Mike Drues, President, Vascular Sciences
Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including stimulating & innovative educational programing, creative regulatory strategy & completive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense, brain-storming sessions, prototype design, product development, benchtop & animal testing, , clinical trial design, reimbursement, clinical acceptance, business development & technology assessment.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.
Scott Dunham, Vice President of Research, SmarTech Markets Publishing
Scott Dunham is Vice President of Research at SmarTech Markets Publishing, bringing with him years of research experience in the areas of advanced manufacturing and 3D printing. Scott holds a Bachelor’s degree in marketing and research from the University of Kentucky’s Gatton School of Business & Economics, and has been a featured speaker at 3D printing industry events around the world.
Brian Ganey, Head of Dental Division, Carbon, Inc
Brian has nearly 20 years of experience in the dental medical device industry, holding various sales management and business development roles in both starts-ups and established corporate environments. Brian joined Carbon after spending over 11 years at Align Technology, where most recently, he was responsible for leading the Special Markets Large Group Practice/Mid-Markets channel sales strategy. At Carbon, Brian is responsible for expanding the global go-to-market strategy and operational execution of Carbon’s entrance into the dental market. Prior to Align technology, Brian was a Dental Program Development Manager at Philips Oral Healthcare and a Regional Sales Manager/National Sales Trainer at Lifecore Biomedical.
Lawrence Gasman, President, SmarTech Markets Publishing
Lawrence Gasman is the founder of SmarTech Markets Publishing and is acknowledged worldwide as an expert on technology forecasting. He has previously founded two other industry analyst firms and has also carried out a wide range of technology assessments in areas ranging from optical networking to advanced materials
to augmented reality.
Session: Welcome to the Conference
Laura Gilmour, Medical Account Manager, EOS North America
Laura Gilmour, Medical Account Manager of EOS North America, oversees more than 20 medical device OEMs and contract manufacturers using EOS technology in North America. She joined EOS in 2016 after working with the company as a customer during her 15 years as a biomedical research and development engineer.
Previously, Laura was a senior research engineer at Smith and Nephew Orthopedics where she and a team of engineers developed an advanced porous structure now used in orthopedic applications around the world. She also worked at Medtronic Spine and Biologics and Abbott Vascular where she was responsible for translating surgical needs into medical device designs. Prior to that, Laura spent two years as a pre-market reviewer for the U.S. Food and Drug Administration (FDA), reviewing and clearing more than 80 orthopedic devices. During her time at the FDA, Laura was a founding member of the organization’s Additive Manufacturing Working Group.
Laura is a member of the SME Medical Additive Manufacturing/3D Printing Working Group and the Society of Women Engineers. She holds a bachelor’s degree in bioengineering from the University of Pittsburgh and a master’s degree in biomedical engineering from the University of Tennessee Health Science Center.
Charles Goulding, Attorney, CPA and President, R&D Tax Savers
Charlie is an Attorney / CPA, and President of two national specialty tax firms, Energy Tax Savers and R&D Tax Savers.
Energy Tax Savers has helped 15,000 buildings obtain energy tax savings and R&D Tax Savers has helped a range of industries obtain hundreds of millions in R&D tax incentives.
Charlie is an author of over 50 published articles related to the tax aspects of 3D printing and is recognized as a top 40 3D printer master mind.
Before starting both firms 12 years ago, Charlie was previously Vice President of Dover Corporation and Managing Director of Eaton/Cooper which are two multi-billion dollar industrial companies.
He is also the Mayor of Oyster Bay Cove, Long Island.
John Hornick, Partner, Finnegan
John has been a counselor and litigator in the Washington, D.C. office of the Finnegan IP law firm (one of the largest IP firms in the world) for over 30 years, where he has litigated close to 100 IP cases and has negotiated hundreds of settlements. John founded Finnegan’s 3D Printing Working Group and advises clients about how 3D printing may affect their businesses. John frequently speaks and writes on 3D printing and has been recognized as a thought leader in this space. He is the author of the book, 3D Printing Will Rock the World, which won a Silver Award from the Nonfiction Authors Association and has been called a “must-read” offering “rare insight into how 3D printing is redefining what can be designed and manufactured.” His articles have been published at www.3DPrintingIndustry.com, www.3DPrint.com, in the Journal of 3D Printing & Additive Manufacturing, where he serves on the Editorial Board, and in Wired Innovation, and he was a columnist for 3D Printing World. He was the only IP attorney selected by the U.S. Comptroller General Forum on Additive Manufacturing (which is the basis of a report to Congress). John has served as a juror for the International Additive Manufacturing Award. John also educates the law enforcement community on 3D printing-related risks and benefits. John holds a certificate in Cybersecurity Oversight from Carnegie Mellon University and the National Association of Corporate Directors.
Rik Jacobs, General Manager, Dental, 3D Systems
Rik Jacobs is a founder and the former CEO of NextDent B.V. The company was founded in 2012 in the Netherlands as an independent subsidiary of Vertex Global Holding to complement the dental materials portfolio of its affiliate Vertex-Dental B.V., which has a 77-year track record in developing and producing traditional denture materials and products. Within four years, NextDent became the leading developer and manufacturer of biocompatible dental 3D printing materials. In January 2017, Vertex Global Holding merged with 3D Systems, a company that provides comprehensive Additive Manufacturing products and services, including 3D printers specifically designed for dental applications, print materials, on-demand parts services and digital design tools. Upon this merger, Rik became the General Manager of the Dental business. He holds a degree in International Marketing Management from NHL University of Applied Science.
David Labiak, Senior Portfolio Manager, Trent Capital Management
David Labiak, President, CFO and Senior Portfolio Manager of Trent Capital Management, a Greensboro, NC-based Registered Investment Advisor providing investment management services since 1987. David is also the Chief Investment Officer for 3D Tech Plus, a private fund/LLC formed in July 2013 with the sole objective of investing in companies involved in the 3D printing industry. He is also responsible for implementing strategic planning and assumes many client-related responsibilities including portfolio reviews. Prior to joining Trent Capital, David was employed by Belk Stores Services in their audit department. David received his bachelor degree in accounting from the University of North Carolina at Charlotte, later obtaining his MBA from the Walker College of Business at Appalachian State University. In September 2000, he received his Chartered Financial Analyst designation and is a member of the CFA N.C. Society.
Joseph Lipman, Director of Device Development, Hospital for Special Surgery
I have over 25 years of medical research and device development experience and have worked with multiple services at HSS including Adult Hip and Knee Replacement, Foot and Ankle, Hand and Upper Extremity, Hip Preservation, Spine and Sports Medicine. In working with these services and the Biomechanics department, I’ve contributed to the development of implants for the knee, hip, elbow and spine. These implants have been licensed to several orthopaedic companies and are sold worldwide. I am an inventor of sixteen patented medical devices and have multiple publications in the medical device area. In addition, I am a registered US Patent Agent.
Justin S. Marks, Founder / CEO, Arfona
Justin Marks, CDT is the Founder and CEO of Arfona LLC, a startup specializing in digital manufacturing methods for dental prosthetics. He is also the owner of Master-Touch Dental Lab in Brooklyn, New York. An accomplished dental technician, educator and lab owner, Justin has lectured and taught courses on removable prosthodontics in more than 40 countries. He is an expert in flexible partial denture materials and applications and a pioneer in the field of digital dentures and partials. Since 2008 Justin has dedicated most of his career to applying computer aided design and 3D printing technologies to removable prosthodontics and is credited with the invention of the world’s first 3D printed Valplast partial denture. Justin graduated Summa Cum Laude from Pace University and holds a BBA in marketing and management.
Dr. Roger Narayan, Professor of Biomedical Engineering UNC/NC State and America Makes Fellow
Roger Narayan is a Professor in the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. He is an author of over two hundred publications as well as several book chapters on medical devices and medical sensors. He has edited several textbooks, handbooks, reference books, including books on medical biosensors for point of care applications as well as on materials for medical devices. Dr. Narayan has received several honors for his research activities, including the University of North Carolina Jefferson-Pilot Fellowship in Academic Medicine and the American Ceramic Society Richard M. Fulrath Award. He has been elected as Fellow of the American Ceramic Society, ASM International, AAAS, and AIMBE. He recently served as an ASME Swanson Fellow with America Makes, the national additive manufacturing institute.
Todd Pietila, Senior Techinical Consultant and Business Development Manager, Materialise
Todd is a Business Development Manager at Materialise where he specializes in delivering 3D software and 3D printing consultancy to the healthcare field. With degrees in Biomedical Engineering and Master of Business Administration, he has spent more than 8 years at Materialise focused on developing applications of 3D printing in medicine.”
Steve Pollack, Research Scientist and Former 3DP Evangelist at the FDA, Carbon, Inc.
Dr. Pollack is Research Scientist at Carbon, focused on life science applications. Prior to this he was Director of the Office of Science and Engineering Laboratories (OSEL), the applied research arm of the FDA’s Center for Devices and Radiological Health and Director of the Division of Chemistry and Materials Science within OSEL. At the FDA he was an evangelist for the acceptance of 3D printing as a viable and safe technology for medical device manufacturing. Prior to this he was Deputy Laboratory Head in the Center for Bio/Molecular Science and Engineering at the U.S. Naval Research, held research and management positions at American Hospital Supply Corporation, Allergan Pharmaceuticals and Springborn Laboratories and has held faculty positions at the University of Cincinnati in Materials Science and Engineering and at Howard University, where he was Professor of Chemistry.
Davide Sher, Senior Analyst, 3DP Adoption Studies, SmarTech Markets Publishing
Davide Sher is Senior Analyst, 3DP Adoption Studies at SmarTech Markets Publishing and has built an extensive experience as a technology journalist and communication consultant. Davide was born in Milan, Italy and spent 12 years in the United States, where he received his BA from SUNY Stony Brook. He now lives in Milan and collaborates with several 3D printing news portals. He founded 3Dprintingbusiness.directory, currently the largest global directory of 3DP related companies, as well as the leading Italian 3DP news portal Replicatore.it
Session: The Market for Bioprinting
Katie Weimer, VP Medical Devices, 3D Systems
As VP Medical Devices, Healthcare, 3D Systems, Katie Weimer leads the company’s Denver healthcare operations, specializing in Virtual Surgical Planning (VSP®), 3D printed medical devices and patient-specific anatomical models, surgical guides and templates. Katie joined Medical Modeling in 2008 (acquired by 3D Systems in 2014), and is passionate about enabling better healthcare through innovative technologies. Katie received her master’s degree in mechanical engineering from the University of Missouri-Kansas City, and writes and speaks frequently on her expertise in personalized surgery.
Robert Wesley, 3D Printing Engineer, St. Louis Children’s Hospital of BJC Healthcare
Robert graduated from Tennessee Tech University in 2013 with a BS in Biomolecular Engineering and North Carolina A&T State University in 2015 with a MS in Bioengineering. He worked in several academic research labs such as environmental health, biomolecular medicine, fuel cell, and computational biomechanics before entering the world of 3D printing. He works as a 3D Printing Engineer for St. Louis Children’s Hospital of BJC Healthcare. Under the direction of Dr. Christine Pavlak, Dr. Shafkat Anwar, Dr. Eric Eutsler, and Dr. Kamlesh Patel, Robert is responsible of the operations of the 3D printing program which involve preparation of process workflow, surgical guides, and virtual and physical models for pre-operative planning and patient education.