”Huld has demonstrated excellence, adaptability, and technical competence. With Huld, collaboration is easy, and the results meet the quality requirements. Huld has proved their value as trustworthy partner in software development, and mechanical and electronics design. At Sooma, we value commitment and high quality. Therefore, we are very pleased with our collaboration with Huld”, – Mika Nikander, COO, Sooma Medical.
Sooma is a Finnish medical device company established in 2013. Sooma develops treatment solutions, which are based on brain neuromodulation.
Huld has collaborated with Sooma to improve the usability of a portable medical device that is based on transcranial direct current stimulation (tDCS). We have supported their product development especially with our comprehensive knowledge of the usability and standards (IEC 60601, IEC 62304, IEC 62366, ISO 15223 ja ISO 14971) of medical devices.
Sooma has developed a non-pharmacological direct current treatment for depression, Sooma depression therapy. It is based on a weak electrical current delivered to targeted areas of the brain, as well as a portable and user-friendly device (Sooma tDCS) with which the treatment is given. In 2020, Sooma decided to develop a new version of the device based on customer feedback. Sooma’s goal was to simplify the use of the device from an end-user’s point of view. In addition to usability, more attention was paid to improving the collection of medical data in the updated device. They also wanted to improve the connectivity of the device and give the device a more modern appearance.
Sooma tDCS is a complex device that has strict accuracy requirements in addition to real-time requirements. The development work requires knowledge of medical device-related standards, and the work must be carried out in accordance with them. Together with Sooma, we improved the usability of the device to meet the customers’ needs. The new version also enables detailed collection of medical data. Moreover, Sooma created a separate mobile application as an addition to the user interface of the device.
Huld already participated in the early stages of the design work. In the beginning of the collaboration, we went over the requirements for the device and defined its functionalities. Huld’s UI/UX specialists participated in the process to make sure that the decisions made during the design work were the right decisions in terms of usability. It was important for Sooma that Huld was able to provide know-how on all design services and supply all the components that were needed for the device, under one roof.
During the collaboration, Huld’s responsibilities included designing and developing the embedded software, electronics, mechanics, and production tests of the device. Sooma was responsible for creating the mobile application. The timing for the design and production of the device was challenging because of the global shortage of components. That is why we strived to pay special attention to alternative components during the collaboration, to ensure the high quality of the final product.
The newest version of Sooma tDCS, which was developed during the collaboration, is a high-quality medical device that is safe for both professional and at-home use. Huld’s skilled team provided support in all stages, from early design to the start of production. The development work progressed in close collaboration with the customer, and our open communication and adaptability helped solve the challenges faced during the collaboration.
Huld is ISO 13485 certified, and we have significant experience in working with medical device-related standards. Huld’s experience with medical devices covers all phases of product development, from early design work and usability assessment to supporting ramp-up of production. At Huld, we have competence in many different fields and the customer can always trust that they get help quickly.