Webcasts | IVD Technology

Update on the Regulation of IVDs, Directly from the Source

Alberto Gutierrez is director of the Office of In Vitro Diagnostics (OIVD) in the Center for Devices and Radiological Health. In this webinar, he’ll expound upon the FDA’s latest IVD regulations and current thinking. This could include the new world of personalized medicine which, in Gutierrez’s words, “Gets the right drug to the right person at the right time."

Date: August 24, 2012
Time: 2 PM ET/11 AM PT
Duration: 60 minutes

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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

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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

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Archived Webcasts

The following webcasts are available on demand. Follow the links to register.

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

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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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The Regulation of Companion Diagnostics: Current Status and Updates

The featured speaker for this Webcast is Dr. Elizabeth Mansfield, PhD, the Director of the Personalized Medicine Staff at FDA's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).

Companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today. Companion diagnostics will significantly impact not only the IVD industry but also the delivery of healthcare. In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency’s current thinking on this area. In an effort to provide further clarity on this matter, the editors of IVD Technology have put together a special Webcast on the regulation of companion diagnostics. Listen in as Dr. Mansfield discusses this guidance and answers audience questions.

Have questions of your own? Dr. Mansfield is still available to respond to your questions, simply email sue.johnson@ubm.com and your questions will be forwarded to Dr. Mansfield to respond.

Originally Broadcast: November 10, 2011
Duration: 1 Hour

Paid webcast: $249 per person. For Group Rates, contact Sue Johnson at sue.johnson@ubm.com

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.

Date: September 7, 2011
Duration: 1 Hour

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Challenges in Clinical Lab Automation and IVD Instrumentation Development

The latest episode in IVD Technology's new on-going Educational Lecture Webcast Series. This Webcast will examine current trends and future developments in automated clinical lab instruments. A number of trends in the laboratory medicine industry directly affect the continuing automation of the clinical lab. This FREE Webcast will provide an overview of such market trends affecting the commercialization of IVD instrumentation technologies and examine how clinical lab automation technologies are evolving to meet current and emerging market requirements.

Originally Broadcast: May 26, 2011
Duration: 1 Hour

Omics and the Development of IVDs

With the advent of the sequencing of the human genome, scientists have been hard at work seeking correlations between human disease and the architecture of individual genes, gene patterns, cellular pathways, and metabolic events. Such work has brought to the table a host of so called omics—genomics, proteomics, metabolomics—all of which are supposed to play a part in developing a personal genome for individuals.

Personalized medicine involves understanding which gene alterations may cause human disease or medical problems. However, the promise of these omics in the development of IVDs for personalized medicine on a grand scale may still have a way to go. Part of the battle is related to the fact that IVD test results are not always a perfect reflection of what may take place in vivo. Another challenge is developing the technology to produce a cost-effective and scientifically relevant map of the human genome that offers correlations to disease risk and gene mutations that can be used for pharmacodiagnostic testing.

Speakers include:
Alexandra Gruber, PhD, Director of Business Development, Biocrates Life Sciences AG
Louisa B. Tabatabai, PhD, Research Chemist, Respiratory Diseases and Immunology Research Unit, National Animal Disease Center, U.S. Department of Agriculture
Svetlana A. Dambinova, PhD, Distinguished Professor, Wellstar College of Health and Human Services, Kennesaw State University

The Webcast concludes with a live Q&A session moderated by Richard Park, Editor-in-Chief of IVD Technology magazine. All attendees will receive our special DX Directions report on Omics and IVDs.

Originally Broadcast: April 21, 2011
Duration: 1 Hour

Challenges in Immunoassay Development

Since the 1960s, immunoassays have continued to make enormous contributions to clinical lab medicine. In 2009, immunoassays of all kinds (e.g., automated, manual, ELISAs, enzyme immunoassays, bead arrays, microarrays) played a dominant role in laboratory medicine. They have become one of the primary and indispensable tools in the diagnosis and monitoring of all areas of disease. The potential of this class of tests is now even more impressive.

Immunoassay developers are on a continuous hunt to discover technologies that can detect nano, pico, and even femtomolar concentrations of proteins in clinical samples. The key to diagnosis is to measure the difference between normal and abnormal concentrations of potential disease markers in blood, urine, saliva, and other fluids. New ultrasensitive test methodologies are being developed to allow researchers to detect highly disease-specific markers for diseases such as diabetes, cancer, osteoporosis, autoimmune diseases, arthritic conditions, and cardiac disease.

The market significance of immunoassays is best shown by the intensive research that continues to bring new test systems, technologies, and tests to market. In 2008 and 2009, market reports estimate that close to 100 new immunoassays were being developed or have come to market. While most of the new tests are for cancer testing, they cover a wide variety of diseases and conditions including allergy, autoimmune, cardiovascular, diabetes, sepsis proteins, and transplant markers.

In this inaugural episode of IVD Technology's new Educational Lecture Webcast Series, Professor Svetlana A. Dambinova, PhD, a distinguished professor at Wellstar College of Health and Human Services at Kennesaw State University, will give a lecture on challenges in immunoassay development and discuss those issues that IVD manufacturers encounter throughout the assay development process.

The Webcast will conclude with a live Q&A session moderated by Richard Park, Editor-in-Chief of IVD Technology magazine.

Originally Broadcast: February 24, 2011

Advanced Assay Technologies and Development Methods

Various market reports and studies have concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment. However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders, and diabetes. The function of genes is measured by the presence of tangible products, such as proteins of every size and molecular structure. Thus, immunoassays combined with DNA probe studies will have an important place in post-genomic medicine.

This Webcast features presentations by Neal Siegel, PhD, Chief Scientific Officer, Sword Diagnostics; Scott Dylewski, PhD, Senior Scientist, Alverix Inc.; and Nick Gee, PhD, CEO/CSO, Innova Biosciences Ltd. The Webcast concludes with a live Q&A session moderated by Richard Park, Editor-in-Chief of IVD Technology magazine. All attendees will receive a copy of our special DX Directions report on Advanced Assay Technologies.

Originally Broadcast: January 26, 2011

Microfluidic Applications for IVDs

This Webcast will feature presentations by Harry Glorikian, Founder and Managing Partner, Scientia Advisors., William W.P. Chang, PhD, Research Scientist, Wako Pure Chemical Industries Ltd., and Jonathan Siegrist, Cofounder, iGlyko Inc. The Webcast will conclude with a live Q&A session moderated by Richard Park, editor-in-chief of IVD Technology magazine.

Originally Broadcast: November 16, 2010

Examining the Past, Present, and Future of the IVD Industry

This Webcast will feature a special episode in IVD Technology's ongoing series covering fundamental aspects of in vitro diagnostics. This installment of the series will commemorate IVD Technology's 15th anniversary by taking a look back at developments in the IVD industry during the past 15 years in the areas of technology, products, and research and development; regulations, standards, and government and legal affairs; and business and marketplace issues.

This Webcast will feature presentations by Larry Mimms, vice president, R&D at Quidel Corp., Jonathan Kahan, partner at Hogan Lovells, and Scott Garrett, president and CEO at Beckman Coulter. The Webcast will conclude with a live Q&A session moderated by Richard Park, editor-in-chief of IVD Technology magazine.

Originally Broadcast: August 5, 2010
Sponsored by:
AbD Serotec
IDEX Health & Science

Innovations in Global Healthcare

Webcast available now – view today: The editors of MD+DI, Medical Product Manufacturing News, European Medical Device Technology, and IVD Technology hosted a panel discussion on "Innovations in Global Healthcare" at MD&M East in New York to address current industry topics and answer questions in front of key industry players. A panel of industry experts fielded questions from our editors and participated in a live Q&A with the audience at the show. Topics of discussion covered global issues such as: Innovation, Healthcare Reform, Comparative Effectiveness, Changes at FDA, Convergent and Emerging Technologies, and more! Now you have the opportunity to watch the Innovations in Healthcare panel in its entirety. Register for this free event.

Available now for on-demand viewing
Duration: 60-minutes

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Developing Next-Generation Sample Preparation Methods for Molecular Diagnostics

This Webcast continues an ongoing series covering fundamental aspects of in vitro diagnostics. This installment of the series will examine current trends and future developments in developing next-generation sample preparation methods for molecular diagnostics.

This Webcast will feature presentations by Lingjun Chen, vice president, operations and strategic planning at IQuum Inc., Russ Higuchi, a fellow in R&D at Cepheid, and Phil Moen, director, product development at IntelligentMDx. The Webcast will conclude with a live Q&A session moderated by Richard Park, editor-in-chief of IVD Technology magazine.

Originally Broadcast: June 22, 2010

Developing Lab Information and Data Management Systems for Next-Generation IVD Instruments

Ever increasing demands for data and the integration of that data into meaningful information will shape the future of laboratory healthcare information systems and IVD instrumentation. This FREE Webcast will examine current trends and future developments in lab information and data management systems for next-generation IVD instruments. Hosted by IVD Technology magazine, the Webcast will bring together a panel of experts from the IVD industry to review these issues and explain how common difficulties can be resolved.

Originally Broadcast: February 23, 2010