Outsource Custom Healthcare Software Application Development
Your team is stuck in compliance quicksand. The backlog keeps growing. And while you’re still decoding HIPAA, your competitors are already shipping. That’s where we come in.
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At Pi Tech, we build healthcare software that meets the rules and makes it to market fast. Our senior engineers speak FDA, HIPAA, and HL7 fluently. While others debate specs, we build working healthcare applications that pass audits and delight users. No drama, no delays.
How We Build Healthcare Software That Ships
Healthcare Requirements & Architecture
We start where it counts: understanding your clinical workflows, compliance needs, and user reality. No 200-page requirement docs. Just enough clarity to build the right thing.
- Map clinical workflows without disrupting care teams
- Define HIPAA-compliant architectures that scale
- Create API contracts that work with EHRs and medical devices
- Identify compliance requirements early (not after you've built everything)
Iterative Healthcare Development
Healthcare apps need flexibility. Requirements change. FDA guidance evolves. We build in weekly cycles, showing real progress while staying compliant.
- Weekly demos with working features, not slideware
- Backend and frontend teams building in parallel, not waiting
- Continuous integration with automated compliance checks
- Real device testing with actual healthcare workflows
Regulatory & Compliance Integration
Compliance isn't a checkbox at the end. We bake it into every sprint, every feature, every line of code. FDA happy. Auditors satisfied. You shipping.
- HIPAA security controls built in from day one
- Audit logging that makes sense to regulators
- 21 CFR Part 11 compliance for electronic signatures
- QMS documentation that doesn't make developers quit
Testing & Clinical Validation
Healthcare software can't fail. We test like lives depend on it (because they might). From unit tests to clinical validation, we catch issues before users do.
- Automated testing for every code commit
- Clinical scenario testing with real workflows
- Performance testing under healthcare loads
- Security testing that goes beyond OWASP basics
Why Healthcare Companies Trust Pi Tech to Build Their Software
Senior-Only Healthcare Developers
Every developer on our team has over a decade building healthcare products. They understand PHI. They know how FHIR behaves in the wild. And they’ve sat across the table from auditors and passed.
Specless Engineering for Healthcare
Our Specless Engineering approach means we move fast, with clear goals and constant feedback. You’ll see working software every week. And compliance? It’s built in, not bolted on later.
Healthcare Industry Expertise
We’ve built everything from telehealth platforms to remote patient monitoring apps. We know how providers think, how clinics operate, and what it takes to build software that fits into the real world.
Proven Regulatory Track Record
We’ve shipped software that cleared the FDA. We’ve passed HIPAA audits for organizations large and small. Compliance isn’t new territory for us. It’s familiar ground.
Real-Time Clinical Intelligence for TAVR Procedures
Xenter is building smart devices, digital tools, and real-time data platforms that help cardiologists make faster, better clinical decisions. One of their breakthrough innovations is the TAVR SmartWire: a dual-sensor guidewire designed to improve how physicians monitor aortic regurgitation and predict para valvular leaks during transcatheter aortic valve replacement (TAVR) procedures.
The SmartWire needed a software platform that could stream live pressure data directly to cardiologists during procedures, operate reliably within a wireless hospital environment, and stay fully HIPAA-compliant while supporting Xenter’s upcoming FDA 510(k) submission. It also had to scale for clinical trials and future commercial use, all while the hardware was still being finalized.
Our Solution
Pi Tech stepped in with our Specless Engineering approach, perfect for a fast-moving, high-stakes medical product that couldn't afford delays or rework. Here’s what we built:
- Real-time data streaming from wireless guidewire to clinical displays. Cardiologists see pressure changes instantly
- HIPAA-compliant architecture with role-based access. Patient data secure, workflows intact
- AI-ready platform for predictive analytics. built for today, ready for tomorrow's FDA guidance
We used API mocks to simulate device behavior while Xenter refined their hardware. Progress didn't wait for perfect specs.
Technologies used: React Native, React Web, HIPAA-compliant cloud infrastructure, real-time data protocols.
FDA submission ready. Xenter shipping. Innovation without compliance drama.
When to Outsource Healthcare Custom Software Application Development
Your Team Knows Medicine, Not Medical Software
You’ve got clinical expertise and a clear product vision. But now your team is spending more time Googling HL7 formats than building actual features. That’s not sustainable. What you need are developers who already understand healthcare tech and know how to move fast without breaking compliance.
Compliance Is Killing Your Timeline
Every new feature sparks a debate: “Is this HIPAA-safe?” “What will the FDA say?” It’s exhausting. If every sprint turns into a regulatory detour, it’s time for a team that bakes compliance into the build, not tacks it on later.
Your Investors Want an MVP Yesterday
You’ve got funding. Partners are lined up. But you can’t afford a 3-month ramp-up for junior hires to get up to speed. You need senior engineers who can start on Monday and already know how to build for this space.
The Competition Is Moving Faster
While you’re refining specs and looking for the right hires, your competitors are launching. In healthcare tech, speed isn’t just about pride. It’s about market share, outcomes, and trust. And experienced teams simply move faster.
Our Healthcare Custom Software Application Development Services
We build tools that fit into actual clinical workflows, pass audits, and scale with your growth. Here’s what we specialize in:
Clinical Software Applications
From EHR integrations to standalone clinical tools, we build software that fits into real workflows. No disruption to care teams, just tools that make their jobs easier.
Medical Device Software & SaMD
Whether it's embedded software for Class II devices or Software as a Medical Device, we handle FDA requirements while delivering innovative features. 510(k) ready from day one.
Telehealth & Remote Patient Monitoring
Build platforms that connect patients and providers seamlessly. Video consultations, remote vitals monitoring, automated alerts; all HIPAA-compliant and user-friendly.
Healthcare Data Integration Platforms
Stop fighting with incompatible systems. We build integration platforms that make disparate healthcare systems talk; EHRs, billing systems, lab interfaces, all playing nice.
Healthcare Mobile Applications
iOS, Android, or progressive web apps designed for healthcare. From patient portals to clinical decision support tools, we build mobile experiences that meet medical-grade standards.
What Our Clients Say
“In my 20 years of working at technology companies such as Amazon, Groupon, Opendoor, and Jawbone, if I had to pick one person to solve a complicated technology challenge in the shortest time possible, Michael [CTO @ Pi Tech] would be at the top of my list. He is resourceful, scrappy, and has focus, unlike anyone I have ever seen.”
Jason Child
CFO, Arm - Former CFO, Splunk, OpenDoor, Groupon
“In my 20 years of working at technology companies such as Amazon, Groupon, Opendoor, and Jawbone, if I had to pick one person to solve a complicated technology challenge in the shortest time possible, Michael [CTO @ Pi Tech] would be at the top of my list. He is resourceful, scrappy, and has focus, unlike anyone I have ever seen.”
Jason Child
CFO, Arm - Former CFO, Splunk, OpenDoor, Groupon
"We’re impressed with their ability to exceed our expectations and go beyond the scope of the project. In addition, they’re very flexible and highly capable of delivering quality work."
David Hose
COO, Blockware Solutions
"Working with Pi Tech was very easy. They streamlined and managed their engineering time to avoid a large bill, and I was pleasantly surprised with their delivery."
Pat Downing
CTO, Action Title Research
"Michael [Pi Tech CTO] relishes tackling and solving the toughest technical problems. He has the ability to almost intuitively find the core of a solution to a difficult problem, but understands and practices the principle that the core idea to solving a difficult problem is often the first step in a long process to achieve a fully workable solution. He has an extraordinary work ethic, and focuses until the job is completely done."
Ross Bott
President & CEO, SEVEN Networks
"For anyone who is looking to get the job done, Michael [Pi Tech CTO] has never let me down. He’s a 24/7 soldier, from experimentation to design to hard-crafted one-offs. Michael is a jack-of-all-trades in addition to being a great manager and leader. You would be lucky to have his hands and mind in translating your vision into a tangible device or solution."
Steven Goldstein
CEO, MYTI.ai
Ready to Build Healthcare Software That Actually Ships?
Stop letting compliance stall your product. Stop watching competitors launch while you're still stuck in planning mode. And stop telling investors it'll be “soon.”
At Pi Tech, we build healthcare software that clears regulatory hurdles and gets into users’ hands. No excuses. Just working, compliant software built by people who’ve done it before.
Let’s get your project moving.
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