Services

E&A over its nearly 25 year history has generated a unique set of skills in medical device development. This multifaceted approach covers a broad range of services to take ideas from a conceptual stage into a finished product, while maintaining close attention on maximizing the value proposition for clients.

Consulting Services Provided by E&A

• Product design, engineering and development of manufacturing process including estimation of manufacturing cost
• Worldwide prior art, literature and patent search services to establish patentability of method, apparatus and system
• Development of intellectual property strategy
• Support the preparation of patent applications--U.S. and Foreign
• Assess clinical landscape to maximize total market size opportunity
• Assessment of competitors' market size opportunity
• Evaluation of regulatory pathway and potential predicate devices for use in regulatory filings
• Preparation of regulatory filings [e.g., 510k or 510(k)]
• Assessment of reimbursement pathway and associated requirements
• Prototype design, fabrication and bench-top testing
• In vivo animal testing (e.g., Ohio State University Medical Center)
• Preparation and application of verification and validation protocols
• Establish contract manufacturing sources where needed
• Assist client in establishing contact with clinical thought leaders in area(s) of interest
• Assist client in conducting clinical trials