Lunchbox Software

Services

Technical leadership for regulated software.

We work with medical device companies, health systems, and life sciences organizations that need senior engineering leadership — and can't afford to get it wrong.

Our Services

Primary Service
01

Fractional CTO

Senior technical leadership on your terms.

We integrate with your team as a working CTO — not an advisor who shows up for quarterly reviews. That means owning the architecture, managing engineering velocity, running vendor evaluations, and keeping the technical roadmap aligned to business outcomes.

Best for: Series A–C medical device and health IT companies that need CTO-level leadership without a full-time executive hire.

What's included

  • Architecture direction and governance
  • Engineering team structure and hiring
  • Technical roadmap development
  • Vendor and platform evaluation
  • Board and investor technical communication
  • Build vs. buy decision frameworks
Discuss this service
02

FDA Compliance Engineering

Compliance built in, not bolted on.

21 CFR Part 11, IEC 62304, and HIPAA compliance integrated into the development lifecycle from day one. We design audit trails, electronic signature workflows, and change control processes that satisfy FDA scrutiny — and don't slow your team down.

Best for: Companies preparing for 510(k) submission, PMA, or FDA audit — or those who've received a warning letter and need to remediate fast.

What's included

  • 21 CFR Part 11 electronic records architecture
  • Audit trail design and implementation
  • Software change control processes
  • HIPAA technical safeguards
  • Pre-submission strategy and Q-Sub support
  • FDA audit preparation and response
Discuss this service
03

Medical Device Software

IEC 62304 from architecture to submission.

Class II and Class III device software development under IEC 62304. We build and document the full software lifecycle — design history files, risk management per ISO 14971, software verification and validation — in a way that holds up under FDA review.

Best for: Medical device manufacturers building or modernizing Class II or Class III device software.

What's included

  • IEC 62304 software lifecycle processes
  • Design history file (DHF) development
  • Risk management per ISO 14971
  • Software verification and validation (V&V)
  • Predicate device analysis
  • 510(k) and PMA technical documentation
Discuss this service
04

Enterprise Architecture

Scalable systems for complex healthcare environments.

HL7/FHIR integration, EHR connectivity, and enterprise-scale healthcare application design. We architect systems that handle the complexity of real clinical environments — interoperability, data governance, security, and scale.

Best for: Health systems, payers, and health IT platforms managing complex integration landscapes or legacy modernization programs.

What's included

  • HL7/FHIR R4 integration architecture
  • EHR connectivity (Epic, Cerner, Meditech)
  • Clinical data architecture and governance
  • Enterprise security and access control
  • Legacy system modernization
  • Cloud migration strategy (AWS, Azure, GCP)
Discuss this service
05

Technical Due Diligence

Know what you're buying before you buy it.

Pre-acquisition and pre-investment technical assessments for PE and VC firms evaluating healthcare software companies. We identify architecture risk, regulatory exposure, technical debt, and team capability gaps — before they become your problem.

Best for: Private equity and venture capital firms evaluating healthcare software acquisitions or investments.

What's included

  • Architecture and codebase review
  • Regulatory compliance risk assessment
  • Technical debt quantification
  • Engineering team capability analysis
  • Scalability and security assessment
  • Post-acquisition integration planning
Discuss this service

How We Engage

Flexible engagements. No discovery theater.

01

Technical Review

A focused 60-minute conversation about your technical challenges, regulatory situation, and what you actually need. No sales deck.

02

Scoped Engagement

We define a clear scope — fractional hours, a retainer, a specific project, or a time-boxed assessment. You know exactly what you're getting.

03

Embedded Work

We work inside your team, not alongside it. Slack, standups, code reviews, architecture decisions — whatever the engagement requires.

04

Measurable Outcomes

Every engagement ends with documented deliverables — architecture decisions, compliance artifacts, assessment reports, or a running system.

Not sure which service fits?

Most engagements start with a technical review. We'll tell you honestly what you need — and whether we're the right fit.

Schedule a Technical ReviewLearn About Us