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OrthoTec Blog |
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OrthoTec regularly produces Webcasts on a wide variety of topics important to medical device professionals. Register below for upcoming webcasts.
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, 2012
Time: 2 PM ET/11 AM PT
Duration: 60 minutes
Sponsored by:
Hosted by:
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, 2012
Time: 2 PM ET/11 AM PT
Duration: 60 minutes
Sponsored by:
Hosted by:
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.
Originally Broadcast: December 6, 2011
Duration: 60 minutes
Cost: $249.00
Group rates are also available. Contact Sue Johnson for information: sue.johnson@ubm.com, (303) 254-4763.
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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.
Originally Broadcast: November 15, 2011
Duration: 60 minutes
Sponsored by:
Hosted by:
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
Sponsored by:
Hosted by:
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