How Do You Define MVP Scope for a Diagnostic Product?
Four constraints define MVP scope for a diagnostic laboratory product: what the assay chemistry requires, what the regulatory pathway locks in, what the workflow depends on, and what drives customer adoption. A feature that fails all four is not minimum viable, it is a "nice to have."
Why Doesn't the Standard MVP Framework Work for a Diagnostic Product?
Software MVP frameworks assume the product ships in a minimal form and improves through iteration after launch. A diagnostic product rarely gets that chance. IVDs require new validation (and potentially new clinical trials) plus an FDA filing before any update reaches customers, and RUO products used as laboratory-developed tests (LDT) shift that validation burden onto the customer, who will not welcome the product changing under them.
For IVD products, that means future version rollouts are rare. The product needs to be right at launch, not the third release. For RUO products used as LDTs, the manufacturer avoids the FDA validation step, but the customer inherits it: a validation effort that is long and expensive to run, and one they will not want to repeat because a feature changed after the fact. One exception here is if you are targeting different customer segments. Release A may be intended for academic medical centers, while release B may be intended for CROs. In this case, the manufacturer must maintain and support both release versions without requiring release A customers to update.
Software teams can defer a scope decision to a later release. A diagnostics team rarely gets that option. So scope decisions get made once, under pressure, and too often on instinct instead of requirement. A feature stays in because a competitor has it, or because a previous platform already built it in. No one tests it against what the assay requires, what the regulatory pathway allows, or whether a lab would buy the product with the feature in or out.
The Fix: A Requirements Framework Built From Assay, Regulatory, Workflow, and Adoption Constraints
Every proposed feature gets tested against what the product actually requires, and what drives adoption by your target market. What survives becomes scope. What doesn't gets descoped, with a documented reason the team can defend instead of an argument that resurfaces at the next design review.
Blanchard Strategic's Approach:
The work starts by mapping every proposed feature against what the product actually needs, then testing what survives before it locks into architecture.
Tests each proposed feature against what the assay chemistry actually requires, separating true requirement from convenience.
Connects scope decisions to what the regulatory pathway locks in, so submission strategy and product scope come together instead of colliding after the fact.
Maps how each feature interacts with real laboratory workflow and operational dependencies, not best-case assumptions.
Designs targeted VOC (voice of customer) survey questions to understand what drives adoption, and what customers say they need instead of what the team assumes. The result is a product your target customer can justify purchasing.
Brings stakeholders to agreement around justified scope, not the loudest voice in the room, and locks in the framework the program uses going forward.
When Is This Work Useful?
This work fits diagnostic programs at the earliest stage, before a feature list turns into locked architecture, when the team needs a scope decision it can defend against assay requirements, regulatory strategy, and what the market will actually buy.
Engagements like this are typically delivered through Strategic Alignment & Program Acceleration.
Written by Megan Blanchard, M.S., Principal Systems Architect at Blanchard Strategic Systems.