Agenda

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June 15, 2021

8:00 am - 5:00 pm

Exhibit Floor

Exhibitor Registration and Set Up


1:00 pm - 2:30 pm

Session Rooms

EU MDR: Tackling Today’s Challenges

The EU Medical Device Regulation (MDR) has presented unique challenges for orthopedic device manufacturers and regulators alike. Gaining clarity on the regulation’s new requirements and ensuring compliant business processes have required...

Moderator

Sharon Starowicz

Regulatory Consultant,

Medical Device

Panelist

Glenda Marsh

Senior Director of Policy Implementation Global Regulatory Affairs Policy and Intelligence,

Johnson & Johnson Medical Devices

Panelist

Mark Schenk

Vice President of Advanced Solutions and Vice President of Regulatory,

Tyber Medical

Panelist

Matthias Fink, M.D.

Clinical Reviewer, Clinical Centre of Excellence,

TÜV SÜD

Panelist

Monisha Phillips, Ph.D.

Global Head, Orthopedic and Dental Devices,

BSI


1:00 pm - 2:30 pm

Session Rooms

Personal Development: Building and Leading High-Performance Teams

We all claim that “culture eats strategy for breakfast,” but we rarely explore what culture really is or ways to build it within our organizations. Similarly, companies talk about teamwork and collaboration but rarely work to understand the...

Speaker

Bryan Warren

President,

J3Personica


3:00 pm - 4:30 pm

Session Rooms

Global Regulatory Roundtable: FDA and Notified Bodies Outlook

Understanding the current landscape and future direction of the global regulatory environment is critical to ensure that requirements are met for market introduction of new products and their continued postmarket compliance. This regulatory...

Moderator

Sharon Starowicz

Regulatory Consultant,

Medical Device

Panelist

Matthias Fink, M.D.

Clinical Reviewer, Clinical Centre of Excellence,

TÜV SÜD

Panelist

Mark N. Melkerson

Deputy Director, OHT6-Orthopedic Devices, Office of Product Evaluation and Quality,

FDA

Panelist

Kim Trautman

Executive Vice President, Medical Device International Services,

NSF International

Panelist

Monisha Phillips, Ph.D.

Global Head, Orthopedic and Dental Devices,

BSI


3:00 pm - 4:30 pm

Session Rooms

Essential Communication Techniques to Influence and Improve Your Relationships

Organizations succeed or fail based on their ability to communicate to their teams, to customers, to stakeholders, to leaders and to each other. Learn to take a more deliberate, practical and effective approach to communication to get the most out of...

Speaker

Bryan Warren

President,

J3Personica


5:30 pm - 7:00 pm

Networking

Customer Appreciation and Welcome Reception

This popular event begins after the day's education has concluded and most exhibitors are done setting up their booths. Connect with peers, partners and friends over light fare and drinks. Joe's Live Rosemont is within walking distance of the hotels...


June 16, 2021

7:30 am - 9:00 am

Keynotes

Digital Disruption Has Arrived: Your Role in the Future Orthopedic Supply Chain

A burgeoning focus on digital health and data collection is forcing orthopedic device manufacturers to consider the adoption of 3D printing, artificial intelligence, augmented reality, big data, robotics, sensors and more. Companies are asking, on...

Speaker

Stefano Bini, M.D.

Professor of Clinical Orthopaedics and Chief Technology Officer, Department of Orthopaedic Surgery,

University of California San Francisco


10:00 am - 10:45 am

Tech Center

Polymers 101: What You Need to Know for Your Next Implant or Instrument

Polymers have unique properties that enable many clinically successful orthopedic implants and cost-effective, single-use instruments. However, they also present unique issues for manufacturers and regulatory agencies. ...

Speaker

Jon Moseley, Ph.D.

Senior Director, Applied Research,

Wright Medical


10:00 am - 10:30 am

Surgeon Pod

Digital Disruption Has Arrived: Your Questions Answered

Stefano Bini, M.D., believes that alternative payment models and measures to decrease the overall cost of orthopedic care will force device companies to invest in the digitization of their supply chains and develop digitally-enabled technology....

Speaker

Stefano Bini, M.D.

Professor of Clinical Orthopaedics and Chief Technology Officer, Department of Orthopaedic Surgery,

University of California San Francisco


11:15 am - 12:00 pm

Session Rooms

How NuVasive Went from Additive Manufacturing Concept to Commercialization in 14 Months

NuVasive saw an opportunity with additive manufacturing. The only snag was that no one at the company possessed additive experience. Leadership knew that it needed to partner with a service and manufacturing provider for the additive manufacturing...

Speaker

Jesse Unger

Senior Project Engineer,

NuVasive

Speaker

Alex Fernandez

U.S. Business Development Manager,

3D Systems


11:15 am - 12:00 pm

Tech Center

New Biomaterials: Essential Steps to Clearing Regulatory Hurdles

Orthopedic devices comprising new biomaterials necessitate a complex regulatory and product development testing plan. The decision tree begins with the answers to three key questions. Is your new biomaterial considered a drug by the regulating...

Speaker

Robert A. Poggie, Ph.D.

President,

BioVera


11:15 am - 12:00 pm

Surgeon Pod

The Future of Infection Prevention: Challenges and Technologies to Know

Hospital-acquired infections are extremely expensive and carry high morbidity and mortality for the patient, making infection prevention the lowest-hanging fruit in medicine. As orthopedic device companies consider the development and...

Speaker

Javid Parvizi, M.D.

James Edwards Professor of Orthopedic Surgery,

Rothman Institute


11:15 am - 12:00 pm

Session Rooms

Collaborative Forecasting: OEMs and Suppliers Share Best Practices

Supply chain priorities of shorter lead times, higher on-time delivery and greater flexibility are a minefield of obstacles. Device companies and contract manufacturers share myriad challenges: forecast visibility, forecast stability, relevant...

Moderator

Julie Sutton

Senior Manager, Sales & Operations Planning,

NN LifeSciences

Panelist

John Kennedy, IV

General Manager,

Autocam Medical

Panelist

Shannon Mills

Supply Chain Director,

Zimmer Biomet

Panelist

Michele Roskowiak

Demand Planning Manager,

Wright Medical

Panelist

Greg Stalcup

CEO,

SITES Medical


12:00 pm - 2:00 pm

Networking

Networking Lunch and “Lunch with the Experts”

New for 2020! Food will be served from stations throughout the exhibit floor from 12:00 pm to 1:30 pm. "Lunch with the Experts" will take place from 12:30 pm to 1:15 pm in a reserved section of the exhibit hall cafe. ...


2:00 pm - 2:45 pm

Session Rooms

What You Need to Know About Supplier Oversight Programs

The orthopedic industry's global supply chain is multi-tiered and geographically remote, making oversight challenging and costly at times. To prevent product deficiencies, critical processes and products must be validated during manufacturing to...

Moderator

Connie Conboy

Director of MedAccred,

Performance Review Institute

Panelist

Ann Sheldon

VP of Global Supplier Quality,

Medtronic


2:00 pm - 2:45 pm

Session Rooms

Big Data and You: An Opportunity and Threat to Your Orthopedic Business

Big Data’s value to medicine lies in its potential to improve the predictability of diagnostics and treatments, while also helping companies develop novel therapies and products. Using big data systems (which include artificial intelligence and...

Speaker

Robin R. Young

Founder and CEO ,

Orthopedics This Week and Pearl Diver Technologies


2:00 pm - 2:45 pm

Surgeon Pod

Know Your Role in Automating Logistics and Surgical Support Processes

Healthcare’s focus on efficiency and quality is driving the use of automation, from artificial intelligence to robotics. However, the orthopedic device logistic management process—preoperatively, intraoperatively and postoperatively—remains...

Speaker

Vinod Dasa, M.D.

Founder and Chief Medical Officer,

SIGHT Medical


2:00 pm - 2:45 am

Tech Center

3D Printing: Understanding the Benefits and Applications of Inks, Polymers and Powders

The 3D printing process creates the final material or alters the starting material during the process, heightening the need for manufacturers to ensure that their final implant has properties that meet their specifications. Further, as 3D printing...

Moderator

Gaurav Lalwani, Ph.D.

Medical Applications Engineering,

Carpenter Technology Corporation

Speaker

James Porteus

Director of Engineering,

Oxford Performance Solutions (OPM)

Speaker

Ramille Shah, Ph.D.

Co-Founder and Chief Scientific Officer,

Dimension Inx


3:15 pm - 4:00 pm

Session Rooms

How a Quality Culture Fosters Internal Improvements and Competitive Advantages

The word “quality” can have multiple definitions. Some view quality as simply meeting compliance requirements, while others look at quality as improving the life of a patient who uses their device. Although both viewpoints are true, only one...

Speaker

Tom Rish

Medical Device Guru,

Greenlight Guru


3:15 pm - 4:00 pm

Session Rooms

Tips for Leveraging the Modern Design for Manufacturability Approach

The real benefits of design for manufacturability (DFM) extend well beyond approval from manufacturing. Product development leaders should leverage a DF(x) mentality and the myriad considerations that often fall under the DFM umbrella—material,...

Speaker

Dale Tempco

Founder,

Dale Tempco Consulting


3:15 pm - 3:45 pm

Tech Center

Recycling Additive Manufacturing Powder: Study Review of Ti64 ELI Aging

Evaluation of aged and recycled titanium powder during the additive manufacturing (AM) process is of chief importance for orthopedic device manufacturers. This presentation reviews a top-up recycling study that was carried out with an EOS M290 laser...

Speaker

Bamidele Akinrinlola, Ph.D.

Additive Manufacturing Research Engineer,

Precision ADM


4:00 pm - 6:00 pm

Networking

Exhibit Floor Open House and Happy Hour

These two hours are solely dedicated to mingling and networking with all of OMTEC's participants...with a special focus on the ~175 exhibitors. ...


June 17, 2021

7:30 am - 9:00 am

Keynotes

How to Drive a Culture of Innovation in Orthopedics: Lessons from HSS

From an onsite 3D printing facility collaboration to artificial intelligence-based software designed to detect and diagnose wrist fractures to numerous total joint and spine technologies, HSS is leveraging its leadership and expertise to blaze a...

Speaker

Douglas Leach

Managing Director, Biomechanical Innovation,

HSS Global Innovation Institute


10:00 am - 10:45 am

Tech Center

Better Bone Integration and Faster Healing: Next-Generation Biomaterials

Orthopedics has emphasized understanding of surface properties as greater attention has been placed on the biological response between patients and implant materials or structures. This focus is leading to a new generation of materials that seeks to...

Moderator

Matt Poggie

Senior Vice President of R&D Operations,

Acuitive Technologies

Panelist

Doug Snell

Engineering & Program Director,

HAPPE Spine

Panelist

Sriram Sankar

Director of R&D,

DiFusion Technologies


10:00 am - 10:45 am

Surgeon Pod

Virtual Reality and Human Factors Engineering

The standard for surgical training and assessment is more than a century old and is starting to fail. Data shows that 30.7% of graduating residents cannot operate on their own after 14 years of education - a number that continues to grow. Virtual...

Speaker

Justin Barad, M.D.

Co-Founder and CEO,

Osso VR


10:00 am - 10:45 am

Session Rooms

Supply Chain 4.0: Take Control to Develop the Next Generation of Leaders

This presentation reveals the latest trends in what companies need from supply chain management professionals to flourish in Industry 4.0, and what they get through traditional recruitment, retention efforts and internal learning development systems....

Speaker

Ken Jones

Principal,

Value Chain Solutions


10:00 am - 10:45 am

Session Rooms

Product Development: Avoid These Problems and Pitfalls

Problems and challenges associated with product development are the norm and not the exception. Your mission, if you choose to accept it, is to recognize the problems, including identifying early signs, being proactive in avoiding them and fixing...

Speaker

Shaher Ahmad

Principal,

4S Med-Device Consulting


11:15 am - 12:00 pm

Tech Center

Expand Your Material Toolbox: Alloys and Processes to Improve Orthopedic Implants

Materials are the foundation of any orthopedic device, and yet, wrought products employed today remain largely unchanged over the last decades. To combat this stagnation, research is underway to improve orthopedic care through both alloy and process...

Speaker

Adam Griebel

Senior R&D Engineer,

Fort Wayne Metals


11:15 am - 12:00 pm

Session Rooms

Orthopedic Device Sterilization Challenges: Where do We Go from Here?

The closure of ethylene oxide (EtO) plants and FDA's subsequent challenge to industry to reduce EtO emissions and identify new sterilization methods has forced orthopedic device manufacturers to consider their own processes. This panel brings...

Moderator

Rodney Parker, Ph.D.

Senior Principal Scientist,

Stryker

Panelist

David Opie, Ph.D.

Senior Vice President of R&D,

Noxilizer

Panelist

Mike Padilla

EO Technical Director,

Sterigenics

Panelist

Gary Socola

President,

HIGHPOWER Validation Testing & Lab Services


11:15 am - 12:00 pm

Session Rooms

Foreseeable Misuse of the New ISO 14971:2019 and EU MDR

Recent changes to ISO 14971 (ISO 14971:2019) and the release of the EU Medical Device Regulation (MDR/2017/745) have reshaped the requirements for risk management for medical device manufacturers. In this presentation, we will discuss the updates to...

Speaker

Rich Granquist

Quality Systems Consultant,

NAMSA


11:15 am - 12:00 pm

Surgeon Pod

Important Benefits of an Open 3D Printing Ecosystem

The orthopedic industry’s largely closed 3D printing manufacturing ecosystem stifles the growth of the technology, as well as implant and instrument innovation. This viewpoint drove Drs. Alan and Alexis Dang, orthopedic surgeons who lead 3D...


12:00 pm - 1:30 pm

Networking