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Leveraging Data to Develop, Execute and Exceed the Expectations of
Your Regulatory Strategy

STRATEGY SESSION ROOM  | Wednesday, June 13 | 11:15 am - 12:15 pm
Speaker: Robert A. Poggie, Ph.D. President, BioVera, Inc.

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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


Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.


Attendee Takeaways

  1. Learn how to identify and use published scientific, clinical, biomechanical and device-performance data to support your FDA 510(k) pre-submissions and 510(k)s
  2. Understand the positioning and relevance of data to establish substantial equivalence in the context of your 510(k)s and Technical Files for CE Mark
  3. Gain practical advice for mining preclinical and clinical evidence to plan device testing and clinical trials
  4. Understand how to leverage device performance measures to reduce risk, liability, cost and time to market

 

 

 


Bio

Poggie Bob 200x200Robert (Bob) A. Poggie, Ph.D. has worked in the orthopaedic industry since 1992, with experience in applied research, regulatory and clinical affairs and medical education. Dr. Poggie was instrumental in the research and development of Smith & Nephew’s Oxynium technology and Implex’s Hedrocel biomaterial, which later became known as Zimmer’s Trabecular Metal technology (TMT). Since 2009, Dr. Poggie has been President of BioVera, Inc. an industry consultancy for strategy and execution of commercialization of new orthopaedic devices, with a focus on regulatory affairs, device testing and applied research. Prior to BioVera, Dr. Poggie was Director of Global Brand Management at Zimmer, where he managed applied research, regulatory and clinical affairs for the TMT portfolio. He wrote the FDA and international submissions that resulted in numerous regulatory clearances for spinal, hip, knee and shoulder products, and created training materials for prospective surgeon users and sales associates. He previously directed Applied Research and Regulatory Affairs for Implex and was a senior research engineer for Smith & Nephew, responsible for metallurgical and tribological research. Dr. Poggie has published numerous peer reviewed papers and presented globally as invited faculty for conferences and education courses. He earned a BE in Mechanical Engineering and MS and Ph.D. degrees in Materials Science & Engineering, all from Vanderbilt University.

 



Related reading from BONEZONE®:
Resubmitting a 510(k) | Integrating Internal Strategies to Impact a Successful Product Launch
Rethinking the Role of Clinical Affairs