The US healthcare system is not complicated. It's complex.
There's a difference and most advisors don't know it.
April Smith-Hirak, PhD | Strategic Advisor to Health Tech, Biotech, Digital Health & AI Companies
Your product works. The evidence is there. The funding came through. Yet still, somewhere between clinical proof and market adoption, things stall. That's not a product problem. That's a systems problem.
Here's what gets missed: US healthcare isn't one system. Payer architecture, health system dynamics, clinical adoption culture, and federal policy each run on different logic and respond to different pressure points. A problem that looks regulatory is often a payer problem. A payer problem often turns out to be a health system adoption question. Misread the layer and you solve the wrong problem.
I spent twenty years inside the federal health enterprise. Not as an observer. At a senior level, across HHS, CDC, and the full interagency infrastructure that shapes whether health technology reaches patients or stalls indefinitely.
I understand how this system thinks, how it resists, and where it actually moves. Now I work directly with the companies and investors who need that clarity most.
Most health tech companies are solving the right problem with the wrong tools.
The US healthcare market is layered: federal regulation, state variation, payer dynamics, clinical adoption barriers, interagency politics, and behavioral constraints that aren't written down anywhere.
That gap is strategic, not scientific.
I analyze complex systems for a living. I identify which constraints are real and which are behavioral. I find the lever: the specific pathway, the stakeholder sequence, the evidence framing, the payer or health system entry point, that opens what looked like a closed door.
I'm not a lobbyist. I don't apply a standard framework. I bring twenty years inside this system, a behavioral scientist's analytical rigor, and the rare fluency to move between the worlds your problem spans: medical and scientific, policy and regulatory, payer and health system, and the culture of early-stage companies navigating all of it simultaneously.
If any of these sound familiar, we should talk.
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Your evidence is strong but payers aren't moving
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Hospital pilots go well. Then nothing happens.
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You're evaluating a health tech investment and need someone who can read the market adoption risk, not just the science
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You're at an inflection point and need your thesis pressure-tested before you commit
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You're entering the US market and the system feels like a black box
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You need someone who moves fluently between the clinical, payer, policy, and investor dimensions of your problem
Two kinds of clients.
One standard of engagement.
Investors, Law Firms & Intermediaries
VC firms, growth equity investors, and law firms who keep me on retainer and call me when their portfolio or client companies hit strategic terrain they can't navigate alone. I bring market and system fluency across payer dynamics, health system procurement, federal program logic, and regulatory environment as the senior resource your team deploysfor problems that require real analytical depth, not a generalist consultant. This includes international regulatory counsel and law firms advising non-US-founded companies on US market entry, who need a trusted senior guide to orient their clients before and during strategy engagement.
Growth-Stage Health Tech & Biotech Companies
Founders and leadership teams at seed through Series B who are evaluating market entry, gaining traction in a new space, exploring new use cases for existing products, or navigating the commercial and system complexity that determines whether technology reaches patients or stalls. I understand payer systems, health system adoption dynamics, and the behavioral and structural barriers to uptake that don't show up in the playbook. This includes companies founded outside the United States, particularly those entering from UK and European markets, who need a clear-eyed orientation to how the US system actually works before committing to a market entry strategy.
At this stage of the practice, every engagement is personally led by me. Depth and direct access are built into how I work.
Twenty years inside the system.
Senior expertise on your side of the table.
🧠 Systems Thinker by Training
Yale-trained behavioral scientist with experimental design, multivariate methods, and translational research grounding. Able to analyze large, complex systems (regulatory, organizational, behavioral) and find the specific inputs that produce movement. This is the foundation of everything else I do.
🏛️ Inside the Federal Health Enterprise
Fifteen years in the Office of the Secretary at HHS, progressing to Regional Health Administrator for 32 million people across New York, New Jersey, Puerto Rico, and the U.S. Virgin Islands. Before that, six years at CDC spanning policy, partnerships, coalition building, and rotational leadership experience, including infectious disease policy and strategy in my final years there. I didn't observe this system from the outside. I worked inside it at a senior level and understand how it thinks, exerts homeostasis, and can be moved.
🤖 At the Intersection of AI, Technology & Policy
Led nationwide digital health and emerging technology strategy across all 10 HHS regional offices. Contributed to HHS AI Taskforce working groups and AI governance strategy that advanced to the White House level. Guest Faculty, Columbia Business School Digital Health Strategy Program.
🤝 Bridge Builder & Coalition Architect
Conceived and led the first regional-office-driven Federal Health Innovation Summit: eight federal agencies, three departments, biotech founders, and investors in one room. Led executive roundtables with NYC Economic Development Corporation connecting growth-stage companies with federal health innovation leadership.
Deep engagement. Real access.
The value I provide is not a deliverable you could get from a junior analyst following a methodology. It's judgment, systems fluency, and the ability to think alongside you at the level your challenge actually requires. That demands depth, which is why I structure my practice to protect it.
Engagements range from focused 30–90 day strategy sprints to ongoing retainer relationships with investors and intermediaries. I'll tell you at the outset whether I think I'm the right fit, and if I'm not, I'll tell you that too.
April Smith-Hirak, PhD
Behavioral scientist by training. Systems strategist by practice.
I spent two decades inside the federal health enterprise, holding senior authority at HHS and CDC, contributing to AI and digital health policy frameworks, and building the deep knowledge of how this system works that I now bring to every client engagement.
Since my federal service ended in July 2025, I've been building 99 Directions: the practice I would have wanted to exist when I was on the other side of the table.
Ready to think through what you're navigating?
I keep my client roster intentionally small. If you're working through a strategic inflection point: a fundraise, a market entry decision, a payer or health system question, a go-to-market inflection, and you want a senior advisor who knows the terrain well enough to read it clearly, let's talk.