Getting an Oncology IVD to Market Faster: What Founders Underestimate Early On

    🕐 3 PM CEST / 1 PM GMT

    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

    Speakers

    Two experts who've seen both sides of the oncology IVD journey — the founder's reality and the regulatory strategy that makes or breaks it.

    Egbert Smit

    CEO, MLA Diagnostics

    Life sciences leader with 20+ years of science and business experience. (Co-)founder of several IVD businesses and currently leading oncology IVD venture MLA Diagnostics (Maastricht) and cardiovascular disease IVD venture PERSUASIVE (Utrecht).

    Annelies Rotthier

    Business Unit Manager IVD CRO, QbD Group

    Who Should Attend

    • Founders and CEOs of early-stage IVD/diagnostic companies
    • Regulatory affairs professionals in oncology diagnostics
    • Clinical evidence and study design leads
    • Quality managers at emerging medtech/IVD companies
    • Business development professionals in the IVD space