HIPAA architecture, SaMD regulatory path, and technical due diligence prep — paired with your clinical co-founder from week one. $5,499/mo Advisory, $9,499/mo full.
- Audit
- Architect
- Scale
monthly retainer
Who this is for
Healthtech founder with a clinical co-founder — pre-seed to Series A — who needs a fractional CTO for healthtech credibility with investors and cannot justify a $300k full-time hire yet. You have a product vision, a clinical expert, and maybe a junior engineer. What you don't have is someone who can design HIPAA-compliant architecture, answer investor technical questions with confidence, and tell you whether you're building a SaMD or not.
The pain today
- No technical co-founder to anchor investor conversations
- Clinical co-founder cannot evaluate architecture or regulatory tradeoffs
- HIPAA scope decisions made ad hoc, creating expensive retrofit risk
- Investor technical due diligence is weeks away with no documentation
- First engineering hires made without senior oversight
The outcome you get
- Fractional healthtech CTO from $5,499/mo, active from week one
- HIPAA and SaMD architecture matched to your actual regulatory path
- Investor due diligence package: ADRs, security controls, scalability plan
- Clinical co-founder pairing protocol so nothing gets lost in translation
- Engineering hiring plan and first-team structure before Series A
Why healthtech investors scrutinize the CTO seat
Healthtech investors probe harder on the technical side than most founders expect. Three things kill deals before term sheets: no credible technical leader on the cap table, architecture that can't survive a HIPAA or FDA audit, and a team slide with no engineering pedigree.
A fractional CTO for healthtech solves all three without burning runway on a $300k full-time salary. I step in as the technical co-founder for investor conversations, own the architecture decisions, and make sure the engineering story holds up under scrutiny. At $5,499/mo Advisory or $9,499/mo for a fuller engagement, the economics compared to a full-time hire are obvious for a pre-Series A company.
Fractional healthtech CTO from $5,499/mo, active from week one
Architecture that fits your regulatory path — not a generic template
Healthtech regulatory paths are not interchangeable. A SaMD product heading toward FDA 510(k) clearance needs design controls, traceability matrices, and risk management documentation baked into the architecture from day one. A HIPAA-only patient engagement tool needs PHI handling, BAAs with every vendor, and audit logging at the data layer. A wellness app sitting below the HIPAA threshold needs neither — and over-engineering it wastes months of runway.
I scope the regulatory path first. Then I design the architecture that fits it, not the other way around. That decision — made in month one — determines how painful every audit, due diligence call, and enterprise sales cycle will be for the next three years.
Beyond HIPAA, most investors in digital health now ask about SOC 2 readiness and FHIR interoperability posture. I factor both into the architecture early so they don't become Series B surprises.
3 weeks: From kickoff to investor demo.
Clinical co-founder pairing: translating care logic into code
The most common failure mode in healthtech isn't bad engineering. It's the translation gap between what the clinical co-founder knows and what the engineering team builds.
I work directly with clinical co-founders on a shared clinical-logic document they control. They write the care rules, protocols, and clinical decision criteria in their own language. I translate those into technical implementation, then review every engineering decision against the source document. Weekly sync — 45 to 60 minutes. Daily async updates.
This catches the class of bugs that automated testing never finds: the ones where the code does exactly what was specified, but the specification missed a clinical nuance.
Investor due diligence: what healthtech founders need ready
Technical due diligence for healthtech is more rigorous than general SaaS. Investors and their technical advisors probe architecture, regulatory posture, data strategy, security controls, scalability assumptions, and team composition. Without a CTO in the room, founders fumble questions that are straightforward to answer with the right preparation.
I prepare the full due diligence package before you enter any process: architecture decision records, HIPAA posture documentation, security controls inventory, scalability and infrastructure plan, regulatory path narrative, and a team hiring roadmap. Then I attend the DD calls as needed.
GigEasy's investor-ready MVP in 3 weeks for Barclays and Bain Capital-backed founders shows what disciplined pre-investor engineering looks like. The same preparation discipline transfers directly to healthtech — compressed timeline, compliance baseline built in, no post-launch fires.
AI in healthtech: new capabilities, new regulatory surface
AI features in healthtech products are accelerating — clinical decision support, triage automation, predictive risk scoring. Each adds regulatory surface. An AI-assisted clinical decision tool may cross into SaMD territory even if the underlying product did not. A predictive model trained on patient data triggers HIPAA considerations the team may not have mapped.
I help founders map AI feature plans to their regulatory implications before building, not after. This is increasingly what digital health investors ask about in 2026 — not just 'do you have AI' but 'have you thought through the regulatory and liability posture of your AI features'.
Pricing and engagement structure
CTO Advisory at $5,499/mo covers one to two days per week: strategy, architecture, investor support. It works for founders who already have a senior engineer and need oversight and credibility.
Fractional CTO at $9,499/mo is three days per week and goes deeper — architecture ownership, hiring, investor prep, team building. It works when there is no senior engineer yet.
14-day money-back guarantee. Cancel anytime. BAA standard for healthtech engagements. NDA standard. Typical engagement runs six to eighteen months — seed through Series A close and into first engineering hires.
When to consider a full-time CTO instead
For some healthtech products, a general-purpose fractional CTO is the wrong fit. Deep clinical informatics platforms — radiology AI, surgical workflow optimization, genomics pipelines — sometimes benefit from a full-time CTO who spent years inside a health system or medical device company. I'll tell you honestly if that's your situation.
For most pre-Series A digital health startups, though, the clinical domain expertise lives with the clinical co-founder. What the team needs is senior engineering judgment, regulatory architecture thinking, and investor credibility. That's the scope I cover. The transition to a full-time CTO makes sense post-Series A when the engineering team grows past five and clinical-informatics decisions become genuinely product-strategic.
Recent proof
A comparable engagement, delivered and documented.
Built and shipped an investor-ready MVP from scratch
Built the entire technological base and delivered MVP in just 3 weeks, enabling a successful rapid launch and investor demo.
Read the case studyFrequently asked questions
The questions prospects ask before they book.
I own the architecture decisions, set the engineering standards, and prepare the investor due diligence package. For healthtech specifically, that means scoping the HIPAA or SaMD regulatory path, designing a compliant data architecture, pairing with the clinical co-founder on care-logic translation, and attending fundraising calls where technical credibility matters. It is a working engagement, not an advisory one.
Clinical expertise and technical leadership solve different problems. A clinical co-founder knows what the product needs to do. I handle how to build it — HIPAA architecture, vendor BAAs, engineering hiring, scalability design, and investor questions about the stack. The two roles are complementary. Most healthtech investors will want to see both.
Investors expect architecture decision records, a HIPAA posture document, security controls inventory, a scalability narrative, and a team hiring roadmap. Beyond the documents, they want a technical leader in the room who can answer follow-up questions without hesitation. I build the package and attend the calls. Preparation typically takes three to four weeks from a standing start.
PHI data boundary definition, encryption at rest and in transit, role-based access controls, audit logging at the data layer, BAAs with every vendor touching PHI, and a breach-notification runbook. These are the decisions that are cheap in month one and expensive to retrofit after a security review. I scope and document all of them before you enter a fundraising process.
SaMD — Software as a Medical Device — applies when software is intended to diagnose, treat, prevent, or mitigate a disease without being part of a hardware device. If your product touches clinical decision-making, triage, or risk scoring, it may be SaMD regardless of how you describe it in your pitch deck. The architecture implications are significant: design controls, traceability matrices, and change management procedures need to be in place from the start, not retrofitted after FDA engagement.
A full-time CTO in digital health costs $300,000 to $400,000 annually in total compensation, takes six to nine months to recruit, and requires equity. Advisory fractional CTO at $5,499/mo runs about $54,000 per year — one-sixth the cost, available from week one, no equity required. For pre-Series A companies where the CTO role is primarily architecture and investor support rather than managing a large engineering organization, the fractional model fits the actual work.
Post-Series A, when the engineering team grows past five people and CTO work shifts from architecture and investor prep toward people management and organization design. At that point the fractional model becomes a constraint rather than a solution. I help founders plan the transition — writing the job spec, running the search process, and handing off properly rather than leaving a gap.