Astrimar, a specialist engineering consultancy, with a track-record helping technology developers through product approval, has won a grant worth £50,000 from Innovate UK, the UK’s innovation agency, to develop a new online tool to help product developers gain rapid acceptance of technology in response to the current Covid-19 pandemic.  

The easy-to-use tool, will be freely available later this year, to help meet the urgent need for emergency product acceptance, and will apply across a range of technologies. The tool will lead the developer through a series of questions to help them define technology and user requirements, to understand how to demonstrate and document fulfilment of the requirements so the technology can be verified/approved for use by the end-user. The tool will also support acceptance/procurement authorities reviewing the submitted evidence of the product’s fitness for purpose and certification when required.

Whilst there has been an unprecedented response by many organisations and individuals to help provide the vast quantities of essential medical and PPE urgently needed by health and social care workers during the current COVID-19 pandemic, many of those inexperienced in supplying the health sector, were unaware of the certification requirements. Gaps in product development, quality control and certification processes resulted in potential wastage of uncertified and unusable medical and PPE products.

Caroline Roberts Haritonov, Astrimar Managing Director said:  "We believe this tool will help hundreds of small-scale producers who have responded to the pandemic with stocks of goodwill PPE and medical components, but are currently restricted from use due to lack of necessary certification and approval.  We are delighted to receive the funding to enable us to develop and prove the concept, trial it as a prototype and launch it for wider use, both for the current and any future crises."

The funding will be used to develop the software tool and to enable collaboration with experts in advanced manufacturing at the National Manufacturing Institute Scotland, operated by the University of Strathclyde, product certification at Lloyds Register and the Medical Devices Unit at NHS Greater Glasgow & Clyde, to achieve clarity on acceptance requirements and effective best practice.  Astrimar aims to develop the framework tool for accelerated technology acceptance and trial it with developer Angus 3D Solutions Ltd to help them gain acceptance for their ventilated PPE hood concept, before making it available to a wider market of technology developers over the next 12 months.

Robin Sayer, Technical Operations Manager and Head of Mechanical Engineering, Medical Devices Unit, NHS Greater Glasgow and Clyde said: “NHS Greater Glasgow and Clyde’s Medical Devices Unit have been integral to the rapid qualification and acceptance of medical devices and PPE during the Covid-19 pandemic. We will be sharing this experience to help ensure the framework is optimised to address the needs of the NHS for future emergency scenarios.”

Founded in 2010 and based in Bedfordshire and Aberdeenshire, Astrimar offers reliability engineering, technical risk management and technology qualification assurance services.  The company helps customers to understand the barriers to product development and deployment and risks to technology success, helping them develop the necessary assurance for technology approval and acceptance.

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Image courtesy of NHS Greater Glasgow and Clyde.

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