1–3 weeks
Portfolio Cliff™ Diagnostic Assessment
A structured executive assessment of portfolio risk across eight decision zones, producing a named set of decisions with owners and deadlines attached. Applies to EU and US portfolios alike.
Nobody is positioned to see the trade
Regulatory sees regulatory exposure. Clinical sees evidence. Quality sees compliance. Finance sees revenue. Commercial sees customers. Each view is accurate and none is complete, and the decision that matters sits between them.
Exposure of this kind is not created by a regulation. It is created by decisions that were deferred, ownership that was never assigned, and data no single function can assemble. It accumulates quietly, and it becomes visible at a certificate lapse or a failed submission. By that point, the window to act on it has closed.
CEO or Business Unit Leader
Accountable for the commercial decision when a product line cannot be carried through, and usually unable to get a single view of what is exposed.
VP Regulatory Affairs or VP Quality
Can assemble the picture but is rarely asked to, and has no route to the decisions the picture implies.
VP Clinical Affairs
Owns the evidence position and needs to understand where evidence weakness changes a renewal, investment, or portfolio decision.
The eight zones
| Leadership | Whether the people who must act have the authority, capacity and continuity to do so. |
|---|---|
| Governance | Whether exposure reaches the executive and board, and whether escalation functions. |
| Evidence | Whether clinical evidence supports the portfolio as claimed, and whether it is maintained. |
| Data | Whether the organisation can produce an accurate view of its own portfolio. |
| Renewal | Whether certificates and submissions are sequenced against real capacity and real dates. |
| Resource | Whether the plan is arithmetically deliverable with the people and budget committed. |
| Commercial | What revenue is attached to each exposure, and whether that has been quantified. |
| Acquisition | What regulatory debt was inherited, and whether anyone owns it now. |
What we do
Each zone assessed against documented evidence and against how decisions are actually made, not how the procedure says they are made. Leadership, governance and resource cannot be assessed from documents alone, so the engagement includes structured interviews.
What leadership believes is under control, compared against what the assessment finds. Each zone lands in one of four states: Managed, Blind Spot, False Confidence, or Undetected Exposure.
Accumulated deferred decisions expressed as a single executive-legible measure, with the underlying zone scores shown rather than hidden.
Findings converted into named decisions, each with an owner, a deadline and a stated consequence of deferral.
What you receive
Five named outputs. Every zone score carries cited evidence.
Eight-Zone Assessment
Each zone is assessed and scored consistently, with the evidence cited for every score, including documents reviewed and interview themes reported without attribution to named individuals.
Detection Matrix
All eight zones positioned against two axes: what leadership reports as controlled, and what the assessment found. The False Confidence positions are the most expensive category of finding, because nobody is looking at them.
Decision Debt Index™
A single measure of accumulated deferred decisions, with the zone-level scores and weights shown beneath it. A decision-support measure, comparative and methodological rather than absolute.
Decision Register
Every decision the assessment surfaces, with an owner, a deadline and the consequence of deferral stated. Where no named approver exists for a decision, which occurs most often with discontinuation, the register states the decision mechanism required, not only the decision.
Executive Readout
A ninety-minute session opening with the Detection Matrix, then the measure, then the decisions. Owners and dates named in the room.
How it runs
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Before the clock starts
Intake list issued across seven functions. A coordinator is nominated with escalation access to regulatory, clinical, quality, finance, HR and IT. Interviews scheduled, and the executive readout confirmed with the general manager or P&L owner attending.
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Week 1
Kickoff and baseline. Leadership, Governance and Data zones assessed, including interviews with regulatory, clinical and quality leadership.
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Week 2
Evidence, Renewal, Resource, Commercial and Acquisition zones. Detection Matrix constructed.
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Week 3
Index calculated, decision register built, report delivered and executive readout held.
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Shorter scope
A focused engagement assesses three zones in one week, typically the zones a Portfolio Cliff™ Scorecard result has already indicated.
What is not included
- Conformity assessment, technical documentation review or clinical evidence assessment. The Diagnostic identifies where evidence is weak; it does not assess the evidence itself. That is a separate engagement.
- Remediation of any finding, or implementation of any decision the assessment surfaces.
- This is not an audit and does not assess conformity with any regulation or standard. The Decision Debt Index™ is a decision-support measure and carries no external standing.
Scope
Focused Diagnostic
One entity, three zones, one week. Typically the zones already indicated by a Scorecard result.
Full Diagnostic
One entity, all eight zones, three weeks, six leadership interviews.
Group Diagnostic
Two or more entities, delivered sequentially, with a consolidated group view following the final phase.
Each engagement is confidential and led directly by Dr. Shola Sulaimon. It is fixed-fee, with scope, deliverables, timing and assumptions confirmed in a written statement of work before the engagement begins. Where a subsequent engagement is commissioned within ninety days, the Diagnostic fee is credited against it up to a stated cap.
Questions
Does this apply if our portfolio is not European?
Yes. Five of the eight zones examine how an organisation makes and owns decisions about its portfolio, and nothing in those zones depends on which agency reviews the file. Two zones are re-mapped for a US portfolio: Renewal becomes predicate dependency, and Evidence becomes substantial equivalence and post-market study adequacy.
Will our team be candid in the interviews?
Interview content is reported thematically and is never attributed to a named individual. That is stated in the statement of work and in the briefing each participant receives before their session. The assessment depends on candour, and attribution would end it.
What happens if required documents or access arrive late?
The delivery date moves accordingly. The engagement timeline assumes the agreed documents, data and access are available when intake closes. If required inputs arrive late, SHOTUNE will confirm the revised delivery date rather than compress the review.
Start with a confidential strategy discussion
Thirty minutes. We will start with the portfolio, what feels exposed, what decisions are unresolved, and who has to make them. If a narrower path makes more sense, you will be told plainly.