“Maryland’s 3D Medical Revolution”
May 16, 2018 • STAR Academy in Timonium
Lauralyn McDaniel joined SME in February 1996 and currently serves as the industry manager of medical device manufacturing. In this role, she guides SME’s medical industry strategy development and implementation, identifying potential markets, products and partners, and becoming the medical industry resource among the SME team as well as leading SME’s support and understanding of the manufacturing innovation ecosystem. McDaniel has been involved in medical manufacturing since 2000, engaging with companies and activities surrounding additive manufacturing, micromanufacturing, nanotechnology, and many other technologies. This work has included identifying challenges and potential solutions for medical manufacturing, writing articles on innovative technologies and processes, and leading SME’s Medical Additive/3D Printing Workgroup as well as the SME Innovation Watch Committee. She also serves as Vice Chair of the America Makes & ANSI Additive Manufacturing Standards Collaborative Workgroup.
0930 Medical Applications of 3D Printing
- Juan Garciais an Associate Professor at Johns Hopkins University School of Medicine, Department of Art as Applied to Medicine teaching in the areas of Ophthalmological Illustration, Anaplastology training and Medical Sculpture. Garcia is the Director of the Johns Hopkins Facial Prosthetics Clinic practice that provides clinical services of custom-made prosthetic substitutes for missing facial, ocular and somatic anatomy. In this context, he began using advanced 3D technologies such as 3D scanning, digital sculpting and 3D printing since 2005 in collaboration with a local 3D scanning firm, Direct Dimensions in Owings Mills, MD. In 2016, he was asked to manage the 3D Printing and Visualization Lab at the Johns Hopkins Carnegie Center for Surgical Innovation. Since then, he has been supporting 3D segmentation, printing, and design services for projects ranging from patient specific anatomical models, surgical guides, custom therapeutic medical devices, and custom models of anatomical regions for surgical simulation. Mr. Garcia holds a Master of Arts in Medical and Biological Illustration from the Johns Hopkins University School of Medicine.
- Jeffrey Hirsch is an assistant professor in the Department of Radiology at the University of Maryland, School of Medicine. He received his B.S. in Optics from the University of Rochester in 1986 and his M.D. from the F. Edward Hebert School of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Maryland in 2000. Prior to his pursuit of medical training, Dr. Hirsch served in the U.S. Navy as a Bombardier/Navigator from 1986 to 1994. He completed a residency in Radiology at Walter Reed Army Medical Center and the National Naval Medical Center in 2005. He then served the U.S. Army as a Radiologist with posts in Ft. Eustis, VA; Ft. Belvoir, VA; and Ft. Meade, MD between 2005 and 2012. Dr. Hirsch also deployed with the 28th Combat Support Hospital to Baghdad, Iraq in support of Operation Iraqi Freedom in 2005 to 2006. After his Army retirement in 2012, he completed a fellowship in Informatics and Musculoskeletal Imaging at the University of Maryland Medical Center. He is currently a member of the Community Radiology group in the Department of Radiology. His interests include Image-based Anatomic Modeling, as well as Musculoskeletal and Abdominal imaging.
- Robert L. Kristovich is the Chief of the Toxicology and Obscurants Division, US Army RDECOM – Edgewood Chemical Biological Center. The Toxicology and Obscurants Division at ECBC has a proud 80+ year history as the leader in preparing the nation for the threat of chemical warfare through toxicity and mechanistic evaluations of threat materials, which allows for informed requirements and operational decision making. Dr. Kristovich is widely regarded as one of the nations’ primary subject matter experts on the toxicity of chemical warfare agents and related compounds. In addition to his multiple positions within the Toxicology and Obscurants Division at ECBC, Dr. Kristovich has also served as a matrixed employee for the Defense Threat Reduction Agency, acting as the scientific lead for the development of the predictive toxicology program for the Department of Defense. Dr. Kristovich has been the author of over 25 research publications and book chapters on the toxicity of chemical compounds and is considered a leader in the incorporation of novel research techniques into toxicity evaluations and risk assessments.
1115 FDA Additive Manufacturing Research and Guidance
LCDR James Coburn is a Senior Researcher in the FDA’s Center for Devices and Radiologic Health (CDRH). His research focuses on patient-based design factors as well as manufacturing variability with advanced manufacturing methods such as 3D printing. His work in metrics and considerations for device evaluation has helped inform Agency Guidance and International Consensus Standards. In addition to research, LCDR Coburn focuses on outreach to industry and consumer stakeholder groups in emerging and innovative technologies. LCDR Coburn currently leads the Agency’s Additive Manufacturing Core Facility, is the FDA’s Technical representative to America Makes. He also Co-chairs the Agency’s Additive Manufacturing Working Group which is responsible for coordinating Agency research, technical knowledgebase, and policy efforts across medical product areas.
1300 Advances in Medical Device R&D
- Chad Schneider, P.E., MSE, is a professional mechanical engineer with over 20 years of experience in the process of product development. Chad grew up in Maryland and was educated locally, with a BS in mechanical engineering from the University of Maryland, College Park and a Master of Science in Engineering (M.S.E.) focused on Haptics and Medical Robotics from the Johns Hopkins University. He enjoys designing practical, efficient, and robust electro-mechanical systems and offers extensive knowledge of various rapid prototyping and manufacturing techniques. He is motivated by the challenge of taking on new and difficult projects. Mr. Schneider founded Root3 Labs in 2012 after having worked in the medical device and engineering consulting industries for 15 years. Root3 Labs’ expert engineering staff helps customers turn ideas into prototypes and prototypes into finished products.
- Gillian Henker manages Baltimore firm Sisu’s products and technical strategy. She is the primary inventor of Hemafuse and has directed Hemafuse’s development from an idea to fully manufactured, injection-molded device. Gillian previously founded a medical device design firm for Ghana. She has been published in the International Journal of Gynecology and Obstetrics, has presented at the Midwest Biomedical Engineering Career Conference and Appropriate Healthcare Technologies for Developing Countries Seminar in London, and was named Baltimore’s “2016 Technologist of the Year” at Baltimore’s 4th Annual Innovation award.
- Michelle Zwernemann, MSE, is a biomedical engineer with 10 years of experience in medical device product development. As a hands-on engineer, she has contributed to the design, testing, and launch of several orthopedic and upper limb prosthetic products. Most recently, Michelle has acted as an instructor for Johns Hopkins Biomedical Engineering undergraduate Design Team course, where she has mentored over 100 students and 15 medical device projects in everything from needs identification and regulatory strategy to hands on prototyping and test design. Michelle is a compulsive tinkerer that loves using found materials for improvisational prototyping. She holds a BS in Biomedical Engineering and an MSE in Bioengineering Innovation and Design from Johns Hopkins University.
- Jonathan Howarth is the Director of Operations and Senior Mechanical Engineer at Vasoptic Medical, a company that develops non-invasive blood-flow imaging devices. Jonathan grew up in Pikesville and graduated from the University of Maryland with a degree in mechanical engineering in 2011. Following graduation, he spent several years at an MTECH company working to commercialize novel battery technologies, and he holds several patents for his work. In 2016, he joined Vasoptic Medical, where he has helped the company design and develop its flagship product, The XyCAM RI, and finish the necessary operational requirements for Vasoptic’s 510k submission later this year.
1345 New Materials Research
Dr. Andelle Kudzal is a manufacturing engineer for the metallic additive manufacturing team at the Army Research Laboratory Center for Agile Materials and Manufacturing Science. Dr. Kudzal earned her PhD in Manufacturing Engineering from the Worcester Polytechnic Institute. Her research interests include material development and process property relations for the additive manufacturing process.
1345 Educational Pathways in Additive Manufacturing
- Harry Preston V is a STEM and CTE Educator in Baltimore City Public Schools. While his background is in Physics, his work has been in Math and Engineering Education. As a graduate of Johns Hopkins School of education Mr. Preston holds a Master’s specializing in Urban Education and Administration. He is the recent recipient of the Next Generations Scholars Grant through the Maryland State Department of Education. This makes him the Director of a program that specializes in getting students in underserved areas involved in intensive STEM and CTE programs starting in 7th Grade to enter STEM based careers and College Programs. Mr. Preston as serves as the Vice President of Career Technology and Education for the Baltimore City Teachers Union as well as an Advisory Board Member for the University of Maryland C.U.R.E. Scholars Program.
- Doug Kendzierski is Chair of the Applied Technology and Engineering School of Art, Technology, & Design at Community College of Baltimore County, overseeing the Aviation, Automotive, HVAC, Manufacturing & Design/Fabrication degrees. His team launched one of the first MIT-affiliated FAB LAB operations, which is a national model for technology democratization and additive manufacturing training, and home to the school’s Associate in Applied Science Degree in Design, Fabrication & Advanced Manufacturing.
- Ryan D. Socholis an Assistant Professor in the Department of Mechanical Engineering within the A. James Clark School of Engineering at the University of Maryland, College Park. Prior to this position, Dr. Sochol served two academic roles: (i) as an NIH Fellow within the Harvard-MIT Division of Health Sciences & Technology, Harvard Medical School, and Brigham & Women’s Hospital, and (ii) as the Director of the Micro Mechanical Methods for Biology (M3B) Laboratory Program within the Berkeley Sensor & Actuator Center at the University of California, Berkeley. Previously, Dr. Sochol majored in Mechanical Engineering, receiving his B.S. from Northwestern University in 2006, and both his M.S. and Ph.D. from the UC Berkeley, in 2009 and 2011, respectively, with Doctoral Minors in Bioengineering and Public Health. At present, Dr. Sochol directs the Bioinspired Advanced Manufacturing (BAM) Laboratory, which leverages micro/nanoscale 3D printing approaches to solve mechanically and physically-complex biomedical challenges. In addition, Dr. Sochol created and teaches the dual undergraduate-graduate course, “Additive Manufacturing”.
1430 BioFab: Delivering on the Promise of Regenerative Medicine
Dr. Becky Robison-Zeigler is a biomedical engineer and the Deputy Chief Regulatory Officer at the Advanced Regenerative Manufacturing Institute (ARMI) where she oversees regulatory activities for the BioFabUSA program and consults with members on their regulatory strategy and preclinical development programs. In this role she assists in the development of technical activities and focus areas for the BioFabUSA program. Prior to joining ARMI in October of 2017 she spent almost seven years at the US Food and Drug Administration (FDA) regulating medical devices at the Center for Devices and Radiological Health (CDRH) and advanced therapy biologics at the Center for Biologics Evaluation and Research (CBER). Dr. Robinson-Zeigler received her undergraduate training in biomedical engineering from Columbia University’s Fu Foundation School of Engineering and Applied Science and her graduate training from Yale University, where she received her MS and PhD in biomedical engineering, with a focus on neuroengineering.
1430 The Business Case for Additive Manufacturing
Ian Wing is a Manager in Deloitte Consulting’s Strategy & Operations practice. He brings over a decade of experience solving complex challenges for federal and military customers to bear on his client engagements. Leveraging his prior experience in research and development at a major defense and intelligence contractor, Mr. Wing now focuses on helping clients realize supply chain efficiencies and develop new capabilities with additive manufacturing and other advanced technologies. Ian earned Bachelors and Master’s Degrees in Mechanical Engineering from Johns Hopkins University, as well as a Masters of Business Administration in Strategy from Georgetown University. He has authored numerous peer-reviewed journal publications and holds two United States patents.