Embracing a Penta helix hub framework for co-creating sustaining and potentially disruptive sterilization innovation that enables artificial intelligence and sustainability: A scoping review

The supply of safe pipeline medical devices is of paramount importance. Opportunities exist to transform reusable medical devices for improved processing that meets diverse patient needs. There is increased interest in multi-actor hub frameworks to meet innovation challenges globally. The purpose of this scoping paper was to identify critical decontamination and sterilization needs for the medtech and pharmaceutical sectors with a focus on understanding how to effectively use the Penta helix hub framework that combines academia, industry, healthcare, policy-makers/regulators and patients/society. A PRISMA scoping review of PubMed publications was conducted over the period 2010 to January 2025. Thirty of the 124 ‘helix hub’ papers addressed innovation where only 3 of 16 healthcare-focused helices used or mentioned the need for key performance indicators (KPIs). Early-phase helix innovation ecosystems are mainly supported by qualitative or non-empirical data. This review explores multi-actor needs along with describing quantifiable KPIs at micro (end-user), meso (innovation hub) and macro (regional, national and international) levels. This integrated Penta hub approach will help to effectively plan, co-create, manage, analyse and utilize voluminous data, for example there are ca. 60,000 and 56,000 publications per year on artificial intelligence (AI) and medical devices respectively along, with some 35,000 adverse reports on devices submitted to the US FDA. This review addresses sustaining and potentially disruptive opportunities for decontamination and sterilization that includes the use of AI-enabled devices, bespoke training and sustainability.