Webinars

Big Changes to ISO 10993-1, what is happening to the main biocompatibility standard now?

In 2018, TC194, the ISO committee for biocompatibility, released a new version of 10993-1. This new version focused more on a risk-based approach and made significant changes. We are now making more significant changes to the main biocompatibility standard. In this talk we will go over the areas of the standard that is being changed, the reasoning behind the change, and the initial acceptance of these changes around the globe.

Smart Manufacturing for Quality and Compliance

One aspect of quality involves a product’s design. If developed correctly, does the product have the form, fit, and function to achieve the desired outcome? Quality, however, does not stop at the design stage. Quality is a practice that accompanies and verifies throughout the entire production process.

One of the key principles of Smart Manufacturing is to build quality checks and balances into the manufacturing process from the first disposition of raw materials to the final shipment of product.

Why Smart Manufacturing? Because quality achieved with cost efficiency is a double win for manufacturing operations. Best practice automated business controls can ensure proper manufacturing processes without additional cost. Real-time quality control—automatically verifying quality at multiple steps in the production sequence—can virtually eliminate bad products from reaching the customer. At the same, it creates a digital thread necessary for documenting compliance and traceability.

This webinar illustrates a ten-step, inline, real-time quality control process that you can use as a model to formulate your own quality procedure using Smart Manufacturing principles.

Global Trends in Medtech: OEMs and the Supply Chain

Session 1: The OEM Landscape—Fundamental Change on the Horizon

Tuesday, March 01, 2022
02:00 PM Eastern Standard Time

• The OEM Landscape and Business Drivers
• How Big Is the Market? What’s the Growth Rate?
• The Impact of COVID and Lessons Learned
• A Slowly but Clearly Changing Business Model for OEMs
• Are Limits on Medical Spending Starting to Appear?
• Four Most Significant Product Trends

• Changing OEM Strategy Triggering a New Supply Chain Structure
• How Big Is the Supply Chain? What’s the Growth Rate?
• Myths Believed by Traditional Supply Chain Companies
• COVID, Automation, and LCCs
• Will Manufacturers of Non-Digital Products Survive?
• Which Supply Chain Companies Are Best Positioned to Prosper?

Speed of Digital Health - Opportunities and Challenges in Software as a Medical Device (SaMD)

Digital health has the potential to make the delivery of healthcare more accessible, convenient and cost-effective. Software as a Medical Device (SaMD), a type of digital health software technology, has the potential to offer tremendous benefits to the healthcare system such as assisting in diagnosis, screening, monitoring and prediction of a disease enabling a professional to take preventive measures at the right time. It also presents new challenges and unfamiliar territory in regulating software that can have frequent updates.

Software, when used as a medical device has several challenges, including cybersecurity, clinical evaluation, scientific validity and clinical validation. International Medical Device Regulators Forum (IMDRF) has produced multiple documents to provide guidance on the regulation of SaMD. However, the regulation of a constantly changing algorithm presents a novel challenge for FDA’s current regulatory scheme, which was built for “static” technology that does not evolve or change its fundamental operation and/or function until it is redesigned by the manufacturer. The FDA is currently piloting a Software Pre-Certification Program to help the development of a future regulatory model for digital health technology such as SaMD.

Join us on February 16th from 2:00 – 3:00 PM EST to learn from our expert speaker, Bob Mehta, on:

• History of Software as Medical Device (SaMD)
• Recent developments and opportunities for SaMD
• FDA’s Artificial Intelligence / Machine-based learning based SaMD Action Plan
• FDA’s Digital Health Center of Excellence and pilot Software Pre-Certification Program
• Concerns, recommendations, and Next Steps

Becoming an OEM's Most Trusted Supplier

Future Proofing Growth and Customer Satisfaction at Burlington Medical

An Introduction to Medical Device Regulation: Pathways, Strategies, and Challenges

Understanding Wireless Device Coexistence in Medical Environments

As wireless technology continues to advance, the number of consumer and industrial radio products is increasing exponentially. Wireless coexistence testing measures how multiple electronics interact in a single environment, helping manufacturers create effective products in increasingly crowded bandwidth. This testing is vitally important for safety-critical wireless medical devices to ensure their safe operation. The FDA has issued updated guidance on radio interference in medical devices, which makes this exploration of wireless coexisting testing timely and relevant for medical device manufacturers. Element is one of the top providers of wireless coexistence testing, and our experts can help ensure your wireless compliance and product testing strategy is robust. 

In this hour-long webinar, Element expert David Schaefer will explain how wireless coexistence testing helps to mitigate the risk of interference and provide safe products for patients worldwide. The webinar will explore: 

• Trends in wireless technology
• A deep dive into medical wireless technology 
• How wireless coexistence testing works
• Satisfying ANSI C63.27:2017 requirements
• How to mitigate poor radio performance
• The future of coexistence

Testing Stents and Other Cardiovascular Devices

Cardiovascular device testing is a critical component of the design validation process. As stent and heart valve designs have evolved, understanding how to characterize the materials, evaluate worst case loading, and define the mechanical product testing parameters can be difficult. This webinar outlines the history and various kinds of cardiovascular devices, discusses the standards and provides an overview of relevant testing methods.

In this webinar, you will learn about

• Vascular applications
• Design characterization
• Overview of testing standards 

Scott Anderson, PE

DFM and Scientific Molding: Reduce Medical Tooling Costs and Validation Times

Looking to reduce lead time and costs in medical tooling? The medical manufacturing experts from Canon Virginia, Inc. walks you through the challenges and opportunities around accelerating time to market for molded medical parts - without reducing quality. Discover how finding the right partner for your medical contract manufacturing needs can help optimize the entire production process and unlock new capabilities.

 

Key Topics

·       Design for manufacturing (DFM)

·       Instrumentation and scientific injection molding

·       Part validation

·       Medical contract manufacturing

Speakers:

Wayne Daniel

Symposium - An MPO Summit Webcast Series

SESSIONS NOW AVAILABLE ON-DEMAND

June 15 - 2:00 PM ET
Session 1—The Evolving World of Product Development

Panelists will discuss the transforming world of outsourced product design and development within the medtech world. As more medical device OEMs seek aid in their product development ventures, they rely on proven partners to work with them early in the process to iterate quickly to eliminate bad designs or unrealistic ideas. Considerations such as Design for Manufacturability, Human Factors, and aesthetics will be discussed as well.

Speakers:
Tor Alden - HS Design Inc.
Darrin Manke - Farm-a Flex company
Philip Remedios - BlackHägen Design
Bryce G. Rutter Ph.D. - Metaphase Design Group Inc.

June 17 - 2:00 PM ET
Session 2—Material Innovations for Tomorrow's Medical Devices

Medical device manufacturers and their engineers may be familiar (or comfortable) with only a handful of materials, but there are many more to consider that could meet their needs on a specific project better than those they’ve selected. Suppliers who are exposed to many more material options have a much better handle on available alternatives. This panel of experts will share their insights and recommendations when it comes to newer materials that have emerged for medical devices, as well as some lesser known options that could be ideal for an upcoming product.

Speakers
G. Lawrence Thatcher - TESco Associates Inc.
Michael Goglia - Elkem Silicones

June 22 - 2:00 PM ET
Session 3—Component Fabrication at a Miniature Scale
 
Component fabrication is a fairly well-understood practice, regardless of the process used. Of course, there are exceptions, however. Included on this list would be micromolding. The art and science that goes into making miniaturized molded parts is a capability of only select few suppliers. Learn from representatives at several of these firms as they discuss the challenges involved and the factors to consider. Material selection, tolerances, things to avoid, and other considerations will be discussed.

Speakers
Gary Hulecki - MTD Micro Molding
Donna M. Bibber - Isometric Micro Molding Inc.
Scott Herbert - Rapidwerks
Aaron Johnson - Accumold

June 24 - 2:00 PM ET
Session 4—The Challenges and Opportunities of Digital Devices
 
The proliferation of electronic medical devices has been occurring for some time, but new capabilities and functionality make them even more useful than ever before. Internet of Things makes these devices “smarter” and ultimately, better for doctors and patients alike. Unfortunately, this connectivity also makes them more prone to vulnerabilities and potential problems. This session will discuss both the positives and negative aspects of these devices.

Speakers
Alan Grau - Embedded Solutions, Sectigo
Bill Welch - Phillips-Medisize, a Molex company
Marco De Angeli - Flex

Why Bad Products Still Ship and Good People Have to Clean Up the Mess

NOW AVAILABLE ON-DEMAND

Recalls, Market Withdrawals, Field Corrections, Safety Alerts 

 If there’s one thing common across manufacturing industries that companies can agree on, they hate recalls.

 There are so many internal quality, external market and unexpected supplier factors that can lead to the very difficult decision to pull back product from the market, or worse yet be told by the FDA to do so.  A product recall is potentially the most risk-laden situation a company can face and this risk is increasing, as supply chains grow more complex and the regulatory landscape becomes more robust.  Whether your business is Food & Beverage, Pharma, Medical  Device or Biopharm your company is vulnerable to these unfortunate events. In the least of cases, faulty products or contaminated foods are an inconvenience for the unlucky buyers. At worst, recalled products are linked to injuries, illnesses and even deaths. For manufacturers, recalls batter brand reputations, bottom lines and share prices.

Yet businesses can often underestimate the impact of a recall, the negative effect it can have, and the great amount of money and resources needed to manage it. It’s backbreakingly hard work. So how do you avoid such a costly and disruptive situation within your own company? Knowledge is power and in this webinar, we will take a closer look at the latest FDA guidance and trends regarding these sometimes avoidable situations and review some of the best practices to help manage them.

• Background on the latest FDA position and expectations for Recalls, Market Withdrawals and Safety Alerts
• Latest product correction trends and where most issues are occurring
• Future product recall complexity with the development of new technology (cyber risk, nanotechnology, 3D printing, etc.)
• Steps to ensure your procedures and processes contain the critical “gates” to help mitigate issues prior to distribution
• How best to manage these market activities, should they be required
• Why the post-recall management strategy is so critical for quick recovery

Speaker:
Tim Fischer, Principal Partner, Great Solutions, LLC