Challenge
Develop, manufacture and deliver safety critical ventilators in six weeks.
Approach
We worked with a UK manufacturer to adapt and scale their technology to meet the national specification for a COVID-19 ventilator. Starting from an existing design, we used an agile, systems engineering approach to manage multiple concurrent development activities: mechanical design, pneumatics and hydraulics, software and electronics, industrial design, human factors, risk management, testing, quality assurance, transfer to manufacture and technical file generation.
Outcome
The Emergency Ventilator Apparatus (EVA 1.5) was developed and design frozen in four weeks with verification, transfer to manufacture and technical file generation completed in six weeks. The full EVA 1.5 design and development history has now been transferred to the UK Government and the Crown.
The project at a glance:
Client
UK Government
Sector
Critical care
Services
Electronics
Software
Mechanical eng.
Human factors
Design
Testing
Industrial design
Quality assurance
Regulatory
Team staff on project
45
Timeline
6 weeks
In March 2020, COVID-19 posed an unprecedented threat to the UK health system and to the safety of the UK population. Facing a perceived risk of lockdown in global ventilator supply chains, the UK Government acted to bolster existing stocks of safety critical ventilators by issuing a challenge: can the UK industry use its ingenuity to develop, manufacture and deliver safety critical ventilators in just a few weeks?
This was an unprecedented timeline for a safety critical device but necessary due to an impending global emergency. The ventilators needed to be appropriate for mass manufacture and built from components which could be acquired from UK suppliers where possible. This ensured we avoided competition for materials commonly used in other ventilators as well as the risk of lockdown in global supply chains.
Lockdown and logistics
A national emergency demands an exceptional response and within 24 hours of being requested to assist, we had assembled an experienced team and established two priorities: identify an already existing ventilator on which we could base our design and secure everyone’s wellbeing and safety during lockdown.
"At Team, we are 100% focused on medical device development and know that no safety critical device has ever been developed from scratch to CE mark in a few weeks. We wanted to allow the fastest possible delivery and minimise supply chain risk, so we based our design on an existing UK ventilator proven to save lives under emergency conditions and in limited resource environments. Recognising that multiple organisations were seeking to source sophisticated ICU ventilators, our approach was to design a ventilator capable of functioning under worst-case lockdown conditions." Steve Blatcher, EVA Product Manager.
Our team quickly identified the ‘Helix’, a CE certified emergency ventilator, manufactured by Diamedica Ltd, a small UK family-owned business, as a system already proven to be capable of saving lives in limited resource settings. We met with Diamedica’s leadership team and established the trust and legal safeguards for them to be able to participate in the programme.
The key was to build a dedicated COVID-19 Emergency Ventilaton Apparatus (EVA) that would use the proven principles and control system of the ‘Helix’ but comprise components that could be readily sourced and scaled under lockdown. Working with Diamedica, we initially proposed a strategy to submit a technical file for EVA that built upon the existing Technical File for the ‘Helix’. However, regulatory experts did not consider a submission based on ‘equivalence’ to be appropriate, so the EVA technical file had to be built from scratch.
With the objectives and regulatory approach clarified, the project ramped-up to full speed with project managers, mechanical, electrical, software and systems engineers, industrial designers as well as human factors, risk management, quality assurance and design for manufacture specialists.
"We allocated and configured a dedicated building to allow the multiple groups to work together safely in accordance with the social distancing guidelines. We also rapidly built a dedicated pilot production area in our offices to allow design for manufacture ahead of transfer to production." Martin Bond, Head of Facilities.
"On top of having to re-configure our office space to accommodate for this extensive project, we ensured we screened employees daily for COVID-19 symptoms and focused on wellbeing and welfare of staff." Tracey Jacob, EVA Project Manager.
An agile systems engineering
Everyone on the team understood the rigour and quality required to build a safety critical medical device. We also ensured that the structure of an MDD compliant technical file was defined from the outset to allow the programme to focus on delivering fully reviewed and approved technical file documentation on an ongoing basis.
Fast, rigorous developments are a core part of Team’s capabilities. Our development teams were well versed and highly skilled in combining agile design sprint methodologies with robust testing and rigorous compliance standards. Concurrency depends on excellent communication, and in lockdown, we were still able to facilitate daily meetings in which the full team (45 engineers and specialists at its largest) were able to review progress against plan and the technical file deliverables.
It was critical to allow challenges and ideas from different workstreams to be openly discussed to quickly identify solutions and manage unforeseen impacts across different groups. Where conflicting requirements were not easily solved, the project managers used safety risk as the final arbiter to prioritise one demand over another.
Simple and safe instructions for use
One of the first questions that came up during this project was: who would be setting-up and using these ventilators under both best-case and worst-case conditions? Under normal circumstances, ventilators are used by intensive care nurses and intensivists. However, in March 2020 the MHRA were considering a worst-case scenario where less experienced healthcare professionals may be asked to support ventilator use outside of current Intensive Care Unit (ICU) settings.
"Due to COVID-19 we had to quickly implement an effective mechanism for video calls with clinicians who work with ventilators and had experience with COVID patients. Thanks to these early discussions and feedback, we learnt a lot about how things were done and used this knowledge to make EVA as usable as possible." Derek Dumolo, Human Factors Consultant.
"We focused on producing clear and simple set-up instructions. We wanted them to be clearly visible to all users, all the time; so we integrated them into the bodywork of EVA. We also ensured these instructions could be used by clinical staff and even potentially by non-clinical staff after brief training." Jess Fox, Human Factors Consultant.
Evolving ventilation strategies
As the pandemic progressed, so did clinical understanding and so did the priorities for ventilation strategies as defined in the national ventilator specification. Fortunately, as the risk of worst-case scenarios diminished, the need for emergency ventilators also diminished and the need for increasingly sophisticated, long-term use ICU ventilators came to the fore. While it remained prudent to continue the development of a limited resource capable ventilator, the challenge was determining how far the fundamental bellows concept of ‘Helix’ and EVA could be adapted to meet increasingly sophisticated ventilation requirements.
As an example, the ability to maintain ventilation and positive pressure in the lungs, while aspirating mucous at very high suction rates became critical for COVID patients. This was not possible for Diamedica’s ‘Helix’ bellows-style of ventilator. Our response was to perform a 48 hour design-sprint to find a solution: a simple suction adaptor, made from components already in the EVA supply chain. This allowed us to maintain a constant positive pressure in the lungs irrespective of the rate of aspiration. The adaptor was designed, prototyped, tested and confirmed to be an appropriate solution by the official test centre.
Close engagement with all stakeholders
In addition to the selfless commitment and great efforts being made by everyone at Team, we were also overwhelmed by the dedication and round the clock support that was offered by our key suppliers. In parallel to the development programme, Team’s commercial department dedicated their time to maintain close dialogue with the UK government, our ventilation challenge partners, and our manufacture partners, Cogent Technology Ltd., to ensure that we worked as seamlessly and efficiently as possible.
"We all shared test equipment which reduced timelines and cost, collaborated on a regulatory strategy and standards’ compliance to ensure a unified approach and worked together to try and stabilise the chaotic fluctuations in availability of key ventilator parts." Iain Ansell, Principal Consultant in the EVA Commercial Team.
The Emergency Ventilator Apparatus (EVA 1.5) was developed and design frozen in 4 weeks with verification, transfer to manufacture and technical file generation completed in 6 weeks. The full EVA 1.5 design and development history has now been transferred to the UK Government and the Crown.
"From over 5,000 offers of support received by the government, your design was picked out by an expert panel made up of clinicians, regulators and other technical professionals. On behalf of the Prime Minister and my Cabinet colleagues, I would like to pass on our sincere thanks for the many long hours, day and night, you have dedicated to designing and building these critically important devices." Rt Hon Michael Gove MP, Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office.