Medical Plastics Data Service November - December 2015

CToabnletoef nts Vol. 23 No. 6 Nov. - Dec. 2015 22 Cover Story • Global Medical Disposables Industry Scenario And Role Of Plastics Disposable Medical Devices are a very important part of the total Medical Device Industry. For the past few years, the disposables market has been growing continuously and trends predict strong growth for the near future. Global demand for raw materials used in the production of medical disposables , the vast majority of which are plastics will increase to………. • Most Widely Used Medical Disposable Products 25 Global Trends • The Eleven Most Implanted Medical Devices In America • Fecal Incontinence Device • Lubrizol To Invest $ 15 mn In Lifesciences Business 28 Book Review • Publications Related to: Medical Devices- Regulations, Standards and Practices, Biomaterials, R&D, Sterilization, Advanced Polymers in Medicine etc. 34 Product Gallery • New Swabbable Needleless Injection Sites with Barbs • New Swabbable Needleless Injection Sites With T-Ports 35 Industry News • Medical Device Sector Delinked From Pharma • AIMED Launches UdaiMed, India’s First Industry - Academia Collaboration For Medical Devices R&D • CM Promises Land For India’s First Medical Devices Park In Gujarat • Compliments To Gujarat FDCA • Arbitary MRP Printing On Imported Medical Devices Raising Healthcare Cost 20 Did You Know? • About Failure of Endotracheal Tubes 42 Article Index • Important Articles published in the magazine from Nov. - Dec. 2014 To Nov. - Dec. 2015 38 Events • Plexpo India 2016 : 07th-11th January 2016, Gandhinagar, Gujarat • 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. 12-13 February, 2016, Ahmedabad. • Plastivision Arabia 2016 : February 22-25, 2016, Sharjah. • Medical Fair India 2016 : March 11-13, 2016, Mumbai. • Medicall 2016 : 22-24 July, 2016, Chennai. • Medical Manufacturing Asia : 31st Aug. - 2nd Sep. 2016, Singapore. Nov. - Dec. 2015 19

Flashback ?YoDKuindow ? September 2003 About Failure of Endotracheal Tubes From Editor’s Desk Endotracheal Tubes are checked before intubation, but still device failures have been documented due to manufacturing defects, e.g. cuff valve failure. Other Dear Readers, complications associated with the use of re-sterilized tubes, breakage of part of First of all we wish “A VERY HAPPY DIWALI” to all our the tube or obliteration of the tube lumen by a foreign body, e.g. mucous plugs readers. have also been documented. Despite the check steps or visual inspection for physical defect, incidences of The Seminar on “MEDICAL DEVICE PACKAGING” device failures are commonly encountered. sponsored by “MEDICAL PLASTICS DATA SERVICE” Laryngoscopy was done on a 1-month-old male infant and intubation was performed and conducted by Central Institute Of Plastics using a 3-mm id endotracheal tube (ETT) under vision.The child had no significant Engineering & Technology, (CIPET) on September 30, other medical complaints. On connecting the ETT to the circuit, the chest did not 2003 was a big success with participants from Medical expand on ventilation, neither was there any air entry on auscultation. So, Devices and Medical Packaging Industries from all over laryngoscopy was done and the position of the tube was assured; still the chest India. did not expand on ventilation. After this, the tube was taken out and without delay The Seminar was inaugurated by Shri Subodhbhai another tube of 3 mm id was connected. The baby was ventilated successfully, Adeshara, Commissioner, Food And Drug Control and on checking the previous tube, it was found that the T-connector of the ETT Administration , Gujarat State. Mr S P Adeshara is also a was obliterated. On inspection, it was found that this was a manufacturing defect member of the Regulatory Committee constituted for as the tube was new. There were no complications due to this delay of intubation. preparing a draft code for approval of Medica Devices. In this case, ETT had obliteration in the T-connector, which caused ventilation Mr Adeshara emphasised the importance of certifications failure. This was a manufacturing defect as the tube was neither being reused nor including GMP. was re-sterilized. Usually on inspection, the obvious defects of the tubes are The Seminar discussed various important issues related discovered but the defects which are visually not very perceptible are missed. This to Medical Device Packaging like : Regulatory Aspects, incidence signifies the importance of reviewing equipment defects for internal Package Specifications, Packaging Materials and auditing purpose, so that complications could be avoided, because negligence Machineries, Package Sterilization Methods, Bar-Code could cost a life. Labeling, International Standards and Compliance, Package Validation etc. Participants also benefited from (Ref: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2943717/) the demonstrations of packaging and testing equipments. While this issue contains some of the presentations made In a during the Seminar, more details are available on our Nutshell.... web site : www.medicalplasticsindia.com. We are also proud to inform our readers that Medical “Today knowledge has power, Plastics Data Service has been selected as one of It controls access to opportunity Biomat.net’s Top 5 sites. The Biomaterials Network (Biomat.net) periodically and advancement.” distinguishes selected internet sites, based on their top general quality, mainly their scientific value and - Peter Drucker suitability to internet browsing. Biomat.net is aimed Nov. - Dec. 2015 at linking the biomaterials community worldwide. We thank our readers for this recognition since without their support and participation, our Magazine and web sites could not have grown to this level. CONTENTS • Cover Story Medical Device Packaging • Importance and Significance of Packaging for Medical Devices • ETO Sterilizationand Role of Packaging Materials • Global Trends US demand for sterile medical packs grows. • Industry News • Did You Know ? About Complications Related to the Use of Vascular Hemostasis Devices • Events HOSPIMedica Thailand, MEDICA2003, ComPaMED 2003 20

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR FromDtheeEsdkitor’s Mr. Rahil Engineer, B.E. (Biomedical Eng.) Recent initiatives , announcements and actions from Government and Medical Device Industry brings to the limelight the Indian Medical EDITORIAL ADVISORY BOARD Device Industry and creates hope and indicates trends in the accelerating growth potential for the Industry. Few of the major Dr. TARANG PATEL initiatives include : M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Delinking of Medical Device Sector From Pharma : Government has accepted long- standing demand and has agreed to delink Schedule M III from the Drug rules , which Mr. C. BALAGOPAL deals with medical devices, from Schedule M, which deals with drugs and Director - Enter Technologies Pvt. Ltd. pharmaceuticals. Industry still demands a separate rule book and separate regulatory Chairman - Mobilexion Technologies Pvt. Ltd. authority. Trivandrum India’s First Industry – Academia Collaboration For Medical Devices R & D launched by “AIMED” : With an objective to catalyze “Make-In-India” program, this Dr. DILIP H. RAIKER collaboration for Industry – Academic/Research Institutes , AIMED launched “UdaiMed”, Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) a new sunrise forum for collaborative interface between User, Developer, Academic Former Chief Manager(P), CIPET - Chennai and Research Institutes and Industry. To take forward this objective, AIMED & UdaiMed also signed its first MoU with TiMed (Technology Business Incubator), a not-for-profit ING LOUIS C. SUHUURMAN registered society promoted by Sree Chitra Tirunal Institute for Medical Sciences and Formerly Sales Director Technology (SCTIMST), Thiruvananthapuram, for encouraging innovation and COLPITT B.V., Holland entrepreneurship in medical technologies through technology business incubation support. Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Government Review For Overpricing Of Medical Devices : There is a great concern in the Industry about arbitrary MRP labeling . The Government has asked the companies Dr. C.S.B. NAIR to review their pricing and submit maximum retail price (MRP) details of their products to Director (R&D), Peninsula Polymers Ltd drug price regulator NPPA. It is expected that the Government would like to take remedial measures to make the pricing of medical devices reasonable. This is likely to resulting Dr. BHARAT GADHAVI in reducing overall healthcare cost in the country. CEO, Medisurge Hospitals Announcements Of Medical Device Parks By Andhra Pradesh , Maharastra and Mr. A.S. ATHALYE Gujarat States . More States likely to follow : The key is implementation. The Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Association however feels that these parks can not flourish without a coordinated National Medical Device Policy, which is said to be pending with Government for quite some time. Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Beyond the above initiatives, the Government has also taken steps to remove some irritants like eliminating need for NOC from Port Office by DCGI for exports of Medical IIT, Kharagpur Devices alongwith Pharmaceuticals. These developments are on and above the previous activities covered in our July – Aug 2015 issue including removal of duty anomalies , Dr. G.S. BHUVANESHWAR Materiovigilance Program to monitor safety of Medical Devices etc. Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and As per Mr. Rajiv Nath, Forum coordinator, “AIMED”, “the Government needs to focus on Jt. Co-ordinator - Regulation, AIMED, India. 6 key issues to create an appropriate Ecosystem for enabling import substitution of 23,000 crores of imports of Medical Devices for “Make-In-India” to be realized”. It includes, Dr. J. V. Tyagi “Business Viability , Consumer Protection, Buy India Policy, Foreign Direct Investment, Consultant, Medical Device Certification Regulations For ensuring Patient Safety and Need for a Department of Medical Devices. PUBLISHED BY : 21 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-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Nov. - Dec. 2015

Cover Story Global Medical Disposables Industry Scenario And Role Of Plastics Disposable Medical Devices are a very important part of the in developing countries keeps growing, mainly due to economic total medical device industry. Medical Disposables are the growth; increased spending by the respective governments on devices which are meant for only single use and have to be healthcare and the increased purchasing power of the general discarded later. They are essential for carrying out any medical public. procedure in Hospital. For the last few years, the disposable market has been growing continuously and trends predict strong Presently, North America holds the biggest share in the global growth for the near future.Products with enhanced performance, medical disposables market ~ 35%. North America exhibited sturdy infection prevention and efficacy are fuelling the demand of demand for all product segments of the medical disposables medical disposables globally.Demand for disposable devices is market. U.S. alone accounted for 70% of the market for medical increasing in emerging economies, as these countries are disposables in North America. modernizing their healthcare infrastructure.The growing presence of medical facilities in developing countries and growing geriatric Asia Pacific is soon going to catch up due to increasing healthcare population in developed countries are the major growth drivers awareness. Other factors likely to drive the Asia Pacific medical for the global medical disposables market. disposables market are the rising disposable income, huge pool of aging population, and increasing expenditure by several Market Segments governments on healthcare. The significant development of the emerging economies of India and China will also lead to The global medical disposables market is segmented on the growth of this region. basis of products, geography and in terms of end users. In India terms of product categorization, India is one of the top 20 markets for Medical Devices in the world the market is segmented into and is the fourth largest markets in Asia after Japan, China and drug delivery disposables, South Korea. The Indian Medical Device market is significantly respiratory disposables, smaller than other overseas markets. products for dialysis, laboratory However, macroeconomic disposables, wound factors suggest a huge potential for double-digit management disposables, non- growth in the Indian Medical Device sector. Upcoming woven medical disposables, developments in the regulatory and policy framework are sterilization supplies, waste expected to accelerate growth of the Indian Medical Devices sector at an estimated 10-year disposable supplies, and others, CAGR of 14–15%. such as diagnostic disposables. Currently, the medical devices market in India is dominated by imported products, including products manufactured using The medical disposables imported material, which comprises approximately 75% of the total sales.However, 60% of domestically manufactured devices are market embraces a variety of exported, with the disposables and consumables segment having the largest share. sub-industries, comprising The Medical Disposable and Consumables sector in India is product areas such as valued at approx. Rs. 15,000 Crore, While 45% Medical Disposables were being imported. In the Year 2014-2015 (April cardiovascular and orthopedic to Oct.), India imported Disposables and Consumables worth 2,170.12 Crore Rs., while, Exported Disposables and devices, wound care products Consumables worth 1,723.02 Crore Rs. Indian disposable medical supplies demand is rising 14.3 percent annually. and disposable supplies. Syringes and inhalers, IV and urinary catheters, hemodialysis bloodlines, peritoneal dialysis kits, tissue sealants, biological Geographically, this market is segmented into North America, wound dressings, Contact Lenses, Class IV garments and textiles, Europe, Asia Pacific, and Rest of the World. While, in terms of and blood glucose test strips are considered to be among the end users, the market has been divided into hospitals, outpatient fastest growing products. facilities, home healthcare facilities, and others such as emergency care, physician offices, etc. Hospitals are currently the leading sector in the global medical disposables market and are expected to soar due to the growing number of surgical procedures, emergency visits, and hospital admissions. Global Medical Disposables Market The global medical disposables market is expected to increase 6.6 percent yearly to nearly $245 billion in 2018.The global market for disposable medical products has experienced robust growth over the past two decades, averaging 12.5% per year. The market will be dominated by the United States, China, Japan, Russia, Germany, France, Brazil, India, Italy, and the United Kingdom, who will comprise the 10 largest national markets, combining to absorb over two-thirds of the total value of global demand in 2018.The United States is the largest market for disposable medical devices closely followed by Europe and Asia. The market 22 Nov. - Dec. 2015

Cover Story The domestic companies are largely involved in manufacturing infections, a global increase in inpatient and outpatient procedures, low-end products for local and international consumption. However and rising worldwide sales of direct-to-consumer medical products lately, many multinational companies have established will fuel growth in the medical disposables sector. local presence in India. Fastest Growing Segments Plastic Resins for Medical Disposables Among the major disposable medical supply product The global medical plastics market is expected to reach USD segments, dialysis disposables is expected to post the fastest 6,978.03 Million by 2020. This growth is fueled by the aging increase in global demand based on an expanding prevalence population increasing the demand for existing and new medical of end-stage renal disorders and the high frequency of technologies and growing application sectors globally. therapeutic requirements. Drug delivery is another fast growing application for disposable medical supplies.Pre- Global demand for raw materials used in the production of fillable and hypodermic syringes, IV catheters, urinary medical disposables, the vast majority of which are plastics, drainage, chronic wound management prefilled inhalers and will increase 5.4% annually to $14.3 billion in 2018. Plastic transdermal patches are some the most widely used medical resins will represent nearly 73% of raw materials used in the disposables in Hospitals. fabrication of medical disposables at that time.North America will continue to account for the largest share—almost $5.3 billion in Other segments projected to command average or better worldwide 2018—but the Asia-Pacific region will post the fastest rate of revenue growth include incontinence goods, infusion and growth. hypodermic devices, nonwoven products, respiratory supplies and devices, sterilization supplies, and various other offerings such as Medical device manufacturers today demand plastics that urinary catheters and accessories, first aid kits, ostomy appliances, are stronger, lighter, and more durable than ever transdermal patches, and waste disposal supplies. before.Several factors are leading to growth in this market. Plastics are an ideal class of materials which cover large Dialysis Market application areas in health and healthcare due to their lightweight, bio-compatibility, non-corrosive nature, chemical inertness, low With more than 2.9 million patients worldwide, end-stage renal cost and comparable densities with that of human organs. disease (ESRD) is the most prevalent form of kidney disease. It ranks as the seventh leading cause of death among globally Many Medical Disposables Devices & Implants incorporate prevalent diseases. The global hemodialysis & peritoneal dialysis polymers, either as key components or as coating to improve the market is valued at USD 69.45 Billion in 2015 and is expected to biocompatibility of other materials.Innovative solutions based on reach USD 93.83 Billion by 2020, at a CAGR of 6.2% from 2015 to polymer technology play a significant role in facilitating diagnosis 2020. and treatment via incorporation in medical devices, implants and disposables. Respiratory Devices Polymers such as are Polyvinylchloride (PVC), Polypropylene The respiratory devices market is growing at a significant rate since (PP), Polysulfone (PS) and Polycarbonate (PC), LDPE (Low the last decade.The total respiratory devices market was valued Density Polyethylene), HDPE (High Density Polyethylene), Ultra- to be USD 6.2 billion in 2013 and is anticipated to have a strong high-molecular-weight polyethylene (UHMWPE) and silicon growth in the coming years of forecast.The global respiratory care hydrogel are used for manufacturing disposable medical devices. devices market is estimated to reach USD 21.9 Billion by 2020 at a CAGR of 9.6% during the forecast period of 2015 to 2020. Some of the most commonly used medical disposable products where plastics are used as the major raw materials are Catheters, Cardiology Devices Masks, Infusion Set, Filters, Cannula, Surgical Gloves, Suction Pipe, IV Fluid Bottles, Syringes, Clamps, Packaging Films, Check The number of minimally invasive surgeries conducted increased Valves, Tubing Connectors and Urine and Blood Collection Bags. globally from 669.5 thousand in 2005 to 805 thousand in 2014. The Global Interventional Cardiac Devices Market earned revenue of Growth Factors $1.49 billion in 2013 and estimates this to reach $6.93 billion in 2020. An estimated 28.9 million Indians suffer from at least one A combination of upgrading and enforcement of infection cardiovascular disease or disorder with disease prevalence tripling prevention standards coupled with an expanding volume of over the past 30 years. The overall interventional cardiology hospital, surgical and outpatient procedures will promote overall products market in India was valued $635.7 million in 2012 and is gains in the market for medical disposables throughout the world. expected to grow at an estimated CAGR of 26.4%. Growing geriatric population, health insurance coverage extension by affordable care act and prevalence of diseases are further Conclusion expected to boost growth of medical disposable market. For the past two decades, disposable medical supplies have been The emerging trend of disposable devices is driven by the factors witnessing a steady growth and this growth seems to be a con- like dwarfing up the effects of cross contamination and to ensure tinuous one due to the importance of their uses in healthcare.Global safety and accuracy.Similarly, rising concerns about health and sales of consumer medical disposables will expand due to the safety of healthcare occupational and awareness about various impact of evolving demographic and epidemiological patterns as allergies and infections are expected to drive growth of medical well as trends encouraging the regular practice of preventive medi- disposable market.Ongoing efforts to prevent hospital-acquired cine and self-treatment. Nov. - Dec. 2015 23

Cover Story Most Widely Used Medical Disposables Products Infusion & Transfusion Respiratory and Anasthesia Urology • Infusion Set • Nebulizer Mask • Urine Collecting Bag • Blood Administration Set • Oxygen Mask and Tubing • Nelaton Catheter • Blood Donor Set • Nasal oxygen Catheter • T.U.R. Set • Blood Bags • Twin Bore Nasal Oxygen Set • Foley Balloon Catheter • Disposable Syringe • Respiratory Exerciser • Male External Catheter • Intravenous Cannula • Guedel Airways (oro pharyngeal • Gibbon’s Catheter [Male & Female] • I.V. Cannula Fixation • Female Catheter • A.V. Fistula Needle airways) • Rectal Catheter • Scalp Vein Set • Laryngeal Airway Mask (LMA) • Uretheral Catheter • Volume Burette Set • Tracheostomy Tube • Urine Leg Bag • Peritoneal Dialysis Transfusion Set • Endotracheal Tube • Paediatric Urine Collection Bag • Extension Tube • Ventury Mask • Urine Culture Bottel • IV Flow Regulator • Suction Catheter • Measured Volume Urine Meter • Three Way Stopcock • Catheter Mount • Urine Drainage Catheters • Three Way Stopcock With Extention • Ventilator Breathing Circuit • Irrigation Sets • Breathing Filter Tube • T-Oxygenator • Pressure Monitoring Line • Bain Circuit • Luer Lock • Epidural Catheter • Injection Stopper • Manual Resuscitators • Disposable Hypodermic Needle • Aerosol Therapy masks Cardiology Surgery Gastroenterology Miscellaneous • Introducer Sheath • Closed Wound Suction • Feeding Tube • Micropipette • Cardiac Catheters Unit • Ryle’s Tube • Syringes • Intravenous Catheters • Stomach Tube • Umbilical Cord Clamp • Central Venous Catheter • Chest Drainage Catheter • Levin’s Tube • Mucus Extractor • Peripherally Inserted • Water Sealed Chest • Kehr’s Tube • Disposable HIV Kit • Feeding Bag Set • Rectal Tube Central Catheters (PICC) Drainage Bag • Colostomy Bag • Corrugated Draiange • Delivery Catheters • Chest Drainage kit • Colostomy Kit • Guide Wires • Chest Drainage Bottle • Umbilical Catheter Sheet • Trocar Catheter • Intra Costal Draianage Set • Yanakaur Suction Set • Polyethylene Gloves • Yankaur Suction Handle • Latex Surgical Gloves • Redon Drain Catheter • Disposable Cap • Sputum Cup 24 • Urine Pot • Urine Culture Bottle • Insulin Syringes • Dry Brush Nov. - Dec. 2015

Global Trends The Eleven Most Implanted Medical Devices In America Implanted medical devices are one of the most profitable necessary earlier than expected.These failures, in addition to businesses of the U.S. healthcare industry. requiring a new hip replacement, can leave behind fragments that can become focal points for infections, cause nerve and vessel 24/7 Wall St. has examined National Health Survey data, multiple damage, and possibly even lead to death. professional physician services, peer-reviewed journals, and SEC filings to complete a list of the most frequently implanted medical 9. Heart Pacemakers devices today. While many of these are life saving, controversy swirls around several others. As with ICDs, pacemakers are used to treat abnormal rhythms in the heart. While ICDs Many of the devices implanted are medically necessary and do treat otherwise fatal their jobs extending lives and improving quality of life, the 24/7 rhythms, pacemakers are Wall St. research shows.Some products, such as artificial knees used when the heart’s may even be under-utilized.Others, like implantable cardio- internal clock is not defibrillators, may be over-utilized. What is certain in most of the maintaining a fast enough cases reviewed is that the effectiveness of these devices is not as pace. Pacemakers well researched or understood as their widespread use may imply. override the aberrant signals in the heart by 11. Implantable Cardioverter Defibrillators passing small jolts of electricity to multiple parts Cardiac arrhythmia, or improper electric signaling in the heart, of the heart muscle, occurs in millions of providing its own people a year. While the vast majority are rhythm.Modern pacemakers will increase with exercise and benign, a select few — decrease with rest to meet the body’s minute to minute needs. usually in patients with Complications of the surgery include a 1%-2% rate of either short- a history of heart attack or long-term infection and, more importantly, up to a 4% rate of or heart failure — can lead malfunction. be fatal if not treated promptly. Implantable 8. Breast Implants cardioverter Breast augmentation with implants is the most frequently defibrillators (ICDs) are devices that monitor and treat these performed plastic surgery rhythms when they are detected by sending a large jolt of electricity procedure in the U.S., beating to the heart, and basically pressing the reset button.Newer models out nose jobs, eyelid surgery, can also function as pacemakers, combining two devices into one. and liposuction by a Complications of ICDs are similar to their pacemaker siblings: 1%- significant margin. Due to the 2% rates of infection and up to a 4% rate of lead failure. While increased public criticism, the these devices are major life-saving technology, the U.S. FDA has since closely Department of Justice has been investigating the industry due to monitored breast implants in the widespread practice of implanting the devices too soon after a the U.S. major cardiac event. 7. Spine Screws, Rods, and Artificial Discs (Spinal Fusion 10. Artificial Hips Hardware) As people age and gain weight the wear and tear on their joints Spinal fusion surgeries are performed for a variety of back builds up. In particular, more than 20 million problems, mainly for pain and weakness. Americans suffer from degenerative The surgery essentially fuses two or more osteoarthritis, which is the leading cause of vertebrae with the help of hardware such chronic disability in the U.S. As one of three as screws and rods. An alternative in a major weight bearing joints in the leg (the number of these cases and a simpler others being knees and ankles), hips are put procedure overall, decompressive under a lot of stress over a lifetime. This surgery removes part of the bone to free stress commonly leads to the wearing down a trapped nerve. Patients of these fusion of cartilage and the painful friction of bone surgeries are most likely to have the least rubbing against bone. Hip replacement can amount of benefit. lead to a decrease in pain and an increase in mobility in over 90% of recipients..But 6. IUDs (Intra-Uterine Devices) when friction or a faulty manufacturing process wears down the replaced joint at a IUDs are extremely popular worldwide and are the preferred method of contraception for almost 25% of women in the rest of faster rate than anticipated, replacement of the hip can be the developed world. The most serious complications associated with the devices today are uterine perforation, which occurs in Nov. - Dec. 2015 25

Global Trends 0.1% of patients, and pelvic Coronary stents are small inflammatory disease (PID), tubes, usually coated with which occurs in 0.2% to 0.9% a drug (drug-eluting stents), of patients. Two forms of IUDs that are placed into the are available in the U.S., with arteries that supply blood to an approximately even split of the heart. Stents are market share: Paragard, a regularly implanted into generic copper-coated IUD patients with unstable offered by Teva angina (unpredictable chest Pharmaceutical Industries pain) and recent heart Ltd; and Mirena, a attack patients whose coronary arteries have been partially blocked by atherosclerotic lesions (cholesterol). Complications progesterone-releasing IUD offered by Bayer HealthCare. from stents include stent thrombosis (clots), stent fracture, and re-occlusion (blood-vessel blockage). However, the risks of these 5. Metal Screws, Pins, Plates, and Rods (Traumatic Fracture complications are hard to quantify when overall decrease in death Repair) and disability is taken into account. Bone fractures are one 2. Ear Tubes (Tympanostomy Tubes) of the most common Otitis Media, or middle ear infection, is one of injuries, occurring in all the most frequently diagnosed childhood age groups for a diseases with at least 80% of pre-school aged multitude of reasons. Of children affected. Billions of dollars are over one million spent every year on doctor visits, medicines, fractures that are and, in chronic cases, surgery. In contrast to the rise in numbers, multiple long-term admitted to the hospital studies have concluded that as many as a third of these procedures are unnecessary. The surgery itself, known as every year, roughly half myringotomy and tube placement, is the most commonly performed pediatric operation. It’s very safe, very quick, and has require surgical very low complication rates. Due to the incredibly low cost of the tubes, and the fact that they have been evolving for well over 50 intervention to realign years, no one manufacturer appears to dominate the market. and stabilize the bone, 1. Artificial Eye Lenses (Psuedophakos) a procedure called Cataracts are a problem faced by millions of elderly Americans yearly, many of open reduction and whom will require surgical replacement of their own lens with an artificial one, internal fixation. This known as a psuedophakos or intra-ocular lens. These lenses come in many procedure occurs on configurations, such as single-focus (like glasses for distance vision), multi-focal almost every bone in lenses (like bifocal glasses), and hi-tech variable-focus lenses (like real eyes). the body, from tiny carpals in the wrist secured with plates no While the vast majority of cataract surgery is safe and effective, there is a 1%-2% more than half an inch long, to femurs (the largest bone in the chance of retinal detachment over the rest of the patient’s lifetime. If this occurs body) requiring foot-long rods, screws and pins to hold the bone and is not treated promptly, patients can completely lose their vision in the effected eye. While researchers are examining non- together. While the techniques and implants needed to perform surgical treatments for cataracts, surgery is currently the only real treatment or cure. these surgeries on the different sites of the body vary widely, the (Ref: http://www.247wallst.com/healthcare-economy/) provider of those implant materials usually does not. 4. Artificial Knees As the other major, replaceable weight bearing joints in the leg, knees frequently wear down faster and in a more disabling fashion than other joints. The constant friction and shifting of weight in the joint leads to a breakdown of cartilage and bone, making knees the most frequently replaced joint in the body. Over 90% of total knee replacements lead to a reduction or elimination of pain and an increase in mobility. Over the long-term, there is a 10% failure rate (need for re-replacement) after 10 years, and a 20% failure rate after 20 years. 3. Coronary Stents 26 Nov. - Dec. 2015

Global Trends Fecal Incontinence Device Fecal The U.S. Food and Drug Administration has recently allowed marketing of a System for the treatment of fecal incontinence incontinence is (FI) in adult women. the inability to “Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery,” said William Maisel, M.D., control bowel M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Eclipse System movements, provides an additional treatment option for women who suffer from this condition.” causing stool The System is intended to treat FI in women 18 to 75 years old (feces) to leak who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the unexpectedly vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of from the FI episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the patient can rectum. It is the inflate and deflate the device at home as needed. The device should be removed periodically for cleaning. inability to Adverse events associated with the device included pelvic control bowel cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse movements and events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed). is a common (Ref: http://www.mayoclinic.org/diseases-conditions/fecal- problem, incontinence/basics/definition/con-20034575 especially among older adults. The most common cause of FI is http://www.postbulletin.com/news/local/medical-tech-company- to-build-plant-in-stewartville/article_d8fb03f8-5729-58e5-b075- damage to the muscles around the anus (anal sphincters). Vaginal 645d443c88f8.html childbirth can damage the anal sphincters or their nerves, which http://www.fda.gov/NewsEvents/Newsroom/ is why FI impacts women about twice as often as men. PressAnnouncements/ucm434130.htm) Also called bowel incontinence, fecal incontinence ranges from an occasional leakage of stool while passing gas to a complete loss of bowel control. Common causes of fecal incontinence include diarrhea, constipation, and muscle or nerve damage. The muscle or nerve damage may be associated with aging or with giving birth. Whatever the cause, fecal incontinence can be embarrassing. Fecal incontinence is even a bigger issue than urinary incontinence. Close to 50 percent of people in long-term care suffer from it. That’s an amazing number. U.S. sales of fecal incontinence products is predicted to hit $1.9 billion by 2018. Lubrizol To Invest $ 15 mn In Lifesciences Business With this, Lubrizol aims to expand its global manufacturing facilities, Vesta Inc, acquired by Lubrizol in August of 2014, is a leading positioning lifesciences business to better serve the growing market contract manufacturer for the global medical device industry. With for medical device contract manufacturing. the addition of Vesta, Lubrizol LifeSciences now offers disposable and implantable silicone medical components and assemblies The Lubrizol Corporation, a Berkshire Hathaway company, will across a wide product portfolio, as well as precision thermoplastic invest $ 15 million in the lifesciences business to expand its global extruded tubing. The recent acquisition of Particle Sciences Inc, manufacturing facilities, positioning lifesciences to better serve a leading contract drug development and manufacturing the growing market for medical device contract manufacturing. organization, has positioned Lubrizol LifeSciences as one of the most comprehensive drug delivery device solution providers, Since 2014, Lubrizol Life Sciences has consolidated its presence offering end-to-end solutions in the healthcare market. in the life sciences market by introducing new products and making strategic acquisitions. This capital investment will expand multiple Robert Miller, global business director, medical devices, Lubrizol, facilities and increase Lubrizol LifeSciences’ in-house engineering said, “With a long history of polymer expertise and significant capacity for both silicone and thermoplastic products. investment, Lubrizol LifeSciences is positioned to offer full-service development for next generation medical and pharmaceutical “We have significantly enhanced our capabilities through the innovations.” combination of strong polymer technology, application know-how (Ref : http://www.business-standard.com/content/b2b-pharma/ and world-class component manufacturing. As healthcare lubrizol-to-invest-15-mn-in-lifesciences-business- companies look for total solution providers, we continue to invest 115120900229_1.html ) in the right areas to provide valuable offerings to our customers,” stated Deb Langer, vice president and general manager, Lubrizol LifeSciences. Nov. - Dec. 2015 27

Book Review Publications Related to : Medical Devices- Regulations, Standards and Practices, Biomaterials, R&D, Sterilization, Advanced Polymers in Medicine etc. Medical Devices: Regulations, Standards and Practices Author : Ramakrishna, Tian, Wang, Liao &Teo, Publication Year : 2015, Number Of Pages : 256 A useful step-by-step guide on designing medical devices to ensure regulatory approval. Key Features • Provides readers with a global perspective on medical device regulations • Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards • Includes a useful case study demonstrating the design and approval process Description Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. UHMWPE Biomaterials Handbook, 3rd Edition Edited by: Dr. Steven M. Kurtz, Published: October 2015, Pages:840 pages Description The book provides a detailed examination of the science, development, properties and applications of UHMWPE in hip, knee, shoulder, elbow and ankle replacements and within the spine. Chapters are included on processing, sterilization and packaging of UHMWPE, the historical development of UHMWPE joint replacements, clinical performance of joints, the use of highly crosslinked materials (HXLPE) and the latest antioxidant technologies for their stabilization. The Medical Device R&D Handbook, Second Edition Editor : Theodore R. Kucklick, Publication Year : 2012, Number Of Pages : 510 Features • Provides tools for quicker, more efficient development of innovative devices • Explains the basics of prototyping medical devices • Offers insights on strategic intellectual property management • Presents examples from key opinion leaders and pioneers • Discusses new rapid-turn molding technologies, medical adhesives, and more • Includes tips on time- and money-saving techniques • Contains chapters on starting and building an entrepreneurial business The Effect of Sterilization on Plastics and Elastomers, 3rd Edition Author : L McKeen, Publication Year : 2012, Number Of Pages : 480 Key Features • Essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment. • 3rd edition includes new introductory chapters on sterilization processes and polymer chemistry, providing the underpinning knowledge required to utilize the data. • Provides essential information and guidance for FDA submissions required for new Medical Devices. Description This reference guide brings together a wide range of essential data on the sterilization of plastics and elastomers, enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials, and right sterilization method for a given product or application. Advanced Polymers in Medicine Editor : Francesco Puoci, Publication Year : 2015, Number Of Pages : 537 Reviews the applications of advanced polymers in a wide range of medical specialties. The book provides an up-to-date overview of the diverse medical applications of advanced polymers. The book opens by presenting important background information on polymer chemistry and physicochemical characterization of polymers. This serves as essential scientific support for the subsequent chapters, each of which is devoted to the applications of polymers in a particular medical specialty. The coverage is broad, encompassing orthopedics, ophthalmology, tissue engineering, surgery, dentistry, oncology, drug delivery, nephrology, wound dressing and healing, and cardiology. 28 Nov. - Dec. 2015

® 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] Nov. - Dec. 2015 29

AN ISO 13485-2012 SHAILESH SURGICAL CE certified Company Leading Manufacturers and Exporters of Manufacturer & Exporter of Medical Surgical Disposable Products Disposable Devices & Surgical Products PRODUCTS MANUFACTURED Range of Products : ISO 9001 • I.V. INFUSION SETS • Infusion Set • SCALP VEIN SETS • Blood Administration Set REGISTERED • BLOOD ADMINISTRATION SETS • Measure Volume Set • BLOOD DONER SET • Urine Collecting Bag 0434 • URINE COLLECTION BAG • Urine Collecting Bag - Uro Meatry • RYLES/FEEDING TUBES • Respiratory Exerciser • DISPOS ABLE SYRINGES & NEEDLES • Twin Bore Nasal Oxygen Set • DISPOSABLE GLOVES • Oxygen Face Mask • SURGICAL DRESSINGS • Nebulizer Kit • ADHESIVE TAPES • Vaccum Suck Suction Set • PLASTER OF PARIS • Latex Surgical Gloves • Umblical Cord Clamp • FORMULATIONS Contact Yogesh Patel Office: M. : +91 98241 21383 L-8, “Manhattan” Near Lion’s Hall, Mithakhali, Ellisbridge, MEDICARE DEVICES Ahmedabad-380 006, India 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, Phone: (91-079) 26420281, 26440236 C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 Nov. - Dec. 2015 E-mail : [email protected] Website : www.medicaredevices.com 30

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VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are a leading Consulting organization providing an integrated services with We are entrusted with the responsibility to manage in India on focus on project technology : behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Quality Management System as per Accredited. ISO 9001, ISO 13485, Medical Devices We are involved on the certification activities in the following CE marking as per MDD/93/42, FDA areas : 510k, Audit, Documentation, training • ISO 9001:2008 - QMS and c-GMP. • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS Sanjay Y .Shah – Owner Promoter • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS M : +91 98240 17850 • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing Obelis European • CE Marking • GMP Authorized Representative Center (O.E.A.R.C) based in We have collaboration with European Notified Body for CE Mark- Brussels, Belgium since 1988 is one of the largest ing & SA 8000 certifications. Regulatory Centers in Europe, assisting non-European We have assisted over 6500 clients all over the country, as an manufacturers’ successful endeavors into Europe. expansion plan we also require well qualified personnel’s in vari- ous districts to conduct the audits and provide after sale services, F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. for Business Associates kindly apply for your location with com- Tel. : +91 79 66090225 E-mail : [email protected], [email protected] plete details. Business Plan preferred. Website : www.unikalindia.com For further details OR clarification pleases contact : Virtue Certification Systems Pvt. Ltd. “Virtue House” 28, Defence Co-Op Society, Nr. Navrachana School, Sama Road, Vadodara – 390008. Gujarat. Ph. : 91-265 – 2794158 / 98250 43523 Email: [email protected] OR [email protected] Products GMP. & ISO 9001 – 2000 Certified Company • Flexible Packaging Material • Paper Pouch AMIGO SURGI CARE PVT. LTD. • Aluminium Foil • Foil Seal Manufacturer of • Ribbon Pack Pouch Disposable Surgical Products: Contact : I.V.CANNULAS / B.T.SETS / I.V.SETS / Jignesh Patel : +91 94265 25388 SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE +91 90163 36699 VOLUME SETS ETC. Kavya Packaging Manufacturers / Exporters / Hospital Suppliers Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Dealer are requested to Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : [email protected] Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) 32 (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • [email protected] • [email protected] Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India Nov. - Dec. 2015

Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 28/29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (F) 22731656 (M) 9825474789 E-mail : [email protected] Nov. - Dec. 2015 33

Product Gallery New Swabbable Needleless Injection New Swabbable Needleless njection Sites with Barbs From Qosina Sites With T-Ports From Qosina Ronkonkoma, NY – December 17, 2015 - Qosina is pleased to Ronkonkoma, NY - December 18, 2015- Qosina is pleased to announce the addition of three new barbed swabbable needleless announce the addition of three new t-port swabbable needleless injection sites (#80209-#80211), in stock and ready for immediate injection sites, in stock and ready for immediate delivery. The delivery. The barbs are available to fit 1/8 (0.125 inch, 3.2 mm), portsare availableto fit0.079 inch OD tubing (2 mm) (#80172), 3/16 (0.187 inch, 4.7 mm) or ¼ (0.25 inch, 6.4 mm) inch ID tubing, 0.122 inch OD (3.1 mm)(#80174) or 0.157 inchOD tubing (4 mm) and feature a swabbable luer activated female luer lock for (#80171) and feature a swabbable luer activated female luer lock aspiration or injection. Made of a tinted polycarbonate housing for aspiration or injection.The t-ports are designed to be bonded and a latex-free silicone valve, these injection sites are EtO and in-line and the valve offers high flow rates. Made of a tinted Gamma sterilization compatible. Qosina offers a variety of IV polycarbonate housing and a latex-free silicone valve, these bags, syringes, tubing, and injection sites in addition to thousands injection sites are EtO, and Gamma sterilization compatible. of stock components. Qosina offers a variety of syringes, tubing, and needleless injection sites to fit your project needs. Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical Qosina is a worldwide supplier of thousands of stock OEM industries including connectors, luers, clamps, adapters, clips, disposable components to the medical and pharmaceutical valves, needle hubs, stopcocks, hemostasis valves, tuohy borst industries including connectors, luers, clamps, adapters, clips, adapters, swabs, and spikes. Qosina operates an ISO 9001 valves, needle hubs, stopcocks, hemostasis valves, tuohy borst and ISO 14001 registered facility. adapters, swabs, and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility. Qosina offers low minimums and short lead times. Call our Customer Service Specialists to request a sample, obtain our Qosina offers low minimums and short lead times. Call our latest catalog or place an order via P.No.:+1(631)2423000, fax Customer Service Specialists to request a sample, obtain our +1(631)242-3230 or email: [email protected]. Visit us at latest catalog or place an order via phone +1(631) 242-3000, fax www.qosina.com to see our latest products. Custom sourcing +1 (631) 242-3230 or email [email protected]. Visit us at services are available. www.qosina.com Custom sourcing services are available Contact: Ryan Edwards, Qosina, 2002-Q Orville Drive North, Contact: Ryan Edwards, Qosina, 2002-Q Orville Drive North, Ronkonkoma, NY 11779, Email: [email protected] Ronkonkoma, NY 11779. Email: [email protected]. Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Products available with CE marking 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 FIRM 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 Wide Range Of Products : Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical The company Cord Clamp etc... manufactures a wide range 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 34 Nov. - Dec. 2015

Industry News Medical Device Sector Delinked From Pharma The government has accepted the long-standing demand of the currently being regulated under the provision of DCR, 1945. medical devices sector to delink it from the pharmaceutical sector. The Drugs Technical Advisory Board (DTAB) in its August 2015 The health ministry has agreed to delink schedule M III of the meeting recommended that Schedule M III be incorporated under Drug Rules, which deals with medical devices, from schedule M, DCR 1945 and the rules amended so that it was exclusively for which deals with drugs and pharmaceuticals.The revised schedule medical devices, while schedule M was applicable only to drugs. is being put up on the website of the Central Drugs Standards “Nowhere in the world are pharmaceutical and medical device Control Organization (CDSCO) inviting comments from the public sector governed by the same set of legislations as has been after which a notification will be issued through the law ministry historically happening in India,” said a statement of the Association for changing the Drug Rules. of Indian Medical Device Industry (AIMED). This has had a Schedule M III provides requirements of factory premises for detrimental impact on the medical devices sector, it added. manufacture of medical devices under the Drugs and Cosmetics But there needs to be a separate law book, separate rule book Rules (DCR), 1945. However, it relates only to three medical and separate regulatory authority. devices, namely sterile perfusion and blood collection sets and syringes and needles. A large number of notified devices are (Ref: http://timesofindia.indiatimes.com/india/Medical-device- sector-delinked-from-pharma/articleshow/50130958.cms) AIMED Launches UdaiMed, India’s First Industry - Academia Collaboration For Medical Devices R&D The Association of Indian Medical Device Industry (AIMED) has a better synergy between industry needs and academic research launched ‘UdaiMed’, a new sunrise forum for collaborative interface while taking care of fund shortages for research,” added Nath. between user, developer, academia, industry and medical device Explaining the need for such an initiative, Nath pointed towards development in India. the ground realities of campus R&D in India stating that, “R&D institutions and engineering colleges do product development in The objective of this momentous milestone collaboration for isolation while industry has little or no idea of work being done academic-industry in India is to make on-campus research more there, and often such researches have no relevance for industry. aligned to medical device industry’s needs and catalyze ‘Make- Collaboration between institutions and industry is completely in-India’ programme. To take forward this objective, AIMED & UdaiMed also signed its absent even as most development is for peer academia acclaim first MoU with TiMed (Technology Business Incubator), a not-for- rather than meeting industry’s needs or contributing to country’s profit registered society promoted by Sree Chitra Tirunal Institute competitive prowess.” for Medical Sciences and Technology (SCTIMST), As a next step, Dr Jitender Sharma, head of Healthcare Technology Thiruvananthapuram, for encouraging innovation and Division of NHSRC, MOH&FW (also party to this initiative) said entrepreneurship in medical technologies through technology “AIMED/UdaiMed could request the government to auction all business incubation support to innovators, start-ups and industry. patents which are not yet commercialised so that these can be TiMed will offer office and laboratory space with several common put to use by Indian manufacturers for the benefit of Indian facilities like internet access, library, canteen, video-conferencing consumers and medical fraternity.” facilities for taking forward this collaboration. (Ref : http://pharmabiz.com/ “I am absolutely positive that the new collaboration will construct ArticleDetails.aspx?aid=91645&sid=1) CM Promises Land For India’s First Medical Devices Park In India Gujarat chief minister Anandiben Patel on Wednesday agreed to provide land in the state for country’s first medical devices park. She was speaking during the stone-laying function of the permanent campus of National Institute of Pharmaceutical Education and Research (NIPER) at Gandhinagar. Earlier in his address, Union minister of chemical and fertilizers Ananth Kumar announced that his ministry is planning to set up country’s first medical devices park in Gujarat. “We will set up the medical devices park if chief minister Anandiben Patel allots us land for the same,” he said. “We are ready to give land for the proposed park. The central government can send officials for land survey and, later, we can decide on the area for the land. We will give all possible help to the Centre,” said the CM. Ananth Kumar said India is exporting medicines to approximately Nov. - Dec. 2015 35

Industry News 200 countries but we are still dependent on other countries for logy campus at Sanand, soon after it receives additional land from medical devices. the state government. Around 12,000 students will get training in plastic engineering following the expansion of CIPET,” said Kumar. “We want to make India self sufficient in the field of medical The Union minister also promised a Pharma Park in the state. sufficient in the field of medical devices. The medical devices park will have a `Centre of Excellence’ where research for medical (Ref: http://timesofindia.indiatimes.com) devices will be conducted,” said Kumar. “The Centre is planning to expand the Central Institute of Plastic Engineering and Techno- Compliments To Gujarat FDCA Mr. Lahouari Belgharbi, Scientist Group Lead, NRA assessment and Policy, Regulatory System Strengthening [RSS], Regulation of Medicines and Other Health Technologies [RHT], Department of Essential Medicines and Health Products [EMP], World Health Organization, visited Gujarat to understand the working of Gujarat FDCA and went back highly impressed giving following compliment. “I came to visit Gujarat because I was told that Gujarat Team and safety of about 50% of the medicines in India. in the FDC is a very effective and Committed team and I found a strong & well developed system, highly committed leaders I just want to wish you to continue this journey of your regulatory and proud of their achievements. work in the best manner and hope my visit that was an enlightenment for me about your state will be also fruitful in our I was amazed to see how much a small team can do for 60 future co-operation.” million of people and also contribute to ensure the quality Arbitary MRP Printing On Imported Medical Devices Raising Healthcare Cost Association of Indian Medical Device Manufacturers (AIMED), the Partnership for Safe Medicines (PSM) India Initiative, has expressed grave concern over the raging malpractice of explained that imported medical devices like many other items arbitrary MRP printing on imported medical devices leading to are imported in bulk and the duty is also paid on bulk and fleecing of unsuspecting Indian consumers. This is forcing Indian importers claim these are not consumer goods but for hospital manufacturers to respond similarly raising the overall healthcare use. The government and customs must ensure that all cost in the country. individually packed units for sale of any medical device - big or small even if X-ray machine, should have the MRP preprinted Industry experts want government to curb this malpractice and on the unit pack. There needs to be an import duty of at least 1% put in place a transparent and stringent MRP regime for imported on this MRP and the bill of entry and invoice should have the goods so that average Indian consumers are not fleeced and transaction price per unit as well as the MRP per unit to ensure retail price parity between domestically produced medical devices no malpractices of switching of labels post import are adopted and imported products is maintained. and will help bring down by the Indian importers. Currently importers pay tax on transaction healthcare costs in the country . invoice value and not on basis of the MRP. Government has a duty to protect the Indian patients from undue Gurmit Singh Chugh MD of Translumina Therapeutics, an enrichment by unscrupulous traders and manufacturers whereby indigenous stent manufacturer added, “The scenario of Indian retail prices go up when ex factory prices are going down and to manufacturers making high-end medical devices like drug eluting ensure that there is level playing field between domestically stents is extremely discouraging. We are concerned with the produced medical goods and imported ones,” said Rajiv Nath, discriminatory pricing policies in this sector which creates an forum coordinator of Association of Indian Medical Device impression that anything “American” should have higher pricing Manufacturers. and higher reimbursements. It is important for various stakeholders to be aware that a medicinal and medical product Nathadded,”The current system helps in maintaining huge price need to be evaluated on the basis of quality and the extent of disparity of imported and Indian goods as Indian manufactures clinical trials performed. However, the patients are impressed can’t increase their MRP by over 10% for those items covered by the hospitals to go for American products which limits the under drug regulation like stents. Consumers can’t access these ability of Indian manufacturers to offer their products at much lower cost devices as hospital and retailers may not stock these lower cost to the patients in India”. lower priced devices. So we have a healthcare system thriving on higher costs on pretext of US FDA approved or American (Ref: http://www.pharmabiz.com/ Origin and resultant high prices to consumers”. NewsDetails.aspx?aid=91878&sid=1 ) Bejon Misra a consumer policy expert and also the Founder of 36 Nov. - Dec. 2015

PACK-EQUIP National Healthcare (Mfg. Packaging Machinery) An ISO 9001 : 2008 Company Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, Manufacturing & Exports of CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Medical Disposables : Phone : 25855027 (M) 9825380739 I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Works : 16, Arbuda Estate, Near Nidhi Bank, Gloves etc. CTM Cross Road, Amraiwadi, Ahmedabad-380 026. 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 : [email protected] Website: nationalhealthcare.in ISO : 13485 : 2012 JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 & CERTIFIED COMPANY Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc. Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: [email protected] • Web: www.jimitsurgicals.com Nov. - Dec. 2015 37

Events The event website www.imdiconferences.com gives most of the • Medical Surgical And Healthcare Industry Trade Association information, the highlights of the events are as follows: • The All India Plastics Manufacturers’ Association (AIPMA) • Gujarat State Plastics Manufacturers Association (GSPMA) Theme: • Indian Plastics Institute (IPI) The Theme of the Conference is: “Indian Medical Device Agenda: Industry: Integrating Market, Technology, Innovation and Ecosystem”. The “Technology Display Show Exhibition” to The two day programme includes presentations from be held in conjunction with the Conference will showcase, knowledgeable eminent speakers from Industry, Government, “Materials, Adhesives, New Technologies, Manufacturing / Testing Research Institutions, Professionals and Academic Institutes from Equipments, Packaging / Sterilisation Equipments and Services India and abroad. A “Technology Display Show Exhibition” will For Medical Device Industry. be held in conjunction with the Conference. Objective: We have already received about 25 confirmations from industry experts and leaders. Our Mission is to create a platform of interactions for the Indian Medical Device Industry as well as the technology / products / Lists of confirmed expert speakers and exhibitors are available at services providers with an objective to facilitate an environment event website, www.imdiconferences.com. We are expecting more of healthy growth. confirmations from Industry Leaders as well as Regulatory, Research, Academic and Government Institutions in the coming Footfalls / Visitors: months. Visit Conference website for more details. During the previous event held in January 2015, more than 45 Events Calender experts shared their rich experience, knowledge and vision with more than 450 delegates. About 40 Companies showcased their • Plexpo India 2016 Products and Services in the ”Technology Display Show 7th International Plastic, Packaging, Printing, Converting & Exhibition”. Expert Speakers, Exhibitors and Delegates came Rubber Industries Exhibition from various countries including USA, UK, Germany, China, The Date : 07th-11th January, 2016. Netherlands as well as from various cross sections of Indian Venue : Exhiition Centre, Near Town Hall, Gandhinagar. Medical Devices and allied industries. The leaders of the Industry / CEOs of leading Companies also participate as speakers during • 13th National Conference And Technology Exhibition on the two day conference. We are expecting more participations in Indian Medical Devices & Plastics Disposables / coming event. Implants Industry 2016. Date: 12-13 February, 2016 Organisers: Venue: Ahmedabad Management Association, A’bad. This annual conference for the Indian Medical Devices and Plastics • Plastivision Arabia 2016 Disposables Industry is being organized by publishers Region’s Leading Plastics Event of a magazine, “MEDICAL PLASTICS DATA SERVICE” and Date: 22-25 February, 2016 promoters of the medical technology internet Venue: Expo Center, Sharjah. Websites, www.medisourceasia.com and www.medicalplasticsindia.com, • Medical Fair India 2016 22st International Exhibition and Conference since 2001 with close involvement and support of the Leading Date: 11-13 March, 2016 Industry, Associations in Medical Devices, Pharma and Plastics Venue: Bombay Convention & Exhibition Center, Mumbai. Sectors as well as Government Regulatory, Export Promotion and Research Organizations include: • Medicall 2016 15th Edition • Association Of Indian Medical Device Industry (AIMED) Date: 22-24 July, 2016 And • Medical Disposables Manufacturers Associations (MDMA) Venue: Chennai. • Society of Biomaterials & Artificial Organs • National Biomedical Engineering Society (NBES) • Medical Manufacturing Asia • Food and Drugs Control Administration, Government of 3rd Manufacturing Processes for Medical Technology Exhibition and Conference Gujarat Date : 31st August - 2nd September 2016. • Indian Drug Manufacturers’ Association (IDMA), GSB Venue : Singapore • Association of Diagnostics Manufacturers of India (ADMI) • Engineering Export Promotion Council (EEPC INDIA) 38 Nov. - Dec. 2015

Nov. - Dec. 2015 39

: 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] 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 40 Nov. - Dec. 2015

GMP MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS ISO - 9001-2008 Certified Company • I.V. Infusion Sets • Blood Administration Sets S. Nath & Co. • Scalp Vein Set • Urine Collection Bags Excellence in Quality • Ryles / Feeding Tubes • Catheters and Tubes Manufacturer & Exporter of • Surgical Gloves. Surgical Disposable Products since 1980 Contact : IDEAL® Mr. Bhavin Shah • Infusion Set MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • Blood Administration Set • Urine Collection Bag 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi • Urine Specimen Container Mill, Narol - Isanpur Highway, Narol, • Umblical Cord Clamp Ahmedbad-382405. (India) Phone : (O) 079- Address 25733318 (R) 079-25430211 (M) +91-9825018952 S. Nath & Co. Email : [email protected], [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Website : www.mescosurgical.com Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 41 BASIL manufacturers PVC COMPOUNDS ac- cording to the customer requirements of strength, flexibility, x-ray traceability, transpar- ency, colour and extraction resistance. BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products. BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : [email protected] www.basilpolymers.com Nov. - Dec. 2015

November 2014 to December 2015 Column Content Column Content November- December 2015 Mfg. Policy • National Medical Device Authority (NMDA)- Recommended By Task Force To Strengthen “Make In Cover Story • Global Medical Disposables Industry Scenario and the India” Drive Role of Plastics Global Trends • Medical Disposables Market Worth $245 Billion By 2018 • Most Widely Used Medical Disposable Products Product Gallery• New Kynar Connectors Global Trends • The Eleven Most Implanted Medical Devices In America Did You Know • About Welding of Thin Polymeric Films For Medical • Fecal Incontinence Device Applications Book Review • Medical Devices: Regulations, Standards and Practices March- April 2015 • UHMWPE Biomaterials Handbook • The Medical Device R&D Handbook, Cover Story • Promotion Of Domestic Production Of High End Medical • The Effect of Sterilization on Plastics and Elastomers • Advanced Polymers in Medicine Devices Did You Know • About Failure of Endotracheal Tubes • The Medical Devices Sector In India : Task Force September-October 2015 Recommendations Cover Story • Medical Tubing And Extrusion Technology • Tubes and Catheters Sizing · • “Medical Plastics Data Service” Thanks And Welcomes • Medical Tubing : Materials and Applications • MPDS Supplier Bulletin : Medical Tubing And Extrusion Mr. C. Balagopal To The Editorial Advisory Board Technology Market • Drug Device Combination Products : Market Review And Manufacturing • Make In India : From Slogan To Policy Implementation Global Trends • Safety Considerations Related To Misconnections Future Trends Between Medical Devices Global Trends • Global Biomaterials Market For Implantable Devices • Modern Medical Tubing for Medical Device Downgauging Product Gallery • New Winged Female Luer Lock To Barb Connectors Driven By Polymers • Breakable Male Luer Lock Connector Did You Know • About Hospital Errors on Medical Tubing Killing Patients Did You Know • About Challenges Of Using Combination Products July-August 2015 January- February 2015 Cover Story • Indian Medical Device Industry : Government Initiatives Cover Story • Manufacturing Medical Devices In India : Many For Regulations, Safety &Competitiveness Opportunities - Department Of Pharmaceutical To Study Factors Affecting - Mr. Himanshu Baid, Managing Director, Poly Medicure Competitiveness Of Indian Medical Devices In Domestic Ltd. Market • How Do We Balance Between Compliance, Quality And - Government to Soon Remove Duty Anomalies in Medical Innovation? Devices Sector - Mr. C. Padmakumar, Chairman & Managing Director, - Ministry Of Health Launches Materiovigilance Programme Terumo Penpol Limited To Monitor Safety Of Medical Devices Technology Global Trends • Understanding Barriers to Medical Device Quality - AdvaMed Demands Passage Of D&C Amendment Bill • China : Medical Technology Potentials Are Enormous To Delineate Medical Devices From Drugs Product Gallery• New Sanitary Flanges With Barbs • Cold Plasma Treatment For Biomedical Applications Did You Know • About Trends In Medical Device Adverse Events • Plasma Treatment Improve Adhesion To Polymers Global Trends • Impact Of New European Regulations On Outsourcing November -December 2014 Of Medical Devices Cover Story • 12th National Conference & Exhibitionon “Indian Medical Did You Know • Balancing Product Development Effectiveness with Book Review Devices & Plastics Disposables/ Implants Industry 2015” Technology Regulatory Compliance • Exhibitors Offering Material, Display Exhibition Adhesives, May-June 2015 New Technologies, Manufacturing/Testing Equipments. Cover Story • Medical Device Manufacturing : Components Bonding • Packaging/Sterilization Equipments And Services For and Joining Techniques Medical Devices, Implants & Diagnostics Industry. • Presentations • Speakers’ Profiles • Exhibitors’ Profile • Advertisers Profile....etc. • Regulatory Affairs for Biomaterials and Medical Devices • Polymeric Biomaterials : 2 Volume Set 42 Nov. - Dec. 2015