What the Portfolio Cliff™ MedTech Risk Diagnostic helps leadership see
The Portfolio Cliff™ MedTech Risk Diagnostic is an executive self-assessment for regulatory, clinical, quality, portfolio, and senior leaders preparing for a meaningful medical device milestone.
That milestone may involve an FDA submission, EU MDR renewal, clinical-evidence decision, Notified Body review, audit, remediation, product change, or product-continuity concern. The visible problem may begin in one function while the underlying risk crosses several.
One provisional view across connected exposure
The Diagnostic examines leadership visibility, portfolio pressure, evidence readiness, data confidence, renewal exposure, resource capacity, cross-functional dependence, and organisational change risk.
The purpose is to help leadership see whether priorities, assumptions, ownership, evidence, timing, and technical conclusions remain aligned.
Why an unsure answer matters
An unsure answer receives the highest provisional exposure value because uncertainty is itself a leadership signal.
A risk cannot be managed consistently when the people responsible for it do not share the same understanding of the issue, available evidence, accountable owner, or timeline.
What the Diagnostic and Scorecard result do and do not provide
The Scorecard result is based on the answers you provide and offers an initial view of where closer leadership attention may be useful.
It does not determine regulatory compliance, certification readiness, clinical sufficiency, quality-system effectiveness, Notified Body readiness, or the appropriate professional response.
When the Scorecard reveals material uncertainty, a founder-led EU MDR Readiness Review or another focused SHOTUNE engagement may be appropriate for deeper document review, senior interpretation, and prioritised next steps.
Use the result before the next major milestone
Review the result with the people accountable for regulatory, clinical, quality, risk, post-market, product, and portfolio decisions.
Look for areas where ownership is unclear, assumptions differ, available evidence no longer supports the plan, or timing pressure is beginning to narrow the organization’s choices.
When the Scorecard reveals material uncertainty, the next useful step may be a focused senior review of the decision and the connected exposure.
Request an EU MDR readiness review