Innovation and development of advanced medical devices.
The Life Sciences and Healthcare environment is characterised by an increase in patient demand, in response to demographic changes and the emergence of new treatments as medical technology advances. For instance, an aging population combined with new possibilities in connectivity is driving strong interest in home based/remote diagnosis, drug delivery, consultancy & health tracking.
The increasing complexity of software-based medical systems has resulted in a sharp rise in the number of costly device failures and recalls due to software. Human errors in the use of medical devices account for a large portion of medical errors, which as a consequence results in greater demands on HMI (Human-Machine Interface) solutions for safety critical functions.
Medical device regulation is driven by the FDA in the US (regulation 21 CFR 820) and by the EEC in Europe (directives 93/42/EEC, 90/385/EEC and 98/97/EEC). Key standards used to satisfy both US and European regulation and which are considered best practice for the medical devices sector include ISO 14971 (Risk management), ISO 13485 (Product design and development), IEC 62304 (Software) and IEC 60601 (electronics safety).
The Intelligent Systems / Altran focus for life sciences and healthcare is the Medical Devices sector. Such devices typically have strong requirements for connectivity, a safe user interface and high integrity software. The key challenge for Medical Devices clients is to innovate & develop new products that meet these requirements, while meeting cost, time-to-market and regulatory constraints.
Intelligent Systems / Altran provides end-to-end Medical Devices product innovation & development, featuring a medical device Delivery Centre certified to ISO 13485 and ISO 14971. Projects have been delivered to meet FDA and EEC regulatory requirements.
Specific offers include:
- Systems Engineering. Packaged offers to develop medical device products and improve lifecycle performance, including Requirements Based Systems Engineering, Model Based Systems Engineering and Innovative Design (to X) which incorporates proprietary eXtreme Systems Engineering techniques (XSA/XSE).
Example projects include:
- Production of system requirements and design for the first wireless digital X-ray detector, using XSA/XSE techniques
- Re-design based on identification of cost-improvements of a compact, intelligent UV-based decontamination system (embedding multiple safety-related functions and multiple technologies)
- Systems Engineering consulting including delivery of a functional analysis and concept definition as part of a consortium developing a remote patient monitoring system
- aSSureD Safety Systems Development: a packaged offer for the design, implementation and assurance of medical devices systems to meet medical safety standards including IEC 60601 and IEC 62304. Offer includes hardware, software and hardware/software integration.
Example projects are:
- Development of a safety-related dynamic motion management system for a nuclear imaging body scanner
- IV&V of critical software controlling radiotherapy treatment
- Development and prototype delivery of a board controlling a dental surgical instruments robot. The board was based on an ARM 7 core for motor control & monitoring, and operated from a PC via an RS232 link
- Software and hardware design reviews of a vital signs monitor against IEC 60601, also advising where software production methods could be strengthened
- Advanced User Experience : a packaged offer providing advanced HMI technology experience and proprietary frameworks and IP for improving human interactions with medical devices and systems.
Example projects are:
- Prototyping of a hand-held solution to train medical professionals to an acceptable standard within the tightened budgets of teaching hospitals. The prototype incorporated a 3D virtual reality environment, real-world physical interaction and detection of gestures and positioning
- Development of the new HMI for a hemodialysis machine
- Safety: End-to-end safety engineering (including safety case development) and Independent Safety Assessment for medical devices, to ISO 14971.
Example projects include:
- Risk assessment of an ultrasonic medical implant system to ISO 14971
- HAZOP studies to identify safety requirements for a Syringe driver & stack and an Infusion Pump
- Connectivity. Intelligent Systems / Altran cross-fertilises connectivity expertise from other industry sectors for medical devices applications.
- Development of a demonstrator to transfer ECG data from a bio-sensor to an iPhone, via WiFi
- Design of a connectivity framework for connecting the following systems while maintaining overall system integrity: client & competitor medical devices, European clinical information systems, blood pressure monitors, medical scales, clinics & hospitals, services & applications
Dialysis equipment re-engineering and upgrade
Intelligent Systems / Altran carried out a major upgrade to its client’s biggest-selling haemodialysis equipment by performing all necessary systems & software engineering, updating the risk assessment, and providing the deliverables and advice needed by the client for FDA approval. The work was carried out to IEC 62304 (software process) and IEC 60601 (electronics safety) standards.
Intelligent Systems / Altran delivered the work to the timescales required by the client to avoid losing USA market share. This was the first FDA submission by the client for which there were no FDA remarks.