When preparing for first-in-human studies, device teams face a critical question: what level of design maturity is sufficient?
In this video, TTP’s James Gooch explains how early clinical devices differ from final commercial products, why their risk profile can be lower, and how a structured risk management approach aligned with ISO 14971 helps teams determine what truly matters for safety.
He also explores the concept of a minimum viable clinical device, focusing development on participant safety and study objectives while avoiding unnecessary over-engineering at this stage.
Rethinking regulatory compliance
Find out how MedTech teams can use regulatory thinking early to avoid redesigns, accelerate progress, and build confidence in every milestone. Discover more.
About TTP’s Biosensing team
TTP’s biosensor device development specialists focus on creating advanced wearable and implantable devices, bringing together multidisciplinary expertise to deliver bespoke solutions for the most demanding requirements.
From exploring new frontiers to advancing your next breakthrough or accelerating your route to market, we tackle complex technical challenges with scientific and engineering discipline. We identify and mitigate risks early, ensuring outcomes that are both high-impact and centred on the needs of end users. When internal capacity is limited, TTP has the resources and know-how to step in and deliver.
