Endo Vascular Associates, a medical device startup was established to develop a minimally invasive procedure and related hardware to treat Abdominal Aortic Aneurysms (AAA)…the 13th largest killer of US citizens…and to bring the resulting ‘system’ to market. Our consultancy was engaged to assist this effort.  

Collaborating with EVA’s peripheral vascular surgeon, H. Trout MD. and his associates we performed an expansive subject literature search re: causative disease process/pros-cons of current surgical approaches and observed surgeries. Our report detailed the • effectiveness/relevance of current treatment modalities • possible alternative approaches/technologies • windows of opportunity for an alternative approach.

Guided by these findings, consultancy led the program…project inception to successful FDA monitored animal trials…and in doing so discovered a unique, beneficial, patentable surgical approach and concurrently, related hardware solutions. A 2nd generation product development group continued the program’s advancement towards human trials.

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Contributions:

 

Subject Matter Research • Concept Exploration • Technology Evaluation • Product Design/Visualizations/Documentation/ Prototyping/Evaluation • Development to FDA Trials • Material/ Processing/Finish Specification