Vivaldy

 
Products become increasingly intelligent, connected and linked with the physical world. Cyber-physical systems (CPS) cause disruptive changes to products, services, business models, and markets. Key aspects of advanced industrial CPS are (i) regular component upgrades (AI, SW, modules and HW) after initial product release and (ii) application of AI techniques to add extra value. A consequence is that the initial verification and validation for CPSs rapidly loses its evidential value throughout the product lifecycle. This holds in particular for professional healthcare systems where patient-safety is paramount. Companies like Philips and Barco face the challenge for cost-efficient re-verification, re-validation, and certification of incremental CPS upgrades ensuring its intended use while being competitive with the development speed of American and Asian companies.

An incremental upgrade release-cycle for (AI enhanced) healthcare CPS promises rapid incremental dissemination of innovations, a better response to fast changing public health challenges, augmenting patient engagement, and improving the quality of care of patients. However, an agile regulatory paradigm to accommodate the faster rate of new product introductions – while ensuring that existing standards of safety and effectiveness are met or exceeded – is still lacking.

This challenge is taken up by the Vivaldy consortium by realizing efficient re-verification & re-validation and effective regulatory approval guidelines for the incremental upgrade of class II, AI-enhanced CPSs in the professional healthcare domain. The Vivaldy KPI’s are to increase the frequency for (i) major system upgrades from 3 years to once a year and (ii) for module and/or AI upgrades from once a year to once every 6 months.

Vivaldy will address re-verification and re-validation by analysing field obtained user/usage data, change-based impact analysis, and integrated virtual and physical testing. Results will be proven on 4 industrial use cases each targeting a specific type of upgrade ranging from hardware, component, to AI applications. Via regular discussions with healthcare certification bodies and partners active in other safety-critical industry domains, Vivaldy will disseminate its results & guidelines to a wider audience, reflect on their experiences, and contribute to standards for certification.