Material Selection and Advanced Assembly for Body-Worn Devices: How Medical Manufacturers Can Improve Their Products to Enhance Patient Care
Medical manufacturers specifying the adhesive components for body-worn devices must factor patient wear time, adhesion strength, and skin condition. This webinar covers the importance of materials selection from experts at 3M, as well as the converting processes, assembly services, and the quality/testing procedures required to ensure body-worn medical devices can be brought to market quickly, cost-effectively, and in full compliance.
Tue, Nov 4, 2014 - 02:00 pm - 03:00 pm
In this webinar Jeff Schipper, Proto Labs LSR Product Manager, will present the ins and outs of liquid silicone rubber molding. He will go over the manufacturing process, materials offered, design considerations, and how LSR can benefit the medical industry. He will also cover Proto Labs suite of services and discuss their Fineline additive manufacturing, Firstcut CNC-machining, and Protomold injection-molding services.
Mon, Oct 27, 2014 - 08:00 am - Fri, Oct 16, 2015 - 08:00 am
Most medical devices require some form of pad printing to mark biohazard labels, measurement indicators, part identification information or required branded logos. But some complex devices pose a challenge to accurately and cleanly print upon. In this webinar we will identify ideal pad printing candidates, and provide an overview of the pad printing process. The webinar will also address common pad printing obstacles, and offer best practices for printing on devices with difficult surfaces, shapes or sizes.
Tue, Oct 14, 2014 - 08:00 am - Wed, Oct 14, 2015 - 08:00 am
Join Stephen Olsen, Product Line Manager for VxWorks and Neil McLellan, Senior Product Manager, Medical Platforms, for Wind River as they cover areas that software developers and manufacturers need to consider when choosing the right system software for medical device applications.
Tue, Oct 7, 2014 - 02:00 pm - 03:00 pm
The final rule has been issued by the FDA – medical devices distributed in the US must carry a Unique Device Identifier, or UDI. How are you supporting this new regulation? And are you prepared for regulations of the future?
Thu, Sep 25, 2014 - 08:00 am - Fri, Sep 25, 2015 - 08:00 am
A bioresorbable coating should enhance the performance of a medical device without adversely interacting with the body’s immune system. The application of Regenerez™, a next-generation bioresorbable elastomer made with poly(glycerol sebacate) (PGS), in a coating formulation has the potential to improve biocompatibility by promoting tissue in-growth, enabling controlled drug release and solving compliance mismatch issues with bodily tissue.
Tue, Sep 23, 2014 - 11:00 am - 12:00 pm
This webinar will discuss chemical characterization and how these test methods can help evaluate the impact of a change to the overall biocompatibility of the device. Medical device manufacturers will walk away with a better understanding of chemical characterization and how to evaluate changes.
Wed, Aug 13, 2014 - 08:00 am
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge and recommendations about how to manage the human factors in processing of reusable medical devices.
Wed, May 21, 2014 - 08:00 am
Optimal Catheter Design: Making the Smart Choices When Selecting Materials and Manufacturing Processes
Today’s sophisticated catheters have become modern marvels of advanced design and polymer technology. This information-filled presentation will help you make the right choices of materials and production processes to achieve cost and performance objectives of a catheter-based project while avoiding the pitfall of over engineering. Topics include cost/benefit trade-offs offered by different manufacturing technologies and the integration of advanced polymers’ characteristics into the design of next-gen catheters.
Thu, Sep 26, 2013 - 02:00 pm - Mon, Sep 26, 2016 - 02:00 pm
Understanding the nature of the microorganisms in manufacturing environments and on or in products is a vital step in medical device and pharmaceutical processing. In this webinar we will discuss the compendial requirements and recommendations regarding:The importance of microbial identification in an environmental monitoring program.How microbial identification is an important tool with gamma sterilized medical device validations in understanding a product bioburden baseline, in defining product families and in determining the frequency of dose audits.How microbial identification can be critical in investigations of environmental excursions, bioburden spikes, sterility failures, Biological indicator (BI) testing and Microbial Limits screening.Information will be included on microbial identification testing at Nelson Labs, from the benefit of sub-culturing organisms to the importance of a Gram stain as part of a polyphasic approach to identification.
Thu, Aug 29, 2013 - 11:00 am
In April of 2013 the FDA released a draft guidance on using ISO 10993 for biocompatibility. This draft is intended to replace the #G95-1 document on the current thinking and application of biocompatibility testing for medical devices. In the webinar we will cover three areas of the new document:1. Summary of ideas that are currently practices by the FDA but this is the first instance that they are put in writing 2. Concepts that can be used for justifying testing plans, and 3. New ideas that are not current thinking with the FDA that could change how you are testing.
Wed, Aug 21, 2013 - 01:00 pm
This topic will cover the relevant standards and test methods for face masks, gowns and drapes testing. The webinar will include a summary of what tests need to be performed, how these tests are performed, sample sizes, and estimated turn-around times. The goal will be to provide a starting point that will allow you to put together a testing plan that is right for you, your product, your budget and your timeline.
Fri, Dec 21, 2012 - 08:00 am
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.
Tue, Nov 20, 2012 - 03:44 pm
Available on Demand
This webinar is specifically directed to cardiovascular medical device manufacturers that will be conducting particulate matter testing on their product. It’s also applicable to anyone that has questions regarding what steps are necessary to develop a testing scheme, what products should be tested for particulate matter and common pitfalls that manufacturers may encounter when submitting data to regulatory for approval.
Thu, Jul 19, 2012 - 08:00 am
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
- Five Key Considerations for Evaluating and Selecting the Most Effective Electronic Quality Management Systems for Medical Device Manufacturers - Webcast
- Prototyping and Low-Volume Production for Medical Applications - Webcast
- Water Quality for Pharmaceutical and Medical Device Processes - Webcast
- Enhancing Medical Device Performance and Reliability with Parylene Conformal Coatings - Webcast
- Best Practices for Medical Device Complaints Handling - Webcast
- Designing Diagnostic Tools for the Developing World - Webcast