Hire Firmware Developers For Healthcare Devices
Your medical device needs firmware that passes FDA scrutiny while shipping on time. Pi Tech delivers senior firmware engineers who speak both hardware and regulatory requirements. Ready to build compliant devices that work?
At Pi Tech, We Connect You With Healthcare Firmware Engineers Who Navigate FDA Requirements While Building Devices That Actually Ship
Skip the recruitment bottlenecks and compliance headaches. Our senior firmware developers build medical device software that satisfies regulators and performs in real clinical environments.
Expert Healthcare Firmware Development For Every Device Challenge
Embedded Systems Architecture
Healthcare devices demand firmware that handles real-time patient data while maintaining power efficiency and regulatory compliance. Pi Tech's firmware engineers architect embedded systems that process biosignals, manage wireless connectivity, and implement safety protocols without compromising device performance or battery life.
• Real-time biosignal processing with sub-millisecond latency requirements
• Power management algorithms extending battery life by 40-60%
• Wireless protocol implementation (Bluetooth LE, WiFi, cellular) with medical-grade security
• Safety monitoring systems with automatic fault detection and recovery
Medical Device Communication Protocols
Modern healthcare requires devices that communicate seamlessly with hospital systems, mobile apps, and cloud platforms. Our firmware engineers implement HL7 FHIR, DICOM, and custom API integrations that ensure your device data flows securely through healthcare networks while maintaining HIPAA compliance.
• HL7 FHIR and DICOM protocol implementation for hospital system integration
• Secure API development with OAuth 2.0 and certificate-based authentication
• Real-time data synchronization with EMR systems and clinical workflows
• Edge computing capabilities for local data processing and reduced latency
FDA-Compliant Software Development
Your device firmware needs to pass FDA scrutiny without killing your timeline. Pi Tech engineers follow IEC 62304 and ISO 14971 standards from day one, building traceability matrices, risk management files, and validation documentation that auditors approve while maintaining development velocity.
• IEC 62304 software lifecycle processes with complete traceability documentation
• ISO 14971 risk management integration throughout firmware development cycles
• Automated testing frameworks generating validation evidence for FDA submissions
• Software Bill of Materials (SBOM) and cybersecurity documentation per FDA guidance
Real-Time Operating Systems (RTOS) Implementation
Medical devices can't freeze, crash, or miss critical timing requirements. Our firmware engineers implement deterministic RTOS solutions that guarantee response times, manage multiple concurrent tasks, and provide the reliability healthcare applications demand in life-critical situations.
• FreeRTOS and ThreadX implementation with guaranteed task scheduling
• Interrupt handling and priority management for critical medical functions
• Memory protection and task isolation preventing system-wide failures
• Watchdog timer implementation and fault recovery mechanisms
Pi Tech Advantage for Healthcare Firmware Development
Specless Engineering Approach
Traditional firmware specs become obsolete the moment hardware changes. Pi Tech abstracts objectives, not implementations. Weekly demos show working firmware features while requirements evolve, reducing risk and keeping projects moving when hardware revisions happen.
Senior-Only Talent Pool
No junior developers learning on your medical device project. Pi Tech's firmware engineers average 10+ years building embedded systems for regulated industries. They debug hardware-software integration issues and optimize power consumption without supervision.
Regulatory Expertise Built-In
FDA submissions don't surprise us. Our firmware engineers document design controls, maintain traceability matrices, and follow IEC 62304 standards throughout development. Your device software passes audits because compliance happens during development, not after.
Outcome-Focused Development
We measure success by devices that ship and pass regulatory review. Pi Tech firmware engineers focus on clinical performance, regulatory approval, and manufacturing scalability. Your firmware works in real healthcare environments, not just lab benches.
Case Study: Real-Time Medical Device Software Platform
Xenter's dual-sensor TAVR SmartWire captured revolutionary cardiac pressure data during heart procedures. But raw sensor data doesn't save lives - actionable clinical insights do. They needed software that could transform device readings into real-time surgical guidance.
The platform had to process continuous data streams while meeting FDA requirements for medical device software.
Our Solution
Pi Tech built a comprehensive software platform for real-time clinical data processing.
- Real-time data interface capturing and displaying aortic and ventricular pressure measurements with millisecond precision
- Clinical visualization tools that transform raw data into clear, actionable insights during TAVR procedures
- Hardware simulation capabilities allowing software development to proceed while physical devices evolved
- FDA-ready architecture with built-in compliance for medical device software submissions
The platform seamlessly processes data streams throughout multi-hour cardiac procedures. Surgeons get instant pressure readings when they need them most. The software bridges innovative medical technology with practical clinical application.
Xenter's platform now provides cardiologists with real-time insights that improve procedural decisions and patient outcomes.
Technologies: React Native (mobile), React (web), real-time data streaming, medical device integration protocols, FDA-compliant software architecture.
When to Outsource Firmware Development
Your Hardware Team Needs Firmware That Actually Works
Hardware engineers designed the perfect PCB. Now they need firmware that makes it function in clinical environments. Your software team knows web apps, not embedded systems with 32KB RAM constraints and real-time requirements.
FDA Pre-Submission Meetings Keep Getting Delayed
Your firmware lacks the documentation FDA expects. Risk management files are incomplete, software architecture doesn't follow IEC 62304, and validation protocols won't satisfy auditors. Regulatory consultants cost $500/hour and still don't write code.
Device Performance Falls Short of Clinical Requirements
Your prototype works in the lab but fails during clinical trials. Battery drains too fast, wireless connections drop, or biosignal processing introduces artifacts. Clinical investigators are asking questions your firmware team can't answer.
Manufacturing Scalability Becomes a Nightmare
Firmware that works on 10 prototypes breaks when manufacturing scales to 1,000 units. Hardware variations, component tolerances, and production testing reveal firmware assumptions that don't hold at scale.
Our Firmware Development Services
Pi Tech connects you with senior firmware engineers who build medical devices that ship and satisfy regulators.
Staff Augmentation for Healthcare Firmware Teams
Your team gains senior firmware engineers who integrate seamlessly with existing hardware and software teams. No learning curve on medical device regulations or embedded systems architecture. They start contributing to your firmware codebase immediately.
Dedicated Firmware Development Teams
Complete firmware development from architecture through FDA submission. Pi Tech assembles cross-functional teams including firmware engineers, regulatory specialists, and validation engineers who deliver production-ready medical device software.
Firmware Architecture and Technical Leadership
Senior firmware architects who design embedded systems that scale from prototype through manufacturing. They establish coding standards, select appropriate RTOS platforms, and mentor your internal team while building compliant firmware.
FDA Submission Support and Documentation
Firmware engineers who generate the documentation FDA expects. Software requirements specifications, design controls, traceability matrices, and validation protocols that satisfy auditors while supporting ongoing development cycles.
Legacy Firmware Modernization
Transform outdated medical device firmware into compliant, maintainable systems. Pi Tech engineers reverse-engineer legacy code, implement modern development practices, and migrate to current regulatory standards without disrupting device functionality.
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
"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
"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
"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 Medical Device Firmware That Ships and Passes FDA Review?
Your device concept deserves firmware engineers who understand both embedded systems and healthcare regulations. Pi Tech's senior firmware developers build compliant medical device software that performs in clinical environments while satisfying FDA requirements. Pi Tech delivers the firmware expertise your medical device needs to succeed.
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