iThera is a technology leader in clinical and preclinical optoacoustic imaging. Combining highly optoacoustic imaging with ultrasound, they achieve unique image quality and resolution. The latest generation of devices was also to be marketed in the USA. In particular for the software, this raised the question: what could be adopted and what needed to be redeveloped? Zühlke was tasked with analysing whether the quality of the software for the research system was sufficient to meet FDA requirements and enable it to obtain approval for the US market.

Zühlke carried out an initial assessment to examine key questions relating to the software architecture, code base, documentation and approval. Short workshops were held to examine key topics. These included fitness of the architecture, the quality assurance process, approval strategy and an evaluation of the planned extension. These were followed by targeted consultancy work from Zühlke on cybersecurity and software architecture for FDA approval.

Zühlke’s goal-focused, needs-oriented consultancy avoided a highly complex redevelopment process and reduced development costs. Zühlke identified an alternative approach involving carefully targeted actions to address points of vulnerability, for example closer coordination with the notified body/FDA, improvements to the documentation and a lightweight refactoring of the codebase to improve demarcation between different software items.