Triteq defines system architectures for clients' designs

Triteq's project manager Ian Fowler believes the company's approach differs from many other consultancies. "There is a general trend for jumping into a solution, instead of taking a step back and understanding the top level user needs," he observed. Triteq, he added, focuses on various requirement 'capture' techniques. "At the start of a project – and even during the creation of a proposal – a systems assessment is considered," said Fowler. "The role of the systems engineer is to define the boundaries of the interfaces across the disciplines, assist in the preliminary requirements for each of the system areas and evaluate design options against the requirements and constraints." Such processes often involve a close collaboration with customers to ensure the consultancy meets expectations and performance of the product under design. "Once the solutions have been analysed, agreed and risk assessed, the requirements trace matrix begins and is developed." This approach enables Triteq to trace down to industrial design, electronic design or software requirements, dependent on the system's function. "Non functional requirements are also considered," he noted, "as well as mitigations highlighted during a risk assessment." Interfaces are managed by Triteq's appointed systems engineer and risk assessed through any development process. Documentation is then created in accordance with ISO 9001 and ISO13495. "With these defined procedures in place, it gives engineers a reminder of the customer's perspective and the quality of product developments expected. The ISO 13485 certificate gives the client additional reassurance that the quality management system is subject to continuous improvements." AP@Home project Triteq's current involvement in a four year project came about due to a personal interest by technical director Ken Hall. Every year, the Framework 7 Consortium lists a set of potential projects that it intends to fund. Hall considered Type 1 treatment of diabetes to be a particularly worthy cause and applied to be a part of the consortium. Triteq was accepted and followed up with appropriate grant submissions. It was at this point that the AP@Home project was established. Through a consortium of academic and industrial partners, Framework 7 aims to develop a 'closed loop' therapy system for the treatment of Type 1 diabetes, known as the Artificial Pancreas (AP). Triteq is designing a hardware system that integrates a continuous glucose monitoring subsystem, a control decision making platform and an insulin delivery subsystem controlled via the AP platform. The platform incorporates an mcu from STMicroelectronics' ST32 family, with a Bluetooth module communicating with the insulin pump. Communication to a continuous glucose monitor (CGM) is enabled via a Wi-Fi module. The ANT+ network transfers and tracks sensor data for monitoring information on the CGM, with the aim of having a single access point through a patient's skin. "At present our platform talks to the system through an ANT+ protocol via USB, then runs software algorithms developed at Cambridge University and Universita Di Pavia," stated Fowler. "These run on our embedded platform, which then tells the pump how much insulin to deliver." "The purpose of the project is to devise a system that is suitable for clinical trials," noted Fowler. "Once this is complete, we want to bring closed loop therapy into the sufferer's home, with little or no clinical intervention. This also introduces the concept of telemedicine." In effect, the device could contact a clinician, who could then analyse data and, if necessary, call in the patient. "This will open the door to remote consultation," asserted Fowler, "but issues still need to be addressed such as, 'will it connect through Wi-Fi?', 'will it connect through GPS?' and we must contend with regulatory and ethical bodies, where security becomes an issue. After all, this is patients' data that is being transmitted." At the start of the AP@Home project, Triteq assessed the intended use of the system as a whole, rather than its constituent parts. "From here, and through numerous discussions with the stakeholders about risk management and hazards assessment, the top level system requirements were defined," Fowler observed. In the next stage, a Triteq systems engineer defined the subsystem interfaces and boundaries, based on the risk analysis, to establish the simplest solution. Fowler pointed out: "This process is iterative and the engineering reviews and assessments are periodically conducted, as well as the risk analysis being updated throughout the design and development process in accordance with ISO14971." There were several issues with the project architecture, such as the system interfaces and the communication protocols interfacing between the subsystems, CGM, insulin pump and AP control platform. There were also a number of internal interfaces that had to be managed carefully as part of the initial stage design. "Interfaces between these modules (subsystems) are critical to the whole performance of our development and its ability to meets its intended use," Fowler noted. Project execution methods All projects, whether software, hardware or industrial design based, are initially run through Triteq's project management office (PMO). Fowler observed: "Our project execution methods are varied – ranging from agile 'time boxing', agile iterative developments, classic waterfall methods, formal iterative developments, feasibility research or confirmation of 'proof of principle' developments." Fowler believes systems architecture is just the first step of the overall process and, as such, all the lower subsystem requirements trace back up to the system's intended use. "This proves to be critical when we are verifying that requirements have been met and then allowing our clients to further progress their product through validation (fit for purpose) and CE marking," he said. "Through reviews and analysis within risk, functional, non functional, user interfaces and value added engineering activities, we strive to get the systems architecture that has been asked for. The process of designing the systems architecture remains consistent, but can be refined through our continuous improvement programme in the PMO by feeding in from the lessons learned database and observing new and inventive techniques and technology advancements." Fowler says Triteq's next objective is to strengthen its presence in industrial design, electronics design/pcb layout and software development. "The expansion of all three departments shows Triteq's commitment to being able to provide total turnkey solutions or becoming the partner of choice for clients by integrating Triteq into an extension of their R&D facility, regardless of size. "The challenge for 2012 is to continue to develop the appropriate system architecture designs that fit an ever increasing diversity of projects; continued cross fertilising of different techniques across disciplines and continuing to raise the quality bar in an effort to meet ever increasing customer demands."