Good fit is not enough. Find the moment the gap becomes expensive.
Recent signals should outweigh old ones. The best outreach connects a visible business event to a specific MedDev capability.
INTENT HIERARCHY
Rank signals by urgency.
Not all intent is equal. A regulatory failure is different from a company quietly researching IEC 62304.
1 · RED ALERTRegulatory crisis
RTA, warning letter, 483, major NC, cyber deficiency.
2 · BUDGETCapital unlocked
Seed/A/B, grant, OEM partnership tied to commercialization.
3 · CAPABILITYHiring imbalance
Scientists and algorithms, but no medical software/SQA depth.
4 · PRODUCTArchitecture shift
prototype to production, hardware freeze, cloud/IoT, RUO to clinical.
5 · MANDATEExternal deadline
MDR transition, AI guidance, change submission, annual report.
SIGNAL → SOURCE → ACTION
Build a system that tells me why to call.
Every signal should create a commercial hypothesis, not just an alert.
FDA deficiency / enforcementRTA · 483 · warning letter · cyber gap
FDA databases + Google Alertsweekly monitoring
Likely needV&V · DHF remediation · cyber · design controls
Call RA/QA + CTO immediately around the exact cited gap.
Funding / grantSeed · A · B · NIH/SBIR · commercialization capital
Crunchbase · PitchBook · company newsfresh capital + milestone language
Likely needcommercialization · QMS · full software project
Map the launch milestone and whether internal regulated-software capacity exists.
Hiring imbalancedata science without SQA / IEC 62304 roles
LinkedIn · ZoomInfo · careerswho they hire and who they do not
Likely needalgorithm hardening · V&V · fractional specialists
Approach CTO / VP R&D with an external-capability thesis.
Prototype → clinical productPython/MATLAB research becomes regulated software
publications · product news · jobs · tech signalsRUO to clinical / production shift
Likely needIEC 62304 SDLC · GUI · traceability · V&V
Position MedDev as the bridge from core IP to production-grade medical software.
New device connectivitycloud · mobile · Bluetooth · IoT
product releases · patents · careers · websitenew attack surface and data flow
Likely needcyber · SBOM · penetration testing · risk
Lead with new regulatory scope created by connectivity.
LEAD IQ
Rank the people inside the account.
Account IQ tells me where to spend time. Lead IQ tells me who deserves the first direct conversation.
Title / authorityMax 35
Problem ownershipMax 30
Direct engagementMax 20
Relationship pathMax 15
0 / 100Low-priority contact. Keep in nurture or find a better stakeholder.