Creating complex medical devices frequently involves rigid schedules and costly change applications, adding to the lengthiness of the development process. What if we told you that there is another approach? The development of a highly accurate patient monitor for visualizing blood glucose levels has been marked by efficiency, flexibility, and transparent communication with Innokas Design Studios' agile methodology
The project achieved its first milestone exceptionally quickly, thanks to the adept application of agile model and transparent communication among developers, Innokas’, and customer’s teams. This efficient approach has maintained remarkable flexibility, crucial for a medical device concepting phase, while adhering to the project schedule and work estimations. The prototypes demonstrate positive results, with ongoing efforts to improve manufacturability and producibility. The future of companionship shows promise, as Innokas is set to manufacture the device in the future.
Highly accurate glucose sensors to reduce unnecessary intensive care unit deaths
GlucoSet is a Norwegian medical device company that seeks to reduce unnecessary deaths in intensive care units by developing highly accurate blood glucose values measuring sensors and monitors that alert the medical professionals when the patients’ values drop below certain thresholds.
GlucoSet's sensor and monitor stand out for their ability to provide precise, quick measurements, and exceptional sensitivity, especially in the hypoglycemic range. The company is focused on developing products that fit into the existing workflow of nurses and physicians, ensuring that the devices are suitable for daily operations of intensive care unit medical professionals.
Using agile approach throughout prototype series development
Innokas Design Studio has been heavily involved in the development of prototype series and industrial design of the monitor since the start of the project in 2022. From the beginning, applying agile model has given significant benefit for the whole timeline of the project.
In the initial stages, flexibility is crucial for navigating development, allowing adjustments before changes become costly and challenging. “By using this model, we get to hand the customer a working prototype very quickly, much before the lengthy and intricate medical device approval process,” says Antti Ylönen, Innokas project manager involved in the project. By utilizing the agile model, early testing of prototype viability establishes a robust foundation and project certainty. The maximum flexibility is preserved throughout, allowing for a low-threshold determination of the product's direction through iterative testing.
GlucoSet collaborators have described the companionship as remarkable success. "The Medical Monitor development collaboration between the teams at GlucoSet and Innokas Medical has been a great success so far,” says GlucoSet’s CTO Lukas Scherer. “Innokas team of engineers, QA, project lead and manufacturing provides a streamlined development process of high quality, where they also show they care about GlucoSets success and budget by actively helping to mitigate product and project risks early. GlucoSet engineered the detailed opto-electronic design, and develops and manufactures the indwelling glucose sensor, while Innokas engineered the detailed electronic hardware, mechanical and industrial design of the Medical Monitor as part of the Glucoset CGM system, and they will manufacture the Monitor in the future,” he adds.
Agile approach outside of Healthech field and its practicalities
This way of working can be applied on a wide range and showcases Innokas’ capabilities outside of the medical sector. “Even in the case of a medical device, we can pick a different route to ensure that development costs stay reasonable, and the pacing is efficient without unnecessary strictness and extensive costs. Our customers do not necessarily have to enter the stringent medical device path when working with us, and on the other hand, we have those capabilities in use when needed,” Antti adds.
Applying the model involves, for example, using a preliminary mock prototype with essential functionalities of the final product, allowing early software team testing for system verification. This step precedes the completion of the real circuit boards. The mock prototype is then quickly followed by an official prototype that has the industrial design of the final product.
“This collaboration has been very rewarding for both us and the customer,” says Antti. “Working with an optical device like this has been fantastic. Projects involving medical devices with components such as a spectrometer and optical fibers are both challenging and gratifying, so they are as fulfilling to work on as they are to complete,” Antti concludes.
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