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OMTEC 2016 Education 

Meet the experts who spoke at at OMTEC 2016.

Click on each speaker's name for full session and biography details.

downloadspeakerpresentations2016 2

BilL Tribe web

Bill Tribe is a partner with A.T. Kearney in the Health Practice.
In his ten years with the firm, he has worked extensively in Europe and North America, addressing global and regional C-suite issues for many of the leading medical device, pharmaceutical and biologics companies. His expertise spans supply chain strategy, portfolio and product design, product distribution and optimization of service and supply across the extended value chains of suppliers, manufacturers and end-users.

steven haas web

Steven B. Haas, M.D., MPH, is Chief of Knee Service and John N. Insall Chair Knee Surgery at Hospital for Special Surgery .  He serves as Co-Chairman of the Quality Coordinating Committee at Hospital for Special Surgery. In addition, Dr. Haas holds multiple U.S. patents for orthopaedic devices and computer software. In 2014, Dr. Haas was awarded a patent for software which is the first and only computerized system for confirming correct medical implant selection for the patient. This commercial software system, OrthoSecure, has been used in over 20,000 joint replacement procedures.

Vicki Anastasi web

Vicki Anastasi is Vice President and Global Head, Medical Device and Diagnostics Research, ICON plc.
 Ms. Anastasi provides leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over 25 years of experience in the medical device industry, with over fifteen years specifically focused on global medical device strategic consulting.

Alejandro Badia WEB

Alejandro Badia, M.D., is a hand and upper extremity specialist running an international practice in Doral, Florida. He founded Badia Hand to Shoulder Center, a fully-integrated clinical facility, and OrthoNOW, an immediate orthopaedic care center franchise. Badia also co-founded Miami Anatomical Research Center (M.A.R.C) and the American Hand Institute.

parimal bapat web

Parimal Bapat, Ph.D., is a Research Engineer at Orchid Orthopedic Solutions,
where he develops and investigates new coatings technologies. As a Graduate Research Assistant at the Center for Nanoscale Material and Biointegration at the University of Alabama in Birmingham, he worked toward his Ph.D. thesis, “Gas Phase Laser Synthesis of Calcium Phosphate Nanoparticles for Biomedical Applications.” 

DawnBardot web

Dawn Bardot, Ph.D., serves as Vice President of Technology Innovation at the Medical Device Innovation Consortium (MDIC). Dr. Bardot is passionate about the application of modeling and simulation to improve healthcare and lower the cost of bringing products to market. She is an active member of the American Society of Mechanical Engineers, serves as Chair of the Verification and Validation in Computation Fluid Dynamics and Heat Transfer Committee and is Sub-Group Chair of the Committee on Verification and Validation in Computational Methods for Medical Devices.

david blakemore web

David M. Blakemore has served as president of BoneSim Laboratories
since 2009. The firm provides medical device lifecycle testing for re-usable medical devices. Prior to joining BoneSim, Mr. Blakemore served as Vice President of Research & Development and CSO of Valpo Orthopedic Solutions and Principal Engineer—Biomechanics at Zimmer. Prior to joining orthopaedics, he was a space shuttle orbiter engineer at NASA Rockwell International.

 Jerry Brown web

Jerry Brown is the Vice President of Global Supply Chain at X-spine Systems, part of Xtant Medical.
He is a talented, energetic and successful operations executive with over 25 years of experience in medical device and pharmaceutical operations. A Supply Chain guru in global operations, Mr. Brown has a proven track record of building world-class teams, streamlining operations, driving profitable revenue growth and improving organizational capabilities.
james burn web

P. James Burn, MB, CH.B, FRACS, is a Christchurch, New Zealand-based orthopaedic surgeon, Co-Founder and Technical Director of Ossis.
Dr. Burn has been active in the development of orthopaedic implants and instruments. Together with Paul Morrison, Dr. Burn established New Zealand's largest orthopaedic instrument company, Enztec, in 1992 and served as a director of that company until it merged with U.S. interests in 2008.

 GregBylo web

Greg Bylo is Vice President, Healthcare at GS1 US. In this role, Mr. Bylo offers strategic guidance on the use of standards and technology to improve business and clinical processes. With his team of standards experts, Mr. Bylo works closely with industry stakeholders to understand their collective objectives and challenges—particularly as they relate to Food and Drug Administration regulations such as Unique Device Identification and the Drug Supply Chain Security Act—and leads the development of best practices that contribute to a safer, more efficient supply chain.

Andy Christensen web

Andy Christensen has been active in the 3D printing/additive manufacturing industry since the mid-1990s
, wholly-focused on medical applications. From 2000 to 2014 he served as Founder and President of Medical Modeling Inc., a world-leading medical device 3D-printing service bureau. Medical Modeling was acquired by 3D Systems, and Mr. Christensen led the creation of a new business vertical for 3D Systems in the Healthcare sector until he left to pursue other interests in 2015. Today, he plays a part in multiple endeavors, including a role as Associate Editor for the journal, 3D Printing in Medicine.

DavidFinch web

David Finch is the President and Founder of Insight Collaboration Partners
, consultants who help companies improve inter-departmental communication, supplier collaboration, strategic sourcing, overall operations efficiency and cost reduction. Mr. Finch has over 25 years of hands-on responsibility in global supply chain and manufacturing operations in the medical device and the orthopaedic industry with Becton Dickinson, Johnson & Johnson, Wright Medical Technology and MicroPort Orthopedics.

JohnGagliardi web

John Gagliardi is President of MidWest Process Innovation LLC. He has had success over the past 45 years in the medical device and pharmaceutical industries because of his practical approach to process orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner.

WarrenGitt web

Warren Gitt is Principal, Overlook International Group LLC and Vice President of Business Development, K2M.
Mr. Gitt is an accomplished senior executive with 35+ years of experience in managing medical device/equipment and healthcare companies, as well as extensive experience in sales/marketing, business development, service and manufacturing operations. His global product development/management experience includes orthopaedic and spinal implants, single-use items, arthroscopic and electrosurgical instruments and equipment and biomedical service marketing programs. 

Ken Gredick Web

Ken Gredick, Engineering Manager, Triangle Manufacturing, is a seasoned profession with over 20 years combined experience in the aerospace and medical industries. Educated in business and Lean/Six Sigma, Mr. Gredick drives his team to collaborate with customers to maximize the manufacturing capabalities of their designs.


Jim Hicks web

James Hicks is Technical Development Engineer at Solvay Specialty Polymers.
Mr Hicks has worked in the plastics industry for 28 years, 25 of them with Solvay. His primary responsibilities include working with medical industry customers on design, processing and failure analysis support. He has a bachelor’s degree in chemistry from Georgia State University. 
RobinHooker web

Robin M. Hooker is Director, Healthcare Marketing at UPS.
Mr. Hooker and his team formulate healthcare solutions designed to serve manufacturers, distributors, providers, labs, clinical research organizations and dispensers to leverage UPS’ healthcare logistics expertise to improve efficiency while maintaining regulatory compliance. He has held previous positions in Marketing and Finance for UPS in numerous locations for more than 26 years.

MarcHorner web

Marc Horner, Ph.D. is the lead healthcare specialist at ANSYS Inc.
 Dr. Horner joined ANSYS after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. He began by providing support and professional services for biomedical clients, primarily in the areas of cardiovascular devices, drug delivery, packaging, microfluidics and orthopaedics. During this time, he developed numerous modeling approaches that can be used to establish the efficacy and safety of medical devices.
Greg Howard web

Greg Howard serves as Dekra Certification's Project Lead for ISO-only clients. He is a quality professional with over 30 years of experience implementing, managing and auditing quality management systems. Mr. Howard is a lead auditor certifying medical device manufacturers to the ISO 13485 standard and to Canadian (CMDCAS) and Japanese (JPAL) requirements. He has extensive, hands-on experience with devices in the orthopaedic, endoscopic and cardiovascular fields.

Dale Kellington Web

Dale Kellington is the Vice President of Business Development at Orthopaedic Innovation Centre (OIC). He brings a solid knowledge base and customer service-oriented approach to both managing and selling technical service offerings. His background in quality management and reference grade calibrations drives him to be detail-oriented while keeping track of the big picture. 

Mukesh Kumar web

Mukesh Kumar, Ph.D., Director, Advanced Process Technology, Zimmer Biomet

Mukesh Kumar webMukesh Kumar is Director of Advanced Process Tech at Zimmer Biomet, with responsibilities for multiple teams such as research, design, process and operations. The operations group is involved with additive manufacturing of clinical use parts made of Nylon or Ti6Al4V. He has over 17 years of experience in the medical device industry, with expertise in bringing platform implant/technology from notebook through regulatory bodies to the market. 

James Kwan web

James Kwan is the Managing Director and Owner of OPM Consulting, LLC, a provider of operational project management, operations process management and organizational performance management services for global clients. Mr. Kwan has held senior leadership positions managing manufacturing and supply chain operations at St. Jude Medical, Tornier, Edwards Lifesciences, Integra LifeSciences and SeaSpine and also previously served as a member of the OMTEC Advisory Board.

Wes Johnson web

Wesley Johnson is an Independent Industry AdvisorMr. Johnson is a medical device executive with a strong track record in three startups and two corporations. He has hands-on experience in all aspects of building a team and leading a device company, including experience in joint reconstruction, spinal fusion, trauma fixation, biologics and bone substitute materials. He most recently served as General Manager & Vice President of Cayenne Medical Inc.

kevin knight web

Kevin Knight cofounded Knight Mechanical Testing in 2006, and currently serves as the company’s president. Prior to starting KMT, Mr. Knight held positions in engineering and finance at Navistar International, with primary responsibility for heavy truck suspension components.

 EvangelineLoh web

Evangeline Loh, Ph.D., RAC (US & EU) serves as Vice President of Global Regulatory Affairs, EMERGO.
Dr. Loh leads the regulatory team supporting Emergo’s 2,700+ medical device and IVD clients globally. She has personally assisted hundreds of medical device and IVD companies, including dozens of orthopaedic companies, with regulatory strategy, registration and consulting projects. Before joining Emergo, she was a Regulatory Affairs Scientist with Cook.

Kelly Lucenti web

Kelly Lucenti is President, Millstone Medical Outsourcing.
 Prior to joining Millstone in 2004, Mr. Lucenti served as Director of Worldwide Operations for Flexcon Industries. Before Flexcon, he worked in a variety of capacities including Production Supervisor and Quality Systems Manager, for several operating divisions of the Johnson & Johnson family of companies, including Codman and Orthopaedics, now DePuy Synthes.

JoeMazzeo web

Joe Mazzeo is the owner of Integrated Lean and Quality Solutions
, providing leadership, lean manufacturing and modern quality management services to a wide variety of industries. Mr. Mazzeo is a retired General Motors executive with 33 years of global experience in manufacturing, quality, product engineering and customer service. Mr. Mazzeo is a member of several professional organizations, including the American Society for Quality, the Society of Manufacturing Engineers and the Specialty Equipment Manufacturers Association.
DaveMersereau web

David Mersereau is the Senior Vice President/General Manager at Boston Centerless.
Mr. Mersereau has over 38 years of experience in operations, manufacturing, quality systems and control processes, supply chain management, material testing and validation and lean manufacturing. Prior to working at Boston Centerless, Mr. Mersereau held senior level positions at Altron Inc., Sanmina Corporation, North American Industries and George Roberts Corporation.

Naomi Murray web

Naomi Murray is Senior Manager, Additive Technologies at Stryker Orthopaedics.
Dr. Murray began her career with Stryker in the Advanced Technology Department, where she has worked on technology development, characterization, technology transfer and validation of Stryker’s Additive Manufacturing, Tritanium®, as well as other new manufacturing technologies.

JobePiemme web

Jobe Piemme is the Chief Technology Officer at Praxis Technology, where he is responsible for overseeing business and product development. Mr. Piemme led the validation and commercialization of the porous titanium manufacturing line, which was cleared by FDA in 2008, and the titanium MIM manufacturing line launched in 2014. He holds a BS in Plastic Engineering and an MS in Materials Engineering from Penn State University.

Terrie Reed web

Terrie Reed recently returned to FDA as Senior Advisor for UDI Adoption after a one year opportunity to work with experts in device informatics research at Duke Clinical Research Institute. Her latest role as Senior Advisor for UDI Adoption is the culmination of years of systems analysis, information science, and regulatory science experience aimed at significantly improving device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem. 

Magnus Rene web

Magnus René is CEO of Arcam AB, a manufacturer of systems for additive manufacturing in metals. Mr. René has served as head of operations at Micronic Laser Systems in Stockholm, a manufacturer of advanced lithography equipment for the semiconductor industry. He holds an M Sc in Electrical Engineering from Chalmers University of Technology.

BlairRhode web

Blair Rhode, M.D., is a sports medicine surgeon.
He brings a unique perspective in that he owns 100% of his orthopaedic practice, Orland Park Orthopedics; his surgery center, South Chicago Surgical Solutions; and his orthopaedic implant company, Rhode Orthopedic Group (RoG). Dr. Rhode approaches his job from the singular perspective of providing the very best product at the very best price. 

Lars Rohrberg web

Lars Rohrberg is the Director of Product Management and Innovation for Cardinal Health Inventory Management Solutions. In prior roles, Mr. Rohrberg was responsible for Marketing at WaveMark, and earlier focused on designing solutions for medical device manufacturers and healthcare providers. His deep roots in supply chain, healthcare and technology have brought several innovative solutions to market.



Antonio Santana Web

Antonio Santana, Ph.D., Global Head Segment Medical, IHI Ionbond, leads global market and product development, providing expertise and support to customers though Ionbond’s vast coating network, which includes dedicated medical coating facilities in Switzerland, the U.S., U.K., France, South Korea and China. Dr. Santana received his Ph.D. in Thin Film Physics from the EPF in Lausanne, Switzerland. He has 17 years of experience in plasma physics and solid state physics from working at Ionbond and CERN.

 Jim Schultz web

James Schultz is Executive Vice President of ECA Medical Instruments, leading the global marketing, sales and program management operations. He has over 40 years of experience in medical, bio-pharma, enterprise software and high-tech product companies and government agencies serving in executive, technical, sales, marketing, investor relations, M&A and operations roles and at firms ranging from start-up to Fortune 500. 

nirav shah web

Nirav A. Shah, M.D., is a board certified orthopaedic surgeon focused on sports medicine and arthroscopic surgery. He collaborates with scientists to develop novel nanotechnology-based methods to improve cartilage repair and soft tissue healing to bone to optimize the latest arthroscopic techniques. Additionally, Dr. Shah is involved as a consultant to Northwestern University’s TEAM lab that is developing 3D-printed tissue inks and biological tissue.

 Jason Sikora web

Jason Sikora serves as Engineering Materials Director at Techmetals. Mr. Sikora is a chemical engineer with a focus on electrochemistry. Working with the R&D department at Techmetals, Inc., Mr. Sikora has experience with development of new coatings, project scale-up to production levels, and tailoring systems to meet customer’s needs.

mike street web

Mike Street is Senior Manufacturing Engineer and Prototype Manager of Paragon Medical. Mr. Street is involved in early engagement with projects at the prototype stage to develop products that are prepared for production. This includes manufacturing process design, along with quality and inspection equipment design. Mr. Street has worked at Paragon for more than five years, with responsibilities from fixturing, tooling and gauge design to project and supplier management. 

Ibim Tariah web

Ibim Tariah, Ph.D., is the Technical Director for BSI Healthcare. In the last 15 years since coming to BSI, Dr. Tariah has been providing expertise in vascular, orthopaedic, dental and other long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the Medical Device Directive (MDD) and development & delivery of specialized MDD training courses.

Ken Trimmer Stryker 150x150

Kenneth Trimmer has spent the last 25 years in various positions within Stryker Orthopaedics. His background includes Quality Assurance Engineering, Product Development, Marketing, Manufacturing Operations and Distribution. In his current role as Chief Engineer, Knees, he is responsible for the technical oversight of Stryker’s global knee products.

JeffTyber web

Jeff Tyber, Chief Executive Officer and President of Tyber Medical, has served in the orthopaedic industry for 12 years in roles of product development, research and management at Aesculap Implant Systems, Extremity Medical and MedShape Solutions, the latter which he also co-founded. He is a named inventor on more than 40 domestic and international patents and patent applications.

Tim Van Cleynenbreugel web

Tim Van Cleynenbreugel, Ph.D., is the Director of Business Development for the healthcare division of 3D Systems Leuven. Dr. Van Cleynenbreugel is a mechanical engineer with a post-graduate degree and Ph.D. in biomechanics from the University of Leuven, Belgium. After receiving his Ph.D., he worked for Dentsply, where he was product manager for patient-specific surgical guides for placement of dental implants. 

blaine warkentine web

Blaine Warkentine, M.D., MPH is trained in orthopaedic surgery, an innovator and entrepreneur
with 17 years of experience in the industry. Today, he focuses on big scalable issues that improve the value of health for all of us. His primary pursuit is as a consultant to American Health Insurance Plans (AHIP), Munich Health and Tenet Healthcare. Dr. Warkentine runs SurgeryTrack and FitnessBuilder, and acts as an advisor to RxREVU.

RichWoods web

Rich Woods is Senior Vice President of Global Research, Development and Engineering at K2M.
Mr. Woods is a 35-year orthopaedic industry veteran who has been involved in seven medical device start-up businesses, including three as a founder. He previously served in executive roles at American Osteomedics, Interpore Cross, Biomet and Kirschner Medical.