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Molecular Diagnostics
Regulated development and commercialization journeys where clinical, quality, and market access align.
bioMérieux
Hologic
Roche
Bio-Rad
Inside this journey
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Pre-Discovery
Align the room on outcomes, decision process, and constraints before deeper discovery.
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Stakeholder Alignment
Confirm decision roles, timeline, and what 'good' looks like across lab leadership, finance, IT/LIS, and clinical stakeholders.
Alignment Questions
Who's In The Room — a quick snapshot of your team and lab
- Who are the primary people (names or roles) who will be involved day-to-day and in decision-making for this project?
- Which lab(s) or departments will this platform affect?
- Which of these roles will be the project champion or final approver?
- Tell us your current on‑hand molecular capabilities (brief): platforms in use, assays validated, and typical sample types.
- What is your average molecular testing volume today (total specimens per day)?
- How would you describe your lab’s staff molecular expertise right now?
If We Keep Doing What We're Doing, What Breaks Next?
- How confident are you that your current approach will meet clinical expectations for rapid syndromic testing over the next 12 months?
- What happens to patient care or clinician decision-making when turnaround times slip beyond your target window?
- Which operational bottleneck worries you most if volumes increase (e.g., staffing, reagent supply, instrument throughput, validation backlog)?
- How often do current testing delays contribute to escalations, repeat testing, or avoidable admissions?
- When these failures occur, who feels the impact most—and how does that typically play out emotionally or politically in the organization?
What’s Getting in the Way Right Now? (root causes, not symptoms)
- What single failure mode do you see repeatedly—where processes, equipment, or people most commonly break down?
- How reliable are your sample collection and pre‑analytic logistics (turnaround from bedside to lab)?
- Where do you tend to get stuck when validating a new molecular assay—technical, administrative, or resourcing issues?
- How long have these pain points been affecting your lab's ability to expand rapid testing?
- Who outside the lab (e.g., clinicians, finance, infection control) raises concerns about these problems, and what do they care about most?
Challenge Assumption: 'Faster Is Always Better' — what tradeoffs are you overlooking?
- Beyond raw TAT, what clinical or operational signals will prove this change was worth it (select all that apply)?
- What minimum turnaround time for key panels would change clinical decisions in your hospital (give specific assays if possible)?
- How do you weigh analytical performance (sensitivity/specificity) against speed and automation—what’s non‑negotiable?
- What measurable throughput targets (specimens/hour or assays/day) would justify moving forward?
- If a solution improved TAT but increased per‑test reagent cost by 20%, what outcomes would you need to see to accept that tradeoff?
Money Talks — let’s be blunt about economic thresholds and expectations
- What budget source will fund this purchase (capital, operating, grant, philanthropic, other)?
- What is your target or maximum acceptable total cost of ownership (TCO) horizon—1 year, 3 years, 5 years?
- What is an acceptable range for per‑test reagent cost for your high‑use panels (enter dollar range or % of current cost)?
- How do you expect this investment to pay back—revenue, avoided costs, clinical downstream savings, or a mix?
- What ROI timeline would make leadership comfortable (months to break-even)?
- Are there contractual constraints we should know about (existing reagent contracts, preferred vendors, GPO restrictions)?
Are You Ready to Change, or Just Curious? (timeline and decision dynamics)
- What is your ideal decision timeline for selecting a platform?
- Who are the decision-makers and approvers we must convince, and what will each care about most?
- What would prevent your team from moving forward even if a solution met clinical needs (procurement, space, competing priorities)?
- How comfortable are you running a proof‑of‑concept or pilot with our systems to validate claims?
- If we proposed a short pilot, what success criteria and timeline would make it compelling to you?
What Would Success Day‑One and Day‑90 Actually Feel Like?
- Describe the one concrete outcome on day one after go‑live that would make you say 'this was worth it'.
- By day 90, what operational metrics would demonstrate success (TAT, %tests automated, staff time saved, clinician adoption)?
- What validation specimens, controls, or clinical samples can you commit to for verification within the pilot/validation window?
- What training model works best for your staff—train‑the‑trainer, vendor‑led on‑site, remote blended learning, or a mix?
- What LIS and network dependencies must be resolved before go‑live (HL7 mapping, middleware, user accounts, VPN), and who owns them?
Final Room: Your Fears, Your Hopes, and Next Moves
- What keeps you up at night about implementing a new molecular platform?
- If everything goes perfectly, what positive change will your clinicians and patients notice first?
- Which of the following next steps would you prefer right now?
- Who should we schedule the next conversation with (name, role, best contact method)?
- Any immediate constraints, holidays, or supplier windows we should avoid when planning pilots or installs?
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Current State Mapping
Document existing workflows, throughput, staffing skills, lab footprint, and failure modes that limit rapid molecular testing.
Current State
Start Here: A Quick Snapshot of Your Molecular Operation
- In one sentence, how would you describe your molecular lab today (scope, size, and primary clinical use)?
- Which sample types and clinical panels do you run most frequently?
- Typical daily molecular test volume (all panels combined)?
- What hours does molecular testing operate in your lab?
- Who is the primary decision owner for changes to molecular workflows in your organization?
Where the Clock Stops: Bottlenecks That Make ‘Rapid’ Feel Slow
- If you had to point to one place that most often derails a promised rapid result, where would you point—and why?
- Which parts of the process routinely create delays (select all that apply)?
- How long does it typically take from specimen receipt to reported result for your most-used rapid panel?
- When delays happen, what downstream clinical or operational impacts do you observe (examples: delayed therapy, longer LOS, ED hold times)?
- How often do you see unexpected run failures or invalids on rapid assays (percent of runs)?
- Tell me about a recent day where throughput fell short—what sequences of events led to that outcome?
Who's Holding the Fort: Skills, Coverage, and Human Limits
- Are your current staff being asked to run molecular workflows beyond their training or capacity?
- Break down your staffing: how many full-time equivalents (FTEs) are dedicated to molecular testing vs. shared bench staff?
- Which skill gaps do you notice most when it comes to molecular methods, validation, or troubleshooting?
- How often do staffing shortages force you to batch runs or delay testing?
- When staffing is tight, what work gets deprioritized or deferred, and who makes that call?
- How do your people feel about the pace and complexity of molecular testing—stressed, energized, ambivalent? Give an example.
The Lab You Have vs. The Lab You Need: Space, Power, and Flow
- If you tried to add a new rapid molecular instrument tomorrow, where would it physically go—and would it fit?
- Describe your current lab layout for molecular work (bench-style, dedicated room, shared space with culture, etc.).
- Which infrastructure items are constraints today (select all that apply)?
- How predictable is your sample arrival pattern during a typical day?
- How long would it take and who would need to approve to reconfigure space or add outlets/vents for a new platform?
- If you were to change sample flow to reduce internal transport delays, what would that look like?
When Systems Break: Failure Modes, Stockouts, and Risk
- Which single failure mode has put rapid testing at risk most often (e.g., instrument failure, reagent stockout, contamination)?
- How long does it typically take to recover from those failures?
- How do you monitor reagent inventory and forecast consumption for critical assays today?
- Have you experienced contamination that required interrupting testing or re-validating assays? Tell me the impact.
- What contingency plans are in place for instrument downtime or critical reagent shortages?
- Who is responsible for incident escalation and how is communication to clinical teams handled during outages?
Decisions That Drive Throughput: Policy, Prioritization, and Trade-offs
- Are your current throughput decisions driven more by cost containment, clinical urgency, or staffing realities—and which is actually winning?
- How do you prioritize samples when capacity is constrained (e.g., STAT ED, ICU, routine inpatient, outpatient)?
- Do you batch runs to save reagents/labor or run immediate single-sample assays for speed? How often is each used?
- What sensitivity vs. turnaround time trade-offs are acceptable clinically for your key panels?
- Which assays or panels would you expand if you had higher sustained throughput and why?
- How often do payer/reimbursement concerns factor into which tests you perform in-house vs. send out?
What Keeps Your People Up at Night: Emotions, Confidence, and Risk Tolerance
- When you think about expanding rapid molecular testing, what worries you most—financial risk, regulatory burden, staff burnout, or something else?
- How confident are you in your lab’s ability to validate and maintain a high-complexity molecular assay long-term?
- Tell me about a time you felt proud of how your team handled a molecular testing challenge—what worked well?
- What emotional or cultural barriers might block adoption of new automation or process changes?
- How would you describe leadership’s appetite for risk when it comes to investing in new lab capabilities?
Small Wins That Unlock Big Gains: Low-Friction Improvements to Try Now
- If you could make one low-cost operational change this month with immediate impact, what would it be?
- Which of these changes would you consider piloting in the next 60–90 days?
- How open is your team to running a short pilot with vendor support (training, on-site validation, data review)?
- What quick metrics would prove a pilot’s success for you (e.g., TAT reduction, invalid rate, hands-on time saved)?
- What internal approvals would be required to run a pilot, and how long do those approvals usually take?
What Would It Take to Move Forward: Decisions, Evidence, and Timeline
- What would have to be true for you to approve a new rapid molecular workflow within 90 days?
- Which stakeholders must sign off before you can purchase or place a new instrument?
- What evidence most convinces your stakeholders—peer site results, internal validation data, economic model, or vendor references?
- What budget or procurement cycles constrain your timeline for new equipment?
- What would be the ideal next step after this discovery conversation to help you make a decision (on-site assessment, pilot quote, peer call, technical deep dive)?
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Outcome Discovery
Define clinical and operational success signals (TAT, sensitivity, throughput), economic thresholds, and acceptance criteria.
Discovery Questions
Start: What's Most Important Right Now?
- What's the single outcome that would make this project a clear success for you?
- Who in your organization will feel that success most directly?
- What's driving urgency now—select the primary trigger that pushed this forward?
- Briefly describe a recent case, report, or moment that made this problem feel urgent.
- Have you ever run a pilot or implemented a rapid molecular test before at your site?
If Faster Tests Didn’t Fix the Problem, What Would?
- What if reducing TAT to hours doesn't change clinical decisions—what else must shift to realize value?
- Which downstream processes most often block benefit from faster results?
- How frequently do clinicians actually act on molecular results within the timeframe you hope to deliver?
- Tell us about a specific instance where a faster result would have changed management—who needed the information and what stopped it from happening?
- Which non-analytical factors (e.g., reporting, education, workflow) would you prioritize fixing if TAT alone is insufficient?
What's the Real Economic Threshold?
- How much additional reagent cost per test can your department realistically absorb without outside funding?
- If faster testing reduced length of stay, what minimum days saved per relevant patient population would justify higher per-test costs?
- Who controls the capital and operational budget for this purchase and what approval level is required?
- Describe any reimbursement or contract constraints that materially affect your willingness to increase test spend.
- Would you consider a reagent-consumption-based pricing model, reagent consignment, or reagent cap if it reduced upfront capital? Which would you prefer?
When Is 'Good Enough' Actually Good Enough?
- If a platform met 80% of your targets but missed one—what compromises would you accept and which failure would be a deal-breaker?
- Target turnaround time (TAT) you need for: emergency/sepsis cases?
- Minimum acceptable analytical sensitivity for key assays (e.g., sepsis or respiratory panels)?
- What is your acceptable invalid/indeterminate rate per run (%) beyond which you require root cause and remediation?
- How critical is walk-away automation versus manual hands-on steps for your staffing model?
- Describe any LIS/EMR reporting expectations or turnaround SLAs that must be met for clinical adoption.
Who Holds the Keys to Yes — and Why?
- Who would veto this project if their concerns aren't addressed—and what would likely trigger a veto?
- Which stakeholders must sign clinical acceptance (results you can act on) before you declare go‑live?
- Who will own post-deployment performance monitoring and dashboards?
- Describe any stakeholders outside the hospital (reference lab partners, public health, payers) with influence over acceptance.
- How do you prefer decisions to be made: consensus, majority, clinical lead authority, or executive sign-off?
How Will Workflows Change — and Who Will Carry the Load?
- If you add rapid molecular testing, which current processes will change most (sample routing, batching, staffing, result distribution)?
- What percent of your current molecular staff are cross-trained and could be redeployed to new workflows?
- How many dedicated FTEs do you expect to allocate to operate and maintain the new platform (including validation and QA)?
- Do you have space, power, and network capacity today for the preferred instrument class?
- Who will own training and competency sign-off for operators and supervisors?
What's the Worst That Could Happen — and Can We Live With It?
- If a new platform caused an unexpected spike in false positives or negatives for 2 weeks, how would that impact willingness to continue?
- Which operational or clinical risks make you lose sleep about introducing new molecular technology?
- What frequency of unplanned downtime is tolerable (hours/month) before you require backup solutions?
- Describe any legal, compliance, or payer-related consequences you worry could follow diagnostic errors.
- What escalation path and timeline do you expect from a vendor when a critical issue arises?
How Will You Measure Success in Day-to-Day Care?
- Which clinical KPIs will you use to judge impact (select top 3)?
- Which operational KPIs matter most to the lab (select up to 3)?
- How will you source the data for these KPIs—LIS, manual audits, EHR, or a mix?
- Who will be accountable for reporting outcomes and how often would you want updates during a pilot?
- What minimum measurable improvement in your top clinical KPI would justify expanding beyond a pilot?
What's the Timeline That Actually Matters?
- If you had to be blunt, what is the earliest realistic date you could have results impacting care (not sales promises)?
- What are the non-negotiable timeline constraints (e.g., board review, fiscal year, seasonal demand)?
- How long of a pilot would you consider adequate to prove clinical and economic value?
- Are there procurement, validation, or regulatory windows that could delay instrument placement beyond your preferred timeline?
- What milestone would make you comfortable committing to a commercial agreement?
What Would Make You Walk Away?
- What single issue would immediately stop this project if unresolved?
- Are there minimum contractual or service guarantees you require before signing (uptime, turnaround, indemnity)?
- Would you require a formal pilot with predefined success criteria before procurement? If yes, list the top 3 criteria you would include.
- What level of vendor involvement in validation and training do you expect as standard?
- If we agreed on a pilot, what sample volumes and specimen types would you need to feel confident in the results?
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Solution Experience
Translate outcomes into realistic workflows showing how instrument selection, assay menu, automation, and staffing will deliver the target results.
Experience Meetings
- Solution Experience Kickoff
- Workflow Mapping Workshop — Clinical & Operational Pathways
- Throughput, TAT & Capacity Simulation
- Integration, Sample Logistics & LIS Workflow Alignment
- Operational Readiness & Validation Planning — From Workflow to Go‑Live
- Seller to circulate agreed future-state sentence and list of proof metrics after the meeting.
- Introductions & Objectives
- Quantify staffing changes and costs versus clinical benefit for decision-making.
- Identify required redundancy or mitigation for peak/surge scenarios.
- Seller to share the simulation model and a sensitivity analysis file for customer review.
- Customer to confirm which scenario (baseline/automated/peak-capacity) they prefer to adopt for the proposal.
- If gaps exist, schedule a focused session to evaluate alternative instrument mixes or scheduling changes.
- Review Required LIS Interactions & Data Elements
- Agree exact LIS interface requirements and validation artifacts needed.
- Confirm instrument placement, sample flow, and any physical constraints that affect workflow performance.
- Assign integration owners and a target timeline for build/test/go‑live steps.
- Customer IT/LIS to provide HL7 interface spec and test environment details.
- Seller to produce a site layout sketch showing instrument placement and sample flow.
- Jointly create an integration test plan with required test messages and specimen lists.
- Document risks and mitigation actions for any identified LIS or footprint constraints.
- Map Validation Activities to Workflows
- Produce a validation protocol mapped to each workflow with specimen lists and acceptance criteria.
- Agree a training and competency schedule that ensures operators meet required performance standards.
- Finalize a go/no‑go checklist with named approvers and post‑go‑live support commitments.
- Align on a realistic timeline from instrument delivery to validated go‑live.
- Seller to draft the validation protocol and provide specimen requirements for customer approval.
- Customer to nominate training leads and confirm operator availability for scheduled training dates.
- Jointly finalize the go/no‑go checklist and list signatories for acceptance.
- Schedule a pre-deployment readiness check 2 weeks before the planned install date.
- Obtain customer confirmation of a single-sentence current state that will guide the experience.
- Surface and quantify the operational/clinical/financial consequence tied to current failures.
- Define and align on a single-sentence future state and success metrics the experience must prove.
- Agree scope, required pre-work, and data owners for subsequent sessions.
- Customer to confirm or correct the one-sentence current state in writing.
- Customer to provide sample volume by shift, LIS interface spec, staff rosters, and floor plan within 5 business days.
- Schedule the Workflow Mapping Workshop and Simulation session with named owners.
- Recap Validated Current & Future State
- Produce validated, diagrammed workflows for each clinical pathway showing instrument/assay/automation fit.
- Identify and document failure modes the proposed workflows eliminate or mitigate.
- Agree on staffing model and FTE impact for each workflow.
- Capture required validation and training artifacts tied to each workflow.
- Seller to deliver draft workflow diagrams annotated with instrument/assay mapping within 3 business days.
- Customer to supply any missing SOPs or local constraints that affect sample routing.
- Jointly produce an FTE estimate sheet mapping staffing to shifts and automation levels.
- List outstanding assumptions and schedule follow-ups for unresolved items.
- Confirm Modeling Assumptions
- Agree on throughput targets and the automation/instrument tier required to meet them.
- Training & Competency Plan
- Map End-to-End Sample Journey
- Sample Routing & Physical Footprint
- One‑Sentence Current State (Facilitator Readback)
- Baseline Scenario Simulation
- Peak & Surge Scenarios
- Explicit Consequence Quantification
- QC, Maintenance & Reagent Supply Workflow
- Identify Decision Points & Failure Modes
- Result Reporting & Exception Handling
- Instrument + Assay + Automation Assignment
- Go/No‑Go Acceptance Checklist
- Bottleneck Analysis & Mitigation Options
- One‑Sentence Future State
- Integration Validation Requirements
- Staffing, Roles & Task Allocation
- Scope of the Solution Experience & Proof Metrics
- Owners, Timeline & Risk Register
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Solution Scope
Specify instruments, assay panels, throughput tiers, LIS integration, validation support, training, and measurable deliverables.
Scope Configuration
- Install and commission instrument on-site
- Execute IQ/OQ validation protocols
- Run analytical validation experiments for selected assays
- Configure and integrate LIS/middleware connectivity
- Provide operator training and competency sign-off
- Supply initial reagent and consumables starter kit
- Deploy automated nucleic acid extraction workflow
- Calibrate and optimize multiplex panel assays
- Provide remote 24/7 technical support and monitoring
- Perform preventive maintenance and firmware updates
- Replace and repair on-site hardware components
- Deliver regulatory and validation documentation package
Scope Questions
Install and commission instrument on-site
- Has the installation site been identified and approved (room number and owner)?
- What are the physical site constraints we should know (bench footprint, clearance, shelving)?
- Which utility connections are available at the site?
- Are there any environmental controls required or present (temperature, humidity, biosafety cabinet)?
- Is there clear delivery and service access for instrument crates and technicians?
- Who will be the on-site point of contact for the installation and what are their contact details?
- Preferred target date or window for delivery and commissioning (include blackout dates)?
Execute IQ/OQ validation protocols
- Do you require vendor-executed IQ/OQ, or will your lab perform with vendor support?
- What accreditation or regulatory standard must IQ/OQ meet (e.g., CAP, CLIA, ISO 15189)?
- Are there specific protocol versions or forms your lab requires for documentation?
- What acceptance criteria will be used to clear IQ/OQ (e.g., electrical safety, software checks, operational checks)?
- How many instrument units and which serial numbers will be included in IQ/OQ?
- What timeline do you expect for completing IQ/OQ after delivery (days/weeks)?
- Do you require IQ/OQ activities to be witnessed or co-signed by an external auditor or lab director?
Run analytical validation experiments for selected assays
- Which assays/panels do you plan to validate initially (list panel names or targets)?
- What sample matrices and specimen types will be used in validation (e.g., NP swab, blood, CSF)?
- Which validation experiments are required (LOD, linearity, precision, reproducibility, cross-reactivity)?
- Do you have access to reference materials, positive/negative controls, and clinical specimens for validation?
- What acceptance thresholds should validation meet (e.g., %CV, sensitivity/specificity targets)?
- How many runs/replicates do you require per validation study?
- Should validation be performed on-site or at a vendor/reference lab?
Configure and integrate LIS/middleware connectivity
- Which LIS and middleware vendor(s) are in use at your site (provide vendor and version)?
- What interface protocol do you require for connectivity?
- Which message types must be supported (orders, results, query, accessioning)?
- Will middleware be used for routing/translation, or direct LIS integration is preferred?
- Who is responsible for providing test and production endpoints and test accounts (customer IT, LIS vendor, or vendor support)?
- Do you require traceability for sample barcodes, accession IDs, and result flags in the integration?
- What is your target go-live date for LIS connectivity and any blackout constraints?
Provide operator training and competency sign-off
- How many users/operators will require initial training and competency assessment?
- What is the desired training modality?
- What competency criteria are required for sign-off (practical run, written test, checklist)?
- Do you require role-based training (operators, supervisors, IT, QA)?
- Will training need to be repeated for multiple shifts or remote sites?
- Do you require training materials to be provided in a specific format or language?
- Do you want the vendor to maintain competency records and certificates, or will customer manage records?
Supply initial reagent and consumables starter kit
- Which assays and volumes should the starter kit cover (list assays and expected weekly/monthly test volumes)?
- Do you require cold-chain shipping and on-site cold storage verification?
- Would you like consignment inventory, prepaid starter, or standard purchase for initial supplies?
- What consumables do you want included (tips, plates, extraction cartridges, controls, waste bags)?
- What is the expected re-order trigger or minimum on-hand quantity to initiate replenishment?
- Do you require lot-matched controls and certificates of analysis included in the starter kit?
- Are there budget or approval constraints we should consider for supplying the starter kit?
Deploy automated nucleic acid extraction workflow
- Is an automated extraction module included in your instrument package or required as an add-on?
- Which sample types and sample input formats will the extraction workflow need to support?
- What throughput target must the extraction workflow meet (samples per hour/shift)?
- Do you require automated sample accessioning and barcode integration prior to extraction?
- Are there containment or waste disposal requirements for extraction reagents and waste?
- Will the extraction workflow require custom protocols or validation for unique specimen types?
- Do you want hands-on time reduction quantified (e.g., operator minutes saved per run)?
Calibrate and optimize multiplex panel assays
- Which multiplex panels require calibration and optimization?
- Are there known local pathogen variants or interference concerns to account for?
- What performance targets should optimization achieve (TAT, sensitivity, Ct thresholds)?
- Do you require analytic calibration materials (standards, quantified controls) supplied by vendor?
- How many iterative runs or sample sets do you anticipate needing for optimization?
- Should optimization include workflow timing adjustments (batching, pooling, alarm thresholds)?
- Do you require documentation of calibration curves, lot-to-lot comparisons, and final optimized parameters?
Provide remote 24/7 technical support and monitoring
- Do you want 24/7 remote monitoring of instrument telemetry and alerts?
- Which support channels are preferred for 24/7 access (phone, email, chat, remote desktop)?
- What escalation SLA do you require for critical issues (response and resolution targets)?
- Do you require on-call bilingual support or coverage across specific timezones?
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Mutual Commit
Finalize commercial terms, reagent contracts, service levels, timelines, and mutual responsibilities required for go‑forward.
Agreement Modules
- Statement of Work (SOW)
- Equipment Purchase / Lease Agreement
- Reagent & Consumables Supply Agreement
- Service Level Agreement (SLA) & Support Plan
- Pricing & Payment Terms
- Implementation & Go‑Live Timeline
- Delivery, Installation & Acceptance Criteria
- Validation & Training Agreement
- LIS Integration & Data Interface Statement
- Data Processing & Privacy Agreement (DPA)
- Warranty, Returns & Replacement Policy
- Consumable Availability & Backstop Plan
- Change Order & Scope Management
- Termination, Exit & Decommissioning Plan
- Insurance, Indemnity & Liability Terms
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Deployment
Operationalize rollout with readiness checks, enablement, and outcome validation.
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Pre-Deployment Readiness
Confirm site readiness: space, power, network/LIS access, sample logistics, and availability of validation specimens and owners.
Readiness Questions
Start Here: A quick snapshot of your lab
- Tell us your role and the type of lab or service you lead
- Roughly how many molecular tests (PCR, multiplex panels, NAAT) does your lab run per day on average?
- Which molecular platforms or vendors are currently in routine use here? List all that apply.
- Tell us about one recent patient or clinical decision that would have been meaningfully different with faster molecular results
What’s keeping you awake about current molecular testing?
- If you could fix one persistent operational failure in your molecular workflow overnight, what would it be?
- How frequently do those failures lead to delayed care, empiric broad antibiotic use, or escalated resource use?
- Which of these failure modes affect you most right now?
- When these issues happen, how does it impact your team's morale, stress, or ability to recruit/retain staff?
- Share a short example of a time a system failure had outsized consequences (operational, clinical, or financial)
The economics nobody often says out loud
- Are you currently absorbing costs of rapid testing that aren’t fully reimbursed?
- Which cost pressures matter most when evaluating a new platform?
- What is your target or acceptable per‑test all‑in cost for the priority assays (give ranges if possible)
- If your economics model required a formal ROI, what payback period would be acceptable (equipment + validation + training)?
- Describe one hidden or recurring cost you wish stakeholders truly understood about rapid molecular testing
What 'good' would actually change practice here
- If your molecular program were a clinical success story in 12 months, what would patients, clinicians, and your lab be saying about it?
- Which outcome measures matter most when judging success?
- Which clinical use cases would you prioritize for rapid on‑site testing first?
- What non‑clinical wins would convince finance and executive leadership (e.g., throughput, staff time saved, downstream revenue)?
- Who are the must‑have stakeholder champions for this success to stick?
What’s the real obstacle people avoid naming?
- What political, cultural, or organizational barrier would most likely stop this project even if the data look good?
- Which roles have explicit or implicit veto power over purchasing or go‑live decisions?
- How aligned are lab leadership, clinicians, finance, and IT today around investing in molecular testing?
- When internal objections arise, what evidence or approach usually moves the conversation forward here?
- Name one internal stakeholder whose concerns we should proactively address and why
Deployment realities: will the lab survive and thrive through installation?
- If an instrument arrived tomorrow, which of these site readiness items would break first?
- How would you rate current readiness across space, power, and network/LIS on a 1–5 scale?
- Do you have dedicated owners identified for site prep areas (facilities, IT, LIS, sample logistics)? If yes, list roles/titles.
- Do you have access to validation specimens and clinical material needed to verify assays? If not, what’s missing?
- What timeline do you realistically need to complete site readiness once an agreement is in place?
Validation and staffing — who will run it and sign off?
- If validation uncovers unexpected issues, who in your organization will be accountable for remediation and final acceptance?
- What is your current bench staffing model for molecular testing and how many dedicated FTEs are available or required?
- How comfortable is your team with hands‑on verification vs. vendor‑led verification and documentation?
- What specific validation outcomes or documentation do your medical and quality teams require to sign off on clinical use?
- Are there regulatory or accrediting considerations (CLIA, CAP, local) that will add steps to your validation timeline?
Decision rhythm: what will make you say yes (and when)?
- What single outcome or piece of evidence would make you comfortable committing in the next 30–90 days?
- Where are you in the decision timeline today?
- Which of these next steps would be most helpful right now to advance the decision?
- Who in your organization will own the coordination and communication for deployment (role/title)?
- Are there contractual or procurement constraints we should be aware of (budget cycles, approval windows, purchasing agreements)? Describe briefly.
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Deployment Enablement
Schedule delivery, install instruments, run verification, provide operator training, and coordinate LIS go‑live with clear owners.
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Validation Checklist
Execute and document assay verification/validation protocols, analytical performance, and clinical acceptance sign-offs.
Validation Questions
Quick Snapshot: Your Lab in a Sentence
- Give us a one‑sentence summary of your lab’s current molecular testing capability and top pressure right now.
- Which best describes your facility?
- Roughly how many molecular/NAAT tests does your lab run per week today?
- Who usually leads decisions about new molecular platforms at your site?
- What feels most urgent about this project from your perspective?
Are You Settling for 'Good Enough'?
- If you keep doing what you’re doing today, what clinical gap or risk are you quietly agreeing to live with?
- Which of the following limitations do you tolerate because change feels harder than the problem?
- How long have these limitations been impacting care or operations?
- Tell a short story about the last time a delay or test gap caused clinician frustration or a missed opportunity (what happened and what was the outcome?).
- If nothing changes in the next 12 months, what negative outcomes do you expect to see most often?
Where the Bottlenecks Live (and Why They’ve Stuck Around)
- Which single bottleneck would you say most frequently prevents you from meeting clinician expectations?
- Walk me through a typical specimen from collection to result—where do delays or errors most often occur?
- How predictable are your daily volumes (do you see surges that overwhelm current capacity)?
- What manual steps consume the most technologist time per run (sample prep, extraction, setup, data review, etc.)?
- How often do you have to send samples out to reference labs because of capacity or assay limitations?
- When bottlenecks occur, how do they make you feel as a leader—frustrated, exposed, resigned, motivated, something else?
What’s the Real Cost of Staying Put?
- If you had to put a number on the annual cost of slow or missing molecular results (clinical, operational, and financial combined), how would you estimate it?
- Which of these downstream costs worry you most when molecular results lag?
- How much visibility does finance or hospital leadership have into the clinical value of faster molecular testing?
- Have you tried to build an ROI case before? What was the result and what stopped it gaining momentum?
- If budget were a clear yes, what would you immediately invest in (instrument, staffing, assays, LIS work, validation support)?
Who’s Really Driving the Decision (And Who Will Be Affected)
- Who could derail this project if they don’t see clear value—and why might they push back?
- Which stakeholder groups must sign off before procurement and deployment?
- How aligned are those stakeholders today on priorities (clinical speed, cost containment, assay breadth, automation)?
- What stories or evidence most persuade your CFO versus your clinical leads (e.g., case studies, cost per case, TAT improvements, peer benchmarks)?
- Who will be the day‑to‑day owner of validation and clinical acceptance once instruments arrive?
- If we helped prepare tailored materials for each stakeholder (finance one‑pager, clinical outcomes brief, IT integration plan), which three would be most useful to you?
What Would Faster, Smarter Testing Actually Change?
- Imagine your team is consistently hitting the TAT and sensitivity targets clinicians need—what tangible differences happen in patient care?
- Which outcome matters most for your clinicians: speed to actionable result, breadth of detectable pathogens, or analytical certainty?
- What are realistic target metrics for your lab in the next 6–12 months? Select all that apply.
- How will you measure clinical impact (length of stay, antimicrobial days, time to therapy, readmissions)? Which one will convince clinicians?
- What would success look like to you in a one‑page summary you could show leadership?
What Would Adoption Take—Really?
- What internal constraints make you doubt that a new platform would be fully adopted (staffing, training time, space, culture)?
- Which training model appeals most given your staff profile—intensive on‑site training, train‑the‑trainer, or staged remote support?
- How comfortable is your team with molecular workflows today (sample prep, QC, troubleshooting, data review)?
- Which change has historically been the hardest for your lab to sustain after go‑live (process adherence, QC discipline, reagent inventory management, LIS results handling)?
- If we committed to a targeted enablement plan, what guarantees or milestones would make you feel confident to proceed?
- Who on your team would be the primary super‑user or champion we should train first?
Validation & Risk: What Would Make You Sleep Better?
- What validation requirements or regulatory expectations are non‑negotiable for your lab to accept a new assay or platform?
- How much of the validation burden do you expect the vendor to own versus your team?
- How many validation samples and of what types would you realistically be able to source in the first 30–90 days?
- What documentation and sign‑offs does your quality team require to accept clinical use (traceable SOPs, QC plan, training records, validation summary)?
- Which validation timelines feel realistic given your workload—30 days, 60 days, 90 days, or longer?
- What would be your biggest fear during validation (clinician distrust, failed concordance, lack of specimens, staffing burnout)?
Next Steps That Feel Doable
- If we agreed on a small pilot, what would a minimally acceptable pilot look like to you (scope, duration, metrics)?
- Which of these immediate barriers would block a pilot from starting in the next 60 days?
- How would you prioritize our support to make the pilot successful: validation paperwork, training, specimen sourcing, or IT integration?
- Realistically, when could your team commit time to a discovery workshop or on‑site readiness assessment?
- What would make you say yes to a vendor‑led validation package in a single sentence?
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Success
Review outcomes against success metrics, capture lessons learned, and maintain a shared channel for issues and enhancements.
Success Reviews
- Success Metrics Review
- Lessons Learned & Root Cause Workshop
- Issue Triage & Shared Channel Governance
- Enhancement Roadmap & Prioritization
- Operational Sustainment & Customer Success Handoff
Issues & Enhancements
- Agree a lightweight governance process for future change requests and roadmap updates.
- Identify a single source-of-truth KB location and migrate relevant artifacts there; grant access to stakeholders.
- Inventory of Current Open Issues
- Create and activate a shared communication channel with clear access, rules, and naming conventions.
- Agree a triage flow and SLA matrix so incidents are handled consistently and predictably.
- Ensure integration between the shared channel and formal ticketing/reporting for auditability.
- Create the shared channel and invite agreed participants; post access and governance notes.
- Publish the triage matrix and SLA table inside the channel and link to ticketing system procedures.
- Configure automated reporting (weekly digest) of open/closed/high-severity incidents to stakeholders.
- Consolidate Enhancement Requests
- Produce a prioritized backlog of enhancements with clear impact assessments and owners.
- Align on which items the vendor will commit to, estimated timelines, and which require customer pilot validation.
- Welcome & Objectives
- Publish the prioritized enhancement backlog with impact/effort scoring and assigned owners.
- Schedule pilot projects for priority items, including sample/validation plans and success metrics.
- Document roadmap commitments and share expected delivery windows with stakeholders.
- Support & Service Model Review
- Confirm a sustainment plan that covers supplies, service, training, and QC to keep the system delivering agreed outcomes.
- Designate operational owners on both customer and vendor sides and set a regular review cadence keyed to KPIs.
- Ensure reagent forecasting and contract mechanics are in place to avoid supply interruptions.
- Finalize and sign-off on the sustainment plan including service schedule, reagent forecast, and training calendar.
- Assign ongoing Customer Success owner and create the invite for the first Quarterly Business Review (QBR) with KPIs.
- Set up the QC/validation calendar in the shared channel and assign owners for documentation and evidence retention.
- Confirm which success criteria have been met and which require remediation or extended monitoring.
- Assign clear owners and deadlines for any remediation actions and metric owners for ongoing tracking.
- Agree on evidence required for final acceptance sign-off or partial acceptance with remediation plan.
- Deliver a consolidated performance report (operations, analytics, financials) to all stakeholders within 3 business days.
- Assign metric owners for TAT, sensitivity, throughput, and cost; owners to declare remediation or monitoring plans within 7 days.
- Schedule any required targeted deep-dive sessions (e.g., clinical outcomes, LIS reporting) with appropriate SMEs.
- Pre-Work Summary & Framing
- Document the factual lessons from deployment with objective evidence and timelines.
- Define and prioritize corrective actions with named owners and target due dates.
- Update operational playbooks and learning artifacts so future deployments avoid the same pitfalls.
- Publish a 'Lessons Learned' report with RCA diagrams and assigned remediation owners within 5 business days.
- Update or create SOPs and training materials tied to the agreed process changes.
- Select Channel & Access Rules
- Reagent & Inventory Forecasting
- Impact Mapping
- Recap of Agreed Success Criteria
- Timeline Walkthrough
- Root Cause Analysis (top 3 issues)
- Operational Performance Review
- Training & Competency Maintenance
- Triage Workflow & Priority Matrix
- Prioritization Exercise
- SLA Targets and Escalation Path
- Analytical & Clinical Performance
- Identify Remediations & Process Changes
- QC, Validation Maintenance & Regulatory Considerations
- Roadmap Alignment & Timelines
- Review Cadence & KPIs for Ongoing Success
- Economic Outcomes
- Integration with Ticketing and Reporting
- Knowledge Base & Handoff Documentation
- Pilot & Validation Planning
- Gap Analysis & Root Cause Hits
- Decisions & Next Steps