Conference Agenda

8:00 – 9:00

Registration and Refreshments

9:00 – 9:10

Opening Remarks
Heather Thompson, Editor-in-chief, MD+DI

9:10 – 10:00

OrthoTec innovation: How to innovate and create a new company in this hostile environment

• Challenges and opportunities for orthopaedic device manufacturers in the current market conditions and technological landscape
• Understanding the evolution of the orthopaedic device industry and changing clinical demands to focus R&D, drive break-through innovations
• Driving quick adoption of new orthopaedic products and implants in the competitive global marketplace
• Overcoming the cost challenges in R&D, design and manufacturing, supply chain management and regulatory changes

10:00 – 10:45

Networking Coffee Break and Exhibition Showcase

10:45 – 11:30

FDA Update and Q&A – 510(k) reform and the MoM hip replacement issues

• Understanding how the FDA determines “substantial equivalence” for orthopedic submissions under 510(k) and reviewing the newly added Refuse-to-Accept policy
• Reviewing 510(k) reform that will impact orthopaedic device sponsors and describing some key focus areas for 2013 at FDA
• Understanding the recently proposed order requiring PMA applications for metal-on-metal total hip replacement systems, previously regulated under 510(k)
• Q&A with the FDA Orthopaedic Device Branch

David J. McGurl, Biomedical Engineer, Orthopaedic Joint Devices Branch/ODE/CDRH/FDA

11:30 – 12:00

Biological Evaluation and Testing of Medical Devices and Raw Materials within a Risk Management Process: EN ISO 10993 Series of Standards

• Explaining the significance of using “harmonized standards” for biocompatibility and toxicology testing
• Reviewing the 19 sub-standards and testing strategies
• Understanding how to biologically classify a medical device and decide which biological risks must be evaluated
• Exploring an evidence-based “bridging approach” to justify minor changes to the medical device without repeating the animal experimental testing

Dieter Dannhorn, General Manager – Medical Device Testing, UL LLC

12:00 – 12:30

The proposed UDI rule and impact on orthopaedic device manufacturing

• Reviewing the FDA’s proposed rule on the Unique Device Identifier requirements and future developments
• Understanding how orthopaedic device manufacturers can benefit from UDI in terms of risk management, post-market monitoring, inventory management and event product development
• Best practices for timely UDI implementation, selecting  standards for compliance and communicating compliance across the supply chain

12:30 – 2:30

Lunch and Exhibition Showcase

2:30 – 3:15

The end-user’s perspective on orthopaedic technologies – Biologics and the future of knee replacement

Kevin R. Stone, MD
Orthopaedic Surgeon and Founder, the Stone Clinic
Chairman, the Stone Research Foundation

3:15 – 4:30

Innovation Panel: Tissue engineering, PRP and scaffold development – Clinical needs, current technology and future application

• An overview of tissue engineering for biologics development and orthopaedic applications
• Examining the benefits and drawbacks of tissue engineering for orthopaedic applications in musculoskeletal disorders affecting bone, ligament and cartilage
• An overview of biomaterial advances and the latest innovation in tissue engineering for orthopaedic interfaces
• Exploring new materials that meet interfacial requirements and new techniques to regenerate the critical interfaces

CHAIRMAN: Scott Bruder, MD, PhD, Chief Medical and Scientific Officer, Stryker
Kevin Stone, Orthopaedic Surgeon and Founder, the Stone Clinic and Chairman, the Stone Research Foundation
Michael Hiles, VP Research & Clinical Affairs, Cook BioTech
Arnold I. Caplan, Professor of Biology and Director of Skeletal Research Center, Case Western Reserve University
Susan Drapeau, Director Biologics R&D, Medtronic Spinal & Biologics

4:30

Networking Reception in Resource Hall. End of Day One.
Reception Introduction: Joseph M. Thallemer, Mayor, City of Warsaw - Indiana

8:00 – 9:00

Registration and Refreshments

9:00 – 9:10

Opening Remarks
Heather Thompson, Editor-in-chief, MD+DI

9:10 – 10:00

ESPN Chief Medical Correspondent on the state of innovation in orthopaedics: How can manufacturers better meet clinical needs?

Keynote Introduction: Joseph M. Thallemer, Mayor, City of Warsaw - Indiana
Keynote Speaker: Michael J. Kaplan, MD, Practicing Orthopaedic Surgeon/ Chief Medical Correspondent, ESPN

10:00 – 10:30

Networking Coffee Break and Visit to the Resource Hall

10:30 – 11:00

Innovation in bone grafts and regeneration materials – The next generation

11:00 – 11:30

Intelligent implants: Sensors and more in orthopaedic devices

• Defining “smart” instruments in orthopedics and why there is a need for developing these devices to achieve optimal joint hardware installation
• Defining “intelligent” implants in orthopedics and why there is a need for developing these devices to facilitate the collection of data, and thereby "closing the loop" with smart instrumentation to drive best surgical practice and joint system design
• Reviewing clinical benefits of intelligent implants in post-operation pain management and recovery, as well as early problem detection facilitating less invasive intervention both acutely and chronically
• Understanding the latest advances in sensors and related technologies for orthopedic implants and implementing best practices for their use in medical design
  

Marc Stein, Chief Technical Officer,, OrthoSensor

11:30 – 12:00

Bioresorbable materials – The past, present and future of metals, ceramics and polymers in high-strength fixation devices

• Addressing issues related to MRI-and-implant interaction and implications for material selection
• Understanding the post-operative advantage of bioresorbable materials in eliminating diagnostic imaging after the implant
• An overview of bioresorbable materials and their clinical benefits in  tissue and bone growth/regrowth
• Discussing the potential of bioresorbable metals and how to define/use such materials
  

Robert Harten, Global VP R&D - Biomaterials, Synthes

MRI safety evaluation of passive implants: A review of current ASTM testing standards and the future role of analysis

• An overview of ASTM standard practice for marking medical devices (ASTM 2503) including recent revisions
• An overview of ASTM standards for evaluation of MRI safety of passive implants: force, torque, image artifact, RF heating
• Understand the role of computational analysis and how it can improve MRI safety evaluation

Lunch & Learn Presented by Solvay Specialty Polymers:
The power of plastics in healthcare:how material innovations are supporting next - generation orthopedic devices - RSVP HERE

12:30 – 2:30

Lunch and Visit to the Resource Hall

2:30 – 3:00

Optimizing Strategic Clinical Research Outsourcing Partnerships and Ensuring Compliance in Asia

• Reviewing industry trends in strategic outsourcing in Asia
• Bridging the business, cultural, and compliance gaps
• Building the foundation of a successful partnership
• Recognizing the common challenges and the possible solutions for the Sponsor and CRO organizations
• Ensuring compliance globally and locally to meet regulatory requirements

Grace Lee, Managing Consultant of Life Sciences and Healthcare Practice, PA Consulting

3:00 – 4:00

Panel Discussion: Supplier quality and value enhancement – Systems and metrics to drive efficiency, reduce costs, boost quality and enhance supplier value

• Examining current models and techniques to measure and manage supplier relationships and assess performance against key criteria to drive process improvement
• Leveraging performance management to inform and improve future relationships and supplier selection
• Understanding Notified Body and FDA’s increased emphasis on purchasing controls and scaling agreements to match the product risk and supplier type to ensure monitoring  and control is appropriate
• Managing supplier control issues around design and process changes, validations, and timely notifications
• Addressing issues related to sub-tier supplier controls and change control in the supply chain

4:00 – 4:30

Implementing Lean in orthopaedic manufacturing: Best practices and tools

Roy C. Wiley, Sr. Director of Manufacturing and Warsaw Site Leader, Medtronic

4:30

Close of Conference