b'BIOFILM REGULATIONS ANDINTERDISCIPLINARY WORKSHOPSSTANDARDISATION IN THE MEDICAL DEVICEThe five interdisciplinary workshops we designed AND PHARMA SECTORS and led have seen 236 attendees with an NBIC, in partnership with the USA Centre for Biofilmapproximate mix of 60:40 academics and industry Engineering (CBE), organised a workshop on Biofilmpartners. These have all taken the format of Regulations and Standardisation in the Medicalexploring the key unmet needs from industry, how Device and Pharma sectors, which took place inthe current state of the science and technology Birmingham, UK, on 29 April 2022. The meeting waslandscape could address these requirements and, supported by a BBSRC Global Partnering Award.in doing so, developed a shared understanding The meeting was unique, bringing together over 40of the opportunities and challenges. The outputs representatives from industry, academia, metrologyfrom our five workshops are summarised below. and standardisation and regulatory bodies to map theFour of these represent our key strategic themes: current landscape, needs, trends and expectations inPrevent, Detect, Manage and Engineer. The fifth is a biofilm standardisation within the UK and to establishworkshop we ran on Microbe - Metal Interactions in industry and regulatory participation in a forwardconjunction with the Center for Biofilm Engineering.working group. Discussions were very candid, open and stimulating, with the aim of working together as a community to advance the field. The presence of international delegates was very useful and provided additional context to the discussions. Participants were asked to consider and debate two questions: What do you see as the current needs with respect to standards and regulations in your setting and business relating to biofilms? What do you believe should be (i) done in terms of concrete next steps by this group? And (ii) the overall long-term goals?The participants shared a plethora of differentBIOFILM PREVENTIONexperiences, needs, ideas and unique views on the subject. Nevertheless, several clear points emerged,In 2021, NBIC held a workshop aimed at exploring both from the pre-work feedback and from the in- unmet industrial needs and resulting research person discussions:questions in the field of biofilm prevention. Prevention There is both the opportunity and desire from therelates to impacting the early stages of microbial community to make progress in creating biofilm- adhesion and colonisation events at surfaces and the related standards.curtailing of the development of early-stage biofilms so that surface performance is retained. In many There is a strong need for a comprehensive review ofcommercial fields (e.g., medical, marine and the built standards, methods and practices that are currentlyenvironment) this is a primary need and is one of the in use by the community. Such a review wouldkey purposes of their products, for example to prevent provide a basis for a gap analysis and identificationcolonisation of indwelling or implantable medical of a pathway for biofilm standards development.devices. It is clear the question concerning the best It is clear that one size will not fit all due to diverseapproaches to prevent biofilm formation remains a sectors and applications and the complexity of thesignificant challenge to both academics and industry. biofilms themselves. It would be more practical to buildCommon approaches are aimed at modifying the a component approach, consisting of a base set ofsurface topology or chemistry of the target item or standards and guidance on how and when to use them.surface. This has resulted in what remain a number It is crucial that regulators are part of the standardisationof unmet or poorly met needs in the field of biofilm activities and engaged from the beginning. prevention which were explored at the workshop.Key needs that emerged were:The lack of suitable biofilm model systems to evaluate the impact of new approaches in the lab that are relevant and predictive for the end setting. It is clear that an improved understanding of the factors promoting or inhibiting biofilm formation is needed, and how this varies with different species. A much deeper understanding of the early colonisation mechanisms leading to biofilm formation is also required.34'