Medical Design Briefs - April 2022 - 17

CONFERENCE SCHEDULE - WEDNESDAY APRIL 13 (current as of 3/16/22)
TIME (PDT)
8:30-9:30 AM
8:30-9:30 AM
8:30-9:30 AM
8:30-9:30 AM
8:30-10:15 AM
9:30-10:30 AM
9:30-10:15 AM
9:30-10:15 AM
9:45-10:30 AM
10:30-11:30 AM
10:30-11:00 AM
10:30-11:30 AM
10:30-11:30 AM
10:45-11:45 AM
11:00-11:30 AM
12:00-12:45 PM
1:15-2:00 PM
1:15-2:00 PM
1:15-2:00 PM
1:15-2:45 PM
1:30-2:30 PM
2:00-2:45 PM
2:00-2:45 PM
2:00-2:45 PM
2:30-3:30 PM
3:00-4:00 PM
3:00-4:00 PM
3:00-4:00 PM
3:00-4:00 PM
3:45-4:45 PM
4:00-5:00 PM
4:00-5:00 PM
4:00-5:00 PM
SESSION
KEYNOTE: Innovation Requirements: More than Materials Science and Biomedical
Engineering
Big Changes to ISO 10993-1: What Is Happening to the Main Biocompatibility Standard
Now?
Panel: The Promises of Additive Manufacturing for Production
Translating Regulatory Requirements to Improve Quality Systems: What Engineers Must
Know
Moving from CFR 820 to ANSI/AAMI/ISO 13485:2016
Updates to E&L for Medical Devices: What About Chemistry on Limited Contact Devices?
Pitch Session #1: Wearables
Software Reliability for Product Development Engineers
Sponsored Session: How Standard, Configurable Automation is Changing the Game
(Think Adult Lego)
Panel: Supply Chain Resiliencies - Understanding Risks and Developing Mitigation
Strategies
Training: Capturing and Controlling Intellectual Property
Culture of Quality
Panel: Using (FDA-Endorsed) MDDAP Best Practices to Improve Your Quality
The 3Rs of EO Sterilization: Sustaining the Continued Safe Use of EO
Training: Human Factors - Leveraging What You Need for FDA Approval to Develop
Devices People Want
Hands-On Device Change Evaluations Biocompatibility and DHF
Panel: What Entrepreneurs Need to Know About Investing in the Medical Sector
The Rise of AI in MedTech: Innovation & Regulation of Artificial Intelligence
Evolving Combination Products International Standards
Workshop: Industry 5.0 - People, Process, and Product Working Together
Radiation Strategies for Improved Processing Options and Timing
Pitch Session #2: In Vitro Diagnostics
Debate: Maintaining a Validated State for Connected Medical Devices, SaMD & DTx in
an Era of Chaotic Innovation
Combination Products Essential Performance Requirements
Changes in the Packaging Environment Relating to Regulations & Test Methods
Manufacturing Optimization: Where Are You on the Data Maturity Scale?
Industrial Sterilization of Medical Devices - Overview and Update
Panel: Resources for the Busy Entrepreneur
Combination Products: Human Factors Considerations
What Is Changing in the Realm of Validations Regarding Reusable Devices?
Pitch Session #3: Medical Devices
Building Consensus Solutions to Wicked Problems in Medical Device Packaging
Interactive Panel Discussion: Ask the Experts
SESSION SPOTLIGHT
Panel: The Promises of Additive
Manufacturing for Production
The promise of creating production parts
using additive manufacturing (AM) has
moved from a limited, niche application to
become practical across multiple industries.
Medical Design Briefs, April 2022
Cov
From dental to rocket engines to medical,
the number of applications and the volume of
production has steadily increased. A panel of
industry experts will cover how various AM
technologies and materials have enabled
this growth, current applications, and challenges
we are still facing.
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ToC
SESSION SPOTLIGHT
The 3Rs of EO Sterilization: Sustaining the
Continued Safe Use of EO
Ethylene oxide (EO) sterilization technology
plays a vital role in enabling critical
medical products and devices to safely
reach patients worldwide. For many medical
devices, sterilization with EO is the
only method available to effectively sterilize
without damaging the device during
the sterilization process. The same properties
that make EO an effective sterilant
require that it be carefully controlled to
protect workers, communities, and
patients. In this talk, experts will go
through the 3Rs of an EO sterilization
program that Sotera Health businesses
Sterigenics and Nelson Labs implemented
to support customers in reducing EO use.
The benefits of reducing the amount of EO
for employees, customers, and communities
can include: continued safe usage of
EO, lower EO-residuals in products, re -
duction in required aeration time resulting
in improved customer supply chain
efficiencies, reduced cycle time resulting
in additional capacity for manufacturers,
and reduced fugitive emissions.
SESSION SPOTLIGHT
Panel: What Entrepreneurs Need to Know
About Investing in the Medical Sector
All companies require financing, and
the sources of that financing vary depending
on the need, stage, and type of enterprise.
This panel brings together a spectrum
of investors including angels, traditional
VC, and corporate VC to discuss
the challenges and opportunities unique
to the medical device space.
SESSION SPOTLIGHT
Building Consensus Solutions to Wicked
Problems in Medical Device Packaging
Medical device packaging experts and
stakeholders around the globe are hard at
work developing consensus-based solutions
to medical device packaging issues
and challenges faced by industry and clinicians.
Learn from leaders from the AAMI
Packaging working group about the latest
developments in international standards
for medical device packaging, including
the recently published new edition of
ISO/TS 16775 and amendments under
development for the ISO 11607 series.
Attendees will also hear about other collaborative
efforts through the Kilmer
Innovations in Packaging group (KiiP) to
solve wicked problems in medical device
packaging - highlights include what's
going on with the Wicked Stability group.
17
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Medical Design Briefs - April 2022

Table of Contents for the Digital Edition of Medical Design Briefs - April 2022
