Dr. David M. Anderson
Build-To-Order Consulting
Fellow of ASME (American Society of Mechanical Engineers)

Dr. David M. Anderson has worked with several medical device companies such as: Baxter Healthcare, Guidant Corporation (formerly medical device group of Eli Lilly), and Allergan. He specializes in training and consulting on implementing Build-to-Order, Mass Customization, Product Line Rationalization, Design for Manufacturability, and on-demand Lean Pro3duction. He focuses on how to rationalize product lines, standardize parts, and concurrently develop products and flexible processes for all the agile paradigms: Build-to-Order, niche markets, Just-in-Time, Continuous/Demand-Flow Manufacturing, Lean Production, Agile Manufacturing, and Mass Customization.

David has written the most recent book on the subject: "Build-to-Order & Mass Customization; The Ultimate Supply Chain Management and Lean Manufacturing Strategy for Low-Cost On-Demand Production without Forecasts or Inventory," and has taught "Spontaneous Build-to-Order" for AME and "Profiting from Lean Manufacturing" for APICS.

Neil Beals
Executive in Residence
Innova/Memphis Bioworks Foundation

Neil Beals has over 25 years experience in the medical device industry, including a broad range of global responsibilities related to orthopedic, spinal, and biologics technologies and applications. His experience has included leadership roles in R&D, technology management, and marketing in the commercialization of numerous products and technologies at Smith & Nephew and Medtronic Spinal & Biologics. These programs have included various hip, knee and orthopedic trauma products; implant and instrument surface modifications; and regenerative biologic options including synthetic and tissue-derived materials and rhBMP-2 technology.

Lee Berger, MD
President & Orthopaedic Surgeon
Orthopaedic Associates

J. Lee Berger holds 13 registered U.S. patents for technological devices and innovations in orthopaedic surgery, with 10 additional patents pending.

Dr. Berger is a board certified Orthopedic Surgeon and Diplomate of the American Board of Orthopaedic Surgery. Dr. Berger has been the President of Orthopaedic Associates since 1984, providing patients with a full array of expert non-surgical care and leading-edge options for minimally invasive spine surgery treatment. He also serves as an Associate Clinical Professor of Orthopaedic Surgery for Seton Hall Graduate School of Medicine.

He has extensive experience performing, teaching and developing minimally invasive spine surgery techniques. Dr. Berger's extensive body of work includes published research and clinical trials focused on the enhancement of surgical treatment for spinal fractures, intervertebral disc disease and carpal tunnel syndrome.

Barbara Blum, Ph.D.
Senior Project Engineer II
Wright Medical Technology, Inc.

Barbara Blum has over 15 years of experience with resorbable and regenerative materials for use in wound healing and orthopedic applications. She is a Senior Project Engineer in Biologics Development at Wright Medical Technology in Arlington, TN where she is involved in the research and development of both soft and hard tissue regenerative materials. She received her BS in Industrial Engineering from California Polytechnic State University, San Luis Obispo, and an MS degree from the joint program in Biomedical Engineering at University of Texas at Arlington and University of Texas Health Southwestern Science Center. She was awarded a PhD in Biomedical Engineering from the University of Alabama at Birmingham (UAB) where she studied the use of natural tissue glues and growth factor delivery for the enhancement of wound healing. She also received an MPH in International Health from UAB. She is an AATB Certified Tissue Bank Specialist, an Expert Committee and Expert Panel member with US Pharmacopeia (USP), and an active member in the American Society for Testing and Materials (ASTM).

Burhan Gharaibeh, Ph.D.
Research Assistant Professor, Stem Cell Research Center
Department of Orthopaedic Surgery, University of Pittsburgh

Dr. Burhan Gharaibeh is a research assistant professor within the Stem Cell Research Center, part of the Department of Orthopedic Surgery at the University of Pittsburgh. Other positions prior to his current appointment include postdoctoral fellow in the Graduate School of Public Health at the University and research associate in Hematology/Oncology at Children's Hospital of Pittsburgh.

Dr. Gharaibeh is a member of the American Orthopedic Society and the International Stem Cell Research Society International Committee. He also participates in community outreach by presenting popular scientific lectures on the topic of stem cells, bioethics, and regenerative medicine to various high schools and adult education programs in the area.

  Scott Hay
President & CEO
3D Engineering

In 1996, Mr. Hay founded 3DE, Inc in Fort Lauderdale FL, which has become the largest firm of its type on the East Coast of the U.S., specializing in rapid prototyping and manufacturing for the Aerospace and Medical industries. During this time he also founded and operated a number of companies including a specialty chemical sales company for the rapid prototyping industry selling a new class of rapid prototype resins called 3D Resins, a clinic based drug dispensing program for physicians called The Physician's RX, and a medical device technology incubator company called MD3.

Scott received a BS in Aerospace Engineering and, in the same field, an MS with an emphasis in astrophysics, advanced mathematics and material science from the University of Florida. Scott holds a number of patents and is recognized as a leader in the field of rapid prototyping. He has recently worked with a company that is currently introducing leading edge tracking products for the Saudi Arabia livestock market, and as a result finds the opportunity of introducing technology to that marketplace compelling in particular medical device products such as innovative spinal implants.

Steven Mounts
Senior Director, Quality Assurance
Musculoskeletal Clinical Regulatory Advisors, LLC (MCRA)

Steve Mounts, Senior Director, Quality Assurance, has more than 20 years' experience in the medical device industry, in the fields of quality assurance, regulatory affairs and logistics. Having held positions in nearly every area of quality assurance, Steve has obtained practical, working knowledge of how to create, implement and maintain effective, compliant quality systems. Steve is an ISO 9000 lead auditor of quality systems and has conducted over 100 supplier and internal audits. He has hosted and/or participated in more than 40 FDA, notified body, and regulatory agency audits/inspections and has extensive experience in S/W validation and electronic records compliance, responsible for overseeing the validation of over 900 S/W applications.

Chris Patterson
Director, Product Development
TL Deformity, Trauma and MAST Fixation Medtronic Spinal and Biologics
Medtronic Spinal and Biologics

Chris Patterson is the Director of Product Development for the Thoracolumbar Complex Therapy Segment at Medtronic Spinal and Biologics. His global R&D responsibilities include design, development and support of implant and instrument systems used to correct spinal deformities, tumor/trauma and degenerative conditions in both open and minimally invasive approaches. Over the last 7 years, Chris and his teams have developed numerous systems that have benefitted over 150,000 patients worldwide. His team's most recent product release was the CD HORIZON® SOLERA™ Spinal System which has become Medtronic's flagship posterior fixation system.

Tim Ruffner
Vice President NBD & Marketing Manager
GPI Prototype & Manufacturing Services, Inc.

Tim Ruffner is the Marketing Manager for GPI Prototype & Manufacturing Services Inc. in Lake Bluff, IL, specializing in additive manufacturing and rapid prototyping. Tim has a mechanical engineering background specializing in both manufacturing and finishing. One of the technologies that Tim is well versed in is Direct Metal Laser Sintering using the EOS M270 & M280 systems. Tim has been a key role in small to large organizations choosing the correct material and finishing for their prototype or additive manufacturing needs. Rapid prototyping is an evolving technology, with several materials and processes to mimic current manufacturing where as additive manufacturing has become the new way to quickly manufacture parts without the need for tooling or long lead times. Tim has spoke at over 25 conferences on conformal cooling channels within tooling inserts created by DMLS technology.