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Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory Guidance and Standards

GE Additive Tech Center | Thursday, June 14 | 10:00 am - 11:00 am
Moderator: Lauralyn McDaniel, Industry Manager, Medical, SME 
Panelists:
Dan Fritzinger, Manager, Global Instrument Innovation, DePuy Synthes
Carl K. Dekker, President, Met-L-Flo
David Hwang, Ph.D., Spinal Device Reviewer, Office of Device Evaluation, FDA

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   Level/Participant 
    While all attendees will benefit from this session, the check marks indicate the skill level and roles that this session targets.
 
    Beginner  |   Intermediate  |   Advanced
 

  √ Manufacturing
Product Management
 Purchasing
 Quality Control
 √ Regulatory/Clinical Affairs
 Research/Development/Design
Supply Chain Management
 

 


Description


FDA published its guidance on additive manufacturing technical considerations late last year, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.

Attendee Takeaways

  1. Current medical device additive manufacturing guidance and standards roadmap
  2. Gaps that have been identified in current guidance and standards
  3. Guidance and standards on the horizon 

 

 


Bios

McDaniel 200x200Lauralyn 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; becoming the medical industry resource among the SME team and leading SME’s support and understanding of the manufacturing innovation ecosystem. Ms. McDaniel has been involved in medical manufacturing since 2000, engaging with companies and activities surrounding additive manufacturing, micro-manufacturing, nanotechnology and many other technologies. This work has included the identification of 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 and sits on the America Makes Governance board. 


Frtizinger 200x200Dan Fritzinger is Manager of Global Instrument Innovation for DePuy Synthes. Prior to his current position, Mr. Fritzinger was the Engineering Team Lead for DePuy from 2012 to 2016. He has 15-plus years of orthopaedic medical device experience in trauma and arthroscopy/sports medicine. He has previously worked for Zimmer Biomet as Senior Development Engineer. Mr. Fritzinger has 25-plus years of engineering experience in medical devices, automotive and consumer products, hold 51 patents and has nine pending. He holds a Bachelor’s degree in Mechanical Engineering from Purdue University.


Dekker 200x200Carl K. Dekker is President of Met-L-Flo, Inc., a service center for additive manufacturing located in Sugar Grove, Illinois. He has been actively involved in research and product development using current technologies and innovative methods. Mr. Dekker has presented his work at various global conferences, including those sponsored by 3DSNASUG, Amerimold, ANTEC, National Manufacturing Week, RAPDASA, RP&M, and SME. He has also provided training and installations at Abbott Laboratories, Delphi, Motorola and other locations. Currently the Chair of the ASTM F42 Committee on Standards for Additive Manufacturing and a Past Chairperson of the SME’s Rapid Technologies and Additive Manufacturing (RTAM) Community (formerly the RPA); he also serves as the Chair of the Direct Digital Manufacturing Tech Group of the RTAM. Being actively involved in fostering education, Mr. Dekker teaches the Rapid Technologies and Additive Manufacturing Technologies Certificate Programs and also remains active in the Bright Minds Program as a member and past Co-Chair. He holds a Master Certificate in Rapid Prototyping and is a proud recipient of the SLA “Dinosaur” award.


HwangNEW 200x200Dr. David Hwang has worked as a Biomedical Engineer in FDA’s Office of Device Evaluation, housed in the Center for Devices and Radiologic Health, for over six years. He is a reviewer in the Division of Orthopedics, with primary responsibility in the premarket review of spinal devices. He is also heavily involved with the Additive Manufacturing Working Group, which leads efforts across the Agency to evaluate medical devices and other regulated medical products. These efforts include guidance and standards development, device review harmonization and regulatory science with the intent to foster innovative and high-quality products that are both safe and effective. He holds a both a Bachelor’s and Doctorate in Bioengineering from the University of Maryland.

 



Related reading from BONEZONE®:
FDA Finalizes Additive Manufacturing Guidance