Medical Plastics Data Service May - June 2018

CToabnletoef nts Vol. 26 No. 3 May - June 2018 20 COVER STORY Material Selection for Injection Molded Medical Parts Suresh V, Sr. Manager Market Development, Covestro (India) Private Limited Medical devices are often designed with complex geometry to meet very high precision hence injection molding the parts involves high skills, precision molds and the material that complements. 24 Unique Properties Make Polymers Suitable to Medical Tubing Applications Dan Lazas, Senior Director, Sales Optimization Medical Components, Tekni-Plex Extruded polymer tubes are used prolifically throughout the medical device industry from intravenous (IV) lines to neurovascular catheters.Advancements in polymers, additives . TECHNOLOGY Polymeric PDC Technology: An Integrated Approach To Autoinjector Design Jonathan Bradshaw, Device Development Engineer, Jonathan Lawson, Senior Design manager and Susanna White, Mechanical Engineer, Oval Medical Technologies. Subcutaneous injection is the preferred route of administration for biologic drug delivery. With the need to reduce costs, autoinjectors have become increasingly important. There are known issues with glass syringes, Polymeric PDC technology offers a new approach that can resolve many known glass issues. 29 GLOBAL TRENDS Enteral Feeding Devices Market Worth 3.19 Billion USD by 2022 31 AiMeD & REGULATORY UPDATES • AiMeD terms new MD procurement policy a lost opportunity to promote indigenous manufacturing of medical devices • CDSCO Proposes To Include All Implantable medical devices & other high end equipment under the category of 'drugs’ as Medical Devices • Health ministry identifies 10 exclusive centres to report serious adverse events as part of MvPI 33 INDUSTRY NEWS • Govt Proposes Over Rs 460 crore Support for Development of Pharma Sector (including Medical Devices) • KIHT Ties Up With JBI To Boost Research In Medical Devices & Diagnostics • CTP Expands To Meet Local Medical Market In India 34 PRODUCT GALLERY • Gamma-Stable, Large-Bore Tuohy Borst Adapters 35 EVENTS • Medical Design & Manufacturing (MD & M) East : Event Report • Medical Manufacturing Asia 2018 the Springboard to billion dollar ASEAN Medtech Market 18 DID YOU KNOW? • About What is a Medical Grade Polymer? May-June 2018 36 EVENTS CALENDER • Medical Manufacturing Asia 2018 : 29 – 31 August, 2018 • Medicall : 27 – 29, July, 2018 • Medicall : 21-23 September, 2018 • 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 : 26-27 October, 2018 • K 2019 : 16 – 23 October , 2019 17

Flashback ?YoDKuindow ? About What is a Medical Grade Polymer? Select Article Index Sept. 2008 to Dec. 2008 In an interesting article as published in the “Medical Plastic News (May – June 2018 ) , Siobhan Bastiansen, Velox, has explained why material suppliers as • Leaders Speak : Interview With Mr. Kishore well as Device Manufacturers would benefit from clarification and shows how Khanna, Managing Director, Romsons Interna- specialized medical polymer producers have risen to the challenge to create tional (September – October 2008) indispensable value for processors and OEMs. • Industry Overview : Kidney Dialysis Equip As per the article, “Polymers have been used in the healthcare and medical ment And Supplies industry for decades. Today, an estimated 50% of all materials used in Medi- (September – October 2008) cal Device manufacturing consist of plastics. However, when it comes to the right polymer choice for a specific medical or pharmaceutical application, things • Manufacturing : Plasticizers for Medical can get complicated. Despite strict international and national regulations as Devices well as demanding requirements for medical polymers, one extra difficulty in (September – October 2008) this choice is the fact that there has been no universally accepted definition of Mr. Carsten Goebel & Dr. Rainer Otter, BASF “medical grade” polymers so far. South East Asia Pte Ltd. She has further explained that, “Medical device development is a long and • Global Trends : Medical Device Industry complex undertaking, with strict compliance regulations, long-term tests, quality Worries About Cost-Focused Approach To checks and certifications. However, the industry has yet to answer one seem- Judging Medical Care ingly simple question: What is a “medical-grade” polymer? The Association of (September – October 2008) German Engineers, VDI, has embarked on defining a standard, with the first draft being presented at the VDI congress in Friedrichshafen in April.” • Market Trends & Analysis : Worldwide Kidney Dialysis Equipment And Supplies It is believed that ,from a legal perspective it is the company that brings the Market medical device onto the market that is responsible for complying with any (September – October 2008) applicable regulatory requirements, but medical grade polymers have no strict definition, and very often such plastics are sold on the basis their • Did You Know ? : About \"Catheters\"..... biocompatibility alone. (September – October 2008) It is estimated that only about three per cent of global plastics production is • Leaders Speak : Interview With Prof. A V destined for the healthcare industry. Considering this, it is clear that not every Ramani Group Vice-President (R & D) - TTK polymer manufacturer will be willing or even able to meet the healthcare OEM's Group Of Companies stringent requirements in the medical and pharmaceutical sectors. As such, (November – December 2008) the overall supply of plastics for medical technology remains limited so that use of standard polymers is still likely to continue in the future. This repre- • Market Trendsz & Analysis : Innovations In sents a potential risk, since change management for standard polymers often Medical Device Sector insufficiently addresses the high demands of medical applications. (November – December 2008) ( References : 1. Medical Plastics News , May – June 2018 ; 2. https:// • Vision : “Indian Medical Device Industry and www.eppm.com/materials/the-medical-grade-polymer-dilemma/ ) Related Regulations “By Mr. Rajiv Nath – President – All India Syringes and Needles In a Manufacturing Association Nutshell.... (November – December 2008) It is simply no longer possible • Global Trends : Market Survey on The Medi- to believe much of the clinical research cal Devices And Disposables Market In The EU that is published, or to rely on the (November – December 2008) judgment of trusted physicians or • Did You Know ? : About \"Intelligent\" Materi- als To Revolutionise Surgical Implants. authoritative medical guidelines. I take no (November – December 2008) pleasure in this conclusion, which I 18 reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine. -Marcia Angell May-June 2018

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. This issue focuses on Medical Polymers and important issues related to processing of Medical Polymers starting with explain- EDITORIAL ADVISORY BOARD ing “What is a Medical Grade Polymer”.... Dr. TARANG PATEL While only about three per cent of global plastics production is M.B.B.S., M.Ch. (ONCO) destined for the healthcare industry, at the same time about 50% Cancer & Reconstructive Surgeon of all materials used in Medical Device manufacturing consist of plastics. Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. It is therefore important to select right quality of Polymeric Materials meeting Chairman - Mobilexion Technologies Pvt. Ltd. healthcare OEM’s stringent requirements in the Medical and Pharmaceutical Sectors. Trivandrum A detailed explanation of selecting materials for Injection molding of Medical Com- Dr. DILIP H. RAIKER ponents is given by Mr V.Suresh, Sr. Manager Market Development, Covestro (In- Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) dia) Private Limited including various factors important to be considered. As very Former Chief Manager(P), CIPET - Chennai rightly mentioned by Mr Suresh, Medical devices are often designed with complex geometry to meet very high precision hence injection molding the part involves high ING LOUIS C. SUHUURMAN skills, precision molds and the material that complements the both. While he has Formerly Sales Director covered all important issues in general, a case study, he explains, “How does COLPITT B.V., Holland Polycarbonate become the material of choice for the renal care products?” Dr. A.V. RAMANI Most widely and commonly used process for Medical Polymers Processing is Group Sr. Vice President (R&D), The TTK Group Extrusion. In a very well researched article by Mr. Dan Lazas, Senior Director, Sales Optimization Medical Components, Tekni-Plex, Mr Dan explains that “extruded Dr. Vinny Sastri polymer tubes are used prolifically throughout the medical device industry from President, Winovia LLC, U.S.A. intravenous (IV) lines to neurovascular catheters. Revisiting unique polymer attributes that precisely benefit certain medical devices can lead to innovative applications in Dr. C.S.B. NAIR future devices.” He has gone at length to give examples of various materials Director (R&D), Peninsula Polymers Ltd including Plasticizers, medical grade PVC and TPUs with application areas like Blood Management, Therapeutic Delivery and Cardiac Intervention. As per Mr Dan, Dr. BHARAT GADHAVI Often, the distinct attributes of polymers that are not found on Polymer Data Sheets CEO, HCG Medisurge Hospitals is the determining factor for why specific medical polymers are consistently used in distinct medical tubing applications. Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai “Technology Column”, covers a very critical area of biologic drug delivery. Article “Polymeric PDC Technology” jointly written by professionals from the Oval group Dr. SUJOY K. GUHA namely Mr Jonathan Bradshaw Device Development Engineer, Mr Jonathan Lawson, B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Senior Design manager and Ms Susanna White Mechanical Engineer, explains how Polymeric PDC technology offers new approach that can resolve many known glass IIT, Kharagpur issues, whilst unlocking opportunities for delivery of biologics. It explains that “during development of combination device, two main streams of development Dr. G. S. BHUVANESHWAR occur; 1) the drug, and 2) delivery device. It is imperative that any device develop- Consultant, Medical Devices – Design, development, ment process places equal importance on delivery requirements of the drug, as well as the requirements of user interface.” It shows how use of polymers provides testing and quality management. increased geometry options combined with improved tolerance management not Adjunct Professor, Dept. of Engineering Design, Indian available with glass. Institute of Technology, Madras. This issue also covers regular columns like Global Trends, Industry News , “AiMED & Regulatory Updates, Products Gallery, Important Events, “Did You Know ?” etc. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. May-June 2018 19

Cover Story Material Selection For Injection Molded Medical Parts Suresh V, Sr. Manager Market Development, Covestro (India) Private Limited Medical devices are often designed with complex geometry to meet very high precision hence injection molding the parts involves high skills, precision molds and the material that complements the both. Material selection is very important for the development of a successful product. Considerations such as appearance, colour and key properties like mechanical strength and heat resistance are vital. Material selection is very important for the development of a medical devices goes through the set of key property evaluation successful product. To meet the in-use functional and selection process. Most of the materials meet very few of these requirements, considerations such as appearance, colour and properties but seldom with a unique combination of all properties. key properties like mechanical strength and heat resistance are vital for medical applications. However, there are additional Polycarbonate resins and blends have excellent thermal, considerations such as chemical disinfectant compatibility, mechanical and environmental properties that make them suitable sterilization requirements and regulatory fulfillment. for a wide variety of medical applications. Polycarbonate resins are an appropriate choice for medical parts that require glass-like The other factors that influence the selection of material transparency, while polycarbonate blends (PC/ABS) are generally includes the ease of processing, local availability and long- opaque. It also can be pre-coloured to achieve different colours term continuation of the product and the commercial viability and special effects to meet the various applications requirements. (cost of the material). Medical devices are often Medical devices usually designed with complex encompass multiple components. geometry to meet very high It is assembled with complex precision hence injection joints / assembly methods and molding the part involves under goes the sterilization high skills, precision molds process before delivery. Hence, and the material that the material used to make the complements the both. At components should support the the same time, frequent necessary combination of the change in the material properties as detailed in the formulation and the product pictorial illustration. The safety of change or discontinuation the entire device system (in terms will result in the huge cost of of biocompatibility to human requalification at the OEM body) must be proven according end so it is also important to to India medical device rule 2017. make sure that the supplier The OEM’s regulatory liability is with long history and better managed if the raw sustainable business model material is already assessed to be while assuring the biocompatible. consistency in the pricing and availability of the Covestro offers many material. polycarbonate resins and blends that have been specially An effective selection of developed to meet the plastics raw material for the requirements of medical 20 May-June 2018

Cover Story Product : Hemo-dialyzer housing applications, including Makrolon® polycarbonate, Apec® high Material : Makrolon® Rx2440 heat polycarbonate, Bayblend® PC+ABS blends andMakroblend® PC+PBT & PC+ PET blends. Advantage : • Biocompatible according to ISO10993-1 and USP How doesPolycarbonate become the material of choice for the renal care products? Class VI • Rigid yet tough Patients who have lost kidney function and have been • Dimensional Stability diagnosed with end-stage renal disease often require external • Glass like transparent, treatment of their blood (hemodialysis) to remove excess water • Steam, EtO, Gamma and eBeamsterializable and toxins. Hemodialysis is most often accomplished by passing the patient’s blood through a semipermeable membrane cartridge. Filter cartridges engineered from polycarbonate provide a rigid housing that supports and protects the fragile hemodialysis membrane. The polycarbonate material resists shattering during manufacture, shipping and during the clinical use.Its thermal stability allows for single-pass steam sterilization or processing via EtO or irradiation (both gamma and electron-beam). In the process, clarity of the housing is vital, enabling the dialysis technician to observe the procedure. 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 : 21 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 : [email protected] May-June 2018

Cover Story Unique Properties Make Polymers Suitable to Medical Tubing Applications Mr. Dan Lazas, Senior Director, Sales Optimization Medical Components, Tekni-Plex Extruded polymer tubes are used prolifically throughout the One reason is a common plasticizer, di-ehtylhexyl phthalate medical device industry from intravenous (IV) lines to (DEHP), used to convert the inherently rigid polymer into a neurovascular catheters. Advancements in polymers, additives flexible product suitable for tubes, bags and films. The FDA and processing technologies have resulted in medical tubing issued an advisory risk in 2002 pertaining to reproductive and precisely tailored to specific applications. This includes functional developmental concerns associated with patient exposure to high attributes spanning mechanical, thermal, electrical and chemical levels of DEHP. performance. While there are other plasticizers available for PVC, DEHP is Often, polymers and processing technologies selected for still commonly used for blood management applications. In devices are based on successful application in similar devices. addition to the economic benefits of using DEHP, studies have This is rational logic for a device designer intent on reducing shown the plasticizer to be advantageous in preserving blood time-to-market by avoiding reinvention. The regulatory filing cells. For example, a 1998 study1 found that DEHP inhibits the process also encourages use of proven technology. For deterioration of red blood cells during storage in PVC containers example, the intent of a United States Food & Drug Administration that use this plasticizer. Hemolysis and microvesicle formation 510(k) regulatory filing is to prove a device is as safe and effective were also shown to decrease with the presence of DEHP in the as a device that is currently marketed, known as a predicate same study. device. Therapeutic Delivery Unfortunately, the repeated application of polymer technologies Due to versatility in properties, thermoplastic polyurethanes based on predicate devices can desensitize engineers to the (TPUs) are used across a wide range of medical devices, extraordinary benefits of these materials for including wound care, healthcare applications. vascular access devices Revisiting unique polymer and IV therapy attributes that precisely applications. TPUs are a benefit certain medical class of copolymers, devices can lead to created from three innovative applications in chemical components: future devices. Some of polyol, chain extender these unique material and diisocyanate. The benefits stem from elastomeric segment of properties that are not the polymer chain is generally desirable in created from polyol and broad context. isocyanate, whereas the strength segment is Blood Management created from the chain Polyvinyl chloride (PVC) extender and isocyanate. is a material of choice for Polyester, polyether and tubing used throughout polycarbonate polyols can the medical device be used in the formulation industry. Applications of TPUs. Likewise, include blood management, cardiovascular pumps, dialysis, and aromatic or aliphatic isocyanates can be used. Variation in the respiratory, suction and drainage tubes. In many instances PVC type and amount of each component can change elasticity and has revolutionized patient care, reduced infections and improved a variety of other material properties. safety. For example, a blood transfusion system in the middle of the 20th century was a reusable device, which was large, A particularly unique characteristic of TPUs is their ability to soften heavy, and diffult to sterilize. Modern transfusion sets, with relatively small changes in temperature. 2 As such, these substantially comprised of PVC tubing, are single-use devices materials tend to soften when placed into the body. The degree that are economical, light weight and easy to use. of softening is dependent on the initial hardness and the chemical make-up of the material. Generally, low durometer polyurethanes Nevertheless, PVC has become controversial in recent years. soften up to 50% when placed in 98.6o F (37o C) water. Hard polyurethanes generally soften to a greater extent. For central 22 May-June 2018

Cover Story flexibility for vascular navigation. catheters, this property is particularly useful. Peripherally Since all PEBAs contain common polyamide constituents, they inserted central catheters (i.e. PICC lines) are indwelling devices can be thermally bonded to each other regardless of flexibility that can remain in a patients arm vein for weeks or longer to characteristics. This is particularly useful in the development of allow for frequent drug delivery. The softening characteristics cardiovascular guide catheters that can require more rigidity at of TPU are ideally suited for maximizing comfort in patients the proximal end, where the device is controlled by the physician, receiving treatment with central catheters. and more flexibility at the distal end, for atraumatic navigation of vascular pathways. Shafts of this nature can be created by Cardiac Intervention thermally bonding multiple segments of PEBA tubes, with The ability to tailor TPU properties from flexible to rigid using variation in flexibilities. variations in chemical constituents and amounts would be seemingly ideal for the flexible catheter shafts used in Data Sheets : Only Part of the Story percutaneous transluminal coronary angioplasty (PTCA) Polymer data sheets contain a host of material properties that procedures. Commonly 2 mm (0.079 inches) in diameter and allow medical device engineers and designers to compare 100 cm (39 inches) long, these catheters require a perfect properties of the polymers. For medical polymers used in device balance between strength and flexibility to be inserted in the tubing applications, these properties include density (i.e. specific upper leg (i.e. femoral artery) and reach the aortic sinus. gravity), strength, elongation, modulus (i.e. rigidity), hardness However, changing properties due to material softening, as is (i.e. durometer) and much more. characteristic of TPUs, would be a disadvantage in these devices. However, these properties only begin to tell the complete story of these polymers. Often, the distinct attributes of polymers Like TPUs, polyether block amides (PEBAs) are thermoplastic that are not found on data sheets is the determining factor for elastomers created through copolymerization of soft and hard why specific medical polymers are consistently used in distinct block molecular chains. Variation in the percentage of these medical tubing applications. components results in physical properties that range from highly flexible to moderately rigid. For PEBAs the hard block is a 1AuBuchon, JP et. el. The Effect of Plasticizer Di-2-Ethylhexyl polyamide, and the resulting polymer is resistant to softening Phthalate on Survival of Stored RBCs. Blood, Vol 71, No 2 when exposed to human body temperature and fluids. As such, (February), 1988: pp 448-452. it retains physical performance characteristics throughout the procedure. Also, these copolymers are slightly more rigid than 2Walder, A. Kulkarni, P. Thermoplastic Polyurethanes as Medical TPUs yet more flexible than nylon 11 or 12. This allows for Grade Thermoplastic Elastomer. Lubrizol Advanced Materials, better “pushability” of these catheters by clinicians while retaining Wilmington, MA. May-June 2018 23

Technology Over the past 20 years, there has been a shift in pharmaceutical characteristics with delivered volume, whilst ensuring a patient- pipelines towards the development of biologics, which make up centric approach. It is these requirements that are pushing the ~70% of drugs currently in development1. Biologics offer better limits of current glass-based technology. efficacy and safety, however the glass-based autoinjector technology used to deliver these drugs has not significantly Polymeric PDC technology offers a new approach that can evolved since the 1950s. resolve many known glass issues, whilst unlocking opportunities for the delivery of biologics. It is this approach Subcutaneous injection is the preferred route of administration to autoinjector design that allows Oval Medical to support a user- for biologic drug delivery. With the need to reduce costs, centric approach, unimpeded by the performance, integration autoinjectors have become increasingly important. Currently, capabilities, and the limited design freedoms of a glass-based single-use autoinjectors typically comprise of a pre-filled glass alternative. syringe, an injection mechanism for delivery of the drug, and a needle safety mechanism for disposal of the device. A USER-CENTRIC APPROACH A user-centric approach to the medical device development There are some advantages of using glass syringes as the process is key in ensuring the design of devices which promote primary drug container (PDC) within an autoinjector including; correct, safe and effective use. The inclusion of human factors engineering from the outset of the development process allows • Proven history of drug compatibility for an understanding of user group needs, their anticipated • Regulatory acceptance limitations and the environment in which the device will be used. • Market familiarisation Ultimately, the knowledge space that human factors engineering • Established manufacturing and filling processes generates allows minimisation of use-related risks, and avoids inadequate device design which could compromise the However, there are known issues with glass syringes, some of effectiveness of the device user interface. which have led to autoinjector recalls; The differences between user populations can be vast – patients • Lubricants risk contamination with migraine may experience aurora, causing visual impairment • Tungsten contamination from glass which hinders their ability to identify device features or text. • Plunger stiction leading to delivery inconsistency, that can Alternatively, patients suffering from anaphylaxis may require administration from a user with good vision, but are naïve with result in wet injections respect to autoinjector use. To create a well-considered and • Risk of glass breakage intuitive device, these examples demonstrate that it is essential • Formulation viscosity and volume limitations to appreciate the various user group dynamics, integrating them • Large manufacturing tolerances effectively into its design. • Complex supply chains reliant on specialist suppliers A truly user-centric approach must involve consideration of the The most recent innovations in biologics are now presenting device interface design. The constraints presented by glass PDC new challenges to the design of delivery platforms. Innovations technology can limit the ability of a design to meet all the such as long-acting injectables (LAIs) are being developed to functionality requirements which can compromise the user provide slow-release capabilities. The consequences, as with interface. Frequently, the use of a glass PDC leads to other biologics, are their viscous formulations and complex fluid compromises in device size, form and/or simplified use steps, properties (e.g. suspensions and emulsions with non-Newtonian preventing a device from fully meeting the needs of its users. properties). The challenge is to balance complex drug May-June 2018 24

Technology designing a fully-integrated device. Oval have developed an Injection Characterisation System (ICS) to thoroughly analyse a Polymeric PDC technology (Figure 1) unlocks the constraints of range of complex formulations and their properties, allowing an glass-based PDC systems through facilitating an integrated improved understanding of how they must be delivered. This approach to device design. Whilst the autoinjector industry has facilitates the correct autoinjector mechanism specification (e.g. been limited by its reliance on glass-based technologies, needle bore, spring force and container type), and also identifies polymeric PDCs allow design freedoms traditionally unattainable factors with the potential to affect the user. in many areas e.g. within user interface design. The result is The ICS includes sensing capabilities at key positions (Figure 2) that a user interface can be fully tuned to the requirements of a to allow feedback on forces and pressures within an autoinjector wide range of user populations without the burden of glass system during drug delivery. breakage, dimensional variability and other known issues associated with glass. Figure 2 : ICS Schematic A load cell reports on the amount of force produced by the Use of polymers provides increased geometry options combined chosen power source. The pressure sensor detects the pressure with improved tolerance management not available with glass. within the drug container and the linear encoder provides data on The benefits of polymer use include : the location of the plunger which can then be extrapolated into delivery speed. Figure 3 shows the outputs of these sensors which • Delivery speed consistency (preventing wet injections even can then be used to inform the design of the delivery system. when injecting challenging formulations e.g. non Newtonian fluids) Figure 3 : Output plots from the IGS during an injection plunger position in mm (green), delivery force in Newtons (blue) and • Shorter injection times for viscous formulations, without container pressure in bar (pink) against time in seconds. the risk of glass breakage Observing the relationship between internal pressure, P, and the speed of the plunger during delivery, V, reveals information about • Needle depth consistency, reducing risk of adverse events the formulation properties. By using the modified form of the • Improved user experience through smaller gauge needles Hagen-Poiseuille equation2, the viscosity of any formulation can then be evaluated : PDC components can be moulded with features that directly interact with device mechanisms which can overcome issues such as device recoil, variable use forces and injection speed. Ultimately this reduces the impact on the user, whilst ensuring all required user interface features are present without com- promise to overall device size or usability. Approaches to solving common user interface pitfalls through high-risk needle-less systems or ‘power-source’ innovations, form distractions which can detract from fully user-centric de- vices which could be better resolved through increased design freedoms. A polymeric PDC provides these free- doms which allow engineers to design-out user interface weaknesses typically observed within glass -based PDC autoinjectors. During the development of a combination device, two main streams of development occur; 1) the drug, and 2) the delivery device. It is imperative that any device devel- opment process places equal importance on the de- livery requirements of the drug, as well as the require- ments of the user interface. For optimal device design and performance, the user in- terface should not be influenced by the forces required to deliver the drug and similarly, the drug delivery mechanism should not be influenced by any force the user applies through the user interface. Regularly, these two sets of requirements conflict; biologics may require high delivery forces, whereas specific user populations may require low operation forces from the user interface. Part of the challenge for engineers is to accept this conflict and design around it effectively. It is possible to ‘decouple’ the conflicting requirements between the user interface and drug delivery mechanism through use of a polymer PDC. To do this effectively, it is imperative that both the needs of the user and the delivery requirements of the drug are fully understood at an early stage in the design process. AN APPROACH TO COMPLEX FORMULATIONS The characterisation of a drug is an important step towards May-June 2018 25

Technology Testing the same formulation under different conditions (e.g. speed, needle gauge, temperature), allows full characterisa.tion of drug viscosity and the uniformity between conditions. Many simple drug formulations are Newtonian (their viscosity will not change with shear force), however, complex formulations are becoming more common. These formulations may take the form of suspensions, emulsions or highly viscous fluids, often display- ing many non-Newtonian characteristics (e.g. shear thinning, shear-thickening or pseudo-plastic behaviour). Comparison between the viscosity of the formulation and other characteris- tics will reveal any non-Newtonian behaviour, allowing it to be modelled accurately. The power law equation is the most common function used to model non-Newtonian fluids. It is assumed that rather than a direct correlation between shear stress, τ, and shear rate, γ, as in a Newtonian fluid, the shear stress is proportional to a power of the shear rate3. Characterising formulations is a vital step towards developing an Figure 4: Sumalen Ovali 6mg 0.5ml Sumatriptan autoinjector for accurate numerical model for the behaviour of an autoinjector. It the treatment of migraine and cluster headaches allows prediction of both delivery characteristics, and the poten- tial effects of external factors (e.g. environmental conditions and This integrated approach is intended to improve clinical outcomes device tolerances). through the greater management of key device aspects such as needle depth. Oval has taken three steps to ensure that the The culmination of this characterisation process is that for each Sumalen Ovali delivers into the correct tissue i.e. subcutaneous: formulation tested, the delivery mechanism can be optimised through the appropriate specification of required functions and 1. Specify an appropriate needle depth: Informed by components, such as needle gauge and length, container dimen- ‘state-of-the-art’ population research e.g. ultrasound sions, and power source. Extensive knowledge of drug delivery studies. Correct inserted needle depth is essential to avoid requirements allows for this aspect of the device to be decoupled compromising drug pharmacokinetics. from that of the user interface. This results in a fully integrated solution which has been developed with consideration to both 2. Manufacture with controlled tolerances: Enabled the user and drug requirements, offering reduced risk, quicker through the use of a moulded polymeric container which development times and a competitive advantage to glass-based ensures needle depth and mechanism interface accuracy. systems. 3. Reduce injection depth variability through device COMBINING USER AND DRUG REQUIREMENTS design: Promotion of consistent tissue compression Oval’s subcutaneous platform embodies this integrated philoso- during use, reducing needle depth variation e.g. through phy to device design (Figure 4). Combining both user and drug user technique differences or high activation force requirements into its development, the platform provides a requirements. patient-centric device for delivery of Sumatriptan to migraine and cluster headache sufferers. The cyclic olefin PDC provides the option to configure compo- nent geometry freely, whilst ‘designing-in’ strength to manage high viscosities (>100cP). This permits the delivery of complex drug formulations alongside the inclusion of a full range of features (e.g. automatic needle insertion, end of delivery feedback and passive needle safety), within a simplified and compact form. The subcutaneous autoinjector platform actively decouples the drug delivery challenges from those of the user interface. The use of separate springs for needle insertion and for drug delivery reduces the risk of recoil and excessive force on the patient, whilst retaining the ability to deliver challenging formulations. 26 May-June 2018

Technology Overlaying the needle length for 30 Sumalen Ovali devices (pink) Jonathan Bradshaw with the results of 30 established Sumatriptan reference prod- Device Development Engineer ucts (grey), (Figure 5) demonstrates the impact of needle depth on the risk of an intramuscular injection at the thigh. The tissue depth risk profile is derived from two ultrasound studies at the thigh in >400 adult subjects 4,5. In summary, the needle length of the Sumalen Ovali is better Jonathan Lawson specified for the population, achieving tighter manufacturing Senior Design manager tolerances than the glass-based reference product (s = 0.09 vs 0.20mm). Tissue compression has the potential to further increase Susanna White the risk of Intramuscular (IM) injection. It should be noted that the Mechanical Engineer intramuscular risk estimates may be conservative, particularly for the reference product that incorporates a secondary activation button. Oval’s integrated device design philosophy has ensured that the ABOUT OVAL subcutaneous platform has overcome many inherent issues seen with existing glass-based systems. Combined with Oval’s drug Oval Medical technologies was founded in 2010 by Matthew characterisation and user research capabilities, the platform is Young to provide autoinjectors to meet the needs of patients and paving the way towards greater compatibility between a broad range of drugs including biologics. Oval platforms autoinjectors and the delivery of biologics. address formulations that are fragile and easily degraded, viscous formulations, some of which exhibit non Newtonian REFERENCES characteristics, and delivery volumes of up to 3ml. Owning the 1. McDonald C, “Pharm Exec’s 2016 Pipeline Report”. primary drug container allows integrated devices to be designed. Pharmaceutical Executive, 2015, Vol 35, Issue 11. This design freedom enables novel mechanisms to be introduced, 2. Sutera S, Skalak R, “The History of Poiseuille’s Law”. smaller devices to be developed and the use of polymeric Annual Review of Fluid Mechanics, 1993, Vol 25, materials gives our Pharma customers complete control over pp 1-19. critical component tolerances and control over their supply chain. 3. Chhabra R P, “Non-Newtonian Fluids: An Introduction”. Rheology of Complex Fluids, 2010, pp 3-34. Today, Oval is an SMC Ltd. Company adding world class 4. Gibney M, Arce C, Byron K et al, “Intramuscular Risk at contract manufacturing of medical devices in locations around Insulin Injection Sites – Measurement of the Distance from the world. Oval/SMC can provide customers with a complete Skin to Muscle and rationale for Shorter-Length Needles service from customisation of our subcutaneous and intramus- for Subcutaneous Insulin Therapy”. Diabetes Technology cular platforms, to production of clinical trials devices, and & Therapeutics, 2014, Vol 16, No 12. commercial scale manufacture. SMC also offers integration of 5. Tsai G, Kim L, Nevis IFP et al, “Autoinjector needle length filled primary drug containers with secondary packaging and may be inadequate to deliver epinephrine intramuscularly distribution. in women with confirmed food allergy”. Allergy, Asthma & Clinical Immunology, 2014, 10:39. Oval Medical Technologies The Innovation Centre, Unit 23 Cambridge Science Park, Cambridge UK CB4 0EY www.ovalmedical.com May-June 2018 27

® Alpha Medicare and Devices Ltd. (taking care…Since1984) Manufacturers & Exporters of Disposable Medical Devices GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : [email protected] : Attention : MEDICAL PRODUCTS MANUFACTURERS FOR Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact : Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : [email protected] • [email protected] 28 May-June 2018

Global Trends Enteral Feeding Devices Market Worth 3.19 Billion USD by 2022 According to a new market research \"Enteral Feeding Devices North America dominated the market in 2016 Market by Type (Feeding Pump, Feeding Tube, Giving Set, Enteral Syringes), Age Group (Adult, Pediatric), Application North America accounted for the largest share of the Enteral (Oncology, Gastroenterology, Diabetes), End User (Hospi- Feeding Devices Market in 2016, followed by Europe. This tal, Home Care) - Global Forecast to 2022\", regional segment shows significant market growth opportunities published by MarketsandMarkets™, the market is expected to reach USD 3.19 owing to the high adoption of enteral feeding Billion by 2022 from an estimated USD devices, increasing prevalence of 2.39 Billion in 2017, at a CAGR of chronic diseases, presence of many 6.0% during the forecast period. large hospitals, and the develop- ment of innovative products. Factors such as the increasing Moreover, a number of major prevalence of chronic diseases, global players are based in rising geriatric population, rising the US. incidence of preterm births, gro- wing demand for enteral feeding The prominent players devices in the home care sector, in the Enteral Feeding and the shift from parenteral to Devices Market are enteral nutrition are the key drivers Fresenius Kabi (Germany), of the Enteral Feeding Devices Halyard Health (US), Medtronic Market. Furthermore, the rising (Ireland), B. Braun (Germany), Abbott demand for user-friendly feeding devices (US), C.R. Bard (US), Boston Scientific (US), and technological advancements are contributing Cook Medical (US), CONMED (US), Nestlé to the growth of this market. However, the complications associ- (Switzerland), Danone (France), Moog (US), Vygon ated with the use of enteral feeding devices and the insufficient (France), and Applied Medical Technology (US). reimbursements for enteral nutrition are some of the major challenges currently at play in the market. (https://www.prnewswire.com/news-releases/enteral-feeding-de- vices-market-worth-319-billion-usd-by-2022-668127923.html) By product, the enteral feeding pumps segment accounted National for the largest share of the market. Healthcare On the basis of products, the enteral feeding pumps segment An ISO 9001 : 2008 Company accounted for the largest share of the Enteral Feeding Devices Market, in 2016. This can be attributed to the low risk of compli- Manufacturing & Exports of cations with the use of feeding pumps, enhanced portable pump Medical Disposables : designs, and the increasing use of pumps in home care settings. I.V. Set, B.T. Set, Urine Bag, The adults segment dominated the market in 2016 Measured volume set, Cord Clamp, Surgical Based on age group, the adults segment accounted for the larg- Gloves etc. est share of the Enteral Feeding Devices Market. The large share can be attributed to the increasing incidence and prevalence of Injection Moulded Medical Components chronic diseases like cancer, diabetes, neurological disorders, and Extended Tubes : and inflammatory bowel syndrome that result in malnutrition along with the rapid rise in the aging population. I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / The oncology segment is expected to grow at the highest CAGR during the forecast period Urine Bag Tubes etc. By application, the Enteral Feeding Devices Market is segmented Contact : into oncology, gastroenterology, diabetes, neurology, hyper metabolism, and other applications. The oncology segment is Naresh Patel expected to grow at the highest CAGR owing to the increasing 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., incidence and prevalence of cancer across the globe and the need for clinical nutrition in such patients. Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 Home care settings to grow at the highest CAGR from 2017 to 2022 E-mail : [email protected] Website: nationalhealthcare.in Based on end user, the home care settings segment is expected to grow at the highest CAGR during the forecast period. The high growth of this segment can be attributed to factors such as the increasing focus on minimizing healthcare costs, development of user-friendly and portable feeding devices for home care, and the favorable reimbursement policies for home care. May-June 2018 29

30 May-June 2018

AiMeD terms new MD procurement policy a lost opportunity to promote indigenous manufacturing of medical devices The Association of Indian Medical Device Industry (AiMeD) has Indian manufacturer wins he will supply at his bid price, not at a expressed deep concern over the final guidelines for implemen- higher price, said Nath. tation of the provisions of the Public Procurement (Preference to Make in India) Order (PPO) with respect to public procurement By denying preferential pricing to genuine Indian manufacturers, of medical devices issued by DoP recently. the policy guidelines are not exactly encouraging. It is sad that genuine concerns and suggestions of domestic medical device “Government of India has the intent but lacks boldness – half- manufacturers are being repeatedly sidelined, noted Nath. hearted attempts will get half-hearted results. It is a clear case of a lost opportunity to promote indigenous manufacturing of DIPP/ DoP needs to do a study of gains made by any MSME medical devices to boost ‘Make in India’ initiative,” said Rajiv Nath, (micro small and medium enterprise ) in winning tenders in past Forum Coordinator, AiMeD. by matching L1 Pricing of imported Chinese products to win 20% of tender under the MSME Policy. If an Indian manufacturer finds If lowest price of tender bid is imported then the Indian manufac- it unsustainable to match L1 of lower priced Chinese imports to turers meeting the criteria of domestic content has option to match get 20% of the business as was earlier too possible then what is lowest price and seek 50% of tender. If lowest is Indian, there are the use of this Policy to get 50% of the tender, queried Nath. no added advantage of course, he added. We can match prices of any country other than China as it has no The DoP guidelines do not provide preferential pricing for Indian global market economies but a subsidised state sponsored devices. There are no incentives on maintaining and improving ecosystem. How can we compete with low priced imports from quality, indigenous development and no penal action based china with non-remunerative, non-sustainable pricing unless disallowance to use exclusionary 3rd country regulatory Indian government has supportive policies, Nath asked insisting approvals like US FDA in tenders. India needs to follow the UN system of procurement based on sustainable costs and not based on L1 Lowest pricing that AiMeD now suggests for Preferential Pricing for domestic manu- motivates some manufacturers to cut corners in regard to quality facturers based on World Bank norms. The preference for ICMED/ and service delivery of product and give poor image to Brand ISO Certified manufacturers will boost quality. India. Preference for India certified manufacturers will give a fillip to Regretfully to compete with low priced Chinese imports that are indigenous development. There needs to be timely payment flooding the market, there is no preferential pricing for Indian against government supplies. There is need for penal provision devices. World Bank provides for this, but our government is against hospitals that keep exclusionary compliance clause of strangely shy despite Ministry of Finance permits the same US FDA certification as 3rd Country Regulatory approval. under General Financial Rules. World Bank has a clause to support domestic manufacturers by http://pharmabiz.com/NewsDetails.aspx?aid=109081&sid=1 adding 15% to import CIF price of imported goods for the sake of May 25, 2018 bid comparison and thereafter the lowest price is winner. So if CDSCO Proposes To Include All Implantable medical devices & other high end equipment under the category of 'drugs’ as Medical Devices Drugs Technical Advisory Board ( DTAB ) in a recent meeting This will be notified in the official Gazette of India and will come has recommended for the proposal to specify the following into force after a period of twelve months from date of publica- medical devices under the definition of drugs. tion. CDSCO has requested all the stakeholders to forward their comments / suggestions. This Public Notice is available on All Implantable Medical Devices, CT Scan Equipment, MRI CDSCO website. Equipment, Defibrillators, Dialysis Machine, PET Equipment, X-Ray Machine, Bone Marrow Cell Separator. Health ministry identifies 10 exclusive centres to report serious adverse events as part of MvPI Having generated 500 serious adverse events (SAE) due to MvPI was launched by Drugs Controller General of India (DCGI) medical devices during the past three months, the Materio on July 6, 2015 at Indian Pharmacopoeia Commission (IPC) Vigilance Programme of India (MvPI) has put 10 exclusive Ghaziabad. IPC functions as a National Coordination Centre centres under it to collect and disseminate reporting of adverse (NCC) for MvPI. events due to medical devices at the point of care besides the 250 adverse drug reaction monitoring centres (AMCs) across the The programme is currently operational along the lines of the country. existing Pharmacovigilance Programme of India (PvPI) and May-June 2018 31

Haemovigilance Programme of India (HvPI) in co-ordination with ries among other relevant details like actions taken immediately 10 medical colleges of the country. The medical colleges are after the incident/event. equipped to collect and disseminate reporting of SAE due to IPC which is the national coordination centre (NCC) for PvPI also medical devices. serves as the nodal agency for the AMCs across the country. Aimed at monitoring the benefit-risk profile of medical devices, The Union health ministry had earlier directed the AMCs across MvPI besides reporting MDAE will start creating awareness the country to also report SAE during the course of usage of a among healthcare professionals about the importance of MDAE medical devices as part of the MvPI. reporting in India. This will help generate independent, evidence- based recommendations on the safety of medical devices and The MvPI is meant to enable safety data collection in a system- communicate the findings to all key stakeholders. atic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data http://www.pharmabiz.com/ generated in India. NewsDetails.aspx?aid=109007&sid=1 The programme requires inputs in biomedical engineering unlike May 21, 2018 in medicines where the mechanism is different for reporting of adverse drug reaction (ADR) reporting. More Headlines …… IPC has also launched a reporting form for MvPI. The reporting • Health ministry issues guidelines on essential form called as Medical Device Adverse Event (MDAE) reporting principles for safety and performance of medical form will help generate independent, evidence-based recommen- devices dations on the safety of medical devices and to communicate the findings to all key stakeholders. • Govt may push for regulating manufacture, sale, import of implantable medical devices The reporting form which has undergone series of scientific consultations, stakeholder meetings with industry and inputs from • Gujarat FDCA appoints 90 medical device officers to scientists across the country will ensure safety of medical implement new MD rules devices through reporting of adverse events due to medical devices in India. • Maha FDA to implement new MD Rules with appoint- ment of notified bodies at CDSCO soon The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number, catalogue number for instruments, date of installation/implantation/explanation and list of accesso- AN ISO 13485-2012 AVAILABLE CE certified Company PRE USED SYRINGE Manufacturer & Exporter of Medical MANUFACTURING Disposable Devices & Surgical Products EQUIPMENT Range of Products : Moulds : 2, 3, 5, 10ml • Infusion Set Syringe Printing Machine : • Blood Administration Set 2/3, 5, 10ml • Measure Volume Set Syringe 4 Parts Assembly Machine : • Urine Collecting Bag 2/3, 5, 10ml • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser Contact : 7895648113 • Twin Bore Nasal Oxygen Set • Oxygen Face Mask [email protected] • Nebulizer Kit • Vaccum Suck Suction Set May-June 2018 • Latex Surgical Gloves • Umblical Cord Clamp Contact Yogesh Patel M. : +91 98241 21383 MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Website : www.medicaredevices.com 32

Industry News Govt Proposes Over Rs 460 crore Support for Development of Pharma Sector (including Medical Devices) The government has proposed over Rs 460 crore support for the The third scheme proposed is for the assistance for cluster development of pharmaceuticals industry with an aim to reduce development. cost of bulk drugs and medical devices through setting up of com- mon facility centres and to help SMEs upgrade technology. \"The scheme termed as cluster development programme for pharma sector (CDP-PS) as a central sector scheme and the Announcing guidelines for five sub-schemes under the pharma total size of the scheme is proposed as Rs 20 crore for CDP-PS development programme, the Department of Pharmaceuticals for 2018-2020,\" the note added. (DoP) said the objective is to reduce cost of production by 20-25 per cent in bulk drug parks. It would be implemented on a public private partnership (PPP) format through one time grant-in-aid to be released in various Similarly, for medical devices also, the aim is to bring down the phases for creation of identified infrastructure and common cost of production significantly in the dedicated medical device facilities to special purpose vehicles (SPVs) set up for the parks, thereby leading to better availability and affordability in purpose, it added. the domestic market. Besides, the DoP said the pharmaceutical promotion develop- The government is looking at providing assistance to bulk drug ment scheme (PPDS) will aim at promotion, development and industry by setting up common facility centres. It has been pro- export promotion in pharma sector by extending financial sup- posed as a central sector scheme with a total size of Rs 200 port for conduct of seminars, conferences and exhibitions, among crore for 2018-2020, the DoP said in an announcement on its other activities.Under the scheme, mounting delegations for pro- website. motion of exports as well as investments, conducting studies/ consultancies, for facilitating growth, exports as well as critical \"The scheme would be implemented through a one-time grant- issues affecting pharma sector will be supported. in-aid to be released for creation of identified infrastructure and It further said a budgetary allocation of Rs 144 crore for 2018- common facilities to a State Implementing Agency (SIA) set up 2020 has been made for pharmaceutical technology upgradation for the purpose,\" it added. assistance scheme (PTUAS). The purpose of the grant is to render the financial assistance for It is possible to extend benefit of interest subvention to around establishment of common facilities in any upcoming bulk drug 250 pharma SMEs under the scheme, it added. park promoted by state governments/state corporations, it added. he goal of this scheme is to facilitate small and medium pharma enterprises (SMEs) of proven track record to World Health Another scheme for which the guidelines for implementation have Organisation (WHO)/Good Manufacturing Practices norms to been mooted is for assistance to medical device industry for enable them to participate and compete in global markets and setting up of common facility centres. earn foreign exchange. \"The scheme termed as development of common facility centre https://timesofindia.indiatimes.com/india/slight-improvement-in- for medical device (DCFCMD) is proposed as a central sector assam-flood-situation-death-toll-rises-to-26/articleshow/ scheme,\" the announcement said. 64735067.cms ; Jun 25, 2018 Assistance under the scheme will be admissible for creation of common facilities in medical device park and it will be implemented through a one-time grant-in-aid, the note said. KIHT Ties Up With JBI To Boost Research In Medical Devices & Diagnostics Kalam Institute of Health Technology (KIHT) a regional hub for con- The Joanna Briggs Collaboration (JBC) is a key body that ducting health technology assessment recognized by department of contributes to the global success of the Joanna Briggs Institute, with health research under the union health ministry has got another respect to scholarly outputs and geographic footprint. The JBC has feather in cap by getting associated with Joanna Briggs grown exponentially over the course of the 20-year Institute (JBI), University of Adelaide as the affiliated group. history of the Institute and now incorporates more than 80 entities internationally across five regions of the world. KIHT would focus on medical devices and diagnostic and associate with other JBI centres in this domain of research. All the studies done WHO has selected AMTZ to host its pre-qualification cell for in vitro in this space would be submitted to JBI and KIHT would like to diagnostics (IVD) which is a first of its kind in South East Asia. involve in supporting and leading JBI in medical devices and diagnostic space globally. This pre-qualification cell, which will provide guidance to Indian manu- facturers on the WHO pre-qualification of IVDs programme and will Andhra Pradesh MedTech Zone Ltd (AMTZ), India’s first government also enable manufacturers to match global quality funded medical devices manufacturing park would now be also host- standards. It will also help manufacturers to participate in UN ing JBI along with cluster of 250 manufacturing units includes com- procurement process for IVD devices enabling export. mon scientific facilities like electro-magnetic interference testing, biomaterials testing, gamma irradiation, rapid prototyping centre, etc., WHO will provide the required training to the support cell staff to Indian biomedical skill consortium, World Health Organization (WHO) guide the manufacturers about WHO pre-qualification expectations pre-qualification cell, directorate of radiation and medical devices while AMTZ will handle day to day operations. AMTZ with in-house promotion council. high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent. These institutes would contribute in developing standard and quality in Indian medical technology industry and services and http://pharmabiz.com/NewsDetails.aspx?aid=109490&sid=1 ; June bring Indian market at par with global market. 16, 2018, 08:00 Hrs [IST] May-June 2018 33

Product Gallery Qosina Now Stocks Gamma-Stable, Large-Bore Tuohy Borst Adapters Ronkonkoma, NY, USA, June 4, 2018— Founded in 1980, Qosina is a leading Qosina is pleased to add tinted, gamma- global supplier of OEM single-use com- sterilizable, large-bore tuohy borst ponents to the medical and pharmaceu- adapters to its existing line of tuohy tical industries. Qosina’s philosophy is to borsts. Qosina now carries 13 distinct, address its customers’ need to reduce off-the-shelf options that can accommo- time-to-market by providing thousands of date instrument sizes up to 18 FR. stock components. The company’s vast Comprised of a clear or tinted polycar- catalog features more than 5,000 prod- bonate body and a leak-proof silicone ucts shown in full-scale illustrations on a gasket, these large-bore tuohy borst one-centimeter grid. Qosina offers free adapters are equipped with female luer samples of most items, low minimum lock and tubing connection sideports for order requirements, just-in-time delivery, flushing, barbed and threaded flare modification of existing molds, and new ends, and red and blue caps. These product design and development. Qosina components are designed to prevent the is ISO 9001, ISO 13485 and ISO 14001 backflow of fluid and are ideal for appli- registered, and operates in a 95,000 cations that require larger instruments square-foot facility with an ISO Class 8 and devices. Qosina also offers a unique build-in style that can Clean Room. To learn about Qosina’s full component offering, be customized into a specific device design. which includes the newest products, Qosina will be showcasing the new large-bore tuohy borst adapt- visit www.qosina.com or call +1 (631) 242-3000. ers, in addition to thousands of stock components, at booth 1529 Contact : Qosina Corporation, Rachelle Morrow, during MD&M East at the Jacob Javits Convention Center in New York, June 12-14. +1 (631) 242-3000 [email protected] Industry News An ISO & CE certified Company CTP Expands To Meet Local Medical AMIGO SURGI CARE PVT. LTD. Market In India Manufacturer of Carclo Technical Plastics (CTP) has announced it is expanding its Disposable Surgical Products manufacturing facility in Doddaballapur near Bangalore, India. The company says the move will enable it to continue serving exist- I.V.CANNULAS / B.T.SETS / I.V.SETS / ing customers in the electronics industry and target the growing SURGICAL LATEX GLOVES / CORD local medical market. CTP’s facility is accredited to ISO 9001 (ISO13485 pending) and CLAMPS / MEASURE has a capacity for approximately 40 injection moulding machines VOLUME SETS / URINE BAG / CATHETERS / plus assembly capability. OXYGEN MASK / NEBULIZER MASK / SCALP VEIN Key to the expansion is a new medical hall, equipped with state-of- the-art, all-electric injection moulding machines from supplier Fanuc. SET / CANNULA FIXATOR ETC. CTP has invested in new manufacturing space, injection moulding machines, ancillaries and specialist staff in Bangalore as it targets Only Manufacturer of IV CANNULA in GUJARAT medical customers in the region. Contact : Gary Allan, CTP India Managing Director, said: “CTP’s global facili- ties have long been involved in manufacture of disposable diagnos- Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) tic and delivery devices and we are delighted to be expanding our Mobile : 0091-9825057180 facility in Bangalore and targeting medical plastic component Tel.: 0091-2764-268249 opportunities in India.” E-mail : [email protected] https://www.eppm.com/industry-news/ctp-expands-to-meet-local- Website : www.ivcannulaindia.com medical-market-in-india/ ; 12 June 2018 Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. 34 May-June 2018

Event Report Medical Design & Manufacturing (MD & M) East, New York, 12- 14, June 2018. Venue : Jacob K. Javits Convention Center The East Coast’s Leading Advanced Design and Manufacturing Event Held Successfully with Tremendous Response. The Event Highlights : • Leading Suppliers : 700+ leading suppliers gave access to a full spectrum of solutions in one end-to-end experience providing solutions to toughest challenges in just one lap! • Education Hubs : Provided Access to in-depth industry education through 3 dedicated hubs on the expo floor spanning medtech, smart manufacturing and packaging. 50+ hours of in-depth education—for free ! • Attendee-to-Exhibitor Matchmaking : Provided Unique Opportunity to connect with suppliers and to connect with suppliers based on their needs discovering a range of options to explore further. • Innovation Tours : Visitors got benefit of expert guide on a one-hour tour of the show floor with focus on a key theme at the forefront of the Industry and innovative tech. • Tech Theater : Provided opportunity to hear from Innovative exhibitors show- casing latest technologies and asking them questions, getting answers and discovering products to engineer into their projects. • 3D Printing Zone : Provided the latest 3D printing tech in a dedicated zone and learn through 3D printing- focused tours, activities, demos and expert-led sessions. May-June 2018 35

Events MEDICAL MANUFACTURING ASIA 2018 The Springboard To Billion Dollar ASEAN Medtech Market Standfirst : Fourth edition of MEDICAL MANUFACTURING ASIA Microtechnology Network, the to provide comprehensive showcase of exhibits and concurrent German-based international events association has an extensive membership with companies Medical manufacturing has seen a boom in the recent years, as in the fields of microtech- innovative medical technology has becoming a vital part of the nology, nanotechnology, ad- industry for delivering efficiency in the wider healthcare supply vanced materials and photonics. Furthermore, visitors will also chain, With the advances in medical technology, precision engi- see first-time exhibitors showcasing the latest technologies from neering, micro-manufacturing processes, and IT, medical devices various countries in Europe. have become more sophisticated. This increased demand has created a medtech market in Asia Pacific that is expected to rise Providing an end-to-end exhibition for professionals in the indus- to US$133 billion a year in 2020. A projection that provides a try, MEDICAL MANUFACTURING ASIA 2018 is synergistically stream of business opportunities in the industry. co-located with Asia’s biggest medical and healthcare exhibition, MEDICAL FAIR ASIA. This provides a comprehensive experi- The fourth edition of MEDICAL MANUFACTURING ASIA makes ence, as the two exhibitions provide upstream to downstream a return to Singapore as the region's leading specialist trade fair solutions and business sourcing opportunities for medical, for Asia's medtech and medical manufacturing processes healthcare, and medical manufacturing sectors. sectors. The exhibition will focus on new manufacturing technol- ogy and automation that will play a pivotal role in the medical The upcoming edition of MEDICAL MANUFACTURING ASIA is manufacturing industries for years to come. Exhibitors will show- gaining traction as the region’s leading specialist trade exhibition case a wide array of the latest solutions in 3D printing technolo- for the medtech and medical manufacturing sectors through its gies, imaging and diagnostic imaging, as well as nano and macro stellar showcase of exhibits and industry-leading concurrent manufacturing. Jointly organised by SPETA (Singapore events. Following the success of the previous three editions, the Precision Engineering and Technology Association) and Messe well-regarded exhibition will feature 250 exhibitors from 20 coun- Düsseldorf Asia, the exhibition part of the larger MEDICAlliance tries showcasing thousands of noteworthy and cutting-edge network, and is modelled after the No.1 global trade fair in the technologies. medtech sector, COMPAMED, held in Düsseldorf, Germany. Pre-registration is already open, please visit Singapore is the ideal platform for the exhibition as its medtech www.medmanufacturing-asia.com. presence continues to gain more leverage, as the nation contin- ues to grow its already sizable number of medtech companies. Pre-register your visit now and stand to win the latest smartphone! The three-day exhibition strongly reflects Singapore’s focus on moving upstream to not just production but also value engineer- ing. This exhibition is thus the perfect platform to source for the latest showcase of the products and innovations to springboard to the greater part of Southeast Asia. With a track record of strong exhibitor line-up, MEDICAL MANU- Events Calender FACTURING ASIA continues to lead the industry forward. The previous edition saw more than 5,000 trade visitors from 52 • Medical Manufacturing Asia 2018 - 4th Manufacturing countries sourcing from products and solutions exhibited by 200 Processes for Medical Technology Exhibition and Confer- exhibitors from 18 countries. It has made a great impression on ence - Date : August 29 – 31, 2018 visitors with trade buyers successfully procuring the latest Venue : Marina Bay Sands Singapore medical technologies and innovative products. • Medicall - India’s Larges B2B Medical Equipment Exhibi- More than a premier sourcing platform, MEDICAL MANUFAC- tion - Date : July 27 – 29, 2018 TURING ASIA’s show floor also features the industry-leading Venue : Chennai Trade Center, Chennai, India conferences, forums and product demonstrations. This serves as a great way to stay up-to-date with the latest industry trends, • Medicall - India’s Larges B2B Medical Equipment Exhibi- demands and innovations. tion - Date : September 21-23, 2018 Venue : Pragati Maidan, New Delhi, India The half-day High-technology for Medical Devices forum will see exhibitors from around the world share the latest developments • 15th National Conference And Technology Exhibition and trends on the global and domestics fronts and market oppor- On Indian Medical Devices & Plastics Disposables / tunities for medtech products from Europe. Organised by IVAM Implants Industry 2018 - Date : October 26-27, 2018 Venue : Ahmedabad Management Association, Ahmedabad, Gujarat • K 2019 - The World’s No. 1 Trade Fair for Plastics and Rubber - Date : October 16 - 23, 2019 Venue : Dusseldofr, Germany 36 May-June 2018

ISO : 13485 : 2012 We are a leading Consulting organization JIMIT MEDICO providing an integrated services with SURGICALS PVT. LTD. focus on project technology : AN ISO 13485 : 2012 & CERTIFIED COMPANY Quality Management System as per ISO 9001, ISO 13485, Medical Devices Manufacturers & Exporters of CE marking as per MDD/93/42, FDA Disposable Medical Devices 510k, Audit, Documentation, training and c-GMP. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, Sanjay Y .Shah – Owner Promoter HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, M : +91 98240 17850 Dressings etc. Obelis European Specialized in Handling Large Quantity Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest & OEM / Contract Manufacturing Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Tele : +91-79-25835567, +91-79-25834850 Website : www.unikalindia.com E-mail: [email protected] • Web: www.jimitsurgicals.com Mar.-Apr. 2018 37

Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking 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, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Wide Range Of Products : Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound The company Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical manufactures a wide range Cord Clamp etc... of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: [email protected]/[email protected] Website : www.angiplast.com GMP I. V. SETS AND MEDICAL ISO - 9001-2008 DISPOSABLES MANUFACTUR- Certified Company ING UNIT FOR SALE S. Nath & Co. Unit in Good Running Excellence in Quality Condition Manufacturer & Exporter of • Holding Gujarat State FDA Mfg. Licence Surgical Disposable Products since 1980 • Located in Industrial Area in Ahmedabad • Built up Area More Than 390 Square Meter IDEAL® • Machinery / Equipments in Good Working Condition • Includes : Assembly Furniture, Clean Room Systems, • Infusion Set • Blood Administration Set E.T.O. Sterilizer, Laboratory Equipments, Urine Bag • Urine Collection Bag Mfg. Machines, Packaging Equipments, Utilities Etc. • Urine Specimen Container • Promoters Interested to sell because of other • Umblical Cord Clamp business commitments. • No Short Term / Long Term Liability Address Contact : E-mail [email protected], S. Nath & Co. [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Mar.-Apr. 2018 Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 38

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com ISO 9001:2008 CERTIFIED COMPANY MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Address : • I.V. Infusion Sets Apex Medical Devices • Blood Administration Sets • Scalp Vein Set Plot No. 10/B, • Urine Collection Bags Shyam Ujjawal Indurstrial Estate, • Ryles / Feeding Tubes Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, • Catheters and Tubes Ahmedabad-382445. Gujarat, India. • Surgical Gloves. Phone No. : +91-79 - 29701333 Contact : E-mail : [email protected] Mr. Bhavin Shah Website : www.apexmedicaldevice.com MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Mar.-Apr. 2018 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 39

ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit • Breathing Circuit • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit • 3 Ball Spirometer • Nasal Canula • Patient ID Belt • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways Nebulizer Compressor • B. P. Meter • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 40 Mar.-Apr. 2018