Case

Vivo 1-2-3 – With total responsibility for every breath

Breas Medical is a global medtech company with over 30 years of expertise in ventilation, airway clearance and sleep solutions. Breas Medical invested in launching a new ventilator platform and reached out for our help to go from idea to product in full-scale production. Together Tech assisted with a complete development team to effectively find the technical solutions required to realise the project.

Pre study for a safe start

Together Tech's role in the Vivo project began with a preliminary study where we evaluated the technical core of the product, the fan and the flow and pressure sensor. In our office, the performance and accuracy of the sensor and different strategies for the motor control of the three-phase brushless motor (BLDC) in the fan were evaluated. This resulted in a project start where the customer and the development team could start on a safe technical basis, convinced that the future ventilator would be able to deliver both CPAP and Bi-level treatment to the patients.

The interaction between design, usability and technology

The project was based on a design concept whose key words were light, compact and intuitive. The design placed high demands on the size and design of the internal components such as circuit board, battery, silencer and humidifier. The integrated humidifier presented major challenges as it needed to follow the design language of the main unit but at the same time hold a lot of water, be user-friendly, safe as well as cost-effective and easy to manufacture.

The limited internal space in the ventilator led to the development of a pragmatic battery solution to minimize its size. This solution brought complicated regulatory issues as the majority of the protection electronics were moved to one of the circuit boards in the ventilator, instead of being mounted on the battery itself. The project team handled the regulatory challenges and were able to achieve a safe, compact, cost-effective and assembly-friendly solution.

Like all product development projects, the path from concept to series production was not a straight line, rather a winding serpentine path.

We encountered several major challenges, including how to efficiently humidify the air delivered to the patient. Delivering the right amount of moisture to the patient's airway is challenging as it places high demands on energy efficiency, temperature measurement and materials. An innovative solution where common immersion heaters could be used was developed together with a user-friendly and efficiently heated hose to prevent condensation between the ventilator and the patient.

Another major challenge was to meet the combination of performance requirements in the form of high dynamic airflow and pressure together with low noise level.

Enabling high dynamic airflow that follows the patient's breath in a compact design that is also quiet enough to sleep next to is an optimization problem like no other. To achieve this, a lot of time and energy was spent simulating airflow, testing prototypes in different plastic materials, damping foam and silicone materials, and evaluating different motor control strategies and fan types.

In addition to these requirements, all solutions were scrutinized from other perspectives such as cost efficiency and producibility. Many lessons were learned and the project team built up a solid foundation of knowledge and this work resulted in a quiet and high-performance ventilator.

The product must not only be developed, but also produced

All included parts were designed to be as easy to produce and assemble as possible. A clear DFM and DFA focus manifested itself in everything from the optimization of details and production processes to the setting of requirements for the materials and the review of materials and details and a close collaboration with factories and toolmakers.

To ensure good quality of the final product and a smooth production experience, assembly and testing methods were developed in close collaboration with the production staff. This led to efficient solutions such as custom-built mounting fixtures being developed within the project.

In order to further ensure quality and efficient production, test equipment was developed at both circuit board and product level. These test equipment made it possible for quality problems to be detected at the right stage in the manufacturing process and that every ventilator delivered to a patient is quality assured and provides the expected treatment.

Modularisation and durability

Vivo 1-2-3 is a modularized series of competent and very user-friendly ventilators consisting of Vivo 1, Vivo 2 and Vivo 3. The different ventilators have different performance and functions where Vivo 1 and 2 are models that offer certain treatment modes. The Vivo 3 is the highest performing model in terms of treatment pressure and flow and is also equipped with a battery. All are based on the same basic platform, but each unit is only equipped with an optimal number of components to minimise climate impact.

The world can breathe

Vivo 1-2-3 was ready for production in 2019 and has since made life easier for patients, doctors and production staff. By taking responsibility for design, engineering, production, testing, validation, certification, yes basically everything, we were able to develop a product that is not only smarter, but also, by extension, contributes to making the world a better place.