Ventilator Regulation and Preparation for Manufacture
Design and Testing
Since our last update a few weeks ago, the team has spent many hundreds of design hours improving on the second version of the prototype. This design review has been driven by a requirement to improve performance, eliminate any design weaknesses identified during testing and continuing our drive to reduce the final production costs.
Our ventilator test equipment includes gas flow analysers, test lungs, electrical test equipment etc. Over a number of weeks, we have been using this equipment to develop the test protocols and have been evaluating the best approach to implementation. Ventilators have remained on testing rigs for up to 12 days of continuous operation over the last few weeks. The system has worked well and has allowed us understand where we needed to make some improvements to function, usability and help improve the design for prolonged, maintenance-free or minimal maintenance endurance.
Even as an emergency device, the documentation required to get an invasive ventilator approved for use is understandably extensive and the project regulatory team are meeting this challenge head-on. Apart from the design documents which include:
· Drawings (example shown above)
· Bills of Materials
· Individual Component Specifications
· User and Maintenance Manuals
· Instructions for Use (IFU)
· Risk Benefit Analysis
· Clinical Risk Assessment
· Usability Test Protocol
· Functional Test Protocols
· Electrical testing protocols
· Standards Compliance Matrices
We have engaged with the Irish Health Products Regulator Authority (HPRA) and the Department of the Health, have had several meetings and submitted significant documents as part of the process which is now underway.
We have initiated discussions with potential manufacturers. We are exploring with companies what they might need if they were to become a legal manufacturer of the ventilator and where in the world this might be. This process of establishing a legal manufacturer that is convincingly competent is a key requirement of all the regulatory authorities around the world.
Once initial testing of this final protype is complete we expect to build between 10 and 15 further identical machines. This is required to satisfy the full testing requirements of the regulatory authorities and to allow us have some machines that we can share with prospective legal manufacturers and potential users for evaluation. We will produce the full manufacture, assembly and production test protocols and documentation and this will be required for full production.