Eric Bannon, senior consultant, has over 30 years of experience providing clinical and regulatory support for medical device companies. His expertise focuses on implementing creative regulatory and clinical strategies from development through commercialization with experience in multiple therapeutic areas including Endoscopy, Orthopedics and Gastroenterology and Metabolic Diseases.

Clinical Strategy and Implementation

  • Built a clinical operations team to support execution of 350 patient trial including CRO management, case support and recruitment to goals
  • Successful completion of OUS first in human trials to support procedural development efforts and establish acceptable safety profile
  • Integration of CMS recommended reimbursement measures into spinal stenosis trial that led to significant coverage of trial execution costs
  • Coordination of multiple clinical programs to support type 2 diabetes indication in the US and EU

Regulatory Achievements

  • Coordinated and led the successful approval of IDEs for hydrothermal ablation catheter for Type 2 Diabetes, suture fixation device for reflux disease and metallic implant to treat spinal stenosis.
  • Developed and executed successful strategies that led to early CE Mark approvals for class II and III devices in the EU
  • Successfully navigated worldwide approvals for initiation of pre and post-market clinical trials in US, EU, Canada and South America
  • Coordinated multinational commercialization effort for broad line of sports medicine devices in EU, Japan, Canada and Korea

Eric received his BS in microbiology from the University of Maine at Orono.

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