At the start of the pandemic, I was asked by Welsh Government & Industry Wales to support C R Clarke & Co UK (Ltd) expedite the manufacturing of 80 CPAP ventilators for field trials. When I joined the project, it was only 7 days into development and needed to pass a series of milestones to gain MRHA approval (Medicines & Healthcare products Regulatory Agency) before being allowed to be used within any hospital or healthcare environment.
As the UK was entering the early stages of the pandemic and registered cases were in the thousands per-day, this project was not only time-critical but could be critical to supporting the country in managing patients through a very dangerous and lethal virus.
Several challenges need to be overcome for this project to be successful.
- Personal – As the rest of the country were being told to stay home and be safe, I was one of the small percentages of people still out on our roads and therefore putting myself in danger. This brought its own concerns and stresses on myself and my family on how to stay safe on a day by day basis and NOT bring the virus home to my love ones.
- Stakeholders – Throughout this project, there were many stakeholders to work and communicate with, not only on a day to day basis but when deadlines were tight, hour by hour. The correct information needed to be given at the appropriate time. As the project gain momentum, the number of stakeholders grew.
- Development – As this machine had a new approach on how to support the patient with Covid-19 the development was being down in the matter of days and hours instead of the normal months and years. To add to the complexity of this project the UK Government brought out a new less complicated guideline. Several prototype machines had been made over 10 days but when the new guidelines were issued a gap analysis was made to the latest version. This generated a technical list that we needed to address to close the gap so the unit could be ready for the field trials.
- Supply Chain – As we were on “Lockdown” many companies had shut or were running on minimal staffing. Trying to source standard components or consumables was just hard work. Due to the Government Ventilator challenge, many companies were trying to source the same items. By using my network and Social Media we over-come many of the roadblocks. I connected to a Senior European Executive on LinkedIn and asked him if he could help. He ran a large well know electronics supplier and within 24 hours he had put together a team to support our project.
- Industrialisation – With the projected quantities that may be required and specification of the unit becoming more complex there was a need to look at an industrialisation route with a larger electronics company that could support the internal electronics and manage the overall supply chain of a project of this size. Once the company was identified it was important to bring their team up to speed with the project status. Co-ordinating both teams was key to ensuring both groups were all aligned and knew what needed to be done. As time progressed the project responsibility moved from the R&D group to the industrialisation team.
- Social distancing – Working on any project with a condensed timeline is tasking for the best of project managers, but everyone involved was now working within environments and disciplines that had never been seen within everyday life. Ensuring everyone involved kept to social distancing and safe working practices was a key daily task.
- Testing – During the development of the unit it needed to be verified and tested within a medical test fixture. This was part of the many steps that we needed to go through to be given authorisation for the units to be sent for field trials. Limited test facilities were available, and we were given dedicated time slots for our units to be delivered and also picked up. Using a logistic company within my network was key in making sure we hit each delivery time.
Within 5 weeks the first CPAP units were developed, manufactured, past medical tests and delivered into the field for the next stage of sign off for MHRA. We then went on to complete a total of 80 units many of these used across Wales for fields trials. At this time, thankfully we did not need to build higher volumes as the number of cases of COVID-19 declined to a reasonable level and the NHS did not need the capacity to cope with demand. However, if the need arises in the future the work carried out so far would enable us to build higher volumes in a short space of time and support our NHS if required.Back to Case Studies