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Wednesday, April 27
Location: FedEx Institute of Technology at The University of Memphis
7:00-8:40 a.m. Registration & Continental Breakfast
Sponsored by:
ECA Medical
8:40-8:45 a.m. Opening Remarks

Speakers:

    Howard Revitch, ODT/MPO Group Publisher
    Sean Fenske, ODT/MPO Editor-in-Chief
8:45-9:00 a.m. Welcome to Memphis
An introduction of the region serving as the host of the 2022 ODT Forum—Memphis, Tenn.—and an overview of why the area is so important to the orthopedic device manufacturing industry.

Speaker: Patrick Fisher, VP & GM—Foot & Ankle, Stryker

9:00-9:45 a.m. The State of Orthopedics: An Industry in Transition
In 2000, how many imagined additive manufacturing, robotics, or payors employing AI systems to manage reimbursements would be playing a role in the orthopedic device industry. Further, that’s to say nothing of a pandemic that cut procedures in half, overnight? Yet, that’s the status of the industry in 2021. The state of our industry is in transition, but the questions of where it’s headed and how fast remain. During this session, Robin Young will review the state of orthopedics now and for upcoming decade.

Speaker: Robin R. Young, CEO, RRY Publications LLC/PearlDiver Technologies Inc.

9:45-10:30 a.m. Biocompatibility Considerations for Orthopedic Devices from the U.S. FDA Perspective
The biological evaluation of medical devices should be in accordance with ISO 10993 series of standards to be acceptable by the U.S. Food and Drug Administration (FDA). Beside general biocompatibility testing considerations applied to all medical devices, each division at FDA has its own risk assessment approach for biocompatibility. In this session, Dr. Kazemzadeh-Narbat will explain the rationales and justifications acceptable for biological risk assessment of orthopedic devices, in accordance with least-burdensome approach, to remove or reduce unnecessary burdens associated with biocompatibility endpoints required by the Agency.

Speaker: Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA; Associate Director, Regulatory Affairs; MCRA LLC

10:30-11:15 a.m. Networking Break
Sponsored by:
ECA Medical
11:15 a.m.-12:15 p.m. Addressing Critical Issues: An Orthopedic Device OEM Roundtable
This panel of representatives from orthopedic device OEMs of varying sizes discuss a number of critical issues impacting the industry. They will share their experiences and how their companies are reacting to changes created by shifting industry forces as well as fallout from the pandemic. Topics covered will include supply chain, reimbursement, global regulatory changes, adaptation of technologies (e.g., AI, data, machine learning, etc.), robotic surgery, additive manufacturing, and more. The audience will be encouraged to pose questions to the panel as well.

Moderator: Lane Hale, President & CEO, ECA Medical

Panelists:

    Dan Justin, CEO, Nanovation Partners
    William Pratt, VP Operations and Director of Creative Design, Kinamed Inc.
    Scott Shankle, Vice President of Operations, MicroPort Orthopedics Inc.
    Carlton Weatherby, VP & GM—Spine & Biologics, Medtronic
12:15-1:45 p.m. Networking Luncheon
Sponsored by:
ECA Medical
1:45-2:30 p.m. Supply Chains Turned Upside Down…and Inside Out!
The world’s healthcare supply chains have been turned “upside down and inside out” over the past 18 months due to the COVID pandemic. There has never been a time in modern history where the term “supply chain” has been more important as well as misunderstood than now. Topics to be addressed will include The Duplicate Capacity Dilemma (the cost of creating contingency capacity vs. the risk of not doing so); Supplier/Partner Model (too much risk and dependence on single supplier sources?); Will the COVID-based hyper-sensed desire for supply control result in more in-sourcing vs. outsourcing? Protecting supply lines; Impact of logistics/transportation/warehousing; Should we/will we be returning to the United States? What time line lenses should I be using to configure my supply chains? What we learned from toilet paper (i.e., inventory value vs. cost); Just In Time/Lean vs. COA Planning Models; and finally, Talent.

Speaker: Christopher Oleksy, Co-Founder/CEO, Next Life Medical; CEO, Emergent Respiratory

2:30-3:15 p.m. Regulatory Considerations for Additively Manufactured Implants
In December of 2017, the FDA published Technical Considerations for Additive Manufactured Medical Devices. This guidance document was provided as an overview and recommendation of how to present information of a 3D-printed medical device to the FDA, with what the FDA knew at the time based on information they sought from industry. The reality is the technology curve for additive manufacturing was still very much in development as were standards for monitoring and testing devices built using the technology. Meredith May has been helping clients navigate FDA submissions for 3D-printed devices across many different indications from a regulatory point of view. Brian McLaughlin has been helping clients design, develop, and manufacture products for testing leading up to FDA submissions, as well as post-production for FDA-cleared devices. Both speakers will discuss their two different, yet similar, experiences with their clients and what types of questions the FDA has been asking more recently.

Speakers:

    Meredith L. May, MS, RAC, CQA, Director of Consulting, Empirical Technologies Corp.
    Brian R. McLaughlin, Founder & CEO, Amplify Inc.
3:15-4:00 p.m. Networking Break
Sponsored by:
ECA Medical
4:00-5:00 p.m. Planning Critical Strategies Alongside Product Development
Early in the product development cycle, companies may be rapidly iterating or trying different manufacturing techniques to design the best end product. What may be put on the sidelines during this period, however, can be just as important to the success of the product itself. This panel discussion will bring together key stakeholders from a medical device product lifecycle who may be often brought in after design freeze. They will share insight on why it is important to have them involved during this early development phase rather than after its conclusion. Representatives for the regulatory, testing, and commercialization segments will be involved in this discussion to offer critical considerations for why it is in a firm’s best interest to have them alongside design engineers during this process.

Moderator: Troy D. Drewry; Professor of Practice—Biomedical Engineering; Operations Manager—Center for Diagnostics, Design, Devices, and Biomechanics; The University of Mississippi

Panelists:

    Mike Carroll, Founder/President, Focus Medical Design and Development LLC
    Christine Scifert, MS, MEM, Partner, MRC Global
    David Sharp, VP of Global Marketing, Catalyst Orthoscience
5:00 p.m. End of Conference
Wifi provided courtesy of Kapstone Medical
* All session times, speakers, and content are subject to change.