AlvaMed is pleased to introduce two new members to our team, Eric Bannon and Roberta Hines. With our expanding client list and one stop shop for regulatory, quality and clinical services, AlvaMed has grown our team to include two highly experienced regulatory and clinical consultants.
Eric Bannon is a highly accomplished regulatory and clinical consultant for over 30 years with extensive global experience in successfully implementing creative regulatory and clinical strategies from development through commercialization. He has experience in multiple therapeutic areas including Endoscopy, Orthopedics and Gastroenterology and Metabolic Diseases.
Clinical Strategy and Implementation Achievements:
- 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
- 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
Roberta Hines has over 30 years of experience managing regulatory, clinical research and quality assurance projects. She has extensive expertise in Class II and III devices including, surgical and percutaneous implantable cardiovascular devices, various interventional cardiology devices including bare metal and drug eluting stents, combination drug/device products, implantable and percutaneous peripheral vascular devices, implantable orthopedic devices including replacement knees, anterior cervical plates, hips and interbody spacers, bubble CPAPs and ventilators, diagnostic and implantable pulmonary devices, and various ancillary accessories and equipment including software and hardware driven devices. With her experience in strategic regulatory and clinical research planning, Roberta guides companies into bringing their products from concept through global market introduction in the fastest time possible.
- Four PMAs approved on porcine and pericardial heart valves;
- Many 510(k) clearances for a variety of devices including annuloplasty rings, guide wires, peripheralatherectomy devices, and pulmonary diagnostic devices
- Many IDE approvals for the above mentioned devices;
- ISO Certification and CE Marks for commercialization of a variety of devices;
- Successful outcome on device classifications with the FDA; and,
- Abbreviated path to market for a variety of CE Mark devices.
If your company is looking for quality, regulatory, and/or clinical support, AlvaMed has the experience and expertise to help. Please contact us at email@example.com or (888) 33 – 13485 and check out our website to explore the rest of the AlvaMed team.