Mission & Safety Critical Product Design | Sydney Australia
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INDUSTRIAL & COMMERCIAL

Delivering Reliable Devices and Systems

Genesys specialises in high-reliability device development for mission and safety critical environments, typically seen in industrial and commercial environments.

Services delivered by Genesys include:
 

Services delivered by our strategic partners include:

  • Commercialisation

  • Regulatory strategy

  • Intellectual property

  • Packaging and logistics

  • Electronics manufacturing

  • Turnkey product assembly  

For more information see our Product Development Services.

Our Case Studies

Industrial roller doors are heavy and powerful devices that require a clear focus on safe operation with a smart interface to optimise facility management. Managing high-voltage, three phase currents, this solution implemented a dual-redundant control system. 

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Powering roller doors
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In the competitive world of smart home automation, this product had to stand out. Leveraging the Apple HomeKit platform, this solution has virtually every smart feature conceivable, from voice control and geo-location automation to built-in proximity sensors and event schedules.

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Smart home automation
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Safety on construction sites is getting smarter with a new range of safety products. Adding vision, motion and proximity sensing to conventional safety equipment provided a competitive edge for this company. 

Detecting Unsafe
Actions
Workers Wearing Helmets and Jackets
Case studies

Why Choose Genesys?

Why Genesys
THE MOST COMPETENT DESIGNER IN AUSTRALIA

With more then 15 specialist software and hardware engineers we are the Go-To product development firm in Australia. Much of our business comes after other design firms have tried and failed.

INTEGRATED DESIGN & COMPLIANCE

Regulatory consultants will tell you WHAT you need to do. We tell you HOW it should be done – fully integrating the technical implementation with all necessary compliance steps.

PROVEN LIBRARY OF MODULAR HARDWARE & SOFTWARE

Genesys has developed a library of hardware and software modules that are already compliant with the IEC 62304 software development standard - the most rigorous of its kind in the world. 

MedTech Whitepaper form

Principles of Success

Genesys has developed several principles that underpin successful smart device development, covering both business and technical decisions:

Business factors

  • Focus on outcomes not features: Start with value propositions, business models and integration of the supply chains. Avoid a focus on features.

 

  • Follow the data trail: Work out what data you need for what purpose, then work backward to what sensors you need, where the data must flow, and how to present it.  

 

  • Be smart about your MVP: Be smart about your minimum viable product - in prioritising the early features consider how to minimise the cost of adding them later.

 

​Beyond these core principles it is important to understand how to manage your learning curve across the emerging IoT technologies, protect your IP, and build funding relationships.

Technical factors

  • Architecture: Create a road map of where you want to go, then develop data models and a system architecture that is scalable.

  • Powering: For battery powered devices, verify the energy characterisation to ensure reliable operation and service life.   

 

  • Sensing and actuation: Consider if custom or virtual sensors can be created to give you a unique edge.

  • Connectivity: Don't be confused by marketing jargon around communication options -- choose the right tool for the job.

 

  • Data management: Have a clear approach to balance edge and cloud processing to guide a coherent data modelling strategy.  

  • User interface: Adopt a systems engineering methodology to ensure reliable delivery of data to user interfaces.

This is just a light sampling of the technical consideration. For more detail, download our whitepaper entitled, What You Need To Know BEFORE Developing Smart Products.

Our Industrial Technologies

Genesys has a library of technologies that apply in a range of health industry sectors. See our white labelling service to have the following example applications adapted for your business, with full  ISO 13485 certification which suprasses that of ISO 9001. 

Industrial Technologies
FULLY COMPLIANT HARDWARE

Our embedded electronics modules are fully compliant with requirements of electrical safety and electromagnetic compatibility

MISRA C COMPLIANT SOFTWARE

Genesys has a library of software modules developed using a rigorous methodology including the world's best practice Misra C coding standards.

PRODUCT
SAFETY

Our embedded electronics modules are fully compliant with requirements of applicable safety standards including IEC 60950. 

EXTENSIVE SENSING EXPERTISE

We have experience in sensing a range of common industrial parameters including gases, temperature, 

CLOUD DATA MANAGEMENT

Our technologies can analyse data in the device or securely deliver it to the cloud. We handle the stringent requirement for privacy and data integrity using encryption and checksum technologies. 

Industrial Product Standards

Genesys is expert in the design of a product to the following standards:

  • Quality Systems ( ISO 13485 ): This is the overarching quality standard system that guides product development for medical devices surpasses the requirements of ISO 9001 for industrial devices.  Everyone involved in the product's development should to be certified to a quality standard or audited by someone that is. Genesys is ISO 13485 certified for electronics hardware and software development.

  • Risk management and hazard analysis (ISO 14971 and ISO 31000): These standards covers the application of risk management to devices, and are commonly used for mission or safety-critical industrial applications. It primarily involves identification of hazards and mitigating risk. Safety by design and other protective measures are key risk management features, as well as the use of information, labeling, warnings and training resources.

  • Electromagnetic Compatability and Radiocommunications (eg CISPR 32): There are many mandatory standards for EMC emissions, EMC immunity and radicommunications compliance.  Genesys can assist you in identifying which standards apply to your product, and how to have then tested to verify compliance.

  • Safety (eg IEC 60950): There are many standards for product electrical and functional safety.  Genesys is expert in design for compliance with typical safety standards that may apply to your product

  • Software development (MISRA C): MISRA C defines coding standards requirements for firmware and software, and is used for all C code which Genesys develops to help ensure that software is reliable and bug-free.

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For more information view the full list of standards we regularly deal with.

Industrial Standards
Insights
CONTACT
Want to better understand the technical and regulatory landscape for MedTech? 
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