Sandra Schaerer and Karolina Snajdarova are Regulatory Affairs Managers at Ypsomed. We spoke with them about where programmes actually slow down on the device side, and what a different approach looks like.

Device development isn’t usually where sponsors expect their programme to stall, but it often does. Why?

Sandra Schaerer: Because the risk tends to be invisible until it isn’t. Sponsors understandably focus first on the molecule, formulation, and clinical strategy, and the device gets treated as something you sort out later. The issue is that “later” is exactly when your options narrow. If you discover a regulatory gap when the design is already fixed, closing it means creating additional documentation, repeating verification work, adding usability and bridging studies, and losing time. That is why regulatory thinking needs to start early, while there’s still room for flexibility in the device and submission strategy.

What does that early regulatory involvement look like in practice?

Sandra Schaerer: We run what we call a regulatory radar, continuously tracking global regulatory requirements and authorities’ feedback, and contributing to standards like the ISO 11608 series, so that when requirements change, we’ve anticipated them rather than absorbed them. For sponsors, that means fewer late surprises, stronger device documentation, and submissions that behave more predictably. This is especially important in fast-moving market areas such as biologics, biosimilars, GLP-1s, peptides, and therapies shifting toward at-home administration. That predictability and readiness have real commercial value.