Atrotech

Atrotech summarized

Atrotech is a Finnish company that develops and manufactures medical tech.  Renowned worldwide for the Atrostim PNS stimulator, Atrotech provides independence for people who would otherwise rely on ventilators.

Medical technology is heavily legislated

Medical technology is a field of high technology that applies artificial intelligence, robotics, and automation to improve human health. Every medical device, from blood pressure meters to AI-powered care robots, requires a robust, high-quality software solution.

Medical technology innovations require exceptionally high-level proficiency and collaboration between different actors. The field is strictly regulated, which means that medical devices must fulfill very high quality and safety standards. Software development regulation is based on industry-specific functional safety standards.

Medical technology is based on robust and reliable software – Bitwise’s software solution sustains life

Bitwise and Atrotech’s partnership began when Atrotech wanted to modernise its nerve stimulator’s programming devices and software to align with the latest user and safety standards. Atrotech needed a reliable, high-quality software solution for the life-sustaining respiratory nerve stimulator, so they approached Bitwise.

The European Council directive concerning medical devices divides medical devices into classes I, II a, II b, and III. Class III includes the highest-risk devices, such as the life-sustaining Atrostim stimulator.

When human lives are at stake, and the software literally needs to sustain life, it is essential to find a partner with cutting-edge software design expertise.

Physicians used to use the nerve stimulator’s earlier, screenless programming devices. To update the device, Atrotech required its software development partner not only high-level expertise in embedded systems but also experience in UI design and development.

Independent life without a ventilator

A nerve stimulator is used when a patient’s neural pathway from the brain to the respiratory muscles is disrupted. This can be caused by a cervical spine injury that usually means the patient will be dependent on a ventilator for the rest of their life. However, the patient can continue life independently with a small implantable nerve stimulator. With the device, breathing is controlled using an external wireless controller unit. The nerve stimulator makes the thoracic diaphragm contract, allowing the patient to breathe again.

To develop software for medical technology, Bitwise had to master many legal standards, such as IEC 62304, IEC 61508, and IEC 60601. The standards control the methods that are used, the development process, and documentation to safeguard human life. “The developers were very involved in the project because they needed to work within strict standards and consider safety in all stages of the project. The entire team was committed to following the standards to achieve functional safety,” says Tuomas Toivola, who was responsible for software development.

Atrotech’s Quality and Design Manager Jani Tarvainen praises Bitwise for smooth collaboration: ”With Bitwise’s professionals, it was easy to run the development and the project’s progress. It was amazing to see them propose many new ideas and implementation options that we, as the client, hadn’t originally even considered.

In software projects for medical devices, it is very important that documentation is carefully written and adheres to all standards. With the documentation produced by Bitwise, we can pursue the approval process of new devices reliably without complications.”

When you need robust, high-quality software, choose Bitwise

When you need robust, high-quality software for a demanding environment, we are the perfect partner. Comprehensive and groundbreaking medical tech solutions require a software development partner who deeply understands industry standards and regulations.

Contact us.