Algorithmic Driven Data
FREE for viewing
Assessment of your innovation and existing FDA approved devices,
for a quick glance of what program costs and time might look like.
Free for Clinical Innovators
Curious
Create a Feasibility Study | ~10min.
YOUR INPUTS
Real-Time Preview in 5 minutes
Generates instant ballpark results based on non- proprietary information.
24 simple product questions
These questions help us evaluate the use of the product you are developing and how it compares to known data.
STUDY OUTPUTS
Comprehensive Report with Graphs
Our review discusses in detail, the impact of the state of your technology; development challenges (which are items that bring greater development uncertainty); And other associated information related to the engineering, regulatory and manufacturing challenges of device development.
FDA Product Classification
Our report evaluates the data and provide feedback on potential FDA classification; providing you a start point for research.
Feasibility Score
The Feasibility Score provides an assessment of your project’s path to market, with higher values indicating lower complexity and fewer anticipated obstacles.
Compliance Service Fees
Estimates for general guidance, submission and FDA fees.
Compliance Costs
Estimates for FDA recognized compliance tests; consultant fees; FDA fees; and Design Control Costs.
Engineering Cost
Estimates engineering fees and expenses including prototype and pre-production tooling.
Development Cost and Time by Phase
Graphs the total development costs and time broken into 5 phases.
Most start-ups look back in wonder at the project path they took.
We provide a pragmatic method of looking forward so you can anticipate costs, processes, and risks to make confident decisions.