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The Challenge of Medical Device Design

Designing medical electronics requires balancing multiple factors, such as: 

  • Product Safety Requirements
  • Applicable Medical Standards
  • Technical performance including isolation
  • Connectivity and cybersecurity
  • Regulatory requirements for applicable markets (e.g. FDA)
  • Human factors and usability 
  • Manufacturing, supply chain, and lifecycle management

Nonetheless, rest assured, Allied Data Systems brings decades of experience delivering systems that meet these exacting requirements. While many of our projects are subject to intellectual property restrictions, we have contributed to numerous medical innovations, including but not limited to: 

  • Remote medical consoles enabling specialist consultations via 4G/5G and Ethernet/WiFi. 
  • Real-time bandage pressure monitoring systems using low-energy Bluetooth. 
  • Hardware platforms for body fluid analysis devices that are manufactured offshore
  • Controller for microkeratome instrument 

Each device must operate reliably under stringent regulatory frameworks, such as IEC 60601 for electrical safety, and meet additional requirements for TGA approval or FDA clearance, as applicable.

Recent Medical Device Projects

The following examples reflect a selection of recent medical device projects delivered in collaboration with customers and technology partners. While specific details are limited by intellectual property considerations, these projects demonstrate our experience.

Bandage Pressure Analysis

We’ve developed a real-time pressure measurement system to measure the force applied as a bandage is fitted to a wound. The solution included custom hardware design and manufacture, low-energy Bluetooth connectivity, and an application that displayed live pressure data on a laptop or mobile device, enabling more consistent and controlled wound care.

Body Fluid Analysis

We designed the electronic hardware for a body fluid analysis device, utilising a system-on-module platform from one of our technology partners. While the analytical software was developed by one of our partners, our hardware formed the foundation of a product that was ultimately manufactured offshore for medical use.

Blood Analysis Units

We continue to supply system-on-module compute platforms for blood analysis units used in clinical settings. These systems were instrumental in early, reliable detection of COVID-19 during the pandemic, supporting rapid and accurate patient diagnosis at a critical time.

Laser Eye Surgery Devices

We designed and manufactured the hardware and embedded software used to control the oscillating blade mechanism in laser eye surgery equipment (Microkeratome). The FDA-approved control unit managed blade motion and vacuum application during corneal flap creation and repositioning, and was deployed globally in a laser eye surgery system.

Reverse Osmosis (RO) Water Treatment for Medical Use

We developed the hardware and software elements for PLC-controlled reverse osmosis water treatment systems used in the manufacture of medical products. These systems complied with TGA and GAMP requirements and incorporated multi-stage filtration, heat sterilisation, and UV treatment to ensure water purity and microbial safety.

USB Isolation Solutions

We actively supply isolated USB interfaces from technology partner Sealevel for use in medical devices. Available as both off-the-shelf and OEM solutions, these USB isolators provide electrical protection and signal integrity, allowing medical manufacturers to safely integrate USB connectivity into their products.

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