Webinars

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

Speakers:
Bob Mehta - Principal Consultant, GMP ISO Expert Services
Sean Fenske - Editor-in-Chief, MPO/ODT

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

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 

Speaker:

Scott Anderson, PE

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

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

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

NOW AVAILABLE ON-DEMAND

The requirements for assessing irritation is now moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing. As we move further to reduce animal testing and incorporate the 3 R’s (replace, reduce, refine) into biocompatibility assessment for medical devices, this is a critical turning point. Join us for an intense and informative discussion on this standard and learn what steps to take to incorporate this testing into your biocompatibility program.

• Review of the in vitro testing method
• When to pursue in vitro or in vivo testing
• How to transition from in vivo to in vitro testing
• Current regulatory acceptance

Speakers:
Audrey Turley, Senior Biocompatibility Expert, Nelson Labs
Dr. Ir. Sophie Michel, Biocompatibility Expert, Nelson Labs

NOW AVAILABLE ON-DEMAND

Presenter: Anthony S. Freeman, President, A.S. Freeman Advisors LLC
 
February 23 - 2:00 PM ET
Session 1—The OEM Landscape and Business Drivers

• Objectives of the Presentation and Sources of Information
• How Big Is the Market? What’s the Growth Rate?
• Where is the Growth (or Decline) Coming From?
• The Impact of Covid
• Evolving Business Models—Growth of Service/Product Pairings
• New Settings For Medicine – Devices outside the Hospital/Doctors Office
• Rise of Non-Medical Companies in Medical Devices
• Four Most Significant Product Trends

February 24 - 2:00 PM ET
Session 2—A Consolidating Supply Chain? A Tiering Supply Chain? Both?

• How Big Is the Supply Chain? What’s the Growth Rate?
• The Rise of the Mega Contract Manufacturer
• The Evolving Role of the Traditional and Smaller Suppliers
• New Opportunities for All Suppliers
• Warning Signs in the Supply Chain—Will You Be Shifted Away from the OEM?
• LCC Strategies vs. Automation in Developed Countries
• Other Than Price, What Will Matter to OEMs?

February 25 - 2:00 PM ET
Session 3—Panel Discussion of Medtech’s Global Trends
 
The final portion of this three-part series will feature a panel of industry representatives discussing topics and points made during the first two sessions. Moderated by Tony Freeman, this candid conversation will look at factors impacting OEMs as well as the supply chain. The audience will be encouraged to pose questions to the panel as they look ahead to what to expect in 2021 and beyond. 

Moderator:
Anthony S. Freeman, President, A.S. Freeman Advisors LLC

Panelists: 
J. Mark King, Operating Partner, Vance Street
Paul Orlando, Vice President of External Operations, OLYMPUS SURGICAL TECHNOLOGIES AMERICA
Randal Ours, Director of Medical Device Procurement, Bayer
William Pratt, VP Operations and Director of Creative Design, Kinamed Inc.

NOW AVAILABLE ON-DEMAND

EUDAMED just kicked off! Ready? Set? Or Need to get started?
The EU Commission Decision for EUDAMED, the European Databank for Medical Devices (to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on invitro diagnostic devices is now live and effective from Dec 1st 2020.

The IT system consist of a total six modules, among which the first one is the Actor registration module. The European Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional. Meanwhile as an Economic Operator or a non-EU manufacturer, the EUDAMED database is to ensure the increase in transparency for medical devices and to improve coordination between member states.

Through this webinar, participants will be able to focus exclusively on “Actor Registration Module” which is key to accessing and using EUDAMED. Participants will learn how to proceed with actor and user registration and management, data to be stored, and the general validation process to receive an SRN.s.

Key Take-Aways:

1. Who are the ACTOR’s and what are their roles in EUDAMED.
2. What is meant by SRN and how to decode the SRN
3. Understand the Actor registration process
4. Different Modules of EUDAMED
5. Countries available in EUDAMED from December 2020
6. Person Responsible for Regulatory Compliance (PRRC) and their responsibilities in EUDAMED

Speaker:
Sundeep Agarwal - General Manager, Compliance & Regulatory Affairs, Datt Mediproducts