make it work the first time
With a small team and limited budget, bring a new vessel sealing technology from concept to product as rapidly as possible.
Identify and address the highest risk items first, allowing:
The technology to evolve toward a final state as rapidly as possible.
Rapid discovery of barriers and rapid mitigation or redirection.
The key was to ask well-poised questions and answer them with actionable data as rapidly as possible.
My three person team was able to achieve an extremely rapid experimental cycle. A typical experimental cycle generating actionable results---concept generation, system modification including machining of new parts, data collection, and analysis---took less than 4 days.
To achieve the fastest possible results, we refined the technology with a bench-top model system before building device prototypes for in vivo testing. The quality of our bench top model was validated when in vivo testing simply confirmed the high performance seen on the bench.
A final cycle of in vivo testing was performed with a top surgeon performing the procedure and providing feedback on the performance of our device. Our technology “simply worked.” It produced high-quality, reliable seals with performance improvements that were obvious to the surgeon.