Framework for Rapid Acceptance of Technology

There has been an unprecedented response by many organisations and individuals to help provide the vast quantities of essential medical and personal protective equipment urgently needed by healthcare and social care workers during the COVID-19 pandemic. The press have indicated many workers do not have sufficient supplies of this essential equipment and as a direct result, many people wanting to help are developing and manufacturing ad-hoc designs, for example using home-based 3D printing. However, many small businesses and individuals working from home are inexperienced in supplying the health industry and have little or no awareness of its certification requirements.

Certification can be lengthy and time consuming, if established processes are not already in place for product development, quality control and certification. Even for experienced organisations, certification of a new product may take some time. In emergency situations such as the COVID-19 pandemic, where large volumes of equipment are needed urgently, there is minimal time for testing and certification ahead of acceptance. Suppliers need to be able to quickly understand what they must and can do in a very short timeframe to ensure their product is fit for purpose and will meet acceptance/certification criteria. The alternative is that much of this good-intentioned "volunteer" effort will be wasted.

The project will create a generic, but easy-to-use, framework, applicable across a range of technologies, to help developers achieve rapid acceptance/certification of technology for emergency response or urgent need. The intention is that the framework will support (i) equipment suppliers understanding minimal acceptance requirements for their product, developing and collating appropriate and necessary assurance evidence for acceptance, and (ii) acceptance/procurement authorities more efficiently reviewing the submitted evidence of the product's fitness for purpose and certification when required.

The project will adapt established technology qualification, certification and quality management best practice to create a fast-track framework to help suppliers to "de-risk" technology in preparation for accelerated certification and more rapid acceptance by relevant authorities. The framework will use a risk-based approach to facilitate an accelerated route to acceptance whilst addressing the risks and reliability requirements associated with safety-critical items, such as PPE. It will be trialled as part of the project with a small design and manufacturing company.

The framework will be provided as a Microsoft Excel tool and will be made freely available. The project partners will also offer support services for those seeking further assistance with its application.

Significant interest in, and positive feedback to the tool, has been received both for COVID-19 response products and for wider industry application. Therefore industry bodies and research organisations have been invited to become “ambassadors” for the tool to raise awareness across different industry sectors and promote wider application of the tool and its associated benefits both for developer organisations and to meet the UK’s needs for urgent COVID-19 response products. Training will be developed and provided both for the ambassadors and for users of the tool with a number of training sessions delivered free over the project extension period. The objective is that this training and the ambassador network will provide greater awareness of the tool, increased uptake of its use and greater success for the products and technologies that use it.