Introductory course

The Legal Landscape in Healthcare 3D Printing

It is our experience that risk can be mitigated with knowledge. In the upcoming months, we plan to invite legal and regulatory experts to provide foundation knowledge and updates on the legal landscape in healthcare 3D printing. These webinars will focus on critical issues faced by entrepreneurs and startups in the healthcare 3D printing ecosystem, ranging from intellectual property, medical device liability, as well as FDA and CE regulations and guidance, focusing both on biological and non biological devices.

Speakers:

Sean Burke

Sean Burke profile

Sean Burke is partner and vice chair of the products liability trial division at Duane Morris. He is in the firm’s Washington, DC office.  Mr. Burke’s practice focuses on representation of manufacturers of medical devices in products liability cases across the country, including in consolidated multi-plaintiff matters in both federal court and state courts. His experience includes defense of large total joint replacements (hips, knees, ankles, and shoulders) and resurfacings, tissue matrices and patches, fusion plates, and surgical instruments.  He has a particular interest and focus on additive manufacturing, consulting and advising clients on best practices in the early stages of development to reduce risk of products liability exposure.  He has tried medical device cases before juries in both state and federal courts while also handling numerous mediations.  He works closely with scientific experts to advance causation and liability defenses in the areas of biomechanical engineering, toxicology, histology, epidemiology, orthopedic surgery and FDA regulations.

Roger Kuan

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Roger Kuan is a Partner at Haynes and Boone and chair of the Precision Medicine and Digital Health Practice Group, where he counsels companies that are uniquely positioned in the convergence of the life/medical sciences and technology industries on how to successfully navigate the complexities of the intellectual property (IP), data rights and regulatory challenges they encounter.Roger has extensive experience in IP strategy and portfolio management (utility/design patents, trademarks, copyrights, and trade dress), data rights strategy, licensing and technology transactions, freedom-to-operate clearances, enforcement, monetization, IP due diligence, and dispute resolution. His practice is focused in the life sciences sector (e.g., research tools, analytical instrumentation/software, digital therapeutics, medical devices, diagnostics, biomanufacturing equipment, etc.) with an emphasis in emerging technologies such as Precision Medicine (e.g., genomic sequencing platforms, AI/ML, computational genomics/bioinformatics, molecular diagnostics, companion diagnostics, etc.), Digital Health (e.g., mobile apps, clinical decision support, software, digital therapeutics, AI/ML Imaging Diagnostics, wearables, etc.) and 3D printing/bioprinting. Prior to joining Haynes and Boone, Roger served as Director, IP Counsel at a multinational biotechnology company, where he managed a team to support the worldwide IP needs of the company’s life sciences tools, bioproduction/biomanufacturing, molecular diagnostics, and nucleic acid sequencing system/software platforms. Prior to finishing his law degree, he worked in the life sciences industry for several Fortune 500 pharmaceutical, medical device, and chemical companies. He has held professional positions in the R&D, sales, engineering, and regulatory affairs organizations.

Dr. Jenny Chen

jenny chen

Dr. Jenny Chen is trained as a neuroradiologist, founder/CEO of 3DHEALS. Her main interests include medical education, 3D printing in the healthcare sector, and artificial intelligence. She is also a current adjunct clinical faculty in the radiology department at Stanford Healthcare.

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Introduction to 3D Printing in Hospitals by Robert Wesley

Summary: 

This is a recorded lecture from 3DHEALS webinar on August 23rd, 2019. The recording includes moderated Q & A.

The webinar introduces the audience to the world of in-hospital 3D printing programs. Robert will share insights and how-tos with interested parties in a direct and intimate setting online.

The technology has been used in recent years for patient consults, medical student training, pre-operational planning, surgical simulation, intra-operative reference, and post-operative assessment. The goal of this webinar is to share insights, how-tos, and pitfalls of ramping up a 3D printing program within a patient-care institution from square-one. The history of point-of-care manufacturing, clinical and operational workflows, patient case applications, and technology choices are discussed.

This webinar is the first in a series which will take the audience from the essentials of “How do I get started?”; to medical image segmentation practices for soft and hard tissue; to the economics and reimbursement options of in-hospital based 3D printing.

About the Instructor:

Robert Wesley

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3D Printing Engineer, St. Louis Children’s Hospital, USA

Bio: Robert is an experienced biomedical engineer, who has managed hospital-based 3D printing programs. He has acted as a consultant non-profit medical centers looking to invest in the 3D printing space in the Southwestern, Midwestern, and Southeastern regions of the United States. He works closely with research teams in designing and producing prototypes, and with clinical teams to identify anatomy, design and manufacture models, and apply quality standards to the entire process. Focused on capturing tangible cost-savings, he works with business development, finance and accounting, and with supply chain to track the utilization of these in-house centers versus outsourcing to external vendors.

Agenda:

First 30 minutes: Presentation

Second 30 minutes: Moderated Q&A Session

Completion of the course will provide students with a certificate of completion.

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Healthcare 3D Printing 101: Why You Should Care

This is a concise industry overview course on healthcare 3D printing and bioprinting. The instructor organizes the industry in a way that will provide a more clarified view on the industry, major players, main driving forces and technologies, its current and future status.