Innovation Brief Videos

  • 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

    3M Medical Specialties

    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

  • The Ins and Outs of Stent Securement Testing Today

    Machine Solutions Inc.

    This presentation will compare the two modes of testing including a comparison of actual test data and ease of test setup and repeatability. The audience will walk away with an understanding of the importance of the test, current test methods and the latest innovations to improve testing methods such as Machine Solutions SR1000.

    19:49

  • MicroBlasted Surface Finishes: How to Specify; How to Control

    Comco Inc.

    This presentation will cover the requirements for specifying and controlling the applied finish. Mechanical bonds and chemical reactions can vary significantly with slight changes in surface properties. As such, the finish must be tightly controlled. Particle velocity is a key component of the equation. This presentation outlines the dynamics of controlling particle velocity.

    16:48

  • Catheter Shaft Optimization for Accurate Axial Positioning

    Medical Murray, Inc.

    This presentation will discuss the challenges related to the mechanics of these catheter systems, and methods available to improve the accuracy of positioning within the catheter. Successful examples that demonstrate the ability to reduce inaccuracy will be shown.

    16:19

  • New Non-Contact, Laser-Based Gauge for Measuring Length and Speed of Medical Products

    Beta LaserMike

    As the medical manufacturing industry is driven to become more efficient and improve product quality, their ability to measure length and speed with increasing accuracy has become essential. Accurate length and speed measurements are critical to all attempts to improve process control automation. Speaker: Stuart Manser, Sales Manager, Western US and Canada, Beta LaserMike

    18:46

  • Medical Connector Options--Custom or Off-the-Shelf

    Affinity Medical Technologies

    Medical connectors are available from a variety of manufactures. Most manufacturers offer many versions of the connectors they manufacture. In many instances, an off--the--shelf connector may be the best choice for a medical interconnect project. However, in other situations, a fully custom connector or a hybrid connector may be a better choice for the device manufacturer. This presentation will address design and specification issues associated with the various types of medical connectors and will offer examples of successful designs. Speaker: Hank Mancini, Business Development Manager, Affinity Medical Technologies

    16:54