Boule Medical are using Polarion in their software development since a few years for a limited group. Currently they have their code repository in Subversion linked to tasks and defects in Polarion for efficient tracking. A new product development initiative triggered an activity to achieve a more holistic approach. The challenge at hand is both the regulatory complexity in the medical device area on a global market and implementing a systems engineering approach to the project. At Taipuva we accept the challenge and have reached an agreement on a tough and concentrated plan covering Requirement Management, Risk Management, Test Management as well as Architecture Design and Engineering.
A comprehensive plan touching several parts of the product development in the same time as the product development project is in a critical phase. The ambition with the project is to not only ramp-up Polarion in all these areas but also document the new way of working in a Polarion project. This makes Polarion the management system for the involved company processes (requirements, risk, test, architecture). This capability also makes it possible to use Polarion to manage IT projects in the organisation.
Boule Medical is part of Boule Diagnostics AB that is a global diagnostics company that develops, manufactures and markets instruments and consumable products for blood diagnostics. The company serves hospitals, clinics, laboratories and companies within blood diagnostics, in both human and veterinary hematology. The company operates via subsidiaries in Sweden, the USA, Mexico and Russia. The company products are sold globally primarily through distributors, supported by Boule’s own local sales and support personnel. The Boule shares are listed on Nasdaq Stockholm since 2011.
The business was founded in 1992 with the acquisition of Karo Bio Diagnostics AB. But the company’s history goes back to the 1950′s when the founder of Swelab Instrument AB, Erik Öhlin, developed Europe’s first automatic blood cell counter. This is an early predecessor of today’s instruments from Boule. The founders of Boule’s American subsidiary, Clinical Diagnostic Solutions Inc., (CDS) has a similar history from Coulter Corporation which developed the world’s first blood cell counter.