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.

Vignette Mobile Connected Systems

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.

Vignette Mobile What You Get

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.

Vignette Mobile Integration

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.

Vignette Mobile Offline Architecture
Vignette Mobile Regulatory Evidence

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

BACtrack was the first company the FDA allowed to market breathalyzers for consumer use, and in 2013 it released the world’s first smartphone breathalyzer.

BACtrack Mobile pairs with a phone over Bluetooth, turning a breath sample into a blood alcohol estimate on the screen in the person’s hand.

That means anyone can know their number before making a decision that depends on it. It also means an accuracy people stake real decisions on has to survive a wireless link to whatever phone they happen to carry.

Connected Consumer Device
Personal Health
Post-Market
Electronics
Embedded Software
Mobile Apps
Systems
BLE
Connectivity SDK
Low-Power Design
Manufacturing Support
Native Android
Native iOS
PCB Design
Sensor Integration
Highlight Cover Bactrack

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
Monitoring
Post-Market
FDA MDDS
HIPAA
Mobile Apps
BLE
BLE Optimization
Cross-Platform
Multi-Vendor Device Integration
Native Android
Native iOS
Highlight Cover Current Health

Ear Technology Corporation designs Tweak hearing products with audiologist Dr. Daniel R. Schumaier, drawing on 50 years of clinical practice.

TweakConnect pairs a Tweak sound amplifier with a smartphone app where the wearer picks an amplification profile, fine-tunes it, and switches programs as their surroundings change.

That means the wearer decides what sounds right, in the room where it matters. It also means a Bluetooth connection that has to work with whatever phone the wearer happens to own, from flagships to budget Android handsets that each handle Bluetooth their own way.

Connected Consumer Device
Audiology
Post-Market
Mobile Apps
Systems
BLE
BLE Optimization
Handset Compatibility
Native Android
Tweak

Electromed’s SmartVest® is the only brand dedicated solely to high frequency chest wall oscillation, an airway clearance therapy for bronchiectasis, COPD, and other chronic lung conditions.

Patients use the vest at home, and the SmartVest Connect app pairs with it over Bluetooth so they and their care teams can track each session and decide on care together.

That means daily therapy at home is visible to the clinic between visits. It also means a device in an ordinary home has to hand every session’s record to the patient’s own phone, reliably enough for a care team to act on.

Connected Medical Wearable
Pulmonology
Post-Market
FDA Class II
FDA 510(k) Cleared
HIPAA
Mobile Apps
Security
Systems
Web Apps & Backends
AWS
Backend API
BLE Optimization
Clinician Portal
Native Android
Native iOS
OTA Updates
Secure Authentication
Security Architecture
Software V&V
Smartvest

In cardiac arrest, survival depends on a defibrillator working the instant a care team reaches for it.

A global acute care company is building wireless connectivity into its next generation of defibrillators, with the security architecture to protect it.

For a care team, that means the data a defibrillator gathers can move with a patient, without a cable. It also means a wireless path into a device that delivers a shock, where security can never slow it down.

Connected Clinical Device
Emergency Medicine
Resuscitation
In Development
FDA Class III
IEC 62304
Embedded Software
Mobile Apps
Security
Systems
BLE
Connectivity SDK
Embedded Linux
FDA Premarket Cybersecurity
PKI & Certificate Management
Secure Authentication
Security Architecture
Highlight Cover Defibrillator

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
Highlight Cover Smartwatch

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
Highlight Cover Hyperice Core

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
Automated V&V
Azure
Backend API
Biosensing
BLE
Clinician Portal
Connectivity SDK
Cross-Platform
Device Simulators
Inductive Telemetry
Highlight Cover Inspire

Kiddo began at GoodParents as a wristband for children ages 4 to 10, built to give parents real-time insight into their child’s health and wellbeing.

The band reads temperature, perspiration, heart rate, and motion, and the parent app turns those readings into scores for health, activity, sleep, and emotional wellbeing.

That means a parent sees how their child is sleeping and coping, along with how active they are. It also means sensors on a small child’s wrist, worn through play and sleep, have to read steadily enough to become a score a parent can trust.

Connected Consumer Device
Personal Health
In Development
Embedded Software
Mobile Apps
Security
Systems
Biosensing
BLE
Charge Management
Hardware Bring-Up
Low-Power Design
Native iOS
OTA Updates
Secure Authentication
Sensor Integration
Goodparents

Orthofix’s CervicalStim™ is the only bone growth therapy device approved by the FDA as a noninvasive, adjunctive treatment to improve cervical fusion outcomes in high-risk patients.

Its latest generation works with the STIM onTrack™ app, which reminds patients of each treatment and, in a first-to-market feature, gives physicians real-time data on whether they follow their prescription.

That means a patient healing from neck surgery gets help staying on schedule, and their physician sees adherence without waiting for a visit. It also means usage data from a Class III device worn at home has to reach the physician reliably, because it stands as the record of treatment.

Connected Medical Wearable
Orthopedics
Post-Market
FDA Class III
FDA PMA Approved
Mobile Apps
Systems
BLE
BLE Optimization
Handset Compatibility
Native Android
Native iOS
Orthofix

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
Contrast Delivery
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
Highlight Cover Osprey

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
Highlight Cover Pnq Health

Pocket Radar makes radar guns used everywhere from MLB coaching staffs to youth teams.

The Smart Coach Radar™ sends every reading over Bluetooth to the Pocket Radar app, which records video with the speed embedded in it, calls the number out loud, and tracks results over time.

That means an athlete sees which pitch or swing produced which number and builds a record of progress. It also means every reading has to reach the app, even when a coach is running ten radars across a few shared iPads at the same practice.

Connected Consumer Device
Health & Fitness
Post-Market
Mobile Apps
Security
Systems
BLE
Handset Compatibility
Multi-Device Connectivity
Security Architecture
Pocketradar

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
Safety-Critical Mobile UI
Secure Authentication
Third-Party Cloud Integration
Highlight Cover 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 Trial
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
Highlight Cover 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
Highlight Cover Neuro Implant

In CT and MRI, the contrast injector sits beside the patient while the technologist runs the scan from a control room next door.

Control from that room is common, but it usually means running cable through the wall. A global radiology company asked whether wireless could replace it.

For an imaging department, that means installing an injector without new cable through the shielding. It also means a command that starts contrast flowing has to work in every facility, and the program had to show where it could.

Connected Clinical Device
Radiology
Contrast Delivery
Proof of Concept
FDA Class II
IEC 60601
IEC 62304
Electronics
Embedded Software
Mobile Apps
Systems
BLE
BLE Optimization
Communication Protocol Design
Embedded GUI
Embedded Linux
Hardware Bring-Up
RF Characterization
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Bactrack
Highlight Cover Bactrack

The World’s First Smartphone Breathalyzer

BACtrack was the first company the FDA allowed to market breathalyzers for consumer use, and in 2013 it released the world’s first smartphone breathalyzer.

BACtrack Mobile pairs with a phone over Bluetooth, turning a breath sample into a blood alcohol estimate on the screen in the person’s hand.

That means anyone can know their number before making a decision that depends on it. It also means an accuracy people stake real decisions on has to survive a wireless link to whatever phone they happen to carry.

Connected Consumer Device
Personal Health
Post-Market
Electronics
Embedded Software
Mobile Apps
Systems
BLE
Connectivity SDK
Low-Power Design
Manufacturing Support
Native Android
Native iOS
PCB Design
Sensor Integration
Current Health
Highlight Cover Current Health

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
Monitoring
Post-Market
FDA MDDS
HIPAA
Mobile Apps
BLE
BLE Optimization
Cross-Platform
Multi-Vendor Device Integration
Native Android
Native iOS
Ear Technology
Tweak

A Sound Amplifier Its Wearer Tunes From Their Own Phone

Ear Technology Corporation designs Tweak hearing products with audiologist Dr. Daniel R. Schumaier, drawing on 50 years of clinical practice.

TweakConnect pairs a Tweak sound amplifier with a smartphone app where the wearer picks an amplification profile, fine-tunes it, and switches programs as their surroundings change.

That means the wearer decides what sounds right, in the room where it matters. It also means a Bluetooth connection that has to work with whatever phone the wearer happens to own, from flagships to budget Android handsets that each handle Bluetooth their own way.

Connected Consumer Device
Audiology
Post-Market
Mobile Apps
Systems
BLE
BLE Optimization
Handset Compatibility
Native Android
Electromed
Smartvest

A Therapy Vest Connected from the Living Room to the Care Team

Electromed’s SmartVest® is the only brand dedicated solely to high frequency chest wall oscillation, an airway clearance therapy for bronchiectasis, COPD, and other chronic lung conditions.

Patients use the vest at home, and the SmartVest Connect app pairs with it over Bluetooth so they and their care teams can track each session and decide on care together.

That means daily therapy at home is visible to the clinic between visits. It also means a device in an ordinary home has to hand every session’s record to the patient’s own phone, reliably enough for a care team to act on.

Connected Medical Wearable
Pulmonology
Post-Market
FDA Class II
FDA 510(k) Cleared
HIPAA
Mobile Apps
Security
Systems
Web Apps & Backends
AWS
Backend API
BLE Optimization
Clinician Portal
Native Android
Native iOS
OTA Updates
Secure Authentication
Security Architecture
Software V&V
Global Acute Care Company
Highlight Cover Defibrillator

A Coronary Pressure System, Secured for Its Next Generation

In cardiac arrest, survival depends on a defibrillator working the instant a care team reaches for it.

A global acute care company is building wireless connectivity into its next generation of defibrillators, with the security architecture to protect it.

For a care team, that means the data a defibrillator gathers can move with a patient, without a cable. It also means a wireless path into a device that delivers a shock, where security can never slow it down.

Connected Clinical Device
Emergency Medicine
Resuscitation
In Development
FDA Class III
IEC 62304
Embedded Software
Mobile Apps
Security
Systems
BLE
Connectivity SDK
Embedded Linux
FDA Premarket Cybersecurity
PKI & Certificate Management
Secure Authentication
Security Architecture
Global Smartwatch Brand
Highlight Cover Smartwatch

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
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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
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