Mobile Apps

iOS & Android Apps for Connected Devices

We specialize in commercial and medical device apps where connectivity, security, compliance, and usability are critical.

Discuss your Mobile App Needs
Illustration of a smartphone displaying a connected medical device app interface with BLE connectivity indicators and secure data elements

What Sets Us Apart

Medical Experience Design
Human-centered design for device interactions from provisioning to HIPAA-compliant clinical data presentation.
Connected System Expertise
Deep knowledge of BLE, Wi-Fi, and integration, ensuring seamless firmware-to-cloud interaction.
Regulatory-Ready Development
IEC 62304 traceability, requirements validation, and audit-ready documentation built in.
Security Built Foundations
PHI protection, encryption, and threat modeling for FDA cybersecurity requirements.

MObile Apps in Connected Systems

Apps are where your connected system gets judged.

Mobile apps are the primary touchpoint for your users and where your entire connected product is evaluated. Users don’t see firmware constraints or cloud latency; they see an experience that either works or fails.

We build apps with system-level awareness. Because we work across firmware, mobile, cloud, and UX, we design the mobile experience around what the system can reliably deliver.

The Result: Mobile apps that integrate cleanly with your connected device ecosystem, handle real-world connectivity, meet regulatory constraints, and scale from beta to production.

Illustration showing a mobile app interface connected to firmware, cloud, and device layers within a connected product ecosystem

What we solve for

Mobile Development at Every Stage

Whether you’re building from scratch, validating user workflows, looking to accelerate development, or fixing critical production issues, we can help.

Technical blueprint illustration of an implantable device with wireless connectivity signals and code overlays representing connected medical device architecture

Building New Products

You're designing a new connected device and need a mobile architecture that won't require rebuilding as complexity grows.
Challenges we help prevent:
  • BLE connection reliability and state synchronization across app, firmware, and cloud
  • Offline-first architecture and data persistence decisions
  • Device provisioning and pairing flow design
  • Authentication architecture and secure credential storage
  • HIPAA compliance requirements and PHI protection
  • Audit logging and regulatory documentation needs
  • Onboarding flows that handle pairing failures and weak signal
  • Connection state feedback and error recovery UX
  • Accessibility compliance and medical device usability standards
  • Real-time sensor data rendering without dropped frames or UI lag
  • Background Bluetooth connection management and battery drain
  • App size optimization for regulatory submissions
Technical blueprint illustration of a connected peripheral device showing wireless protocol pathways and embedded code elements for feasibility validation

Validating Feasibility

You need proof that critical connectivity and sync workflows will function reliably before committing to full development.
Scenarios we help answer:
  • BLE pairing failures across iOS/Android device matrix
  • Connection stability during movement and signal interference
  • Background connection maintenance and app state transitions
  • Mobile-to-device command latency and timeout handling
  • State consistency during offline/online transitions
  • Cloud sync conflict resolution under degraded connectivity
  • Firmware update interruptions and rollback failures
  • Multi-device management complexity
  • Authentication flow reliability under real-world conditions
Technical blueprint illustration of a mobile device with code elements and a clock representing accelerated development timelines for connected device apps

Accelerating Development

You need additional mobile expertise or development capacity to deliver features and meet your timeline.
Bottlenecks we help clear:
  • BLE/Wi-Fi device discovery and pairing workflows
  • Firmware OTA update UI and state management
  • Real-time sensor data display and push notification integration
  • Native iOS/Swift and Android/Kotlin expertise
  • Mobile/firmware and mobile/cloud API coordination
  • App Store/Play Store compliance and regulatory documentation
  • Multi-device management and user provisioning workflows
  • Data visualization, export features, and biometric authentication
  • Features your team can’t prioritize without sacrificing core development
  • Automated UI testing for device interaction flows
  • Platform-specific testing and CI/CD pipeline setup
  • Crash reporting and analytics integration
Tell Us About Your Challenge
Mobile App Capabilities

Mobile App Expertise for Complex Connected Systems

The capabilities that enable intuitive, reliable, and system-aware mobile applications for connected medical devices and digital health products.

We architect mobile apps for wireless connectivity across the full stack. This dual perspective enables robust data flows, reliable synchronization, and graceful handling of the edge cases where connectivity matters most.
Key Capabilities:
  • BLE, WiFi, and web API connection flows with reconnection and background handling
  • Background connection management across app states and termination
  • Connectivity stacks that abstract platform inconsistencies in native BLE APIs
  • Device provisioning workflows for embedded WiFi and cellular configuration
  • Custom binary protocol support beyond standard GATT profiles
  • Reliable data syncing across device, mobile app, and cloud
  • Edge-case handling for timeouts, failures, interference, and offline states
Discuss Your Connectivity Architecture
We engineer mobile interfaces with attention to performance, responsiveness, and platform-native behavior, writing maintainable code that stays true to design intent across the full range of devices and OS versions.
Key Capabilities:
  • Native iOS (SwiftUI/UIKit) and Android (Jetpack Compose/Views) UI implementation
  • Design system implementation and component library development
  • Smooth animations, transitions, and gesture-based interactions
  • Responsive layouts across screen sizes and accessibility modes
  • Performance optimization for rendering, scrolling, and memory usage
  • Cross-platform code sharing strategies (when using React Native or Flutter)
  • Unit/UI test traceability via language-specific tools (Kotlin annotations)
  • Hardware-in-the-Loop testing with real or simulated BLE peripherals
Discuss Your UI Requirements
We design security and privacy practices for consumer, medical, and digital health products, building protection into every layer. Our approach balances simplicity and rigor, implementing the right level of protection without unnecessary complexity.
Key Capabilities:
  • Secure device pairing and encrypted BLE/WiFi communication
  • Authentication, authorization, and session management aligned with regulatory requirements
  • Secure local storage using iOS Keychain and Android Keystore
  • PHI and PII protection for HIPAA and GDPR compliance
  • Data minimization, user consent, and App Store privacy manifest compliance
Discuss Your Security Requirements
We architect mobile apps for long-term maintainability, testability, and evolution. Whether building from scratch or refactoring existing codebases, architecture decisions made early determine whether apps scale gracefully or accumulate technical debt.
Key Capabilities:
  • Modular architecture isolating Class B/C components for simplified validation
  • Separation of business logic, UI, and data layers for independent testing
  • Dependency injection and abstraction layers isolating third-party dependencies
  • Offline-first database architecture (Room, Realm, Core Data) with automatic sync
  • State management for complex device interactions and offline scenarios
  • Code organization supporting multi-developer teams and long product lifecycles
  • Refactoring strategies addressing architectural debt in existing applications
  • CI/CD pipelines with automated testing, code coverage reporting, vulnerability scanning, and deployment automation
Discuss Your Architecture Approach
We integrate mobile apps with cloud platforms, backend APIs, and third-party services. Whether working with existing infrastructure or building alongside backend teams, we design integration patterns that handle real-world connectivity, offline behavior, and data consistency challenges across the full system.
Key Capabilities:
  • RESTful API and GraphQL integration with authentication and error handling
  • Third-party platform integration (EMR systems, cloud storage, analytics services)
  • API contract definition and validation in collaboration with backend teams
  • WebSocket and MQTT implementation for live device data streaming
  • Real-time data sync and conflict resolution for offline-first architectures
  • Backend service coordination for device provisioning and firmware updates
Discuss Your Integration Needs
We build mobile interfaces that balance usability, performance, and the unique constraints of connected device interactions. Whether working with your UX team or our design partners, every flow is validated through iterative testing to ensure it works as intended under real-world conditions.
Key Capabilities:
  • High-fidelity UI implementation with performance and platform conventions
  • Intuitive data visualization for sensor readings, health metrics, and device status
  • UX patterns for device pairing, connection states, and offline/online transitions
  • Onboarding flows optimized for authenticated, secure environments
  • Accessibility compliance (WCAG) for clinical and consumer applications
  • Iterative usability validation and refinement throughout development
  • Usability engineering and human factors documentation (IEC 62366)
Discuss Your UX Challenges
Mobile App Encryption & Mobile Device Management (MDM)
For high-risk environments and regulated deployments, we implement custom cryptographic solutions and managed device configurations that go beyond standard platform security.
Key Capabilities:
  • Custom end-to-end encryption for defense-in-depth against MITM attacks
  • Hardware-backed key generation and storage via iOS Keychain and Android Keystore
  • Local database encryption for PHI/PII protection
  • Threat modeling and vulnerability analysis (MITM, certificate pinning, jailbreak detection)
  • MDM configuration (Knox, Jamf, Intune) and Kiosk Mode for clinical deployments
Discuss Your Deployment Requirements
We build native iOS/Android apps and hybrid/cross-platform solutions when appropriate, choosing the approach that best supports performance, long-term maintainability, and connected system requirements. Our teams deeply understand the tradeoffs between platform approaches for connected device applications.
Key Capabilities:
  • Native development for high-performance, connectivity-intensive apps
  • Cross-platform frameworks (Flutter/React Native/Maui) for sharing business logic across platforms or less connectivity-intensive workflows
  • Shared architecture and code layering to maximize reuse
  • Performance tuning across both platforms for connected workflows
  • Strategic QA approach for connectivity scenarios and platform-specific behavior
Discuss Your Platform Strategy
We develop mobile apps with the documentation, traceability, and verification practices required for regulated medical device software. We implement IEC 62304 lifecycle processes that support FDA submissions and quality system audits without unnecessary overhead.
Key Capabilities:
  • Requirements traceability linking user needs, design inputs, and test cases
  • Software architecture documentation and design output generation
  • Design history file (DHF) preparation and regulatory submission support
  • Risk management integration (ISO 14971) for software hazards and mitigations
  • Verification and validation evidence with automated test coverage
  • Change control and configuration management aligned with design controls
  • Automated SBOM generation for vulnerability scanning and supply chain security
  • SOUP management and third-party component risk analysis
Discuss Your Regulatory Requirements
Device connectivity and integration capability icon

Mobile App Device Connectivity & Integration

We architect mobile apps for wireless connectivity across the full stack. This dual perspective enables robust data flows, reliable synchronization, and graceful handling of the edge cases where connectivity matters most.
Key Capabilities:
  • BLE, WiFi, and web API connection flows with reconnection and background handling
  • Background connection management across app states and termination
  • Connectivity stacks that abstract platform inconsistencies in native BLE APIs
  • Device provisioning workflows for embedded WiFi and cellular configuration
  • Custom binary protocol support beyond standard GATT profiles
  • Reliable data syncing across device, mobile app, and cloud
  • Edge-case handling for timeouts, failures, interference, and offline states

Connection Management

  • BLE, WiFi, and web API connection flows with reconnection and background handling
  • Background connection management across app states and termination
  • Connectivity stacks that abstract platform inconsistencies in native BLE APIs

Device Provisioning & Configuration

  • Device provisioning workflows for embedded WiFi and cellular configuration
  • Custom binary protocol support beyond standard GATT profiles

Data Synchronization & Reliability

  • Reliable data syncing across device, mobile app, and cloud
  • Edge-case handling for timeouts, failures, interference, and offline states
Discuss Your Connectivity Architecture
Mobile Frontend Development Capabilty Icon

Mobile App Front-End Development

We engineer mobile interfaces with attention to performance, responsiveness, and platform-native behavior, writing maintainable code that stays true to design intent across the full range of devices and OS versions.
Key Capabilities:
  • Native iOS (SwiftUI/UIKit) and Android (Jetpack Compose/Views) UI implementation
  • Design system implementation and component library development
  • Smooth animations, transitions, and gesture-based interactions
  • Responsive layouts across screen sizes and accessibility modes
  • Performance optimization for rendering, scrolling, and memory usage
  • Cross-platform code sharing strategies (when using React Native or Flutter)
  • Unit/UI test traceability via language-specific tools (Kotlin annotations)
  • Hardware-in-the-Loop testing with real or simulated BLE peripherals
Discuss Your UI Requirements
Mobile App Security Capabilty Icon

Mobile App Security & Privacy

We design security and privacy practices for consumer, medical, and digital health products, building protection into every layer. Our approach balances simplicity and rigor, implementing the right level of protection without unnecessary complexity.
Key Capabilities:
  • Secure device pairing and encrypted BLE/WiFi communication
  • Authentication, authorization, and session management aligned with regulatory requirements
  • Secure local storage using iOS Keychain and Android Keystore
  • PHI and PII protection for HIPAA and GDPR compliance
  • Data minimization, user consent, and App Store privacy manifest compliance
Discusss Your Security Requirements
Mobile Scalable Architecture Capabilty Icon

Scalable Mobile App Architecture

We architect mobile apps for long-term maintainability, testability, and evolution. Whether building from scratch or refactoring existing codebases, architecture decisions made early determine whether apps scale gracefully or accumulate technical debt.
Key Capabilities:
  • Modular architecture isolating Class B/C components for simplified validation
  • Separation of business logic, UI, and data layers for independent testing
  • Dependency injection and abstraction layers isolating third-party dependencies
  • Offline-first database architecture (Room, Realm, Core Data) with automatic sync
  • State management for complex device interactions and offline scenarios
  • Code organization supporting multi-developer teams and long product lifecycles
  • Refactoring strategies addressing architectural debt in existing applications
  • CI/CD pipelines with automated testing, code coverage reporting, vulnerability scanning, and deployment automation
Discuss Your Architecture Approach
Mobile Cloud Integration Capabilty Icon

Mobile App Cloud & Backend Integration

We integrate mobile apps with cloud platforms, backend APIs, and third-party services. Whether working with existing infrastructure or building alongside backend teams, we design integration patterns that handle real-world connectivity, offline behavior, and data consistency challenges across the full system.
Key Capabilities:
  • RESTful API and GraphQL integration with authentication and error handling
  • Third-party platform integration (EMR systems, cloud storage, analytics services)
  • API contract definition and validation in collaboration with backend teams
  • WebSocket and MQTT implementation for live device data streaming
  • Real-time data sync and conflict resolution for offline-first architectures
  • Backend service coordination for device provisioning and firmware updates
Discuss Your Integration Needs
Mobile Experience Design Capabilty Icon

Mobile App UX & UI Design

We build mobile interfaces that balance usability, performance, and the unique constraints of connected device interactions. Whether working with your UX team or our design partners, every flow is validated through iterative testing to ensure it works as intended under real-world conditions.
Key Capabilities:
  • High-fidelity UI implementation with performance and platform conventions
  • Intuitive data visualization for sensor readings, health metrics, and device status
  • UX patterns for device pairing, connection states, and offline/online transitions
  • Onboarding flows optimized for authenticated, secure environments
  • Accessibility compliance (WCAG) for clinical and consumer applications
  • Iterative usability validation and refinement throughout development
  • Usability engineering and human factors documentation (IEC 62366)
Discuss Your UX Challenges
Mobile Encryption Capabilty Icon

Mobile App Encryption & Mobile Device Management (MDM)

For high-risk environments and regulated deployments, we implement custom cryptographic solutions and managed device configurations that go beyond standard platform security.
Key Capabilities:
  • Custom end-to-end encryption for defense-in-depth against MITM attacks
  • Hardware-backed key generation and storage via iOS Keychain and Android Keystore
  • Local database encryption for PHI/PII protection
  • Threat modeling and vulnerability analysis (MITM, certificate pinning, jailbreak detection)
  • MDM configuration (Knox, Jamf, Intune) and Kiosk Mode for clinical deployments
Discuss Your Deployment Requirements
Mobile Native And Crossplatform Capabilty Icon

Mobile App Native & Cross-Platform Development

We build native iOS/Android apps and hybrid/cross-platform solutions when appropriate, choosing the approach that best supports performance, long-term maintainability, and connected system requirements. Our teams deeply understand the tradeoffs between platform approaches for connected device applications.
Key Capabilities:
  • Native development for high-performance, connectivity-intensive apps
  • Cross-platform frameworks (Flutter/React Native/Maui) for sharing business logic across platforms or less connectivity-intensive workflows
  • Shared architecture and code layering to maximize reuse
  • Performance tuning across both platforms for connected workflows
  • Strategic QA approach for connectivity scenarios and platform-specific behavior
Discuss Your Platform Strategy
Mobile Design Controls Capabilty Icon

Mobile App IEC 62304 & Design Controls

We develop mobile apps with the documentation, traceability, and verification practices required for regulated medical device software. We implement IEC 62304 lifecycle processes that support FDA submissions and quality system audits without unnecessary overhead.
Key Capabilities:
  • Requirements traceability linking user needs, design inputs, and test cases
  • Software architecture documentation and design output generation
  • Design history file (DHF) preparation and regulatory submission support
  • Risk management integration (ISO 14971) for software hazards and mitigations
  • Verification and validation evidence with automated test coverage
  • Change control and configuration management aligned with design controls
  • Automated SBOM generation for vulnerability scanning and supply chain security
  • SOUP management and third-party component risk analysis
Discuss Your Regulatory Requirements

WHAT YOU GET

Production-Ready Apps Built for Regulatory Approval

We deliver tested, traceable iOS and Android apps, complete with design artifacts, verification evidence, and regulatory documentation.

Illustration of delivered mobile app artifacts including source code architecture, design system documentation, test reports, and regulatory submission packages

Modular architecture, comprehensive inline documentation, and clear design rationale mean your engineering team (or your next vendor) can understand, modify, and extend the app without archaeology work.

Complete design system with wireframes, user flows, accessibility specs, and style guides aligned to FDA usability standards.

Automated test suites with unit, integration, and UI tests provide code coverage metrics and IEC 62304-compliant test reports that satisfy auditors.

Requirements traceability matrices and ISO 14971 risk analysis delivered throughout development and ready when you need them for submission.

Threat analysis, PHI protection implementation, encryption evidence, and cybersecurity documentation aligned to FDA premarket guidance and ready for submission.

Securely signed release binaries, build configurations, provisioning profiles, privacy documentation, and submission packages prepared to meet Apple and Google review requirements.

HOW WE WORK

Integration & Regulatory Evidence From the Start

We coordinate across disciplines, validate with real devices, and build regulatory evidence as we develop to prevent failures at integration and FDA review.

Illustration showing mobile app development coordinated across firmware, backend, and clinical engineering teams with shared integration points

Cross-Discipline Integration

Mobile coordinated with firmware, backend, and clinical teams.

We work alongside your firmware, backend, and clinical teams throughout development, not just at integration points. Mobile architecture decisions account for device constraints, API capabilities, and clinical workflows from the start.

Example in practice: Hardware-in-the-Loop testing validates connectivity with real BLE devices, catching edge cases that simulators can’t replicate.

Offline-First Architecture

Data integrity is maintained even when connectivity fails.

Mobile apps for medical devices must be able to handle intermittent connectivity. We architect apps with local data persistence, sync conflict resolution, and queue management from the start—ensuring data integrity even when devices disconnect or users go offline.

Example in practice: When a glucose monitor loses a BLE connection mid-reading, queued data syncs automatically upon connectivity resume, with conflict resolution handling overlapping measurements.

Diagram illustrating offline-first mobile app architecture with local data persistence, sync queuing, and automatic reconnection for connected medical devices
Illustration of IEC 62304 regulatory documentation generated during mobile app development including traceability matrices, risk analyses, and verification reports

Regulatory Evidence as we build

IEC 62304 traceability and verification are integrated into the development process.

We don’t save compliance for the end. Requirements traceability, risk mitigations, and verification evidence are built alongside code. Formative usability testing happens in parallel with development.

Example in practice: Each sprint delivers not just working features but also the traceability matrices, risk analyses, and test protocols needed for your FDA submission, and prevents last-minute documentation scrambles.

Want to understand our full development process?
See how we work across disciplines.
Program Highlights

Apps That Carry the Weight of the Whole System 

From consumer wellness to Class III medical devices, mobile apps shipped for real products, users, and regulatory submissions.

Programs •
5

Current Health builds the platform hospitals use to care for patients at home instead of in a bed.

A patient goes home with a wearable and a kit of connected devices, and their vital signs and readings flow to a clinician’s dashboard, with telehealth on top.

For a patient, that means recovering in their own bed with someone still watching. It also means hospital-grade monitoring riding on consumer Bluetooth, in homes no one controls, across medical and consumer devices from different makers that each behave differently.

Connected Health Platform
Remote Patient Monitoring
Monitoring
Post-Market
FDA MDDS
HIPAA
Mobile Apps
BLE
BLE Optimization
Cross-Platform
Multi-Vendor Device Integration
Native Android
Native iOS
Smiling woman using a smartphone for remote health monitoring, surrounded by UI elements showing pulse rate, spirometry reminders, medication alerts, and wearable health data.

A global fashion brand’s smartwatches reached millions of wrists across several product generations, and they were designed to look like watches first.

Under the face they tracked health and activity, moved logs and firmware updates to a phone over Bluetooth, and ran on a battery sized for a fashion case.

For the wearer, that meant a watch chosen for how it looked that still did what a smartwatch does. It also meant pairing with every phone and OS version its wearers owned, each handling Bluetooth its own way, at a scale where a one-in-a-million quirk came up every day.

Connected Consumer Device
Health & Fitness
Post-Market
Design
Electronics
Embedded Software
Mobile Apps
BLE
BLE Optimization
Device Simulators
HIL Testing
Low-Power Design
Miniaturization
Native Android
Native iOS
OTA Updates
PCB Design
Case Study Hero Watchmaker

Hyperice’s Core™ Meditation Trainer is a handheld device you cup in both palms, with heart sensors in the handles and a pulse you breathe along with.

It reads heart rate and heart rate variability to tell when you have settled into a focused state, and the app’s guided sessions respond to that.

For someone who wonders whether they are meditating right, that means a device that can tell them. It also means a consumer product whose first act out of the box is updating its own firmware over Bluetooth, in a living room, where a failed update is a returned product.

Connected Consumer Device
Wellness
Post-Market
Electronics
Embedded Software
Mobile Apps
Biosensing
BLE
Native Android
Native iOS
OTA Updates
RF & Antenna Design
Sensor Integration
Hyperice Core handheld meditation trainer shown with companion mobile app displaying biofeedback metrics like calm percentage and session history.

Inspire® is the first FDA-approved neurostimulation therapy for moderate to severe obstructive sleep apnea.

A small implant stimulates the nerve that controls the tongue in time with the patient’s breathing, and a connected system sits around it, with a Bluetooth remote the patient holds, an app, and a clinician web portal that monitors the implant wirelessly.

For someone who could never live with a mask, that means sleeping with nothing on their face and starting therapy with a click. It also means the system around a Class III implant has moved through several device generations while every implant already placed stays in a body for years, so no part of the system can change without accounting for every implant in the field.

Connected Medical Implant
Pulmonology
Neuromodulation
Post-Market
FDA Class III
FDA PMA Approved
IEC 60601
IEC 62304
Design
Electronics
Embedded Software
Mobile Apps
Security
Systems
Web Apps & Backends
Azure
Backend API
BLE
Clinician Portal
Connectivity SDK
Cross-Platform
Inductive Telemetry
Infrastructure as Code
Legacy Device Support
Mobile Device Management
Patient using the Inspire Sleep Apnea Therapy System, with implantable device, handheld remote, and mobile app display for tracking therapy and sleep duration.

One in four angiography patients has chronic kidney disease, and the contrast dye that makes the procedure possible is hard on the kidneys.

Osprey Medical’s FDA-cleared DyeVert™ PLUS diverts part of the dye before it reaches the patient, cutting the amount delivered by about 40 percent with no loss of image quality, and tracks each patient’s cumulative dose against their kidney function in real time.

For those patients, that means a heart procedure with less risk of kidney injury. It also means a tablet talking wirelessly to bedside devices inside a cath lab, one of the noisiest radio environments in a hospital, where nothing can drop mid-procedure.

Connected Clinical Device
Cardiology
Monitoring
Post-Market
FDA Class II
FDA 510(k) Cleared
IEC 60601
IEC 62304
Electronics
Mobile Apps
Systems
Web Apps & Backends
BLE
Embedded GUI
Embedded Linux
Manufacturing Support
Mobile Device Management
Native iPadOS
OTA Updates
Qt
Remote Device Management
RF & Antenna Design
Osprey Medical’s DyeVert PLUS contrast reduction system, showing the catheter interface and monitor display used to reduce contrast dye exposure during procedures.

One in ten people lives with persistent tinnitus, the ringing that does not stop.

PNQ Health’s therapy is software. An iOS app delivers personalized sound therapy through ordinary earbuds, and the app itself is what the FDA cleared, as Class II software as a medical device.

For a patient, that means treatment at home, self-guided, with a clinician overseeing it remotely. It also means the app is the entire clinical product, so it has to hold to a medical standard while feeling like something a person opens every day.

Connected SaMD
Audiology
Digital Therapeutics
Post-Market
FDA Class II
FDA 510(k) Cleared
IEC 62304 Class B
Design
Mobile Apps
Design System
FDA Submission Support
MVP Definition
Native iOS
Requirements & Traceability
Secure Data Model
Software V&V
UX & UI Design
Three smartphone screens displaying the PNQ Health tinnitus therapy app, a SaMD solution, with views of the login screen, treatment progress dashboard, and ear selection interface.

Portal Diabetes holds FDA Breakthrough Device designation for the Portal Pump™, an implantable insulin delivery system.

The pump is designed to sit in the abdomen, dose from a continuous glucose monitor with a heat-stable concentrated insulin, and take refills in a clinic after weeks or months.

For someone with type 1 diabetes, that means no carbohydrate counting, no meal announcements, and no waking in the night. It also means a loop that closes with no one in it, which has to be trusted before it is ever implanted and then stays in for five to seven years.

Connected Medical Implant
Endocrinology
Drug Delivery
In Development
FDA Class III
HIPAA
Embedded Software
Mobile Apps
Security
Systems
Web Apps & Backends
Backend API
BLE
Device Simulators
Mobile Device Management
Native Android
Secure Authentication
Third-Party Cloud Integration
Case Study Hero Portal Diabetes

Knowing how well a failing heart is pumping usually takes an echocardiogram and a trained operator, or a catheter threaded into the heart.

Sensydia’s Cardiac Performance System reads ejection fraction, cardiac output, and pulmonary artery pressure from disposable sensors on the chest, in minutes, at the bedside. Its ejection fraction measurement was first FDA-cleared in 2018, and the full platform holds Breakthrough Device Designation.

For a patient in an ICU or emergency department, that means answers without a referral or a procedure. It also means one measurement running across sensors, a gateway, a tablet, and the cloud, carrying patient data the whole way, while the platform is still being proven in clinical studies.

Connected Clinical Device
Cardiology
Diagnostics
Clinical Trials
FDA Class II
HIPAA
IEC 62304 Class B
Mobile Apps
Security
Web Apps & Backends
AWS
Backend API
BLE
Clinician Portal
Edge Gateway
Embedded Linux
Native iPadOS
Secure Authentication
Threat Modeling
Case Study Hero Sensydia

A stealth-stage medical startup is developing an implanted neuromodulation therapy that its clinicians can adjust without the patient in the room.

For the patient, that means a therapy that changes when it needs to instead of at the next appointment.

It also means every adjustment travels from a clinician’s screen to a device inside someone’s body, and that path has to be trusted at Class III stakes before anything is implanted.

Connected Medical Implant
Neurology
Neuromodulation
Proof of Concept
FDA Class III
IEC 62304 Class C
Design
Embedded Software
Mobile Apps
Security
Systems
Web Apps & Backends
Backend API
Biosensing
BLE
Clinician Portal
Embedded Algorithms
FDA Premarket Cybersecurity
Human Factors
Interactive Prototyping
Native Android
Remote Follow-Up
Client Grey Stealth Startup
Programs •
9
Current Health
Smiling woman using a smartphone for remote health monitoring, surrounded by UI elements showing pulse rate, spirometry reminders, medication alerts, and wearable health data.

Reliable Device Connectivity for a Care-at-Home Platform

Current Health builds the platform hospitals use to care for patients at home instead of in a bed.

A patient goes home with a wearable and a kit of connected devices, and their vital signs and readings flow to a clinician’s dashboard, with telehealth on top.

For a patient, that means recovering in their own bed with someone still watching. It also means hospital-grade monitoring riding on consumer Bluetooth, in homes no one controls, across medical and consumer devices from different makers that each behave differently.

Connected Health Platform
Remote Patient Monitoring
Monitoring
Post-Market
FDA MDDS
HIPAA
Mobile Apps
BLE
BLE Optimization
Cross-Platform
Multi-Vendor Device Integration
Native Android
Native iOS
Global Smartwatch Brand
Case Study Hero Watchmaker

A Fashion Smartwatch Shipped by the Millions

A global fashion brand’s smartwatches reached millions of wrists across several product generations, and they were designed to look like watches first.

Under the face they tracked health and activity, moved logs and firmware updates to a phone over Bluetooth, and ran on a battery sized for a fashion case.

For the wearer, that meant a watch chosen for how it looked that still did what a smartwatch does. It also meant pairing with every phone and OS version its wearers owned, each handling Bluetooth its own way, at a scale where a one-in-a-million quirk came up every day.

Connected Consumer Device
Health & Fitness
Post-Market
Design
Electronics
Embedded Software
Mobile Apps
BLE
BLE Optimization
Device Simulators
HIL Testing
Low-Power Design
Miniaturization
Native Android
Native iOS
OTA Updates
PCB Design
Hyperice
Hyperice Core handheld meditation trainer shown with companion mobile app displaying biofeedback metrics like calm percentage and session history.

A Meditation Device Built to Survive Its First Five Minutes

Hyperice’s Core™ Meditation Trainer is a handheld device you cup in both palms, with heart sensors in the handles and a pulse you breathe along with.

It reads heart rate and heart rate variability to tell when you have settled into a focused state, and the app’s guided sessions respond to that.

For someone who wonders whether they are meditating right, that means a device that can tell them. It also means a consumer product whose first act out of the box is updating its own firmware over Bluetooth, in a living room, where a failed update is a returned product.

Connected Consumer Device
Wellness
Post-Market
Electronics
Embedded Software
Mobile Apps
Biosensing
BLE
Native Android
Native iOS
OTA Updates
RF & Antenna Design
Sensor Integration
Inspire Medical
Patient using the Inspire Sleep Apnea Therapy System, with implantable device, handheld remote, and mobile app display for tracking therapy and sleep duration.

Sleep Apnea Therapy, Connected From Body to Cloud

Inspire® is the first FDA-approved neurostimulation therapy for moderate to severe obstructive sleep apnea.

A small implant stimulates the nerve that controls the tongue in time with the patient’s breathing, and a connected system sits around it, with a Bluetooth remote the patient holds, an app, and a clinician web portal that monitors the implant wirelessly.

For someone who could never live with a mask, that means sleeping with nothing on their face and starting therapy with a click. It also means the system around a Class III implant has moved through several device generations while every implant already placed stays in a body for years, so no part of the system can change without accounting for every implant in the field.

Connected Medical Implant
Pulmonology
Neuromodulation
Post-Market
FDA Class III
FDA PMA Approved
IEC 60601
IEC 62304
Design
Electronics
Embedded Software
Mobile Apps
Security
Systems
Web Apps & Backends
Azure
Backend API
BLE
Clinician Portal
Connectivity SDK
Cross-Platform
Inductive Telemetry
Infrastructure as Code
Legacy Device Support
Mobile Device Management
Osprey Medical
Osprey Medical’s DyeVert PLUS contrast reduction system, showing the catheter interface and monitor display used to reduce contrast dye exposure during procedures.

Next-Generation Remote Management for a Cath Lab Device System

One in four angiography patients has chronic kidney disease, and the contrast dye that makes the procedure possible is hard on the kidneys.

Osprey Medical’s FDA-cleared DyeVert™ PLUS diverts part of the dye before it reaches the patient, cutting the amount delivered by about 40 percent with no loss of image quality, and tracks each patient’s cumulative dose against their kidney function in real time.

For those patients, that means a heart procedure with less risk of kidney injury. It also means a tablet talking wirelessly to bedside devices inside a cath lab, one of the noisiest radio environments in a hospital, where nothing can drop mid-procedure.

Connected Clinical Device
Cardiology
Monitoring
Post-Market
FDA Class II
FDA 510(k) Cleared
IEC 60601
IEC 62304
Electronics
Mobile Apps
Systems
Web Apps & Backends
BLE
Embedded GUI
Embedded Linux
Manufacturing Support
Mobile Device Management
Native iPadOS
OTA Updates
Qt
Remote Device Management
RF & Antenna Design
PNQ Health
Three smartphone screens displaying the PNQ Health tinnitus therapy app, a SaMD solution, with views of the login screen, treatment progress dashboard, and ear selection interface.

A Tinnitus Therapy SaMD, Concept to FDA Clearance in Months

One in ten people lives with persistent tinnitus, the ringing that does not stop.

PNQ Health’s therapy is software. An iOS app delivers personalized sound therapy through ordinary earbuds, and the app itself is what the FDA cleared, as Class II software as a medical device.

For a patient, that means treatment at home, self-guided, with a clinician overseeing it remotely. It also means the app is the entire clinical product, so it has to hold to a medical standard while feeling like something a person opens every day.

Connected SaMD
Audiology
Digital Therapeutics
Post-Market
FDA Class II
FDA 510(k) Cleared
IEC 62304 Class B
Design
Mobile Apps
Design System
FDA Submission Support
MVP Definition
Native iOS
Requirements & Traceability
Secure Data Model
Software V&V
UX & UI Design
Portal Diabetes
Case Study Hero Portal Diabetes

A Connected Care Platform Around an Implanted Insulin Pump

Portal Diabetes holds FDA Breakthrough Device designation for the Portal Pump™, an implantable insulin delivery system.

The pump is designed to sit in the abdomen, dose from a continuous glucose monitor with a heat-stable concentrated insulin, and take refills in a clinic after weeks or months.

For someone with type 1 diabetes, that means no carbohydrate counting, no meal announcements, and no waking in the night. It also means a loop that closes with no one in it, which has to be trusted before it is ever implanted and then stays in for five to seven years.

Connected Medical Implant
Endocrinology
Drug Delivery
In Development
FDA Class III
HIPAA
Embedded Software
Mobile Apps
Security
Systems
Web Apps & Backends
Backend API
BLE
Device Simulators
Mobile Device Management
Native Android
Secure Authentication
Third-Party Cloud Integration
Sensydia
Case Study Hero Sensydia

A Non-Invasive Cardiac Assessment Platform for Clinical Studies

Knowing how well a failing heart is pumping usually takes an echocardiogram and a trained operator, or a catheter threaded into the heart.

Sensydia’s Cardiac Performance System reads ejection fraction, cardiac output, and pulmonary artery pressure from disposable sensors on the chest, in minutes, at the bedside. Its ejection fraction measurement was first FDA-cleared in 2018, and the full platform holds Breakthrough Device Designation.

For a patient in an ICU or emergency department, that means answers without a referral or a procedure. It also means one measurement running across sensors, a gateway, a tablet, and the cloud, carrying patient data the whole way, while the platform is still being proven in clinical studies.

Connected Clinical Device
Cardiology
Diagnostics
Clinical Trials
FDA Class II
HIPAA
IEC 62304 Class B
Mobile Apps
Security
Web Apps & Backends
AWS
Backend API
BLE
Clinician Portal
Edge Gateway
Embedded Linux
Native iPadOS
Secure Authentication
Threat Modeling
Stealth Medical Startup
Client Grey Stealth Startup

An Implanted Therapy Its Clinicians Configure From Anywhere

A stealth-stage medical startup is developing an implanted neuromodulation therapy that its clinicians can adjust without the patient in the room.

For the patient, that means a therapy that changes when it needs to instead of at the next appointment.

It also means every adjustment travels from a clinician’s screen to a device inside someone’s body, and that path has to be trusted at Class III stakes before anything is implanted.

Connected Medical Implant
Neurology
Neuromodulation
Proof of Concept
FDA Class III
IEC 62304 Class C
Design
Embedded Software
Mobile Apps
Security
Systems
Web Apps & Backends
Backend API
Biosensing
BLE
Clinician Portal
Embedded Algorithms
FDA Premarket Cybersecurity
Human Factors
Interactive Prototyping
Native Android
Remote Follow-Up
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Device-to-Cloud Capabilities

Connected Medical Systems, Engineered As One.

Punch Through can own every discipline, so each is built for the way the others behave inside one program. Explore our capabilities across the disciplines.

Users Don't See Your Firmware. They See Your App.

You don't need a finished plan or a clean starting point. Tell us where your program stands today and we'll take it from there.
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Team Consultation
We dig deeper into technical challenges, needs, and where we can add the most value.
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