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Upcoming Webcasts
MD+DI and MX: Medtech Executive regularly produce Webcasts on a wide variety of topics important to medical device professionals. Register below for upcoming webcasts.
Conquering Complexity - Medical Device Biological Wet Testing
Outsourcing is a normal part of medical device design and manufacturing. However, for some complex devices, it goes well beyond production and into qualified wet testing. Wet testing is a complex laboratory methodology itself, and the qualification of partners that specialize in wet testing is no less important than for device manufacturing.
Take part in this webinar developed by Sparton Corporation that will cover general concepts and value of wet testing and the options that you have as a complex device OEM.
During This Webcast, learn:
- General Concept of Wet Testing
- The value of wet testing
- The options you have as an OEM
Available On-Demand
Duration: 20 minutes, including Q&A
Sponsored by:
Hosted by:
HD-PLM 101: Smarter Decisions, Better Products for Orthopedics and Medical Device Development
Every great medical device is the product of great decisions. Not just the milestones, but the millions of decisions that led to them. Decision makers like: The engineer in London. The machinist in Munich. The supplier in Shanghai. The compliance specialist in Boston. The marketing director in Chicago. That’s why the vision of HD-PLM is to give everyone involved in making a product a clearer view of the information they need to make optimal decisions. That means more than simply enabling collaboration. It means building an immersive decision-making environment in which people don’t search for information; the information finds them. And they don’t interpret information when it arrives; it comes in a context they readily understand.
Join Siemens PLM Software and a special guest from Abbott Diagnostics in this informative webinar to learn how HD-PLM can help your company make great decisions and ultimately lead to successful medical devices.
Date: December 11, 2012
Time: 2 PM ET/11 AM PT
Sponsored by:
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Ethylene Oxide Clinical Batch Release Webinar
How do you sterilize product when you only have enough product produced to make up one sterilization load? How do you demonstrate a sterility assurance level (SAL) of 10-6 when you do not have the time or sample quantity required for a full EO validation?
The batch release method is a rapid and cost effective approach to sterilizing single or small batches of product needed for clinical or animal trials with minimal sample requirements. The presentation on batch release testing gives a general outline on the background and requirements on performing an appropriate sterilization validation for these small or infrequently produced lots. The overkill concept, properties of ethylene oxide, and testing requirements will be discussed.
The webinar will demonstrate how the sterility assurance level can be achieved and outline all of the necessary testing required to be able to safely release product. The batch release method can be performed in small laboratory vessels as well as at contract sterilization facilities and provides the much needed flexibility to get product to trials or to market without the time and expense of waiting for the completion of a full sterilization validation.
Available on-demand
Sponsored by:
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Medical Device Designing with the Manufacturer in Mind - A Subtractive Solid Modeling Approach
Discover a new approach to designing medical devices as if you were the manufacturer. This webinar details a new way of solid modeling that imitates the way a machinist would manufacturer a part. This approach can help with reducing machine cycle time, setup time, material cost and lead time, which are all huge factures in today medical device design and manufacturing. Engineers and individuals tasked with improving performance, productivity, life, efficiency, and design will benefit from this FREE webinar. What you can learn: A different way of solid modeling, a different way of conceptualizing designs with manufacturing in mind, a way to verify manufacturability, and more.
Available on-demand
Sponsored by:
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The Steps to Preparing for a Successful FDA Device Panel Meeting
Given the Food and Drug Administration’s (FDA) increased scrutiny of device efficacy and long-term safety, the agency is conducting more panel meetings each year. Strong clinical data alone are no longer enough to win approval. In today’s environment, it is critical for sponsors to prepare a clear, credible and engaging presentation. You must also ensure that your team is ready for the most difficult questions in order to sustain credibility and achieve a positive committee recommendation. Most companies are ill-equipped to prepare for this critical, yet daunting meeting. With so much at risk in a single presentation, all stakeholders must mobilize and have a clear strategy when approaching FDA for market approval. This webinar will provide you with proven steps that will optimize your success before an FDA Device Panel. Upon the presentation's conclusion, you should be able to:
- Understand all the essential steps necessary to be successful at an FDA Device Panel meeting
- Create a realistic schedule / timeline
- Staff a team of internal personnel and external advisors to properly prepare
Date: November 1, 2012
Time: 12 p.m. ET
Sponsored by:
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Fluid Delivery and Absorption Components for Diagnostic Devices
The Webinar will cover the following topics:
- Fluid collection components for lateral flow point of care diagnostic devices, including methodologies for regulating the both the amount of liquid collected and the flow of liquid into the device, and passivation of components to reduce non-specific binding.
- Liquid absorption components to facilitate the flow of liquid through high throughput analyzers, point of care devices and microfluidic devices.
- Recent developments in urine and saliva collection media.
- Sufficiency indicator technology, which informs the user (patient or medical professional) when enough fluid has been collected to present a valid test.
- Passive fluid delivery components for microfluidic devices.
Date: October 25, 2012
Time: 2 PM ET/11 AM PT
Sponsored by:
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How To Choose the Right Heat-Shrink Tubing for Your Application
Think medical tubing is a commodity? Think again! Not all heat shrink tubing is created equal. Today’s medical applications and designs demand tighter tolerances, thinner walls, advanced materials, and greater functionality in much smaller packages. It’s also critical to choose the right formulation for your application. This webcast will address these emerging demands and discuss how to optimize tubing for your minimally invasive product.
Date: October 16, 2012
Time: 2 p.m. ET
Sponsored by:
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Turning Research into Insight
Market Research has been used to drive strategy and execution in the Pharmaceutical and Biotech industries for decades. But many firms do not use market research properly. Firms might not be getting their money’s worth. Medical device companies must seize competitive advantages through insight generation, analytics, and cross-functional implementation. This presentation will help medical device executives understand how to tap into market data and intelligence to make informed business decisions and grow the bottom line.
- Why market research is critical to medical device companies
- Trends among hospital executives and their impact on medical device and capital equipment expenditures
- Generating insights from first-to-market PO level data for the medical device space
- Case study: How market research insights drove strategy execution for leading medical device manufacturer
- Integration of market research into cross-function strategies including: Manufacturing, Sales, Marketing, New Product Development, Technical Service Support
Date: September 18, 2012
Time: 12 p.m. ET
Sponsored by:
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Biomedical Textiles Enable Device Design
Explore the advantages of biomedical textiles technologies to enable device design. Engineered from polymeric, metallic or resorbable materials, implantable textiles enable advanced designs for high-performing applications such as cardiovascular, orthopedics, neurovascular and general surgery. Biomedical textile engineering blends together advanced biomaterials, textile forming technologies and unique fabric geometries o create flexible, minimally invasive device designs.
Date: August 2, 2012
Time: available now on-demand
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How to Prepare for, and Manage, an FDA Inspection or Notified Body Audit
In this one-hour specialty webinar, Emergo Group and UBM will cover major components of both FDA QSR quality system inspections and Notified Body quality system audits. Issues addressed in the webinar will include key differences between inspection and audit processes; setting up mock inspections and audits to prepare your firm for the real thing; and common mistakes to avoid when dealing with FDA inspectors or Notified Body auditors. In addition, the webinar will cover:
- Dealing with nonconformities
- Inspection and audit timelines
- Logistics involved
- Proper selection of Notified Bodies
Date: August 7, 2012
Time: 2:00 p.m. ET
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Alternatives to Animal Biocompatibility Testing: Possible Changes to ISO 10993
Recently the medical device biocompatibility standards committee (ISO 10993) met to review and discuss proposed changes for hemocompatibility and genotoxicity testing. This webinar will discuss these proposed changes along with chemical characterization, evaluation of leachables, and the effect on the body. These currently require costly and time consuming animal testing; however current testing procedures are being evaluated and in vitro methods are being considered. The presentation will also focus on proposed changes in the ISO 10993 standard and help users be aware and prepare for these changes. Along with the changes, we will discuss the latest points from the ISO committee members on ISO 10993-3 and ISO 10993-4, including:
- An overview of the testing in ISO 10993-4: Selection of tests for interactions with blood and ISO 10993-3: - Inspection and audit timelines
- Tests for genotoxicity, carcinogenicity and reproductive toxicity, specifically the hemocompatibility and when to perform the direct and indirect methods.
- The complement activation test and why the FDA has been requiring this test and future considerations.
Date: August 15, 2012
Time: 2:00 p.m. ET
Sponsored by:
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Playing it Safe: How to Mitigate Risk and Improve Medical Device Quality
- Webcast overview
- US medical device approvals and innovation stagnating
- Medical device adverse event reports are skyrocketing – are we less safe?
- How can we improve medical device safety?
- Spotting specific safety issues earlier
- Greatest needs for improved safety across the medical device industry
- Identifying safety risk within a portfolio
- Addressing specific safety risks and driving innovation
- Summary
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Profitable Paths to Overcome the Conflict between Innovation, Regulatory Shifts and Quality
Most medical device companies are growing, but only a quarter are achieving financial significant business performance improvements at the same time. A new research study by UBM Canon MD&DI and its research partner Cambashi Inc. reveals that “Advancers” who are achieving rapid growth and improving key financial metrics actually have more product variants and are less focused on traditional cost management than others. The Advancers focus more on improving cost of quality -- not just quality-- and managed to improve an array of operational metrics to do so. This webinar session will reveal research results for the first time from the new report.
Sponsored by:
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Particulates: Their Role in the Medical Industry
Particulates that may be present on intravenous medical devices such as guidewires, catheters, and stent delivery systems pose potential health risks to patients. This webinar is aimed toward companies that develop such products or manufacture other cardiovascular medical devices or devices that are likely to come in contact with a patient’s bloodstream. The FDA has frequently requested these devices be tested for particulate matter. General testing methods and validation techniques will be discussed as well as sources of particulate matter, particulate matter monitoring and effectively establishing limits for your device. Available standards and guidance documents such as USP <788>, EN45502/ISO14708 and AAMI TIR 42:2010, will also be a topic in the presentation. Lastly, methods for particulate matter analysis (light obscuration and microscopic) will be discussed along with the advantages and disadvantages of each
available now on-demand
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Mom and Pop Job Shop vs. Next-Gen Production Partner: Which are You Currently Working With?
Have you struggled with juggling multiple suppliers, archaic cost-reducing engineering recommendations, and drawn-out production times? Yeah, we hear that a lot. But you don’t have to. Due to the vast array of advanced processes currently available to clients from CO2 Lasers, EDM and CNC machining, to class 10K clean room assembly, tool and die, and metal forming, now, more than ever, Peridot is witnessing first hand clients work to simplify supply chains, eliminate headaches, and reduce costs through innovative design consultation and end-to-end component manufacturing. Luckily, these are tenets Peridot was founded on over 16 years ago, so we’re well versed in the “new” way of doing things. Join us to witness first hand the vast differences between a mom and pop shop and a modern day, next-gen production partner.
available now on-demand
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Innovative Tubing Solutions to Reduce Costs for Single-use Disposable Instruments
You need medical tubing. There's no getting around it. But is there a difference between the tubing from different manufacturers? And have there been any innovations recently in tubing? The answer to both questions is a resounding "Yes!"
Attend this webinar to hear from the experts, and you'll learn:
- how innovative solutions from in-house product development teams can reduce lead times for single-use disposable instruments;
- about the various capabilities available to cut, form, sharpen, weld, and laser mark products;
- how simultaneously combining processes can reduce overall product costs;
- about the many choices/tradeoffs in raw materials, including conventional tubing and new technologies.
Date: April 11, 2012
Time: 2 PM ET/11 AM PT
Sponsored by:
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Stand-Alone Medical Software: Understanding Compliance
At the end of January 2012, the European Commission published MEDDEV 2.1/6. This document is designed to provide a frame of reference for stand-alone software under the three medical device directives, which is important for compliance purposes. Many companies coming from a software background are new to medical device regulations and lack the tools for compliance. Since software that assists a medical device in its function also is regulated as a medical device, an understanding of medical device regulation is critical for vendors of software used in clinical settings. In this webcast, Erik Vollebregt, a Dutch lawyer specialised in EU legal matters related to medical devices, will discuss in detail the regulatory issues surrounding stand-alone software and explain how MEDDEV 2.1/6 helps manufacturers achieve compliance and where it may fall short. Attendees will come away from the one-hour session with a clear understanding of compliance as it relates to stand-alone software from a legal perspective.
Erik Vollebregt is a founding partner of Amsterdam-based Axon Lawyers, a boutique law firm that focuses entirely on the life sciences industry. He is specialised in legal, regulatory and IP issues involving the life sciences with a focus in biotechnology and medical devices. He also maintains the medicaldeviceslegal.com blog.
The one-hour webcast will include a question and answer session and will be moderated by Norbert Sparrow, Editor in Chief, EMDT and medtechinsider.
Webcast Details:
This pay-per-view webcast will take place on Tuesday, April 24 at 14:00 London/15:00 Paris.
Attendance is €99 per person.
*Please note: Credit card charges will appear in US dollars.
Group rates are also available.
Contact Sue Johnson for information: sue.johnson@ubm.com, +1 (310) 740-9013.
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Innovative Conformal Coating Technologies for Advanced Medical Devices
Coatings have been utilized in the medical device industry to modify surfaces for over 30 years. Reasons for such coatings include enhancement of electrical and frictional properties, provision of chemical and moisture barrier properties, improvement of the hygienic properties of the surface, and sometimes simple enhancement of the cosmetic perception of a product. Coatings may also be used to facilitate the application of other coatings (a primer or tielayer role) and to control the extraction or release rates of compounds from within or on substrate materials.
The webinar will review the variants of Parylene, their unique and highly useful attributes, their application processes and examples of how Parylenes have solved device performance and materials challenges.
Parylenes ...
- have solved patient allergenic reactions to device materials;
- have allowed drug/polymer combinations to be applied to metal stents that were otherwise incompatible;
- have prevented galvanic interaction between dissimilar metals in cerebral vascular coiling procedures;
- have permitted the use of less expensive but non-biocompatible metals in surgical instruments;
- have enabled smaller device dimensions and tighter components packaging due to ultra-thin coatings.
Parylenes are solvent, catalyst and plasticizer-free organic coatings that have an impressive array of attributes. These attributes include:
- excellent chemical inertness and resistance
- superior chemical, fluid, gas, moisture and electrical barrier properties
- coefficients of friction equal to or better than some PTFEs
- temperature performance to 450°C.
Parylenes are biostable and biocompatible, having passed an array of ISO 10993 and USP Class VI biological evaluations, documentation of which can be found in FDA Drug and Device Master Files.
Date: May 3, 2012
Time: 9:00 a.m. ET/14:00 London/15:00 Paris
Duration: 60 minutes
Sponsored by:
Hosted by:
Archived and On-Demand Webcasts
The following webcasts are available on demand. Follow the links to access archived content.
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
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).
Originally Broadcast: March 8, 2012
Duration: 60 minutes
Sponsored by:
Hosted by:
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.
Available On Demand
Duration: 20 minutes
Sponsored by:
Hosted by:
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.
Originally Broadcast: January 31, 2012
Sponsored by:
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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.
Originally Broadcast: February 22, 2012
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:
Cleaning Validations of Reusable Medical Devices
This 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.
Available on demand
Sponsored by:
Hosted by:
PLM and the Patient
Developing Breakthrough Technologies in the Medical Device Industry
PLM: One Single Source of Truth to Make Safe, Compliant and Effective Products
Uncertainty 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
Originally Broadcast: December 13, 2011
Duration: 60 minutes
Sponsored by:
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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 secure
- Prevent users from making unauthorized changes to your device
- Make your devices more easy for hospitals and healthcare providers to monitor, manage and maintain compliance with various state and federal regulations
- Help ensure your devices avoid malware infections that can create unforeseen support calls, warranty returns, and technicians going onsite to make repairs
Originally Broadcast: December 13, 2011
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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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.
Available on demand
Sponsored by:
Hosted by:
Don't get bogged down making the transition to IEC 60601-1 3rd edition
Medical device manufacturers will find substantial changes to the 3rd Edition of IEC 60601-1. Most notable is the requirement of additional risk analysis. The added responsibility of risk mitigation on the manufacturer has implications for getting new products to market, and can be overwhelming to medical device designers and original equipment manufacturers (OEMs). Failure to implement this new requirement can result in delaying your product to market and in lost revenue. It's crucial to understand the changes in the Standard and how those changes affect you as a medical device manufacturer.
This webinar will examine the changes to IEC 60601-1 3rd Edition and the reason for the changes. Manufacturers and designers will learn about the impact to your business, as well as the actions, steps and deadlines to ensure a smooth transition to the 3rd Edition.
Originally Broadcast: November 10, 2011
Duration: 60 minutes
Sponsored by:
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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:
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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.
Available now for on-demand viewing
Sponsored by:
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The Opportunities and Challenges of Risk Management Compliance in Medical Device Engineering
When executed well, risk management provides opportunities for product innovation, as well as reducing costs of defects and rework. However, when executed inefficiently Risk Management compliance can bog down development and result in increased regulatory scrutiny. Our panelists will present strategies for leveraging risk management efficiently and effectively to create opportunities to reduce costs and improve quality while also demonstrating compliance. The presentations will then be followed by a panel discussion on challenges medical device manufacturers commonly face when complying to ISO 14971.
Originally Broadcast: September 20, 2011
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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?
Originally Broadcast: September 13, 2011
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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
Time: 2 PM ET
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Packaging Test Methods for Validation of Sterile Barrier Materials
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outline in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission (ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
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Outsourcing Thermoplastics Extrusion? Lessons That Could Save You Thousands
Did you ever think you could save thousands of dollars by adjusting your tolerance by a half-thousandth of an inch (0.0005")? Did you realize you could do it without sacrificing any aspect of your product's performance? We'll tell you how one medical innovator did it through close collaboration with a contract manufacturer. You'll also learn the tricks to reducing time, frustration and failures so every medical device you design performs as you intend—from the design phase to full-scale manufacturing to the final point of care. You won't want to miss these lessons, as presented through dozens of recent case studies and real-life stories collected over decades. Join us for this revealing webinar on June 22 2011, at 12:00 PM ET. Register now, it's FREE.
Originally Broadcast: June 22, 2011
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Managing Life Cycle Requirements for Developing and Maintaining Medical Device
Complying with the IEC 62304 standard to produce safe and effective medical devices requires that software design and development follows defined and controlled processes. This demands hardware and software teams to establish a common set of systems requirements, develop software with proper verifications, risk management, and maintain traceability. This is the third in the series on IEC62304 webinars that will take a deeper dive into managing requirements, modeling, testing, verification, and maintaining traceability throughout the product life cycle. It will demonstrate the power of team collaboration, and efficiency of re-usability to produce high quality reliable products, with lower costs and faster cycle times, that are safe, effective and compliant with regulations. Register now, it's FREE.
Originally Broadcast: June 23, 2011
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MEMS Inertial Sensors in Healthcare
MEMS inertial sensors are proving to be extremely versatile with usage only limited by the imagination of designers. Learn how this innovative technology is shaping next generation healthcare device designs. See why it is a viable alternative to optical or mechanical sensors that often have limitations on performance, size, power or cost. Understand how this innovative technology is being used for precise positioning in imaging systems, highly accurate guidance in surgical instruments, and accurate motion sensing in patient monitoring devices.
You will learn the basics on MEMS motion sensing including:
- Architectures and technology including accelerometers, gyroscopes, and inertial measurement units (IMUs)
- Device specifications and understanding the critical parameters necessary depending on the specific application requirements
Applications explored include precise positioning/tracking of healthcare scanning equipment, surgical tool guidance, balance and control of prosthetics, and motion sensing in eldercare activity monitors and wellness devices. View now, it's FREE.
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Reduce FDA Validation Costs with Mobile Applications
For medical device manufacturers today, managing the traceability of products to ensure proper documentation is critical to complying with current FDA regulations. The questions that businesses like yours are often asking include: how will I ensure my systems are validated to comply with FDA regulation and how can I reduce this cost of compliance?
Join us for this webcast and hear from Andrew Dancan, Director of ERP at Cardiovascular Systems, Inc on how they use mobile applications to comply with FDA regulations and reduce compliance costs. They are using mobile technology specifically to:
- Report on and control products on the plant floor
- Streamline the steps of production to reduce the cost of validation of systems
- Increase the amount of automation in business processes to further reduce costs
- Enable the use of visual cues and pull type systems in production to improve business processes
Register for this webcast now and learn how your company too can reduce FDA validation costs and improve compliance processes with mobile applications.
Originally Broadcast: May 25, 2011
Duration: 60 minutes
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Mitigation Strategies for ECG Design Challenges
Join us in this FREE webinar and learn more about:
- Patient and operator safety relating to isolation from AC mains and sourced or sinked current relating to the patient electrode attachment.
- Common mode rejection of the isolated AFE of the subsystem, relative to its isolated ground and earth ground.
- INA differential and common mode input voltage range requirements and how to address input overloads.
- Input protection from environmental and human made transients.
- Input noise floor requirements and limits on "structured noise" as measured in uV peak to peak over a bandwidth of 0.05 to 150 Hz for a period of 20 seconds or longer.
- Radiated emissions and incoming EMI based on the clinical environment and IEC, ISO, AAMI standards and guidance documents.
Various hardware and software/DSP techniques that address these issues will be discussed.
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Fundamentals of ADC Technologies for Healthcare Designs
Choosing the best ADC for an application can be a confusing task, as architectures and technology rapidly develop, and the old rules no longer apply in many cases. This session will explain the main ADC architectures in use today, and their advantages and disadvantages for different medical and healthcare applications such as ECG, diagnostics and ultrasound. It will present the latest developments in:
- Successive approximation
- Sigma delta
- Pipelined architectures
Design guidance on clocking, grounding, shielding and other techniques to get the best performance from the device will be presented. Analog reference load characteristics and how to drive these for optimal results will also be discussed.
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The Big Three: Cytotoxicity, Sensitization & Irritation
There's myriad tests medical device manufacturers need to be prepared to conduct on their creations in order to pass regulation requirements before they are released to the marketplace. None more important than the Cytotoxicity, Sensitization, and Irritation tests—the Big Three as we call them.
They are the Big Three because they must be conducted on every device before they can be submitted to the Federal Drug Administration (FDA). There is no way you can get around doing the three tests. Other tests may or may not need to be conducted.
By attending this webinar you will learn and be better prepared for:
- The importance of each test and why they have to be done. It helps to know what each test is looking for and the acceptance standard for each.
- An idea of the potential dangers in each test and what impact your device may have on the test.
- What the reaction to the patient may be based on the results of a failed test. Is it something you can justify? Do you need to reevaluate the materials and processes you are using to get it to pass? Can a risk assessment on the toxicity of the device be made or does the toxicity need to be eliminated?
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Telehealth Aggregation Managers
Telehealth Aggregation Managers: Choosing the right semiconductor solutions and wireless technologies for your personal connected health system. With aging populations, the increasing incidence of chronic diseases and the need to control health care costs, connected health technologies are becoming increasingly important for remote patient monitoring as well as personal health and fitness management. The Telehealth Aggregation Manager (AM) is an essential device in the connected health system enabling personal health devices to log data in a remote Electronic Health Record (EHR) for family and clinical review. It also allows real-time interaction between patients and doctors, families and friends. Choosing the right semiconductor solutions and wireless technologies simplifies design, addresses interoperability concerns and enriches the user experience. This webinar will address how advances in semiconductor technology including embedded processing, power management and wireless connectivity can help you accelerate your telehealth aggregation manager system design and which tools are available to facilitate your design process.
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Optimizing Ultrasound Systems using Integrated Receivers
- TGC noise analysis techniques will be presented to aid designers in determining receiver noise contributions in near and far field B mode imagining.
- The key IC performance specifications that determine PW Doppler mode sensitivity will be discussed.
- Analysis of the CW Doppler signal path critical noise sources and suggested filtering techniques will be presented.
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How to Choose the Right Semiconductor Solution for your Flexible, Low-power Ultrasound System Design
Ultrasound system designers are looking to increase image quality and add advanced features in ultrasound systems while reducing board space and power consumption. Ultrasound systems can range from handheld, portable systems to cart-based, high-end systems with different system requirements and trade-offs. This webinar will address how analog, digital, mixed-signal and power management semiconductor solutions can help you achieve your ultrasound system design goals and which tools are available to facilitate and speed the design process.
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Portable Power for Medical Devices
As the medical world becomes ever more portable and field-responsive, the need for smaller, lighter, and untethered devices is becoming more important. Many manufacturers of portable medical devices have upgraded their medical devices to operate on Lithium ion (Li-ion) battery technology, while others still use older battery technologies such as Nickel-cadmium (Ni-Cd), Nickel Metal Hydride (NiMH) and/or Sealed Lead Acid (SLA) in their products. This webcast outlines the options available to medical device manufacturers in Li-ion battery technologies. This webcast will educate electrical and mechanical engineers of portable medical equipment about the different design advantages and use constraints of Li-ion batteries, while examining the chemistry tradeoffs between various battery choices. Registrants will gain insight on how to implement a battery solution that will enable differentiation in this increasingly competitive market.
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Breakthrough Devices for the Diagnosis and Treatment of Skin Cancer
This webcast will focus on two cutting-edge technologies related to medical devices in skin cancer research. Melanoma is the leading cause of skin cancer in the United States with 68,000+ new cases annually and 8,700+ deaths. The average patient can have a high rate of survival if the skin cancer is diagnosed and treated early enough. This webcast will discuss how several leading universities in the United States (Georgia Tech, Johns Hopkins University, and Georgia Health Sciences University) are addressing the deadly potential of melanoma by helping to diagnose and treat the disease in its earliest stages of development. The researchers at these universities have dedicated their time and efforts to developing new medical devices that could potentially save the lives of countless people in the near future. Both of these technologies are available for license and further development at the respective universities' technology transfer office.
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Ethylene Oxide Sterilization
This webcast is designed to acquaint those in the medical device community with the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process. The properties and hazards associated with ethylene oxide and the process required to successfully validate a medical device will also be discussed. The validation methods used are outlined in ANSI/AAMI/ISO 11135-1:2007. Some of the related testing includes comparative resistance, bioburden resistance, bioburden enumeration, sterility testing, sterilant gas residues, and temperature/humidity distribution studies. In addition, the batch release method will be outlined. This process allows the manufacturer to sterilize a single lot of product for use in clinical trials or animal studies where large numbers of samples are not available. This provides a rapid and cost effective way to provide sterile product without undergoing the full validation process.
Available on demand
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