Custom Software Development Healthcare Companies
Your healthcare startup needs software that passes FDA scrutiny while you ship fast. Pi Tech builds compliant healthcare solutions without the usual development nightmare. Ready to build something that works?
At Pi Tech, We Build Healthcare Software That Survives Real-World Medicine and Regulatory Audits Without Breaking Your Timeline or Budget
No hand-holding needed. We know HIPAA, speak FDA, and build software that doctors use. Your compliance headaches become our problem to solve.
How We Transform Healthcare Software Development
Discovery & Strategy
Healthcare software fails when developers don't understand clinical workflows. We start by mapping real user journeys, not imaginary ones. Our discovery process identifies regulatory landmines before they explode your timeline.
• Clinical workflow analysis with actual healthcare providers
• Regulatory requirement mapping for your specific use case
• Technical architecture planning that scales with patient data
• Risk assessment for FDA submissions and HIPAA compliance
Architecture & Security Design
HIPAA isn't a checkbox. It's architecture. We design systems where security makes sense to developers and compliance officers alike. Your PHI stays protected without making the software unusable.
• Zero-trust security architecture with role-based access controls
• Encryption strategies that protect data in transit and at rest
• Audit logging systems that satisfy OCR requirements
• Scalable infrastructure that handles patient data growth
Development & Validation
Every line of code gets traced to requirements. Every feature gets tested against real clinical scenarios. We build software that passes validation audits on the first try.
• Feature-driven development with weekly demos and feedback
• Automated testing pipelines for regulatory compliance
• Documentation that satisfies FDA submission requirements
• User acceptance testing with actual healthcare professionals
Deployment & Maintenance
Shipping healthcare software means ongoing compliance, not just initial approval. We handle updates, patches, and regulatory changes so you can focus on growing your business.
• HIPAA-compliant deployment pipelines and monitoring
• Automated backup and disaster recovery systems
• Ongoing regulatory update management and implementation
• 24/7 system monitoring with healthcare-specific alerting
Pi Tech Advantage for Healthcare Custom Software Development
Specless Engineering
Requirements change. Regulations evolve. We build with scope abstraction, not rigid specifications. Your software adapts to real-world healthcare without starting over.
Senior-Only Talent
No junior developers learning HIPAA on your dime. Our team has built healthcare software that's actually used in hospitals, not just demos.
Regulatory Expertise
We speak FDA. HIPAA compliance isn't research for us. We've navigated Class II device submissions and know what auditors want to see.
Outcome-Focused Development
Your success metrics become our development priorities. Revenue, user adoption, regulatory approval. We build software that moves your business forward.
Case Study: Building FDA-Ready Software for Breakthrough Medical Technology
Xenter's dual-sensor TAVR SmartWire promised to revolutionize heart procedures. The hardware was ready. The software? Nonexistent. They needed a platform that could capture real-time pressure data during procedures, integrate with hospital systems, and meet FDA requirements for medical device software.
Most dev shops would demand perfect specifications. We started building with their vision and a whiteboard sketch.
Our Solution
Pi Tech's Specless Engineering approach was built for challenges like this. We didn't wait for complete requirements. We built, tested, and refined alongside Xenter's evolving needs.
- Developed real-time data interface capturing aortic and ventricular pressures with millisecond precision during TAVR procedures
- Built "AI-ready" platform for predictive analytics while maintaining FDA compliance for future algorithm deployment
- Created HIPAA-compliant architecture with role-based access that integrates seamlessly with hospital EHRs
We used API mocks and hardware simulators to keep development moving while Xenter's backend evolved. No delays. No waiting for perfect specs.
The platform went from concept to working software in weeks, not months. Clinicians got actionable insights during procedures. FDA submission requirements? Built in from day one.
Technologies: React Native (iOS & Android), React (web), HIPAA-compliant APIs, real-time data streaming, FDA 510(k)-ready architecture.
When to Outsource Custom Software Development
Your Investors Want Progress, The FDA Wants Perfection
Venture funding comes with timelines. FDA approval comes with paperwork. We build software that satisfies both without compromising either. Your runway stays intact while compliance gets handled.
Your In-House Team Knows Medicine, Not HIPAA
Clinical expertise doesn't translate to software compliance. Your team understands patient care. We understand how to build software that supports it without regulatory nightmares.
You Need Software That Scales With Patient Data
Healthcare data grows exponentially. Patient records, imaging files, sensor data. We build architecture that handles growth without performance degradation or security vulnerabilities.
Auditors Found Something and You Need It Fixed Yesterday
Compliance violations shut down operations. We've seen every type of healthcare software audit. When regulators find problems, we know how to fix them fast.
Our Custom Software Development Services
Pi Tech builds healthcare software that works in the real world. No theoretical solutions or academic approaches.
Medical Device Software Development
Class I, II, or III devices need software that satisfies FDA requirements. We build embedded systems, mobile apps, and web platforms that pass regulatory review.
Healthcare Data Analytics Platforms
Turn patient data into actionable insights. We build analytics systems that handle PHI securely while providing the business intelligence your organization needs.
EHR Integration Solutions
Healthcare systems don't talk to each other. We build bridges between EHRs, practice management systems, and specialty applications without compromising data security.
Telemedicine Platform Development
Remote patient care needs secure, reliable software. We build telehealth platforms that handle video consultations, patient data, and billing integration seamlessly.
Clinical Trial Management Systems
Research data requires specialized handling. We build CTMS platforms that manage patient enrollment, data collection, and regulatory reporting for clinical studies.
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
Ready to Build Healthcare Software That Actually Works?
Stop fighting with compliance while your competition ships. We handle the regulatory maze so you can focus on building a business that matters. Your healthcare software project gets the expertise it deserves without the enterprise consulting price tag.
Pi Tech turns healthcare software challenges into competitive advantages.
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