A New Generation of Blood Testing
Testing a patient’s blood is one of the most common procedures that takes place at any medical center. Boule Diagnostics is one of the global leaders in this field, with more than 60 years’ experience since developing its first blood cell counters. Today it provides a full set of solutions, covering instruments and consumables for different types of medical and veterinary offices.
A few years ago, Boule started the development process for its next generation of blood testing equipment, all based on a new system platform. The company has two main R&D facilities, one in Stockholm, Sweden, and one in Florida, USA. With two separate sites the ability to manage and control its development process across geographies was becoming increasingly important.
From zero to hero
– Before the development of our new platform started, we had no dedicated tool for a more formalized handling of the design and development process, says Helena Börjesson, Chief Technology Officer at Boule. Instead, we relied on keeping files with written documents, with all the risks and challenges that this represents; for example when it comes to traceability or managing specification levels and versions. I joined Boule early in 2020 and it soon became clear that we would benefit from a common tool to help manage all our development initiatives. After all, we are in life science, an industry where aspects such as traceability, documentation and compliance are extremely important and where the formal requirements for these areas are very high.
Boule had done some small trial projects with Polarion before Helena Börjesson came on board but had not fully implemented the tool in its development program.
– As we had been happy with the initial trials, we did not see the need to look elsewhere for alternatives before deciding on a full deployment of Polarion, says Helena Börjesson. We are by no means ready with our developments yet, but we have been extremely pleased with the results to date. Indeed, even though we have seen a lot of benefits from the system already, it is only now that that we are entering into the industrialization stages that I expect to see the real value that Polarion can deliver.
Boule uses Polarion for a range of support functions in the design and development process. Polarion handles all requirement specifications, risk assessment and testing, and is included in Boule’s quality management system. The digital approval and signature functions in Polarion are accepted by the relevant medical and life science authorities, which is a significant advantage for efficient administration, traceability, and quality control.
Ease of use a key factor for smooth implementation
– One of the key advantages with Polarion is its user interface, explains Helena Börjesson. We have expanded the use of Polarion in many of our processes and have therefore also introduced many new users to the system. I have been very impressed with how quickly our people have embraced it. When we started the full deployment with Polarion we set ourselves a tight completion deadline – and delivered on time with 100% delivery against specification. Of course we all worked hard to achieve the target, but without Polarion we would never have been able to make it on time. In fact, I can honestly say that the implementation of Polarion in our design and development process has been both the smoothest and most efficient tool deployment project I have ever been involved in – and I have seen a lot of them in my career.
A seasoned partner
– Taipuva played a key role in the smooth implementation, says Helena Börjesson. They have such a wealth of experience that we were able to benefit from, as they could draw on this to guide and coach us throughout the implementation process. They have been a great partner and have made sure we avoid making numerous common basic mistakes that easily could have happened otherwise.
Three key learnings
Helena Börjesson believes there are a few key success factors when implementing a system like Polarion together with Taipuva. These are her top three learnings:
- Don’t reinvent the wheel. You are not the first company to have this need, so listen to the advice that an experienced partner like Taipuva can give you. Ask questions like “how have other companies handled this, and what priorities did they have?” before you commit yourself to a specific solution or process. By learning from others the process will be both faster and more successful.
- Have a dedicated internal structure. Even the best implementation partner needs a clear project structure on the client side to ensure the project runs smoothly. Make sure the key people on your project team are given enough time and resources to be able to dedicate themselves sufficiently to the project and manage it properly.
- Be brave and set ambitious goals. Working to tight deadlines and stretch targets brings out the creativity in people, as long as they are given relevant resources for their project and the freedom to manage their work. Of course, the goals should be achievable and realistic, but too often companies want to play safe and allow deadlines to be extended or lower their expectations etc. The outcome will not be twice as good if you double the time for the project. Focus on getting a “minimum viable content” off the ground quickly and then expand the scope in successive steps, rather than try to do the full effort in one go.