You don't have an FDA problem. You have a project management problem.

Most medical device delivery delays — missed submissions, stalled validation programs, late-to-market launches — trace back to one root cause: no one is truly owning the program. That's exactly what I do.

THE IMPACT BLUEPRINT™: THE PARTNERSHIP PATH

Every engagement runs on THE IMPACT BLUEPRINT™ — my proprietary method for taking a program from diagnosis to a stable, sustainable outcome your team owns. The path from first conversation to that outcome runs in three stages:

  • The Medical Device Delivery Assessment — a fixed-fee, ~4-week diagnostic. Separate engagement, done first.

  • The 90-Day Execution Partnership — sized into one of three tracks based on what the Assessment finds and what leadership wants to hand off.

  • Month-to-month continuation — same rate, for engagements that extend through 6 months where the fit is right.

 

STEP 1 — The Medical Device Delivery Assessment

Before any resource is spent, you get a clear, evidence-based picture of what's actually broken. This is a structured, five-dimension diagnostic — not a guess, not a gut check.

  • Strategy & Priorities — are project resources going to the right things?

  • Governance & Accountability — is there clear ownership and fast decision-making?

  • Execution & Process — is there a consistent way projects actually move forward?

  • People, Resources & Cross-Functional Alignment — do teams have the capacity and clarity to execute?

  • Visibility, Risk & Performance — does leadership have an accurate picture of project health?

You walk away with an Executive Findings Report, a 90-Day Project Delivery Improvement Roadmap with 3-5 priority actions, and a 60-minute Executive Debrief to align on the path forward.

 

STEP 2 — The 90-Day Execution Partnership

Once you know what's broken and what to fix first, this partnership answers who does the work of fixing it, and how much of it you want to hand off. Same 90-day arc, three different levels of hands-on involvement from me — and the same three tracks whether the priority is project management or software validation.

TIER A — Advisory Track

“You have the team. I make sure the decisions being made are the right ones.”

Time commitment: 8–12 hrs/month (~2–3 hrs/week)

Best fit:

  • Internal PM and quality resources are capable, but leadership wants an experienced outside check on decisions

  • Assessment findings point to alignment, governance, or prioritization gaps — not a capacity or bandwidth problem

  • Leadership wants accountability and a second set of eyes, not another operational hire

My role:

  • Trusted advisor to leadership — translating Assessment findings into a working action plan

  • Reviewing project/portfolio health and flagging emerging risk

  • Sitting in on governance or steering meetings as an experienced voice

  • Flagging anything that looks like a compliance or quality concern for the right internal owner — not auditing it myself

Deliverables:

  • Implementation Action Plan · Periodic Project Health Review · 90-Day Progress Summary

 

TIER B — Implementation Track

“You know what needs to change. I work alongside your team to make it happen.”

Time commitment: 20–25 hrs/month (~1 day/week)

Best fit:

  • Assessment surfaced multiple execution gaps — governance, reporting, cross-functional handoffs

  • Internal team knows the destination but doesn't have the bandwidth or process expertise to build the path

  • Leadership wants hands-on implementation support, not just advice

My role:

  • Building or improving project governance and reporting cadence

  • Standing up dashboards and portfolio visibility

  • Facilitating cross-functional planning and decision-making sessions

  • Coaching internal project leads and supporting day-to-day execution

Deliverables:

  • Implementation Roadmap · Project Governance Framework & Reporting Cadence · Portfolio Dashboard · 90-Day Progress & Impact Report

 

TIER C — Embedded Executive Track

“Your critical initiatives need direct, hands-on leadership. I lead them with you.”

Time commitment: 40–60 hrs/month (~2–3 days/week)

Best fit:

  • Assessment findings point to systemic delivery risk — the program itself, not just the process, is at risk

  • No strong internal PM leadership currently owns the critical initiative

  • Leadership needs someone driving deliverables directly, not just advising or facilitating

My role:

  • Embedded fractional PM executive with direct ownership of priority initiatives and deliverables

  • Running the operating rhythm: governance, reporting, cross-functional accountability

  • Hands-on work on the deliverables themselves where the timeline requires it

  • Building internal capability so the org needs less of me over time, not more

Deliverables:

  • Executive Project Portfolio & Health Dashboard · Governance Model & Operating Rhythm · Strategic Initiative Roadmaps · Future-State Project Delivery Roadmap

 

IF THE ASSESSMENT SURFACES SOFTWARE VALIDATION GAPS

 

  • NPD program leadership

  • Software validation

  • Medical-device software V&V

  • Governance and project recovery

  • Cross-functional execution

  • Audit/readiness remediation

 

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