Collaboration and problem solving were the key elements to success
The team faced significant challenges in preparing for volume production. The Plexus Supply Chain, Transition Management, Legal, Quality, Design and Manufacturing Engineering teams worked collaboratively with our suppliers and our logistics teams to resolve the constraints of a rapid ramp to production.
Due to global surge in ventilator production, our Supply Chain team overcame a number of challenges as they established a supply of materials that would keep the project on track. Faced with shortages for multiple parts, the team leveraged innovative thinking and problem solving to identify alternative parts and possible sources. A number of alternative parts, including a power supply, required in-depth quality and performance verification prior to being approved. Due to strong existing relationships, our suppliers worked in partnership with us and, in many cases, went above and beyond to ensure we could meet key project milestones.
The test engineering team worked to implement additional functional tests to ensure compliance to the demanding regulatory requirements. Plexus’ Transition Management, Quality Assurance and Regulatory teams rose to the challenge of creating significant content for a new technical file, something that was not in the original scope of work. This was required to support device approval for use as the project had evolved from manufacturing under Diamedica’s existing CE marking and product registration, to manufacturing directly for the UK Government under the RMVS (Rapidly Manufactured Ventilator System) program using the “Exceptional use of non-CE marked medical devices” approval by the MHRA (Medicines and Healthcare products Regulatory Agency).
The Plexus production team in Kelso adapted well to the changing environment. To support the rapid schedule, while also ensure our team was safe and able to adequately socially distance, multiple changes in shift patterns were required to accommodate the COVID-19 environment and keep our employees safe.