Medical Plastics Data Service Magazine July - August 2019

Table of

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41 42 18 42 July-August 2019

No. 4

July-August 2019

COVER STORY Global Trends In Medical Plastics Technology And Applications - Dr. Ajay D Padsalgikar - Ph.D. DSM BioMedical Pennsylvania, USA The worldwide medical devices market is expected to grow at a rate of 6% per annum for 2019-2024.

More than half of market for medical devices comprises market for implantable medical devices…

COVER STORY NMDPC : To Catalyse Growth of Medical Device Sector in India - Dr. Jitendar Sharma - Member Secretary, National Medical Devices Promotion Council and MD & CEO AMTZ. NMDPC is poised to be the National Forum now to discuss and consult stake holders of the Medical Device ecosystem and partner with organizations of international repute…

EDITORIAL BOARD MPDS Welcomes Two Distinguished Experts To The Editorial Advisory Board Dr. Ajay D Padsalgikar, Ph.D. Senior Principal Scientist DSM Biomaedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D

TECHNOLOGY

Better Hearing Thanks To Laser Welding - Phonak Hearing Aid : The development of hearing aids has been facilitated by the incorporation of laser welding using the mask welding concept.

Call For Technology Transfer & Industry Driven Products : Sree Chitra Tirunal Institute For Medical Sciences & Technology invites proposals for developing products of interest to industry....

MED TECH START-UPS • DRIPO - A Portable Infusion Monitor To Be Attached To IV Sets • Karnataka Govt And IISc To Support Medical Device Start-Ups To Create Affordable Product Solutions

GLOBAL TRENDS • Increasing Ageing Population Drive Global Medical Plastic Compounds Market • How Raumedic Are Achieving Enhanced Sliding Properties In Thermoplastic Products

AiMeD & REGULATORY UPDATES • • • •

How GST Failed Medical Devices Health Ministry Constitutes MDTAG To Advise CDSCO On Matters Related To Regulation CDSCO Notifies 6 Bodies To Audit Medical Device Manufacturing Sites MVPI Reports 1,213 Medical Devices Adverse Event Reports From Across Country Since 2014

INDUSTRY NEWS • Meril Life Sciences Receives CE Marking For Bioresorbable Scaffold Stent

PRODUCT GALLERY • Open-Bore Syringes

CORPORATE

18 • Qosina Launches European Operations

DID YOU KNOW? • About Innovation Challenges For New Developments In Medical Device Sterilization

EVENT CALENDER 17

Flashback Select Article Index

Sept 2011 to March 2012 • Technology : All Electric Plastic Injection Moulding Machine For Medical Application (September – October 2011) Mr. Kaushik Bhuva, Ferromatik Milacron India, Manager- Design & Development • Global Trends : Global Medical Device Industry Report (September – October 2011) • Global Trends : Driving Biomedical Innovation : Initiatives to Improve Products for Patients (September – October 2011) • Did You Know ? : About Ultrasonic Welding For Assemblying Of Medical Components (September – October 2011) • Learning Zone (Basic-Discoveries-Innovations) : Plastic Sleeves That Cures Diabetes (September – October 2011) • Cover Story : Indian Medical Device Industry – Quality Management (November – December 2011) • Technology : Medical Plastics Creating Better Healthcare Delivery Options (November – December 2011) Paresh Mehta, Director, Welset Plast Extrusions Pvt Ltd, Mumbai • Global Trends : US FDA issues two draft guidance documents to facilitate medical device studies in humans (November - December 2011) • Did You Know ? : About Risk Management For Medical Devices (November – December 2011) • Learning Zone (Basic-Discoveries-Innovations) : Chest Drainage (November – December 2011) • Materials : Silicon in Perfection - Moulding and Application (January – February 2012) Mr. Sanjiv Mukund Lakhani - Operations Manager, ET Elastomer Technik, Germany

Did You Know ?

About Innovation Challenges For New Developments In Medical Device Sterilization.

?

The FDA is sponsoring two public innovation challenges to encourage new developments in medical device sterilization.

1 : Identify New Sterilization Methods and Technologies 2 : Reduce Ethylene Oxide Emissions Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe.

For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process.

Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide.

Literature shows that about fifty percent of all sterile medical devices in the U.S. are sterilized with ethylene oxide. The types of devices that are sterilized with ethylene oxide range from devices used in general health care practices (for example, wound dressings) to more specialized devices used to treat specific areas of the body (for example, stents).

For ethylene oxide sterilization, two voluntary consensus standards (ANSI AAMI ISO 11135:2014 and ANSI AAMI ISO 10993-7:2008(R)2012) describe how to develop, validate, and control ethylene oxide sterilization processes for medical devices and the acceptable levels of residual ethylene oxide and ethylene chlorohydrin left on a device after it has \ undergone ethylene oxide sterilization. These standards help ensure levels of ethylene oxide on medical devices are within safe limits since long-term and occupational exposure to ethylene oxide has been linked to cancer.

The Environmental Protection Agency (EPA) reviews and enforces the Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that they protect the public from significant risk.

On July 15, 2019, the FDA announced two public innovation challenges : • Challenge 1 : Identify New Sterilization Methods and Technologies : The goal of this challenge is to encourage the development of new approaches to device sterilization methods or technologies for medical devices that do not rely on ethylene oxide.

• Challenge 2 : Reduce Ethylene Oxide Emissions : The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process. (https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethyleneoxide-sterilization-medical-devices )

• Global Trends : Most Medical Implants Never Tested for Safety (March - April 2012) • Global Trends : US Medical Device Companies Visit India to Explore Burgeoning Healthcare Market (March - April 2012) • Technology : Innovative Antimicrobials Growing Potential for Medical Market (March - April 2012) • Technology : Designing Medical Devices for Global Health Both “Difficult” and “Thrilling” (March - April 2012)

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The Greatest Danger In Times Of Turbulence Is Not Turbulence.

It Is To Act with Yesterday's Logic -Peter Drucker

July-August 2019

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.

EDITORIAL ADVISORY BOARD 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 Mr. 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.

Dr. AJAY D. PADSALGIKAR, Ph.D. Senior Principal Scientist DSM Biomedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.

However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

July-August 2019

Editor’s Desk

From the

Use and Selection of Polymers for Medical Applications Polymers / Plastics are the major constituents of a large number of Medical Devices and the trend is increasing day by day resulting in the growth of medical plastics materials world over. While there is no doubt about the importance of plastics for medical applications, it is necessary that the specific material/s used remain fit for the purpose for which the device is to be used and continue to meet the design specifications for the shelf life of the product. The material has to fully take care of the mechanical, physical and environmental conditions that the devised might get exposed to along with the conditions during processing, assembly, storage, transport and use.

In an very analytical article, Dr Ajay Padsalgikar, Senior Principal Scientist, DSM Biomedical Exton, PA, USA has highlighted many important and critical issues related to “Global Trends in Medical Plastics Technology and Applications”.

Discussing the background and importance of use of Plastics in Medical Devices, Dr Ajay has given detailed information on various materials (polymers) and their respective applications. He has shared very elaborate information on opportunities/ important applications in the specialised field Cardio-Vascular, Neurological Devices and Drug – delivery devices while also explaining operations and manufacturing of medical plastics components.

The National Medical Devices Promotion Council ( NMDPC ) We had already covered the announcement of formation of NMPDC with an objective to promote and facilitate the Indian Medical Device Industry by creating a nurturing ecosystem in one of our earlier issues. While briefing on the key activities of the council, Dr Jitendar Sharma, Member Secretary, NMDPC and MD & CEO, AMTZ, has given detailed information on how the council is trying to boost indigenous manufacturing particularly monitoring the tenders floated by various State & Central Govt. agencies.

A technical article introduces a new welding technique – Laser Welding, a patented mask welding process – developed and patented by the Swiss laser system manufacturer Leister Process Technologies. The article gives a detailed case study on how the technique provides improvement in quality of life of people with hearing damage.

Medical Plastics Data Service Welcomes Two Distinguished Experts To The Editorial Advisory Board.

The continued success of our magazine- being published since last 27 years is because of the strength, support, advice and guidance from learned members of our editorial advisory board and expert professional contributors both from India and abroad. We are happy to announce two more additions – Dr. Ajay Padsalgikar, an expert from US Medical Device Industry and Dr. K Sivakumar, a Pharmaceutical Technologist and Medical Device Expert from India – both with more than 4 decades of rich experience in the industry as detailed in this issue.

While the “Did You Know” column in this issue talks about “Innovation Challenges For New Developments In Medical Device Sterilization”, the issue also includes regular columns – Global Trends, Technology, Medtech startup, AiMeD, Govt, Notifications, Regulations, Industry News, Events etc.

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Cover Story

Global Trends in Medical Plastics Technology and Applications Dr. Ajay D Padsalgikar, Ph.D. Senior Principal Scientist DSM BioMedical in Exton Pennsylvania,USA ajay.padsalgikar@dsm.com

Introduction Medical science continues to advance in both disease treatment strategies and the understanding of medical conditions. Concurrent with these advances in health care, there is an increased use of medical devices targeted to treat several conditions. The global market for medical devices is estimated to be around $400 billion. With an increasingly aging population, greater governmental involvement and newer emerging markets, the worldwide medical devices market is expected to grow at a rate of 6% per annum for years 2019-2024 (Ref: The Global Market for Medical Devices, 4th Edition – Kalorama information). More than half of the market for medical devices comprises the market for implantable medical devices.

The medical device market in India is relatively small and in 2018 was estimated to be of the order of $5.2 billion (Ref: Invest India, GOI website). This figure is considerably small given the size and population of India, however, the growth rate over the coming years is

Medical Devices and Plastics Plastics have an inherent advantage over traditionally used materials, such as glass and metals, in medical devices. Plastics are lightweight, inexpensive and often compatible with bodily fluids. Most plastics are also comparable in density to the body and thus are easier to be incorporated into the body. They, for the most part, also have a high degree of resistance to chemicals, both natural and synthetic, that make them suitable to be used in medical applications.

Plastics can also be formulated with a myriad of different chemistries. They can be soft or hard, elastomeric or rigid, thermoplastic or thermoset etc.

They can also be formulated as biologically stable or degradable. A stable formulation is one that can resist the action of body fluids and can be inert, making them suitable for the construction of long term implants. A degradable formulation, on the other hand, can be broken down into easily digestible and harmless elements over time. The degradation can be programmed

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expected to be more than double the global growth rate. India is the fourth largest market for medical devices in Asia and the expected growth rate has the potential be close of 30% per annum.

The size of the market at the moment is partly due to the low per capita spend by the government on health care; another significant obstacle cited in the growth of the market is the lack of indigenous manufacturing.

Plastics constitute an important part of medical devices and the global market for plastics in medical devices is said to be close to $18 billion (Ref: Medical Plastics News, Feb. 2018). This figure includes plastics usage in everything from devices to diagnostics to packaging. With growth foreseen in the devices market, the growth in plastics usage in the devices should at least match that growth. Within the medical devices sector, about half of the market for plastics is in the area of implantable devices.

The role of the nature and properties of plastics in the correct functioning of a device is critical. Very often the selection of the plastic can dictate the efficacy of the device and the treatment of the disease. Unfortunately, during the design process of medical devices, the role of plastics is quite often either ignored or not well understood. There is, therefore, a strong need for the amalgamation of plastics professionals, polymer scientists and medical device design experts in order to exploit the full potential of plastics and facilitate effective treatment of medical conditions. to occur either at a specific time or upon a specific action. This makes biodegradable plastics attractive options in areas such as drug-device combinations and regenerative medicine.

The use of plastics in medical applications spans a wide spectrum of applications. Many plastics form a part of medical disposables such as wipes, bandages, syringes, tubes, blood bags, packaging materials etc. As the name suggests, these are discarded after a single use in a medical procedure. They do come in short-term contact with medicines and/or the human body.

The use of plastics has revolutionized the area of medical diagnostics. Whether it be in simple blood pressure measurement devices or the much more complex Magnetic Resonance Imaging (MRI) machines, plastic materials offer many advantages in the construction of this equipment such as design flexibility, light weight, robustness etc., this has enabled the doctors to diagnose the patient’s condition accurately and monitor the progress of any condition. Often these diagnostic equipment work outside the body and remain external.

July-August 2019

Cover Story The majority of medical devices are made to be implantable systems. These devices are implanted inside the human body and perform critical functions either in the area of drug delivery or regulation of some bodily function. Plastics form the core of many of these devices, and the properties of the plastic material allow greater functionality of the device.

The implantable devices are further divided into short term implantable and long term implantable devices depending on the duration of the dwell time of the implantable device inside the body. Most devices shorter than a 90 day dwell time are classified as being short-term implants. Biological stability becomes an important consideration for long term implantables.

Selection and Evaluation of Plastics The selection of plastic materials is clearly based on the properties of the material. The first criterion is the physical properties of the material. This is primarily based on the application and the requirements of the device.

Once a material is chosen based on the physical properties of the material, several other material properties allow for the evaluation of suitability of a particular material.

Thermal Properties: The behavior of the material in thermal environments is of interest. This is particularly relevant during sterilization of medical devices. The process of sterilization can be done under different conditions, usually at higher temperatures or with exposure to high energy radiation. The ability of the medical device material of construction to withstand these conditions is big factor in deciding the suitability of a material.

Chemical Resistance: The application of the device will determine the type and the frequency of contact with any chemical.

The chemical may either be a medicinal fluid or a bodily fluid.

The higher the resistance of the material to those chemicals, the greater will be the efficiency and longevity of the device.

Electrical Properties: Plastics are in general good electrical insulators; however, there may be differences in the specifics of their dielectric constant and breakdown voltages. Devices such as implantable cardioverter defibrillators (ICD) carry high voltages and depend on the surrounding insulation to withstand that level of voltage. Measurement of the electrical properties of a plastic material constitutes an important part of the overall characterization.

Polymer Composition: Very often additives such as anti-oxidants, ultra-violet protectors, plasticizers etc. are mixed into a plastic to enhance their performance. These additives, however, may not be compatible with body contact and this has to be carefully assessed before selecting a plastic. The extent of elution of the additives can be assessed by doing an extraction test in both polar and non-polar solvents. The extraction test conditions and solvents are clarified in the Internal Organization for Standardization (ISO) testing procedures, specifically ISO10993.

geometry aids mixing and are effective compounders.

Biocompatibility and Biostability : ISO 10993 also details out the protocol for the determination of the biocompatibility of a plastics. The series of toxicity tests, as given in the standards, clarifies the short term toxicity issues as well as the long term genetic issues resulting from the material. Quite often, the plastics material manufacturer also has this information in their product datasheets.

Another aspect that is important in long term implantable applications is the biological stability of the material, often referred to as the biostability of the material. When a device is implanted into the human body, the implantation of a biomaterial elicits an immediate response from the immune system of the human body.

This immediate response is intended to attack, destroy or isolate the foreign body as the body sees the implanted device as a foreign body. Monocytes, from the body’s white blood cells (WBC) also migrate to the site of inflammation and rapidly differentiate into macrophages. When macrophages encounter a foreign object that is too large to be phagocytosed, such as an implant, they adhere and fuse to form larger foreign body giant cells (FBGCs) in what is termed ‘frustrated phagocytosis.’ Clinical observations indicate that these adherent cells may persist at the tissue/implant interface for the lifetime of the implant. During frustrated phagocytosis, adherent macrophages and FBGCs form a closed compartment between the cell and the biomaterial that facilitates the generation of high local concentrations of reactive oxygen intermediates (ROIs), acids and enzymes at the cell /polymer interface. This is indicated in Figure 1.

Monocytes FBGS

White blood cells adhere and fuse to cover the foreign body (PU)

Adherent cells release oxygen radicals, hydrolytic exzymes

Figure 1: Depiction of the body response to the implantation of a biomaterial The ability of a plastic material to withstand these ROIs is key to the survival and functioning of the device. In addition to the ROIs that induce oxidation response in the material, it is also important that the material withstands the hydrolytic action induced by the hydrophilic components in the body. Therefore, it needs to be hydrolytically stable in addition to being oxidatively stable to function as a biostable material.

Additive packages most frequently used in medical applications are radiopaque additives such as Barium sulfate. These radiopaque materials do not allow x-rays to pass through them and they, therefore, are clearly visible in x-rays making them very useful in correct placement of devices.

Hydrolytic stability is often used in the opposite manner in the design of biodegradable plastics. Certain chemical bonds such as esters are very susceptible to hydrolytic action and thus are attractive as plastics that degrade in the body. The rate of degradation is dependent on the molecular weight and the structure and alterations to these can tailor the degradation rates. These biodegradable plastics are especially useful for shorter term implant devices that complete their function over a period of time and the device forms a part of the regenerative medical treatment.

The addition of most packages into polymers is done using twin screw extruders. Twin screw extruders with their variable screw

Processing: Processability is a big advantage of plastics as their ability to the transformed into a variety of complex shapes makes

July-August 2019

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Cover Story them very attractive for existing and new medical device designs.

Thermal processing is the primary route for plastics, however, other techniques involving solvents such as dipping and spraying are also popular. Thermoplastics are, with some exceptions,

are preferred over thermosets. Silicone polymers, one example of thermosets, are widely used in the medical industry. Silicone polymers are chosen mainly due to their chemical inertness, biocompatibility and biostability.

Below are some examples of plastics and their applications: Polymer

Medical Applications

Polytetrafluoroethylene (PTFE, Teflon, Gore-Tex®)

Vascular grafts, catheters, introducers

Poly(ethylene terephalate) (PET, polyester, Dacron®)

Vascular grafts, drug delivery, non-resorbable sutures

Poly(methyl methacrylate) (PMMA, Perspex, acrylic)

Bone cement, dental cement, intraocular lens

Polyurethane (PU, TPU, Pellethane, Bionate, Elast-Eon)

Catheters, tubing, artificial heart, pacing lead insulation

Silicone rubber (Polydimethylsiloxane, PDMS)

Catheters, feeding tubes, drainage tubes, ventricular shunts, introducer tips, adhesive systems

Polycarbonate (PC)

Renal dialysis cartridge, trocar, inter tubing connector

Polypropylene (PP)

Non-resorbable sutures, hernia mesh

Plastics in Medical Applications Plastics form the main structure of numerous medical devices.

Some examples are listed below: Cardio-vascular: Devices are used directly inside the heart to correct the functioning of the heart. In cardiac rhythm monitoring, devices capable of delivering electrical pulses are used to slow down or speed up heart rhythm. Plastics form the insulation of the leads delivering the electrical pulses, the body of the headers and connectors on the device. A device is illustrated in the Figure 2.

Figure 3: Illustration of Neurological Devices, on the left, a Deep Brain Stimulation (DBS) device for Parkinson’s disease and on the right a ventricular shunt for hydrocephalus.

Devices are also used in the areas of orthopedic treatment such as artificial spinal discs or articulating joints, within the area of dental medicine as artificial crowns, fillings and adhesives, plastic surgery, ophthalmology etc.

Figure 2: Illustration of a cardiac rhythm monitoring device Stents are metallic wire structures that are used to open up clogged arteries. Stents are frequently coated with polymer solutions incorporating drugs.

Vascular grafts are used in bypass surgeries as conduits for blood flow. These grafts, frequently greater in size than 6 mm, are made from Teflon or polyester resins.

Neurological: Devices are currently being tested and manufactured to treat diseases such as Parkinson’s disease and dystonia. These devices are similar in construction to cardiac pacemakers in that they comprise a can delivering electrical impulses through an insulated lead. Ventricular shunts are devices used to treat hydrocephalus, wherein the cerebro-spinal fluid pressure builds up in the brain and this is relieved by use of a regulated flow device and usually into the peritoneal cavity.

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A growing area of the use of plastics is in the field of combination devices, here the plastic is part of the device as an excipient or carrier for drug delivery (Figure 4). Drug delivery occurs mainly through diffusion of the drug though the polymer matrix. There is also development in the use of resorbable plastics, plastics that degrade over time in the body and this degradation allows the drug to escape from the device and enter the body. Since drugs can be both hydrophilic and hydrophobic, the ability of the polymer matrix to accommodate the differing polarity of the drug is an important aspect and therefore the design of plastics to act as effective excipients is an area of considerable research.

Another area where plastics are increasingly being used is in the coating of devices that act as continuous glucose monitoring (CGM) devices in the monitoring and treatment of diabetic conditions (Figure 5). CGM sensors rely on the coating to be permeable to the right substances so that it can accurately sense the level of glucose in the blood. The area of selective permeability is an area of important research.

July-August 2019

Cover Story Figure 4: A drug delivery device where the drug infused in a polyurethane is a contraceptive

Figure 7: Various catheter geometries and shapes

Figure 5: A continuous glucose monitoring (CGM) sensor coated with a polymeric film

Operations and Manufacturing of Plastic Components for Medical Devices The manufacturing operation for the manufacturing of a plastic component of a medical device can be depicted as in Figure 4.

Figure6: Depiction of the steps in the manufacturing process of a component for medical devices Plastic: The plastic can be chosen as a commodity plastic or it can be custom made. The choice of the plastic will be decided by the application of the device the component is intended for. In many instances, the quantity of plastic required for a medical device is small, often measured in grams. Thus, it is entirely feasible that a small batch of specialized plastic can be synthesized for a particular device. Of course, knowledge of the chemistry of the plastic, its reaction kinetics and certain chemical engineering fundamentals are required. However, as the quantities required are small, it is entirely feasible to set up manufacturing operations. This is especially true where certain special materials such as biodegradable formulations are involved, device applications may require specific behavior from its components such as degradation characteristics and drug elution.

Processing: The processing of the plastic components is usually done by standard thermoplastic processing techniques such as extrusion and injection molding. Other techniques, such as thermoforming, laser ablation, solvent processing and silicone rubber processing, may be used depending on the material and the device requirements.

As an example, catheter extrusion is one of the common devices that are used for a variety of different devices and purposes.

Various configurations are possible within the extrusion of this tubing geometry. Catheters with multiple lumens, lumens with different geometries and curved or straight tubes are some of the variants in the design, this is illustrated in Figure 5. Catheter production requires an extrusion line, water bath, dimensional control, a winder and an annealing oven.

July-August 2019

Medical device assembly is done in a cleanroom. A cleanroom is defined as A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.

The greater the criticality of the device, the greater the restrictions placed on the construction of the cleanroom. Medical plastics, in general, are the components of the device rather than the device itself and consequently, most of the medical plastic processing can be done in less stringent environments.

Sterilization: All medical devices have to go through the process of sterilization. Sterilization is the process of killing of all micro-organisms (bacteria, virus and fungal) by use of either physical or chemical means. Human skin can never be completely sterile, hence covering the human skin is an important aspect of a sterile environment. The inside of the human body is devoid of bacterial growth and is termed aseptic. Transfer of germs into an aseptic environment is contamination Sterilization of all items used in surgery is essential to the maintenance of asepsis.

There are different methods of sterilization. The method could be based on thermal elimination of contamination, either using Dry heat or Steam. The method could be based on chemical means, using an Ethylene oxide (ETO) environment, or the method could be based on the use of high energy radiation.

Conclusion As the importance of the use of medical devices in healthcare is increasing, the worldwide market for these devices is forecast to increase robustly. Plastics form the core of many medical devices and therefore the use of plastics in medical applications is a fast growing market.

Plastics have a great range of properties and this huge variety of plastics properties means a number of different medical device applications can be satisfied by plastics. However, many times the applications are not fully satisfied as the properties of the plastic material are not completely exploited. There is clearly a distinct need for plastics expertise to be involved in the further development of the medical field.

The selection of a particular plastic material is dictated by the needs of the device and application. Many aspects of the behavior of the material in different conditions and environments are taken into account in order to select the right material.

The production of plastics components for the medical industry requires discipline, certain extra procedures and controlled methods.

Plastics production for medical applications is, however, not onerous and difficult.

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Cover Story

NMDPC : To Catalyse Growth of Medical Device Sector in India Dr. Jitendar Sharma Member Secretary, National Medical Devices Promotion Council and MD & CEO AMTZ.

An Introduction to NMDPC: The National Medical Devices Promotion Council (NMDPC) has been set up as a catalyst-organization for facilitating and promoting the Indian Medical Device Industry, under the aegis of Department for Promotion of Industry and Internal Trade (DPIIT) on 7th December 2018, with Andhra Pradesh MedTech Zone (AMTZ) as its technical secretariat. On 14th of December 2018, the then Hon’ble Minister of Commerce & Industry inaugurates NMDPC at the “4th WHO Global Forum on Medical Devices”, held at the AMTZ Campus, Visakhapatnam, Andhra Pradesh.

NMDPC with its core objective to promote and facilitate the Medical Device Industry and create a nurturing ecosystem (which the sector lacked), is poised to be the National Forum now to discuss and consult stake holders of the Medical Device ecosystem (ranging from policy makers, start-ups, incubators, R&D institutions-to-manufacturers of vivid size and capabilities) and partner with organizations of international repute, who can add value and prescribe solutions pertaining to growth of medical device manufacturing and exports.

As the apex Council for facilitating and promoting the Medical Device industry and to position India as a pioneer in Medical Device and Health technology space, following are some key activities undertaken by the council: • Policy Facilitation • Strategic Forums (Policy, Best Practices, Partnerships) • Dissemination of International Norms • Industry Support (Manufacturing, Regulatory Challenges, etc.)

• Market Access Boosting Indigenous Manufacturing-Enabling Level Playing Opportunities to Harness True Potential: Since inception, the council has been interacting closely with the stake holders from government, as well as private sectors (manufacturer/ supplier), healthcare providers and patient groups. It was found that initiatives that are directed towards benefitting the medical device manufactur-

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ers with respect to Preference to Make in India, Order 2017 or through the implementation provisions from Department of Pharma were in a way not followed in heart and spirit and doesn’t reflect in the tenders floated by many State & Central Government Agencies. Additionally, the Make-in-India proposition may also take a back seat if timely payments are not released to the manufacturers or suppliers whose payments are pending for year/ s together from the State/ Central Health Corporations. Though the manufacturers are integral part of the value chain, however such discouraging instances may lead to a severe cash crunch to them or land them in bankruptcy or put a threat to their existence or sustainability of their existing projects, performing R&D, finding markets, commissioning newer initiatives, all of them can take hit for the same reason.

Tender Deviations: NMDPC has reviewed more than 200 odd tenders across the country from the period April 2019 to July 2019, and have found 38% of them deviating in terms of mandating foreign regulations or some of them are even upright asking specific company for supplying or mentioning their brand name, thus killing fair competition and are once again not adhering with General Financial Rules, 2017 (GFR) guidelines. Such tenders are possibly biased, and are against the larger interest of the manufacturing community, especially narrowing the scope of Indian manufacturers to participate in the state/ central led procurement process.

Table1: Total number of Tenders studied from April to July 2019 No. Period Deviations Without Total Tenders Deviations 1 1 - 30 April 2019 8 15 23 2 1 - 15 May 2019 8 16 24 3 16 - 31 May 2019 16 41 57 4 1 - 15 June 2019 11 13 24 5 16 - 30 June 2019 11 20 31 6 1 - 15 July 2019 8 15 23 7 16 – 31 July 2019 18 12 30 Total 80 132 212 Total Percentage of Deviations 38% Total Percentage without Deviations 62% July-August 2019

Cover Story From Table 1, the percentage of tender deviation is approximately 38% accounting to 80 tenders which are asking exclusively for foreign regulatory approvals in India. Of these deviations the GoI or Central government organizations have shown overall 26% deviation while Haryana state government alone has shown about 20% deviation as shown in graph 1 below.

Graph 1: Tender Deviations amongst State and Central organizations

Considering the high value and importance of medical device equipments in the field of Radiology and Cardiology, NMDPC has further assessed deviation of tenders into three categories, namely – 1. Radiology, 2. Cardiology, and 3. Others. It is found that of the total deviations 36% of tender deviations fall under Radiology and Cardiology categories.

Way Forward: Transparent procurement practices with adherence to Public Procurement Order 2017 can open a lot of avenues for Indian manufacturers, provided payments are also settled with the manufactures in a timebound manner. Secondly, National Medical Devices Promotion Council realizes that there is a distinct ecosystem advantage which can be provided to the medical device stakeholders while operating out of a cluster, considering Andhra Pradesh MedTech Zone (AMTZ) as a model cluster where common resources like infrastructure, scientific facility, testing facility, sterilization facility, regulatory enablement and market access are in complete synchrony with manufacturing. Replicating such clusters and linking them with each other or linking them to the existing clusters for enabling smooth flow of services can go a long way as far as import substitution is concerned, and thus making the best use of the capabilities which already exists.

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THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTICS/DEVICES TECHNOLOGY AND TRADE

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

July-August 2019

High Concentration Mask

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

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount

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Editorial Board MPDS

WELCOMES

TWO DISTINGUISHED EXPERTS TO THE

EDITORIAL ADVISORY BOARD Australia - Chief Scientific Officer – (Dec 2002 – July 2011), AorTech Europe Ltd., Bellshill Scotland, UK - Senior Polymer Scientist – (June 2002 – Nov. 2002), Polymer Science Division, Global Research Center - Senior Research Scientist – (Aug. 1999 – May 2002), Process & Manufacturing Division, Global Research Center - Process Research Engineer – (Aug 1996 – Aug 1999), Garware-Wall Ropes Ltd., Pune, India - R&D Engineer – (Aug' 1990 – Jan’ 1992).

Dr. Ajay D Padsalgikar, Ph.D. Senior Principal Scientist DSM BioMedical in Exton Pennsylvania,USA ajay.padsalgikar@dsm.com Introduction Dr. Ajay Padsalgikar, USA, is working as a Senior Principal Scientist at the Innovation Center of DSM Biomedical in Exton, Pennsylvania, USA. He has more than 30 published scientific papers and 10 patents. In 2017, he wrote a book titled “Plastics in Medical devices for Cardiovascular Applications” that was published by Elsevier.

His Professional Experience Include DSM Biomedical, Exton, PA, USA - Senior Principal Scientist (Oct 2018 – Present), Abbott Labs, Rogers, MN, USA - Senior Principal Scientist – (Dec 2012 – Oct 2018), AorTech Polymers & Medical Devices, Rogers, MN, USA - Chief Scientific Officer – (Aug 2011 – Nov 2012), AorTech Biomaterials Ltd., Scoresby,

No. of Publications to his credit : Books Plastics in Medical Devices for Cardiovascular Applications Dr. Ajay D Padsalgikar, Elsevier Publications, ISBN 9780323358859 (March 2017), Polyurethanes in Medical Devices Ajay D Padsalgikar, Elsevier Publications (In Progress).

Peer Reviewed Journal Articles in prestigious pubications like : Journal of Biomedical Materials Research, Journal of Biomaterials Science, Polymer Edition, Polymer, Pulication by Department of Materials Science and Engineering and Materials Research Institute, The Pennsylvania State University, USA, International Polymer Processing, Journal of Applied Polymer Science, AorTech Biomaterials, Kunstoffe Plastics Europe, Polymer Engineering and Science, International Polymer Processing.

No. of Patents to his credit on : (1) Gels (2) Biostable polyurethanes, their preparation and their use in biomaterials, devices, articles or implants. (3) Crosslinked siloxane-based polyurethanes. (4) Gas Assisted Injection Moulding. (5) Bonding Process. (6) Implatable Prosthesis (7) Soft Tissue Implant. (8) Polyurethane Header Formed Directly on Implantable Electrical Devices. (9) Polyisocyanurate Compositions and Composites.

Introduction A Pharmaceutical Technologist by education, with over 45 years of experience in the Pharmaceuticals and Medical Devices industry, with expertise in areas of Production, Quality Assurance, Regulatory Affairs, Research and Development and Corporate Management, while working in multinational industrial organisations. Hold leading roles and membership in coveted International Standardisation bodies and regulatory activities.

Extensively travelled worldwide for professional and business meetings.

Dr. K.Sivakumar, M.Pharm, Ph.D

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Academic Qualifications B. Pharmacy from Madras Medical College, Chennai, in 1971, securing the Gold Medal and IDMA Award for university top rank.

M. Pharmacy from Birla Institute of Technology and Science, Pilani, in 1973, specializing in Pharmaceutical Technology.

Ph.D in Pharmaceutical Technology from Birla Institute of Technology and Science, Pilani in 1978.

July-August 2019

Editorial Board Professional Career Technical and Management Consultant: From Dec 2010 till date Currently engaged in offering technical and management consultancy services to Healthcare, pharmaceutical and medical devices industry, International procurement and Regulatory agencies, Community institutions and Academic bodies in the areas of technical and business development . Managing Director, Pharmedices Technical Services.

WHO, UNFPA Temporary Adviser, Expert, Consultant for development of specifications and technical literature, facilitating training programmes and workshops in several regions helping the national regulatory agencies and national laboratories in building capacity relating to development and implementation of regulations and testing laboratories in the fields of pharmaceuticals and medicals devices, technical assistance and assessing product technology and manufacturing capabilities for pharmaceuticals and medical devices, development and implementation of prequalification and post qualification monitoring programmes for international procurement and distribution of pharmaceuticals and medical devices.

FHI 360, USA. Consultant on QA activities for Global Health Supply Chain (GHSC) programmes covering pharmaceuticals and medical devices for United States Agency for International Development (USAID) and related international agencies, involving product and technology assessment, onsite manufacturing capability

July-August 2019

assessment and review of technical training and capacity building in the field of pharmaceuticals and medical devices.

Other Current / Previous Postions • Strategic Head, Medical and Health Services, TUV – SUD South Asia • President, Quality and Research and Development: • General Manager, Quality Assurance • Chief Manager , Quality Assurance • Manager, Formulation Development and QA (July 1979 to January 1988) • Faculty Member, Pharmacy Discipline Professional Affiliations 1. International Organisation for Standards ( ISO) 2. Bureau of Indian Standards 3. Indian Council of Medical Research, India 4. Association of Indian Medical Devices industry 5. Voluntary Health Services, Chennai , India 6. Indian Pharmacopoeia 7. Organisation Of Pharmaceutical Producers of India 8. Indian Pharmaceutical Association Academic Affiliations 1. BITS, Pilani - Conducted M.S. Pharmacy Distance Education Programme and guided 5 Post graduate students 2. Anna University, Chennai, Tamil Nadu, India - Member, Board of Studies, Anna University and Member, Executive Committee 3. Annamalai University and JSS University, India - Visiting faculty, examiner and research guide

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Technology

Better Hearing Thanks To Laser Welding Phonak Hearing Aid

The development of hearing aids has been facilitated by the incorporation of laser welding using the mask welding concept.

It is necessary to provide protection in the area of the sound outlet in order to guarantee reliable functioning of hearing aids that are getting ever smaller and which are worn within the ear.

In the novel «SmartGuard» cerumen protection concept by Phonak, a highly elastic, extremely thin diaphragm is welded onto a small carrier ring. The mask welding process, developed and patented by Leister Technologies, enables this high-precision joining process providing protection from contamination.

Difficulty of hearing and reduced hearing capability is widespread. In many cases these conditions can be alleviated to a large degree using modern hearing aids.

Continuous development of hearing aids also leads to miniaturisation, with the aim of providing the user with smaller, more comfortable and virtually invisible hearing aids. There are different types of hearing aids which differ in their shape: so-called BTE (behind the ear) hearing aids and the considerably smaller ITE (in the ear) hearing aids. In addition to the technical differences, the ITE hearing aids primarily have the optical advantage that, depending upon the shape, they are virtually invisible from the outside.

A big problem with all hearing aids is the contamination of the sound outlet by ear wax in the auditory channel, the so-called cerumen. The loudspeaker – also called the earpiece – is located deep within the ear channel, particularly in the case of the ITE hearing aids. In order to ensure long term functioning, this must be effectively protected from contamination and moisture. The demands on such protection are high. In addition to the acoustic properties, strength, durability and media resistance as well as consistent high quality of sound play a significant role.

The Swiss hearing aid specialist Phonak has a turnover of more than a billion Swiss Francs and a global market share of 16 to 17% and is thus one of the leading hearing aid manufacturers in the world. Phonak is constantly making new innovations that make a considerable contribution to the society.

Leister collaborated with Phonak to Laser weld cerumen protectors on Phonak hearing aids.

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The improvement in quality of life of people with hearing damage is beyond imagination. One of these innovations is the new cerumen protector «SmartGuard». This uses a 15 µm (micron) thick polymer diaphragm to protect the sound outlet from cerumen and moisture, without having any significant deleterious effect on the acoustic properties. The diaphragm is mounted on a thermoplastic carrier ring. The strength of the connection to the carrier ring is high, despite the small area of the joint. Any deposits on the diaphragm can be removed by regular wiping with a soft cloth. This does not damage the diaphragm or the connection to the carrier ring, thus ensuring a long working life for the cerumen protector.

Laser welding also means that the necessary media resistance of the joint is achieved. The recommended period of use of two months exceeds the period of use of the existing fabric-based protection systems. After this period of use, the cerumen protection can easily be replaced using a special tool.

July-August 2019

Technology Mask Welding

Prospects

The mask welding process – developed and patented by the Swiss laser system manufacturer Leister Process Technologies and operating on the principle of laser transmission welding – is used for joining the diaphragm to the carrier ring. This involves connecting a joining partner that is transparent to laser radiation with an absorbing joining partner.

Because of the properties already referred to, the mask welding process is particularly suited to applications in medical technology. In this way foils can be welded onto micro well plates without the melt flowing into the apertures. Mask welding is also recommended for fluidics in general – and for micro fluidic components in particular. This precise and cost-effective process finds applications in products for the entertainment electronics and computer peripherals.

In the case of the cerumen protection, the diaphragm is transparent to laser radiation. The carrier ring, on the other hand, is made from a thermoplastic material which has a fixed shape. It is black in colour and thus absorbs the laser radiation. In the mask welding process used here, a mask is inserted between the laser source (diode laser) and the component. A linear, well collimated – in other words, parallel – laser beam is moved over the parts to be joined.

The laser radiation only impinges on the parts to be joined that are not blocked off by the mask. The use of the mask makes it possible to illustrate the finest of structures. This means that mask welding can achieve high levels of precision. This welding concept allows fulfilling a further requirement, namely the need to keep the area for welding to a minimum. This means that there is more area available for the acoustically active diaphragm surface. It is only with the mask welding process that the necessary strength can be achieved with the smallest of welding areas. A further significant advantage is the minimal weld pool depth. The formation of a weld bead can be virtually eliminated. This, in turn, has advantages with regard to dimensional reproducibility and acoustics.

Another process developed by Leister is radial welding. In this process, rotationally-symmetrical parts are welded together without having to move with respect to the laser. In medical technology this process is used for welding catheter attachments.

Radial welding also finds applications in sensor technology, fluidics and in the automotive engineering.

The GLOBO welding process, patented by Leister, also finds applications in medical technology. It allows dynamic pressing together of the joining parts, and, for example, it allows two transparent foils to be welded together. The heat energy is transferred to the foils by an absorbent black substrate [which has a melting point which is higher than that of the parts to be joined together].

This concept can be used to join large area components and endless applications.

Success Story, No 2/08 / ENG © Copyright by Leister India Headquarters : Leister Technologies India Pvt Ltd No. 4/27B, Kambar Street, Alandur, Chennai 600016 phone: +91 44 45583436, info@leister.in Leister Technologies AG is an ISO 9001 certified enterprise

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

Phonak evaluated various joining processes for this demanding application. The requirements for welding consisted, in general, of the resistance to mechanical and chemical activity. Laser welding had the following advantages when compared with the other processes: No pre-treatment of the surfaces, such as plasma irradiation or priming (chemical activation of the surfaces) is required. These would have a negative effect on the foil. Joining processes which produce melting would not be acceptable because of space restrictions.

The high level of reproducibility associated with mask welding has proven to be an advantage over joining processes involving the application of additional materials.

In addition to the process-technological reasons, mask welding also has economic advantages. The consumption of supplies is regarded to be low, when compared with other processes. Batch processing processes, which are carried out semi-automatically and which can be run on plants such as the NOVOLAS WS allow volumes of several millions to be produced in a year. Not least is the advantage that the joining process is even more economical because of the lack of additional material consumption.

July-August 2019

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.

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

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Technology SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES & TECHNOLOGY

MEDICAL CENTRE FOR HEART & BRAIN DISEASES

BIOMEDICAL TECHNOLOGY WING

ACHUTHA MENON CENTRE FOR HEALTH SCIENCE STUDIES

The Biomedical Technology Wing (BMT Wing) located at the Satelmond Palace at Poojappura, Trivandrum consists of culturally diverse and pluralistic team committed to medical device development, research & teaching. The broad areas of activities of the wing include : Medical Devices, Biomaterials, Biocompatibility, Tissue Engineering, Product incubation and commercialization BMT Wing has been instrumental in establishing a medical device industry base in India by successfully developing and commercializing technologies of a number of devices and implants. Some of the commercialized technologies include blood bag, membrane oxygenator, hydrocephalus shunt, artificial heart valve, dental materials, hydroxyapatite based materials and implants.

The Biomedical Technology wing has implemented a quality system meeting international standard ISO/IEC 17025 and is accredited by Le Comite Francais d'Acreditation (COFRAC), France.

Head, BMT Wing is responsible for the overall administrative, technical and academic operations of BMT Wing and reports to the Director of the Institute. The activities of BMT Wing are classified into six groups. Each Group consists of various divisions / laboratories.

Call For Technology Transfer & Industry Driven Products - Expression Of Interest (EO) SCTIMST – BMT Wing is actively engaged in applied and translational research in areas of biomedical devices, biologics and biomaterials since late 1970s. The technologies developed indigenously by SCTIMST have been transferred to several industries, which have benefitted both the industry and society at large. Our record is marked with development of innovative and popular products such as the artificial heart valve (TTK Healthcare Ltd), blood bags (Peninsula polymers, now Terumo Penpol Ltd, HLL Lifecare Ltd), hydrocephalus shunt (HLL Lifecare Ltd), membrane oxygenator& cardiotomy reservoirs (SIDD Lifesciences Ltd), bioceramic composites for dental and orthopedic applications ( Basic Healthcare Ltd, IFGL Refractories Ltd,), dental composites ( Anabond Stedmann Pharma Ltd), Intrauterine Device (HLL Lifecare Ltd), vein viewer (Agappe Diagnostics Ltd) to name a few. Also post Technology Transfer activities are ongoing for many more products like cholecyst derived scaffold for wound dressing applications, Diagnostic kit with antibiogram for Urinary Tract Infection (UTI), Tuberculosis screening device, PT/INR monitoring device, injectable hydrogel for cartilage repair, lint free absorbent wound dressing etc.

Last date extended to 5th August 2019 Technology Transfer - Expression Of Interest (EOI) SCTIMST is now offering technologies for licensing to enterprises including start ups for further scaling up and commercialization.

These technologies are available in different stages of readiness levels such as proof of concept, pre-clinical / clinical evaluation.

The technologies can be licensed either on exclusive or nonexclusive basis against payment of a combination of up-front lumpsum fee and annual royalties, which will vary from product to product. Information on the technologies currently available for licensing may be viewed from the right side links.

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Those interested are encouraged to contact Technology Business Division on phone - 0471-2520309/308 or email: tbd@sctimst.ac.in for further information or clarifications on the above and to facilitate visits and detailed discussions.

Interested parties may submit EoI proposals in the specified format(Annexure 1,2 & 3) indicating the technology/product of interest addressed to Head, BMT Wing, SCTIMST, Poojapura, Trivandrum-695012, latest by 12:00 noon on 31st July 2019 as signed hard copy.

Industry Driven Products - EOI SCTIMST invites proposals for developing products of interest to industry (Industry driven product development) in the following broad areas: • • • • • • • • •

Cardiovascular devices Neuroprosthetic devices Orthotics & Rehabilitation devices In Vitro Diagnostic (IVD) Devices Hard Tissue Devices Biologics Regenerative Technology Point of Care Devices Connected Health

Interested companies may submit their interest in the EOI Format – Industry driven products. Based on the merit and feasibility of the proposal, SCTIMST will explore possibilities of jointly initiating product development activities with the industry on a case to case basis. https://www.sctimst.ac.in/Technology-Transfer/

July-August 2019

Med Tech Start-ups DRIPO – A Portable Infusion Monitor To Be Attached To IV Sets – Counts The Drops And Calculated Real-Time Drop Rate DEVICE DESCRIPTION Dripo, the handy device clamped to the drip chamber of the IV set, counts the drops and calculate real-time drop rate. There is a fine regulator in the device, which can be used to adjust the flow to the required rate. The device alerts rate variations, blockage and completion.

TECHNICAL SPECIFICATIONS Flow Rates 0-250 drops/min 12 hours of battery back-up Charging time 2 hours to full charge Compatible IV sets-13mm to 20mm diameter any drop factor Drop detection accuracy-99.2% COV 0.4% Training - No training required.

Areas like pediatrics, anaestasia and chemotherapy where giving accurate rate is concerned and no need of installing infusion pump, can use Dripo.

Background A study by NICE, UK says one in five patients on an IV drip suffer from complication due to wrong infusion rates.

Current method of gravity infusions are prone to errors as it is hard to set flow-rate using watch and the roller-clamp.

Infusion pumps available in market are too costly and is not simple to use. Lack of effective real time monitoring systems force the nurses to either leave the rate setting process behind or tediously spend time over it. This makes infusion therapy unsafe in wards where nurse to patient ratio is low.

Infusion pumps are the available option to reduce rate errors.

But as they are costly and complex to use, hospitals resort to them for highly critical medications only. However, the requirement for accurate infusions are way higher and cannot be sufficed with infusion pumps. Gravity fed infusions are the most common and cost-effective way of giving medications, but this method is prone to errors.

An international systematic review estimated the probability of making at least one error in the preparation and

administration of a dose of intravenous medication to be 0.73, with most errors occurring in administration steps. Inpatient preventable medication errors cost approximately $16.4 billion annually. IV therapy being one of the major means of IP medications, Dripo can help to reduce administration errors in IV effectively. An average nurse spends 30 percent of his/her time on administering medicines and dripo can help to reduce the time taken for monitoring and administration by 50 percent on IV therapy administrations. One of the major reason for IV errors is lack of training and all the devices available in the market is complex to use. Dripo can be used by any practitioner without training.

Initially, they wanted to propose a project idea, that is simple, effective and inclusive. They started Evelabs in 2016 as they got selected to the incubation program at TIMED SCTIMST, Trivandrum.

The Innovation Dripo is a simple portable connected infusion monitor that helps a health practitioner to set infusion rates accurately and monitor it from anywhere. It counts the drops and calculate real-time drop rate. It also has a fine flow regulator to adjust the fluid flow, so that the nurse can set rate precisely and easily with out much training. The device will send data to a central software installed at the nursing station, where rate changes and completion of every source will be alerted. The hub is also a smart infusion chart, where the status of every ongoing and upcoming infusion and the patient histories will be shown.

Doctors can also view the patient history and treatment status from the server and can make informed decisions based on the data. Dripo costs one sixth of the cost of an average infusion pump available in the market.

About the Innovators A group of all engineers with multi-directional interests. Vishnu and Sanjai did their bachelor's in Electrical and Electronics Engineering and Sruthy has a degree in Polymer Engineering. Vishnu later went to the National institute of Design and specialized in new media design. Sanjai has a Master’s degree in Electronics and communication from the College of Engineering, Trivandrum.

Worked as a teacher for a short term and then started Evelabs. Sruthy is a social science researcher and Writer by profession, with experience in ethnography, technical writing and media management.

Current Status They have launched the standalone version of the drip monitor in market and have been granted patent for the same. They received further investments and support from BIRAC under department of biotechnology india, TIMED Sree Chitra Institute of Medical Sciences and Kerala Startup Mission and other angel investors for scaling up.

They plan to sell 6000 units in the coming year.

July-August 2019

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Med Tech Start-ups Karnataka Govt And IISc To Support Medical Device Start-Ups To Create Affordable Product Solutions For Geriatric Care In a major initiative to design and develop promising advanced medical solutions for the growing ageing population in the country, the Technology Business Incubator at the Centre for Product Design and Manufacturing of the Karnataka government is supporting innovative technologies that drive affordable product solutions for geriatric care. These address areas such as visual, aural, oral and dental, bowel and urinary issues along with their impact on mobility that hinder a senior citizen from having an active social life.

At the first-ever medical device hackathon for geriatric care titled ReImagineHealth 2019 by MedTech and Geriatric Healthcare Technology Business Incubator, Centre for Product Design and Manufacturing, Indian Institute of Science (IISc), 14 teams vied for top honors.

The key purpose has been to stimulate and cultivate systemic innovation in the development of products for the elderly care and medtech covering diagnostics, monitoring and rehabilitation.

Here ReImagineHealth 2019 provided a peek into the technologically advanced and socially sustainable needs of the senior citizens so that they can continue to be independent, agile and enjoy their life to the fullest.

field of finance, engineering and medical along with mentors who have experience in these fields.

While team Novae presented a ‘Sonic Walker’ which is a device that helps detect obstacles and alerts the user, the Decubators developed a technology to ensure better and cheaper ways to prevent pressure ulcers in non-ambulatory patients. In the case of team iDams, it developed Eye(i) Drops Dispensing Aid and Monitoring Systems.

“The focus of this hackathon is on geriatric healthcare and new innovations that would help improve the quality of life for senior citizens. Through this, we intend to place selected participant in the technology business incubator which we have in association with the Karnataka government. Winners will therefore be able to take their products and services to the next level.” said Prof.

Amaresh Chakrabati, Senior Professor and Chairman, Centre for Product Design and Manufacturing, IISc. The objective is to attempt to give senior citizens a normal life.

We have two hackathon series that we run with our partners, one is ReImagineHealth and the other is ReImagineWaste which is on reutilizing waste in a different way and improve quality of life,” he added.

Various companies, hospitals, policy bodies, entrepreneurs, legal and regulatory organizations and NGOs were part of the initiative.

The kind of response that ReImagineHealth Hackathon 2019 witnessed was overwhelming, especially from youngsters. In fact, one of the members of a winning team was a student of Class -9.

Fourteen teams consisting of 64 participants took part in the hackathon with each team having at least one person from the

http://pharmabiz.com/NewsDetails.aspx?aid=116955&sid=1 (July 17, 2019)

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July-August 2019

Global Trends Increasing Ageing Population To Drive Global Medical Plastic Compounds Market Past US$80 Bln By 2025 The global medical plastic compounds market size is expected to reach US$80.40 bln by 2025, according to a new report by Grand View Research, Inc, at a CAGR of 5.2% during the forecast period. Increasing ageing population in economies such as China, India, Germany, and Austria is projected to remain a key driving factor. Growing demand for healthcare facilities and services coupled with government initiatives and support towards healthcare is projected to have a positive impact on the market growth. Increasing aging population in countries, such as Germany, Belgium, Austria, Denmark, and Japan is anticipated to prompt growth of the medical plastic compounds market.

Increasing use of medical devices such as MRI, X-ray, robotic dispensing systems, and apheresis machines would further drive the demand over the forecast period.

Polyethylene was the second largest product segment, in terms of volume and accounted for over 18% market share in terms of revenue in 2017. Increasing usage of polyethylene for manufacturing surgical cables, artificial tendons, orthopedic sutures, and tubing is anticipated to compliment demand.

Asia Pacific is expected to remain the fastest growing regional market with projected CAGR of 5.8% in terms revenue from 2016 to 2025. Developing healthcare infrastructure and rising disposable income in countries, such as China, India, and Japan is projected to propel the growth.

Drug delivery system is anticipated to register a CAGR of 5.4% in terms of revenue over the forecast period. Polymers are widely used in drug delivery system to enhance drug stability and to disguise the unpleasant taste of the drugs.

Plastics have found a wide scope of usage in medical and healthcare industry owing to superior properties of the product, such as non-magnetism, impermeability, durability, and sustainability. Radiation resistance of this plastic would offer lucrative growth opportunities and new avenue for the manufacturers. Surging demand for medical device plastics in applications, including surgical instruments, catheters, disposables, bags, implants, and drug delivery systems is anticipated to drive the demand. Rising R&D spending to produce bio-based plastics with superior properties, such as better quality and minimal health hazards is expected to further boost the medical plastic compounds market over the forecast period. Stringent regulations associated with manufacturing and disposal of waste is expected to offer lucrative growth opportunities to the key players. Manufacturers are coming up with various innovative ideas to improve durability and quality and to reduce the cost of devices. http://www.plastemart.com/news-plastics-information/increasing-ageing-population-to-drive-global-medical-plastic-compounds-market-past-us$80-bln-by-2025/52290 (06-Jul-19)

How Raumedic Are Achieving Enhanced Sliding Properties In Thermoplastic Products Medtech company, Raumedic announces new biocompatible additive which aims to enhance the sliding properties of medical plastic components.

Katharina Neumann, head of the materials chemistry department, Raumedic commented: “We see tremendous improvement potential for our catheter products because they are easier to introduce into the body thanks to their reduced gliding force.”

This new additive can be added to thermoplastic elastomers, polyamides, polystyrenes and polyolefin, and has been tested in combination with a base polymer over the last six months.

The mix of materials claims to significantly lower the coefficient of friction, and thus improve sliding properties, whilst ensuring there is no effect on parameters such as dimension, stability, flow rate and tensile strength.

July-August 2019

It is hoped that this additive will ensure the optimisation of devices within areas such as regional anaesthesia, drug delivery and minimally invasive surgery.

Additionally, Neumann believes that the material could potentially lower costs due to the high price of thermoplastic polytetrafluoroethylene compared to this new compound.

Neumann concludes: “The additive can be used for all applications in which plastic has to glide well on plastic." https://www.medicalplasticsnews.com/news/how-raumedic-areachieving-enhanced-sliding-properties-in-th/ (31 July 2019)

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How GST Failed Medical Devices As the Indian medical devices market is barely growing at 10-12% overall, the data of 24% increase in imports indicates further erosion from under 30% market share to less than 20%.

devices under the Drugs Act, the rest of over 6,000 devices have free access to an unregulated market.

While medical device makers in the US allege that the regulatory environment in India has hindered the growth of their exports, the data suggests otherwise.

Two decades ago, China was in the same boat, importing most of their medical equipment. But, today, they manufacture most of their medical devices because they have a policy that disallowed continued market access unless if you were manufacturing within China. India

By Rajiv Nath The MSME-dominated medical devices’ domestic manufacturing has taken a hit post GST, as imports have become cheaper and shot up by an alarming 24%, up from Rs 31,386 crore in 2017-18 to Rs 38,837 crore in 2018-19.

As the Indian medical devices market is barely growing at 10-12% overall, the data of 24% increase in imports indicates further erosion from under 30% market share to less than 20%.

After the introduction of GST, imported medical devices became cheaper by 11%. But how? The basic import tariff stands in the range of nil-to-7.5% for most medical devices compared to 20% for bicycles and 50% for motorcycles. Before the GST regime, imported medical devices attracted excise duty and special additional duty, over and above the basic import duty. After GST, only import duty and GST are levied. However, since one gets input credit in the GST regime, which was not available to traders in the earlier tax regime, the effective taxation is reduced, making imports more attractive than manufacturing to even indigenous manufacturers.

Unfortunately, no steps were taken to neutralise this by raising basic customs duty. The MSME sector has been worst hit, with huge job losses.

It is ironic that whereas, on one hand, the Narendra Modi government is touting the success of Make in India initiative, on the other hand the beleaguered medical devices domestic industry continues to lose market share to imports on account of lack of adequate tariff protection, lack of non-tariff import barriers and unfair market. In fact, the market favours perceived higher quality of familiar MNC brands with attractive trade margins and higher MRP versus unfamiliar new Indian brands that, even if priced lower as compared to European or American or Japanese brands, if not the Chinese, do not adequately induce retailers and hospitals to push their products, nor do they have the deep pockets to match the sales promotion and marketing budgets of their competitors.

While medical device makers in the US allege that the regulatory environment in India has hindered the growth of their exports, the data suggests otherwise. India imports around 80% of its medical device requirement and nearly a fourth of that comes from the US. The top five countries that India imports these devices from are the US (21%), Germany (14%), Singapore (11%), China (10%) and the Netherlands (7%). Except 23 medical

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has no such rules.

There is an urgent need for the government to expedite steps to reverse the 80-90% import dependence forced upon us.

Priority issues • Need to encourage employment and local manufacturing of medical devices, and address 70-90% import dependency by a predictive nominal tariff protection policy as done for mobile phones. This will ensure a vibrant domestic industry and competitiveness, and price stability driven by competing domestic players.

• Need to regulate all medical devices under a patients’ safety medical devices law to protect patients and aid responsible manufacturing.

• Need to protect consumers from exploitative and high prices in medical devices by rationalised price controls and aid ethical marketing.

• Need to incentivise quality in healthcare products in public healthcare procurements by preferential pricing for Q1—for example, ICMED (QCI’s Indian Certification for Medical Devices) instead of L1 (lowest price)—to ensure that patients have access to acceptable quality.

These steps are vital to meet the health-for-all national agenda of Prime Minister Modi and aligned to the Health Policy 2017 to make quality healthcare accessible and affordable for the masses, and to place India among the top five medical devices manufacturing hubs—instead of an ever-increasing import bill (Rs 38,837 crore). Pseudo manufacturing and unethical marketing is harming consumers, and is disallowing manufacturing to succeed in India by well-meaning investors.

The government needs to take bold policy decisions, as done for mobile phones, to give a strategic advantage to domestic manufacturing while safeguarding consumers, or else India will remain 80-90% import-dependent in this sector.

The author is Forum coordinator, Association of Indian Medical Device Industry https://www.financialexpress.com/opinion/how-gst-failedmedical-devices/1625275/ (July 2, 2019) July-August 2019

Health Ministry Constitutes MDTAG To Advise CDSCO On Matters Related To Regulation Of Medical Devices In order to advise Central Drugs Standard Control Organisation (CDSCO) on matters related to regulation of medical devices, the Union health ministry has constituted a Medical Devices Technical Advisory Group (MDTAG) with Drugs Controller General of India (DCGI) as the Chairperson and Deputy Drugs Controller of India, Medical Devices Division, CDSCO as the Member Secretary.

MDTAG has been envisaged to examine the issues relating to implementation of medical devices regulations, suggest CDSCO regarding strengthening of medical devices regulations in the country including Make in India, ease of doing business etc. and taking up matters with Drug Consultative Committee (DCC), Drug Technical Advisory Board (DTAB) and the Union health ministry as per requirement.

The meeting will be called by DCGI at least once in four months at CDSCO, headquarters, New Delhi. The group may co-opt other experts from relevant field as deemed necessary.

MDTAG will have representatives from Department of Science and Technology (DST), National Institute of Biologicals (NIB), Indian Council of Medical Research (ICMR), Atomic Energy Regulatory Board (AERB), Defence Research and Development Organization (DRDO), Bureau of Indian Standards (BIS), IIT, New Delhi, Department of Electronics and Information Technology

(DEITY), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), National Health Systems Resource Centre (NHSRC), state drugs controller (Haryana state), Confederation of Indian Industry (CII), Medical Technology Association of India (MTAI), Association of Diagnostics Manufacturers of India (ADMI), Association of Indian Medical Device Industry (AIMED), Federation of Indian Chambers of Commerce and Industry (FICCI) and American Chamber of Commerce in India (AMCHAM India) as its members.

Besides this, it will have members which are representatives from notified body like Dr. Sandeep Bansal, HOD, Cardiology, VMMC and Safdarjung Hospital, New Delhi, Dr SN Bhattacharya, head, Department of Dermatology, University College of Medical Sciences, New Delhi, Dr. Vijay Kumar Jain, associate professor, Department of Orthopaedics, RML Hospital, New Delhi, Dr Arjun Ahuja, head, Seth G S Medical College and KEM Hospital, Mumbai.

As per the notice, all associations and government departments are requested to nominate their representative indicating name, designation, contact number and email id and inform CDSCO at the earliest. http://pharmabiz.com/NewsDetails.aspx?aid=117159&sid=1 (July 26, 2019

CDSCO Notifies 6 Bodies To Audit Medical Device Manufacturing Sites As Per Provisions Of New MD Rules The medical devices division of Central Drugs Standard Control Organisation (CDSCO) has notified 6 bodies to carry out auditing of manufacturing sites as per the provisions of new MD Rules.

New Medical Device (MD) Rules 2017 were notified last year and has come into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.

MD Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate manufacture, import, sale and distribution of the medical devices.

The notified bodies registered with CDSCO under provisions of medical devices rules, 2017 are Intertek India Pvt. Ltd, TUV Rheinland India Pvt. Ltd, TUV Sud South Asia Pvt. Ltd, Dnv GI Business Assurance India Private Limited, BSI Group India Pvt. Ltd and BSCIC Certifications Pvt Ltd. New MD Rules 2017 cover medical devices, invitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices.

July-August 2019

State licensing authority has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new rules.

Class C and Class D category are audited by the CDSCO independently as per the new rules.

In order to implement MD Rules effectively, the Maharashtra Food and Drug Adminsitration (FDA) conducted workshops to sensitise drug inspectors about new MD rules.

The state drug regulator has notified 100 medical device officers, seven assistant commissioners and seven joint commissioners as notified licensing authorities to implement MD Rules 2017.

Notified officers have got user id and password for effective implementation of new MD rules through centralised online service SUGAM portal.

CDSCO had launched the online service SUGAM for grant of import, manufacture, clinical investigation, sale and distribution licences of medical devices through single window clearance. http://pharmabiz.com/NewsDetails.aspx?aid=117280&sid=1 (August 2, 2019)

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MVPI Reports 1,213 Medical Devices Adverse Event Reports From Across Country Since 2014 Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Coordinating Centre (NCC) for Materiovigilance Programme of India (MvPI) has received 1,213 Medical Devices Adverse Event (MDAE) reports from across country since 2014.

pan India to analyse MDAEs exclusively as part of MvPI.

During the period, January 1 to March 15, 2019, MvPI received 252 reports.

MDAEs need to be intensively analysed in view of patient safety as devices are different from drugs with a different shelf life.

Uptil now MDAEs used to be reported through the Pharmacovigilance Programme of India (PvPI). Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 and MvPI in 2015 to track adverse drug reactions (ADRs) and MDAE respectively.

IPC has also set a mandate to set up a total of 300 ADR monitoring centres (AMCs) by 2020 as part of PvPI with focus on North Eastern (NE) states. It is in the process of identifying district hospitals in NE states which wish to participate as AMCs under the PvPI at district level.

This is a significant milestone as the Union health ministry has also been contemplating to introduce a high risk medical device registry to track MDAEs due to faulty medical devices.

The MvPI is being coordinated by the IPC at Ghaziabad which functions as the NCC and Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health Systems Resource Centre (NHSRC) in New Delhi.

MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated in India. This is also envisaged to develop the culture of reporting of adverse events in healthcare institutions in country.

IPC has recently identified 17 medical device monitoring centres

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This is a welcome change for the consumers and patients who are administered high risk medical devices like stents and implants as part of therapy in cardiac and orthopaedic disorders.

The purpose of the programme is to study and follow MDAE and enables dangerous ones to be withdrawn from the market. http://pharmabiz.com/NewsDetails.aspx?aid=117476&sid=1 (August 12, 2019)

July-August 2019

Industry News Meril Life Sciences Receives CE Marking For Bioresorbable Scaffold Stent Meril Life Sciences has announced that its indigenously designed and manufactured scaffold -MeRes100 BRS becomes the first thin-strut bioresorbable scaffold to receive CE marking.

Headquartered in Vapi, Gujarat, Meril is a global medical device company that manufactures a wide array of medical solutions like vascular intervention devices, orthopaedic implants, in-vitro diagnostics, endo-surgery and ENT products.

Meril’s MeRes100 has received both DCGI and CE (European Conformity) marketing approval. Backed by rigorous research and encouraging clinical trial data, MeRes100 is planned to be launched in various countries, including European countries, later this year.

The role of a DES is to provide temporary scaffolding to the blockage or lesion site and also to deliver a drug to facilitate healing.

After healing is complete, the metallic stent remains in the body as a permanent implant. Such metallic DES are associated with incremental risk of clinical or adverse events: on an average, 2% to 3% of patients with metallic DES implants may require a repeat intervention year on year.

MeRes100 was designed as a solution to bridge this gap between the temporary treatment horizon for opening a blockage and the undesirably permanent nature of a metallic DES implant.

Across clinical trials, MeRes-1 (the first in-human study conducted in India) and MeRes-1 Extend (conducted in Brazil, Europe and Asia), MeRes100 BRS has shown long-term positive safety and sustained efficacy outcomes for patients with coronary artery

®

disease in treatment of de-novo coronary artery lesions. Its proprietary hybrid-cell design has optimal strut thickness and improved crossing profile for better deliverability. The scaffold strut thickness is 100 microns, which leads to faster endothelialization and healing, resulting in lower risk of scaffold thrombosis. Both trials have also validated this benefit, by demonstrating zero scaffold thrombosis and very low major adverse cardiac event (MACE) rate of 1.87% with MeRes100 BRS in MeRes-1 Study at three years and 1.61% MACE in MeRes-1 Extend Study at two years.

“First generation bioresorbable scaffolds have not shown the most favourable results at long term horizons. The next generation bioresorbable scaffold with reduced strut thickness, improved profile for better deliverability, faster degradation and possibly lower scaffold thrombosis is a revolutionary advance in interventional cardiology” said Principal Investigator for the MeRes-1 trial Dr. Ashok Seth, chairman of Fortis Escorts Heart Institute in New Delhi, India.

Cardiovascular diseases (CVDs) such as coronary artery disease are the biggest cause of mortality in India and there is evidence that CVD begins to affect Indians at least a decade earlier than it affects Europeans. Stents are widely accepted as a primary intervention for treating coronary artery disease and associated lesions or blockages due to fat deposition and plaque formation. Metallic drug eluting stents (DES) have a metallic platform with drug coating. http://pharmabiz.com/NewsDetails.aspx?aid=117436&sid=1 August 9, 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 July-August 2019

0434

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Product Gallery Qosina: One-Stop Source for the Largest Selection of Open-Bore Syringes Ronkonkoma, NY, USA, August 5, 2019— Qosina carries a unique selection of openbore syringes that are ideal for applications involving viscous substances.

These syringes have a larger inner diameter and higher flow rate compared to traditional male luer syringes, and they’re easy to handle as minimal force is required to dispense. There is also less clogging and buildup than with conventional fluid delivery systems.

Each of Qosina’s open-bore syringes offers distinct dosing and dispensing options. Features include: with or without graduations; ring and wing grips; removable tip caps; dispensing volumes up to 20 ml; vented plungers; internal tip threads; or palm pads.

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 13485, ISO 9001, ISO 22301 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

Qosina Launches European Operations Ronkonkoma, NY, USA, May 8, 2019—Qosina Corp. is pleased to announce the establishment of operations in Europe. Qosina Europe is located in Milan, Italy, and is managed by Giampaolo Meana.

“The decision to expand into Europe was a logical step in our business growth strategy,” said Scott Herskovitz, President and CEO of Qosina. “Our European market has grown considerably, and more companies look to Qosina to support their medical device development and production requirements. It’s critical that we have visibility where our customers live in order to serve them effectively.”

With over 30 years of experience and a strong presence in the medical device industry, Mr. Meana has a proven track record of success and in-depth technical knowledge related to medical device development and manufacturing. “We expect Giampaolo will have a significant impact on strengthening our existing customer relationships and is well positioned to support our new customer and project inquiries,” said Jeff Cushner, Qosina’s Director of Sales.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. The Qosina 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. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of

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beauty supplies to the cosmetic, skincare, spa and salon industries.

Rachelle Morrow Marketing Communications Manager Qosina Corp.

2002-Q Orville Drive North, Ronkonkoma, NY 11779 USA T: +1 (631) 242-3000, ext. 281 Email: rmorrow@qosina.com • www.qosina.com

Events Calender K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber 16 - 23, October, 2019 Venue : Dusseldofr, Germany Medica 2019 Leading International Trade Fair 18 - 21 November, 2019 Dusseldort, Germany Compamed 2019 Leading International Trade Fair 18 - 21 November, 2019 Dusseldort, Germany Medicall 2019 India's Largest & No. 1 Medical Equipment Exhibition 13 – 15 December 2019 Mumbai 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 July-August 2019

ISO : 13485 : 2012

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

MACHINERY FOR SALE

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.

1. Machine for Assembly opf Disposable ESR Pipettes with Dies & Moulds.

2. Machine to make Velcro Tourniquet.

3. Ultrasonic Plastic Welding Machine.

4. 32 Cavity Mould for RIA tube/Test tube(PS/PP).

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com

July-August 2019

Contact : Sushil Kumar Soni +91-9789966873

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SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : sanidhya.ent@gmail.com

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July-August 2019

Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

ISO 9001-2000

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

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 July-August 2019

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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 46

July-August 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 July-August 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 47

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter

• • • • • • • • • • •

Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026.

M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901

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.

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July-August 2019