A Quick Hello — Who's in Front of Us?

• What's your title and primary responsibility for post-market activities? Options: VP Quality, Director, Post-Market Surveillance, Regulatory Affairs Director, Quality Manager, Head of Clinical Safety, IT / Data Integration Lead, Other
• Which product families or device lines will you be focused on for this program? (list product names or codes)
• Who else on your immediate team is expected to be involved day-to-day? Options: Post-Market Surveillance / Vigilance, Regulatory Affairs, Quality / CAPA, Clinical Affairs, Field Service, IT / Data Engineering, Other
• What is the most important outcome you personally want from improving PMS now? Options: Fewer regulatory deficiencies, Faster signal detection, Reduced manual reporting effort, Clear audit trail, Better cross-team collaboration, Other
• When you think about past platform projects, what has made you trust a vendor quickly — or lose trust?

Who Could Quietly Stop This Project?

• Which stakeholders outside your core team have the power to say ‘no’ or put this on hold, even if everyone else agrees? Options: Legal, Executive Leadership / CEO, Head of R&D, Manufacturing/Operations, Finance, IT Security, Regulatory Competent Authority Liaison, Other
• Why do you think each of those stakeholders might object—budget, risk, resource, validation burden, or something else? Options: Budget/cost, Validation/regulatory risk, Data security/privacy, Change fatigue, Competing priorities, Technical integration complexity, Lack of clear ROI, Other
• Tell us about a time a project stalled because an unexpected stakeholder raised concerns—what happened and how was it resolved (or not)?
• Which of these stakeholders would you want us to engage early to avoid surprises? Options: Executive sponsor, Legal counsel, IT security, Clinical safety lead, Quality assurance, Validation lead, Other
• If one of those stakeholders could only be shown a single thing to gain their buy-in, what should that be (e.g., cost avoidance, audit trail, validation package)? Options: Cost avoidance/efficiency, Audit-readiness documentation, Evidence of regulatory compliance (MDR/IVDR/FDA), Data security & access controls, Demonstrated signal detection performance, Other

Timelines That Will Make or Break Us

• If the timeline slips even a little, where will you feel the pain first—and why? Options: Regulatory deadlines (PSUR/MDR), Product launch or maintenance schedules, Internal reporting cycles, Audit readiness windows, Resource reallocation, Other
• What specific external deadlines are non-negotiable for you in the next 6–18 months (e.g., MDR report due dates, FDA submissions)?
• What internal milestones or board check-ins must we align with? Options: Monthly leadership review, Quarterly compliance steering, Product safety committee, Validation sign-off milestones, Other
• Realistically, how much calendar slack do you have between a project delay and the first regulatory impact? Options: None — immediate risk, 1–2 months, 3–6 months, 6+ months, Unsure
• If we commit to a target go-live date, what are the single biggest internal blockers that usually prevent you from hitting it? Options: Data readiness, Validation resource, Third-party integrations, Legal/commercial approvals, User training availability, Other

What Are We Assuming About Compliance That Might Be Wrong?

• Where do you feel the team has been 'making do' with processes that wouldn’t pass a close regulatory or auditor review?
• Which regulations are you most anxious about meeting with this project—pick all that apply Options: EU MDR, EU IVDR, US FDA (MDR/MAUDE), UK CA/UK MDR, Other national competent authority, Not sure
• Have you ever received a finding or observation tied to post-market surveillance or vigilance? What was the nature and impact? Options: Yes — major finding, Yes — minor observation, No, Prefer not to say
• Which compliance artifacts do you currently lack or find weakest (e.g., traceability matrix, validation evidence, audit logs)? Options: Validation protocol/execution, Data lineage documentation, Audit-ready reports, Algorithm validation, SOPs for surveillance, Other
• How would you describe your comfort level with the current ability to show 'audit-ready' processes to an inspector? Options: Very comfortable, Somewhat comfortable, Barely comfortable, Not comfortable at all

When Everyone Says 'Good'—Do They Mean the Same Thing?

• If we asked Legal, Quality, and the Head of Product to define 'good' for this program, how different do you think those answers would be? Options: Largely aligned, Some overlap, key differences, Mostly different, Completely different
• For each stakeholder group, what would a successful outcome look like? (List stakeholder → measurable sign of success)
• Which stakeholder’s definition of success is most likely to require trade-offs, and what trade-offs do you foresee? Options: Quality vs Speed, Cost vs Coverage, Usability vs Rigor, Local process vs Global standardization, Other
• How important is preserving existing manual workflows versus moving to automated processes? Options: Preserve mostly manual, Hybrid approach preferred, Lean toward automation, Full automation preferred
• If forced to prioritize, which success metric must we hit first (choose one)? Options: Regulatory submission readiness, Signal detection sensitivity/speed, Reduction in manual effort, Complete audit trail and traceability, Other

The Data Gatekeepers — Who Controls Your Sources?

• Who controls access to your primary complaint and adverse event feeds (CRM, field service, clinical safety, literature monitoring)? Options: Complaint CRM team, Field Service Ops, Clinical Safety team, IT / Data Platform, Third-party vendor, Other
• How confident are you that the data owners will agree to mapped exports and ongoing integration? Options: Very confident, Somewhat confident, Uncertain, Not confident
• What are the common reasons data owners say 'no' to integrations in your organization? Options: Security concerns, Data quality doubts, Resource constraints, Lack of formal API, Contractual/third-party limits, Other
• Which data source do you expect to be the trickiest to normalize for signal detection (CRM notes, field service logs, literature, legacy databases)? Options: CRM notes, Field service logs, Adverse event reports, Literature feeds, Legacy systems, Other
• If a key data owner resists, what compromise would be acceptable to you (e.g., delayed integration phase, partial extracts, anonymized records)? Options: Phased integration, Partial/filtered extracts, Pseudonymized data, Manual handoffs until automated, No compromise – must fully integrate, Other

How Will We Know We’ve Succeeded (Beyond Feeling Better)?

• What concrete KPIs will you use to decide this project is a success at 3 months, 6 months, and 12 months?
• Which of the following outcome measures matter most to your regulators and auditors? Options: Audit documentation completeness, Time-to-signal detection, False positive rate of alerts, Automated submission accuracy, Traceable data lineage, Other
• What level of reduction in manual effort (hours/week or FTE) would justify the investment to your finance sponsor? Options: <1 FTE, 1–2 FTEs, 3–5 FTEs, >5 FTEs, Unsure
• How do you prefer acceptance criteria to be documented—detailed test cases, executive sign-off checklist, or both? Options: Detailed test cases, Executive checklist, Both, Other
• Who will have final sign-off authority for acceptance—name role(s) and their tolerance for risk?

Governance: Who Keeps This Ship on Course?

• If we set up a steering committee, who do you insist must be on it and why? Options: Executive sponsor, Head of Quality, Regulatory lead, IT/Data lead, Clinical Safety Lead, Finance, Other
• How often should governance meetings occur to keep momentum without creating meeting fatigue? Options: Weekly, Bi-weekly, Monthly, Ad-hoc by milestone, Other
• What decisions need to be escalated versus handled by the project team?
• Who do you trust to make trade-off decisions when compliance, budget, and timeline conflict? Options: Executive sponsor, Head of Quality, Regulatory Affairs Director, Project Manager, Other
• What forum or artifact (e.g., decision log, RAID register) has helped you avoid repeated scope churn in previous programs? Options: Decision log, RAID register, Change control board, Weekly status report, Other

Unspoken Deal-Breakers — Tell Us the Hard Stuff

• What is a non-negotiable constraint for this program that would cause you to stop the project immediately if unmet? Options: No third-party access to PHI, Complete validation evidence, Meeting specific regulatory date, Budget cap, No changes to core CRM, Other
• Are there commercial terms or procurement red lines (e.g., liability limits, data residency) that must be resolved before technical work begins? Options: Data residency, Liability cap, IP ownership, Long-term commitment length, None, Other
• What internal political sensitivities should we avoid when engaging teams or communicating progress?
• If this program fails, what’s the worst organizational consequence (regulatory action, product recall, leadership fallout)? Options: Regulatory warning/recall, Increased inspections, Leadership consequences, Financial penalties, Reputational damage, Other
• What's one thing you haven’t told other vendors that we should know to avoid blind spots?

Early Commitments — Small Bets That Demonstrate Progress

• Which of these low-risk early wins would be most persuasive to your stakeholders? Options: Proof-of-concept with a single product line, Clean data extract + lineage for one source, Simulated MDR submission, Algorithm sensitivity demo on historical data, Validation template delivery
• Who needs to see those early wins and in what format (demo, deck, validated report)? Options: Executive sponsor — exec summary, Quality — validation evidence, Regulatory — sample submission, IT — integration specs, All of the above
• What is a realistic 30/60/90-day success plan that would get broad stakeholder confidence?
• Would you be open to a short pilot with real data under an NDA to validate assumptions quickly? Options: Yes — eager, Yes — with conditions, Maybe — need more info, No
• What resources can you commit in the near term (e.g., SME hours, IT support, validation reviewer) to make a fast pilot possible? Options: SME hours, IT integration support, Validation reviewer, Data extraction support, None right now, Other

Close the Loop — Clear Next Steps and Owners

• Based on this conversation, what are the top three immediate actions you expect from us?
• Who on your side will be the day-to-day project owner and who will be the executive sponsor (name/role)?
• What decision or deliverable would make you comfortable signing an initial statement of work? Options: Pilot scope and success criteria, Validated data mapping for one source, Commercial terms agreed, Regulatory acceptance criteria defined, Other
• When should we schedule a follow-up meeting to review the pilot plan and stakeholder engagement strategy? Options: Within 1 week, Within 2 weeks, Within 1 month, Other
• Is there anything we missed in this discussion that could change your priorities or timeline?

Quick Snapshot: Who’s on the Field?

• Who on your team will be the day-to-day owner for post-market surveillance and integrations?
• Which markets and competent authorities does your product portfolio currently report into? Options: United States (FDA), European Union (MDR/IVDR), United Kingdom (MHRA), Other regulated markets
• Roughly how many distinct medical device SKUs or device families are in active post-market surveillance today? Options: 1–5, 6–25, 26–100, 100+
• What systems currently store complaint and field data (select all that apply)? Options: CRM (Salesforce, Dynamics, other), Field service management, Safety/adverse event system, Literature monitoring feeds, Spreadsheets/Shared drives, Other
• Who is your single point of contact for integrations and IT security approvals?

Are You Missing the Signals That Matter?

• Tell us about a time when a safety issue emerged late—what signs existed beforehand that were missed?
• How do you currently define an emerging signal versus routine variation? Options: Statistical trending thresholds, Clinical review, Manual suspicion/intuition, Regulatory trigger lists, Other
• How confident are you that your current process would detect a low-frequency but high-severity signal in time to meet reporting requirements? Options: Very confident, Somewhat confident, Not confident, Unsure
• Which types of signals do you worry are most likely to be overlooked? Options: Field service patterns, Customer complaints re pattern, Literature case clusters, Adverse events across regions, Software-related issues, Other
• How often do you review sensitivity and specificity of your trending methods? Options: Monthly, Quarterly, Annually, Rarely/Never

Where Does the Noise Live? Mapping Your Data Blockages

• What percentage of complaint and service records are digitized and accessible for automated analysis today? Options: >90%, 60–90%, 30–59%, <30%
• Which of these best describes where your most valuable surveillance data is stored? Options: Centralized data warehouse, Multiple departmental systems, CRM is primary but not structured, Ad hoc spreadsheets and emails, Other
• Do you have consistent device identifiers (UDI, catalog numbers, serial) across systems to enable traceability? Options: Yes, standard across systems, Partially consistent, No, inconsistent or missing, We use different identifiers per system
• Which technical connectors are available for the systems you want integrated? Options: REST API, SFTP/flat file exports, Direct DB access, Vendor connectors available, None/Manual only
• Describe the most common data quality issues you see (e.g., missing fields, inconsistent coding, duplicates).
• Who currently owns reconciliation and remediation when data quality issues are found? Options: Quality/Regulatory, IT/Data team, Business unit, Shared ownership, Not defined

When Reports Become a Bottleneck

• How long does it typically take to produce a full PSUR or EU MDR periodic report from initial data pull to final sign-off? Options: <2 weeks, 2–4 weeks, 1–3 months, >3 months
• Which steps in your reporting process are most manual or error-prone? Options: Data extraction, Data cleaning/mapping, Signal review and adjudication, Report assembly and formatting, Regulatory submission process
• Have you missed statutory reporting deadlines in the past 3 years? If yes, what caused the delay? Options: No missed deadlines, Yes—data availability, Yes—review/approval bottleneck, Yes—technical submission failure, Other
• How do you currently document audit trails and traceability for report contents? Options: System-generated audit logs, Manual change logs, Not consistently documented, Third-party validation documents, Other
• In a crisis requiring urgent vigilance submission, what is your typical time-to-submission today? Options: <24 hours, 24–72 hours, 3–7 days, >7 days

What’s Really Risking Your License to Operate?

• If a regulator audited your post-market surveillance tomorrow, where would you expect the toughest questions to land? Options: Data integrity and lineage, Signal detection methodology, Traceability to devices, Timeliness of reporting, Validation and change control
• Have you received any regulatory observations, CAPAs, or warning letters related to post-market surveillance in the last five years? Please summarize.
• How formalized is your method for prioritizing regulatory risk exposures (e.g., risk matrix, RAG status)? Options: Formalized and tracked, Informal but used, Ad hoc decisions, Not defined
• Who signs off on acceptance criteria that determine when a signal becomes a reportable event? Options: Head of Quality, Head of RA, Cross-functional safety board, Ad hoc reviewers, Not defined
• How stressed or resourced is your team during peak reporting periods? Options: Well resourced, Manageable strain, Significant strain, Unsustainable

What Would Audit-Ready, Automated Surveillance Look Like?

• Imagine your ideal state: how sensitive should signal detection be (e.g., favor fewer false positives vs. maximize catch rate)? Options: Maximize sensitivity (catch all), Balanced, Favor specificity (fewer false positives), Unsure—need guidance
• Which automated outputs would deliver the most value for you right away? Options: Automated MDR/vigilance submissions, Pre-populated PSUR drafts, Trend dashboards by device family, Alert workflows to reviewers, Data lineage reports for auditors
• What measurable success signals would show you the solution is working (choose up to three)? Options: Faster report generation time, Fewer missed reportables, Higher confidence in trending, Reduced manual effort, Stronger audit outcomes
• What level of explainability do you require for trending algorithms in audit (e.g., statistical detail, adjustable thresholds, human-readable rationale)? Options: Full statistical detail, Configurable thresholds + summary, High-level rationale only, Unsure
• How would achieving that ideal change day-to-day life for your team and stakeholders?

What Would It Really Take to Change?

• If we proposed an integration and pilot, what would be the single biggest internal obstacle to moving forward? Options: Budget, IT approvals/security, Validation effort, Stakeholder alignment, Change fatigue
• Which groups must be involved and signed off for you to proceed (select all that apply)? Options: Quality/Compliance, Regulatory Affairs, IT/Security, Clinical, Legal, Executive sponsor
• What is your target decision timeline for selecting a post-market surveillance platform? Options: Immediately/This month, 1–3 months, 3–6 months, 6+ months
• What level of integration and validation support would you expect from a vendor to consider a pilot successful? Options: Full integration + IQ/OQ/PQ deliverables, Partial integration + validation playbook, Advisory support only, We define requirements
• What budget posture exists for this initiative and who controls allocation? Options: Dedicated budget in place, Budget under review, Cross-functional funding required, No budget yet
• What would ‘success’ look like at the end of a 3-month pilot (be specific)?

One Last Thing: Practical Next Steps and Quick Wins

• Which small, high-impact data source could we integrate first to prove value quickly? Options: CRM complaints, Field service logs, Adverse event system, Literature alerts, Device registries
• Who should be on a 30-minute technical discovery to confirm connectors and security requirements?
• Would you find it helpful to run a short data health checklist together to estimate effort and timelines? Options: Yes—schedule it, Maybe—need more info, No
• What is the best way to show early ROI to your leadership (select top two)? Options: Time saved per report, Reduced missed reportables, Audit-ready documentation, Lower external consulting spend, Faster regulatory response time
• Is there any other context, sensitive issues, or recent changes we should know before proposing a pilot?

Start Here: A Quick Snapshot of Your World

• Who is in the room for post-market decisions at your company (names or roles)?
• Which markets and regulations are highest priority right now? Options: EU MDR, EU IVDR, FDA (US), Other regulated markets (APAC, LATAM), All of the above
• Roughly how many active device SKUs or product families does your PMS program cover? Options: 1-10, 11-50, 51-200, 200+
• What are the top three immediate deliverables that keep your team up at night (e.g., MDR reports, PSURs, trending, audits)? Please list.
• How would you describe your current approach to signal detection? Options: Ad hoc manual review, Rule-based periodic trending, Statistical/algorithmic monitoring, Outsourced or vendor-driven, Not sure
• How confident do you feel today that your current PMS process would stand up to a regulatory inspection? Options: Very confident, Somewhat confident, Concerned, Not confident at all

What Could Be Hiding in Plain Sight?

• If a safety signal today led to a recall, how likely is it that the root cause was visible in your existing data but simply not found? Options: Very likely, Somewhat likely, Unlikely, Unsure
• Which data sources do you currently rely on for surveillance (select all that apply)? Options: CRM complaints, Field service records, Adverse event inbox, Literature monitoring, Distributor reports, Clinical complaints, Other
• How regularly are those sources consolidated into a single surveillance view? Options: Daily, Weekly, Monthly, Quarterly, Ad hoc/never
• Tell us about a time you missed an emerging issue—what signs were present and what stopped the team from acting?
• How much manual work goes into taking a raw complaint to a reportable event today? Options: Minimal (mostly automated), Moderate (some manual review), High (manual triage and escalation), Unknown
• Which part of the data pipeline feels most fragile or error-prone to you? Options: Intake/classification, Deduplication/record linkage, Mapping to product families, Trending/algorithms, Report generation, Audit trail

Who Really Pulls the Trigger on Safety Actions?

• When a potential signal appears, what usually determines whether it becomes an investigation rather than a note in a tracker? Options: Regulatory threshold, Business impact, Clinical risk, Resourcing capacity, Existing SOPs, Other
• Which roles must sign off on an MDR or vigilance submission in your organization? Options: Quality Director/VP, Regulatory Affairs, Clinical Safety Lead, Head of Engineering, Legal, Other
• How aligned are timelines between compliance, operations, and commercial teams when an event needs escalation? Options: Fully aligned, Mostly aligned with occasional delays, Often misaligned, Completely siloed
• Describe how disputes about reportability are resolved today and how long resolution typically takes.
• What acceptance criteria do you currently use to close a signal as 'no action'—and how often are those criteria formally documented? Options: Clear and documented, Partially documented, Informal and inconsistent, No formal criteria
• If decision roles could change tomorrow, what single change would most speed up safe, compliant action?

Where the Compliance Paper Trail Breaks (and How That Feels)

• When auditors ask for traceability from complaint intake to regulatory submission, where do you most struggle to produce clean evidence? Options: Data lineage, Versioned reports, Validation records, Investigation files, Sign-off stamps
• Have you had recent audit findings, warning letters, or regulatory feedback related to post-market surveillance? If yes, what were the themes? Options: Yes—data integrity, Yes—timeliness of reporting, Yes—invalid classification, No recent findings, Prefer not to say
• How complete are your validation artifacts for the systems used in surveillance (IQ/OQ/PQ, traceability matrices, test scripts)? Options: Complete and up to date, Partially complete, Outdated, Not started/unknown
• Tell us about a moment when documentation or process gaps created extra risk or rework—what happened and how did it land on the team?
• Which regulatory controls do you consider non-negotiable to demonstrate before go-live? Options: Data access controls, Audit trails, Validated algorithms, Change control, Retention policies, Other
• How does it feel internally when an audit exposes PMS weaknesses—embarrassing, urgent, paralyzing, motivating, or something else? Options: Embarrassing, Urgent, Paralyzing, Motivating, Other

If Reports Came Out Right, Every Time—What Would Change?

• Imagine MDR/PSUR/FDA reports are delivered accurately and on time for the next 12 months—what immediate business outcomes do you expect? Options: Fewer regulatory actions, Faster corrective actions, Lower cost of compliance, Improved product quality, Stronger executive confidence
• What specific metrics would convince you the platform is delivering value (e.g., reduction in manual hours, time-to-report, signal detection lead time)? Please prioritize top 3.
• How important is automated linkage between PMS events and CAPA/engineering workflows to your success? Options: Critical, Very important, Nice to have, Not needed
• If you could reduce one downstream cost or burden by 50% (e.g., report prep, audit prep, manual triage), which would you choose? Options: Report preparation, Audit preparation, Manual triage, Cross-team coordination, Other
• What would signal to your executive team that the surveillance program is strategic rather than purely operational?
• How would your customers or end users notice a meaningful improvement in post-market surveillance? Options: Fewer recalls, Faster responses to complaints, Clearer communications, Improved product safety, They wouldn't notice

What Implementation Really Looks Like (Not the Sales Pitch)

• If implementation revealed three hidden integration tasks, how would that change your timeline or budget appetite? Options: Acceptable impact, Moderate concern, Major blocker, Depends on scope
• Which systems must be connected at go-live (select all that apply)? Options: CRM (complaints), Field service system, EHR/clinical feeds, Literature monitoring tool, Distributor portals, ERP/MDM
• Do you have a validated test environment strategy (SIT/UAT/PRE-PROD/PROD) and if so, which environments are available today? Options: SIT, UAT, PRE-PROD, PROD only, No environments available
• Who will own data mappings, and what internal capacity exists for mapping and data cleanup? Options: Quality team, Regulatory team, IT/Integration team, External consultants, Not assigned
• What are the must-have validation deliverables for your launch (e.g., test scripts, traceability matrix, performance reports) and which are most likely to slow you down?
• How ready is your IT/security team to grant the access rights needed for integration and ongoing operations? Options: Ready and resourced, Somewhat ready, Understaffed/delayed, Unknown

One Thing We Could Remove Today—Where Would You Start?

• If you had to name the single biggest blocker to a smooth go-live, what is it?
• Which internal stakeholders do we need onboard for a successful pilot and who is the likely executive sponsor?
• What would success look like after a 90-day pilot (concrete outputs and acceptance criteria)?
• How much runway (time and budget) do you realistically have to validate, train, and transition teams before regulatory deadlines force prioritization? Options: <1 month, 1-3 months, 3-6 months, 6+ months
• Which types of training or enablement help your teams adopt new surveillance workflows fastest? Options: Live workshops, Role-based playbooks, Short video modules, On-demand sandbox access, Train-the-trainer
• Are you open to a staged rollout (pilot product family first) or do you require a big-bang approach? Why? Options: Staged pilot, Big-bang, Undecided

Quick Intro: Who’s in the Room?

• Please tell us your name, role, and which part of the product portfolio you represent (brief).
• Which function best describes where you sit? Options: VP Quality/Head of Quality, Director Post‑Market Surveillance, Regulatory Affairs Director, Head of Safety/Vigilance, Clinical/Medical Safety Lead, IT/Integration Lead, Other
• Which regulated markets are highest priority for your organization right now? Options: EU (MDR/IVDR), United States (FDA), UK (MHRA), Canada (Health Canada), Australia, Other
• How many active marketed device families would this program initially cover? Options: 1–5, 6–20, 21–50, 51–200, 200+
• Roughly how many FTEs are dedicated to post‑market surveillance, vigilance, or complaint handling today? Options: <2, 2–5, 6–15, 16–50, 50+
• In one sentence, what outcome would make you say this engagement was worth it?

Are You Comfortable Flying Blind?

• How often have you felt confident that you would catch an emerging safety signal before it became a regulatory event? Options: Always, Most of the time, Sometimes, Rarely, Never
• Tell us about a moment when your team discovered a safety issue late—what happened and what was at stake?
• How frequently do you identify potential signals that later turn out to be meaningful (true positives)? Options: Weekly, Monthly, Quarterly, Annually, Rarely/Never
• When a potential signal arises, what is your typical time to triage and escalate (from detection to decision)? Options: <24 hours, 1–3 days, 1 week, 2–4 weeks, >1 month
• What emotions come up for you when you think about missed signals, late reports, or surprise audits? Options: Anxious, Frustrated, Motivated to improve, Resigned/used to it, Other

Where Your Data Is Hiding (and Why It Matters)

• If an auditor asked for a full lineage on a complaint today, how many separate systems would you need to query to assemble the story? Options: 1, 2–3, 4–6, 7–10, More than 10
• Which data sources currently feed your post‑market surveillance view? (select all that apply) Options: CRM/Case management, Field service logs, Adverse event feeds, Clinical literature monitoring, Distributor/complaint portales, Call center transcripts, Device telemetry, None of the above / manual only
• Which CRM or complaint system is the primary source today? Options: Salesforce Service Cloud, Oracle/Argus, Veeva, Zendesk/Freshdesk, Custom/Legacy, No formal CRM
• How would you describe the quality of your existing data mappings and unique identifiers across systems? Options: Robust and consistent, Mostly OK with gaps, Weak and inconsistent, Nonexistent
• What percent of your complaint records are structured (fields) versus unstructured (free text, attachments)? Options: >90% structured, 60–90% structured, 30–60% structured, <30% structured, Unknown
• What are the top three technical or organizational blockers to connecting those systems? (list)

What Would a Regulator’s Worst Day Reveal About You?

• If a regulator requested all records and rationale behind a MDR/MAUDE submission made in the past 12 months, how confident are you that you could provide an audit‑ready trail? Options: Very confident, Somewhat confident, Unsure, Not confident at all
• Have you had recent audits, FDA inspections, or Competent Authority inquiries that flagged PMS, trending, or reporting gaps? Options: Yes—within 12 months, Yes—1–3 years ago, No, We had internal findings only
• What formal validation documentation do you currently maintain for your surveillance workflows (e.g., algorithm validation, data mapping verification, user acceptance test scripts)? Options: Full validation package, Partial documentation, Ad hoc notes only, None
• Who in your organization is accountable for regulatory acceptance criteria and final sign‑off for MDR/vigilance submissions? Options: Head of Regulatory, Head of Quality, Safety/Vigilance Lead, Cross‑functional committee, Not clearly assigned
• Describe one traceability gap you worry would show up in an audit and what would be required to fix it.

What If Your System Actually Found the Next Problem?

• Imagine an early signal that prevents a recall—what would that success look like for your team and patients?
• Which outcome matters most when measuring signal detection effectiveness? Options: Speed to detection, True positive rate (precision), Sensitivity (recall), Actionable prioritization, Regulatory defensibility
• How tolerant are you of false positives (noise) if it means catching more true signals? Options: High tolerance, Moderate tolerance, Low tolerance, No tolerance
• Which cadence do you need for automated reporting and dashboards to feel useful? Options: Real‑time/streaming, Daily, Weekly, Monthly, Quarterly
• What measurable success signals would make you comfortable to expand a pilot into full deployment? (select up to 3) Options: Reduced time to report, Increased signal detection rate, Fewer regulatory findings, Lower manual processing hours, Faster audit responses, Improved cross‑functional collaboration

What Needs to Be In Scope to Make This Real?

• Which functional modules must be included in scope for an initial implementation? Options: Complaint intake & triage, Automated trending & algorithms, Regulatory report generation (MDR/PSUR), Literature monitoring, Field service integration, CAPA linkage, Audit documentation & validation
• Which integrations will be required as part of scope (select all that apply)? Options: CRM/case system, ERP/service management, EHR/clinical data, Literature providers (e.g., PubMed feed), Third‑party safety databases, Device telematics
• What kinds of trending algorithms or analytic approaches are you most interested in testing? Options: Disproportionality (PRR/EBGM), Time‑series anomaly detection, Text/semantic clustering, Hybrid rule + ML models, Custom statistical models
• Which validation deliverables are must‑haves for your QA/regulatory teams? Options: Requirement trace matrix, Algorithm performance report, Data lineage maps, IQ/OQ/PQ scripts, User acceptance test results, SOP updates
• Who must own operational responsibilities post‑deployment (data steward, surveillance analyst, regulator liaison)? Please name roles and one primary owner each.
• Are there any hard deadlines (regulatory filings, audits, product launches) that constrain scope or timeline? Please specify dates.

Can We Agree on a Practical Pilot That Proves Value?

• If we designed a pilot to demonstrate value in 8–12 weeks, what single objective would make it a success for you?
• What dataset(s) are available for a focused pilot? (select all that apply) Options: Recent CRM complaints (last 12 months), Field service logs, Adverse event reports, Literature corpus, Synthetic/test dataset only, None available currently
• What acceptance criteria would you require to sign off the pilot? (select up to 3) Options: Detection of X% more signals, Reduction of manual triage hours by Y%, Validated data lineage for pilot cases, Successful simulated MDR submission, User adoption by core team
• Who are the decision makers who must approve pilot continuation or commercial terms? Options: VP Quality, Head Regulatory, CRO/CEO, Head of IT, Procurement/Finance
• What budget posture exists for a pilot and follow‑on deployment? Options: Committed budget, Budget under discussion, Requires business case, No budget yet
• What would be a realistic launch window for a pilot given your internal constraints? Options: Immediately (within 2 weeks), In 1–2 months, In 3–6 months, Later this year, Unsure

How Will This Change Feel Day‑to‑Day?

• Who will be the daily users of the platform and what are their primary frustrations with current tools? Options: Surveillance analysts, Regulatory authors, Quality engineers, Field service managers, IT/integration staff, Other
• What training or enablement format helps your teams adopt new systems fastest? Options: Hands‑on workshops, Role‑based eLearning, Shadowing and coaching, Quick reference guides, Blended approach
• Which internal change blockers do you expect (culture, process, tooling, headcount)? Options: Process inertia, Limited headcount, Data ownership disputes, IT priorities, Regulatory skepticism, Other
• How will you measure user confidence and adoption after deployment? (select up to 3) Options: Login/usage metrics, Time saved per case, Number of validated signals, User satisfaction surveys, Reduction in audit findings
• If adoption stalls, what escalation path or incentives have historically worked to get teams back on board?

Next Steps: What Would Success Actually Look Like?

• Summarize in one paragraph what would need to change for you to declare this project successful at 6 months.
• Which three KPIs should we track together during implementation and beyond? Options: Time to detect signals, Number of validated signals, Time to MDR submission, Audit response time, Manual processing hours saved, User adoption rate
• Who else should we bring into the conversation to make decisions faster (names and roles)?
• What are your biggest remaining concerns about moving forward—technical, regulatory, people, or financial? Options: Technical integration, Regulatory defensibility, User adoption, Budget/ROI, Validation burden, Other
• Finally, what would you like us to prepare for the next meeting to make it as valuable as possible? Options: High‑level implementation plan, Pilot data checklist, Estimated cost and timeline, Example validation artifacts, Demo using sample data