medical Device units of Ahmedabad/Vadodara faced a major challenge in achieving the stricter quality norms increasingly demanded by the Indian regulatory authority as well as by large-scale units, which can be their potential clients. This is because, in order to attain quality certifications the small firms often lack the required information, appropriate technical training, knowledge of desired plant layout/machinery requirements and were not able to locate affordable Business Development Service ( BDS ) providers to organize such activities. The programme addressed these challenges in a step-bystep approach by building awareness among firms, sustaining a group approach to purchase of business development service
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(BDS), creating institutional linkages and finally building the capacity of existing and newly created associations to ensure the sustainability of the process. The major problems faced by the cluster at the beginning of the intervention were: i. Need for quality up-gradation ii. Need of manpower training iii. Business linkage through new channels iv. Strengthening of institutional linkages Implementation Strategy The above problems were addressed in a step-by-step approach by creating awareness among firms, building consensus on group approach, organizing institutional linkages and building capacity of the associations. In these interventions , industry association , “Medical Disposables Manufacturers’ Association,” ( MDMA ) , played a special role in disseminating a new vision for the cluster, which initially contributed significantly to ice-breaking and later triggered multiplication of initiatives; technical institutions provided training inputs; private BDS providers propped up confidence by securing business orders; and financial institutions provided financial support to the various activities. All these initiative where coordinated by the UNIDO methodology that triggered a proactive mentality and a growing dialogue among the various cluster actors. As a result of these initiatives large number of units in Gujarat embarked on quality up-gradation, many of them made an investments varying from Rs 5 to 50 lakhs. New BDS providers were introduced in the areas of quality, factory level training, contract business, export market and other support services. The program created or strengthened linkages with technical/developmental institutions like PERD, CIPET, SIDBI, GITCO, SIDBI, SISI, etc. International networking has been undertaken with development agencies like CBI and NMCP. Strong Supply Chain Industry : Parallel to the growth of the medical device industry, number of supply chain and ancillary units also started growing. At present there are more than 150 small and big companies manufacturing important inputs starting from basic raw materials to components, subassemblies, manufacturing / testing / sterilization and other machineries. The UNIDO program also supported number of service providers to focus on this sector. Moving To The High End Technology Products: With the passage of time, as the medical device industry sector became visible, manufacturing of relatively high investment as well as high technology critical care medical device products started in Gujarat with investments ranging from few crores to few hundred crores. With more and more products getting covered under drug licensing, the span of the industry also started widening . This is further supported by the presence of large scale engineering units in the state as well as support by the state and central governments in establishment of industrial infrastructure as well as research institutes like NIPER. Nov. - Dec. 2016
Industry Cluster The wide range of manufacturing of medical devices include products like : • • • • • • • • • •
Orthopedic Implants Ophthalmic Implants / Products Diagnostic Products Cardiology Implants / Products Surgical Instruments / Accessories Bandages And wound care products Non-woven and medical textiles Dental Implants / Products Electro-Medical Equipments Medical Electronics Equipments
guiding and motivation force all through out the growth of medical device companies in Gujarat. With many innovative initiatives like E-Governance the Gujarat FDCA has won even many awards not only in India but from international agencies like WHO, Bill and Melinda Foundation etc. Many of these initiatives by Gujarat FDCA have been replicated by various leading states in the country. (Ref: Chronicle Pharmabiz, Sept. 01, 2016. The Author is Editor & CEO, Medical Plastics Data Service)
These units are supported and serviced by manufacturers / companies across the value chain • Packaging Materials For Medical Devices And Pharmaceuticals • Plastics Raw Materials / Components (Injection moulded / extruded) Laboratory Supplies • Services including: Testing / Sterilization / Calibration / Validation / Quality Certification / Product Developments / R & D / Man Power Training etc. • Engineering Services including : Surface Treatments / Coating / Electrical Mechanical Maintenance Catalytic Role By Gujarat FDCA From the beginning to the current stage of development, the role of Gujarat FDCA has been exemplary. It has remained more a
Contact Address : Operon Strategist, Office : 10, Third Floor, MSR Capital, Pimpri, Pune-411 018. Tel. : 020-65283438 Mobile : +91-98232 83428 +91-90280 43428 E-mail : anil@operonstrategist.com bd@operonstrategist.com Skype : operonstrategist
Nov. - Dec. 2016
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Global Trends Healthcare Plastics Recycling A collaborative multi-hospital recycling project between the Healthcare Plastics Recycling Council (HPRC) and the Plastics Industry Association (PLASTICS) in Chicago proved to be successful . Plastic materials in hospitals are currently difficult to recycle in an economically viable way due to the material failing to represent enough value to attract the attention of recyclers. The project brought together multiple hospitals in an attempt to overcome this issue. Plastics primarily from main operating rooms and ambulatory surgery centres were collected and then transported by waste haulers to material recovery facilities (MRFs) for processing, or transferred to specialised plastics recyclers. A project aimed to address the issues surrounding the use and recycling of plastics used in the healthcare industry was carried out in Chicago . HPRC and Plastics aimed to introduce a viable recycling model for healthcare plastics, the focus being on noninfectious plastic packaging and products collected from clinical areas of the hospitals. The project was a success in many areas, such as defining the relative quantities of material types and understanding the complexity of sorting the materials once collectively amassed. The highest volume of material collected was sterilisation wrap and as such, the material was evaluated as a viable substitute or supplement for virgin resins in product manufacturing. Other packaging materials such as film plastics, as well as rigid plastic packaging were also collected.
demonstrate value through energy conversion and chemical recycling, showing that value can still be realised through other recovery processes. Chris Rogers, HPRC project manager said: “This project provided valuable insights into the realities of implementing plastics recycling programs in clinical healthcare settings. What we learned is that collection of plastics must be made simple for clinical staff in order to be effective. Detailed sorting at the point of generation is too complex and a distant priority from clinician’s primary focus of ensuring positive patient outcomes. It’s also important to remember that behavioural change around recycling can be a slow process, one that takes constant reinforcement over time.” Kim Holmes senior director of recycling and diversion at PLASTICS said: “In addition to testing the recovery and mechanical recycling of healthcare plastics, we were also able to explore alternative pathways of chemical recycling and conversion to fuel products with our technology partners. Proving the value of these hospital plastics in the conversion process was an exciting dimension of this project and underscores the importance of adding non-mechanical recovery technologies to our resource management tool kit.” Participating hospitals included Advocate Illinois Masonic Medical Centre, and NorthShore University HealthSystem’s Evanston, Skokie and Glenbrook Hospitals. Ref: (http://www.medicalplasticsnews.com/news/healthcareplastics-recycling-project-is-a-success/ - December 20, 2016)
The team were also successful in testing the potential to
Europe Medical Plastic Market - Trends and Forecast by 2024 The Europe medical plastic market is expected to reach USD 4.84 billion by 2024, according to a new report by Grand View Research, Inc. Growing demand for medical plastics in applications such as disposables, surgical instruments, diagnostic components, implants, and orthopedics is expected to drive demand. Rising demand for healthcare services and facilities coupled with increasing government support to the medical industry in the Europe is expected to have a positive impact on the industry growth. Rising R&D expenditure related to the manufacture of biocompatible medical plastics with superior quality, low cost, and minimal health hazards is anticipated to propel demand. However, stringent regulatory scenario associated with the medical device manufacturing and waste disposal are anticipated to be key challenges for the industry in the region. Europe medical plastic industry is highly competitive and fragmented owing to the presence of numerous players. Manufacturers are coming up with various innovative technologies in order to reduce cost and improve product quality and durability. Price volatility of the feedstock and stringent government regulations associated with the medical device manufacturing are expected to be the key factors affecting the industry growth. Competition in the medical plastic market is likely to help consumers in terms of cost, quality and product innovation. Cost
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competitiveness and product quality are anticipated to be the key factors influencing buyer power decision. High production volumes and ease of availability of the product is expected to propel demand over the projected period. Polyethylene was the largest product segment for Europe medical plastic industry in terms of volume in 2015 and is expected to grow at a CAGR of over 5% from 2016 to 2024. Rising demand for the product for manufacturing artificial tendons, surgical cables, tubing and orthopedic sutures is expected to drive growth. Disposable was the key application segment for the industry, accounting for 25% of the total market in 2015 and this trend is expected to continue over the forecast period. Growing demand for devices such as disposable enemas, cleaning gloves, contact lenses, hypodermic needles and Dialysis disposables is anticipated to drive demand for various plastic materials such as PVC, silicones, and PE. In the UK, demand for silicon for surgical instrument manufacturing was valued over 3 million in 2015 and is expected to grow at a CAGR of over 5% over the projected period. Silicone furnishes medical device manufacturers with numerous choices for improvement of new items. Rising demand for silicone in surgical instrument manufacturing owing to its biocompatibility, bioinactivity, and superior physical properties is expected to have a positive impact on the industry growth. Nov. - Dec. 2016
Global Trends Engineering plastics demand for implants in France was valued over USD 6 million in 2015 and is expected to grow at a CAGR of over 7%, from 2016 to 2024. Polyetheretherketone (PEEK), an engineered plastic material finds wide application scope in the implants. Biocompatibility, strength, and inertness offered by the product is expected to open new avenues for the market growth over the forecast period. Germany is a key market for the medical plastic industry in the Europe and is expected to grow at a CAGR of over 5% from 2016 to 2024. The country is one of the leading business locations for medical technology in the world. The manufacturers in country invest over 9% of their total income in the R&D and product innovation, which is likely to open new avenues for the industry growth over the projected period.
Key players in the industry include Rochling Group, Nolato AB, GW Plastics, Saint-Gobain Performance Plastics Corporation, Orthoplastics Ltd., Eastman Chemical Company, Celanese Corporation, The Dow Chemical company and Tekni-Plex. For more details : Orbis Research (orbisresearch.com ) - Hector Costello , Senior Manager – Client Engagements , 4144N Central Expressway, Suite 600, Dallas, Texas–75204, U.S.A. P.N. :+1(214)884-6817;+9164101019,sales@orbisresearch.com Ref: (http://www.medgadget.com/2016/11/europe-medicalplastic-market-analysis-share-trends-and-forecast-by-2024market-research-report-2016.html)
Global Medical Polymers Market Estimated To Register CAGR Of 13% By 2022 Medical Polymers Market is expected to reach US$19,014 mln by 2022, growing at an estimated CAGR of 13% from 2016 to 2022, according to a report by Allied Market Research. Resins is the leading segment in 2015 and is expected to maintain its lead throughout the forecast period. Further, in the application segment, devices dominate occupying a share of nearly half of the global medical polymers market. Medical polymers are widely used across various applications, as they are easy to manufacture and facilitate customizations. Moreover, they provide ease of fabrication, flexibility, and biocompatibility, and remarkable mechanical, electrical, chemical, and thermal properties of materials that are used as composites for medical implants. Increasing number of medical procedures, such as joint reconstruction & heart surgeries and rise in cosmetic and plastic surgeries in the developing countries are the few other key drivers of the market.
contributes majorly towards the revenue of the segment. • Disposables is the fastest growing application segment and is expected to grow at an estimated CAGR of 14.2% during the forecast period of 2016-2022. • U.S. was the largest market in terms of demand for medical polymer in 2015. (Ref: http://www.plastemart.com/plastic-factsinformation.asp?news_id=38734&news=Global-MedicalPolymers-market-estimated-to-register-CAGR-of-13-by-2022)
“Increase in adoption of medical polymers owing to low prices and versatility, coupled with increase in the sales of medical implants and devices globally will garner the growth of the global medical polymer market”, said Eswara Prasad. Resins dominate the medical ceramics market due to a significant replacement trend of conventional medical devices materials with advanced polymers such as polyphenylene ether and few others, which provide highquality medical devices. Further the application segment is led by devices holding nearly half of the global polymers market. This is mainly due to advancement in the technology provided by the polymers manufacturers such as polymer laminate technology and so on. Devices captured a major share in the global medical polymers market followed by disposables such as gloves, syringes and others. Key Findings of the Medical Polymers Market • The bioresorbable plastics (PGA) of polymer market is expected to grow at a highest CAGR of 17.1% during the forecast period. • Resins hold the highest share of four-fifths of the total medical polymers market in 2015. • In the application segment, devices hold nearly half of the market share in 2015, where Diagnostics equipment Nov. - Dec. 2016
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Required
ISO : 13485 : 2012
Medical Device Manufacturing Facility On Loan License Basis We are looking for loan license for Epidural, CVC and Dialysis catheters, fistula needles, biopsy needles, spinal needles, pressure monitoring lines, Guidewires, ETC. Party having manufacturing license or willing to take license or interested to work together should write immediately. For Enquiries and Detail mail us on :-
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.
loan.license@gmail.com Contact : Mr. Pradip Barot M. 93214 14111
Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com
: Attention :
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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 30
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Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
Manufacturer And Exporter Of a wide range Of Medical Devices Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc... The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing. – Supply of Components for Medical Devices.
ANGIPLAST Private Limited
ISO 9001-2000
REGISTERED FIRM Wide Range Of Products :
The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.
Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com
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Nov. - Dec. 2016
®
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
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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 Nov. - Dec. 2016
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Industry News Medical Devices Industry Wants Govt To Create Investor Friendly Environment Annoyed by the continual lackluster attitude adopted by the central government in addressing the long pending issues of the medical devices industry in the country, experts in the sector want immediate intervention from the government to bolster the lagging confidence of the industry. Industry feels that too many policy decisions awaiting announcement amidst differences between the ministers to get consensus amongst cross lobbyists is hurting the interest of the industry. Experts stressed that rather than creating an investor friendly environment by easing and simplifying the process, the Centre has further complicated the matter by creating fear and confusion among stakeholders. Rajiv Nath, forum coordinator of AIMED, stressed that just marketing and sloganeering about ‘Make in India’ will not do any good for the industry unless it is backed by clearly defined policy framework, strategies and listed reforms that are
tangible.
Centre,” Nath informed.
Instead of taking any pro-active measures in sprucing up the domestic manufacturing arena, the government is further creating a complicated market condition for the industry. Though the government has started taking baby steps towards reviving the sector, their initiatives are not sufficient, and they need to walk the talk by making sure that the ministers are involved in the reform process, Nath stressed.
He stressed that bureaucrats have to see the ground realities and work with the industry to ensure that the sector gets its due. Reiterating AIMED’s call for action on its suggestions, Nath pointed out that since medical devices being a critical sector, it is only expected of it to have a centralized regulation for all medium and high risk devices categories, leaving the re-sellers whether wholesalers, retailers or healthcare providers to be regulated by state regulatory bodies. Thus in this context considering the present limitations of the regulatory bodies in terms of competency, capacity and resource capabilities, our suggestions to the regulatory body to encourage voluntary compliance backed by third party certification to ensure patient safety stands valid, Nath added. (Ref: http://pharmabiz.com/ PrintArticle.aspx?aid=98402&sid=1)
“In spite of all these promises, the industry is still reeling under pressure due to the government creating unfavorable conditions for the investors. Even after announcing setting up of medical devices park across the country, there are lot of uncertainties on the regulatory front. We strongly fear that it will be huge challenge to attract investors to these parks with so mach confusion which will undoubtedly derail the ease of doing business assurance given by the
Medical Device Industry Rues Recommendations Not Incorporated In The Draft For New Medical Device Rules Government must consider industry recommendations for Medical Device Rules to circumvent severe jeopardy to critical healthcare in India and it falls short of the expectations of the medical devices sector, feels the industry. In a statement, the industry experts say that the Medical Device Rules were initially prepared with industry consultation, however the comments of the industry as well as certain elements where agreement was obtained between industry and Health Ministry officials were not incorporated in the draft that was published on October 17th, 2016 for stakeholder’s comments (within 30 days). “In their current form the Medical Device Rules could severely jeopardize the continued supply of critical care medical devices to India. They will also endanger the huge investments made in Manufacturing in the country by global companies & will dent the FDI which has been growing multifold since it was sagaciously brought on the automatic route by the current government. Having said that, we are engaged with the Health
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Ministry as well as the CDSCO on the Rules, and if the past is anything to go by, their inclusive approach and nuanced understanding of the issues will help us once again reach solutions so that the supply of critical care devices will continue uninterrupted to the Indian patient,” commented Pavan Choudary, director general, Medical Technology Association of India (MTaI) in a statement. Also, the Advanced Medical Technology Association (AdvaMed) – a trade association expressed that the rules in its current form lack harmonization with international norms of medical device regulation, which is necessary to provide the necessary fillip to the sector that provides extraordinary growth opportunity for the country through creation of high paying jobs, economic value and better patient outcomes. In addition to the device rules, the Association also, strongly, recommends inclusion of the globally harmonized definition of medical devices into the current Act, which is not part of the drug definition, it says in a statement. Varun Khanna, chairman, AdvaMed India
Working Group, and Executive Committee Managing Director, BD India & South Asia said, “All policy decisions need to be based on scientific due diligence. The Medical device draft rules 2016, at this stage, need more clarity and alignment with global best practices to fully meet the sector specific requirements in order to ensure predictability in the Indian market, which is a critical factor when it comes to investment decisions. The current rules address some but not all of the issues that were deliberated upon during several industry consultations while working on this draft. AdvaMed and its members appreciate the efforts made by the Indian government to improve the overall landscape for medical devices. We request the Government to continue consultations with the innovative industry and build on their experience to come up with a methodology that will address reasonable concerns around access and affordability while promoting research and med-tech innovation.” He also said, “The government needs to be mindful of the fact that without sufficient Nov. - Dec. 2016
Industry News capacity it will be challenging for them to implement these rules. Therefore, a critical step for the successful implementation of the medical device rules would be to take measures for building capacity of the relevant ministries and ensure greater understanding of the sector dynamics and criticalities among the regulators.” The association members have urged the regulators to make necessary revision in provisions that hinder operational ease of doing business for the device companies. For instance, the additional requirement for clinical investigation of medical devices already approved in GHTF countries shall
cause unnecessary delay in the availability and access of innovative medical devices to the HCPs and the patient population. Moreover, the provisions with respect to labeling of medical devices should be aligned with the Draft rules published in July 2016, and the clause with respect to the shelf life of medical devices should be amended to be in line with global requirements. The members said that while the implementation of UDI is a positive step, it is imperative for the government to have realistic timelines. For example, as per the US and EU implementation timeline, the
complete implementation including direct part labeling will be over only by 2022. Hence, it is premature to incorporate this in the current rules, as manufacturers are not ready for implementation of UDI. The association said that encouraging measures for medical device regulation would enhance penetration of essential medical devices, and it is hopeful that its perspective would be reflected in the final version. (Ref: http://pharmabiz.com/NewsDetails .aspx?aid=98982&sid=2&fromNewsdog=1)
AIDCOC Urges Health Ministry To Empower State Licensing Authorities (SLAs) To Grant License To Critical Medical Devices The All India Drugs Control Officers Confederation (AIDCOC) has urged the Union health ministry that the State Licensing Authorities (SLAs) should be made competent authority for grant of license to manufacture medical devices of all classes for the purpose of clinical investigations or test or evaluation or demonstration or training. As per the proposed draft of Medical Device Rules, 2016, the licensing of medical devices is divided into two categories which are critical and not so critical. The SLAs were entrusted to license the not so critical medical devices and the Central Drugs Standard Control Organization (CDSCO) will handle the critical ones. With this proposed rules, AIDCOC is of the view that the draft is focusing towards the centralization of powers rather than ease of delivering goods. “It is to bring to the kind attention of the government that the state authorities have been handling all the more critical drugs like vaccines, sera, rDNA and high end critical medical devices like cardiac stents all these years successfully and it is pertinent to mention that there is no specialized knowledge or wherewithal existing with CDSCO to be specifically entrusted with the handling of critical medical devices. It clearly shows that the proposed draft rules are focusing towards the centralization of powers rather than ease of delivering goods and making the system more complex,” opined Ravi Uday Bhaskar, secretary of AIDCOC. The proposed rule says that the SLA shall Nov. - Dec. 2016
be the competent authority for enforcement of rules in matters relating to manufacture of class A or class B medical devices, sale, stock, exhibit or offer for sale of medical devices and other related functions, provided that where any person who intends to manufacture any medical device which does not have its predicate medical device shall obtain prior approval from the Central Licensing Authority before applying to the State Licensing Authority for grant of manufacturing licence. It further says, the Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to import, manufacture of Class C and Class D medical devices, clinical investigation and clinical performance evaluation, of medical devices and other related functions. Whereas, the AIDCOC has proposed that the Class A medical devices need not be licensed at all, the
Class B medical devices may be licensed by the SLA only and the Class C and Class D medical devices be licensed by SLA and approved by Central Licensing Approving Authority (CLAA). (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=98933&sid=1)
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
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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
•
I.V. Infusion Sets
•
Blood Administration Sets
•
Scalp Vein Set
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Urine Collection Bags
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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, Address : APEX MEDICAL DEVICES Plot No. 10/B, Shyam Ujjawal Industrial Park, Opp. SBI Bank, Phase-1, G.I.D.C. Vatva, Ahmedabad-382 445 (India) E-mail : apexmedical@live.in Website : www.apexmedicaldevices.com
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Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com
Nov. - Dec. 2016
January to December2016 Column
Content
Column
November-December 2016 Cover Story
• Medical & Healthcare Plastic Pavilion – The Dedicated Zone In The Biggest Plastics Show Manufacturing • Diversifying Into Medical Device Molding Industry Cluster • Gujarat Medical Device Industry : Moving Up in Value & Technology Chain Product Gallery • New Multi - Cavity Channel Clips With Guide Wire Slit From Qosina Global Trends • Healthcare Plastics Recycling • Europe Medical Plastic Market - Trends and Forecast by 2024 • Global Medical Polymers Market Estimated ToRegister CAGR Of 13% By 2022 Industry News • Medical Devices Industry Wants Govt To Create Investor - Friendly Environment • Medical Device Industry Rues Recommendations Not Incorporated In The Draft For New Medical Device Rules • AIDCOC Urges Health Ministry To Empower Slas To Grant License To Critical Medical Devices Did You Know • About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials Press Notes • PLASTINDIA 2018 – Special Preview • Qosina Receives ISO-13485 Certification • Revolutionary Conveying System with Variable Speed Capability from Conair September – October 2016 Technology Manufacturing
• INDIA ’S First Medical Technology Zone – AMTZ • How To Meet Biocompatibility Needs Of Polymeric Medical Components Quality • Quality Management System: Changing Scenario & Challenges In Medical Device Regulations Product Gallery • New Barbed Check Valves Global Trends • How Plasma Can Aid Catheter Manufacturing Industry News • NIPER Ahmedabad To Collaborate With 2 US-Based Cos Towards Development Of Medical Device Industry • Centre To Establish 3 Mega Industrial Parks In Gujarat For Medical Devices, Bulk Drugs • Sahajanand Medical Technologies Opens New R&D Facility In Ireland Did You Know • About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices July-August 2016 Cover Story
• Medical Plastics – New Materials & Technologies Help Medical Device Industry Manufacturing • Supply Chain Management–Boon Or Bane For The Medical Device Industry Product Gallery • New Barbed Check Valves • New Micro Pinch Clamps Global Trends • Medical Device Companies Fear Parallel Regulation After Brexit Vote Nov. - Dec. 2016
Industry News
Did You Know
Content • Plastics Remain Material Of Choice In Parenteral Packaging Market • HMD Becomes First ICMED Certified Medical Device Company In India • Boston Scientific Launches Integrated Facility In India To Develop Minimally Invasive Technologies • States And Central Health Agencies For Indian Products While Procuring Medical Devices • New Niper Campus In Gandhinager ( Gujarat ) To Emerge As A Vibrant R & D Centre Dedicated To Medical Device Industry • Gujarat FDCA To Tie-Up With NIPER Ahmedabad For Skilled Manpower For Medical Device Park • About Implants As The Fastest Growing Application For Medical Plastics May – June 2016
Cover Story
• Effective Vendor Management For Medical Device Industry • Supplier Quality Management For Medical Device Manufacturers : A Critical Step Towards Global Regulatory Compliance • Medtech Companies Need Collaboration With External Partners For Innovation And Growth Technology • Innovative Computer-Aided Catheter Reprocessing System (CRS) for Cleaning Catheters Developed By Chandigarh Biomedical Engineer • India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector Product Gallery • Enteral Feeding Connectors that Meet the ISO 803693 Standard Global Trends • Medical Adhesives: Fastest growing Segment Industry News • Andhra Med Tech Zone Gets Formal Registration To Set Up Asia’s First Dedicated Medical Devices Park • Gujarat Govt Allocates Land For Setting Up Medical Device Park At Sanand • Industry Wants ICMED Certification Mandatory For All Medical Devices Marketed In India • India And Japan To Seek Regulatory Collaboration For Medical Products • Separate Rules To Spur Medical Devices Sector Soon • Centre To Notify Revised Schedule M III For Medical Devices By June End Did You Know • About Best Practices to Ensure Good Supplier Management March – April 2016 Cover Story
• Indian Medical Device Industry: Integrating Market, Technology, Innovation And Ecosystem • Important Announcements - “IC-MED” – QCI-AIMED Voluntary Initiative On Medical Devices. - Delinking Medical Devices From Pharmaceuticals And Revision Of Schedule MIII
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January to December2016 Column
Content
Markets
•
Materials
•
Product Gallery • Global Trends Industry News
• • •
• Did You Know
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- BIS Certification For Medical Devices Southeast Asia: Region On The Rise For The MedTech Industry Thermoplastic Polyurethanes: Enabling Innovative Competitive Technologies Through Advanced Materials Needleless Injection Site With A Non-Disconnect Male Luer Lock Medical Plastics Packaging Trends Keep Expanding IMDI 2016 Welcomes Govt Industry Friendly Measures Towards Growth Of Medical Device Sector CDSCO To Grant Online Registration Certificate, Renewal Of Licence For Import Of Medical Device Soon Medical Plastics Market By Type, By Application And Region-Forecast 2020 About effect of Medical Device Quality Performance On Business Performance
Column
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• • • • •
Industry News
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• 13th National Conference & Exhibition on “Indian
• • • •
January – February 2016 Cover Story
Content
Article Index
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Medical Devices & Plastics Disposables / Implants Industry 2016” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. Conference Theme : “Indian Medical Device Industry : Integrating Market, Technology, Innovations and Ecosystem”. Speakers’ Introduction Presentation Abstracts Exhibitors’ Profile List & Profile of Advertisers Student Programme : Career Opportunity Presentations, Poster Presentations & Paper Presentation Competitiions Technology Display Show 2016 Import duty on medical devices raised AP showcases exclusive medical device park at Arab Health Expo DBT collaborates with AIIMS and IITs for medical device technology Important Articles published in the magazine from Nov.-Dec. 2014 To Nov. - Dec. 2015
Nov. - Dec. 2016
Product Gallery New Multi - Cavity Channel Clips With Guide Wire Slit From Qosina ETO or Gamma sterilization, these new channel clips are LatexFree as well as REACH and RoHS compliant. Qosina offers a variety of guidewire accessories and dispensing tubes, along with thousands of stock components to help complete your design. Visit Qosina.com today to request samples! Qosina offers low minimums and short lead times. Log on to Qosina.com to see pricing, obtain our latest catalog, request complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product additions. Custom sourcing services are available through our extensive network. Call our Customer Service Specialists to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com.
Ronkonkoma, NY – November 2, 2016– Qosina is pleased to announce the addition of four newmulti-cavity channel clips (#12536 - #12539) to their line, in stock and ready for immediate delivery. Equipped with a unique slit which isdesigned to retainguidewires, these channel clips help to hold a wire in place when not in use. Three of these clips have two, 0.144 inch channels (#12537 - #12539), while the other (#12536) has two, 0.142 inch channels; all with different size slits to accommodate a variety of guidewires.Made from a soft, TPV (Thermoplastic Vulcanizate) material, these channel clips are flexible, allowing for easy attachment to a dispensing tube. Recommended for
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
Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing components, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Founded in 1980, Qosina is now based in Ronkonkoma, NY in a 95,000 square foot facility with an ISO Class 8 Clean Room and is ISO 9001 and ISO 14001 registered. Contact : Deanna Whelan Qosina 2002-Q Orville Drive North, Ronkonkoma, NY 11779. Phone +1 (631) 242-3000. Fax +1 (631) 242-3230. Email: deanna@qosina.com
Surgical Industry For
SALE In Hyderabad, R. R. District, Telangana.
An ISO 9001:2008, 13485:2012 & GMP Certified Company
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 Nov. - Dec. 2016
Contact through:
surgicalindustrysale@gmail.com 41
Events Plastics Industry In Gujarat Set To Grow At 20 % To Over Rs. 90,000 Crores
Plastindia Foundation to announce the Special Preview of PLASTINDIA 2018 Swachh Bharat initiative and Make in India campaign contributing to robust growth Exports of finished plastics goods set to double in 5 years. Plastic Industry is making significant contribution to the economy, development and growth of various key sectors in the country namely Automotive, Agriculture, Electronics, Construction, Healthcare, Textiles, FMCG etc. It is one of the fastest growing industries in India. Plastic industry would also contribute in a big way in the success of Government initiatives such as Make in India, Skill India, Digital India, Swach Bharat Abhiyan etc which are opening up opportunities and accelerating growth even more rapidly. Talking on Gujarat Plastic industry scenario, Gujarat has been a major contributor to over all Plastics Industry Globally, India stands third in polymer consumption with China being the second largest consumer, while US tops with 25 million ton polymer consumption per annum. “India per capita consumption is approx. 10 kg per annum’ and world’s average per capita plastic consumption is more than 25 kg per annum. “Smart cities, rapid urbanization, increase in sale of packaged products through retail and ecommerce mode, low per capita consumption, shifting consumer lifestyles, large young population, majority of population of middle income group, many manufacturing segments adopting higher percentage of plastics, etc. are contributing towards the growth of Plastics industry. Indian Plastics industry has geared itself to take up the challenges of quantitative and qualitative growth for serving the nation and its citizens and also to take the country to a higher growth path”. This was shared by President Plastindia Foundation Mr. K. K. Seksaria at the formal launch of Plastindia 2018 held in Ahmedabad on Nov. 18, 2016. PLASTINDIA 2018, to be held bet. Feb 7-12, 2018 in Gandhinager (Ahmedabad) will showcase the increasing usage of Plastics in major Growth sectors, and it shall provide unlimited opportunities for all who are looking at growth avenues. Moreover, PLASTINDIA 2018, for the first time, will feature ‘Industry Focused Pavilions’ for the new and emerging sectors that are going to redefine the future of Plastics. The sectors in focus are Sports, Plastic Composite, 3D Printing, Robotics, etc.
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Qosina Receives ISO-13485 Certification Qosina is pleased to announce that we have received ISO 13485 Certification, a globally recognized standard that specifies the requirements for a quality management system that can be used by organizations providing medical devices, components and delivery of related services. This certification allows Qosina to comply with the ever-changing needs of our customers while meeting and maintaining regulatory requirements. Qosina is also ISO 9001 & ISO 14001 certified and is committed to maintaining and continually improving our quality and environmental systems. Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components 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, 14001 and 13485 registered. Contact for more details : via p:+1(631) 242-3000 nfo@qosina.com.
Revolutionary Conveying System with Variable-Speed Capability from Conair Conair displayed dense-phase vacuum-conveying system to minimize pellet fracturing, “angel hair” and equipment wear caused by conventional dilute-phase conveying, at K 2016 in October in Germany . The system can be “tuned” to match material speed to application requirements and the characteristics of the material being conveyed. Other products exhibited by Conair included : • The new, patent-pending Conair Invisible Line Proofing(ILP) system, which is based on an otherwise standard resin selection station but uses a proprietary nonelectrical sensing technology to confirm that the proper resin source is connected to the selected destination. • A new dual-spindle automatic cut-and-transfer coiler(ATC), designed for high-speed winding of smalldiameter extruded tubing and flexible profiles. Even at high speeds, little or no friction or winding tension is generated, preventing deformities in delicate products. Fully automated transfer of winding to a new reel increases line speed and performance during changeover. • The compact and remarkably quiet NCF-814 Granulator, which has a super-tangential cutting chamber to turn containers and other bulky scrap intoclean, uniform regrind for better product quality. The Conair Group (www.conairgroup.com) is a leading global supplier of auxiliary equipment for plastics processors, including resin drying systems, blenders, feeders and material-conveying systems, temperature-control equipment and granulators. Extrusion solutions include line-control systems, film and sheet scrap-reclaim systems and downstream equipment for pipe and profile extrusion. Nov. - Dec. 2016
Events Events Calender • Plastivision India 2017 : International Plastics Exhibition & Conference Date : 19-23 January 2017. Venue : Bombay Convention & Exhibition Center, Mumbai. • Confederation of Indian Industry (CII), Health Tech India. Date : 3-5 February 2017. Venue : Pragati Maidan, New Delhi, India. • 3rd National Conference On Safety And Risk Management For Healthcare Professionals 2017 : Dedicated Exhibition Pavilion For Safety, Infection Control & Biomedical Wast Management. Date : 11 February 2017. Venue : The Gujarat University Convention Exhibition Centre, Ahmedabad. • Meditech Healthcare Asia 2017 : International Exhibition and Conference On Healthcare & Medical Technology Date : 10-12 February, 2017. Venue : The Gujarat University Convention Exhibition Centre, Ahmedabad. • 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposable / Implants Industry 2017 : March, 2017. Ahmedabad. • Medical Fair India 2017 : 23rd International Exhibition and Conference Date : 06-08 April, 2017 Venue : Pragati Maidan, New Delhi.
Nov. - Dec. 2016
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.
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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
GMP. & ISO 9001 – 2000 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 / URINE BAGS / MEASURE VOLUME SETS ETC.
Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India
National Healthcare An ISO 9001 : 2008 Company
Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch E. O. Indicator Pouches Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699
Kavya Packaging Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : kavyapack@yahoo.com
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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 Nov. - Dec. 2016
