PenMed are using state of art technologies to develop the P3, a modular anaesthesia and ventilator system to improve efficiency and safety in high-risk critical care environments.
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“A patient was transferred from theatre, post operatively on a portable ventilator. In the ICU they were connected onto an ICU ventilator, but quickly desaturated and cardiac arrest ensued. CPR was commenced and the ICU ventilator was found still to be in ‘stand-by’.”
PenMed is led by a senior management team with over +60 years of experience in critical care, product design, regulatory compliance, intellectual property, high-tech manufacture, MedTech and commercialisation across multiple sectors.
Dr. Sebastian Brown MA (Cantab) MBCHb (Oxon) FRCAAs.
Seb is a doctor in Anaesthesia and Intensive care, with a background in immunology/virology and anaesthesia research. In 2015, Seb invented and patented a system using supercritical carbon dioxide for the recycling of volatile anaesthetic gases and co-founded SageTech Medical Equipment.
David has worked in major medtech corporates such as Genzyme and Janssen-Cilag and most recently Baxter in the role of Commercial Director for Europe. Before joining PenMed he was Innovation Lead at the University of Exeter focusing on managing an EDRF programme to support SMEs.
Simon is managing director and owner of Bristol Fluid System Technologies (T/A Swagelok Bristol), Simon leads the strategic management and direction of the company. Prior to purchasing the company in 2010, Simon held a variety of positions at both Swagelok Bristol and one of its principle suppliers, Swagelok Company, a $2.0Bn privately held US company.
Steve has worked in lead Quality Management and production roles under GMP (GSK and Ministry of Defence, Porton Down) and under medical device legislation (MDD). He has led the implementation of ISO9001 at PenMed (currently awaiting 2ndstage assessment) and compliance with ISO13485. Steve leads Transfer to Production.
Alex Chu is the Engineering Manager for BFST and leads risk evaluation for the P3, ensuring engineering compliance to user and regulatory requirements.
Jennifer has worked for 9 years as a qualified lead 9001 external auditor. She has been operations manager at BFST for 7 years, successfully leading SAP integration, cyber essential skills deployment and supply chain accreditation to JOSCAR aerospace, defence and security sectors. She has delivered outstanding rated ISO9001 audits at Swagelok Bristol for the past 8 years. Jennifer worked with Steve Yates on Transfer to Production and QMS compliance.
PenMed have established a network of engineering, clinical, academic, R&D and supply partners with complimentary expertise and capabilities with a track record of success in their respective fields.
PenMed has successfully funded the R&D programme through several grants from Innovate UK, European Regional Development Fund (ERDF), the Centre for Process Innovation (CPI) and the NIHR i4i programme.
PenMed works closely with Bristol Fluid Systems, its partner for the UK Ventilator Challenge, to establish manufacture in the UK and deliver a market-leading, made-in-UK solution for the NHS and export.
PenMed was awarded IUK grant funding to build on their significant progress during the ventilator challenge. This will support the integrate of the ventilator technology with anaesthesia systems and further collaboration with Swagelok Bristol, the Plymouth College of Art (Fab Lab), University of Exeter and Cambridge base TEAM Consulting.
The National Institute of Health Research (NIHR) i4i Connect Committee approved funding of PenMed’s application which will support the development of PenMed’s prototype alongside Clinical and Patient engagement. ‘PenMed are delighted to be working with the NIHR to provide a UK designed and manufactured, safer and more efficient ventilation solution for the NHS’ say Dr Seb Brown.
Innovate UK, CPI and ABHI have developed the Health Technology Regulatory and Innovation Programme to support small and medium-sized (SME) businesses to navigate the complex and ever-changing HealthTech regulatory landscape. PenMed is delighted to have been awarded funding under this programme to support the development of their Quality Management Systems. PenMed’s device is in the detailed design phase with planned manufacture in Bristol.
PenMed has applied with key collaborators for the BMC funding to support the final development of a novel modular device for use in the critical care environment. The project in the final stages of prototyping and user testing which will allow PenMed to take the device into first in human studies to demonstrate safety towards regulatory approval. The NHS spends over £140m on these types of devices and PenMed system provides the UK with a market-leading device in critical care and anaesthesia.