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Qmed Webcasts

  • Cleaning Validations for Newly Manufactured Medical Devices and Single Use Implants

    Most medical device manufacturers know the importance of sending their product through rigorous cleaning and testing before they release to market. Standard sterility and biocompatibility tests are already an essential part of many manufacturers' protocols. What may not be as commonly understood, however, are the different ways a product can be contaminated during the manufacturing and production, cleaning processes, and packaging of medical devices. To avoid detrimental contamination, manufacturers should test their devices to examine the surface residues remaining on the device after these processes. This presentation on cleaning validations for newly manufactured medical devices and single use implants is a useful guide to help develop a successful test plan to provide cleanliness data. In addition, this presentation gives guidance on industry trends to justify residue limits.Available On Demand

    Thu, Apr 5, 2012 - 09:00 am

    60 Minutes

  • Maintaining IEC 62304 compliance needn’t be a harrowing experience

     Companies in the medical space are required to work with a host of regulatory agencies. The information they request/require is sometimes similar, sometimes slightly different, and sometimes completely different, especially when you're dealing with IEC 62304. As you'll learn in this webcast, fulfilling these requests needn't be an insurmountable task. A series of tools will be explored, including the Rational Publishing Engine (RPE). Date: March 8, 2012Time: 2 PM ET/11 AM PTDuration: 60 minutes

    Thu, Mar 8, 2012 - 02:00 pm

    60 Minutes

  • Easier to Use UIs: How to Win Approval from users and the FDA

     Your customers have told you that your next-generation medical device must be easier to use and you've heard about the new FDA human factors testing that might be required. You know you've got to have some kind of information display, and now you're ready to move towards creating that highly-desired, simple, engaging, and FDA approved medical user interface. This webinar covers the fundamentals of how to go about creating such an interface and how to smooth the path through FDA HF testing. Two companies, Bridge Design and Design Science, each with great expertise in their respective fields (UI design and human factors), will explain and illustrate how to:  *Understand what your specific users and stakeholders mean by "ease-of-use"*Appreciate the fundamentals of good usability*Know the criteria to help you choose the right style of interface (e.g., touchscreen or softkey-based, or using other input devices)*Understand how to integrate a UI into the other components of your medical device or system*Create that customer-appealing interface*Develop an optimal prototype-test-iterate process with your users that will validate its usability and smooth the path to regulatory approval*Deliver the UI to the software development-team in a simple and clear way that is as easy to implement as possible Attendees of this webinar will get immediately actionable ideas on all the above topics as well as access to downloadable articles and whitepapers that provide data and further explanations of good practices and processes. Bridge Design's Director of User Experience, Diana Greenberg, and Design Science Principal and Founder, Steve Wilcox, will provide the core content of this webinar. Bridge Design (San Francisco, CA) is a medical product development company with 20 years of experience creating market-winning medical user interfaces, including the Cozmo insulin pump, which set the standard for ease-of-use in this category, and the recently announced AcelRx NanoTab PCA delivery system, that integrates RF tags and a small color screen into a small delivery device that enables secure and safe drug delivery. Design Science (Philadelphia, PA) provides human factors support, including contextual inquiry and usability testing, for medical-device manufacturers, including a number of divisions of J&J, Baxter, and Abbott, among many others. Date: February 22, 2012Time: 2 PM ET/11 AM PTDuration: 60 minutes

    Wed, Feb 22, 2012 - 02:00 pm

    60 Minutes

  • Microcontrollers for Healthcare: Hello, Kinetis (Goodbye, MSP430)

    Portable healthcare devices are evolving into comprehensive gadgets that include advanced communication protocols, stylish user interfaces and bountiful data logging resources. This evolution cannot come at the cost of key application requirements for long battery life, accurate and reliable measurements, and cost effectiveness. To address this demand, Freescale has recently launched the KinetisK50 ARM Cortex-M4 microcontroller with integrated analog front end. The K50 microcontroller satisfies healthcare device requirements with exceptional low power design and integration of key peripherals such as capacitive touch sensing hardware. These features are integrated with a high performance, industry standard 32-bit ARM Cortex-M4 CPU with DSP instructions, and are part of a portfolio of devices that contain integrated Flash memory sizes from 32KB to 1MB. The Kinetis K50 microcontroller is poised to be the healthcare microcontroller of choice for 2012 and beyond. Goodbye, MSP430.

    Tue, Jan 31, 2012 - 02:00 pm

    60 Minutes

  • Pharma Lok™ Single-Use clamps and Value Plastics bag ports

     This FREE webcast presentation will focus on the Biopharm market needs that resulted in designing a new line of unique single-use clamps that closely align with ASME-BPE specifications and significantly improve operators' ease of use and time spent on assembly. We incorporated input received from process designers and engineering into this innovative tri-clamp design. The presentation will also look at an ongoing problem identified by one of the largest consumers of bag ports, and confirmed by multiple other manufactures of bags, that they were seeing cracking issues due to contact with IPA while under stress. This problem was found in all LDPE products tested. The cracking appeared anywhere within 7 seconds to 2 minutes and spread through the entire surface of the port. I will discuss how we addressed this issue, and then review testing results surrounding the new design features that allow bags to drain 17 to 24 percent faster and with improved flow characteristics. This distinctive design is pending being patented. Value Plastics worked with a leading resin manufacturer to come up with an exclusive resin that overcomes the stressing cracking issue, is UPS Class VI certified and Animal Derivative Free while heat sealing to existing polyethylene films used in Single-use bags. Available On Demand

    Mon, Jan 23, 2012 - 12:00 pm

    30 minutes

  • Cleaning Validations of Reusable Medical Devices

    This on-demand webinar is designed to provide information for the beginner and the intermediate level person seeking further details into performing cleaning validations of reusable medical devices. The webinar covers the fundamentals of the cleaning process and goes into more depth about how to contaminate and perform the dwell time of the devices, what methods are used to clean the devices, what residuals are appropriate to test for specific device types, evaluating the recommended cleaning procedure for a reusable device according to AAMI TIR12:2010 and AAMI TIR30:2003, and the acceptance criteria for each residual tested. This information is needed to assure that once the device has been used, it can be properly cleaned. It is the responsibility of the manufacturer to apply this data, along with their own functionality and sterilization data, to the label claims. Lastly the topic covers several of the standards along with case studies and examples.

    Wed, Jan 4, 2012 - 11:32 am

    60 Minutes

  • Did Your Medical Device Just Contract A Virus?

     Today, technology advances are enabling a whole new class of intelligent, programmable, and even internet connected and enabled medical devices. Such new devices range from implantable pacemakers and insulin pumps to next generation networked imaging and diagnostics equipment. While these new high-tech enabled devices are creating significant advances in patient care and health care, what good are these devices if they aren't secure? Many device manufactures have taken precautions to ensure their devices are not tampered with and don't get infected. Yet, device manufacturers' core business is all about developing great new medical devices—they aren't in the business of knowing the most recent viruses spreading through the internet or internal corporate networks.In this webinar, learn how to:Make your devices more safe and securePrevent users from making unauthorized changes to your deviceMake your devices more easy for hospitals and healthcare providers to monitor, manage and maintain compliance with various state and federal regulationsHelp ensure your devices avoid malware infections that can create unforeseen support calls, warranty returns, and technicians going onsite to make repairs Date: December 13, 2011 Time: 2 PM ET/11 AM PT Duration: 60 minutes

    Tue, Dec 13, 2011 - 02:00 pm

    60 Minutes

  • PLM and the Patient

     Developing Breakthrough Technologies in the Medical Device IndustryPLM: One Single Source of Truth to Make Safe, Compliant and Effective ProductsUncertainty in FDA regulations, expiring patents, industry consolidation and organizational complexity have one thing in common – the potential to change a life sciences company.During this event, chief editor, Heather Thompson will highlight recent trends in MedTech innovation and facilitate discussion on how one of the leading healthcare companies in the world, Johnson & Johnson – Medical Device & Diagnostics, is leveraging Product Lifecycle Management (PLM) solutions to develop breakthrough products, streamline regulatory reporting and deliver process transparency in their product development and quality assurance processes.  Featured during this discussion will be Steve McCarthy, Vice President Quality Management Systems - Medical Devices & Diagnostics, Johnson & Johnson.In addition, you’ll hear from Jean Colombel, Vice President, Life Sciences Industry Strategy, Dassault Systemes, the latest in 3D PLM collaborative solutions for Life Sciences and how its technology allows you to put patients at the heart of your company’s strategy; experience your product in a 3D virtual environment to simulate product behavior and improve patient outcomes; and engage with regulators and customers to develop the most effective products possible.Key Learning Objectives•   Understand industry challenges and limitations of current approaches•   Understand how a lifecycle management approach merges the product and the process from conception to commercialization•   Learn pragmatic ways to get started implementing PLM strategies•   Discuss the urgency for improved safety and maximized profits while complying with increasing regulatory 

    Tue, Dec 13, 2011 - 10:00 am

    60 minutes

  • Don't Let Your IP get Ripped-Off in China

    Join Knobbe Martens Olson & Bear LLP Partner, Jerry L. Hefner, Ph.D., J.D., for a discussion around this hot topic and learn how to protect your technology. Until recently, it was commonly believed that there was little value in obtaining IP rights in China. The expense of obtaining and maintaining patents and patent applications in China combined with the lack of an effective means for enforcement, made Chinese IP generally an unattractive investment. Over the last decade, however, China has made significant advancements in providing applicants with reasonably cost effective means for both securing and enforcing IP rights. In view of China's new found wealth and glut of well-trained scientists and engineers, any innovator would be remiss not to include China as part of its IP strategy. In this seminar you will learn the types of IP protection that the Chinese system has to offer as well as cost effective approaches that non-Chinese entities can employ to reduce the likelihood of unauthorized exploitation of their technologies in China. In addition, you will learn how to control infringing activities through enforcement actions as well as realistic expectations for enforcement outcomes in China. Date: December 6, 2011 Time: 2 PM ET/11 AM PT Cost: $249.00 Group rates are also available. Contact Sue Johnson for information: sue.johnson@ubm.com, (303)254-4763.

    Tue, Dec 6, 2011 - 02:00 pm

    60 Minutes

  • Radiation Sterilization Validations

    This topic is designed to provide information for the beginner and the intermediate level person seeking further details into the Radiation sterilization process. The training starts with the fundamentals of testing involved in radiation validations including the necessary key terms and definitions and an overview of bioburden and sterility testing. The training then describes the common validation approaches The different types of methods for doing radiation sterilization including VD Max, Method 1 and Method 2 are discussed in detail. Lastly the topic covers several other key concepts involved with radiation sterilization.

    Mon, Dec 5, 2011 (All day)

    60 Minutes

  • Material wear characterization in medical implants with 3D optical microscopy: scar depth and volume removal

    3D microscopy based on white-light interferometry has provided precise, quantifiable three-dimensional surface measurements for over 25 years. Over the past few years interest has grown in using this method to measure the quality and wear of medical implant surfaces. This interest has developed because 3D microscopy can deliver rapid, non-contact surface area measurements with sub-nm vertical and sub-micron lateral resolution. Felds of view of many millimeters can be obtained, and large areas may be examined by stitching together multiple measurements. This webinar argues for the advantages of using Bruker’s 3D interferometric microscope for material surface quality and wear characterization of medical implant devices. We show the capabilities of our system for measuring volume, depth, length, area, direction of wear, scars and defects. In addition, we compare measurement results using our system with those of the stylus profiler and a gravimetric measurement. Time: 1 p.m. ET/10 a.m PT

    Tue, Nov 15, 2011 - 01:00 pm

    60 Minutes

  • Li-ion Battery Solutions for Mobile Hospital Equipment

    Most electronic medical equipment used in a hospital has always required some kind of battery back-up power, especially if the application is used in life support or life monitoring applications. Doctors, nurses and patients expect devices to be more mobile and portable. Applications that have traditionally been powered by lead acid batteries - like ventilators, infusion pumps, and anesthesia delivery systems - can benefit from direct replacement with new Lithium Iron Phosphate battery technology. Benefits of this new technology are thousands of cycles (even with complete discharge), better energy and power density and little self-discharge in storage. There are several factors that make this chemistry easily adapted to a drop-in replacement for lead acid batteries, and you will learn about them in this brief webcast.

    Mon, Oct 31, 2011 - 01:27 pm

    20 mins

  • The Medical Software Pandemic: Challenges and Solutions

    The software complexity of critical medical devices is growing rapidly. Pacemakers can be remotely programmed. Infusion pumps have been hacked. Digital radiography systems contain millions of lines of code. Some devices, such as electronic medical record (EMR) tablets, are effectively a generic personal computer, running massive operating systems. Medical device manufacturers face tremendous competition, promoting intense cost containment measures and time to market pressure. The result is that the current international regulatory environment for life-critical medical devices is hopelessly inadequate. Unlike the avionics industry, which has extremely rigorous requirements for flight-critical software and requires a comprehensive validation prior to flying, medical device regulators have historically focused instead on documentary guidance. While medical device software failures have caused patient fatalities and hundreds of recalls, there has never been a commercial airline passenger fatality directly attributed to software. There is a simple solution to this apparent untenable dilemma. Highly robust medical software can be developed at the speed and cost of high volume consumer electronics, such as smartphones and PCs. The methodology for achieving this combination of safety and efficiency is not widely understood. This seminar will describe the key principles and how they can be applied without sacrificing the latest and greatest multimedia, connectivity, and open source software features that improve usability. Furthermore, we discuss how regulators can dramatically improve medical software safety by reusing validated components and standards from other industries.

    Wed, Sep 28, 2011 - 09:37 am

    60 Minutes

  • Intellectual Property Considerations During Product Development

    Intellectual property is often one of a medical device company's most valuable assets. Learn how to avoid common pitfalls that could lead to accidental loss of intellectual property rights and how to efficiently integrate a patent strategy into your product development plan. • What should every product development professional know about the patent system? • How important is patent protection to a medical device company? • How to avoid accidental loss of patent rights? • How to efficiently integrate a patent strategy into a product development plan? • Is it better to patent or keep inventions as trade secrets? • Why is it important to include the IP team during the entire product design and development process? • How can patent and FDA strategies overlap and affect each other?

    Tue, Sep 13, 2011 - 02:00 pm

    60 Minutes

  • Fluidic Miniaturization in Biomedical Diagnostics: Needs, Accomplishments, and Ongoing Research

    Microfluidic devices have emerged as powerful and reliable analysis platforms for proteomic applications and biomarker screening. The goal for clinical biochips and lab-on-a-chip devices is to include sample injection, separation, test labeling, and detection, and to have everything done in a few minutes. Thus biochips make a perfect match for the new wave of tests that rely on gene and protein expression patterns. Microfluidic devices have evolved and have been developed to miniaturize various diagnostic technologies, such as nucleic acid amplification and detection, immunoassays, mass spectroscopy analysis, flow cytometry, and sequencing.

    Wed, Sep 7, 2011 - 02:00 pm

    60 Minutes

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