“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective;…
Our process including design and development
Project success is dependent on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. We follow a structured, phase-gated process that allows for a disciplined product development approach. Our process encourages an early focus on clear problem definition and de-risking a wide variety of potential solutions.
From the 30,000 foot level, the phases can be reasonably defined as:
- Manufacturing transfer
By later phases, the funnel of design options narrows significantly, converging on a final product that has been thoroughly shown to meet the customer needs and is ready for commercialization.