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Sectors : Medical

Pedigree

Altran Praxis has been engineering safety critical software throughout its entire history. This service has spanned highly regulated markets, including medical. In addition we have many years experience in advanced Human Machine Interface (HMI), connectivity and innovative consumer device technology.

These combined experiences provide Praxis with a unique perspective on high integrity systems engineering and innovation to enable cost-effective solutions for medical clients.

Focus

The Praxis focus is to:
  • Develop critical embedded systems to meet exacting medical, safety and environmental standards including IEC 60601 and IEC 62304.
  • Provide innovative connectivity and advanced HMI solutions to accommodate all user demographics and prototyping capabilities.
  • Provide expert advice for the engineering and certification of safety critical systems.
  • Provide independent verification, validation and assessment services to meet relevant industry standards.

Example Medical projects

  • Oncology - development of a safety related dynamic motion management system for an OEM.
  • Radiotherapy – independent verification and validation for critical software controlling the treatment process.
  • Connectivity – development of a demonstrator to transfer ECG data from a bio-sensor to an iPhone, via WiFi.
  • Oncology - assessment and audit of a medical equipment manufacturer’s software development process.
  • Oncology – development of a Gantry motion management system for an OEM.
  • Nuclear imaging body scanner – supported motion control software development.
  • Health service - we developed the requirements specification and prototype for a patient treatment database and later produced the independent test specification for the final system.

Why Altran Praxis for Medical?

We have the pan-industry experience that can help you specifically within the medical sector:
  • We are experts at helping customers meet regulatory requirements by applying best software and safety assurance practices to critical software.
  • We provide open, modular system and software architectures with dynamic service and device engagement, allowing easy upgradeability of devices and software and reduced product development costs.
  • We are experts in advanced HMI solutions, providing dynamically adaptable user interfaces that strengthen system usability, extendibility and safety.

Case reference

Dynamic Motion Management subsystem for an oncology system.

Altran Praxis Medical case image

Challenge

Adding a Dynamic Motion Management subsystem to a radiation treatment simulator used in the medical industry in order to detect and take corrective action for collisions between the moving parts of the machine, the ceiling, the floor and/or the patient.

The subsystem needed to maintain the high-speed performance of the equipment whilst at the same time ensuring that the patient’s safety was never compromised.

Engagement and approach

Praxis developed the software system and safety case, designated as ‘safety-related’, using industry best-practice techniques and its own Correctness by Construction method. A software partitioning strategy was devised in order to distinguish critical and non-critical functions and hence to save development and assurance costs. The required safety assurance of all functions was achieved by following the project’s Safety Plan, developed and managed under the auspices of the Praxis Safety Management System, and was fully compliant with FDA requirements.

Outcome

The subsystem was delivered and accepted by the OEM, approved by the regulatory authorities and is now in operational service for oncology.

Market Factors

The increasing complexity of software based medical systems means that the number of costly device failures and recalls due to software are increasing. A recent publication based on FDA information reports a 25% increase of recalls from 1995 to 2004 due to software failures.

Remote systems in patients’ homes and connected health solutions are required for future health.

Human errors in medical device use account for a large portion of medical errors, which as a consequence results in greater demands on HMI solutions for safety critical functions.