Sagentia Ventilator – UK Government

Our client asked:

Sagentia Medical was selected by the UK Government to develop a new ventilator design suitable for rapid manufacturing scale up with minimised supply chain risk. Sagentia Medical deployed a cross functional team of 80 FTEs to go from specification to regulatory submission in rapid development.

The project story:

The design philosophy was based on fabrication of parts rather than use of OTS components that were required by other ventilators to scale up their production lines at that time. We deployed a large, in-house team to work weekends and extended hours to fulfil the unprecedented development timescales for a medical device of its kind. There was collaboration with other local, and normally competing, consultancies that were all united in the common goal yet each developing their own ventilators in parallel. There was also intense, rapid part procurement from a large network of suppliers. To enable rapid development, no software was built into the system. We established an in-house manufacturing line which was assessed by a notified body, to ensure rapid transfer to manufacture. Finally, we completed the Technical File submission to UK Competent Authority (MHRA) for exceptional restricted use approval.

Results: deliverables and outcomes

• From specification to regulatory submission in 5 weeks and 3 days

• The system can ventilate stiff lungs of COVID-19 patients

• Low oxygen usage

• Volume controlled; pressure limited ventilation

• Control of FiO2, PEEP, PIP limit

• Alarms for safe use

• Simple and intuitive UI for non-specialists

• Assist mode for patients taking spontaneous breaths

• O2 bypass adapter to use during suctioning

• Sagentia Medical Ventilator was one of the 5 designs that remained in the final stage of development