Sucheth Koppa
Head of Software V&V, Computational Science & Informatics Roche
Mr. Sucheth has 20+ years of experience working extensively in various areas of software engineering such as Development, Testing, V&V and Support across Bio-Technology, Medical Devices, Software Services and Semiconductor industries. He has spent the last decade in Oncology informatics, specifically building Next Generation Sequencing (NGS) and Digital Pathology informatics solutions for Research and In Vitro Diagnostics markets. He is a strong advocate of SAFe development practices and has been part of the AAMI Software Working group that is responsible for TIR45, Guidance On The Use Of Agile Practices In The Development Of Medical Device Software.
Seminars
This dynamic fishbowl debate brings engineers, clinicians, and regulatory leaders into a rotating inner‑circle conversation, creating a rare, real‑time exchange between those designing AI systems, those deploying them, and those overseeing their safety. With audience members stepping into the discussion throughout, the session becomes a living model of the very human‑machine interaction it examines.
- Discuss how assistive, decision‑support, and autonomous AI shift risk, validation, and oversight, enabling attendees to match autonomy levels to the appropriate regulatory and safety strategy
- Examine where AI improves consistency and where it introduces over‑reliance or hidden errors, giving participants clearer judgment on when human review adds safety value
- Explore how claims, labelling, and clinical context constrain autonomy, helping attendees align design decisions with regulatory positioning
- Break down models for “human in the loop,” “on the loop,” and supervisory control guiding teams to design workflows, interfaces, and monitoring that meet regulator and clinician expectations
- A high level look at how AI/ML is embedded in biotech and oncology solutions and how current approaches differ from earlier ML
- What modern AI tools support engineering teams during software development, from code assistance to design and implementation, in regulated medical device environments
- Emerging uses of AI in testing and validation, including intelligent or agent based methods for evaluating software behavior and their impact on quality and compliance
