S11 / Design

Feasibility analysis.

Pre-engagement assessment whether a study, system, or vendor can deliver the regulatory and scientific need.

4 min read

You'll leave with: What a real feasibility assessment surfaces that an internal go-decision misses — particularly for combination products.

/ Who this is for

The fit.

Sponsors evaluating study designs. CROs evaluating capability fit. Founders evaluating combination-product feasibility.

/ The work itself

What this delivers.

Feasibility assessment with go/no-go recommendation, risk register, alternative-pathways analysis.

/ Why this matters

Where the edge is.

Domain-cross-cut feasibility (BA + BE + CT). Combination-product feasibility uncommon in the market — most consultancies treat device and pharma as separate practices.

/ How engagement runs

The shape of the work.

Every engagement is scoped per situation. The shape — focused diagnostic, structured implementation, ongoing partnership — emerges from the discovery conversation rather than a fixed package. Some engagements are short and intense; some are months-long structural builds; some are recurring quality oversight. We talk first, then scope.

Discovery.

Confirm scope and feasibility question.

Scoping.

Proposal aligned to assessment depth.

Analysis.

Document review, scientific assessment, regulatory pathway analysis.

Report.

Go/no-go recommendation, risk register, alternative-pathway analysis.

What to do next.

If this is the work in front of you, the next step is a conversation. I read every message and respond personally. No contact forms. No sales sequence. Just a discovery conversation to understand whether the fit is real, and what the shape of the work would be.

Cadence promise: I publish weekly on regulated AI governance. If a week is missed, the journal entry explaining why goes up in real-time.

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