Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Susan M. Bowley, Ph.D. joined the Biologics Consulting Group, Inc. (BCG) as a Senior Consultant on April 15, 2008.

Susan received her Bachelors Degree in Mechanical Engineering from the University of Connecticut in 1988, her Master's Degree in Mechanical Engineering (thermosciences concentration) from Stanford University in 1992, and her Doctorate in Biomedical Engineering from the University of Virginia in 2000.

Susan has over twenty years of diverse experience as a Mechanical and Biomedical engineer. Her work on medical devices started as an undergraduate working on hip implant finite element analyses. Moving on to her first job out of school, she was hired by NASA Ames Research Center in California in 1988. During this time, she was also working on her Master's Degree in Mechanical Engineering. As part of her independent study project at Stanford she worked on development of a non-invasive medical device used to measure transpired epidermal water loss in premature infants. This device has been through several modifications since then, and a patent application was filed on the original device.

Susan's career then moved to the Life Science Division at NASA where she worked on various heat transfer and fluid dynamic analyses of Space Shuttle life science payloads. She also worked in the Biomechanics Lab under the mentorship of Dr. Robert Whalen during the time spent on her dissertation research where she studied the effects of bone adaptation to activity levels in humans. This work involved the development of a new non-invasive medical device used to measure daily activity in humans by monitoring ground reaction force events over time.

After thirteen years at NASA, Susan left in 2001 to pursue a post-doctoral fellowship at the Food and Drug Administration laboratories in Maryland. During this time, she was tasked with the study of blood fragility and hemolysis testing in medical devices. After about a year and a half of post-doctoral lab work, in 2002 Susan was hired by the FDA as a medical device reviewer in the Division of Cardiovascular Devices, working in the Interventional Cardiovascular Devices Branch.

Susan spent four years as a reviewer at the FDA working predominately on balloon catheters, arthrectomy devices, stents, and drug eluting stents. Most of her time was spent on reviews for the unique and dynamic area of development in drug eluting stents, being involved in all of the submissions for these novel products. Much of this time was also spent providing extensive input to both the existing bare metal stent guidance and the emerging drug eluting stent guidance document (recently released), along with working closely with the ASTM F04.30.06 task group. Susan spent her time as both a lead reviewer and engineering reviewer for various cardiovascular devices, including splitting about half her time doing engineering reviews for the Peripheral Vascular Devices Branch. Also, as her involvement in standards grew, Susan eventually took over as co-chair for the ASTM F04.30.06 Task group serving in this capacity for about one year prior to her departure from the FDA in 2006.

Susan moved out of the FDA and back to California, taking a consulting job at a forensic engineering firm performing analyses of accident reconstruction, product liability, and injury causation accidents. Susan also served as an independent medical device consultant for several small medical device companies in the Bay Area.

Susan brings expertise in Mechanical and Biomedical engineering with a broad background in development of medical devices, both from the research and regulatory points of view. She has an overwhelming knack to easily understand testing requirements for both new and innovative medical products, with a focus on engineering testing FDA would deem necessary and prudent, particularly where no prior FDA guidance exists. Serving as a lead reviewer for combination medical products has also given her the expertise to advise industry on additional aspects of a submission to the FDA including: manufacturing/CMC, animal testing, clinical testing, and biocompatibility recommendations.

As a Senior Consultant with Biologics Consulting Group, Susan will utilize her broad scientific education and professional experience in medical device development and regulatory affairs to assist clients with:

• Strategizing, preparation and critical review of all types of medical device regulatory document filings to the FDA including pre-IDE, IDE, 510(k) and PMA submissions
  
• Product development and research for drug/device and biologic/device combination products
  
• Product development and research for engineering testing and requirements for medical devices
  
• Preparations for FDA meetings
  
• Representing clients in interactions with the FDA
  
• Creation, implementation, and review of client-specific regulatory strategies
  
• Planning, writing, review of responses to agency questions
  
• Development of client training classes to help clients better understand the regulatory process as related to medical device submissions
  

View Dr. Bowley's Curriculum Vitae...

Page Updated August 21, 2008