Ryuichiro Kodama

Experiences with commonality control procedures to develop clinical instrument system

This paper reports our experience with software development based on the Software Product Line (SPL) approach employed for Clinical Instrument Integration Management Software (CIIMS). CIIMS is the system software which systemizes heterogeneous clinical instruments. These instruments require their particular management so that various parts of CIIMS are forced to be changed. This makes it difficult to create development plans to connect new instruments to CIIMS. In this paper we summarize a new estimate method called the Architecture Domain Matrix (ADM) method which effectively solved this problem in our experience. In ADM each architectural element is further decomposed into clinical operation flow elements and core assets of software are extracted from these elements. This method estimates the CIIMS commonality with precision and finally enables to successfully connect new instruments. In addition this method provides a Work Breakdown Structure (WBS) and supports development team building. WBS is generated by collecting all the changes for each operational flow element. A development team suitable for change is organized by taking into consideration all the changes for each architecture element. We integrated three different instruments into CIIMS in 18 months after applying this method to a real project and achieved 2.5 times greater productivity with the embedded software than that with our previous non-SPL process.

Modularized system architecture for flexible clinical laboratory systems

The increase in medical expenses resulting from longer life expectancy is an increasing serious social problem in Japan. Reducing the cost of clinical laboratory systems, increasing quality of service to patients, and safeguarding the health of hospital staff are important issues for hospitals. A flexible clinical laboratory system is needed to reduce system development cost. Automated clinical laboratory systems, for large and small hospitals alike, are needed in order to reduce waiting time and the risk of workers being exposed to infectious diseases. Flexible systems could meet all these needs. We have developed a modularized system architecture to provide a flexible clinical laboratory system. The hardware and software of the clinical and sample transfer equipment are modularized in this system. Each piece of equipment can autonomously decide where to transfer samples and how to process them. The clinical equipment works autonomously and can be added or suspended without influencing the other equipment. The transfer equipment is also autonomous, and the sample transfer lines can be changed easily in accordance with space limitations. We applied this modularized system architecture to a pre-analytical sample-handling system, and demonstrated its effectiveness. This system was developed by using equipment from different vendors, thus demonstrating that such a system can be easily built.