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The World's First Completely Internal Cochlear Implant
The First FDA-Approved Sleep Apnea Implant, Connected From Body to Cloud
A Connected Care Platform Around an Implanted Insulin Pump
An Implanted Therapy Its Clinicians Configure From Anywhere
An Implant That Turns Thought Into Touchscreen Control
The World's First Completely Internal Cochlear Implant
The Acclaim™ Cochlear Implant restores hearing with a system that lives entirely inside the body. Nothing external to wear also means nothing easy to power, charge, or connect.
Every one of those problems had to be solved through living tissue, then proven at Class III reliability in FDA pivotal clinical study.
Envoy had already built the first FDA-approved fully implanted hearing device. For the Acclaim™, its second first, they brought us in at prototyping to own firmware across the system’s power and connectivity chain. We architected and developed the firmware for the implanted battery pack, the charger, and the clinician fitting hub, along with the charger’s user interface, and stood up automated hardware-in-the-loop testing alongside manual verification. We’ve stayed engaged through early feasibility and into the pivotal trial.
Our firmware runs in the implanted battery pack of every Acclaim™ in the pivotal trial, and in the charger and clinician fitting hub beside it. The same expertise that shaped the prototype carried the system into patients, and a first-of-its-kind device keeps advancing toward market.
The First FDA-Approved Sleep Apnea Implant, Connected From Body to Cloud
Inspire® treats obstructive sleep apnea with an implanted neurostimulator that works with the patient’s natural breathing.
Nothing about it came with a precedent. First-of-its-kind inductive telemetry, device generations evolving without breaking the fleet, and a security posture that had to stay ahead of FDA guidance, all at global scale.
Inspire brought us in for the connectivity architecture and security design of the entire end-to-end system, and has kept us across every layer since. We built the embedded software and hardware for the patient remote and programmer cable, the native iOS and Android connectivity SDKs and the cross-platform rewrite now succeeding them, the secure cloud-to-implant firmware distribution infrastructure, and the UX across embedded, mobile, and cloud, through multiple device generations.
An FDA-approved product deployed worldwide runs on connectivity and security we designed. The Connection Checker feature measurably cut patient service calls, the security posture has stayed ahead of FDA guidance through every generation, and secure OTA distribution keeps a multi-generational ecosystem current.
A Connected Care Platform Around an Implanted Insulin Pump
Portal is building automated insulin delivery for people with type 1 diabetes. The implanted pump is only half of that product. The other half is the care platform, moving therapy data between patients, clinicians, and the cloud.
That half had to be built first, before the hardware was final, fast enough for proof of concept and strong enough for what a Class III program eventually demands.
Portal brought us in at the earliest stage to architect the cloud, backend, and web layer and grow it through platform maturity. We designed the early connectivity and security architecture, implemented Android device management with Microsoft Intune, integrated Galen Data to accelerate delivery, and built a pump behavior simulator so UI development never had to wait for hardware.
Portal’s platform runs on a cloud and backend foundation built to scale from first proof of concept through a Class III program’s demands. Early development accelerated, data flows stayed secure, and the architecture has flexed with every stage of product maturity, now carrying a program with FDA Breakthrough Device designation as it develops toward clinical studies.
An Implanted Therapy Its Clinicians Configure From Anywhere
An early-stage implanted therapy platform whose ecosystem spans firmware, patient and clinician mobile apps, and secure cloud workflows.
Changing a therapy without the patient in the room puts clinical stakes on every layer. The system needed real-world reliability, security across every transport, and IEC 62304 Class C compliance from day one, at proof-of-concept speed.
The client brought us in as a full-stack partner across six disciplines. We built the system architecture and connectivity strategy, the implantable firmware, the Android apps for patient and clinician workflows, the cloud backend and web application, and system-wide security with SPDF implementation, tailoring IEC 62304 processes with SOPs, SDP, and DHF contributions along the way.
An extensible architecture for a connected implantable therapy ecosystem, with reduced integration risk across firmware, mobile, and cloud, a scalable security foundation, and a clear path from proof of concept to clinical-stage development.
An Implant That Turns Thought Into Touchscreen Control
For people with severe paralysis, the Stentrode® gives back digital control, and the connection carrying it is their hands and voice.
That system had to grow from an early-generation device into an architecture ready for clinical studies and commercialization, serving patients, caregivers, and clinicians with security designed in from the foundation.
Synchron brought us in with an early device and a commercialization path to architect for. We ran user story discovery across every stakeholder role, selected the connectivity technology, and designed the connectivity and security solution for the full system. We developed embedded software for the implantable and external devices, and designed, implemented, and tested a custom cybersecurity solution.
The architecture we designed carried the system into the first FDA-approved IDE trial of a permanently implanted BCI, now complete with its primary endpoint met. Security and reliability were designed in from the foundation, and data flows proved feasible at clinical scale.
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Smart Privacy Glass on a Scalable Embedded Linux Platform
Reliable Device Connectivity for a Care-at-Home Platform
A Connected Docking Station for Clinical Microneedling Devices
The World's First Completely Internal Cochlear Implant
A Personal Urinalysis Device, Investor-Ready on a Pre-Seed Budget
A Fashion Smartwatch Shipping by the Tens of Millions
A Meditation Device Built to Survive Its First Five Minutes
The First FDA-Approved Sleep Apnea Implant, Connected From Body to Cloud
Patient-Specific Opioid Risk, Delivered as Regulated Software.
Next-Generation Remote Management for a Cath Lab Device System
A Tinnitus Therapy SaMD, Concept to FDA Clearance in Months
A Connected Care Platform Around an Implanted Insulin Pump
A Non-Invasive Cardiac Assessment Platform for Clinical Studies
An Implanted Therapy Its Clinicians Configure From Anywhere
A Building Automation Concept Proven in the Real World in Weeks
An Implant That Turns Thought Into Touchscreen Control
Smart Privacy Glass on a Scalable Embedded Linux Platform
CLiC switches glass between transparent and private on demand, tying into smart home and commercial building control systems.
The platform underneath arrived partially built, carrying someone else’s technical debt, and its containerized architecture had to be completed to serve multiple end clients before manufacturing could start.
Cardinal IG brought us in to stabilize and finish what they’d inherited. We assessed the full system across software, OS, and integration points, took ownership of the Yocto-based OS and its image updates, completed the interface layer between the application containers and the base OS, managed third-party container integrations, and left behind developer documentation and targeted testing strategies.
CLiC reached manufacturing on a platform ready to scale to multiple clients and end users.
Reliable Device Connectivity for a Care-at-Home Platform
Current Health lets providers monitor patients at home, pulling physiological data from a growing mix of connected devices into a clinician-facing cloud.
That means hospital-grade reliability riding on consumer Bluetooth in uncontrolled homes, across devices from different manufacturers with different quirks, without ever slowing the platform down.
Current Health brought us in after launch as the specialist for the hardest part, device connectivity. We set the cross-platform BLE strategy with Capacitor plugins and targeted native iOS and Android work, debugged device integration and interoperability, improved BLE performance and stability, and led the highest-risk connectivity workstreams.
Connectivity reliability improved across the whole multi-device ecosystem, new devices could be added without fear, and patients at home hit less friction. The platform’s technical foundation now carries clinical monitoring at scale.
A Connected Docking Station for Clinical Microneedling Devices
The Dp DOCK connects Dermapen’s microneedling pens to their mobile app, updating firmware and tracking battery health between clinical treatments.
Every pen generation in the field had to work with it, and its own firmware and electronics had to be designed, corrected, and made manufacturable offshore, all on a launch deadline.
DermapenWorld brought us in to take the DOCK from concept through launch, end to end. We designed and developed the full ESP32-based firmware with BLE and Wi-Fi, backwards compatible across every pen generation, with seamless OTA updates. We took the electronics from corrected schematics and improved component selection through PCBA design, and built the device programming processes and production acceptance tooling with the offshore manufacturing partner.
The Dp DOCK launched on deadline and scaled through manufacturing, a secure, reliable product with a seamless clinical experience across every generation of pens.
The World's First Completely Internal Cochlear Implant
The Acclaim™ Cochlear Implant restores hearing with a system that lives entirely inside the body. Nothing external to wear also means nothing easy to power, charge, or connect.
Every one of those problems had to be solved through living tissue, then proven at Class III reliability in FDA pivotal clinical study.
Envoy had already built the first FDA-approved fully implanted hearing device. For the Acclaim™, its second first, they brought us in at prototyping to own firmware across the system’s power and connectivity chain. We architected and developed the firmware for the implanted battery pack, the charger, and the clinician fitting hub, along with the charger’s user interface, and stood up automated hardware-in-the-loop testing alongside manual verification. We’ve stayed engaged through early feasibility and into the pivotal trial.
Our firmware runs in the implanted battery pack of every Acclaim™ in the pivotal trial, and in the charger and clinician fitting hub beside it. The same expertise that shaped the prototype carried the system into patients, and a first-of-its-kind device keeps advancing toward market.
A Personal Urinalysis Device, Investor-Ready on a Pre-Seed Budget
FlowIQ attaches to any standard toilet and reads hydration and early UTI signs, sending results to a phone in real time.
One prototype had to be two things at once, a rigorous R&D platform for spectroscopy validation and a demonstration that could win investors, on a pre-seed budget with no room for a second try.
FlowIQ brought us in at concept to make the product real. We wrote the device requirements, product design description, and governing specification, kept the client’s vision aligned with the R&D partner’s sensing requirements, architected the system with an extensible serial firmware interface and ICD, and designed the electronics from sensor selection through prototype assembly and integration testing.
A functional prototype delivered on a pre-seed budget, carrying novel IP that stayed protected and comprehensive design files ready for the next development phase, with the working demonstration supporting the fundraise.
A Fashion Smartwatch Shipping by the Tens of Millions
A fashion-first smartwatch with connected health and activity tracking, tens of millions of units in the field across multiple product generations.
At that scale, rare Bluetooth failures happen thousands of times a day. Log and firmware transfers demanded throughput beyond what standard BLE stacks allow, and battery life had to survive daily wear under a fashion-first design mandate.
The client brought us into the first generation mid-design, then made us foundational to the second. We built the multi-processor RTOS architecture, achieved maximum BLE throughput by working directly with silicon vendors to modify Bluetooth stacks at the source, developed iOS and Android apps and brand experiences, designed PCBs for development kits, built automated regression testing across dozens of watch and phone combinations, and created a web-based watch simulator so design teams could iterate without hardware.
Fast pairing, seamless data transfer, and reliable OTA updates hold across tens of millions of devices. The platform meets fashion and performance requirements at once, and novel features have shipped across multiple generations.
A Meditation Device Built to Survive Its First Five Minutes
The Core™ Meditation Trainer guides breathing and meditation through touch, a handheld device and mobile app sold as one premium experience.
The first thing a new Core does out of the box is update its own firmware, and if that moment fails, the product fails in the customer’s hands. BLE had to hold on both platforms, and wireless performance had to survive real homes, not lab benches.
Hyperice brought us back across multiple engagements, bridging mobile, firmware, and wireless through launch. We built the native iOS and Android apps, designed and implemented the end-to-end OTA/DFU update system, developed firmware for device behavior and sensing, supported RF and antenna design, and ran integration testing across the whole stack through consumer launch.
Core launched on time as a polished, reliable connected product. Its firmware update path still keeps devices current in the field, and the wireless improvements carried a premium wellness product through commercialization.
The First FDA-Approved Sleep Apnea Implant, Connected From Body to Cloud
Inspire® treats obstructive sleep apnea with an implanted neurostimulator that works with the patient’s natural breathing.
Nothing about it came with a precedent. First-of-its-kind inductive telemetry, device generations evolving without breaking the fleet, and a security posture that had to stay ahead of FDA guidance, all at global scale.
Inspire brought us in for the connectivity architecture and security design of the entire end-to-end system, and has kept us across every layer since. We built the embedded software and hardware for the patient remote and programmer cable, the native iOS and Android connectivity SDKs and the cross-platform rewrite now succeeding them, the secure cloud-to-implant firmware distribution infrastructure, and the UX across embedded, mobile, and cloud, through multiple device generations.
An FDA-approved product deployed worldwide runs on connectivity and security we designed. The Connection Checker feature measurably cut patient service calls, the security posture has stayed ahead of FDA guidance through every generation, and secure OTA distribution keeps a multi-generational ecosystem current.
Patient-Specific Opioid Risk, Delivered as Regulated Software.
GPS-Opioid™ reads a patient’s genetic and clinical factors and generates an individualized opioid risk report.
That report isn’t a dashboard, it’s an input to a prescribing decision. Stakes like that meant regulated SaMD under active FDA oversight, built on an accelerated IDE timeline with FDA-grade verification constructed alongside the software itself.
OpalGenix brought us in to build the platform and carry it through FDA engagement. We architected and developed the backend, implemented the clinical risk algorithms as SaMD, built the automated test and verification system, authored the Software Development Plan, and supported the IDE submission and FDA responses directly.
OpalGenix submitted for IDE on a platform whose documentation and automated verification held up to FDA engagement, with a regulated clinical study now supported by software built for exactly that purpose.
Next-Generation Remote Management for a Cath Lab Device System
DyeVert™ PLUS monitors and reduces contrast dye in real time during cardiac procedures, lowering patients’ kidney injury risk.
Scaling it meant wireless reliability in the cath lab, one of medicine’s harshest RF environments, hospital IT security compliance, and a way to service a growing fleet without pulling hardware from clinical use.
Osprey brought us in on the first generation to fix RF performance and reliability, then kept us on to design the next. We diagnosed the wireless problems and redesigned the tablet antenna, drove device iterations that raised manufacturing yields, and architected a next-generation system with lower COGS, an iPad and MDM foundation, and fully remote device management. Along the way we worked directly with hospital IT teams on cybersecurity and network readiness.
Osprey’s cath lab fleet is now updated, logged, and managed entirely over the air, ending physical hardware retrieval. COGS came down, and hospital IT security compliance opened new sales conversations for their team.
A Tinnitus Therapy SaMD, Concept to FDA Clearance in Months
The Auris™ system pairs a non-invasive in-ear device with an iOS app that delivers AI-powered tinnitus therapy, self-guided at home.
In roughly three months the application was delivered feature-complete, fully verified, and documented, and it then cleared FDA 510(k), without giving up consumer-grade accessibility in a clinical product.
PNQ brought us in to lead iOS development through the 510(k)-cleared release. We refined product definition, requirements, and UX, produced the complete traceability matrix and verification artifacts behind the FDA submission, implemented a compliant data security model, and shaped the MVP roadmap with a growth plan beyond it.
Auris cleared its 510(k) and launched as a polished iOS SaMD, with documentation quality that carried the submission and a scalable mobile foundation for the iterations that followed.
A Connected Care Platform Around an Implanted Insulin Pump
Portal is building automated insulin delivery for people with type 1 diabetes. The implanted pump is only half of that product. The other half is the care platform, moving therapy data between patients, clinicians, and the cloud.
That half had to be built first, before the hardware was final, fast enough for proof of concept and strong enough for what a Class III program eventually demands.
Portal brought us in at the earliest stage to architect the cloud, backend, and web layer and grow it through platform maturity. We designed the early connectivity and security architecture, implemented Android device management with Microsoft Intune, integrated Galen Data to accelerate delivery, and built a pump behavior simulator so UI development never had to wait for hardware.
Portal’s platform runs on a cloud and backend foundation built to scale from first proof of concept through a Class III program’s demands. Early development accelerated, data flows stayed secure, and the architecture has flexed with every stage of product maturity, now carrying a program with FDA Breakthrough Device designation as it develops toward clinical studies.
A Non-Invasive Cardiac Assessment Platform for Clinical Studies
The Cardiac Performance System assesses heart function non-invasively, from proprietary sensors through an embedded Linux gateway to the iPad that guides clinicians through every measurement.
Its software is the product’s clinical front door. It had to orchestrate multi-device workflows in real time, protect PHI and proprietary algorithms, and stay submission-ready through every study phase.
Sensydia brought us in to lead the full software stack. We designed, developed, and evolved the native iPad application as the primary clinical interface, built the core AWS cloud with authentication, patient data APIs, and clinician web tools, and delivered targeted cybersecurity across gateway, BLE, app, and cloud, from hardening and threat modeling through FDA pre-submission alignment.
A production-quality iPad application is running in active clinical studies on secure, reliable communication we built. Cybersecurity risk came down ahead of the studies, PHI and proprietary algorithms stayed protected, and the platform stands positioned for FDA submission.
An Implanted Therapy Its Clinicians Configure From Anywhere
An early-stage implanted therapy platform whose ecosystem spans firmware, patient and clinician mobile apps, and secure cloud workflows.
Changing a therapy without the patient in the room puts clinical stakes on every layer. The system needed real-world reliability, security across every transport, and IEC 62304 Class C compliance from day one, at proof-of-concept speed.
The client brought us in as a full-stack partner across six disciplines. We built the system architecture and connectivity strategy, the implantable firmware, the Android apps for patient and clinician workflows, the cloud backend and web application, and system-wide security with SPDF implementation, tailoring IEC 62304 processes with SOPs, SDP, and DHF contributions along the way.
An extensible architecture for a connected implantable therapy ecosystem, with reduced integration risk across firmware, mobile, and cloud, a scalable security foundation, and a clear path from proof of concept to clinical-stage development.
A Building Automation Concept Proven in the Real World in Weeks
An intelligent automation platform for commercial buildings, controlling and monitoring dense fleets of connected devices across multi-tenant facilities.
Buildings are among the harshest wireless environments there are, metal enclosures, motor interference, extreme device density, and the client needed security proven along with the concept before committing to full development.
The client brought us in to validate the concept before betting the program on it. We ran needs discovery, designed the system architecture and selected the hardware, built custom tooling to test in-building Wi-Fi and BLE performance in the real world, and designed the full solution, from firmware and mobile apps to a multi-level security architecture with threat modeling, authentication controls, and privilege tiers, with device provisioning aligned to production workflows.
A working proof of concept landed in weeks, with real-world wireless validation and a security architecture the client could trust. That gave them cost certainty, and they greenlit the full development program on the strength of it.
An Implant That Turns Thought Into Touchscreen Control
For people with severe paralysis, the Stentrode® gives back digital control, and the connection carrying it is their hands and voice.
That system had to grow from an early-generation device into an architecture ready for clinical studies and commercialization, serving patients, caregivers, and clinicians with security designed in from the foundation.
Synchron brought us in with an early device and a commercialization path to architect for. We ran user story discovery across every stakeholder role, selected the connectivity technology, and designed the connectivity and security solution for the full system. We developed embedded software for the implantable and external devices, and designed, implemented, and tested a custom cybersecurity solution.
The architecture we designed carried the system into the first FDA-approved IDE trial of a permanently implanted BCI, now complete with its primary endpoint met. Security and reliability were designed in from the foundation, and data flows proved feasible at clinical scale.
Mobile Widget (Accordion, Single Column)
Smart Privacy Glass on a Scalable Embedded Linux Platform
CLiC switches glass between transparent and private on demand, tying into smart home and commercial building control systems.
The platform underneath arrived partially built, carrying someone else’s technical debt, and its containerized architecture had to be completed to serve multiple end clients before manufacturing could start.
Cardinal IG brought us in to stabilize and finish what they’d inherited. We assessed the full system across software, OS, and integration points, took ownership of the Yocto-based OS and its image updates, completed the interface layer between the application containers and the base OS, managed third-party container integrations, and left behind developer documentation and targeted testing strategies.
CLiC reached manufacturing on a platform ready to scale to multiple clients and end users.
Reliable Device Connectivity for a Care-at-Home Platform
Current Health lets providers monitor patients at home, pulling physiological data from a growing mix of connected devices into a clinician-facing cloud.
That means hospital-grade reliability riding on consumer Bluetooth in uncontrolled homes, across devices from different manufacturers with different quirks, without ever slowing the platform down.
Current Health brought us in after launch as the specialist for the hardest part, device connectivity. We set the cross-platform BLE strategy with Capacitor plugins and targeted native iOS and Android work, debugged device integration and interoperability, improved BLE performance and stability, and led the highest-risk connectivity workstreams.
Connectivity reliability improved across the whole multi-device ecosystem, new devices could be added without fear, and patients at home hit less friction. The platform’s technical foundation now carries clinical monitoring at scale.
A Connected Docking Station for Clinical Microneedling Devices
The Dp DOCK connects Dermapen’s microneedling pens to their mobile app, updating firmware and tracking battery health between clinical treatments.
Every pen generation in the field had to work with it, and its own firmware and electronics had to be designed, corrected, and made manufacturable offshore, all on a launch deadline.
DermapenWorld brought us in to take the DOCK from concept through launch, end to end. We designed and developed the full ESP32-based firmware with BLE and Wi-Fi, backwards compatible across every pen generation, with seamless OTA updates. We took the electronics from corrected schematics and improved component selection through PCBA design, and built the device programming processes and production acceptance tooling with the offshore manufacturing partner.
The Dp DOCK launched on deadline and scaled through manufacturing, a secure, reliable product with a seamless clinical experience across every generation of pens.
The World's First Completely Internal Cochlear Implant
The Acclaim™ Cochlear Implant restores hearing with a system that lives entirely inside the body. Nothing external to wear also means nothing easy to power, charge, or connect.
Every one of those problems had to be solved through living tissue, then proven at Class III reliability in FDA pivotal clinical study.
Envoy had already built the first FDA-approved fully implanted hearing device. For the Acclaim™, its second first, they brought us in at prototyping to own firmware across the system’s power and connectivity chain. We architected and developed the firmware for the implanted battery pack, the charger, and the clinician fitting hub, along with the charger’s user interface, and stood up automated hardware-in-the-loop testing alongside manual verification. We’ve stayed engaged through early feasibility and into the pivotal trial.
Our firmware runs in the implanted battery pack of every Acclaim™ in the pivotal trial, and in the charger and clinician fitting hub beside it. The same expertise that shaped the prototype carried the system into patients, and a first-of-its-kind device keeps advancing toward market.
A Personal Urinalysis Device, Investor-Ready on a Pre-Seed Budget
FlowIQ attaches to any standard toilet and reads hydration and early UTI signs, sending results to a phone in real time.
One prototype had to be two things at once, a rigorous R&D platform for spectroscopy validation and a demonstration that could win investors, on a pre-seed budget with no room for a second try.
FlowIQ brought us in at concept to make the product real. We wrote the device requirements, product design description, and governing specification, kept the client’s vision aligned with the R&D partner’s sensing requirements, architected the system with an extensible serial firmware interface and ICD, and designed the electronics from sensor selection through prototype assembly and integration testing.
A functional prototype delivered on a pre-seed budget, carrying novel IP that stayed protected and comprehensive design files ready for the next development phase, with the working demonstration supporting the fundraise.
A Fashion Smartwatch Shipping by the Tens of Millions
A fashion-first smartwatch with connected health and activity tracking, tens of millions of units in the field across multiple product generations.
At that scale, rare Bluetooth failures happen thousands of times a day. Log and firmware transfers demanded throughput beyond what standard BLE stacks allow, and battery life had to survive daily wear under a fashion-first design mandate.
The client brought us into the first generation mid-design, then made us foundational to the second. We built the multi-processor RTOS architecture, achieved maximum BLE throughput by working directly with silicon vendors to modify Bluetooth stacks at the source, developed iOS and Android apps and brand experiences, designed PCBs for development kits, built automated regression testing across dozens of watch and phone combinations, and created a web-based watch simulator so design teams could iterate without hardware.
Fast pairing, seamless data transfer, and reliable OTA updates hold across tens of millions of devices. The platform meets fashion and performance requirements at once, and novel features have shipped across multiple generations.
A Meditation Device Built to Survive Its First Five Minutes
The Core™ Meditation Trainer guides breathing and meditation through touch, a handheld device and mobile app sold as one premium experience.
The first thing a new Core does out of the box is update its own firmware, and if that moment fails, the product fails in the customer’s hands. BLE had to hold on both platforms, and wireless performance had to survive real homes, not lab benches.
Hyperice brought us back across multiple engagements, bridging mobile, firmware, and wireless through launch. We built the native iOS and Android apps, designed and implemented the end-to-end OTA/DFU update system, developed firmware for device behavior and sensing, supported RF and antenna design, and ran integration testing across the whole stack through consumer launch.
Core launched on time as a polished, reliable connected product. Its firmware update path still keeps devices current in the field, and the wireless improvements carried a premium wellness product through commercialization.
The First FDA-Approved Sleep Apnea Implant, Connected From Body to Cloud
Inspire® treats obstructive sleep apnea with an implanted neurostimulator that works with the patient’s natural breathing.
Nothing about it came with a precedent. First-of-its-kind inductive telemetry, device generations evolving without breaking the fleet, and a security posture that had to stay ahead of FDA guidance, all at global scale.
Inspire brought us in for the connectivity architecture and security design of the entire end-to-end system, and has kept us across every layer since. We built the embedded software and hardware for the patient remote and programmer cable, the native iOS and Android connectivity SDKs and the cross-platform rewrite now succeeding them, the secure cloud-to-implant firmware distribution infrastructure, and the UX across embedded, mobile, and cloud, through multiple device generations.
An FDA-approved product deployed worldwide runs on connectivity and security we designed. The Connection Checker feature measurably cut patient service calls, the security posture has stayed ahead of FDA guidance through every generation, and secure OTA distribution keeps a multi-generational ecosystem current.
Patient-Specific Opioid Risk, Delivered as Regulated Software.
GPS-Opioid™ reads a patient’s genetic and clinical factors and generates an individualized opioid risk report.
That report isn’t a dashboard, it’s an input to a prescribing decision. Stakes like that meant regulated SaMD under active FDA oversight, built on an accelerated IDE timeline with FDA-grade verification constructed alongside the software itself.
OpalGenix brought us in to build the platform and carry it through FDA engagement. We architected and developed the backend, implemented the clinical risk algorithms as SaMD, built the automated test and verification system, authored the Software Development Plan, and supported the IDE submission and FDA responses directly.
OpalGenix submitted for IDE on a platform whose documentation and automated verification held up to FDA engagement, with a regulated clinical study now supported by software built for exactly that purpose.
Next-Generation Remote Management for a Cath Lab Device System
DyeVert™ PLUS monitors and reduces contrast dye in real time during cardiac procedures, lowering patients’ kidney injury risk.
Scaling it meant wireless reliability in the cath lab, one of medicine’s harshest RF environments, hospital IT security compliance, and a way to service a growing fleet without pulling hardware from clinical use.
Osprey brought us in on the first generation to fix RF performance and reliability, then kept us on to design the next. We diagnosed the wireless problems and redesigned the tablet antenna, drove device iterations that raised manufacturing yields, and architected a next-generation system with lower COGS, an iPad and MDM foundation, and fully remote device management. Along the way we worked directly with hospital IT teams on cybersecurity and network readiness.
Osprey’s cath lab fleet is now updated, logged, and managed entirely over the air, ending physical hardware retrieval. COGS came down, and hospital IT security compliance opened new sales conversations for their team.
A Tinnitus Therapy SaMD, Concept to FDA Clearance in Months
The Auris™ system pairs a non-invasive in-ear device with an iOS app that delivers AI-powered tinnitus therapy, self-guided at home.
In roughly three months the application was delivered feature-complete, fully verified, and documented, and it then cleared FDA 510(k), without giving up consumer-grade accessibility in a clinical product.
PNQ brought us in to lead iOS development through the 510(k)-cleared release. We refined product definition, requirements, and UX, produced the complete traceability matrix and verification artifacts behind the FDA submission, implemented a compliant data security model, and shaped the MVP roadmap with a growth plan beyond it.
Auris cleared its 510(k) and launched as a polished iOS SaMD, with documentation quality that carried the submission and a scalable mobile foundation for the iterations that followed.
A Connected Care Platform Around an Implanted Insulin Pump
Portal is building automated insulin delivery for people with type 1 diabetes. The implanted pump is only half of that product. The other half is the care platform, moving therapy data between patients, clinicians, and the cloud.
That half had to be built first, before the hardware was final, fast enough for proof of concept and strong enough for what a Class III program eventually demands.
Portal brought us in at the earliest stage to architect the cloud, backend, and web layer and grow it through platform maturity. We designed the early connectivity and security architecture, implemented Android device management with Microsoft Intune, integrated Galen Data to accelerate delivery, and built a pump behavior simulator so UI development never had to wait for hardware.
Portal’s platform runs on a cloud and backend foundation built to scale from first proof of concept through a Class III program’s demands. Early development accelerated, data flows stayed secure, and the architecture has flexed with every stage of product maturity, now carrying a program with FDA Breakthrough Device designation as it develops toward clinical studies.
A Non-Invasive Cardiac Assessment Platform for Clinical Studies
The Cardiac Performance System assesses heart function non-invasively, from proprietary sensors through an embedded Linux gateway to the iPad that guides clinicians through every measurement.
Its software is the product’s clinical front door. It had to orchestrate multi-device workflows in real time, protect PHI and proprietary algorithms, and stay submission-ready through every study phase.
Sensydia brought us in to lead the full software stack. We designed, developed, and evolved the native iPad application as the primary clinical interface, built the core AWS cloud with authentication, patient data APIs, and clinician web tools, and delivered targeted cybersecurity across gateway, BLE, app, and cloud, from hardening and threat modeling through FDA pre-submission alignment.
A production-quality iPad application is running in active clinical studies on secure, reliable communication we built. Cybersecurity risk came down ahead of the studies, PHI and proprietary algorithms stayed protected, and the platform stands positioned for FDA submission.
An Implanted Therapy Its Clinicians Configure From Anywhere
An early-stage implanted therapy platform whose ecosystem spans firmware, patient and clinician mobile apps, and secure cloud workflows.
Changing a therapy without the patient in the room puts clinical stakes on every layer. The system needed real-world reliability, security across every transport, and IEC 62304 Class C compliance from day one, at proof-of-concept speed.
The client brought us in as a full-stack partner across six disciplines. We built the system architecture and connectivity strategy, the implantable firmware, the Android apps for patient and clinician workflows, the cloud backend and web application, and system-wide security with SPDF implementation, tailoring IEC 62304 processes with SOPs, SDP, and DHF contributions along the way.
An extensible architecture for a connected implantable therapy ecosystem, with reduced integration risk across firmware, mobile, and cloud, a scalable security foundation, and a clear path from proof of concept to clinical-stage development.
A Building Automation Concept Proven in the Real World in Weeks
An intelligent automation platform for commercial buildings, controlling and monitoring dense fleets of connected devices across multi-tenant facilities.
Buildings are among the harshest wireless environments there are, metal enclosures, motor interference, extreme device density, and the client needed security proven along with the concept before committing to full development.
The client brought us in to validate the concept before betting the program on it. We ran needs discovery, designed the system architecture and selected the hardware, built custom tooling to test in-building Wi-Fi and BLE performance in the real world, and designed the full solution, from firmware and mobile apps to a multi-level security architecture with threat modeling, authentication controls, and privilege tiers, with device provisioning aligned to production workflows.
A working proof of concept landed in weeks, with real-world wireless validation and a security architecture the client could trust. That gave them cost certainty, and they greenlit the full development program on the strength of it.
An Implant That Turns Thought Into Touchscreen Control
For people with severe paralysis, the Stentrode® gives back digital control, and the connection carrying it is their hands and voice.
That system had to grow from an early-generation device into an architecture ready for clinical studies and commercialization, serving patients, caregivers, and clinicians with security designed in from the foundation.
Synchron brought us in with an early device and a commercialization path to architect for. We ran user story discovery across every stakeholder role, selected the connectivity technology, and designed the connectivity and security solution for the full system. We developed embedded software for the implantable and external devices, and designed, implemented, and tested a custom cybersecurity solution.
The architecture we designed carried the system into the first FDA-approved IDE trial of a permanently implanted BCI, now complete with its primary endpoint met. Security and reliability were designed in from the foundation, and data flows proved feasible at clinical scale.
