UK manufacturer Portsmouth Aviation has appointed 42 Technology (42T) as a strategic development partner to help bring its unique Exovent negative-pressure ventilator (NPV) system to market.
42T will be responsible for the design and development of the control unit, monitoring and alarm system for the new medical ventilator, including system hardware, firmware and rigorous regulatory compliance. The consultancy’s medical device engineers will then work closely with the development and manufacturing teams at Portsmouth Aviation, along with clinicians from the Exovent charity, to successfully integrate the control system into the ventilator.
The work will comply fully with IEC/EN 60601 standards for the safety and performance of medical electrical equipment and will involve the development of class C safety-critical software to meet IEC/EN 62304 standards.
‘42 Technology will play a pivotal role in developing the control system for the Exovent ventilator, and their medical device engineering and regulatory experience will be essential in helping us to advance it into initial production and first clinical trials,’ said Simon Escott, managing director of Portsmouth Aviation. ‘42 Technology’s appointment follows a complete review of the development programme and series of improvements that we decided to make to the initial designs for the new ventilator. We have worked closely with the team at Exovent to improve key aspects, including the usability and aesthetics of the patient enclosure, noise levels and the seals around the patient. We have also modified the design so units can be more easily and cost-effectively manufactured using our existing in-house production technologies and teams.’
The Exovent NPV system is being developed as a convenient, lightweight device that encloses the patient’s torso from neck to hips. The system allows patients to talk, drink and eat normally while being ventilated, unlike traditional positive ventilator systems, which require patients to be sedated and intubated or wear a mask.
The Exovent NPV system was first proposed and designed by a group of anaesthetists, critical care consultants, medical clinicians, engineers and others who set up a task force in March 2020 in response to the Covid-19 crisis and inspired by the UK government’s Ventilator Challenge.
Although the government’s initiative was subsequently disbanded (and they were only looking for innovations in positive-pressure devices), the volunteers have continued their mission by setting up the Exovent charity to help raise awareness of the potential benefits of negative-pressure ventilation.
The charity transferred its initial system designs to Portsmouth Aviation in 2021 and the Exovent NPV system is now being developed by a strategic partnership between the company and the charity. Portsmouth Aviation will be the legal manufacturer of the device but will use its subsidiary healthcare company, Illustrious Healthcare Solutions, for marketing and sales.
42T’s appointment follows an earlier successful project by the consultancy to review the proposed control-system architecture for Exovent NPV. This led to a recommended improvement in how the monitoring/alarm system, main controller, pump assembly and user interface could be effectively segregated as distinct parts of the system. The new approach significantly reduces the reliance on safety-critical software, minimises development risks and will ensure a fast-paced development while prioritising safety and security.