At a time of such momentous change, it is hard to focus on actively supporting our researchers of the future. It is a core principle of ETHOS that we do all we can to support development of evidence-based approaches to the deployment of technology. Especially where that technology is likely to interface directly with patients and the public.
It was in this vein that we were happy to get involved with the @UCLSTEaPP research project looking at regulatory and security challenges for connected and intelligent medical devices.
STEaPP research students were looking for a wide range of voices to provide industry insights into the challenges across the product lifecycle. In partnership with BSI, the research project focuses on medical devices, regulatory challenges, and innovation. Specifically, the regulatory and standardisation challenges for connected and intelligent medical devices.
It gave us time to reflect on ETHOS experiences of working with companies striving to build a holistic safety offer across clinical safety, cyber/information security, and medical device international regulation. This in the context of human centred design and accessibility and meeting the needs of our most vulnerable and digitally excluded communities.
One of our take home messages was the difficulty organisations entering this market face trying to navigate standards and regulation.
We urge that a more simplified format and approach with open communities to progress case studies. Examples and guidance will encourage innovation within the boundaries of ‘state of the art’, standards and regulations and not perceive them as barrier.
Why would you enter a market and wish to sell any product or service without a diligent approach to basic good manufacturing process?
We hope this debate will continue and look forward to the results of the STEaPP research. For more on UCL STEaPP check out their work: https://www.ucl.ac.uk/steapp/
