Innovation Brief Videos

  • Novel Copolyesters to Meet Current Trends in the Medical Industry

    Recently, Eastman TritanT copolyester was introduced into the medical market and has generated considerable interest due to the clarity, outstanding toughness and chemical resistance resulting from the unique chemistry of the polymer. The combination of properties, in addition to being BPA--free, makes TritanT well suited to meet these emerging trends in medical devices and packaging applications. Speaker: Emmett P. O'Brien, Applications Research and Development, Eastman Chemical Company

    28:55

  • Engineered to be Green: Practical guide to introducing sustainable approaches

    The "Engineered to be Green" presentation will provide valuable insight into and best practices for sustainable machine design and redesign for machine builders (OEMs) and end-users. Niels Ouwersloot, Area Manager/Sales Engineer, Beckhoff Automation

    22:42

  • Electron Beam & Laser Welding--New Developments in Machine Design and Applications

    Electron Beam Engineering was founded in 1991 and provides electron beam and laser welding services to a vast array of customers including many medical and aerospace companies. EB welding machines have progressed through the years and now offer a wide variety of features that allow for manipulating the components during welding. In 2008 we launched our own line of electron beam welding equipment called the "Beamer" series. Our line offers many modern features for today's intricate component designs and can provide weld penetration in steels from 0.001" to 0.7" at 30 inches per minute. Speaker: Richard E. Trillwood, CEO, Electron Beam Engineering, Inc.

    15:19

  • Biocompatibility Explained: A Simple Understanding to a Complex Topic-Toxikon

    Toxikon Corp.

    Toxikon at MDM East 2013, Philadelphia, PA

    Biocompatibility testing involves the safety evaluation of medical devices and materials according to the guidelines set forth by regulatory bodies around the world such as ISO 10993, EP, USP, MHLW etc. Biocompatibility is typically performed on the final version of devices, although cases exist where specific tests are designed for the analysis of raw materials. The determination of which guideline to follow depends upon to which countries the devices will be submitted to, as well as the nature of what is being tested (medical device vs. raw material).

    35:05

  • Low Temperature Sterilization: Discussion of Current Methods including Nitrogen Dioxide

    Noxilizer, Inc.

    There are a number of low temperature sterilization options for medical device, pharmaceutical and biotech products. Today, the most common methods are: ethylene oxide (EO), gamma and hydrogen peroxide. EO is the oldest method, first used in the 1940-50's. Hydrogen peroxide was introduced in the early 1990's. Each method has its' strengths and weaknesses. With the rise of bioresorbable implants, drug-device combination products and prefilled syringes, more options are needed. This presentation will include the current sterilization technologies, and a discussion of the newest option, nitrogen dioxide gas. An overview of the strengths and weaknesses of NO2 will be discussed with a focus on the scientific data. One to two case histories will be shared demonstrating application to marketed products. In addition, a financial analysis will be presented contrasting the costs of contract sterilization vs. bringing sterilization in house. The intent is for this presentation will stimulate discussion in and questions from the attendees.

    19:22

  • New Trends in Cleaning and Disinfection Validations for Reusable Devices

    Nelson Laboratories Inc.

    1. Necessity and basics of cleaning and disinfection validations on reusable devices
    2. Non-patient contacting devices need cleaning and disinfection validations
    3. Simulated use of devices prior to the cleaning and disinfection validations

    22:56

  • Current Innovations with Radiation Sterilization

    Nelson Laboratories Inc.

    There are currently a number of innovative activities in the world of radiation sterilization. This presentation will provide an overview of those activities which include irradiation of tissue/biologics/combination products, new VDmax sterilization doses, discussions on use of SALs other than 10^-6 and a new approach to evaluating the potential impact that changes to SAL might have on patient safety.

    14:06

  • 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

  • Complex Catheter Construction - Tips, tricks and best practices

    Medical Murray, Inc.

    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

  • MicroBlasting - Optimizing Process Control and Automation

    Comco Inc.

    Comco Inc.'s presentation on MicroBlasting.

    21:23

  • Parylene Coatings in Drug Containment and Elution Technologies

    Specialty Coating Systems

    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

  • 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

  • Addressing Quality Control Inspection & Measurement Challenges Utilizing Vision Technologies

    Advanced machine vision solutions are making possible 100% inspection in high speed or high precision environments. Now micron level inspection of surfaces for defects as well as measuring parts to ensure specification compliance is not only viable but highly cost effective. Carlos Jorquera, CEO/CTO, Boulder Imaging

    10:52

  • Additive Manufacturing with ISO 10993 Class VI materials "parts in hours ready for gamma"

    Significantly reduce your time to market utilizing Additive Manufacturing with ISO 10993 Class VI materials. Parts in hours not days or weeks or months. Ready for gamma or ETO sterilization. Rapidly increasing your time to market.

    21:28

  • 3M™ Silicone Adhesive: An Answer to Gentle Skin Adhesion

    In 2012, 3M™ - Medical Specialties is pleased to introduce a new skin-friendly adhesive technology, silicone pressure sensitive adhesives, into its line of products for use in the design and manufacturing of medical devices. Skin is a difficult substrate on which to adhere a medical device. Too little adhesion results in device failure whereas excessive adhesion may result in skin damage upon removal.

    17:19