Medical Plastics Data Service Magazine March - April 2019 by Medical Plastics Data Service

Table of

Contents Vol. 27

No. 2

Mar.-Apr. 2019

COVER STORY Polymers And Medical Device Manufacturing The medical device market is booming with innovation .Medical Device industry needs to stay on top of emerging trends by successfully blending new materials into device developments… Polycarbonate : For Thin-Wall Designs In Healthcare Applications In the healthcare industry, the growing trend of miniaturization is impacting how products are designed. New medical grade features high-flow properties for a variety of healthcare applications, such as…

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REWARDS & RECOGNITIONS Dr Jitendar Kumar Sharma, AMTZ In Top 40 Under 40 EU - India Leaders List Given to leaders, all under the age of 40, who are going to play an important part in shaping European Union - India trade relations during the next few decades…

TECHNOLOGY Med-Tech Devices Developed By Start-Ups Stall Life-Threatening Fatalities Like Lung Infection & Neonatal Respiratory Distress Such technologies priced at affordable levels have the potential to transform the healthcare landscape if used at scale…

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Mar.-Apr. 2019

GLOBAL TRENDS • Antimicrobial Technology Helps Develop Device For Leg Ulcer And Wound Treatment • How A US Contract Manufacturer Produces Silicon Components For In-Vitro Fertilisation In China

AiMeD & REGULATORY UPDATES • • • •

Categorise All Medical Devices As Drugs : Panel Medical Devices Ind. Urges Govt To Ensure Compliance Of Labeling Requirement As Is Done In Drugs Government To Introduce Provision For Compensation For Faulty Medical devices / Implants After J&J Implant row, Govt Plans To Hire 750 Officers To Regulate Medical Devices

INDUSTRY NEWS • • • • •

Milacron Investing $30M In Second India Factory Maharashtra Price Cut Boosts Use Of Drug- Eluting Stents : Study Cipla Targets Small Airway Respiratory Disease With An Innovative Two-In-One Inhaler Opto Circuits Expects To Grow At 25% During The Current Year Ascent Meditech Embarks On Rs.70 Crore Expansion Plan To Achieve Four Times Growth

PRODUCT GALLERY • CPC® ASEPTIQUIK® Series Connectors CPC

• Multi-Purpose, Single-use Hand Instruments

BOOK REVIEW Emerging Trends In Medical Plastic Engineering And Manufacturing Dr. Markus Schonberger / Dr. Marc Hoffstetter Enabling engineers to anticipate new developments and gain a strategic advantage over competitors.

DID YOU KNOW? • About Transvaginal Mesh Complications

EVENT CALENDER & EVENT REPORTS • Seminar on “Advances and Developments of Plastics in Medical Sector” : 24 July, 2019, Pune • Medicall 2019 - Chennai : 26-28 July, 2019, Chennai • K 2019 : 16 - 23, October, 2019, Germany

• Medica 2019 : 18 - 21 November, 2019, Germany • Compamed 2019 : 18 - 21 November, 2019, Germany • PLASTIVISION INDIA 2020 : 16 - 20, January 2020, Mumbai • Medical Fair India 2020 : 5 - 7 March, 2020, Mumbai

Flashback Select Article Index

Sept 2010 to Jan 2011 • Cover Story : Process Validation In Medical Device Industry (September – October 2010) • Cover Story : Guidance Document On Application For Grant Of Licence For Manufacture of Medical Devices in India : Abstracts (September – October 2010) • Global Trends : Global Forum Calls For Strategies On Medical Devices (September – October 2010) • Did You Know ? : About Complications Associated With Urological Devices (September – October 2010) • Cover Story : Can India Become Knowledge And Professional Services Hub To The World For Medical Device Industry? (November – December 2010)

Did You Know ? About Transvaginal Mesh Complications

Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue. It is a cloth-like piece of netting made of synthetic material that is used to support the abnormal descent of the pelvis in women; for instance, after childbirth or due to increasing age or hernia. Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.

• Cover Story : Innovators and Achievers (November – December 2010)

Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.

• Global Trends : Early Europe Approvals for Medical Devices Could Fade (November – December 2010)

The US FDA has stopped the sale of the surgical mesh. Indian government is also reviewing the situation. “The mesh is among the 23 regulated medical devices in India and a committee has been formed to discuss the US FDA move and its relevance to India.”

• Market Trends : Capitalizing On India’s Growth Potential : Medical Device Industry Will Not Be Left Behind (November – December 2010)

In India, however, several players sell these devices. According to an analysis by the All India Drug Action Network (AIDAN), an NGO, the CDSCO has granted registration certificates to over 10 companies to import the mesh.

• Did You Know ? : PU Dressings Help Wounds To Heal (November – December 2010)

“As per AIDAN’s analysis, a number of mesh products for use in hernia repair, urinary incontinence and prolapse repair have been approved in India,” said Malini Aisola, co-convenor of AIDAN.

• Learning Zone : Learning Zone (Basic-Discoveries-Innovations) (November – December 2010) • Materials : Biodegradable Thermoplastic Elastomers (Btpe) In Critical Clinical Practice (January – February 2011) Dr. S.C. Shit, Dy. Director, CIPET – Ahmedabad • Markets : Introduction To Global Medical Device Market (January – February 2011) Mr. Raghuveer Gopalkrishna Kini, Additional Executive Director, Pharmaceutical Export Promotion Council – Mumbai

“Given the horrific adverse events associated with the mesh in Western countries, which has led to the US ban, the CDSCO must take immediate measures to protect Indian patients by initiating local investigations and issuing showcause notices before ordering the mandatory withdrawal of these products from India,” she said. As per Mr Rajiv Nath, forum coordinator of the Indian Medical Device Industry. the move to curb import of unsafe vaginal mesh is overdue, especially after a Netflix documentary and investigative report by a newspaper. (https://theprint.in/india/governance/sales-of-pelvic-surgical-mesh-for-women-could-bestopped-in-india-after-us-ban/223548/amp/ )

• Global Trends : Medical Technology Innovation Scoreboard (January – February 2011) • Did You Know ? : About UHMwPE Fibres : One Of The Most Recent Advances In Biomedical Materials (January – February 2011) • Learning Zone (Basic-Discoveries-Innovations) : Drug Eluting Stents & Balloons - A Breakthrough In Interventional Cardiology (January – February 2011)

The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency. - Bill Gates

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

Editor’s Desk

From the

Because of numerous research and development activities in the Polymeric materials and their manufacturing, Medical Device Industry benefited for products with countless applications and substituted metallic, ceramic or glass materials. Medical Device Industry offers so many opportunities to plastic industry if it understands the sector. And the same is true for medical device manufacturers. While, for the device industry, introducing a new biocompatible material requires enormous efforts in verification, validation, additional testing requirements as well as market acceptance, however, the characteristics of plastic materials make their applications indispensible. For the selection of right material for the right application , the need of the hour is higher level of integration between medical device manufacturers, medical professionals and may be patients also. The growth in investment towards research and development, increase in adoption of medical polymers and development of low cost materials are driving the demand for medical polymers in the healthcare industry. The global market for medical polymers is expected to reach $19,014 million by 2022. The cover story for this issue is focusing on , “Polymers and Medical Device Manufacturing”. Medical Device industry needs to stay on top of emerging trends by successfully blending new materials into device developments. This is applicable not only for new products but also to improvements in existing designs. The “cover story” and “global trends” columns highlight case studies for medical device developments with the help of innovations in medical polymers and their processing. As rightly mentioned in another cover story article by “Covestro” , in the healthcare industry, the growing trend of miniaturization is impacting how products are designed. Smaller medical devices call for seamless, unobtrusive and lightweight designs to improve patient comfort and overall compliance. Also smaller devices are often used in surgery to advance patient recovery times. As a result, these products require materials with excellent flow properties suitable for thin-wall applications. To meet quality demand, “Covestro “developed the polycarbonate grade with high-flow properties for a variety of healthcare applications, such as on-body devices, surgical instruments, pen injectors and IV components. The consequences of using inappropriate materials result in complications to the patients as described in the “Did You Know” column with respect to Surgical Mesh made of synthetic material. This issue gives wealth of information through the regular columns - Global Trends, Technology, Regulatory & Industry News, Product Gallery, Book Review 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.

Mar.-Apr. 2019

Cover Story

Polymers And Medical Device Manufacturing The changing technology trends in medical polymers and its processing techniques contribute immensely towards the development, growth and innovations not only for Medical Device Industry but for the new polymeric materials. This is possible with close interaction between medical polymer manufacturers and device manufacturers. This is a great contributing factor for addressing unmet needs in medical device manufacturing. The medical device market is booming with innovation .Medical Device industry needs to stay on top of emerging trends by successfully blending new materials into device developments. This is applicable not only for new products but also to improvements in existing designs . At the same time, the emerging polymer technologies for Medical applications must always be seen in combination with changing and evolving regulatory boundaries.

Emerging Trends In Medical Polymer Materials & Processing The following are few of the examples of important medical device made with the help of developments in medical polymers & their processing.

PEEK For non-metal lumbar cage in Japan FDA cleared the first foot-and-ankle implant made from Invibio Biomaterial Solutions’ PEEK-Optima HA Enhanced polymer comes word that Solvay’s Zeniva PEEK was selected by medical device OEM KiSCO Co. (Kobe, Japan) for the first non-metal lumbar cage for vertical interbody fusion made in Japan. The advanced spinal cage is commercially available only in Japan, where that country’s Pharmaceuticals and Medical Devices Agency (PMDA) approved the implantable medical device for production. It is said that the materials was selected because of its performance properties, including fatigue resistance and a modulus similar to bone. The company The wanted an implantable medical material that could facilitate post-operative diagnosis. PEEK is an alternative to titanium, which is typically used in this application, because its radio transparency allows for easy visualization in medical X-ray and MRI imaging. The primary function of a spinal cage is to maintain the proper intervertebral angle and height until spinal fusion occurs. However, spinal cages also need to accelerate bone fusion and support adjustments during surgery. The company’s spinal cages allow surgeons to use a screw-and-spacer mechanism to make these necessary adjustments. During clinical trials, the material enabled the spinal cage to maintain structural stability even when screws were used to expand the spacers. The materials supplier’s ability to provide quality data for biological evaluation and its responsiveness facilitated the regulatory process, allowing device manufacturer to secure approval from PMDA in a short period of time, said the company.

New Grade Of Silicone Elastomer For Microfluidic And Implantable Medical Device Applications Materials innovator Gelest Inc. (Morrisville, PA) has introduced ExSil 50, a softer grade of an ultra-high elongation material that has been formulated to meet the requirements of soft-tissue implants or extracorporeal device applications. The ExSil class of elastomers have unprecedented elongation greater than 5000% and shape recovery behavior, according to Gelest. They also have self-sealing and tear-resistance properties. The materials are available in an industrial grade, GelestExSil 100, as well as soft-tissue compatible ExSil 50.

Polyarylamide Resin For Single-Use Bone-Fixation Device In developing a more robust, single-use bone-fixation system than currently available devices, medtech startup Reign Medical (Tulsa, OK) went on the hunt for a biocompatible material with exceptional stiffness properties. A polyarylamide (PARA) resin from Solvay (Alpharetta, GA) stood out and is used to mold several components of the medical device soon to be on the market. The Clench compression staple system comprises a disposable sterile surgical tool set for fixating hand and foot bone fragments and performing related procedures. A patented threaded hub Mar.-Apr 2019

Cover Story allows surgeons to incrementally expand the implant for proper insertion while retaining the mechanical properties of the nitinol staples for continuous compression across the fusion site after implantation. Reign Medical specified Solvay’s 50% glass-fiber-reinforced grade, for the device’s implant sizer, drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits and the threaded compressor that forces the staples fully open, said Solvay in a press release. A high-stiffness material was required for this application because of the mechanical strain that the components experience. Offering metal-like strength, rigidity and dimensional stability, the biocompatible polymer has to provide an exceptional surface finish .Gamma-stabilized colors are optimized for sterilization

using high-energy gamma radiation, showing no significant change in appearance or performance after sterilization. The material has to be evaluated for ISO 10993 limited-duration biocompatibility and is supported by an FDA Master Access File. After briefly considering polycarbonate and ABS blends, the company selected this material primarily for its outstanding stiffness, which enabled even the smaller components of the delivery tool to reliably withstand the compression of the staples, as well as the torsional, tamping and axial loads applied during fixation procedures.” Reign Medical’s Clench staple system received FDA clearance in April of this year. The company is now conducting beta testing in advance of its first production launch.

Importance Of Compounding In Medical Device Sector This is particularly for various types of balloon catheters. Catheters used for vascular and other critical care applications need polymeric tubing requiring high precision, close tolerances and high level of functionality. This is particularly used for minimally invasive surgical techniques. Along with the above mentioned properties, it is also necessary important to consider manufacturing process required to manufacture the medical device. The inside diameter of the catheter is required to be very smooth to allow the guide wire to slide. For catheter balloon manufacturing, it is important that the extruded tubing is amorphous prior to the balloon forming process. In order to arrive at the right grade of compounded material, the device manufacturer has to work with the material supplier to meet not only the processing / manufacturing requirements but also the regulatory needs.

Carclo Technical Plastics Ltd (CTP) Announces Manufacturing Facility In Doddaballapur Near Bangalore Carclo Technical Plastics Ltd (CTP) announces that its manufacturing facility in Doddaballapur near Bangalore, India, has been recommended by BSI for accreditation to the international standard ISO13485:2016 for medical applications. Managing Director of CTP India, Gary Allan, stated “We at Carclo Technical Plastics are delighted to have achieved this accreditation at our facility in Bangalore as we target medical plastic component manufacturing opportunities in India. I would like to congratulate the CTP team in India and further afield for their hard work and diligence in achieving this important landmark”.

UK, East and West USA, Czech Republic, India and China. The business is a specialist injection moulder of tight tolerance plastic components and increasingly adds value to its customers by assembling and packaging finished devices for the medical, pharmaceutical, diagnostic and ophthalmic sectors. Typical products include drug delivery devices such as injection devices and asthma inhalers and diagnostic consumables such as pipette tips, reagent packs and Point-of-Care cartridges. Contact Martin Day, Director, European Sales & Marketing, on +44(0)208 685 0500 for further details.

Carclo Technical Plastics, www.carclo-ctp.co.uk, is the largest division within Carclo plc with manufacturing operations in the Mar.-Apr. 2019

Covestro high-flow polycarbonate enables intricate, thin-wall designs in healthcare applications In the healthcare industry, the growing trend of miniaturization is impacting how products are designed. Smaller medical devices, such as on-body drug delivery or monitoring applications, call for seamless, unobtrusive and lightweight designs to improve patient comfort and overall compliance. Additionally, smaller devices are often used in surgery to advance patient recovery times. As a result, these products require materials with excellent flow properties suitable for thin-wall applications.

Formulated specifically to meet rigorous healthcare industry requirements, Makrolon® Rx2235 polycarbonate is biocompatible according to ISO 10993-1 test requirements and designed to be sterilized using gamma or e-Beam methods. It is complementary to Makrolon® 2258 polycarbonate, another ideal material for medical devices. This grade is suitable for ETO and steam sterilization, biocompatible according to many ISO 10993-1 test requirements, and offers low viscosity and easy release.

To meet the toughest device design challenges, Covestro developed Makrolon® Rx2235 polycarbonate. This new medical grade features high-flow properties for a variety of healthcare applications, such as on-body devices, surgical instruments, pen injectors and IV components.

“Makrolon® Rx2235 polycarbonate is a significant addition to our broad range of medical polycarbonates,” said Doug Hamilton, global healthcare segment leader – Polycarbonates, Covestro LLC. “This is just the latest example of how we continue to innovate and expand our polycarbonate portfolio, giving healthcare OEMs access to the advanced materials they need to design, develop and produce their next breakthrough.”

“Makrolon® Rx2235 polycarbonate sets a new benchmark for flow length and brings the expected transparency and toughness of polycarbonate to help manufacturers fill very thin walls and accurately replicate intricate features with lower pressures,” said Pierre Moulinié, global technology lead, Healthcare – Polycarbonates, Covestro LLC. Furthermore, Moulinié points out that material savings with thin walls could be pushed even further with increased cavitation to reduce production costs.

In the emerging medical device market like India, biocompatibility of the medical device is better secured when the risks are reduced in its part development and production stage itself. One of the important factors can be using biocompatible resin like Makrolon Rx2235 polycarbonate that offers formulation consistency, ISO 10993-1 biocompatibility statement that support OEM’s clinical trial and registration.

The 28th China International Medical Equipment Fair (CMEF), one of the most prominent industry events, will be held at the National Date : May 14 – 17, 2019 Location : National Exhibition and Convention Center Shanghai (No. 333, Songze Avenue, Qingpu District, Shanghai) Visit our website for more Successful Cases of Covestro’s Medical-Grade Plastics www.plastics.covestro.com Local contact: suresh.v@covestro.com

Exhibition and Convention Center in Shanghai, China from May 14 to 17, 2019. Located in the Hall 6.1 at Booth No.6.1O23, Covestro will share insights about medical-grade plastics and successful cases. As your innovation partner, Covestro is dedicated to “Formulating Life-Enhancing Solutions,” joining customers in meeting today’s challenges. At the Covestro Booth, you will find our latest solutions in surgical equipment, renal dialysis, miniaturization and wearable drug delivery concept products. You will also see our latest medical-grade plastics, including Makrolon® Rx2235,Makrolon® Rx3440, and the Continuous Fiber-Reinforced Thermoplastic (CFRTP) Composites of Maezio™. We look forward to sharing the latest insights, exploring cooperation possibilities with you and together, building the next big thing in industry.

Let’s work together to make the world a brighter place!

Mar-Apr. 2019

Rewards & Recognitions Dr. Jitendar Sharma among “Top 40 under 40 EU India Leaders list” by London based think tank Europe India Centre for Business & Industry (EICBI) released at the European Parliament in Brussels Dr Jitendar Kumar Sharma from Andhra Pradesh MedTech Zone who was featured in this year’s EuIndia 40 list is Known in policy forums as the “Med Tech Man of India”, is the Managing Director & CEO of Andhra Pradesh MedTech Zone (AMTZ)

Against backdrop of Brexit, London based think tank Europe India Centre for Business & Industry (EICBI) released its EuIndia40 list at the European Parliament in Brussels, featuring young entrepreneurs, policy leaders, thought leaders, business executives, trade body leaders, all under the age of 40, who are going to play an important part in shaping European Union - India trade relations during the next few decades. The list was released by Hon Caroline Nagtegaal, who is the Member of European Parliament - Netherlands & Vice Chair- European Parliament delegation for relations with India and Mr Sujit S Nair, who is the Chairman of EICBI during the Europe India Business Leaders Conference which took place at the European Parliament on 10th April. Europe India Business Leaders Conference 2019 follows the hosting of 22 business summits in the European Union (at the British Parliament and European Parliament) by EICBI’s delivery partner Sivaleen and these summits have played a key role in connecting 3100 stakeholders in EU, India, UK corridor. The women leaders and men leaders who made to the EuIndia40 list come from all walks of life and represent 16 different nationalities - Austria, Belgium, Denmark, Germany, France, India, Ireland, Italy, Luxembourg, Netherlands, Portugal, Romania, Slovakia, Spain, Switzerland, United Kingdom. Dr Jitendar Kumar Sharmafrom Andhra Pradesh MedTech Zonewho was featured in this year’s EuIndia40 list is Known in policy forums as the “Med Tech Man of India”, is the Managing Director & CEO of Andhra Pradesh MedTech Zone (AMTZ) which is Asia’s first medical devices manufacturing city besides being the Adviser for Health to Govt. of Andhra Pradesh, India and Executive Director of Kalam Institute of Health Technology (KIHT)- a technology policy research body set up with the support of Govt. of India. He is adjunct faculty at University of Adelaide, Australia; and program Director for Health Technology Assess-

Mar.-Apr. 2019

ment (HTA) fellowships in India. He has been founder of 6 organizations and architect of Universal Health Coverage for the state of Andhra Pradesh- the first state in India with 50 million people to declare UHC. He is also the National Chairperson for Indian Bio-Medical Skill Consortium which is an active congregation of over 20 national academic institutions. Awarded among the “100 most impactful healthcare leaders” in global listing by Health & Wellness Congress, Dr. Sharma served as the Founder Head of Healthcare Technology Division and Head of Health Financing Divisions at National Health Systems Resource Centre (NHSRC) under Ministry of Health & Family Welfare, Government of India. He was also the Founder Director of WHO Collaborating Centre for Medical Devices in India. His past experience includes that as Hospital Administrator at Sri Sathya Sai Medical Institutions-one of India’s largest not for profit health organizations, as consultant to the World Bank for health financing, as Expert Consultant to the World Health Organization, Geneva and advisor to Health Technology Innovation Centre at Indian Institute of Technology (IIT). Dr. Sharma has authored seven books, twenty research papers and six compendiums on technical specifications for medical technologies besides contributing to a number of WHO reports on health technologies, health financing and Non-Communicable Diseases. He has been a key designer and coordinator for several health programs in India and teaches courses on health policy & health technology in several countries. India and the EU celebrated 55 years of diplomatic relations in 2017. With Brexit opening new possibilities for furthering EU India relations, there has been a lot of discussions in the EU India trade corridor that Brexit will make trade deals between the EU and India a little easier.

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

High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount

Mar-Apr. 2019

Technology

Med-Tech Devices Developed By Start-ups Stall Life-Threatening Fatalities Like Lung Infection & Neonatal Respiratory Distress Novel medical technology devices developed by Indian start-ups for critical care are proving to be stalling fatalities among critically ill-patients in the country. Only recently indigenous start-ups are creating novel technologies that are directly targeting unmet needs in India. Such technologies priced at affordable levels have the potential to transform the healthcare landscape if used at scale. These are only just beginning to be introduced into the Indian market. So the transformative impact will only be seen after some years, Siraj Dhanani, Founder and CEO, InnAccel Technologies told Pharmabiz. Every medical device developed must solve a serious medical problem. We developed products for the lower-end medicare setting that do not have the infrastructure to support hi-end equipment and priced for the mid-tier Indian healthcare sector, he added. Our products development teams identified the need in a critical

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Contact : Sushil Kumar Soni +91-9789966873 Mar.-Apr. 2019

care setting to prevent fatality. They spent three months in the ICU, emergency wards, NICUs and rode along with patients in ambulances. Thus came about VapCare and Saans devices which are CE certified and under USFDA approval process. VapCare holds a US, China and India patent and has already

evinced positive customer response from Indian hospitals. This device automates an oral hygiene procedure currently done manually in a patient under a ventilator which results in high risk infection and high rate of fatality. Saans was developed in response to tragic situations of premature babies rushed to NICUs for ‘Continuous Positive Airway Pressure’ (CPAP), but succumbed during transport to hospitals. In the absence of CPAP therapy for a sick baby in transit, Saans is designed to provide breathing support to neonates in non-NICU settings. The light weight and battery operated device has completed the field trials. It received a Sparsh grant initiated by BIRAC and the Millennium Alliance programme by FICCI. Around 90 babies under the study reported cent percent success and no product failure. Here 24 percent of the babies were brought in ambulances and 27 percent in auto rickshaws with the remaining in hired cars or buses along with a qualified medical attendant to monitor and travel with the patient. Going by the valuable benefits of both VapCare and Saans, the company expects a strong government demand. The product is going through USFDA certification, besides other global validations as InnAccel is keen on exports. According to Vijayarajan, founder & CTO, InnAccel, the basic design is completed at the Coeo Labs, the InnAccel subsidiary and the Kaynes Technology in Mysuru which is armed with certificate for manufacture for these devices. We are also working on extensive customer demonstrations where enquiries would be converted into sales going by the potential of the devices. More details about the company is available at : http://innaccel.com/ (http://pharmabiz.com/NewsDetails.aspx?aid=115043&sid=1)

Mar-Apr. 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 Nov.-Dec. 2018

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

Nov.-Dec. 2018

Global Trends Antimicrobial Technology Helps Develop Device For Leg Ulcer And Wound Treatment Medical device company CMC Hygea has developed a new way to aid the treatment and bathing of leg ulcers and lower limb wounds in healthcare facilities. The PathAguard LUCA contains a reusable antimicrobial washbasin and a single-use, low density antimicrobial polyethylene liner designed to accommodate the liquid solution required to cleanse ulcerated limbs and wounds. Michael Malone, CEO of CMC Hygea, said: “This IMSTA, Irish Medical and Surgical Trade Award-winning PathAguard LUCA sleeve, which received the accolade of the IMSTA award for best product for primary care in the community in 2016, introduces a new and unique method of cleansing and treating ulcerated legs and lower limb wounds. Currently there is no comparable product on the market in which to safely wash ulcerated limbs and treat podiatry issues".

The biomaster antimicrobial technology built into the plastic provides a barrier to inhibit the growth of pathogens, and is effective against hospital-acquired infections (HAIs) such as MRSA. Ageing populations and increasing obesity levels has resulted in an increase in certain conditions such as leg ulcers which have to be managed in an efficient and timely manner. People with open wounds however are always vulnerable to bacterial cross-contamination from hands and from the environment. https://www.medicalplasticsnews.com/news/medical-devices/ biomaster-antimicrobial-technology-helps-develop-device-for-/

How A US Contract Manufacturer Produces Silicon Components For In-Vitro Fertilisation In China To manufacture a medical device specialising in in-vitro fertilisation, a European OEM required a special injection moulding component made of silicon. Not only did this need to be high quality but should also have very precise dimensions, and special surface characteristics. As the component also had to be manufactured within a short timeframe and on a low budget - a volume of 400,000 units - the supplier Polyfluor Plastics decided to appoint the Chinese branch of the US contract manufacturer Flexan due to its expertise and ability to reduce the time to market. The project with Flexan Suzhou progressed swiftly – the plant produced the injection moulding tools within five weeks and provided the first samples just five days later.

“With other manufacturers, it would have taken four to six months until the injection moulding tool had been built,” confirmed Wetzels.

“We were appointed by an OEM, to manufacture components for a product for in-vitro fertilisation,” explained Eric Wetzels, managing director of Polyfluor Plastics, a Dutch supplier of polymer products. This also includes a special silicon injection moulded part, which is not very complex in itself, but whose manufacture in a cleanroom according to the strict specifications of the customer, posed a challenge.

However, the particularly short delivery time in Suzhou can also be attributed to the fact that the factory has many different injection moulding tools, and therefore has fixed capacity commitments with a large number of qualified tool manufacturers.

In contrast, Flexan was able to agree a time of two months. “In Europe and the USA, for example in our factory in Chicago, express tool manufacture is of course still possible – but with additional costs,” explained Werner Karau, European commercial leader at Flexan, who is responsible for the project with Polyfluor. “Here, the client has to think carefully, particularly if the same quality can be provided in China.” Injection moulds finished in five weeks

“These reserves generally allow us quick tool manufacture,” said Karau. At the same time, the Chinese branch can also rely on the knowledge of high precision medical silicon components, which has “On the one hand, there were very small tolerances for the been accumulated since 1946. Due to these various factors, the dimensions, but on the other hand it is required that its surface injection moulding tools were able to be completed within five weeks, feels pleasant and smooth. This requires extensive knowledge, and the first samples were sent to Polyfluor around five days later. as for example the original material must be injected into the “Due to our collaboration with Flexan Suzhou, we received our comtools and cooled correctly.” ponents very quickly, in the correct quality, in a high volume and at a The quote from Flexan for production in Suzhou offered the best competitive price,” said Wetzels. conditions, for example in terms of tool costs and delivery time,” “The only difference between the American sites and China is that continued Wetzels. Suzhou is more set up to manufacture many different tools and parts The advantage of the Chinese branch with regards to time to in high quantities, while the US factories specialise in the manufacmarket can be attributed to an industry-wide development. West- ture of even more complex parts, and services for the end product ern production sites are currently so stretched, that there are such as assembly and secondary operations,” added Karau. long waiting times for tools and products.

Mar.-Apr. 2019

https://www.med-technews.com/features/how-a-us-contractmanufacturer-produces-high-precision-compo/

Categorise All Medical Devices As Drugs : Panel India’s topmost advisory body on pharmaceuticals has recommended regulating all medical devices as “drugs” for better safety, quality and performance of the devices, ranging from syringes at one end to implants and pacemakers on the other side. The Drugs Technical Advisory Board (DTAB) has agreed to notify all medical devices as drugs in its last meeting. At the moment 23 medical devices are regulated as “drugs” — ranging from hypodermic needles and condoms to cardiac stents, heart valves and orthopaedic implants — under the law. Moreover, in two separate notifications issued in December 2018 and February 2019, the Union Health Ministry brought another 12 devices under the same category from 2020 onward. The new devices include nebuliser, glucometre, digital thermometer, X-ray, CT, MRI and PET scan machines among others. All implants too would be in the same class. The agenda before the DTAB was to prepare a roadmap for the regulation of more than 5,000 types of medical devices, as only 35 received the government’s attention so far. The board not only gave its go ahead for such a move, but also

suggested suitable changes in the Drugs and Cosmetics Act, 1940 and Medical Device Rules 2017. Besides, it approved nearly 450 new posts in a separate wing of the Central Drugs Standard Control Organisation to regulate the devices and setting up of five testing laboratories with 300 staff in the next five years to support the regulatory activities. All the recommendations, however, have to be approved by the government before they come into effect. Meanwhile, the medical device industry thinks that the DTAB suggestions are perfunctory in nature and coming out with a new law on medical devices will be the right step going ahead. “It’s imperative to have a separate law as devices are engineering items and not medicines - an X-ray machine by no stretch of imagination can be called a drug, so continued attempts to regulate devices as drugs is illogical and incorrect,” said Forum Coordinator of AIMED (Association of Indian Medical Device Industry). “Medical devices are generically different from drugs and can’t be treated as drugs in the long run. The government should institutionalise a suitable and exclusive legal framework for medical devices so that areas of quality, adverse events, compensation, prices, healthcare training and health technology assessment are comprehensively addressed,” added Pavan Choudary, chairman, MTaI (Medical Technology Association of India). https://www.deccanherald.com/national/categorise-all-medicaldevices-as-drugs-panel-729261.html

Medical Devices Industry Urges Govt To Ensure Compliance Of Labeling Requirement As Is Done In Drugs Medical device industry has urged the ministry of consumer affair and ministry of finance to ensure compliance of the rules related to labeling requirement. It has also asked to mandate printing of maximum retail price (MRP) on each unit pack of medical devices at the time of import by deputing a port officer for checking each shipment of medical devices. This has to be followed much in the similar manner as is being followed by Drug Controller General of India (DCGI) for the pharmaceuticals whereby the port officer/ADC Port issues the clearance for each shipment of pharmaceutical products to the Customs Officer as per the Drugs & Cosmetics (D&C) Act. Department of Consumer Affairs through a notification dated June 23, 2017 had made it mandatory for all medical devices including those notified as drugs to have MRP on unit pack and if sold by a hospital to patient then they can’t claim the status of institutional customer. Additionally, country of origin is now mandated to be labeled on the unit pack. Said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), “Many state level and world bank assisted public health tenders have a price benefit of 10 to 15%

for Indian origin goods to help establish the domestic industry of medical devices. In the absence of enforcement of labeling of country of origin, benefit would not be available to an Indian manufacturer who has spent a considerable amount of money to establish a factory and infrastructure to manufacture medical devices.” Now that GST has been introduced and there is a uniform tax structure, Government may consider to regulate the maximum mark up between ex factory (weighted average price) and the MRP. This is because ex factory price is coming down by competition but retail prices are shooting up to induce Indian retailer/ corporate hospitals to push their brands by offering superior trade margins. This is a never ending race and the consumer is needlessly suffering with this artificial inflation. The Medical Device Market in India which is over Rs. 70,000 crore at retail and institutional level is mainly dominated by imports. Corporate Hospitals and MNC’s have lobbied for 0% import duty in name of affordability and accessibility of medical devices over the last 10 years without any proof of passing reduction of MRP to consumers who have actually suffered by Mar-Apr. 2019

artificial inflation. Retailers and hospitals prefer to use imported devices with derived higher profitability as in many cases imported unit packs do not carry MRP but this is labeled only on their shelf box which enables them to charge any price as per their discretion and also for many medical devices the importers by claiming goods are for institutional sales and not for sales over the retail counter so MRP not applicable. Domestic manufacturers need to print MRP on unit pack and complied.

On the devices that did carry MRP the market has witnessed huge disparities in MRP between brands of various suppliers for same / similar products as a higher MRP (and higher trade margin) strategy to induce retailer and hospital to push their brand. The market is not operating based on open competition to drive down prices but is skewed leading to rapid artificial inflation as domestic manufacturers also increase their MRP to catch up and offer similar profitability. http://pharmabiz.com/NewsDetails.aspx?aid=114583&sid=1

Government To Introduce Provision For Compensation For Faulty Medical devices / Implants The government was likely to introduce a provision within existing regulations for compensation in future cases of faulty medical devices and implants.

India, Dr S. Eswara Reddy, told Business Today. The government, he said, was likely to introduce a provision within existing regulations for compensation in future cases of faulty medical devices and implants.

The government clearly intends to make an example of Johnson & Johnson by directing the firm to pay hefty compensation to the first victim of a faulty hip implant it manufactured.

Meanwhile, a government committee is examining other cases relating to J&J hip implants for possible compensation. With J&J asserting that the matter is subjudice, this move by the government would be a step towards ensuring that compensation is legally enforceable.

And, to deal with any future cases, the government may soon lay down norms for compensation, the Drug Controller General of

https://www.businesstoday.in/magazine/the-buzz/deterrentmeasures/story/329203.html

After J&J Implant row, Govt Plans To Hire 750 Officers To Regulate Medical Devices Plan is to hire these officers, who will exclusively regulate sale of medical devices such as coronary stents & hip implants, through a written exam conducted by UPSC.

New Delhi: The Modi government plans to recruit 754 officers to exclusively regulate the sale of medical devices and monitor their efficacy in India, ThePrint has learnt. The proposal includes forming a vertical body under the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority for drugs and medical devices. These 754 officers will be separate from the existing drug regulatory officers, who also function under the CDSCO but primarily regulate medicines, besides monitoring devices such as coronary stents, pacemakers, orthopaedic knee implants and hip implants among others. The government’s decision to consider this long-pending demand is a fallout of the controversy over the faulty Johnson & Johnson Articular Surface Replacement (ASR) hip implants. As pointed out by The Indian Express, the government had granted a fresh registration certificate for the ASR implants in 2009, the same year that the implants were recalled in Australia. The implants have hurt more than 4,000 patients in India, with Mar.-Apr. 2019

government efforts to ensure compensation for them stuck in a stalemate with the American pharma major. The Modi government is now acting on a report submitted by the Drugs Technical Advisory Board (DTAB) — the country’s highest statutory decision-making body on technical matters related to medicines and medical devices. The report is a result of a meeting the DTAB held on 2 April. “The idea is to do fresh recruitments and create a separate vertical altogether,” said a bureaucrat from the Ministry of Health and Family Welfare, which oversees the DTAB. “Presently, we don’t have even half of the manpower as planned (at CDSCO). This had led to a huge workload on the regulator and hence, strengthening the medical device vertical is the need of an hour.” The proposal The DTAB proposal calls for the government to deploy 754 officers. Around 449 of these officers are to deal with regulatory affairs such as audits at manufacturing sites, granting approvals

for imports, cancellation and approval of trade licenses among others. The remaining 305 are to be laboratory personnel to check the safety and efficacy of devices apart from cross-checking the claims made by the manufacturers. The government plans to hire these inspectors through a written examination conducted by the Union Public Service Commission. The DTAB has also proposed that the new body should be led by an additional drugs controller who will be assisted by four joint drugs controllers — one each for invasive medical devices, noninvasive medical devices, in-vitro diagnostic medical devices and legal enforcement and training. “There should be 12 deputy drugs controllers, 48 assistant drugs controllers, 192 inspectors and 192 assistant inspectors for medical devices,” the DTAB proposal reads. The DTAB has also proposed to recruit 31 experts — orthopaediacians, dermatologists, surgeons, biomedical engineers, biocompatibility experts, and cardiologists — on deputation or on contractual basis for advice on medical devices pertaining to their specialisation.

Body may take years to form, industry experts Industry experts, however, are sceptical about the proposal, suggesting that it is time-consuming and may take several years before becoming fully effective. “It will take 5-10 years to create the infrastructure and put the requisite manpower in place,” said Rajiv Nath, forum coordinator at the association of Indian Medical Device Industry (AiMeD). “Moreover, we are increasing the size of our regulatory departments at a time when across the world regulators are downsizing their staff by delegating the work to professional agencies.” Nath is referring to programmes such as the Medical Device Single Audit Programme (MDSAP), developed by global medical device and drug regulators of five countries to jointly leverage regulatory resources. The five countries are Australia, Brazil, Canada, Japan and the United States. These audits are conducted by professional auditing organisations that are authorised by the global regulators involved. https://theprint.in/india/governance/after-jj-implant-row-govtplans-to-hire-750-officers-to-regulate-medical-devices/222442/

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Mar-Apr. 2019

Industry News Milacron Investing $30M In Second India Factory Satnam Singh Milacron CEO Tom Goeke and Mahendra Patel, vice chairman of Milacron's India operations, at Indiaplast 2019. Greater Noida, India — Milacron Holdings Corp. plans to invest at least $30 million in a second plastics machinery factory in India in the next two years to handle growth there, the company's top executive said at a recent trade show in the country. Currently, the Blue Ash, Ohio-based company operates a plant in the city of Ahmedabad, in the western Indian state of Gujarat, where it makes about about 2,400 injection and blow molding presses annually. But that site is nearing capacity, Milacron CEO Tom Goeke said. "The existing site could produce up to 3,000 presses yearly with some more investment. The Gujarat plant could handle the demand up to the next two years only," Goeke said, adding that "capacity would likely be utilized fully by 2020 and a new production facility is required in 2021."

The company said it supplies about 1,700 presses in the domestic market and exports about 700 to neighboring countries in the South Asia Association for Regional Cooperation bloc, such as Bangladesh and Sri Lanka, along with the Middle East, Africa and the United States. About two-thirds of its exports go to Africa. Goeke said India's economic growth and expanding plastic processing industry drives the investment. "With India's GDP surging at around 7.5 percent yearly, the plastic business could go up at 8-10 percent annually as plastic consumption grows," he said. In January 2018 Milacron announced it would close a factory in Malterdingen, Germany, a year ahead of schedule, and said it was evaluating shifting that work to its plants in the United States and India. The new plant in India would design and build next generation all-electric injection molding presses, the company said.

He spoke in an interview at the Indiaplast 2019 show, held Feb. 28-March 4 in Greater Noida, near New Delhi. Milacron was showcasing its range of presses at the fair.

Goeke said the new site would employ about 1,000. The company currently employs about 1,000 in Gujarat, and another 400 at its Mold-Masters hot runner subsidiary in Coimbatore, in southern India.

"The new site involves an investment of between $30 million-$40 million over a period of three years," Goeke said.

Goeke said the ongoing trade tiff between the U.S. and China has started to negatively impact the company's sales.

The company, which opened the Ahmedabad factory in 1995, would likely put it close to the current factory to capitalize on existing manpower.

"Negotiations between both the countries are going on. We will see if it goes longer or is settled by March [or] April," he said. "But we are anticipating it to be resolved by March."

"India's evolving dynamics fits in to our growth strategy as there is a market opportunity to grow, availability of local talent to support the growth and passion among the people to make that happen," he said.

He said the trade spat impacts the company's China operation, with slower orders specifically for the Mold-Master business.

The second plant would likely be spread over more than 320,000 square feet and add capacity of 2,000 presses annually, ramping up the cumulative capacity of two Indian plants to 5,000 units yearly. The new plant could add more capacity over time, he said.

"Our equipment business is small, around 350 in China, which has also become slower," he said, without sharing the exact number. Milacron posted revenue of $1.2 billion in 2018, with the India business growing by more than 10 percent and contributing about 10 to 15 percent of the company's total revenue.

"We are evaluating all options as it would either be greenfield or a brownfield facility which may involve buying out an existing operational site," Goeke said.

At last year's Plastindia 2018 trade fair, Milacron said it would invest $8 million in expanding existing operations in Gujarat to bring that plant's capacity up to 3,000 injection presses.

The company's existing India factory makes injection presses from 50-3,200 tons and exports about 35 percent of its production.

https://www.plasticsnews.com/article/20190305/NEWS/ 190305454/milacron-investing-30m-in-second-india-factory

Maharashtra Price Cut Boosts Use Of Drug- Eluting Stents : Study MUMBAI: Underlining the effect of price control in healthcare, a new research paper by state government doctors and high ranking bureaucrats shows that the use of drugeluting stents (DES) among poor cardiac patients ballooned to 70% from 40% after these became cheaper. Till 2013, a majority of poor patients-almost 60% - got bare metal stents which cost one-fifth of DES but are not as effective in preventing reappearance of blockages in arteries. Maharashtra took up price control strategies in 2014 after it introduced free health insurance for families that earn less than Rs. 1 Lakh per annum. It invited tenders from various companies for DES and managed to get the latest generation stents for around Rs. 30,000 from 2014-15. State bureaucrats shared a note on this experiment with the Centre, which capped the price of stents at Rs. 29,600 in 2017. Mar.-Apr. 2019

Industry News Now, the effect of the state experience from 2013 to 2015 has been captured in a research paper appearing in the April issue of the medical journal ‘Circulation: Cardiovascular Interventions’. Authored by former health secretary Sujata Saunik and cardiologist Bhanu Duggal from state-run J J Hospital in Byculla, the paper looked at stent use among 2,274 beneficiaries of the state government’s free health Insurance scheme in 87 hospitals from 2013-2015. “The proportion of DES use rose in the overall study population from 40.7% to 71.3% after institution of the price reduction strategy,” said the paper. Dr. Duggal said, “By the price lowering strategy, millions of people of lower socio-economic strata suddenly had access to the best drug-eluting stents.” The increase was seen in both public and private hospitals, with almost 96.2% patients in public hospitals and 65.2% in private hospitals getting DES. “In private hospitals, only 32.7% of all angioplasty patients under the scheme would get DES and the remaining would get bare metal stents,: said Dr. Duggal. The study, though, found that the use of DES continued to be lower despite the price reduction in vulnerable groups such as the elderly, women, and the poorly educated. The paper underlines how pricing mechanism is important to improve healthcare access. “Our people deserve better quality stents. Just because they are getting treated in public sector,

should they be implanted with bare metal stents? Asked Saunik. A previous study last year by the same doctors found that the use of DES had led to better survival outcomes among patients in Maharashtra. Incidentally, on April 1, the Union government increased the cost of stents by 4.2% to Rs. 30,080. Saunik, who conducted this research as a part of her study leave to Harvard T H Chan School of Public Health in Boston, said, “As a policy-maker, the evidence is clear that government can control the prices and also provide insurance coverage as it reduces costs. In this way, insurance cover can remain sustainable over time.” If costs keep rising every two years and volumes increase, the government spend will also increase, she added. Dr. Brahmajee Nallamothu from the University of Michigan, who is also an author in the study, noted that improvement in the quality of made-in India stents might help. “Stents are a cornerstone therapy for coronary artery disease, a growing problem in India. In Western countries, DES are the most common type of stent used. But their high costs have led to limited access among lowincome patients in India, but the study shows improved access,” he added. https://timesofindia.indiatimes.com/city/mumbai/maharashtraprice-cut-boosts-use-of-drug-eluting-stents-study/articleshow/ 68803624.cms?utm_medium=referral&utm_campaign=iOSapp &utm_source=WhatsApp.com

Cipla Targets Small Airway Respiratory Disease With An Innovative Two-In-One Inhaler In an effort to address patients with small airway respiratory diseases, drugmaker Cipla has rolled out its extra-fine particle beclomethasone-formoterol combination hydrofluoroalkane (HFA) inhaler for adults, touted to be the first of its kind in the country. This is not an innovation in isolation, said Cipla’s India business head Nikhil Chopra, referring to other novel respiratory products from the company including its breath-actuated inhaler with dose counter called Synchrobreathe. The latest two-in-one inhaler Niveoli is a product of about three years of research, and addresses an unmet need associated with obstructive airway diseases (OAD) such as asthma and chronic obstructive pulmonary disorder (COPD), Chopra told BusinessLine. Role in asthma, COPD Small airway diseases are known to have a significant role in asthma and COPD, he said, and often such patients were seen to not get the desired relief from their existing medication. The new inhaler is priced at ?595 for 120 doses, working out to about a month’s supply for a person with mild or moderate asthma, doctors familiar with the product said.

Sujeet Rajan, a consultant respiratory physician with Bombay Hospital, observed that CT scans were revealing more people with small airway diseases. And this accounted for why some patients were not responding as desired to their earlier medication, he said, adding that the extra fine-particle inhaler would bring much relief such patients. In fact, even regular patients with mild or moderate asthma were seen to be open to this inhaler that used half the dose of steroid (beclomethasone), he said. The next step should be to have a similar product with greater strength so it can be used in severe cases, he suggested. Chopra said that there were about 93 million people with asthma and COPD and only half that number is diagnosed. Making matters worse, only 15 per cent adhered to their treatment regimen, he said. https://www.thehindubusinessline.com/companies/cipla-targetssmall-airway-respiratory-disease-with-an-innovative-two-inone-inhaler/article26817726.ece

Opto Circuits Expects To Grow At 25% During The Current Year The focus on research and development activities has enabled the company to develop devices which are technologically superior to other devices available in the market.

to deliver good fourth quarter performance. This would result in 25% growth in revenues and profitability of the company during the current year.

Opto Circuits India, the leading global medical devices and technology group with a diversified product portfolio, dealing in products like vital signs monitoring, emergency cardiac care, vascular treatments and sensing technologies expects to grow at 25% during the current year.

The company has undergone various market related challenges across the geographies and is fairly able to come out of majority of them and had started fresh life last year with a profit of Rs. 35 crore and revenues of Rs. 225 core.

The company has already achieved last year revenues in the first three Quarters [April to Dec 2018]of the year and expected

Going forward the company is expecting good growth from both domestic and international business. The company’s subsidiaries also seeing good flow of orders. Mar-Apr. 2019

Industry News The Indian medical device market is growing steadily and it is valued at US $4.8 billion. With the company’s focus on driving organic growth in India and with the Indian medical device industry though in its nascent stages shows great potential for the company. Other factors like strong private healthcare system, growing middle class with increasing income levels, change in the disease profiles (lifestyle diseases), greater penetration of health insurance, Government focus on healthcare infrastructure development and arising awareness of personal health care the company sees a great scope for its growth in India. Currently the company along with its subsidiaries are engaged in the design, development, manufacture, marketing and distribution of a range of medical products that are used by primary, secondary and tertiary healthcare establishments as well as in public access facilities such as schools, fire stations, policy offices in over 150 countries. The company specializes in vital signs monitoring, emergency cardiac care, vascular treatments and sensing technologies. The US FDA listed and CE marked products are manufactured in

India, Malaysia, Germany and the United States. The company’s biggest competitive advantages is the propriety technology developed by the in house teams which gives the company the control over features and intellectual property costs of devices and helps minimize their dependence on third party technologies. The focus on research and development activities has enabled the company to develop devices which are technologically superior to other devices available in the market. Commenting on the development, Mr. Vinod Ramnani, Chairman, Opto Circuits India said, “As India's economic, healthcare, and social landscapes evolve, its medical device market emerges as a promising opportunity for manufacturers like us. Also, with medical tourism and luxury healthcare markets are among India's fastest growing industries, which create significant demand for specialized, high-tech medical equipment. We have streamlined all our businesses and on the path of delivering healthy growth for the next two to three years.” https://www.biospectrumindia.com/news/74/13036/optocircuits-expects-to-grow-at-25-during-the-current-year.html

Ascent Meditech Embarks On Rs.70 Crore Expansion Plan To Achieve Four Times Growth In Next Five Years Aiming to grow four times in the next five years, Ascent Meditech, a Mumbai-based leading player in orthopedic soft goods (OSG), mobility, wound-care and healthcare products, has embarked on a Rs.70 crore expansion plan to set up a state of the art integrated manufacturing plant spread over 15-acre land in South Gujarat. The plant will be operational by Q1 in fiscal 2020-21 and is expected to increase the production of orthopedic soft goods, mobility, wound-care and healthcare products to around 2 lakh units from the existing 40,000 pieces at five plants in Daman to cater to the growing demands in domestic and global markets, said Rajiv Mistry, founder and managing director, Ascent Meditech Limited. The company, which currently has more than 350 products under the Flamingo brand, has raised growth capital of Rs.70 crore from the UK-based private equity player LeapFrog which will be utilized to set up advanced manufacturing facility, he informed. The plant will comply with regulatory norms governing all medical devices from April 2020 and help the company overcome the capacity constraints, he said, adding that as of now certain products in wound care segment are regulated under Medical Devices Rules 2017 but orthopaedic soft goods are unregulated. The orthopaedic soft goods market is highly unorganized in the absence of regulations thus hampering the growth of the segment. Currently, OSG industry in India is estimated to be worth Rs.2,000 crore growing at a rate of 15-18% annually but we are growing at 35% CAGR over last 27 years. Our current turnover stands at Rs.140 crore. Of them, export constitutes 20% of the turnover. The company exports products to 47 countries including UK, Canada, Australia, he stated. Talking about changing trend in OSG segment, Mistri said “Earlier critical patients used OSG on the advice of medical practitioners. Now people started buying OSGs for pain management on Mar.-Apr. 2019

their own thus fueling the growth of the segment. An OSG can be used in injuries caused by fractures, muscle pain, and other orthopedic complications. The industry is at a nascent stage and that awareness can help increase user base.” Shedding light on business prospects, he said “The aim of the company is to make product affordable and exploit the untapped potential of Asian, African markets. We want to reach out to emerging markets having higher population to reap benefits. We will soon foray into sports, fitness and mobility products in a big way.” http://pharmabiz.com/NewsDetails.aspx?aid=114707&sid=1

Events Calender Seminar on “Advances and Developments of Plastics in Medical Sector” 24 July, 2019, Venue : Pune 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 Medical Fair India 2020 26th International Exhibition and Conference 5 - 7 March, 2020 Bombay Convention & Exhibition Centre, Mumbai Medica 2019 Leading International Trade Fair 18 - 21 November, 2019, Dusseldort, Germany Compamed 2019 Leading International Trade Fair 18 - 21 November, 2019, Dusseldort, Germany

Event Reports

K 2019 Düsseldorf – Driving force for innovation and international business Messe-Duesseldorf the organizers of K 2019 - the World’s No.1 Trade Fair for Plastics and Rubber, arranged media and industry interaction at Ahmedabad and Mumbai during the second week of March 2019. On the panel in Ahmedabad, were Mr. Werner M. Dornscheidt, Chairman of the Board of Messe Düsseldorf GmbH, Dr. Büschl - Member of Exhibitors’ Council K 2019, Mr. Thomas Schlitt - Managing Director, Messe Düsseldorf India & Mr. Jigish Doshi – President, PlastIndia Foundation, while the panel in Mumbai had Mr. Werner M. Dornscheidt, Chairman of the Board of Messe Düsseldorf GmbH, Dr. Büschl Member of Exhibitors’ Council K 2019, Mr. Thomas Schlitt - Managing Director, Messe Düsseldorf India, Mr. Ajay Shah – National Executive Council Chairman, Plast India 2021 & Mr. Meela Jayadev – President, AIPMA who interacted and updated the Industry on the latest developments at K 2019 , market trends and Industry insights”

Other Important Features of K-2019 Fair are : • Key performers: Polymer materials • Addressing challenges • Special presentation “Plastics shape the future” • Special: Science Campus • Bioplastics Business Breakfasts • Excellent ratings from visitors • K 2019 – on all channels with smart online services • Optimized matchmaking tool • Düsseldorf: A destination that always appeals • K 2019 – Looking at the future of the industry

More than 3,000 businesses from the plastics and rubber industry will again present products, processes and practical solutions for a productive and responsible future. K Düsseldorf has been the most important meeting place of the international plastics and rubber industry for 68 years – and counting. At tri-annular intervals, exhibitors and visitors from all global continents come together in Düsseldorf in order to present and experience at first hand leading edge developments and products from this dynamic and innovative industry. They use the opportunities offered by the K flagship fair, a unique information and networking platform for innovators seeking new prospects. Only in Düsseldorf, can visitors experience and compare such a varied and international range of developments, solutions and trends and enjoy a practical discourse with experts. Only the K trade show features such a high density of international product launches. In terms of importance, the K plastics flagship fair leaves all other international events of its kind far behind. K 2019 represents the industry’s complete production chain in unparalleled depth and breadth including rubber, which plays an important role, despite the fact that this segment is rather small compared to other segments of the plastics industry. Important user industries however, attach major importance to it and its highly innovative developments. Rubber Road in hall 6 is an indispensable constituent of the K exhibition and is much appreciated and cherished by visitors.

Mar-Apr. 2019

Event Reports MEDICAL FAIR INDIA was in top shape for its anniversary with an increase in exhibitors and visitors

Expansion of themes around rehabilitation and care met with broad approval

MEDICAL FAIR INDIA proved to be in top shape for its 25th anniversary with a record number of over 600 exhibitors from 25 countries and over 15,000 visitors. MEDICAL FAIR INDIA is the leading trade fair for the Indian healthcare industry and took place from 21 to 23 February in New Delhi (Pragati Maidan). This signifies an increase in visitors compared to both last year’s event in Mumbai (12,350) as well as the event in New Delhi in 2017 (13,480). “MEDICAL FAIR INDIA can keep up with global developments, shows innovations based on current trends, offers a varied program for deepening knowledge and expert dialogues and has proved to be the ideal platform for market access from the providers’ point of view,” says Thomas Schlitt, CEO of Messe Düsseldorf India, explaining the main success factors in a nutshell. At the same time, Schlitt points out that domestic companies view the trade fair as promoting economic development: “The exhibitor pavilion “Make in India”, presented by the Association of Indian Manufacturers of Medical Devices (AIMED), was spectacular and confirmed India’s tremendous potential as a centre of design, innovation, manufacturing and export. The new subject segment “rehaindia”, with a range of products and services for rehabilitation and care, was well-received by exhibitors and visitors alike. “MEDICAL FAIR INDIA 2019 proved to be a great platform for business development. The rehaindia concept is innovative and increases the attractiveness of the event,” says Biju Sebastian Alex, Senior Manager for Sales & Marketing at the internationally active group DeVilbiss Healthcare (USA), positively summing up the event. CU Medical Systems (South Korea) were also on the lookout for new business partners, according to Sales Manager Jonathan Barkai. “We see great opportunities in the Indian medical device market and that is why taking part in this trade fair was important to us with regard to our growth plans.” The YTY Group (Malaysia) comes from a similar starting point, as Bhaskar Mukherjee, Vice President for India, states: “As the industry leader for disposable hand protection solutions and an OEM provider for leading global brands, MEDICAL FAIR INDIA

Mar.-Apr. 2019

proved to be an effective platform for us which enabled us to meet national distribution partners and gain an understanding of the possibilities and complexity of one of the largest emerging markets.” Once again, the event’s supporting program contributed to the success of MEDICAL FAIR INDIA 2019. Here, we find established elements such as the CLIN LAB INDIA, organised in cooperation with Scherago (USA) and Health Care Events (India), a conference with an exhibitor area on trending topics in laboratory medicine as well as the two-day conference Voice of Healthcare. Here, the popular sessions looked at current technology trends and aspects of international cooperation with manufacturers and institutions, among other topics. One highlight was the anniversary gala on 22 February, at which a big announcement was made: With the FAMDENT shows, Messe Düsseldorf India has acquired the top specialist events in the field of dentistry. These events are now members of MEDICAlliance, the umbrella brand for the Messe Düsseldorf Group’s global healthcare trade fair activity. Thomas Schlitt signed an agreement to this effect on behalf of Messe Düsseldorf India, as did Dr. Anil Arora and Dr. Jyotika Arora, who have organized all the FAMDENT shows. In terms of content, the MEDICAL FAIR INDIA 2019 included the following areas and many more: Medical Products and Medical Technology, Laboratory Technology and Diagnostics, Equipment and Furniture for Clinics and Health Centres, Products for care and Rehabilitation and Health IT and Mobile health solutions. All the details on MEDICAL FAIR INDIA are available online at: http://www.medicalfair-india.com The next MEDICAL FAIR INDIA will take place from 05 to 07 March 2020 in Mumbai (Bombay Convention & Exhibition Centre).

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

Mar-Apr. 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 Nov.-Dec. 2018

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

Nov.-Dec. 2018

Product Gallery Qosina Stocks Full Line of CPC® AseptiQuik® G and S Series Connectors

Ronkonkoma, NY, USA, March 4, 2019— Qosina, a trusted distributor of innovative CPC® quick disconnect couplings, now carries the full line of AseptiQuik® G and S Series connectors. These connectors are ideal for providing easy sterile connections for small-flow applications—even in non-sterile environments. The G and S Series connectors boast a genderless design, which allows them to mate universally, simplifying system integration. Their intuitive, three-step FlipClick-Pull function promotes reliable execution, reducing the risk of operator error. The robust construction eliminates the need for clamps, fixtures or tube welders, and the integrated pull-tab covers maintain sterility and ensure simultaneous removal of both membranes. Qosina will be conducting a live demo of the AseptiQuik® G and S Series connectors on March 12-13 at Booth 400 during the BioProcess International Conference & Exhibition at the Santa Clara Convention Center in Santa Clara CA.

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 Multi-Purpose, Single-Use Hand Instruments Are Ideal for Procedure Kits

Ronkonkoma, NY, USA, April 1, 2019— Qosina stocks a wide selection of singleuse hand instruments in an assortment of lengths, colors and distinctive style tips. These tools are suitable for use in many diverse applications and industries, and are ideal for kit-packing. They are constructed of high quality plastics and stainless steel, and are designed to perform under the toughest conditions. Qosina’s single-use hand instruments are cost-effective; there are no maintenance, repair, sterilization or reprocessing fees. The tools are sturdy and reliable, greatly reduce the risk of cross-contamination and provide added assurance of functionality. 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. Mar.-Apr. 2019

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. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty supplies to the cosmetic, skincare, spa and salon industries. Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

Book Review

Emerging Trends in Medical Plastic Engineering and Manufacturing Markus Schonberger and Marc Hoffstetter A practical guide to the state of the art technologies in plastics for medical Devices and healthcare applications, enabling engineers to anticipate new developments and gain a strategic advantage over competitors. Description Emerging Trends in Medical Plastic Engineering and Manufacturing is a roadmap to the emerging technologies for polymers in the medical device industry – including coverage of autoregulated volume – correction to achieve zero defect production, the development of “intelligent” single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes. As medical devices get smaller, the book discusses the challenges posed by miniaturization for Injection Molders, and how to respond to these challenges. Additionally, the book examines rapid prototyping technologies in detail, as these open up the possibility of new treatments with individually tailored medical devices and implants. The authors discuss where rapid manufacturing technologies are feasible, which materials are appropriate for such ventures, and the potential challenges.

ABOUT THE AUTHORS

Markus Schonberger Dr. Markus Schonberger holds a diploma (M.Sc. equivalent) and a PhD (Dr.-Ing) in Mechanical Engieering. He is employed currently as a Head of R&D at Frank Plastic AG (Waldachtal. Germany). Marc Hoffstetter Dr. Marc Hoffstetter holds a diploma in Mechanical Engineering (M.Sc. equivalent) and a PhD (Dr.Ing) in Biomedical-Engineering. He developed profound knowledge in medical device development, injection molding and biomaterials during this previous research at the Institute of Medical and Polymer Engineering of the Technische Universitat Muchen and as Manager Medical Devices at Scholz-HTIK GmbH (Kronach, Germany). Currently, Dr. Hoffstetter is employed as Head of R&D at MAVIG GmbH (Munich, Germany). Publisher : Matthew Deans For more details : www.elsevier.com and www.bookaid.org

This book will enable product designers, biomedical engineers, polymer processing engineers and manufacturing engineers to navigate and anticipate the special requirements of this field in relation to biocompatibility, sterilization methods, and government regulations. The information provided in this book is also useful to materials scientists working in this field.

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.

Mar-Apr. 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

Mar.-Apr. 2019

0434

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 48

Mar-Apr. 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

Mar.-Apr. 2019

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

Mar-Apr. 2019

GMP ISO - 9001-2008 Certified Company

S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980

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

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

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 Mar.-Apr. 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 51

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

Mar-Apr. 2019

Medical Plastics Data Service Magazine March - April 2019

Articles inside

TECHNOLOGY

EVENT CALENDER & EVENT REPORTS

AiMeD & REGULATORY UPDATES

INDUSTRY NEWS

COVER STORY

Such technologies priced at affordable levels have the potential to transform the healthcare landscape if used at scale

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