COURSE DESCRIPTION

OVERVIEW

As technological advancements continue to permeate the medical device world, few hold more promise than 3-D printing.  Everything from prosthetics to organs have been (or can be, theoretically) “printed.”  Thus, the opportunity presented has intrigued device firms because of increased product efficacy, manufacturing benefits, and other advantages.  Now that the guidance ‘Technical Considerations for Additive Manufactured Devices’ (May, 2016) has been finalized, many questions have been answered but several remain.  What does this guidance mean? How do I enter the market?  What are the considerations regarding scale-up for manufacturing of product?

During this interactive, 90-minute webinar you will learn what the guidance says, and how to apply that knowledge to making an informed decision about the benefits vs. risks of 3-D printing in the therapeutic space.

LEARNING OBJECTIVES

Primary examples of what will be covered in the session include:

1. FDA Final Guidance on 3-D Printing: What it means, and the rewards/risks
2. Understanding specific regulatory challenges, and how to use the regs to your competitive advantage
3. What is currently being done in biomedical 3-D printing
4. The technical and regulatory challenges, and how to address them
5. New technologies in development
6. What you can do to enter this promising market

Some questions to be answered/discussed include:

1. Can we ‘print’ medical devices?
2. Can we ‘print’ permanent implants?
3. Can we ‘print’ combination products?
4. Can we ‘print’ drugs (i.e., new molecular entities)?
5. Can we ‘print’ living tissue?

This course will use case studies from a variety of clinical specialties to highlight salient points.