--- title: "Defining the Intended Purpose: The Strategic Foundation of Oncology IVD Development" description: "Learn why the intended purpose statement is the most important strategic decision in oncology IVD development and how it shapes regulatory approval, clinical evidence, reimbursement, and adoption." url: https://qbdgroup.com/en/blog/intended-purpose-oncology-ivd-development type: "Blog post" language: en published: 2026-07-01 author: "Annelies Rotthier" category: "Clinical" publisher: "QbD Group" citation: "QbD Group, \"Defining the Intended Purpose: The Strategic Foundation of Oncology IVD Development\", https://qbdgroup.com/en/blog/intended-purpose-oncology-ivd-development" --- # Defining the Intended Purpose: The Strategic Foundation of Oncology IVD Development > Learn why the intended purpose statement is the most important strategic decision in oncology IVD development and how it shapes regulatory approval, clinical evidence, reimbursement, and adoption. For: Founders, CTOs, CSOs, and clinical leads at early-stage oncology IVD companies, developing, refining, or revisiting their intended purpose statement. During the development of oncology in vitro diagnostics, one statement defines whether years of investment produce a commercially viable product or an approved test that fails to be adopted: the intended purpose statement. When treated as a regulatory deliverable, it is a statement drafted by regulatory affairs and filed in the technical documentation. But when treated as what it actually is, the strategic input from which every subsequent clinical, regulatory, and commercial decision flows, it becomes the most consequential decision in the development programme. The intended purpose is the decision that determines which patients you serve, what clinical evidence you need to generate, how your product gets classified under international regulations, what your reimbursement pathway looks like, and whether clinicians will actually use your product in practice. Get it right and every downstream decision becomes clearer. Get it wrong and you spend years generating evidence that does not answer the questions that matter: the question payers, clinicians and healthcare ask in the journey to adoption of your test. This article draws on a QbD Group webinar featuring **Egbert Smit** (CEO, MLA Diagnostics), who has navigated this challenge with a melanoma prognostic test, and **Annelies Rotthier**, QbD Group's clinical evidence lead. ## A Regulatory Requirement Harboring Your Most Consequential Business Decision Under the EU In Vitro Diagnostic Regulation, the intended purpose statement is a formal requirement. It determines the classification, risk management activities, anchors the Performance Evaluation Plan and defines the scope of every clinical performance study conducted to support the CE mark. That regulatory function, however, is only one part of its significance. It also shapes clinical adoption potential, study design, endpoint selection, sample requirements, and reimbursement strategy. There is no abstractly correct formulation. There is only the version that optimally balances clinical impact, regulatory feasibility, evidence generation capacity, reimbursement potential, and commercial scale for a specific technology in a specific market, and that balance cannot be defined by one business department in isolation. ### Your intended purpose drives everything | If you define it too narrowly… | If you define it too broadly… | | --- | --- | | Patient population is smaller, limiting commercial scale | Evidence required may be impossible to generate within budget | | Reimbursement may be difficult for a niche indication | Clinical studies become unwieldy and statistically underpowered | | Classification may be simpler and faster | Regulatory classification becomes complex and slower | | Adoption is limited, even with a good product | Timeline and costs grow, threatening the whole programme | ## Three Structural Forces Are Pulling on Your Intended Purpose Three forces simultaneously shape intended purpose definition in oncology IVDs, and they rarely move in the same direction. ### Dynamic scientific and clinical pressure Oncology biomarker science is constantly evolving from single-marker assays toward multi-marker panels, pathway signatures, and scoring systems such as Tumour Mutational Burden. Tissue-based testing is increasingly augmented by liquid biopsy and multi-modal diagnostics. A biomarker definition aligned with current standard of care may be displaced within a few years. ### Structural regulatory constraint IVDR requires a locked intended purpose underpinning the Performance Evaluation Plan; substantive changes during or after the conduct of clinical performance studies are slow and costly. For companion diagnostics, the intended purpose is further constrained by drug label alignment and co-development obligations with the pharmaceutical partner. ### Clinical evidence feasibility The intended purpose must be supportable by evidence the sponsor can actually generate. Low-prevalence target populations, biomarker heterogeneity, sample availability, and endpoint complexity all constrain what can be demonstrated within a realistic timeframe and budget. > It is easy to shape an intended purpose that fits the CE mark. It is quite difficult to make one that also fits clinical adoption at a later stage. > > — Annelies Rotthier, QbD Group Defining the intended purpose that sits at the intersection of these forces is challenging. Applying structured methodology early, makes the difference between a CE mark that opens market access and one that delivers regulatory approval without commercial uptake. ## Methodology: How MLA Diagnostics Used Early Health Technology Assessment to Find Their Answer The webinar walks through the structured approach to define clinical use cases: clinical pathway mapping, scenario identification, and early Health Technology Assessment (HTA). HTA is a structured analysis that evaluates your technology against specific clinical scenarios based on two criteria: 1. **Patient benefit** — what is the clinical impact of the test at this point in the patient pathway? 2. **Cost effectiveness** — what does it cost the healthcare system, and what does it save compared to current standard of care? The output is a defensible commercial strategy with a regulatory document that follows from it. The session includes a case discussion with **Egbert Smit** on how MLA Diagnostics applied this approach to its melanoma prognostic test, including how the team identified its target positioning from several plausible scenarios within the melanoma care pathway, and what that selection meant for the subsequent evidence strategy. ### What early HTA gives you that a literature review does not - A structured, evidence-based comparison of every plausible clinical scenario for your technology - Quantified patient flow through each point in the pathway. This is the foundation of a robust intended purpose - A reimbursement-ready economic argument that HTA bodies and payers will recognise - External validation of your clinical positioning before you commit to an evidence strategy > Follow the patient pathway and determine where you have the best fit through scenario mapping. Then test your intended purpose with external stakeholders, to confirm you are developing something they will actually use. > > — Egbert Smit, CEO MLA Diagnostics ## It Takes a Room to Define It. Not a Template. One of the clearest messages from the webinar: the intended purpose cannot be defined by a single function or person. It requires alignment among executive leadership, who own the commercial vision and funding model; clinicians and KOLs, who can confirm whether the result would actually change practice at the proposed point in the pathway; regulatory and quality, who must execute the evidence strategy within IVDR constraints; HTA and reimbursement specialists, who must defend the economic case to payers; and, for companion diagnostics, the pharmaceutical partner whose drug label and trial design impose additional dependencies. | C-level leadership | Clinical experts | Regulatory and QA | | --- | --- | --- | | Commercial vision, funding model, and timeline commitments must align with the intended purpose from the start | Would clinicians act on this result at this point in the pathway? Is the intended use clinically meaningful? | Is the classification manageable? Can the evidence strategy be executed within IVDR constraints? | Securing this input before locking your intended purpose requires time and effort. It is also the difference between a CE marked product that opens doors and one that fails to be clinically adopted. ## Where to Start if You Have Not Yet Locked Yours If your intended purpose is not yet finalised, or if you are reconsidering it in light of new data, new partnerships, or new clinical evidence, here is the sequence that Egbert and Annelies recommend: 1. Map your clinical pathway in detail: patient flow, decision points, who acts on what information and when. 2. Identify 2 to 4 plausible implementation scenarios and evaluate each on patient benefit and cost-effectiveness. 3. Commission an early HTA to pressure-test your scenarios with external partners. 4. Validate the shortlisted positioning with clinicians: would this result change their practice? 5. Define the intended purpose as a documented, cross-functional business decision, with full stakeholder sign-off. The intended purpose is not the first step in your regulatory process. It is the output of your strategic thinking. It is the foundation on which your entire development programme is built. ## Key Takeaways
## Ready to sharpen your intended purpose strategy? Watch the full on-demand webinar to hear Egbert Smit (MLA Diagnostics) and QbD Group's clinical experts walk through real case examples, including how MLA used early HTA to define their melanoma test strategy. **[Watch the free on-demand webinar →](/en/webinars/oncology-ivd-market-faster-what-founders-underestimate)** --- Source: https://qbdgroup.com/en/blog/intended-purpose-oncology-ivd-development — © QbD Group. Quote freely with attribution and a link back.