Systems

End-to-end system design for connected Devices

We architect devices, mobile, and cloud as one system for regulated medical devices, digital health, and connected products.

Discuss your system design needs
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What Sets Us Apart

Requirements Drive Integration
Technical decisions validated against real user needs and business outcomes.
Device Constraints Shape the Stack
Architecture designed from hardware realities outward.
Engineers Who Architect
System designers implement their own architecture, ensuring practical decisions.
Regulatory From Day One
FDA and compliance requirements embedded in architecture decisions.

Problems we solve for

System Challenges That Derail Connected Device Programs

We architect connected device systems with cross-stack planning to prevent integration failures, security gaps, and performance issues.

Electronics Antenna Design Capabilities Icon

System Integration Failures

When device, mobile, and backend are designed separately, integration problems emerge late.
  • Device, mobile, and backend teams building against incompatible assumptions
  • State synchronization breaking across offline/online transitions
  • Commands not reaching devices reliably
  • OTA updates that work in testing but fail in production
  • API versioning conflicts discovered during integration
Embedded Product Security Icon with white background

Security & Compliance Risks

Security designed in isolated layers instead of across the full stack creates vulnerabilities.
  • Security boundaries that don’t align across the stack
  • Authentication failing between layers
  • Key management and encryption strategy gaps
  • Regulatory review finding system-level gaps too late
Embedded Device Functionality Icon with white background

Performance & Scalability Issues

Isolated technical decisions across components compound into system-wide performance constraints.
  • Latency budgets that don’t add up across device/mobile/cloud
  • Power and battery constraints are compounding across system design
  • Data flows that bottleneck under real-world conditions
  • Cloud infrastructure costs are scaling beyond projections
Electronics Design For Manufacturing Capabilities Icon

Unidentified Technical Assumptions

Without cross-stack visibility, critical technical assumptions go unvalidated until integration.
  • Critical technical paths are unvalidated until integration
  • Technology selections that don’t work together
  • Requirements conflicts discovered during integration
  • Regulatory implications of technical decisions surfacing too late
Tell Us About Your Challenge

Our Systems Approach

Architecting Device, Mobile, and Cloud as One Integrated System

We produce the traceability matrices, design rationale, and interface specifications that regulators expect, and maintain them as living documentation.

Systems Approach Dark 2

The specialist problem

Most connected device companies split the work across separate teams for hardware, firmware, mobile, and cloud. Coordination meetings are supposed to keep everyone aligned. But when an app decision affects device battery life, or cloud APIs can't support what the device needs, or security gaps fall between teams, the cracks show up fast.

How we design differently

We start by figuring out how devices, mobile, and cloud will work together before anyone writes code. Where does processing happen? How does data move through the system? How do components communicate?
Every technical decision considers the full picture: what the device hardware can handle, how the mobile app needs to perform, what cloud infrastructure can scale to, where security controls need to be, and what documentation will be required for regulatory review.

What this looks like in practice

When we architect device-to-cloud communication:

  • Updates work in the field without breaking devices already deployed
  • The app handles spotty connectivity and syncs reliably when connection returns
  • Security works as one system, from initial device setup through cloud data storage
  • Performance accounts for Bluetooth timing, cellular realities, and battery constraints
  • Design decisions are documented with the rationale regulators need to see
Systems Design In Practice Dark 2
Systems In Practice Results Dark 4

The Results

Teams can build simultaneously because they know how their work connects.
Integration issues get caught early when they're easy to fix. When it's time for regulatory submission, the architecture documentation and design rationale are already there. And the system works reliably in real-world conditions because we designed it for actual constraints from the start.

System Architecture Expertise

From Edge Processing to EHR Integration

Technical evaluators often ask if we’ve solved problems like theirs. Here are system integration patterns we’ve architected across multiple connected device programs.

Icon showing data flow from embedded system to mobile app

Data Acquisition & Edge Processing

Edge architectures for signal integrity, preprocessing, compression, and efficient relay under bandwidth or power constraints.
Icon representing device-to-cloud data pipeline through mobile app.

Store-and-Forward via Mobile/Gateway

PHI-safe buffering with idempotent delivery, replay protection, and offline resilience.
Bidirectional data exchange between device and app.

Provisioning & Device Control

Secure provisioning, authenticated pairing, and configurable calibration and control flows within regulatory bounds.
Device-to-Cloud OTA configuration pipeline

OTA & Configuration Pipeline

Staged, signed updates with rollback and audit support to meet safety and cybersecurity requirements.
Device streaming data through cloud to external system.

EHR/HL7/FHIR Integration

Validated HL7 and FHIR interoperability, including clinical data mapping and secure transport.
Synchronization among multiple connected devices.

Multi-Device Coordination

Coordinated timing across devices with clock sync, jitter management, and tolerance handling.
Discuss Your Architecture Needs

Our Systems Engineering Process

Requirements, Architecture, and Validation as Connected Disciplines

We produce the traceability matrices, design rationale, and interface specifications that regulators expect, maintained as living documentation.

Systems Engineering Process Dark 2
Architecting integrated systems requires disciplined requirements management, traceability, and validation planning.
Our systems engineering process ensures that technical architecture decisions connect to user needs, that risk controls link to the design rationale, and that validation evidence supports regulatory submissions.
Explore Our Engineering Methodology

System Integration In Practice

Integrated Systems Across Our Capabilities

Systems thinking isn’t separate from our technical work; it’s embedded in how we deliver capabilities across the stack and cross-cutting concerns.

Program Highlights

Architected Across Medical, Clinical & Connected Product Programs.

Each of these systems required formal boundaries, traceability, and integration across devices, apps, and cloud.

Programs •
5

FlowIQ is developing a small device that attaches to any standard toilet and reads what a bathroom visit already contains.

It is designed to measure hydration and screen for early signs of urinary tract infection by spectroscopy, with nothing to collect and nothing to do differently.

For someone at risk of either, that means a daily check that never becomes a task. It also means proving that optics compact enough to clamp onto a toilet can read chemistry reliably, before there is a product to sell and on a pre-seed budget.

Connected Consumer Device
Urology
Monitoring
Proof of Concept
Electronics
Systems
Rapid Prototyping
Sensor Integration
Signal Processing
Spectroscopy
Case Study Hero Flowiq

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.

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

A smart building startup is developing an automation platform for commercial buildings, one that controls and monitors dense fleets of connected devices across facilities shared by many tenants.

For a building operator, the aim is one system running the connected devices of an entire property. It also means radio working through metal enclosures and motor interference at extreme device density, and a security model that has to hold across every tenant, device, and door it touches.

Connected Smart Building System
Smart Building
Proof of Concept
Security
Systems
BLE
BLE Optimization
Connectivity SDK
Cross-Platform
Embedded Linux
Native Android
Native iOS
Secure Authentication
Threat Modeling
Wi-Fi
Case Study Hero Conduit

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

Synchron ran the first FDA-approved clinical trial of a permanently implanted brain-computer interface, and all six patients met the primary safety endpoint.

The Stentrode® is placed through a blood vessel, with no open brain surgery, and sits in a vein beside the motor cortex reading the intent to move.

For someone with severe paralysis, that means texting, browsing, and opening apps by thought alone. It also means the connection out of the body is the whole product, at Class III stakes. Nothing the implant does reaches a screen unless that link holds.

Connected Medical Implant
Neurology
Brain-Computer Interface
Clinical Trials
FDA Class III
FDA IDE Approved
IEC 62304 Class C
Embedded Software
Security
Systems
Automated V&V
BLE
BLE Optimization
Embedded Linux
FDA Premarket Cybersecurity
HIL Testing
Protocol Interoperability
Threat Modeling
Illustration of Synchron’s brain-computer interface system, showing a neurotech implant connected from the brain to a chest-worn device, with a zoomed-in view of the brain-embedded stent-electrode array.
Programs •
7
FlowIQ
Case Study Hero Flowiq

A Personal Urinalysis Device, Investor-Ready on a Pre-Seed Budget

FlowIQ is developing a small device that attaches to any standard toilet and reads what a bathroom visit already contains.

It is designed to measure hydration and screen for early signs of urinary tract infection by spectroscopy, with nothing to collect and nothing to do differently.

For someone at risk of either, that means a daily check that never becomes a task. It also means proving that optics compact enough to clamp onto a toilet can read chemistry reliably, before there is a product to sell and on a pre-seed budget.

Connected Consumer Device
Urology
Monitoring
Proof of Concept
Electronics
Systems
Rapid Prototyping
Sensor Integration
Signal Processing
Spectroscopy
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
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
Stealth Building Startup
Case Study Hero Conduit

A Building Automation Concept Proven in the Real World in Weeks

A smart building startup is developing an automation platform for commercial buildings, one that controls and monitors dense fleets of connected devices across facilities shared by many tenants.

For a building operator, the aim is one system running the connected devices of an entire property. It also means radio working through metal enclosures and motor interference at extreme device density, and a security model that has to hold across every tenant, device, and door it touches.

Connected Smart Building System
Smart Building
Proof of Concept
Security
Systems
BLE
BLE Optimization
Connectivity SDK
Cross-Platform
Embedded Linux
Native Android
Native iOS
Secure Authentication
Threat Modeling
Wi-Fi
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
Synchron
Illustration of Synchron’s brain-computer interface system, showing a neurotech implant connected from the brain to a chest-worn device, with a zoomed-in view of the brain-embedded stent-electrode array.

An Implant That Turns Thought Into Touchscreen Control

Synchron ran the first FDA-approved clinical trial of a permanently implanted brain-computer interface, and all six patients met the primary safety endpoint.

The Stentrode® is placed through a blood vessel, with no open brain surgery, and sits in a vein beside the motor cortex reading the intent to move.

For someone with severe paralysis, that means texting, browsing, and opening apps by thought alone. It also means the connection out of the body is the whole product, at Class III stakes. Nothing the implant does reaches a screen unless that link holds.

Connected Medical Implant
Neurology
Brain-Computer Interface
Clinical Trials
FDA Class III
FDA IDE Approved
IEC 62304 Class C
Embedded Software
Security
Systems
Automated V&V
BLE
BLE Optimization
Embedded Linux
FDA Premarket Cybersecurity
HIL Testing
Protocol Interoperability
Threat Modeling
Would you like to see additional programs?
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.

Team Alignment Isn't System Integration

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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01
Quick Discovery Call
Share what you're building, timelines, and constraints. We'll confirm fit and the next best step.
Bofu Engagement Discovery Call White
02
Team Consultation
We dig deeper into technical challenges, needs, and where we can add the most value.
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03
Scope & Kickoff
We align on milestones, documentation, and delivery. Then we get moving and keep you informed.
Start a Conversation
Happy to sign an NDA before we get into specifics. We reply within 1-2 business days.

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How can we help?

Share a few details about your project or challenge. We’ll confirm fit and the next best step within a couple of business days. NDA available.

Person fotoJason SheardTina Hanley
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