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...
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
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...
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...
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
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...
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. ...
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
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...
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...
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...
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...
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 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...
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...
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...
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...
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...
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...
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,...
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...
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...
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...
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....
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...
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...
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...
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...
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
Beers, Burgers and Biomechanics
New for 2020! ...