Medical Plastics Data Service Magazine January - February 2019 by Medical Plastics Data Service

Table of

Contents Vol. 26

16 35 Jan.-Feb. 2019

No. 6

Nov.-Dec.2018

COVER STORY Opportunity For New Entrepreneurs In Medical Textiles - Dr. Ketankumar Vadoria, Head, Centre of Excellence for Medical Textiles-SITRA, Coimbatore Medical Textile is one of the fastest growing technical textile fields in India and across the globe comprising of as simple products such as wipes to life saving and more complex products such as vascular grafts.....

EXPORT MARKETING EEPC India Initiatives In The Medical Device Sector - Mr. Suranjan Gupta, Executive Director, EEPC India EEPC India is dedicated to the cause of promotion and development of medical device sector in India and to achieve the objective, the council has taken several initiatives in the sector...

MANUFACTURING Components Handling Solution For Medical & Pharmaceutical Applications - Mr. Nishant Upadhyay, Product Manager, Prasad Crilec Automation Pvt Ltd. The best solution to convey injection moulded and blow moulded parts from moulding machine to other space for Processors who are in Medical & Pharmaceutical Application is convey belts...

GLOBAL TRENDS Global Antimicrobial Coatings Market In recent past, the antibiotic local application directly on the local surface is considered more efficient as compared to antibiotics penetration through biofilm...

AiMeD & REGULATORY UPDATES • AHPI & AIMED Collaborate To Promote Indian Medical Devices Industry • AiMed Seeks Reduction In Import Duty On Raw Materials, Financial & Technical Support To Spur IVD Industry Growth • Centre Plans To Cut Prices of 400 Medical Implants

INDUSTRY NEWS • Euro Alliance signs MoU with AMTZ to provide market access to medical technology companies in Switzerland and India • Health Minister confers ‘Award of Appreciation’ to Rajiv Nath of AIMED for his contribution to global healthcare

PRODUCT GALLERY • Qosina Introduces New ISO 80369-7 Compliant Needleless Injection Sites • Qosina’s Barbed, Tube-to-Tube Connectors Help Reduce Time to Market • Surgical Pads : First Time In India With Phase Change Material From Outlast by Natroyal Group

DID YOU KNOW? • Why Non-Woven Fabrics For Medical Textiles ?

EVENTS CALENDER • Medicall 2019 : 8-10 March, 2019, Hyderabad • K 2019 : 16 – 23 Oct., 2019, Germany

• Medicall 2019 : 26-28 July, 2019, Chennai • Plastivision 2020 : 16-20, January 2020, Mumbai

Flashback Select Article Index

May 2010 to Sept. 2010 • Cover Story : Indian Medical Device industry needs to develop products indigenously at affordable costs (May – June 2010) Dinesh Trivedi, Hon. Minister of State for Health and Family Welfare • Cover Story : Medical Device Markets – The Growth set to Accelerate - Global v/s India (May – June 2010) • Technology : Injection moulding: A vital high technology – innovation driver in medical technology (May – June 2010) • Global Trends : Trends in Medical Device Innovation (May – June 2010)

Did You Know ?

Why Non-Woven Fabrics For Medical Textiles ?

Nonwoven medical textiles have become indispensably important in surgery and medicine; the range of uses for this material is a testament to its incredible versatility and adaptability. The products made possible by this technology may appear to be the realm of the technologically knowledgeable. But that perception belies the fact that everyone, at one point or another, will benefit from this technology. Nonwoven medical textiles, therefore, aren’t just something for the medical industry to appreciate but, rather, something everyone needs to be openly thankful for and appreciative of.

• Did You Know ? : About Human Factors Lead ing to Medical Device Adverse Events (May – June 2010)

Things like tissue bioengineering, nanotechnology, and the ever-expanding science of bio-materials are literally opening new horizons in the medical textile and related industries. Nonwovens are one of the many exciting catalysts for these promising technological developments.

• Cover Story : Performance Polymers For Development of Medical Devices With High Performance (July – August 2010)

Most people know that disposable incontinence/personal hygiene products are increasingly important products but what about the use of nonwoven technology to repair/replace bones, organs, vascular systems and skin grafts?

• Cover Story : Lubricating Medical Devices With Silicones (July – August 2010) Mr Brian Reilly, Product Director – Healthcare Materials and Nathan Wolfe, Technical Sales, NuSil Technology, USA

Simply put, nonwoven technology has greatly improved the life of many individuals with the use of the relatively new exciting field of biomedical textiles.

• Cover Story : Acrylic –Based Multi Polymer Compounds (July – August 2010) • Quality : Toxicity / Biocompatibility Evaluation Of Materials (July – August 2010) Dr. PV. Mohanan, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram • Global Trends : Syringes beat spoons for children’s medicine (July – August 2010) • Global Trends : DES Make Up Sizeable Chunk of Rising Medicare Costs for CAD Patients (July – August 2010) • Did You Know ? : About Catheter Introducers – A Potentially Life Threatening Episode (July – August 2010) • Cover Story : Medical Device Manufacturing : Processes & Techniques Ultrasonic Welding of Filter Elements in Drip Chamber of I.V. Set (September – October 2010) Mr. Lokesh Upadhye, Deputy General Manager - (ATG Sales), Branson Ultrasonics, Mumbai • Cover Story : Antimicrobial Coatings (September – October 2010)

Here are just a few of the controllable properties of nonwovens that make them ideal for medical applications: • Porosity, Fabric weight, Thickness • Sterilization capacity/ease-of • Limitless manufacturing customization • Cost-effectiveness • Uncanny effectiveness/efficiency • High performance (vapor transmission, • Excellent user protection (high tearing air permeability, comfort, feel, etc.) & abrasion resistance, etc.) • Good cross-contamination control • Unbeatable wound-caring (absorbent pads, drug-delivery devices, bandages, etc.) Well-documented usage in ICUs, labs, operating rooms, etc. Nonwovens can be manufactured using eco-friendly, natural fibers. Nonwovens often use cotton, which has many wonderful applications/properties for medical settings (e.g., hypoallergenic, naturally absorbent, soft, etc.) New bio-polymer substances (e.g., polyactide or PLA) are another plausible biodegradable, recyclable and renewable alternative to synthetic fibers (https://www.wptnonwovens.com/blog/non-woven-fabrics-used-medical-textiles/ )

In a Nutshell.... The true sign of intelligence is not knowledge but imagination. - Albert Einstein

Jan.-Feb. 2019

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

Editor’s Desk

From the

The Swachh Bharat Abhiyan is the most significant cleanliness campaign by Government of India and a mission launched by Shri Narendra Modi supported by awareness across the country. Because of Hygiene & Health Concerns, countries are actively involved in educating the masses.

ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland

“Medical Textiles” contribute significantly towards maintenance of Health & Hygiene. As one of the fastest growing sector, it not only includes simple products but critically important implants as well as extracorporeal Medical Textiles.

Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group

Disposable incontinence/personal hygiene products find growing importance. However, at the same time, use of nonwoven technology to repair/replace bones, organs, vascular systems and skin grafts

Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY :

Tissue bioengineering, nanotechnology, and the ever-expanding science of bio-materials are literally opening new horizons in the medical textile and related industries. Nonwovens are one of the many exciting catalysts for these promising technological developments.Novel technologies in antimicrobial finishing are successfully employed in non-woven sector especially in medical textiles. Rising concern regarding the growth of hospital-acquired infections among human beings is also an important factor to boost the overall growth for antimicrobial coatings as explained in the “Global Trends “ column in this issue. In a very well researched article by Dr Ketankumar Vadodaria, Head, SITRA Centre Of Excellence (CoE) for Medical Textiles, has highlighted the opportunities for new entrepreneurs. SITRA CoE has a great contribution including development of number of technologies successfully transferring them to Industry. Apart from 45 research article published, they also filed patents, developed medical textile standards, offer pilot scale production and incubation services as well as assist for developing new products from concept to commissioning. SITRA CoE is a role model for developing such centers across the country focusing on different sub-sectors of Medical Device Industry. This issue also highlights one more such Institution contributing tremendously to boosting Medical Devices Exports – EEPC INDIA (Engineering Export Promotion Council). As elaborated by Mr Suranjan Gupta, Executive Director, EEPC India in his introductory article, EEPC has number of initiatives to its credit dedicated to promoting exports by Indian Medical Device Industry. Mr Nishant Upadhyay, Product Manager, Prasad Crilec Automation P. Ltd explains how to improve handling of Compnents by Medical / Pharma companies and improve productivity and efficiency. Other important contents of this issue includes Industry & Regulatory News, Product Gallery, Events etc.

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.

Jan.-Feb. 2019

Cover Story Opportunities For New Entrepreneurs In Medical Textiles - A Sun Rise Industry And Role Of Centre Of Excellence SITRA In Promotion Of Medical Textiles Dr. Ketankumar Vadodaria Head, Centre of Excellence for Medical Textiles-SITRA, Coimbatore Ketankumar Vadodaria,* E. Santhini, T. Suresh ram, Abhilash Kulkarni, D. Veerasubramanian and K. Agalya Devi. The South India Textile Research Association, Coimbatore, India

Abstract India is the second largest player in textiles after China. But when it comes to technical textiles where almost 16 different fields have been identified, India is still an infant. Medical textiles is one of the fastest growing technical textile fields in India and across the globe. Medical textiles is a sunrise industry. Medical textiles comprises of as simple products such as wipes to life saving and more complex products such as vascular grafts. India being second largest populous country in the world, with more baby birth rates and increase in average lifespan, the demand for medical textiles is going to increase year on year. Moreover, capabilities to produce cost effective medical textile products opens up doors of the international market also. The paper presents an introduction, classification, scope and challenges in the field of medical textiles.

1. INTRODUCTION Medical textiles is one of the fastest growing technical textile fields in India. Technical textiles are the textiles developed and manufactured textiles to meet specific functional properties for specific end use, engineered required by combining properties of different textile structures and materials. Below is the Classification list of technical textiles: Medical Textiles Hygiene and Medical (Healthcare Textiles) Agro Tech Agriculture, Aquaculture, Horticulture and Forestry Build Tech Building and Construction Cloth Tech Technical Components of Footwear and Clothing Geo Tech geotextiles and civil engineering Home Tech Technical Components of Furniture, Household Textiles Indu Tech Filtration, Conveying, Cleaning and other Industrial uses Mobil Tech Automobiles, Shipping, Railways and Aerospace Oeko Tech Environmental Protection Pack Tech Packaging Components Pro Tech Personal and Property Protection Sport Tech Sport and Leisure

2. Classification of medical textile products Medical textiles are those technical textiles in day to day life for maintaining hygienic & health conditions as well as in assisting / performing medical | surgical procedure including inplantables. • Corresponding author: coemed@sitra.org.in; lab.bd@sitra.org.in. Medical textiles can be divided into: 1) Consumer products – Eg: Sanitary napkins, baby diapers, wipes, adult diapers 2) Hospital products – Eg: Surgical gowns, surgical drapes Medical textiles is classified into 5 categories

• • • •

Implantable Non-Implantable Extracorporeal device Healthcare textiles

• Hygiene textiles

: : : :

inside the patient’s body on the patient’s body Besides the patient’s body For the body (Usually hospital products) : For the body (Usually consumer products)

2.1 List of products in all sectors Hygiene and Healthcare Medical Textiles 1. Surgical gown/drapes 4. Feminine hygiene products 2. Surgical facemasks 5. Wet wipes 3. Beddings, blankets, 6. Adult incontinence diapers sheets, pillow covers. 7. Underpads Non-Implantable Medical Textiles 1. Compression stockings 4. Tubular bandages 2. Wound dressings 5. Gauze 3. Waddings 6. Pressure garments Implantable Medical Textiles 1. Vascular grafts 2. Abdominal wall patches/ meshes 3. Sutures 4. Heart patches/valves 5. Stents: pet monofilament

6. Tendon/ligament reinforcements 7. Dura patches (Non-woven) 8. Artificial veins 9. Artificial joints and bones 10. Artificial skin and artificial cartilage Extracorporeal Medical Textiles 1. Hemodialysis 4. Artificial heart 2. Artificial liver 5. HME filter 3. Extracorporeal membrane 6. Leukodepletion filter oxygenation

3. Features of medical textiles The desired features of medical textiles would be • High levels of breathability/Non breathability/barrier performance Jan.-Feb. 2019

Cover Story • Hydrophilic/ Hydrophobic • Broad spectrum of antimicrobial resistance such as bacteria, viral, fungal, mould resistance etc • Biocompatibility • Cell adhesion/Cell non-adhesion surface • 2 D & 3 D structures • Sterilability • Biodegradable/Non biodegradable • Elasticity/non elasticity • Strength

4.Textile structure in Medical textiles Medical textile products can be made from each stage of textile manufacturing. Textiles structuring is broadly divided into 4 categories : - fabric, yarn, fabric and garments. Product such as surgical cotton, wadding, ear buds, etc., is produced directly from textile fibres. Products such as sutures, heart valve stitching thread, dental floss, dialysis membrane filaments produced gram filament / yarn etc. In fabric structure there is further classification in terms of woven (vascular graft, reusable bed sheets & pillow covers), non woven (surgical gowns, disposable bed sheets & pillow covers), knitted (vascular graft, hernial mash, heart patch fabric), braded (Anterior cruciate ligament sutures etc), (rotator cuff). All the operational theatre garments come under stitched garment products (surgical gowns, bed sheets, etc), products made up of different textile structure (sanitary napkin/under pad, fibers of non woven, wound dressing – fibers + woven/non woven/knitted structure, etc.

5. Overall opportunities in medical textiles Opportunities lies in technical textile machine manufacturing, specialised raw material manufacturing, setting up laboratories to test these materials /products, manpower training, etc. • Many medical textile products are imported and not manufactured in India, so there is a huge potential for manufacturing them in India. Many medical textiles products are classified as medical devices. There is no concrete data available for medical textiles, but 80% of medical devices are imported. • Though India is the second most populous country, the penetration of medical textiles is very less in India due to factors such as less awareness among people, cost of products and non availability of many products to common people. But now the usage of medical\ technical textiles is increasing due to the new generation with a higher disposable income, more education, easy access to media/internet. • Higher child birthrates - mother and child. • Medical tourism - Cost of getting treated is cheaper and faster compared to the developed countries. • More modern hospitals are coming up, so growth of medical textiles is proportional by hiked with growth of medical business. • Increased awareness for Medical insurance. Medical insurance companies insist hospitals to maintain a proper environment to reduce risk of HAI. • The shift in Indian culture to western influence and globalisation has created / helped in creating more awareness about usage of medical textiles in day-to-day life such as wipes, sanitary napkins, diapers to maintain cleanliness & hygiene environment. • Many medical textiles are used for maintaining an hygienic environment. Young Indians are interested in more comfort and Jan.-Feb. 2019

cleanliness. • Availability of almost all basic raw materials in India. • Mandating suggestions by GOI in different ministries such as MoD, MoHFW, MoLE, MoR, MoHA. • Government initiatives by creating centres of excellence in different fields of technical textiles. Formation of Centre of excellence for medical textile at SITRA has helped industry in many areas such as R&D, standard formation, testing/ characterisation etc. • Proactive approach of government towards boosting TT sectors by different government scheme for business community in terms of subsidies, special zones (Meditech zone, Visakhapatnam), ATUF, TMTT, etc as well as promotion of the TT scheme by every state government. • Government is planning to mandate a few products as per BIS standards; this will help to eliminate usage of substandard products (manufactured or imported). • Creating awareness such as distribution of free napkins by many NGOs as well as government agencies • Cheap labour and abundance of manpower, cheap power compared to many countries can help manufacturing cheaper medical textile products. • Mandating purchase from MSMEs • Schemes such as Swachh Bharat Abhiyan, Ayushman Bharat. • M/C manufacturing for medical textiles such as Sanitary napkin making ,face mask making m/c etc have potential to grow huge.

6. Sector wise opportunities in medical textiles 6.1 Implantable Usually not many life saving products are manufactured in India. India is almost fully dependant on imports. Ultimately, very costly products are not affordable to an average Indian. If invented and manufactured by Indian companies, the cost may come down drastically. Lives of many Indians can be saved. Though the demand is low and the regulatory requirements are stringent, the profit margins are high.

6.2 Non-implantable These are the products that are used on the skin. Low profit but high demand.

6.3 Extracorporeal devices Same as Implantable life saving and again very costly products dependent highly on imports. Though the demand is low and the regulatory requirements are stringent, the profit margins are high.

6.4 Hygiene textiles Not much dependant on imports but still MNCs of foreign origin have considerable stake compared to the Indian manufacturers. Demand is high and investment required is low.

6.5 Healthcare textiles Not much dependant on imports but still MNCs of foreign origin have considerable stake compared to Indian manufacturers. Demand is high and investment required is low.

Cover Story 7. Challenges for medical textile business

rebated rates for easy paybacks for the startups. • Medical device products may require license to produce or sell 9. Statistics on medical textiles in India products in India (New medical device rule is implemented The total market size of medical textiles was $600 million in 2014 recently). and reached $780 million by 2017 growing at 8-9% CAGR. • And still classification of medical textiles under different In 2014, surgical dressings and surgical sutures alone accounted categories as medical devices will take time. for more than 50 per cent at $380. Universal health coverage • Still many medical products are needed to be classified as scheme, 100 per cent FDI under automatic route and support to medical devices. It may have impact on the small scale PPP model to improve availability of health care services are industry. among the initiatives which will have an impact on consumption. • Lack of standards - So far, SITRA has identified many medical textile products and have The medical textile market in developed standards for India was at around $600 milthose. lion in 2014, of which surgical Detailed • Non availability of expertise dressings and surgical sutures Training Prototype Project for the manufacture of alone accounted for about more Development Report specialised raw materials than 50 per cent at $380. UniKevlar, Nylon66, Aramid, versal health coverage scheme, etc., and machinery manu100 per cent FDI under autofacturing techniques in matic route and support to PPP Technical India. Pilot Scale model to improve availability of Consultancy Production • Lack of interest, awareness health care services are among CoE and confidence among big the initiatives which will impact industries to enter into the Meditach consumption (Medical textiles Medical Textile business. set to grow at 9% CAGR in • Scattered industry. Research & India, ITJ, September, 2015). Incubation Development • Lack of trained skilled manServices The market for medical textiles, power with interdisciplinary segment-wise is given in the knowledge. following table. (R. Alagirusamy • Disposal of medical textile Information and A. Das, 2010, Technical texStandard wastes. Testing & Resources tile yarns-Industrial and medical Formulation • Cheap import from Evaluation applications, Woodhead neighbouring countries publishing limited, UK). such as Bangladesh, China due to reasons such as Medical Textiles Market size Annual growth lack of BIS standards. rate (%) 8. Initiatives required Surgical dressings $154.43 million 5-10 Government can incentivize manufacturing in terms of a) Healthcare textiles $ 26.72 million 13-16 Converting and b) Rolled goods manufacturing for development Sutures $ 98.00 million 15-20 of more customized entrepreneurial activity. An entire ecosysSanitary napkin 8-10 tem of R&D, market linkages (treaty), incubation services, easy terms in technology development and manufacturing for global Diapers $17.4 million 5-10 markets can be developed Medical implants $154.43 million 10-15 1. Development of new Infrastructure; more specialized zones and devices such as Medtech Zone in Visakhapatnam. 10. Role of SITRA as a Centre of Excellence in 2. Focus on Indian IPR regime Medical Textiles • The Government should strengthen India’s IPR regime through development of highly equipped patent offices and Our national / International clients include textiles covering both provision of online patent filing facility. conventional textiles, technical as well as non-textile units, 3. More tax incentives & subsidies by government from raw manufacturing industries, traders, universities, individuals, materials to final production, machine imports, machine spares defence, government agencies, etc. The basic services offered and machine manufacturing by CoE – Medical Textiles are as below 4. Organising or funding to organize more buyers to seller meets 10.1 Testing and Evaluation at domestic exhibitions as well as international levels. CoE-Medical Textiles has Analytical, Physical, Microbiological and 5. Identifying the potential and existing medical textile manufacBiotechnology, Material Characterization and tissue culture laboturing clusters and help them to produce, test and market their ratories with high end equipment such as GCMS, LCMS, HPTLC, products FeSEM, etc. The centre provides testing facilities as per na6. Incentivise MSMEs who are making medical textiles by offertional / international standards such as BIS, ISO, ASTM, DIN, ing benefits under schemes such as TUF. Kenyan standards, etc. The laboratories are one of the best of 7. For a better entrepreneurial resurgence, incentives should be its kind in the world, with NABL Certification as per ISO 17025 provided to develop more indigenous machines. Subsidy to with well qualified and experienced staff. develop machines and technology and offering the same at

Jan.-Feb. 2019

Cover Story Few of the products developed at SITRA are listed below:

11. Technical consultancy

S. No. Product Name 1 Orthopedic Shoe Insoles 2 Hernia Mesh

SITRA scientists regularly provide consultancy in different areas of medical textile products/manufacturing/quality process, etc. So far more than 60 technical consultancies have been provided by SITRA CoE.

3 4

11 12 13

14 15

End use Product Image The developed product reduces the risk of foot ulcer in diabetes patients A warp knitted mesh fabric helps to fasten the hernia and enhance the healing process Cut resistant The cut resistant garment protects garments the wearer against injuries caused by sharp objects 3D Spacer The developed product helps to fabric avoid the complications associated Compression with the conventional compression bandages bandage such as skin necrosis and also reduces the treatment period Nano finished Nano finished surgical gowns have surgical improved finish durability as gowns compared to conventional finished surgical gown Spunlaced The developed products handle nonwoven heavy exudates and remove of wound care malodour from the wound site dressings Chitosan Controlled release of the drug in the Coated cotton coated gauzes ensures availability gauzes the drug in the wound site for a longer duration Embroidery The embroidery based woud based wound dressings stimulate angiogensis in dressings the wound site which helps to increase the rate of wound healing Leukodeple- The nanotechnology based develtion blood oped products provide better leukofilter cyte filtraion efficiency without affecting the other blood components Herbal drug The usage of herbal drugs to treat incorporated the infected wounds improves the PCL Nanowound healing efficiency membrane Rotator cuff The developed products reduces repair devices the treatment period PVA/Chitosan The developed product which have nanomemantibacterial property helps to treat brane the infected wounds Hospital Bed To improve the comfort of the Linen with immobile patients Improved thermal properties Bifurcated To increase the life of the patient who Vascular has under gone a graft replacement Graft by means of improved blood flow Barbed BiThe developed knot failure sutures Directional help to avoid the complications Surgical associated with conventional Sutures. sutures such as knot failure HME Filter The developed HME filters are used as a filter in breathing circuits to remove micro – flora and maintain humidity and heat of the supplied air

Jan.-Feb. 2019

12. Research and Development SITRA has well-equipped research laboratories with qualified scientific staff to carry forward R & D in the field of medical / technical textiles. Considering the highly inter-disciplinary nature of research, SITRA has well qualified scientists team of Ph.Ds, Masters, Bachelors, Diploma holder’s from various disciplines such as textiles technology / engineering, chemistry, medical textiles, microbiology, bio-technology, biochemistry, polymer chemistry, analytical chemistry. The scientists aim to develop various medical textile / Technical textile products by developing different textile structures, materials, and processes. SITRA has developed many products using in-house funding or by contract-based research with industry partners or by getting funding from public / private agencies.

Some of the Instruments developed at SITRA are as listed below: S. No. 1

Equipment/ Instrument End use Image Compression The developed instrument will bandage serve as a catalyst for more pressure research in development of measurement advanced compression bandages system SITRA Barb The developed equipment helps Introducer to produce barbed surgical Machine (SBIM) sutures that lead to knotless surgical procedures. Sitra Particulate The developed instrument helps Filtration to initiate new research in the Efficinecy Tester field of surgical as well as N95 (SPFET) masks interms of raw material optimization Sitra Blood The developed instrument helps Penetration research and development in Resistance surgical gowns towards raw Tester (SBPRT) material optimization SITRA Bacterial This SITRA developed instrument Filtration helps in research and development Efficiency Tester in surgical face masks towards the (SBFET) consumption of raw materials and their characterization SITRA Advanced The developed instrument is used Splash Resisto assess the resistance of given tance Tester material against high velocity stream of blood SITRA Fluid The developed instrument is used Handling to assess the fluid handling Capacity Tester properties of most types of wound care dressings with exudates absorbing capacity

Instrument/ Equipment Name

Centre of Excellence for Medical Textiles (Sponsoted by the Office of the Textile Commissioner, Ministry of Textiles, Govt. of India)

The South India Textile Research Association SITRA CoE has published more than 45 research articles in reputed journals. Apart from the publications, SITRA CoE has also filed a few patents. SITRA has done many product developments with industrial assistance. Contract research projects are partly sponsored by the Ministry of Textiles and - partly by the Industry. 1. Development of Collagen coated hernia mesh with Cologenesis Health Care Pvt Ltd as the industry partner. 2. Development of mopping pad using non-woven and woven structures with Care Med as the industry partner.

No. Name of the Product / Process

Name of the Industry

Nanofinish – antimicrobial

M/s Erode Venus dyes and Chemicals

Collagen Coated Hernia Mesh

M/s Cologenesis HealthCare Products Pvt Ltd

Mopping Pad/Laparatomy sponge M/s Caremed surgical

a) Face masks manufacturing facility for manufacturing tie and ear loop type face masks b) Alcohol swabs / Wet wipes manufacturing facility c) Cotton wool roll conversion machine for manufacturing various sizes of absorbent cotton. d) Sanitary napkin manufacturing facility e) Spunlace fabric manufacturing facility for manufacturing raw material for wet wipes tissues. f) Ultrasonic sealing/stitching machine for manufacturing disposables surgical gowns. g) Coating and laminating machine for finishing medical textile substrates with antimicrobial, blood repellent finishes, etc.

Vascular Graft

M/s TTK Healthcare Ltd

Standards formulation

Reusable facemasks

M/s Kristaa Clean Carbon Pvt ltd

4 layer wound dressings

Chitosan Dressings

Curcumin Dressings

SITRA has developed few medical textile standards for the Bureau of Indian Standards (BIS) for standardizing the quality of the medical textile products. The status of the various BIS standards for which SITRA has played a role is shown in. Figure 1.

EDTA WIPES

Some of these projects were commercialized under process of being commercialized. The details are as follows.

DRDO (Defence Research and Development Organization)

Printed - 19

Finalized draft for prnting - 1

Completed wide circulation - 2

Draft standards under wide circulation - 2

Draft standards approved for wide circulation - 1

Working draft standards - 17

Subjects dropped - 7

Submitted to BIS - 49

Standards identified - 68

10) Surgical mask 11) BVB Fabric

M/s Shiva Tex yarn

12) Hospital Bed Linen

M/s Kadri Wovens

13) Gelatin based nanotech wound dressings

M/s Nitta Gelatin

14) Biodegradable sanitary napkin, Adult diaper

M/s Aprus Bio-medical Innovations Pvt. Ltd

Pilot Scale Production / Incubation services Looking to the future local and international demand in medical / technical textiles, SITRA has already established an incubation centre. The centre aims to help new entrepreneurs or enterprise transformation for existing enterprises in emerging fields of medical / technical textiles. All necessary assistance for developing a new product from the concept stage to final production would be rendered at the incubation centre. SITRA CoE Incubation centre has industrial scale production machinery for producing various medical textile products such as sanitary napkin, face mask, wet wipes / alcohol swabs and cotton wool rolls. These machines can be used by new entrepreneurs at nominal rates for production of the products. SITRA CoE has state-of-the-art manufacturing facilities with an area of 60, 214 sq.ft for promoting the medical textile products to the interested entrepreneurs. SITRA CoE has the following medical textile product manufacturing facilities.

Figure 1 Status of BIS standards initiated by SITRA SITRA has formulated standards for the following medical textile products, for the first time in India, in association with the Bureau of Indian Standards. Product details BIS Standard Paraffin Gauze dressings

IS 16291:2014

Knitted viscose primary dressings

IS 16290:2014

Orthopaedic Stockinet

IS 16302:2014

Cast Padding for orthopaedic plaster

IS 16303:2014

Povidone iodine ointment based knitted dressing – Specification

IS 16466:2016

Graduated medical compression stockings – Specification

IS 16467:2016

Absorbent cotton – Specification

IS 16468:2016

Open weave bandage

IS 16469:2016 Jan.-Feb. 2019

Elastic surgical adhesive tape

IS 16470:2016

Nonwoven Bandage roll - Specification

IS 16660:2017

Absorbent cotton ribbon gauze

IS 16670:2017

Belladonna adhesive plaster

IS 16671:2017

Salicylic acid adhesive plaster

IS 16668:2017

Tubular bandages

IS 16946:2018

Permeable Nonwoven surgical adhesive Tape

IS 16948:2018

X-ray detectable absorbent cotton gauze

IS 16950:2018

Elastic adhesive dressings

IS 16669:2017

Adhesive Extension plaster

IS 16949:2018 IS 16289:2014

15. Detailed Project Report (DPR) Detailed project report contains information about the rawmaterials, machinery and space requirement for producing the meditech products. It helps the new and existing entrepreneur to understand the product manufacturing method and cost required for starting the industry in medical textiles field. The list of detailed project reports prepared by the CoE meditech is as follows. 1) Surgical Non-woven face mask 2) Alcohol wet wipe 3) Non woven surgical aprons 4) Compression stockings 5) Crepe bandage 6) Wet wipes 7) Surgeon’s cap 8) Shoe cover

9) Sanitary napkin 10) Surgical cotton 11) Buffount cap 12) Surgical gauze 13) Adult diaper 14) Baby diaper 15) Disposable under wears 16) Hernia mesh 17) Underpad+

Training / Seminars / Workshop Many techno-commercial programs for the training of technical manpower as well as for new entrepreneurial startups have been carried out by the division. During period 2011-18 (upto Oct 2018), 6998 people were trained. SITRA has already conducted more than 248 training programs for the benefit of new entrepreneurs who aspire to start a business in medical textiles. SITRA has also conducted several programs/ seminars/ talks in different states such as Kerala, Andhra Pradesh, Maharashtra, Telangana, Karnataka, Tamil Nadu, etc. Our training programmes have benefited new startups to go in for full scale business ventures producing medical textile products. Some of the technical and entrepreneur development programs are as follows. 1. National workshop on plasma techniques for textiles, Coimbatore 2. One day seminar on business development in technical and medical textiles, Telangana, Visakhapatnam – Andra Pradesh, Kerala, Bengaluru – Karnataka. 3. Absorbent Hygiene Medical Textiles, Coimbatore 4. Physical and Biological Characterization of Medical textile products, Coimbatore 5. Entrepreneurship Development Programs, Coimbatore 6. Business Development in Specific (for sanitary napkin, baby diaper etc) Medical Textiles, Coimbatore 7. Training on Wound Care Dressings, Coimbatore

2. International workshop on “Biocompatibility evaluation of medical devices” 3. International seminar on “Advances in medical textiles” 4. International seminar on “Medical textiles – Smart & functional materials – polymer processing & fibre synthesis” 5. International seminar on “Implantable medical textiles Some of the National level workshops conducted by the CoE are as follows : 1. National workshop on “Drug delivery & tissue engineering”. 2. 3 days national level workshop on “Bio composites & fibre reinforced polymers”. 3. National workshop on “National Workshop on PLASMA techniques for textiles”. 4. National workshop on “Characterization of medical textile products”. 5. National workshop on “Hygiene medical textiles” in association with ICAR. 6. National work shop on “Medical textiles products and its scope”. SITRA COE offers customised training as well as hands on training based on requirements from industries, academic, government agencies in the area of technical textile garment/product manufacturing (gowns, pillow covers, heavy duty stitching etc), analytical chemistry (ICMPS, GCMS, LCMSMS, HPTLC, HPLC, HPLC, UV-VIS, FTIR etc), polymer & biomaterials (Electro spinning bio/new polymer for medical textiles, wound dressing etc) physical textile of medical\technical textiles, Micro biological, Tissue culture, In vitro toxicity testing and evolution and manufacturing of healthcare & hygiene textiles.

Information resources SITRA library has books and journals in the field of both technical and medical textiles from reputed publishers.

Prototype development So far, SITRA CoE has developed 53 prototype products

Overall achievements of SITRA CoE-Meditech The overall achievements of CoE (from Apr 2011 to Oct 2018) are as follows Projected physical deliverables/Activity

Achievement

Numbers of persons trained by CoE

6998

Prototypes developed (Numbers)

Number of products commercialized / under commercialization

Number of specification/Standards formulated

Research projects (Numbers)

Some of the International workshops conducted by the CoE are as follows :

Number of training programme/Seminars/Conferences organized 248 No. of research papers published

1. International workshop on “Electro spinning and Electro spraying”

Number of DPRs prepared to set up technical textile units

Number of technical consultancy assignments

Jan.-Feb. 2019

SYRINGE MANUFACTURING PLANT AVAILABLE Complete running plant with world class machinery and moulds ³ Includes : Injection Moulding Machines, Automatic Assembly lines (Korea) for 2 ml, 3 ml and 5 ml Syringes, Packaging and Sterilization Units ³ Almost new plant capable of Producing High Quality Products ³

Possibility of looking at Plant in running condition ³ Promoters : Successfully established Company with good brand image ³ Plant offered because of spare available capacity ³

For more details, please write to : MEDICAL PLASTICS DATA SERVICE E-mail : medicalplastics@gmail.com and dlpandya@gmail.com

Jan.-Feb. 2019

Export Marketing

Components Handling Solution For Initiatives In The Medical Medical & Pharmaceutical Applications Device Sector Mr. Suranjan Gupta, Executive Director, EEPC India EEPC India has been the face of Indian engineering exports over a span of 63 years when India grew from a nation exporting just $10 million of engineering goods in 1955 to $76.2 billion in 201718 and is regarded as the model EPC in India by the Union Ministry of Commerce and Industry. EEPC India is now a full member of the France-based UFI – the Global Association of the Exhibition Industry – and our Annual Show, IESS received the status of ‘UFI-approved International Event’ from the VIIth edition held in March 2018. EEPC India also received BMO accreditation of the Quality Council of India (QCI) – NABET (National Accreditation Board for Education and Training is one of the constituent boards of the QCI). The BMO accreditation mechanism by all stakeholders is becoming a gamechanger towards nation-building, in promoting and developing strategies for MSMEs to participate in various government schemes including Make in India, Zero Defect Zero Effect (ZED), and Start Up India.

This show is also important to encourage foreign investments in line with the newly-initiated Make in India campaign by the Government of India. Extending its regular agenda, EEPC India publishes several reports/studies to make its members aware about international trends and opportunities in order to enhance their global footprint. With ‘Engineering the Future’ as its motto, EEPC India serves as the reference point for the Indian engineering industry and the international business community in its efforts towards establishing India as a major engineering hub in the future. EEPC India initiatives in the Medical Device Sector :EEPC India is dedicated to the cause of promotion and development of medical device sector in India and to achieve the objective, the council has taken several initiatives in the sector as listed below :

EEPC India is the premier trade and investment promotion organisation in India. It is sponsored by the Ministry of Commerce & Industry, Government of India, and caters to the Indian engineering sector. As an advisory body it actively contributes to the policies of the Government of India and acts as an interface between the engineering industry and the government. Set up in 1955, EEPC India now has a membership base of over 13,000 out of whom 60% are SMEs.

Creation of dedicated Panel for Medical Device Sector-

EEPC India organises a large number of promotional activities such as buyer-seller meets (BSM) – both in India and abroad, overseas trade fairs/exhibitions, and India pavilions/information booths in selected overseas exhibitions to demonstrate the capabilities of the Indian engineering industry and to provide overseas buyers with true value as propagated by Brand India.

2. Since, the inception of a dedicated Medical Device Panel, the issues and concerns of the industry have been put across at various Government level forums in order to find suitable and amicable solutions which could help in the growth and development of the sector.

Indian Engineering Exhibition (INDEE) is EEPC India’s own brand and is one of the largest expositions of engineering in the world. Over a period of 41 years INDEE has been established as the largest and most important showcase for Indian engineering abroad.

3. EEPC India has been closely working with national bodies like Association of Indian Medical Device Industry (AIMED), Andhra Pradesh Medtech Zone Limited (AMTZ), Biotech Consortium India Limited (BCIL) to have a holistic and a comprehensive picture of the Medical Device Sector.

EEPC India facilitates sourcing from India and encourages MSMEs to raise their standard at par with international best practices. It also encourages MSMEs to integrate their business with the global value chain.

Technology Upgradation for Boosting Medical Devices Exports

To encourage building global partnerships with India, EEPC India organises the International Engineering Sourcing Show (IESS), the largest display in the country of engineering products and services, every year. This is recognised as the only engineering sourcing event in India – showcasing the latest technologies and a preferred meeting place for global buyers and sellers. Jan.-Feb. 2019

1. Medical Device has been identified as a focus sector and a sunrise industry in Indian Engineering. Realising the significance and the immense opportunities which this sector offers, EEPC India set up a dedicated Panel for the Indian Engineering Medical Device and Pharma Machinery Sector in year 2014. Addressing issues and concern of Medical Device Industry-

Linkages with National Bodies-

4. In order to boost exports in the sector, EEPC has realized the need for technology upgardationas the key Intervention area in medical devices sector.Under this initiative EEPC India has identified key clusters for Medical Devices, and R&D Academia which are working in the medical device technologies. EEPC with support from Department of Commerce and Office of the Principal Scientific Advisor to the Government of India is organizing Technology meets to bridge R&D Academia with

Export Marketing Industry to identify new technology development areas, facilitate dissemination available expertise and knowhow. Brand India Engineering Campaign for Medical Device Sector5. EEPC India with the support and guidance of Ministry of Commerce and Industry and IBEF launched a dedicated “Brand Engineering Campaign” for the Medical Device Sector. The campaign with the tag line “Quality Precision, Affordability” is focussed with an aim to showcase Indian Engineering Sector effectively in the International arena. The objective of the campaign is to project Indian Medical Device products from supplier of low quality products and services to high quality dedicated and customized solutions. Knowledge Paper6. EEPC India along with YES Bank as the “Knowledge Partner’ presented dedicated report on “India’s Medical Device & Pharma Machinery Sector Strategy Paper To Boost Exports” in the year 2013. The strategy papers highlighted the current scenario of the Global Medical Device market and the short term and long term strategies to boost Medical Device exports from India. Directory for Medical Device Sector6. EEPC India was the first to bring out a dedicated “Directory Of Medical Devices, Surgical Equipment &Pharma Machinery”. The Directory having more than 100 entries from the Indian Medical Device Sector was a first of its kind initiative by any Medical Device agency in India.

E product catalogue for Medical Device Sector7. Realising the need for having regular updation in the product catalogue for the Indian Medical Device Sector, EEPC India brought out a dedicated e-product catalogue for the Medical Device Sector. The basic premise of the catalogue was to include only such entries and manufacturing units which fulfil minimum product standards and meet certain specifications. The companies in e-product catalogue can periodically update the entries and also new listing is open “free of cost”. Participation in Reputed International Exhibitions related to the sector8. EEPC India has laid emphasis on the showcase of Indian Medical Device Sector most appropriately at International platforms. EEPC India is arranging focussed pavilion for Indian Medical Device Sector in International exhibitions to repute. EEPC India for the last 3years is participating at Arab Health. Members get benefit of subsidisedparticipation, focussed marketing and promotion, offsite and onsite branding, newspapers advertisements, digital media campaign etc. Organising Reverse Buyer Seller Meets9. EEPC India is also organising the Reverse Buyer Seller Meets for renowned Medical Device Exhibitions held in India. EEPC India has been inviting “Sponsored buyers for focussed exhibitions in the sector like “Advantage HealthCare”. 10. EEPC India has also been participating regularly at National Seminars, Conferences like IMDI Conferences held annually in Ahmadabad.

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 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 26

Jan.-Feb. 2019

Contents Foreword, Preface to First Edition, Preface to Second Edition, Acknowledgments Chapter 1 : Introduction to Medical Device 1.1 Medical Devices: Managing The Mismatch 1.2 “Catheters”.... 1.3 Self-Expanding Plastic Stents Used In The Treatment Of Benign Esophageal Conditions 1.4 A Combination Product 1.5 Defining A Medical Device Chapter 2 : Adverse Events . 2.1 Serious Health Consequences Due to Faulty Tracheostomy Tube Sets 2.2 Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results 2.3 Failure of Endotracheal Tubes 2.4 Hospital Errors on Medical Tubing Killing Patients 2.5 Trends In Medical Device Adverse Events 2.6 How Easily Bacteria Clog The Medical Devices…!! 2.7 Risk Management For Medical Devices 2.8 Complications Associated With Urological Devices 2.9 About Trends In Medical Device Adverse Events 2.10 Catheter Introducers – A Potentially Life Threatening Episode 2.11 Human Factors Leading To Medical Device Adverse Events 2.12 Luer Taper Fitting As Connectors In The Medical Industry Jan.-Feb. 2019

2.13 Problems With Transvaginal Surgical Mesh 2.14 Heparin In Medical Devices Linked To 11 U.S. Deaths 2.15 Preventing Dangerous Hemodialysis Catheter Disconnections 2.16 Particulate Matter In Blood Bags 2.17 Complications Related To The Use Of Bone Cement 2.18 Failure Of The Tracheostomy Tube 2.19 Potential Cross-Contamination Linked To Haemodialysis Treatment 2.20 Complications Related To The Use Of Vascular Haemostasis Devices 2.21 Occluded Endotracheal Tubes 2.22 Allergic Reactions To Medical Devices Containing Latex 2.23 IV Catheter-Associated Infections 2.24 That Long Needles ‘Cut Injection Pain’ For Babies 2.25 Old Dialysis Filters Are Responsible For Kidney Patient Injuries Chapter 3 : Applications 3.1 PU Dressings Help Wounds To Heal 3.2 The Economics Of Prefilled Syringes 3.3 Coronary Drug-Eluting Stents 3.4 Intravenous Infusion Sets (IV Set) In Anaesthesia Practice Chapter 4 : Regulations & Quality Issues 4.1 Compensation To Patients For Faulty Medical Devices 4.2 Balancing Product Development Effectiveness with Regulatory Compliance 4.3 Modernizing Biocompatibility and Biological Risk

Evaluation of Medical Device Materials 4.4 Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices 4.5 Effect of Medical Device Quality Performance on Business Performance 4.6 Challenges Of Using Combination Products 4.7 FDA Regulations Regarding Medical Devices Chapter 5 : Markets & Emerging Trends 5.1 Drug / Device Combination Products & ASEAN Markets 5.2 Implants As The Fastest Growing Application For Medical Plastics 5.3 What Global Medtech Manufacturers Need To Copy From India And China 5.4 India’s Success In Developing Its Own Health Related Technologies 5.5 The WHO Report On Medical Devices And Equipment 5.6 Humanitarian Use Medical Devices (Huds) 5.7 The Ageing Population In Europe 5.8 About Implants As The Fastest Growing Application For Medical Plastics 5.9 Challenges Of Using Combination Products 5.10 Drug / Device Combination Products & ASEAN Markets Chapter 6 : Innovation & Product Developments 6.1 High Impact Frugal Innovations In India 6.2 Medical Device Innovation 6.3 Replacement Cornea Makes Clear Difference 6.4 First Medical Device Derived From New Class Of Biopolymers: Absorbable Suture Product 6.5 Remote Monitors For Medical Devices 6.6 Silicon Sensors For Use In Catheters 6.7 Phatik Intraocular Lenses 6.8 Temporary Artificial Heart 6.9 Coatings For Blood-Contacting Devices 6.10 Knowledge Management 6.11 Why The Great Scientist APJ Abdul Kalam Developed Orthosis Callipers Weighing Just 300 Gms ! 6.12 Why I.V. Administration Sets Require In-Line Filters? 6.13 Balancing Product Development Effectiveness with Regulatory Compliance Chapter 7 : Materials : Medical Polymers, Biopolymers & Other Materials 7.1 What is a Medical Grade Polymer? 7.2 Using Medical Polymers Reduce Hospital-Acquired Infections 7.3 Advanced Medical Polymer For Treating Diabetic Patients 7.4 The “Medical Grade “ Polymer Dilemma 7.5 Why “PEEK” offers success for the manufacture of medical parts 7.6 Polymers To Restore The Sound Of Music? 7.7 Conductive Plastic Which May Preserve Eyesight...!! 7.8 UHMWPE Fibers 7.9 Engineered Medical Coatings Advancing The Performance Of Medical Devices 7.10 Intelligent Materials To Revolutionise Surgical Implants 7.11 Medical Device Coatings 7.12 Why You Should Not Use PVC Tubing In The O2/ Aircircuit If You Are Using Forane

Chapter 8 : Manufacturing : Technologies & Trends 8.1 Why Clean Room Is Important -- For Medical Plastics Manufacturing 8.2 Best Practices to Ensure Good Supplier Management 8.3 Welding Of Thin Polymeric Films For Medical Applications 8.4 When To Consider Outsourcing Medical Device Manufacturing To A Contract Manufacturer? 8.5 Health Technology Assessment (HTA) 8.6 Ultrasonic Welding For Assembling Of Medical Components 8.7 Filters In Intravenous Filter Sets 8.8 Hypotension And Bedside Leukocyte Reduction Filters Chapter 9 : Packaging & Sterilization 9.1 Determining Breathable Area Of Sterilization Package? 9.2 Packaging Failures: The Largest Source Of Sterility Recalls 9.3 Sterilization Of Plastics 9.4 Using Steam For Sterilization 9.5 Packaging Combination Products (Medical Devices) 9.6 How Different Sterilisation Methods Were Developed? 9.7 The Importance Of Keeping Premixed IV Bags Covered In Their Plastic Overwraps Chapter 10 : Healthcare Practices, Procedures & Techniques 10.1 Safe Injection And Safety Practices 10.2 Prevention Of Catheter-Related Infections 10.3 Dialysis Procedure 10.4 Five Steps To Safer Healthcare 10.5 Healthcare Supply Chain 10.6 The “Distribution Channel” For Hospitals 10.7 The Reuse Of Single-Use Devices Chapter 11 : Environment, Waste management & Safety Concerns 11.1 PVC : The Environmental Perspective For Health Products 11.2 Establishing A Healthcare Plastics Recycling Program 11.3 Healthcare Plastics Recycling 11.4 Shared Responsibility For Medical Device Safety And Performance 11.5 Safeguarding Cardiac Guide Wires To Avoid Breakage 11.6 Infectious Hospital Waste 11.7 Safety Of Healthcare Professionals 11.8 Vinyl And The Environment? Chapter 12 : Industry, Government Research & Academic Institutiona 12.1 Sterilization Packaging Manufacturers Council 12.2 Pediatric Medical Device Institute 12.3 The Center For Devices And Radiological Health (CDRH) 12.4 The US Healthcare Industry About the Author, Product and Subject Index, References

Jan.-Feb. 2019

Manufacturing

Components Handling Solution For Medical & Pharmaceutical Applications

Mr. Nishant Upadhyay Product Manager Prasad Crilec Automation Pvt Ltd. The best solution to convey injection moulded and blow moulded parts from moulding machine to other space for Processors who are in Medical & Pharmaceutical Application is conveyor belts.

Close - Loop Automation on IMM

The Part & scrap handling solution for injection & blow moulding is the burning need for processors these days.

understand processor's need quickly and execute it on machine simply.

The Conventional part conveying is not the one that Industrialists are looking for, rather, it's conceptual solution that they are looking for, like more sophisticated operations in part handling without labors, whether it is conveying, sprue separating, sorting or counting, that saves labor too.

The Conveyor belt is a tailer made job and is manufactured based on the type & size of article, application & size of machine.

The major advantages of using Conveyor belts in parts handling are…

Now a days FDA approved conveyor belts and moulded plastic linked carpet conveyors are used where hygenity is the main moto. Some medical & pharma application needs conveyors compatible with class 10000 & upper level clean room condition.

• • • • • •

Saving of Labour. Clean Room condition - untouched by human. Integrated with Robots - Semi automatic assembly line. Automatic counting of parts & filling into Box. Separation of Sprue and Parts automatically. Can be placed under the mould and convey sprue to online granulator. • Can be integrated with any existing line. • High quality and consistency in Production. • Prevent Contamination The right Selection of the conveyor belt should be properly done by applicator. Understanding of Processor's need, and. supplying right product are very much essential for a conveyor belt supplier. An experienced conveyor belt manufacturer is smart enough to

In application of blow moulding machine high temperature withstanding capacity based conveyors are demanded where special felt materials belts are requested to avoid torn out of belt while pinch-off & perision temp is to high . Usually mother conveyor belts are made from PU green belts. Which all can be integrated with robots or assembly line. We can also use them in common conveyor belt between two machines conveyor belt. Apart from part conveying, separating and counting of parts are also important and can accelerate the job of part conveying with separators and carrousel system. It's very much essential to separate the moulded sprue from the article. The special drum Separators are used in multi cavity moulded sprues and parts separation.

Online - Conveying - Separating - Grinding - Ratio Loading - Dosing Automation in Close - Loop Jan.-Feb. 2019

Manufacturing

T - Conveyor Belt Automation on High Speed PET Performs Machine

Clean Room Condition

Stock Box System for saving labour & Untouched by human

FDA Belt with Auto Counting Carrousel system

Part counting and stacking are needed after conveying of part. The carrousel systems are specially design for counting and filling a part in proper boxes or bags. The precision indexing is necessary in corporate business. European technology is always appreciated by processors in the market.The technology involved is plastic link based conveyors (PU) imported belts and separators & Corrousel system. All these conveyor belts and accessories are used in various industries like Medical and Pharmaceutical, apart from Caps, Preforms, Jars, Engineering Plastics Components, House hold products, and automobiles. The PET preform manufactures use conveyor belt and carrousel system for automatic preform counting & handling. Wherever hygenity and health are the main motto and human touch is not permitted, use of conveyor belt is a must. Conveyor belts play vital role in maintaining continuous production line with consistence quality. With the conveyor belt, separator and counting system, labour related issues are avoided and also it hasn't any holidays. Are you looking for any solution please feel free to contact us. For, Prasad Crilec Automation Pvt Ltd. Mr.Nishant Upadhyay- Product Manager Cell : +91-9909945059, Crilec@prasadgroup.com

Jan.-Feb. 2019

Global Trends Global Antimicrobial Coatings Market The global antimicrobial coatings market size was valued at USD 2.44 billion in 2015. Growing concern regarding cleanliness in various professional industries has led the rapid development of this industry. These are used to protect surfaces against microorganisms which primarily includes parasites, germs, bacteria and unwanted micro-organisms.

This was initially developed to deter the growth of micro-organisms on the surfaces to which they were applied. However, owing to growing health concerns & infections regarding the effect of such micro-organisms on people, they are now readily used to protect both surfaces and human.

U.S. powder antimicrobial coatings market volume, 2014 - 2025 (Kilo Tons)

Rising concern regarding the growth of hospital-acquired infections among human beings is also an important factor to boost the overall industry growth. Nowadays, doctors prefer using these products as compared to disinfectants and powerful cleaning agents. This would also help to reduce both coat and time for the hospitals in which they are increasingly used. They help in stopping the spread of germs, which can otherwise cause weakened immune systems among people. Never the less, health concerns related silver usage in various applications along with strict regulations in the European Union and the U.S. is presumed to create the hindrance for the overall demand. The SHER-NAR coating which primarily consists of three coat finishing process is required to meet the standards of the American Architectural Manufacturers Association’s specification. AAMA 2605-13 is considered the most stringent solution used mainly in architectural applications. In recent past, the FDA began considering drug-device combinations as a separate regulatory class. They meet the safety and efficacy part based on specified requirements. Moreover, the guideline has also been established for urological devices with antimicrobial claims. In recent past, the antibiotic local application directly on the local surface is considered more efficient as compared to antibiotics penetration through biofilm. The bacteria is killed instantly before the biofilm is formed. These antibiotics can be applied in bone cement that is used to fix implants associated with orthopedic and orthodontic implants.

drastically and also an improvement in recovery after infection. (https://www.grandviewresearch.com/industry-analysis/ antimicrobial-coatings-market )

Events Calender

Medicall 2019 - Hyderabad India’s Largest & No. 1 Medical Equipment Exhibition 8-10 March, 2019 Venue : Hitex Exhibition Center, Hyderabad, India Medicall 2019 - Chennai India’s Largest & No. 1 Medical Equipment Exhibition 26-28 July, 2019 Venue : Chennai Trade Centre, Chennai, India K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber 16 - 23, October, 2019 Venue : Dusseldofr, Germany PLASTIVISION INDIA 2020 16 - 20, January 2020 Venue : Mumbai

Biodegradable surface type containing antibiotics can also be implemented for the same application with the similar strategy. The antibiotics can be slowly released directly to the surfacetissue interface. The use of poly(D, L-lactide) which contains gentamycin on orthopedic implants has reduced the infection rates Jan.-Feb. 2019

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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Jan.-Feb. 2019

January 2018 to December 2018 Column

Content

Column

Content

November-December 2018

Events

• Jigish Doshi elected as President of Plastindia Foundation for 2018-21 Ravish Kamath takes over as Vice President and Jayesh Rambhia as Treasurer

Cover Story

• National Medical Devices Council • Quality and Regulations of Medical Devices in India : A Glimpse Global Trends • Understanding Europe’s New Medical Device Regulation ( EU MDR ) AiMeD & Regu- • Industry Urges Centre To Change Definition Of Manufacturers In Guidance Document For Medical Devices • CDSCO Proposes To Add Surgical Gowns & Drapes To Notified Devices List As High-Risk Pacemakers, Defibrillators Stay Off Radar • Govt Plans To Use BIS Act To Regulate Medical Devices For Quality Control • Maha FDA Urges CDSCO To Place Intraocular Lenses Under NLEM To Prevent Overcharging* • Central Govt Plans 75% Trade Margin Cap On Imported & Domestic Medical Devices Industry News • WHO Supports Manufacturers from Developing Countries In Defining AD Syringes • Indian Device Maker Meril Life Sciences Joins Big League With Artificial Heart Valve Technology • Medical Compounds Company Expands TPE Range • Peters Surgical Invests •5 Million To Expand India Plant • HMD procures 2018 Good Design Award in Japan* (Ind News) Product Gallery • New Bonded Extension Lines Article Index • Medical Plastic Data Service - 2018 Article Index Did You Know? • About Compensation To Patients For Faulty Medical Devices

September - October 2018 Cover Story

• Event Highlights : The 15th National Conference and Technology Exhibition on “Indian Medical Devices & Plastics Disposables / Implants Industry 2018” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. Conference Theme : “Medical Device Sector : Making India Globally Competitive” • Building Manufacturing Capabilities for Medical Devices in a Developing Country - India, a case study • Plastics For India’s Medical Devices And Pharmaceutical Packaging Vital Role in the Design of Safe Treatments AiMeD & Regu- • MoU to foster cooperation in Manufacturing of Hi tech latory Updates Medical Equipment in India between South Korea's Busan Techno Park Healthcare Technique Division & Aimed • AiMeD recommends tariff protection & quality assurance for access to indigenous medical products by 2030 • Medical device sector seeks price preference in public tenders to boost domestic manufacturing Product Gallery • Now Carries Unique TPE-Coated-Stem Check Valves Jan.-Feb. 2019

July – August 2018 Cover Story

• Clean Room Environment For Medical Devices – ISO 14644 • Injection Moulding Machines For Clean Room Applications • Simplifying Setting-up Of Plastic Processing Clean Room Materials • Polymer Compounds For Medical Devices Manufacturing • Design Control : Importance and Regulatory Aspects Global Market • Medical Polymers, Medical Injection Molding, Medical Insights : Snapshots Device Contract Manufacturing. PVC Hospital Waste Recycling AiMeD & Regu- • Mitsubishi expanding Indian footprint with PVC business latory Updates acquisition • Covestro Strengthens its Global Film Production • AMTZ sets up Centre for Bio-Materials Testing • India, US move a step closer : Trade Issues including Medical Devices Product Gallery • New Closed Male Luer Lock Valves / New Line of Tyvek® Sterilization Supplies • Qosina Unveils a New Line of Tyvek® Sterilization Supplies Did You Know? • Why Clean Room Is Important For Medical Plastics Manufacturing

May – June 2018 Cover Story

• Material Selection for Injection Molded Medical Parts • Unique Properties Make Polymers Suitable to Medical Tubing Applications Technology • Polymeric PDC Technology: An Integrated Approach To Autoinjector Design Global Trends • Enteral Feeding Devices Market Worth 3.19 Billion USD by 2022 AiMeD & Regu- • AiMeD terms new MD procurement policy a lost opporlatory Updates tunity to promote indigenous manufacturing of medical devices • CDSCO Proposes To Include All Implantable medical devices & other high end equipment under the category of 'drugs’ as Medical Devices • Health ministry identifies 10 exclusive centres to report serious adverse events as part of MvPI Industry News • Govt Proposes Over Rs 460 crore Support for Development of Pharma Sector (including Medical Devices) • KIHT Ties Up With JBI To Boost Research In Medical Devices & Diagnostics • CTP Expands To Meet Local Medical Market In India Product Gallery • Gamma-Stable, Large-Bore Tuohy Borst Adapters Event • Medical Design & Manufacturing (MD & M) East : Event Report • Medical Manufacturing Asia 2018 the Springboard to billion dollar ASEAN Medtech Market

Column

Content

Did You Know? • About What is a Medical Grade Polymer?

March – April 2018 Cover Story

• Challenges and Opportunities For Medical Disposables & Implants Industry in India • Growth Dynamics For Indian Medical Device Industry Materials • Bio-Compatible, Lightweight Polycarbonate Utilized in Respiratory Device Global Trends • The Asean Medical Device Market AiMeD & Regu- • AIMED urges GoI to take policy decisions to boost latory Updates Domestic Mfg & to Make Healthcare Affordable in India • New guidelines for medical device grouping to streamline licensing • Govt. invites proposals from labs for testing medical devices, IVDs as per new MD rules • Gujarat FDCA sends draft notifications to state govt for approval to implement new Medical Devices Rules Industry News • QCI, UL team up with govt and industry to spur robust quality ecosystem to build 'Brand India' in medical devices • Hindustan Syringes and Medical Devices gets ‘India Design Mark’ Product Gallery • Cost-Effective Off-the-Shelf and Custom Tubing Solutions • Slide Clamps Did You Know? • About Serious Health Consequences Due to Faulty Tracheostomy Tube Sets

January – February 2018 Cover Story

• Medical Device Rule 2017

Column

Content

• Frequently Asked Questions On Medical Device Rule, 2017 Rewards & • Dr. S Eswara Reddy Appointed As New DCGI Recognitions • Award For “Outstanding Contribution For Image Building Of Plastics” To D L Pandya, Editor & CEO, Medical Plastics Data Service at Plasticon Awards 2018 Technology • Medical Components Cleaning by Vapour Degreasing • Covestro’s Developes New Tougher Medical Grade PC • Teleflex Medical Launches New Suture Technology to Reduce Tissue Strangulation • Needle-Free Injection Device Developed by MIT spinout Global Trends • 13485 Revision: What it Means for Medical Device OEMs and their Supply Chains Industry News • QCI, AMTZ and AiMeD form Indian Bio-Medical Skill Consortium to certify capacity of Indian biomedical engineers • MTaI pitches for tax breaks to medical device R&D centres to boost investment in innovation based in-house capabilities centres • Domestic medical device makers seek hike in basic custom duty • PolyOne to Begin Thermoplastic Elastomer Production in India • Inauguration of Clariant's new healthcare packaging plant in Cuddalore, Tamil Nadu Product Gallery • Revolutionary PenBlade® Safety Scalpels • Line of Stopcocks Did You Know? • Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results

Jan.-Feb. 2019

Industry News Euro Alliance signs MoU with AMTZ to provide market access to medical technology companies in Switzerland and India An MoU has been signed between Euro Alliance SA represented by chairman & managing director, Rakshit Mehta and Andhra Med Tech Zone (AMTZ) headed by Dr. Jitendar Sharma, MD & CEO, AMTZ in the presence of Dr Poonam Malakondiah, Special Chief Secretary of the department of health, Government of Andhra Pradesh as part of the three-day World Economic Forum Summit being held at Davos from January 22 to January 25, 2019. Under this arrangement, medical devices manufacturing in Andhra Pradesh will get a major boost and also support manufacturers at AMTZ to reach Swiss market. Says Dr. Jitendar Sharma, MD & CEO, AMTZ, “Andhra Pradesh headed by IT minister of the state, Shri Nara Lokesh has been at the forefront attracting investments to the newly conceived state of Andhra Pradesh. It is a welcome move that Euro Alliance SA has come forward to enable two-way market access.” AMTZ has been generating significant interest from many international firms in the field of medical technology during the three-day Summit being held at Davos. Two major international firms, Chronos Imaging and Energy Vault have already shown interest to set up their base at AMTZ in Visakhapatnam, Andhra Pradesh. To strengthen the state economy, manufacturing plays a

significant role. It creates wealth for the common population by creating opportunities for the local youth. It creates wealth for government and the companies that are establishing their base in Andhra Pradesh. AMTZ which has been dedicated to the nation by Chief Minister of Andhra Pradesh has been at the forefront of this mission by creating opportunities and make Andhra Pradesh stand first in medical devices industry there by placing India on the global map in this sector. Kalam Institute of Health Technology (KIHT) has also tied up with the Emergency Care Research Institute (ECRI) to develop approaches for improving patient care in Indian healthcare system. This association would help Indian healthcare system, medical providers, government agencies, insurance payers and other organizations in the private and public sectors. An independent non-profit organization founded in the early 1960s, ECRI in India would be the fifth office managed by KIHT at medical technology capital of India, AMTZ, Visakhapatnam. ECRI is an international organization with offices in the US, UK, UAE and Malaysia. It has been undertaking brand and model comparative evaluations of medical devices since 1971. http://pharmabiz.com/NewsDetails.aspx?aid=113661&sid=2

Health Minister confers ‘Award of Appreciation’ to Rajiv Nath of AIMED for his contribution to global healthcare New Delhi: Rajiv Nath was conferred with the prestigious ‘Award of Appreciation’ by Ashwini Kumar Choubey, Minister of State for Health & Family Welfare for his contribution to the Global Public Healthcare sector at The Award of Appreciation Ceremony held yesterday at Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi, organized by Diaspora Foundation. As the Founder and Forum Coordinator of Association of Indian Medical Device Industry (AiMeD), with over 350 Members nationwide, Nath has taken many initiatives of establishing a collaborative framework with various Dept. of the Govt. and media to bring to their attention issues troubling the industry and attract investments into India in his quest to make India as the Global Manufacturing Hub of Medical Devices – Make in India, Preferred Manufacturing Destination and the leading supplier of Medical Device worldwide. Recently Rajiv Nath has also been appointed as the Member on Board of National Medical Devices Promotion Council by DIPP established to boost and strengthen the Indian Medical Devices Jan.-Feb. 2019

Sector and lead India to an export-driven market in the Medical Devices sector. https://www.siasat.com/news/health-minister-confers-awardappreciation-rajiv-nath-aimed-his-contribution-globalhealthcare-1462181/

Jan.-Feb. 2019

AHPI & AIMED Collaborate To Promote Indian Medical Devices Industry AHPI and AIMED will work together to jointly promote Indian Medical Devices Industry and specially promote ICMED certified products in over 10000 member Indian hospitals. Association of Healthcare Providers of India (AHPI) and Association of Indian Medical Device Industry (AiMeD) recently signed a memorandum of understanding (MoU) to support Make in India of Medical Devices to transform India into a global medical devices manufacturing hub and simultaneously promote the India Certification of Medical Devices Scheme (ICMED) country’s first indigenously developed international class quality assurance system for India manufactured medical devices. The MoU was signed by Mr. Rajiv Nath, Forum Coordinator, AiMeD and Dr. Girdhar Gyani, Director General, AHPI. As per the MoU, AHPI and AIMED will work together to jointly promote Indian Medical Devices Industry and specially promote ICMED (from Quality Council of India) certified products in over 10000 member Indian hospitals aimed at enhancing patient safety, increasing consumer protection along with providing much needed product credentials to manufacturers to instill confidence among buyers. The scheme is also intended to significantly eliminate trading of sub-standard products or devices where supply chains are unknown, a widespread and injurious occurrence in the Indian market. The move is likely to have a huge positive impact on 'Make in India' program while giving a big shot to manufacturing of medical devices within the country, promote Medical Devices manufactured in India as high quality products, promote “Buy Indian” initiatives and bring esteem to the Indian Industry & Nation thereby building Brand India.

Both AHPI and AIMED recognize specifically the need for setting up of an independent, multi stakeholder governing structure for the Scheme(s). AHPI shall operate the Scheme(s) by setting up independent multi-stakeholder steering committee(s) and any other committees necessary for the purpose in consultation with AiMeD. AiMeD shall provide the technical documents developed by by QCI for ICMED quality management system certification and ICMED Plus product certification to AHPI for enabling 1 Step Beyond Endorsement and shall provide all technical support to AHPI in managing and promoting the Scheme(s). Under the joint mechanism, both associations will soon roll out activities to achieve the objectives of this MoU. https://www.biospectrumindia.com/news/74/12913/ahpi-aimedcollaborate-to-promote-indian-medical-devices-industry.html

AiMed Seeks Reduction In Import Duty On Raw Materials, Financial & Technical Support To Spur IVD Industry Growth Indian health care industry heavily depends upon imported devices and reagents. Major MNCs like Roche, Siemens, Beckman Coulter, Johnson and Johnson have captured 72-80% of total IVD segment. In a bid to assist in-vitro diagnostics industry for ‘Make in India’, Association of Indian Medical Device Industry (AiMeD) has urged the central government to take a slew of measures including abolition of inverted duty structure, improving funding facilities to encourage IVD manufacturers to take up WHO pre-qualification certification and providing support to National Institute of Biologicals' (NIB) to procure comprehensive global panel for evaluation of diagnostic kits used to diagnose infectious diseases prevalent in India. These measures will facilitate growth of indigenous IVD industry so that patients and consumers in India can have access to indigenously-developed low- cost affordable high quality IVDs, said Dr Manoj Chugh, General Manager and Head- R&D (Reagents) at Transasia Bio-Medicals Ltd, who represented AiMed at second meeting with stakeholders of IVD regarding support cell for WHO pre-qualification programme organized by NIB in collaboration with WHO and Central Drugs Standard Control Organization (CDSCO) on February 13, 2019. At the meet, AiMeD and AIMA jointly proposed that Indian IVD manufacturers be allotted a transition time of 2 -3 years for WHOPQ of their products. This will help avoid monopolistic and reJan.-Feb. 2019

strictive situation. During this period WHO-PQ certification should not be a mandatory qualification for bulk purchases through tenders by state/ central governments. NIB should acquire and characterize panels for prior-pre qualification of kit manufactured by domestic IVD manufacturers. NIB should submit the timeline they need to procure and characterize the panel. At present only three Indian companies-- PMC, Arkray and Meril have their malaria rapids certified by WHO-PQ; and only PMC has their HIV 1&2 rapid certified by WHO PQ. AiMed has appealed to NIB and WHO to propose to Union health ministry on behalf of Indian IVD manufacturers for partial financing of the WHO PQ fee (USD 17000 per product). The central government could pay 70% of the fee to encourage IVD manufacturers to qualify for WHO-PQ certification. The industry body also sought reduction in import duty on raw materials (RMs) and hike import duty on finished goods (FGs). This move will support Make in India initiative. At present import duty on FGs is lowest in India, compared to BRIC countries. As an example, ELISA finished kits under HS Code: 38220019 List 4/ Sr. No. 32, are exempted from import duty (0%) and 5% IGST whereas raw material for ELISA kits under HS Code: 38220019. attracts 520% import duty plus 12% IGST. India, having around Rs. 6,000 crore IVD industry, imports raw materials worth Rs. 2,400 crore per annum.

AiMeD also appealed to government to designate an area for IVD manufacturers for storage of thermo-labile RMs at 2-8 oC. At present, IVD manufacturers experience difficulties in importing expensive thermo-labile RMs. Even if a manufacturer opts to store the consignment at 2-8 oC at an additional cost, at times due to lack of space or any other logistics limitations these thermo-labile materials are stored at room temperature. Such RMs stored at inappropriate temperature, by the time reach the manufacturer, are already deteriorated leading to not only financial losses, but inadvertent delays in research. The industry body sought another faster route to be devised by customs authority to get the biological RM cleared faster, in case IVD manufacturer is able to produce the respective test/manufacturing license. It also urged WHO to support NIB in development of a comprehensive global panel for infectious diseases such as HIV, HBV, HCV, malaria and dengue. “Seroconversion panels could be procured by NIB in bulk, for getting products from all Indian manufacturers evaluated. The government should financially support NIB, if needed. We have suggested that NIB could represent as a sole Indian buyer, since supply from Seracare is always limited. This could be beneficial, as most of these standards are not stable for long, once reconstituted. So, with one vial they can test products from many IVD manufacturers at a time,” said Dr Chugh.

Centre Plans To Cut Prices of 400 Medical Implants The Union health ministry is likely to issue a notice next week to regulate the prices of more than 400 medical devices and implants, including pacemakers, lens, artificial hip and spine implants. HIGHLIGHTS • The prices will be reduced by at least 50 per cent • It also includes medical devices such as BP machines, CT and MRI machines • The Centre is also planning to further amend the Drugs and Cosmetic Act It also includes medical devices such as BP machines, CT and MRI machines. With this, the government officials can check the prices and quality of those medical implants which are still not the under the control of the health ministry. The prices will be reduced by at least 50 per cent. The Centre is also planniing to further amend the Drugs and Cosmetic Act. "As of now, there are various types of medical implants that are out of regulation. Once it is done, the government will have the authority to check the prices and quality. And every manufacture has to take the licence," said a health ministry official, requesting anonymity. "These regulations imply to international manufactures who want to sell their implants in India," he said. Dr SumedhSandanshiv, a senior orthopedic at RML Hospital, said: "It is a good step and will bring a big relief to patients. In ortho, there are more than 100 implants which used to cost Rs 50,000 to Rs 1,50,000. But now the prices will be cut by 50 to 80%. Once the market will get regulated, the prices and quality will be in check." https://www.indiatoday.in/mail-today/story/prices-cut-400medical-implants-1436188-2019-01-22

Companies in India who can manufacture antigens, antibodies, enzymes need to be supported. Stronger interface between academia and industry could help these companies in skill development for protein purification, recombinant expression of chimeric proteins, characterization of these purified proteins etc, he said. Besides this, AiMed made a slew of suggestions to NIB including evaluation of all HIV gen 4 kits for the analytical sensitivity, getting the HIV antibody panel characterized to determine the sub type (M, N or O) of HIV 1 Serotype by molecular analysis, making sure that its sample panel encompasses all DenV 1, 2, 3 and 4 serotypes, verified by a molecular test to distinguish between all four serotypes. AIMeD representatives also requested to NIB to share statistical guidelines for determining clinical sensitivity and specificity and characterize their panels and submit the complete report in the format which is followed by WHO. “Once these characterized panels are ready with NIB, manufacturers can submit their products once again (re assessment) for prior qualification by NIB before submitting these products to WHO for PQ,” said Dr Chugh. http://pharmabiz.comArticleDetails.aspx?aid=114189&sid=1& utm_source=feedburner&utm_medium=twitter&utm_campaign= Feed%3A+PharmabizNews+%28Pharmabiz+Top+News%29

An ISO & CE certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.

Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. Jan.-Feb. 2019

Product Gallery Qosina Introduces New ISO 80369-7 Compliant Needleless Injection Sites

Ronkonkoma, NY, USA, February 4, 2019—Qosina has introduced three new needleless, swabbable injection sites. These ISO 80369-7 compliant components are ideal for use in flushing, sampling and IV applications. They prevent dripping and leakage when disconnected, eliminating the need for clamps. And because they’re needleless, they provide a safer, more convenient method of delivering fluids. These new injection sites are luer-activated, meaning when the male luer lock connects to the female luer lock, the stem opens the bidirectional valve, allowing for fluid transfer. The internal threads on the male luer match up with the external threads on the valve, creating a secure connection. Upon disconnection, the valve closes. Qosina will be showcasing its new needleless injection sites, in addition to thousands of stock components, at Booth 2121 during MD&M West at the Anaheim Convention Center in Anaheim CA, February 5-7.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 9001, ISO 13485 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products. visit www.qosina.com or call +1 (631) 242-3000. Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

Qosina’s Barbed, Tube-to-Tube Connectors Help Reduce Time to Market

Ronkonkoma, NY, USA, January 3, 2019—Qosina carries a diverse selection of barbed, tube-to-tube connectors in many different configurations including straight, reducing, Y, T and elbow. These connectors are cost-effective, reliable and versatile. They can be used with various types of tubing, accommodating inner diameters as small as 1/16 inch (0.0625 inch, 1.59 mm) and as large as 1 inch (25.4 mm). Bonding or adhesives are not necessary, so assembly is simple and quick. Qosina will be showcasing its barbed, tube-to-tube connectors, in addition to thousands of stock components, at Booth 2121 during MD&M West at the Anaheim Convention Center in Anaheim CA, February 5-7.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 9001, ISO 13485 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

Jan.-Feb. 2019

Product Gallery Surgical Pads : First Time In India With Phase Change Material From Outlast by Natroyal Group Major Concerns of a Patient with Plaster” • • • •

For orthopaedic plaster, the process is to use surgical pads or stretch fabric on which the plaster is applied. It will be opened only after 4 – 6 weeks Due to less air flow, the patient perspires and as it can not be cleaned, there is a foul smell There is itching problem

Outlast Coated Phase Change Material – A Solution The Outlast fabric, coated with Phase Change Material is used along with non woven surgical pad and wound up at the required part of the body (Steps 1 – 4) and then plaster is applied Non Woven (Step 1)

Outlast Fabric (Step 2)

Outlast Coated Phase Change Material – A Solution After 4 – 6 weeks, it was observed that there is no bad odour and it was easier to remove.

Both fabrics Together (Step 3)

Fabric Wound (Step 4)

For more details, visit : www.outlast.com

Jan.-Feb. 2019

REQUIRED Medical Device Company In Good Running Condition We are looking for a small manufacturing unit on long lease or outright in Ahmedabad or near Ahmedabad for manufacturing of Medical devices as per CDSCO regulations. Must have all the approvals for manufacturing licences from state and central government. Contact : Ms. Dimple Sitpura – 9372778449 email your details on dsitpura@gmail.com

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

Jan.-Feb. 2019

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

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

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

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

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com 46

Jan.-Feb. 2019

ISO : 13485 : 2012

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

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

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

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

CERTIFIED COMPANY

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

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA

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

Jan.-Feb. 2019

Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 47

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

Jan.-Feb. 2019

AVAILABLE

GMP ISO - 9001-2008 Certified Company

PRE USED SYRINGE

S. Nath & Co.

MANUFACTURING

Excellence in Quality

EQUIPMENT

Manufacturer & Exporter of Surgical Disposable Products since 1980

IDEAL®

Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml

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

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

Contact : 7895648113 pawantiwari1978@gmail.com

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

ISO 9001:2008 CERTIFIED COMPANY

•

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

Address :

Apex Medical Devices Plot No. 10/B, Shyam Ujjawal Indurstrial Estate, Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, Ahmedabad-382445. Gujarat, India. Phone No. : +91-79 - 29701333 E-mail : apexmedical@live.in Website : www.apexmedicaldevice.com Jan.-Feb. 2019

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 49

National Healthcare An ISO 9001 : 2008 Company

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

Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in 50

Jan.-Feb. 2019