Webinar - Getting an oncology IVD to market faster: what founders underestimate early on
In this 60-minute session, Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
In oncology IVD, the decisions you make earliest often cost you the most later. Intended use assumptions, sample strategy, study endpoints, these choices quietly shape your regulatory path, your timeline, and your credibility with investors.
Yet most founders only discover this when they're already locked in.
In this 60-minute session, Egbert Smit, CEO of MLA Diagnostics, and Annelies Rotthier from QbD Group unpack the clinical evidence decisions that trip up oncology diagnostic startups, and how to get them right the first time. Egbert brings the founder's perspective from building a melanoma risk stratification diagnostic. Annelies brings the strategic lens on study design and IVDR readiness.
No generic CRO talk. Just the early-stage thinking that separates fast, credible paths to market from expensive detours.
What you'll learn
- Why clinical evidence decisions made in the first months can lock you into the wrong regulatory path
- How to design a study when your samples are limited, expensive, and irreplaceable
- Where founders most often misalign intended use, performance claims, and study endpoints
- What a first-time-right clinical evidence strategy looks like under IVDR — and why it matters to investors too