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Medical Grade Polymers 2015 September 15-16, 2015


Crowne Plaza Boston-Woburn, Boston, Massachusetts, USA


AMI is pleased to invite you to the next international conference on medical device manufacturing technology, materials and qualifi cation. Medical Grade Polymers 2015, will be held on September 15-16 at the Crowne Plaza Boston-Woburn.


The medical device market is expanding worldwide providing vital health technology to the growing population and enabling a much higher quality of life through new advances. These developments include custom-made personalized devices, such as 3D-printed artifi cial bone implants and tissue scaffolds, and combination devices providing drugs and functions in the same piece of equipment. At the other end of the scale, bulk cheap devices such as syringes and fl uid delivery bags and tubing are reaching much wider markets with advances in healthcare in developing nations. Polymers offer a cost-effective, accurate mass manufacturing option.


Reliable materials and clean room manufacturing processes are critical for safety in medical production. Hence a wide range of test protocols are specifi ed by the regulatory and standards authorities, primarily the FDA and ISO, to maximize the safety of healthcare technology at source. This includes chemical tests on the materials and devices for extractables and leachables, which could migrate out in use, and mechanical specifi cations for specifi c devices. Sterilization protocols and packaging can affect devices and must be carefully selected. In addition, suppliers are subject to inspections. The scale of the legal liabilities in this industry has deterred some of the larger materials companies from participating. Device failures do occur and statutory reporting ensures that lessons are learned.


Infection prevention is a big issue for healthcare providers who aim to eliminate the pain and costs of hospital-acquired infection. There are options in device development to incorporate anti-microbials in coatings and device surfaces.


Manufacturing costs are being driven down by fi erce market competition. It is vital to fi nd the most effi cient production technology and best components to build a viable future for the medical device industry without cutting corners.


Join leading experts to debate successful medical device engineering with polymer materials at Medical Grade Polymers 2015.


CONFERENCE HOTLINE


Contact: Stephanie Berchem, Conference Coordinator Tel: +1 610 478 0800 Fax: +1 610 478 0900 Email: sb@amiplastics-na.com


FIVE GOOD REASONS WHY YOU SHOULD ATTEND:


1. Review medical polymer developments 2. Keep up with device technology 3. Consider critical issues 4. Debate standards 5. Add to your professional network


2:40


C ONFERENCE Tuesday, September 15, 2015


8:00 Registration and welcome coffee 9:00 Opening announcements MARKET OVERVIEW 9:10


Compliance and speed to market - yes, we can have both! Mr. Mark Moyer, Administrative Director, CAMLS INNOVATION CENTER USF HEALTH (Mark Moyer was formerly with SMITH & NEPHEW), United States


9:40 Medical device innovation - an overview of market, technology, manufacturing trends, costs and new projected future for medical devices Ms. Asmita Khanolkar, Manager, Manufacturing Engineering, CEQUR, United States


10:10


Biomaterials supplier liability issues - FDA regulation and managing risk Mr. Frederick Stearns, Partner, KELLER AND HECKMAN LLP, United States


10:40-11:10 Coffee break SESSION 1 - MANUFACTURING


11:10 Design requirements and manufacturability of medical tubing for stent and balloon delivery systems Mr. Steve Maxson, Technical Sales Manager, RAUMEDIC INC., United States


11:40


Two ways to cut medical manufacturing costs Dr. Michael Hansen, Senior Technical Development Engineer, MACK MOLDING COMPANY, United States


12:10 Metal to plastic conversion for instruments in healthcare; a retractor case study Mr. Trevor Spence, Sales Development Manager, SOLVAY SPECIALTY POLYMERS, United States


12:40-2:10 Lunch SESSION 2 - MATERIAL OPTIMIZATION 2:10


Polymer pitfalls: Use, manufacturing and interaction Dr. Fahmida Hossain, Director of Materials Engineering, MASSACHUSETTS MATERIALS RESEARCH, INC., United States


Polymers in combination products: Safety and effi cacy considerations of device/drug/biologic interactions Ms. Rosalyn Año, Business Development Manager – Medical Devices, TOXIKON CORPORATION, United States


3:10 Translucent radiopaque polymer formulations for specialty medical devices Dr. Jack Frautschi, Sr. Biomaterials Scientist, POLYONE/NEU, United States


3:40-4:10 Coffee break 4:10


The importance of polymer structure - property relationships in preventing failure in medical devices Dr. Steven MacLean, Sr. Managing Engineer, EXPONENT, INC., United States


4:40


Uses of thermoplastic polyurethane in medical devices Dr. Anthony Walder, Global Technology Manager, LUBRIZOL, United States


5:10-6:40 Cocktail Reception


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