Eric Bannon is Senior Vice President of Regulatory and Clinical Affairs at AlvaMed. Eric has 40 years of experience providing regulatory and clinical 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 both in the US and abroad.
Regulatory Affairs
- A small company developing a pediatric implant for a gastrointestinal disease had limited resources to create a strategy and FDA submissions. Eric led a cross-functional team to define the regulatory strategy and author the Investigational Device Exemption (IDE) leading to FDA approval for the first human clinical evaluation in the US.
- Working with the internal team developing a SaMD with limited regulatory experience, Eric led efforts to define the regulatory and clinical pathway through the FDA Q-Sub process resulting in successful IDE approval. He also successfully executed the significant risk determination submission and classification request per 513(g).
- Has authored numerous Regulatory Plans, Opinions and Q-Sub submissions to define regulatory pathway, test plans and clinical strategy for US and EU companies looking to enter the US Market.
- Challenged by a difficult process to expand the indication for use for an existing endoscopic device, Eric successfully utilized the Q-Sub process to define the De Novo pathway and worked with the internal team to submit and successfully complete the De Novo classification process.
- Successfully completed 510(k) submissions in woman’s digital health, orthopedics, endoscopy, neurology and ENT products among others.
Clinical Affairs
- Working with a start-up neurovascular company with a challenging timeline to complete its first safety evaluation outside the US, Eric and the AlvaMed team identified potential geographies and working with the team drafted study protocol, consent and CRFs leading to successful launch of the study.
- After a successful IDE review, the AlvaMed team completed all clinical study activities to support the US based First in Human study. These included authoring all study documents, database creation, DSMB management and study monitoring.
- Successful completion of both US and OUS first in human trials to support procedural development efforts and establish acceptable safety profile.
- Integration of CMS recommended reimbursement measures into trial that led to significant coverage of trial execution costs.
- Coordinated protocol development for pilot and randomized pivotal clinical trials including study endpoint definition, sample size determination and novel staged designs.
Eric holds a B.S. in microbiology from the University of Maine at Orono and is a member of RAPS.
