Clinical Trial with Human Factors Validation

Med tech company's clinical and systems engineering team were moving into the pilot clinical trial with a system that was considered final (device and implant procedure). The Human Factors team was circled in to do formative testing during the pilot clinical trial for feedback of the device.

Lack of combined path to market was slowing down the go to market strategy. Moving into the pilot without the expectation of changing the design deemed formative testing irrelevant. The risk documentation was written incorrectly, and all three items were pressing. 

-Work with all three teams to find alignment for the validation/go to market process.

-Re-worked the risk documentation updated prior to pilot clinical trial.

-Talked the team into validation the product (device interactions and implant procedure) in the pilot 

-Send the validation to the FDA for approval.

-The HF team validated the product in the pilot clinical trial parallel to the clinical team.

-The submission for validation and approval for larger clinical trial was granted by the FDA 180 days after submission.

-Med tech’s successfully validated a new implant procedure during the pilot clinical trial removing user risk from the remainder of the validation process. 

-This saved Med tech millions in R&D by avoiding a simulated use validation study and enabled them to reach the market just four years after submission