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Thermal Drilling - Formdrill USA, Inc.
What is thermal drilling: Purpose & Advantages, how it is done. Formdrills perforate thin metals using friction. They form holes and push through a bushing from the displaced material that is normally cut. These bushings can be tapped to avoid the use of welded nuts or inserts. Can be used in drill presses or CNC systems. Saves labor, time and materials. David Claudio, North American Operations Director, Formdrill USA, Inc.
8:22
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Reducing Cost in Functional Safety Systems through Virtualization
Advanced virtualization technology can help you adhere to safety standards in your devices. • IEC 61508 Safety Systems • Aspects of IEC61508 System Design • Advanced Concepts for Safety & Security Jeff Fortin, Director of Field Engineering, Wind River
16:09
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Long-Fiber Composites for Metal Replacement
This presentation will cover the basics of Very Long Fiber (VLF) reinforced thermoplastics and the unique performance benefits these compounds bring to metal replacement applications. A brief review of the manufacturing of Very Long Fiber (VLF) will be followed by discussions covering resins, fibers, property comparisons, and metal replacement case studies. The goal of the presentation is to provide the attendee with the basic knowledge required to evaluate which applications in their market area might benefit from the use of Very Long Fiber reinforced thermoplastics. Dave Sterling, Global Application Development Manager, RTP Company
15:22
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Parylene in Medical Devices
Although the demand for reliability and safety has always been at the forefront in medical device design, the challenges of minimally invasive and micro/nano devices require new and different packaging solutions. Implantable devices often incorporate microelectronic components and systems intended to either sense or facilitate a physiological response. Speaker: Lonny L. Wolgemuth, Sr. Medical Market Specialist, Specialty Coating Systems
28:17
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Extractables and Leachables: A Powerful Tool in Qualifying your Product as Medical Grade.
All materials used in medical device manufacturing must be proven to be safe. With improvements in device effectiveness comes more intricate, unique, novel and specialized technologies. As these advancements evolve, understanding their impact on safety becomes more critical. A primary measure of the safety associated with a device or material is biocompatibility. There are specific tests that are recommended by the regulations to determine the overall biocompatibility of the device. Upon successful completion of this testing, a device can be submitted for use in the industry. Select biocompatibility tests can be utilized as a screening tool prior to that biocompatibility testing used to meet the regulatory requirements. Understanding how the change of a material can impact the biocompatibility of the overall system can be achieved by determining the extractable and leachable profile of the device. Extractable and leachable determination essentially models the interacting compounds between device and patient. Understanding these interactions allows one to predetermine the expected impact. Additionally, identification of these compounds allows one to determine the source that may be affecting the biocompatibility of a material/device. Ultimately, this chemical characterization can be implemented to determine the source of a failure, as a screen measure to ensure optimized material selection during product development, maximize the efficacy of specialized devices, and/or to provide key input in a toxicological risk assessment. Along with demonstrating the usefulness of extractable and leachable determination, an overview of how this determination is made will be presented.
21:23
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The Big Three: Cytotoxicity, Sensitization, & Irritation
There's a myriad of tests medical device manufacturers need to be prepared to conduct on their creations in order to pass regulation requirements before they are released to the marketplace. None more important than the Cytotoxicity, Sensitization, and Irritation tests the Big Three as we call them. They are the Big Three because they must be conducted on every device before they can be submitted to the Food & Drug Administration (FDA). There is no way you can get around doing the three tests. Other tests may or may not need to be conducted. By understanding these three tests, you can be better prepared for submission to the FDA and better prepared to write justifications when the tests indicate a failure.
20:15
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Complex Catheter Construction - Tips, tricks and best practices
Accomplishing new minimally invasive procedures often requires the construction of complicated catheters to access different anatomies, deliver devices or drugs and incorporate sensors to assure proper results. This requires the combination of many materials to provide different flexibility, low friction, torsional resistance, multiple paths and functional components; all in small diameters. Materials commonly utilized to achieve the required results include Nitinol, polyurethane, high density polyethylene, stainless steel, silicone rubber, Pt-Ir, PTFE, conductive wires, etc. Techniques for assembling these complex catheters will be explained; to include braiding over multiple lumens, axial reinforcement, injection molded access ports integrated into the handles, silicone balloons bonded to polyurethane, release mechanisms and sensor integration.
16:57
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Medical Design Solutions for Medical Device Assembly
3M Medical Tapes and Adhesives
Medical devices require cleaning, disinfecting and sterilization techniques to protect the patient from infections. A variety of sterilization methods have been used to condition medical devices over the years. Typically, devices were constructed of materials such as metal, glass and rubber. However, as devices became more intricate and higher performing, the types of materials used for construction were modified. Thermoset and thermoplastics have replaced the materials of a few decades past and the assembly methods used for medical device construction have also been modified. With development of reusable medical devices, sterilization between uses has become an important consideration in the development of medical devices. In May 2011, the FDA distributed the Draft Guidance for Industry and FDA staff, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. When finalized, medical device manufacturers will need to include validated labeling instructions for reprocessing reusable medical devices in premarket submissions. Medical Design Adhesive Solutions are used in the manufacture of medical devices because of design flexibility, stress distribution, bond dissimilar materials and seal simultaneously and can be automated. With the shift to reusable medical devices, these devices must be able to withstand the specified sterilization methods outlined by industry requirements. Testing has been conducted on the integrity of these products to several industry protocols. To meet the requirements of various types of medical devices different cleaning, disinfecting, and sterilization techniques were tested including steam, radiation and chemical immersion.
13:31
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Medical Device Application Considerations for Silicone PSA's
3M Medical Tapes and Adhesives
What does it mean when developers or customers ask for a silicone adhesive? Do they fill a need in your medical device? Explore why silicone pressure-sensitive adhesives continue to grow in popularity and examine their usage trends in medical devices, especially in applications that adhere to skin. Several recommendations for effectively utilizing, processing and incorporating these materials into medical devices will also be discussed.
25:38
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MicroBlasting - Optimizing Process Control and Automation
Comco Inc.'s presentation on MicroBlasting.
21:23
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Parylene Coatings in Drug Containment and Elution Technologies
Parylene [poly (para-xylylene)] is a thin, continuous, inert, transparent, biocompatible conformal coating. It is applied in room temperature vacuum deposition chamber by a process known as vapor deposition polymerization (VDP). The coating process involves the spontaneous re-sublimation of a vapor formed by heating a powdered, dry precursor material. The vapor converts to an inert polymer coating on target surfaces in a dry, solvent and catalyst-free process. Parylene provides useful barrier properties per unit thickness, as well as extreme chemical inertness and freedom from extractables or leachables. The coating itself is also free of catalytic, solvent and plasticizer residuals. Parylene has been widely used to eliminate problems related to lubricity, microporosity, biocompatibility, and biofluid corrosion protection in medical devices for over 30 years. In recent years, it is being used as a bonding, or tie layer, in the production of coronary stents. It is also used to protect containers and pharmaceuticals as well as to control the elution rates of drugs. To understand the unique properties that make it so useful in these applications, it is important to understand the characteristics that make Parylene so well suited for in vivo applications.
23:01
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Additive Manufacturing 101: How the Future of Product Development and Manufacturing is Changing
This presentation will explore how additive manufacturing systems such as 3D printers and 3D production systems are changing the future of product development and manufacturing. Jon Cobb, VP of Global Marketing, Stratasys, Inc.
26:44
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3D Printers Thrive in the Medical Device Industry
Medical device manufacturers and their products are becoming more competitive. Products are designed with maximum efficiency from the perspective of both design and production. This is commonly translated into elements that are small in size and that require fine details and high accuracy, which are essential in the medical device industry. David Cox, President Purple Platypus Innovation Video Briefs
10:09
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Powering and Controlling Solid State Lighting (LEDs) in Medical Applications
This presentation will contrast LEDs with traditional lighting sources; review some of the more common applications; examine what is required to power and control LEDs; cover the special requirements for powering LEDs; review the difference between a generic power supply and an LED driver; contrast LED dimming methodologies and their impact on LED light output; examine manual and remote control dimming methods; and review various regulatory requirements that impact using LEDs in medical applications. Speaker: Peter F. Wagner, Product Manager, Powerbox USA
21:50
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High Performance Conformal Coatings for Medical Electronics
Understanding the coating requirements of the medical electronics application and determining the conformal coating process that fits the need. Speaker: William Yager, Sales Manager, Para Tech Coating, Inc.
20:26