Cleveland, Ohio
World-Class Healthcare Innovation.
Code That Can’t Survive an Audit.
Cleveland is the global epicenter of healthcare innovation. 83,000 Cleveland Clinic employees. Patients from 130+ countries. The world’s first healthcare-dedicated quantum computer. We’re the onshore engineering team that makes sure the software behind it all is built to hold up under scrutiny.
AI-Generated Code Is Touching Clinical Research Data
Vibe coding ships fast. But when that code touches patient records, clinical trial data, or genomic research pipelines, your HIPAA auditor and your IRB aren’t grading on velocity.
Your Offshore Team Has Access to PHI and Research Data
HIPAA violations start at $100 per record. FDA 21 CFR Part 11 requires audit trails on electronic records. An offshore contractor with access to both is a compounding liability.
Your Medtech Integration Was Built by a Contractor Who Left
One bad deployment, one missed dependency, one engineer touching the wrong module, and device data, patient records, or trial results go dark. It’s not a matter of if.
The Risks Nobody Talks About Until It’s Too Late
01
Vibe Coding Is a PHI Breach Waiting to Happen
Your dev team is using AI to ship faster. That’s fine. Until it isn’t. AI-generated code doesn’t get reviewed the way human-written code does. It introduces logic errors, insecure dependencies, and auth gaps that slip through code review because nobody fully understands what was generated. In a city where clinical research data and patient records flow through every system, one unchecked endpoint can trigger a HIPAA investigation and jeopardize FDA submissions.
02
Offshore Isn’t Cheaper When PHI and Research Data Leave the Country
The hourly rate looks great. Then you add: timezone delays, miscommunication overhead, rework cycles, and the realization that patient health records, clinical trial data, and proprietary research left the country. Cleveland’s healthcare ecosystem handles some of the most sensitive data on the planet. HIPAA, FDA regulations, and institutional data governance policies don’t care where your contractor sits. One overseas exposure and your compliance posture collapses.
03
Your Clinical Systems Are Held Together With Duct Tape
You’ve been adding to it, patching it, hiring contractors to “just keep it running.” But nobody really knows how all of it fits together anymore. The original dev left years ago. The documentation is a lie. One bad update, one deprecated library, one new integration, and patient data goes dark. In Cleveland’s research-intensive healthcare ecosystem, a system failure doesn’t just disrupt operations. It can compromise years of clinical data.
04
Compliance Gaps Don’t Wait for Your Renewal Date
HIPAA, FDA 21 CFR Part 11, HITRUST. These aren’t annual checkboxes. They’re continuous requirements. Every new integration, every new team member, every infrastructure change is a potential gap. Cleveland’s healthcare and biotech companies operate under overlapping regulatory frameworks. The companies we talk to are almost always surprised to learn how many gaps they have. Not because they were careless. Because nobody was watching.
05
Cyber Insurers Are Auditing Healthcare and Research Code
The days of filling out a form and getting a policy are over. Underwriters are asking technical questions, especially when clinical data and research IP are involved. Do you have MFA? How is your code reviewed? What’s your incident response plan? If vibe-coded features are handling PHI in production with no audit trail, your claim could be denied. Or your premium just tripled.
06
You’re Automating the Easy Parts, Not the Expensive Ones
Most teams automate the easy stuff. The hard stuff (legacy EHR workflows, manual clinical data pipelines, cross-system research integrations, device data reconciliation) stays manual because nobody wants to touch it. That’s exactly where your operational costs are hiding. We’ve seen healthcare and biotech companies cut 40+ hours of manual work per week by automating the workflows everyone assumed were too complicated.
Built for the Companies That Keep This City Running
Cleveland isn’t just another Midwest market. It’s the global center of healthcare innovation, home to 10 Fortune 500 companies, the world’s most advanced medical research ecosystem, and a manufacturing base that still builds things the rest of the country depends on. That’s exactly where we operate best.
Cleveland Clinic & Health System Ecosystem
World-Class Medicine Needs World-Class Code
Cleveland Clinic reported $18 billion in operating revenue and nearly 16 million patient encounters in 2025 alone. Patients travel from over 130 countries. Behind every appointment, every clinical trial, every cross-continental telehealth session are software systems processing massive volumes of PHI. EHR integrations, patient portals, research data platforms, and clinical workflow tools all carry HIPAA obligations that multiply with every new facility and every new partnership. One improperly configured API and you’re managing a breach, not a patient.
Biotech, Medtech & Life Sciences
Research Code Has to Meet FDA Standards, Not Just Ship Dates
Cleveland’s biotech and medtech ecosystem is built around the Clinic’s innovation engine: 207 new invention disclosures, 58 license agreements, and a strategic collaboration with Khosla Ventures all in the past year. Startups are spinning out of incubator programs. Clinical-stage companies are handling FDA submissions. Every one of them generates code that touches regulated data. FDA 21 CFR Part 11 requires complete audit trails on electronic records. HIPAA governs the patient data feeding those systems. Vibe-coded shortcuts don’t survive regulatory review.
Insurance & Financial Services
$75 Billion in Revenue Demands Auditable Code
Progressive alone generated $75.3 billion in revenue last year, making it the highest-ranked Fortune 500 company in Greater Cleveland. Add Medical Mutual, KeyCorp, and the network of financial services firms, and you have a dense concentration of companies processing sensitive customer financial data, claims records, and policyholder PII. State insurance regulations, security attestation requirements, and GLBA obligations create overlapping compliance surfaces. The offshore teams processing this data often have access that would concern your compliance officer and your regulators alike.
Advanced Manufacturing & Aerospace
Defense-Adjacent Manufacturing Needs Compliance-First Code
Cleveland’s manufacturing DNA runs deep. Parker-Hannifin builds motion control systems for aerospace and defense. TransDigm supplies critical aircraft components. Cleveland-Cliffs produces the steel. NASA Glenn Research Center pushes aerospace innovation. These companies carry serious data obligations: IP protection, CMMC requirements for defense contracts, export controls, and supply chain integrity expectations from Tier 1 customers. This isn’t the place for offshore contractors or unreviewed AI-generated code touching your production systems.
Enterprise Technology & Materials Science
Industrial Innovation Needs Secure Infrastructure
Cleveland is a global hub for materials science and polymers. Sherwin-Williams just completed its new global headquarters downtown. Avery Dennison, RPM International, and Nordson all operate from the region. These companies run complex R&D platforms, supply chain management systems, and customer data infrastructure across global operations. Cloud migrations, AI workloads, and enterprise SaaS platforms all require compliance-first engineering that protects both customer data and proprietary formulations.
Stop Duct-Taping. Start Automating.
Every patch you add to a 15-year-old system is borrowed time. You know the person who built it is gone. You know nobody fully understands what happens when X triggers Y. You know it’s going to break, you just don’t know when.
We go in, map the thing, document it properly, and build a modernization path that doesn’t take your operations offline. Then we find every manual process that should have been automated five years ago and we fix it.
40+
Hours/week recovered through automation
0
Offshore contractors touching
your data
100%
US-based
engineering team
1
Point of contact who actually
knows your stack
If You Handle Sensitive Data,
You Have Compliance Obligations. Full Stop.
We don’t just build software. We build software designed to hold up under an audit. Whether you’re preparing for security reviews, building to HIPAA requirements, or pursuing a DoD contract, we engineer with compliance in the architecture, not bolted on at the end.
HIPAA
Healthcare data, PHI handling, covered entity and Business Associate requirements
FDA 21CFR
Electronic records, audit trails, clinical data integrity for regulated submissions
CMMC
Defense contractor compliance, CUI handling, DoD supply chain requirements
The Comparison Your CFO Needs To See
Offshore looks cheaper until you run the real numbers. Vibe coding looks faster until the auditor shows up.
Here’s what the comparison actually looks like.
Hoyack Core Service |
Hoyack (Onshore) |
Offshore/Vibe Coding |
|
Code practices built with HIPAA requirements in mind |
Built in from day one |
Assumed, rarely verified |
|
Data stays onshore (US soil) |
Guaranteed |
Often unclear or outright no |
|
Audit-ready code and logs |
Architected for it |
Retroactive fixes required |
|
Code review by human engineers |
Every commit |
AI-gen code often skipped |
|
Cyber insurance eligibility |
Documented & defensible |
Increasingly at risk |
|
Legacy system knowledge transfer |
Full documentation |
Knowledge walks when contract ends |
|
Real total cost (incl. rework, risk, delay) |
Predictable |
Unpredictable & compounding |
If You’re Not Sure Where Your Gaps Are, That’s the Problem.
We’ll do a no-pressure technical assessment of your current stack, compliance posture, and automation opportunities. You’ll walk away knowing exactly what’s at risk, and what it takes to fix it.
