Webinars

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A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly tested – and impure materials are used - there is an elevated risk of contamination that can produce false results. The already lengthy FDA approval process for medical device manufacturers can be extended dramatically without certified pure materials, which will, in turn, increase the cost of commercialization. When considering porous materials for functional applications including filtration, venting, wicking, applying, and absorbing, these manufacturers should consider those already third party tested to stringent analytical, clinical, and life science procedures.

In this webinar designed for medical device engineers and researchers, the team at Porex will provide a comprehensive overview of Certified Pure Porex® program, a technical performance and medical certification program that provides purity assurance of its porous polymeric materials. Based on extensive experience with many life science applications, they have tiered this program to align with the various FDA requirement classes so that, based on the medical device’s intended application, the proper porous media is selected and tested to an appropriate scale. The third-party testing looks at leachables and extractables, as well as viral and bacterial filtration efficiency. This application-specific purity certification can accelerate your FDA validation timeline and enable a faster device market launch.

When you attend this webinar, you will learn about the:

• Science & importance of material purity in the FDA validation process
• Applications associated with each tier
• Testing procedures associated with each tier

Sponsored by:

This webinar is sponsored by Porex Corporation, a business of Filtration Group.  Porex is a global leader in developing and manufacturing custom-engineered porous polymer solutions that turn into high-value functional components in our customers’ end products.  By combining our material science expertise in absorption, diffusion, filtration, wicking and venting with our global manufacturing capability, we help our customers overcome their complex product development challenges and turn their product ideas into reality.  As a partner for 17 out of 20 of the world’s leading medical device companies and brands, Porex designs custom-engineered components specifically for the end device. Whether the medical device involves inhalation, injection, diffusion, or topical application, porous polymer technologies can be used for particulate filtration, flow metering, sterility, and even sound diffusion. Porex engineers leverage decades of experience with many types of devices to innovate with our customers to develop the perfect component for their unique products.
 

Presented by:

SPEAKERS:

Nadia Hajjar
Category Manager - Life Sciences
Porex

Sam Brusco
Associate Editor
MPO / ODT

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Millar is the pressure sensor technology expert when you need innovative, integrated solutions to take your medical devices from concept to commercialization fast, efficiently, and cost-effectively. 

Today, more value is being placed on enhancement of medical devices through miniaturization and added capabilities such as pressure sensing components. Proper integration of a MEMS pressure sensor in a medical device requires in-depth knowledge of sensor types, capabilities, validation, and manufacturing requirements. The nuances of these processes to ensure quality and expected performance of the sensor requires in-depth knowledge from years of trial and error.
 

Join us on Wednesday, September 21, 2022, at 2pm EST as the Millar OEM team discusses The Benefits of Working With a Pressure Sensor Integrator. Some topics that will be explored in this webinar include:

• The various pressure measurement applications that Millar supports, including heart assist devices, heart failure, airways, urology, neuro, compartment pressure and more. 
• Why choosing the right sensor matters and the benefits of selecting a MEMS sensor for your device.
• The numerous user considerations that we have expertise with, such as sensor size, barometric compensation, implantation time and more.
• The benefits of working with Millar, including our 50 years of MEMS packaging & catheter manufacturing expertise, our on-site ISO Class VII cleanroom, our experience around the regulatory submission process, and our proven track record of delivering low drift and highly accurate clinical products.

SPONSORED BY: 

Millar is known as a leader in the innovation of MEMS sensor-enabled devices from mouse to man, enabling medical advancements from heart failure research in mice to providing clinical pressure feedback data through integrated medical devices. Our high-performance MEMS pressure sensors and wireless pressure platforms seamlessly integrate with clinical and life sciences advancements to shape the future of medicine. With over 50 years of design and manufacturing expertise in pressure-sensing products, Millar delivers expert insight to our customers’ innovations enabling better patient outcomes.

PRESENTED BY: 

SPEAKERS: 

Michelle Davis
OEM Engineering Manager
Millar

NOW AVAILABLE ON-DEMAND

This webinar is designed for the diagnostic innovators—the engineers, product teams, R&D professionals, and subject matter experts continually working to diagnose and detect nearer, faster, and at a lower cost within a smaller device footprint.

Devices like lab-on-chip or cartridge-based point-of-care (PoC) systems help to bring the world of diagnostics closer to everyone. Yet, taking lab processes onto a micro-device requires optimizations to meet or exceed lab test accuracy. Subtle interactions of microfluidic cartridge design and materials cause changes in fluid dynamics and create challenges, such as bubbling that can lead to poor optical detection.

In this webinar, we bring in specialized microfluidic engineering development subject matter experts who are helping the industry bring their systems to commercial success. You will learn their observations to applying bioanalytical principles into microfluidic design to address the common and most difficult challenges. We present how porous polymer technologies solve multiple design challenges and bring you one step closer to sensitivity and accuracy for the point-of-care test.

POREX partners with ALine, Inc to present this webinar



SPONSORED BY:




This webinar is sponsored by Porex Corporation, a business of Filtration Group. Porex partners with customers in over 65 countries to deliver design innovations that turn product ideas into reality. Through a collaborative engineering partnership, Porex develops high-value porous polymer solutions to product design challenges in reflectivity, absorption, application, diffusion, filtration, venting, and wicking.

The Porex Virtek® PTFE membrane (Polytetrafluoroethylene) technology uses a patented and proprietary sintering process method to ensure a consistent and repeatable pore structure with no supporting layers needed. These material solutions can be used in medical device, analytical sciences, and in-vitro diagnostics applications to improve performance and consistency via filtering and venting. POREX products form the standard of material excellence to bring your next medical device to life –and create a safer, healthier and more productive world.



PRESENTED BY:

SPEAKERS: 

Dr. Leanna Levine
Founder of ALine, Inc

Dr. Stefano Begolo
Key Technical & Business Leader
ALine, Inc

Kaila Hutchison
Global Product Marketing, PTFE Business Unit
Porex

Sam Brusco
Associate Editor
MPO/ODT

The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices are used by patients instead of trained healthcare providers, user error is common and can impact the patient’s wellbeing. In addition, since the devices are typically placed in open cavities such as the nose or mouth, contamination of the device from viral or bacterial particles found in those cavities can decrease the safety of the device.

In this webinar designed for inhalation device engineers, learn how to use porous polymer technology to create a single custom component that can solve these multiple design challenges and bring your new inhalation device to market. Regardless of system design, porous polymers can be used to direct flow with precision, meter dosing, and filter out viruses and bacteria. With the increasing trend towards delivering drugs to the central nervous system via the nasal cavity, engineers will learn how porous polymers can be used to enable precise and calculated dosing in this specific type of design.

When you attend this webinar, you will:

• Understand the science behind filtration, wicking, and diffusion that can be used to solve common inhalation device challenges
• Learn how the collaborative innovation process works when designing custom porous polymer materials
• See examples of inhalation design challenges that were solved with porous polymers

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.

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.

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

Session 2: OEM Product Trends Will Reshape the Supply Chain—Dethroning Current Kings

Wednesday, March 02, 2022
02:00 PM Eastern Standard Time

• 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?

Session 3: Panel Discussion of Medtech's Global Trends

Thursday, March 03, 2022
02:00 PM Eastern Standard Time

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 as to what they expect in 2022 and beyond.

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