MedTech · IVD Diagnostics · Product Management

Navigating complex
MedTech landscapes

Senior product management and systems expertise for medical technology companies worldwide. From IVD diagnostics software to regulated device ecosystems — we guide your product from concept to market.

10+
Years MedTech
IVD
Domain depth
B2B
Global clients
What we do

Services built for regulated environments

Bridging the gap between clinical requirements and technical delivery — with deep fluency in both worlds.

01

Product Management

End-to-end PM for IVD diagnostics software products. Roadmap definition, stakeholder alignment, and delivery governance across complex multi-team environments.

02

Digital Health Strategy

Strategic advisory for connected diagnostics and IoT-enabled laboratory instruments. From device integration architecture to data pipeline design for QIAsphere-style ecosystems.

03

Regulatory Alignment

Supporting software documentation strategy for IVD Regulation (IVDR), FDA submissions, and CE marking. Risk management artefacts, traceability matrices, and SaMD classification.

04

Team & Process Scaling

Structuring development processes, agile ceremonies, and cross-functional collaboration models for MedTech product teams navigating rapid growth or regulatory audits.

05

Fractional PM Services

Senior product leadership on a contract basis — ideal for scaling startups, SMEs, or established companies needing MedTech PM expertise without a full-time hire.

Domain expertise
IVD · SaMD
ALM · IVDR

Deep roots in diagnostics software

Lighthouse Software was built on years of hands-on delivery within global IVD diagnostics — the kind of experience that comes only from being inside the process, not consulting from outside it.

  • IVD diagnostics software product management with direct instrument and cloud platform experience
  • Agile delivery within regulated MedTech environments — IEC 62304, IVDR, ISO 13485
  • Connected laboratory ecosystems and IoT instrument telemetry platforms
  • B2B enterprise stakeholder management across global, distributed teams
  • Technical background in software development (C++, Java, .NET) enabling deep engineering collaboration

A structured path to clarity

Every engagement follows a disciplined approach — no overhead, no guesswork.

I

Discovery

Understand your product landscape, regulatory context, team structure, and immediate challenges.

II

Alignment

Define scope, deliverables, and success metrics. Agree on engagement model and reporting cadence.

III

Delivery

Embedded or advisory mode — driving roadmap, documentation, and stakeholder alignment concurrently.

IV

Handoff

Clean knowledge transfer, documented artefacts, and sustainable processes your team owns fully.

Ready to navigate together?

Whether you need a fractional PM, an ALM consultant, or a strategic partner for your MedTech product — let's talk.