Professional support in the development of new, innovative medical devices

When developing new devices, it is often imperative to look for and verify technical concepts and possible solutions based on a prototype. This was also the case when developing a new product for one of our customers. The technical challenges were in the areas of user-friendliness, energy and storage efficiency, and long-term operational readiness of the devices, which may have to be stored for several years before they are used. The key to achieving an energy-saving mode and therefore guaranteed operational readiness in the case of long storage periods was to use the STM32 microcontroller in ultra-low power mode. Since this is a device that communicates with the customer’s back-end system via a smartphone, energy-saving data transmission is also essential during operation. We were able to achieve this by using Bluetooth Low Energy. At the same time, user-friendliness was increased by using an NFC chip. NFC was used for easy and fast Bluetooth pairing of the medical device with the user’s smartphone. In addition, we have used the memory available in the NFC chip for ongoing data storage and thus made optimal use of the total memory capacity of the device. All configuration data for the device was stored on the NFC chip as well as log files regarding the operation of the device. Since wireless access to the data stored on the NFC chip is extremely easy and efficient, we have been able to improve user-friendliness for all those responsible for providing, maintaining and repairing the devices. It is clear this also leads to lower production and maintenance costs. Implementing reliable mechanisms for software updates “over the air” (OTA) also reduces operating costs for the device and increases user-friendliness. Implementation of the touch-sensitive user interface was a further contribution to user-friendliness. With the help of this technology, we have succeeded in making it very easy to put the device into operation.

Another innovative application is the implementation of a stall detection function in the control element for the stepper motor in the medical device. Thanks to the embedded software’s reliable detection of motor downtime, the installation of additional hardware components to control the stepper motor was dispensed with, resulting in lower production costs. Noise reduction thanks to microstepping is the last in a long list of technical innovations within the small confines of a medical device.

Since implementation of the technical solutions outlined above is not exactly trivial, their viability must first be tested on the basis of a prototype. In cases like these, a “straight forward” working method is required, which allows ideas to be reviewed quickly and efficiently, thus paving the way for the subsequent release of the future product. However, the processes to be used for mass production of the product are not suited to the development of a prototype. As this is a Class B medical device (for safety purposes), which must meet very strict functional safety requirements, the development processes must be ISO 13845 and IEC 62304 compliant. Here, great importance is attached to, among other things, the formal handling of the development process and ensuring complete documentation, which is checked by third parties. Once again, our employees have demonstrated their flexibility and competence by actively supporting the customer with formal specification of requirements, specification of software and hardware interfaces and in the introduction of unit tests.

The transfer of know-how to the customer, who wants to drive the strategically important further development of the device itself, rounds off the wide range of services provided by our employees.

The result is an innovative product, equipped with modern technologies, that meets the highest demands.