For clinical genomics & molecular diagnostics labs
Get the big decisions right — before you commit.
No vendor relationships, no referral fees, no implementation revenue. The only alignment is with your lab’s outcome.
Fixed scope, fixed fee. Priced on the outcome, not the hours.
Advisory, architecture, and decision-readiness work that happens at the inflection points in the lab’s lifecycle — not implementation, configuration, or post-go-live support.
Molecular workflows are connected systems — the decisions made about them need to be connected as well. Three fixed-scope Insights, each one answering the question that matters at the inflection point before you commit.
Free go / no-go in 5 business days — before any deposit
Initiative Alignment Insight
Initiative Reality Assessment
Do your stakeholders agree on what this initiative is — or has the initiative already gone sideways because they never did?
Surface the divergent assumptions across stakeholder groups before — or after — they become a project crisis. Engagement runs in one of two modes confirmed at the discovery call: Pre-Initiative (failure mode pre-mortem) or Post-Mortem (root-cause analysis).
Initiative Reality Assessment
Do your stakeholders agree on what this initiative is — or has the initiative already gone sideways because they never did?
Molecular workflows are connected systems. The stakeholders making decisions about them usually aren’t. Major lab initiatives — vendor selections, platform migrations, automation rollouts, new assay launches, M&A integration — fail at the seams between groups more often than they fail on technical merit. Each group brings its own priorities, scope, and lens — and evaluates rigorously within it. What’s missing is the unified view across the connected workflow that no single function is positioned to provide. The cost of that gap compounds long before anyone names it. This Insight surfaces those gaps at either point in the lifecycle: pre-initiative (before commitments are made and the misalignment becomes expensive) or post-mortem (when an initiative has stalled or failed, and the path forward depends on understanding what actually broke down between groups).
- Stakeholder belief map: documented current understanding of initiative purpose, scope, success criteria, timeline, and ownership across each major stakeholder group
- Divergence register: explicit catalog of where stakeholder beliefs diverge, ranked by severity of likely downstream impact (or, in post-mortem mode, where divergences caused the observed failure)
- Implicit assumption surface: assumptions each group made about scope, ownership, or success that were never validated with other groups
- Failure mode pre-mortem (pre-initiative) or root-cause analysis (post-mortem): documented scenarios in which the divergences become — or already became — project failures
- Decision-readiness assessment (pre-initiative) or path-forward readiness assessment (post-mortem): whether the initiative is currently structured to succeed or to fail
Requirements Insight
Requirements & RFP Readiness
Do you know exactly what you need to buy — and where your departments quietly disagree on it?
Turn cross-department needs and your technical documentation into a vendor-neutral, RFP-ready requirements set — with the conflicts surfaced before the RFP goes out, while they’re still cheap to resolve.
Requirements & RFP Readiness
Do you know exactly what you need to buy — and where your departments quietly disagree on it?
A vendor selection is only as good as the requirements behind it. Most labs write the RFP from one department’s view of the world — and discover the gaps only after the contract is signed, when the product’s specs collide with the lab’s operational reality. Done right, the requirements come first: mapped across the end-to-end workflow before a single line of the RFP is written. This Insight is built collection-first — up to ten hours of structured interviews across every function that will rely on the system, plus a full review of your technical documentation, distilled into a prioritized, vendor-neutral requirements set and the cross-department conflicts that have to be settled before you go to market.
- RFP-ready requirements draft: vendor-neutral, prioritized (Must / Should / Could), structured to drop straight into your RFP
- Cross-department requirements map: what each function — lab operations, IT, quality/compliance, finance, clinical — needs from the system
- Requirements conflict register: where department needs collide or trade off, each flagged with severity and the decision to settle before the RFP
- Vendor evaluation criteria: a weighted scoring framework aligned to the prioritized requirements, ready to score RFP responses
- Requirements assumptions register: the unstated assumptions each department is making about what the system or vendor will do
Value Recovery Insight
LIMS Utilization Analysis
Is your LIMS actually delivering what you paid for — or has the lab quietly routed around it?
Take your highest-value workflow, model it end to end, and find where value leaks — bottlenecks, traceability gaps, unused capability — then map each gap to the LIMS features you already pay for that would close it, with a remediation plan and the value at stake. One workflow, done deeply; BenchForge included to extend it to the rest.
LIMS Utilization Analysis
Is your LIMS actually delivering what you paid for — or has the lab quietly routed around it?
Most LIMS implementations underdeliver — the system goes live, but the lab quietly reverts to spreadsheets, modules sit unused, and the ROI that justified the purchase never shows up. This Insight takes your highest-value workflow and models it end to end — every integration, handoff, and shadow system — then finds the rate-limiting steps, traceability gaps, and risks, and maps each one to the capability you’re already paying for that would close it, with a remediation plan and the value at stake. Vendor-neutral and workflow-first — not a product-configuration audit. Scoped to one workflow, with BenchForge included so you can extend the method to the rest.
- Current-state workflow model: your highest-value workflow mapped end to end — every step, LIMS touchpoint, integration, handoff, and the shadow systems (spreadsheets, manual workarounds) people route through
- Constraint, traceability & risk analysis: the rate-limiting steps, chain-of-custody and data-lineage gaps, and operational/compliance risks, with evidence and confidence
- Gap-to-licensed-capability map: each gap mapped to the LIMS features you already license that would close it — plus the few that genuinely need something new
- Remediation plan: prioritized and sequenced (quick wins to structural), each item scoped with a suggested owner and dependencies
- Value-at-stake & effort estimate: what the gaps cost today — throughput, turnaround, OpEx, risk — and the level of effort to remediate each, for a leadership conversation
- Expanded scope. Engagements that grow beyond the original scope (multi-workflow, multi-site, multi-initiative, multi-technology-selection, or substantially expanded) move forward via a Change Order to absorb the expansion within the existing engagement.
Structured intake
Every engagement opens with a Background document plus an Insight-specific instrument — so scope is grounded in your reality, not a template.
Free go / no-go in 5 business days
I review the intake and tell you in writing whether the engagement will succeed against your inputs. The SOW and deposit only follow a ‘ready to proceed.’ If you’re not ready, nothing is invoiced — we tighten scope or prep first.
Fixed-scope delivery
~4 weeks. Every deliverable is enumerated up front — the fee covers them all regardless of effort. No bait-and-switch, no scope creep.
LIMS Readiness Assessment — Results Review
After you complete the LIMS Readiness Assessment, I review your results and walk you through the material gaps, the risks, and the highest-leverage next step — live, no written deliverable.
Coming soon — with the LIMS Readiness AssessmentA clear scope is a better engagement for everyone.
What these engagements cover
- Decision-point strategy and architecture (pre-decision advisory)
- Integration strategy design and review
- Vendor-neutral requirements and RFI/RFP development
- Stakeholder alignment surfacing for cross-functional initiatives
- Deliverables are yours to own and act on — no lock-in, no ongoing dependency
What these engagements do not cover
- Software implementation, configuration, or system administration
- Post-go-live support or system optimization
- Code development or integration build-out
- Audit preparation, validation execution, or QMS implementation
- Instrument performance optimization or sequencer technical evaluation
- Vendor negotiation representation or legal proceedings
- Ongoing managed services or staff augmentation
- On-site work — all engagements are conducted remotely
I identify compliance-relevant gaps in lab systems and workflows so the audit is unremarkable; I don’t run the validation or prepare the response.
My direct experience is in defining requirements and informing architectural decisions for products and systems intended to meet CAP/CLIA, ISO 15189, ISO 13485, IVD/IVDR, 21 CFR Part 11, 21 CFR Part 820, and FedRAMP/FISMA requirements. I worked alongside engineering architects, QA, and regulatory teams who owned architecture, certification, and audit response — my contribution was translating lab operational reality into product decisions and surfacing implications (deployment, latency, usability) that engineering teams might not catch on their own. I am not a certified inspector or lead auditor under any of these frameworks.
Get started
Request a discovery call — or an engagement
30 minutes, no charge. Tell me about your situation and which Insight you’re weighing — or, if you’re not sure which fits, I’ll recommend where to start. Either way, I’ll tell you honestly whether and how I can help.
Just need a quick consult or help getting intake-ready? Hourly Advisory is available at $275/hr (capped at 5 hrs/month) — select it above.