For clinical genomics & molecular diagnostics labs
Insights for the Molecular Lab.
No vendor relationships, no referral fees, no implementation revenue. The only alignment is with your lab’s outcome.
Fixed-scope, fixed-fee engagements priced on the value of the deliverables — never a meter running against your budget. You pay for the result, not the hours behind it.
Advisory, architecture, and business-case 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. Four fixed-scope Insights, each one answering the question that matters at the inflection point before you commit.
Free go / no-go in 5 days — before any deposit
01 / 04 · Cross-Functional Initiative Alignment
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
02 / 04 · Pre-Implementation Readiness & Vendor Evaluation
Workflow & Infrastructure Readiness Assessment
Are you ready to buy — and can you own the vendor process when you do?
Document current state, map the gaps, and understand what needs to be true before a technology investment can succeed.
Workflow & Infrastructure Readiness Assessment
Are you ready to buy — and can you own the vendor process when you do?
Before you can evaluate a vendor, select a platform, or scope an implementation, you need a clear picture of where you are today. This engagement produces a documented current-state assessment across the ten domains that determine whether any technology investment succeeds or stalls — gaps rated by severity, system boundaries defined, and a prioritized remediation list you can act on before a vendor walks in the door.
- Scored readiness assessment across 10 domains: end-to-end workflow, system inventory and architecture, IT infrastructure, change governance, data architecture and PHI boundaries, regulatory validation and quality operations, staffing and change capacity, budget and total cost of adoption, vendor governance and implementation partnership, and security/risk/continuity
- Gap report with severity ratings and prioritized remediation list
- System boundary memo: what belongs in your LIMS vs. what must stay in the LIS/EMR — before any vendor decides for you
- RACI matrix covering integration ownership and system SME assignments by platform
- Decision-ready leadership summary for IT, executive, and budget stakeholders
03 / 04 · E2E Workflow & Integration
E2E Workflow Architecture & Bottleneck Analysis
Does your current workflow scale — and what’s the architecture for where you’re going?
Model your end-to-end workflow across systems and identify the rate-limiting step — before you invest in the next thing.
E2E Workflow Architecture & Bottleneck Analysis
Does your current workflow scale — and what’s the architecture for where you’re going?
Most labs invest in the next system before they have mapped the workflow that system has to slot into. This engagement produces that map: a full-stack current-state workflow model from sample accession through report delivery, capacity analysis at each node, identification of where constraints migrate as throughput grows, and a prioritized investment roadmap grounded in how your system actually behaves — not in vendor claims.
- Full-stack current-state workflow map: sample accession → liquid handler → LIMS → instrument → middleware → LIS/EHR → report delivery
- Peak capacity model at each node, benchmarked against current and projected volume
- Rate-limiting node analysis: which nodes become limiting at what throughput threshold
- Integration risk register: data handoff points, failure modes, and maintenance exposure at each node
- Investment summary memo: areas of investment surfaced by the analysis, with rationale grounded in node-level evidence and sequencing considerations
04 / 04 · Business Case & Strategic Planning
Technology Investment Business Case
Can you justify this — and can you reframe the lab as an asset instead of a cost?
An independent business case built from your organization’s actual numbers — modeled across the connected workflow the investment will live inside, with every assumption documented and every caveat named.
Technology Investment Business Case
Can you justify this — and can you reframe the lab as an asset instead of a cost?
Vendors know their platform. They don’t know how it will behave inside your workflow. The result is a business case accurate in the abstract but blind to the upstream and downstream effects that determine whether the projected ROI actually shows up — integration burden, change control overhead, compensating effort across adjacent systems. Independent modeling closes that gap. This engagement produces an independent business case built from interviews with your techs and admin, anchored to your actual data — with every assumption documented, every caveat named, and every metric traceable to its source.
- Stakeholder interview summary: lab tech and administrative interviews synthesized without vendor bias
- Operational data summary: documented baseline metrics with sources and confidence levels
- Independent ROI / TCO model with risk-adjusted scenarios over a defined horizon
- Investment brief structured for leadership or budget committee review
- Scenario analysis across two client-selected variables — tested against the ROI/TCO model with documented trade-off analysis
- 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 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 and priced on outcomes, not hours — the fee covers them all regardless of effort. No bait-and-switch, no scope creep.
A clear scope is a better engagement for everyone.
What these engagements cover
- Decision-point strategy and architecture (pre-decision advisory)
- Workflow gap analysis and bottleneck identification
- Integration strategy design and review
- Vendor-neutral requirements and RFI/RFP development
- Stakeholder alignment surfacing for cross-functional initiatives
- CFO-ready business cases and investment narratives
- E2E workflow mapping across LIMS, LIS/EHR, middleware, and reporting
- 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
Book 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.