Developing emergency ventilators to support treatment efforts at the height of the COVID-19 pandemic.
Background:
We were approached by the NSW Government at the height of the COVID-19 pandemic to build 600 emergency ventilators within 28 days, helping efforts to support those suffering severe illness as a result of the virus.
In collaboration with innovation partners including The University of Newcastle, ResTech, NewieVentures and Safearth, we set about designing and developing viable ventilators that could facilitate the growing demand in the Hunter New England Local Health District (HNE LHD).
Solution:
Twenty engineers were tasked with developing four ventilator concepts, with a successful prototype to be delivered within the space of four weeks. Rather than focus on a single prototype, Ampcontrol and our innovation partners worked on multiple simultaneously, increasing our success rate and reducing project delivery time.
One of the approaches was to create a ventilator using commercially available parts. This was to avoid supply chain issues and minimise in-house design and manufacturing requirements.
Another prototype involved assessing ‘best of the internet’ ventilator models and adapting these to suit the requirements of Hunter New England LHD. However, these prototypes had limitations inherent to their operations. And with the changing nature of the virus, we needed to establish a model that would meet evolving treatment necessities. A pivot was made to use parts that had already been proven in industry, but many had to be manufactured locally due to export bans prevalent during the COVID-19 pandemic. What followed from extensive research and development, advanced manufacturing and innovation came functional prototypes delivered in the space of 11 days—an incredible feat in industry. And within 18 days of project commencement, testing with clinical staff at John Hunter Hospital was completed.
Leveraging our experience in Quality Management Systems (QMS) required for the production of Ex certified electrical equipment, a stringent safety and compliance process was implemented to ensure the reliability of the ventilators. The design team utilised existing ventilator test equipment with a bespoke test bench developed by our innovation partners. Continued testing and feedback from John Hunter Hospital clinical staff allowed the design to be iterated from prototype through to production. The team utilised what they referred to as “The Grandpa Test”, which posed the question at each assessment “Would you allow your grandfather to be attached to this device?” as a model for mitigating safety risks.
The NSW government then selected Ampcontrol to proceed to pre-production phase. Clinical user group assessment and testing with the Ventasys demonstrated compliance with TGA (Therapeutic Goods Administration) COVID-19 Ventilator Emergency Exemption approval requirements.
Outcome:
As a testament to partnerships, Ampcontrol in collaboration with its innovation partners delivered an alpha-prototype, beta-prototype, and 10 production “shelf-ready” TGA COVID-19 Ventilator Emergency Exemption approved ventilators within eight months. Ventasys exceeded expectations for an emergency ventilator, offering Synchronised Intermittent Mandatory Ventilation (SIMV-PC and SIMV-VC) modes as advanced care features.
