Mechanical, electronics, firmware, apps and test systems
Every discipline a connected therapy device needs, in one team, working under one design control process. Each discipline produces documentation that drops straight into your design history file.
Mechanical & pneumatic design
Structures that carry traction loads safely, enclosures that survive clinic cleaning, and pneumatic systems that hold pressure for years.
What we do
- Industrial design, ergonomics and human factors for clinicians and home users
- Parametric 3D CAD and production drawings with GD&T
- Tolerance stack-up analysis and FEA for load-bearing traction frames and joints
- Design for manufacture and assembly: injection-moulded, sheet metal, machined and cast parts
- Pneumatic systems: manifolds, valves, pumps, bladders and RF-welded compression garments
- Thermal design for heat therapy pads and electronics enclosures
- Ingress protection (IEC 60529) and cleaning and disinfectant compatibility
You receive
PCB & electronics design
Circuits designed from the first schematic to pass IEC 60601 electrical safety and EMC testing, not fixed after they fail.
What we do
- Schematic capture and multilayer PCB layout with design-rule and EMC review
- Patient and operator isolation (MOPP / MOOP), with creepage and clearance designed in
- Motor drives and force sensing for traction; pressure sensing and valve control for compression
- Heater control with independent hardware thermal cut-offs
- Battery and charging circuits, with cells certified to IEC 62133-2
- EMC design and in-house pre-compliance testing to IEC 60601-1-2
- Component selection with lifecycle and obsolescence checks, and an approved vendor list
- Design for test: test points and interfaces ready for production test fixtures
You receive
Embedded firmware
Control software for force, pressure and temperature, built to the IEC 62304 medical software lifecycle with safety designed in.
What we do
- Embedded C / C++ on 32-bit microcontrollers, bare-metal or RTOS
- Closed-loop control: traction force profiles, chamber pressure sequencing, temperature regulation
- Safety architecture: watchdogs, self-tests, fault detection and safe-state handling, backed by hardware interlocks
- IEC 62304 lifecycle, software safety classification and SOUP management
- Coding standard (MISRA C), static analysis, and unit and integration testing
- Secure bootloader and firmware updates, including over the air
- Display and touch user interfaces, Bluetooth Low Energy and Wi-Fi stacks
You receive
Mobile apps & connected devices
Companion apps that run therapy programs, track compliance and connect clinicians to patients, with cybersecurity documented for your submission.
What we do
- iOS and Android apps that pair with the device over Bluetooth Low Energy
- Therapy programs, session logging, reminders and progress tracking for users
- Clinician dashboards and cloud back-ends for remote monitoring
- Apps that control a device are developed as medical device software under IEC 62304
- Cybersecurity by design: threat modelling, SBOM and security testing, following FDA premarket cybersecurity requirements, IEC 81001-5-1 and EU guidance MDCG 2019-16
- Privacy by design for GDPR, and HIPAA where it applies
- App store release, versioning and maintenance
You receive
Wearable therapy devices
Compact, battery-powered compression, heat and vibration devices that people wear during daily life or recovery.
What we do
- Miniaturised electronics, flexible circuits and low-power design for all-day battery life
- Skin-contact materials selected and evaluated under the ISO 10993 series
- Sizing, fit and comfort studies across body types
- Safe surface temperatures and charging safety for products worn on the body
- Home-use design to IEC 60601-1-11
- Radio certification planning for each market: FCC (US), Radio Equipment Directive (EU), RCM (Australia)
You receive
Test equipment & fixture design
We design the rigs that prove your device works during development, and the testers that check every unit in production.
What we do
- Verification rigs: force and load testers for traction, pressure-cycling rigs for bladders and garments
- Endurance and life-test rigs that run devices through thousands of cycles
- PCB test fixtures: bed-of-nails, functional and programming fixtures
- End-of-line testers with automated pass / fail and results saved to each unit's device history record
- Calibration jigs for pressure, force and temperature sensors
- Test method validation and gauge R&R studies
- Validation of test software, as ISO 13485 and FDA's QMSR require
You receive
See how the disciplines fit together
All six disciplines work through the same phase-gated process and hand over to production through a formal design transfer.