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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

The Regulatory & Quality Challenges of 3D Printing

Michael Drues, PhD (President, Vascular Sciences)

Location: 208B

Date: Thursday, February 7

Time: 1:15pm - 2:00pm

Track: 3D Printing Innovation Summit

Vault Recording: TBD

Do you have a new medical device, combination product, drug, or tissue that is 3D printed? Not sure if you need FDA approval and if so, how do you go about getting it? For example, is printing a knee really any different than printing a drug? If you understand the regulatory logic, the regulatory strategies are exactly the same. In terms of quality, how do you maintain consistency when you are printing products that are all a little bit different? Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive presentation including:

  • What are the regulatory and quality challenges of 3DP?
  • How have existing products been approved and why?
  • What regulation currently exists and more importantly, what regulation does not?
  • How do you conduct a clinical trial for “unique” products?
  • How can you use regulation to your competitive advantage?
  • What does the future hold?