Developing advanced applications for the medical industry requires a high level of expertise. Developing new technological solutions requires in-depth knowledge, broad experience and creativity to seek out and sometimes even push technical boundaries.
With over thirty years of experience in the medical industry, inomed is one of the market leaders in Europe. The company develops, produces and sells specialized medical systems, which are used for a wide range of surgical procedures to protect and treat neurological functions.
Pioneer in neurology
As a pioneer in the field of neuromonitoring, inomed successfully launched the first facial nerve neuromonitors for ENT (ear, nose, throat) on the German market as early as 1992. With the launch of the C2 Xplore in the summer of 2020, inomed is introducing a next generation of neuromonitors, fully in line with the increasing digitalization of the operating room. The device is the result of intensive research in the field of intraoperative neuromonitoring. The C2 Xplore is the first inomed device with touch control, for maximum user-friendliness and high efficiency. Thanks to this innovation, which was developed together with users, the device is smooth and intuitive to operate.
Customized solutions
When developing and producing such highly specialized medical applications, standard solutions are not enough. With years of experience in developing specific, customized control systems and complete solutions for the medical industry, inomed found SCHURTER to be the most suitable development partner. The fact that SCHURTER has all production processes in-house was an important factor.
Supplier and partner
The (standard) solutions of the existing supplier for control systems could not fully meet the increased requirements of inomed. With the in-depth knowledge, the broad and innovative technology portfolio and the availability of all production processes in-house, inomed was quickly convinced of SCHURTER as the optimal partner.
Jörg Wipfler, Technical Director of inomed Medizintechnik GmbH: "We know SCHURTER from our regional network. The product portfolio, the short travel distance and the friendly and competent contact persons were the decisive factors for choosing SCHURTER. After visiting the production facility, we were convinced of the possibilities that a collaboration with SCHURTER offers us, after which we agreed to create a prototype together."
Innovative and customer-specific
In direct cooperation with inomed, the design of the thermo-foam housing (TSG), which had already been developed by inomed, was optimized for integrating the control panel. A feasibility study was carried out based on the existing housing design and the requirements from the specifications. For example, minimum requirements were set for the edge distances, the dimensions of the cover glass and the mounting options for the display. In addition, the rotary encoders had to be connected to the metallized housing via a conductive connection.
From the wide range of certified technologies for control systems, SCHURTER selected the most suitable assembly. This assembly consists of cover glass, a PCAP sensor with controller and a display that was specially designed for the inomed application. A 3D integration model was first created for this. The development departments of inomed and SCHURTER jointly further developed this model until the final production version. The choice of adhesive was made on the basis of a laboratory test, in which the surface tension of the connecting parts was checked. SCHURTER was responsible for the design of the glass surface and the automated printing with UV ink.
Qualification tests
Based on the requirements specified in the specifications, SCHURTER developed a qualification plan. Already in the early start-up phase, samples for qualification were produced in small series and verified in SCHURTER's own laboratory. The qualification tests included environmental tests such as heat and cold storage and temperature cycling tests. In order to guarantee function and adhesion, a new function test was also carried out and an additional "push-out test" of the touchscreens. All tests were successfully passed in the first run.
Mathias Bürklin, Department Manager Development Systems II at inomed, played a major role in the development process. “SCHURTER’s many years of experience were of great value in the development of the prototype. From the selection and printing of the cover glass, to the adaptation of the touch controller firmware and the final environmental test of the first series in SCHURTER’s own test laboratory.”
Custom adjustments
At the same time, the firmware of the PenMount controller used was adapted to the Windows 10 IoT Enterprise operating system according to inomed's requirements. An additional adjustment to the firmware prevents high-frequency interference signals from surgical equipment in the immediate vicinity of the application, so that ghost-touch triggers are actively suppressed. The parameters of the median and peak filters as well as the extended frequency hopping procedure were implemented in the firmware. Using the supplied utility, inomed can independently set further functional parameters, such as water detection and anti-noise settings. The codes developed as command lines enable inomed to adapt the firmware in already integrated systems.
During series production at SCHURTER, automated programming and recording (traceability) of the controller and series data takes place.
In retrospect, Bürklin summarizes: “During development, the SCHURTER specialists provided support, among other things, in the design of the HMI and in adapting the firmware to our requirements, so that the HMI continues to function undisturbed in the event of malfunctions and is suitable for the special requirements in the operating room. Challenges were always investigated and solved in very constructive cooperation.”
From prototype to series production
Thanks to the excellent cooperation between the experts, this medical application could be developed, qualified and produced in series within a very short time. The first prototypes were produced within three months, after which three pilot series were delivered for approval tests at inomed and qualification tests at SCHURTER. After a two-year development period at inomed, the first series delivery of the HMI units took place in the summer of 2020.
Result: a first-class medical application
Thanks to SCHURTER's know-how, the automated production process including life-cycle management, inomed is assured of a constant, reliable supply according to the highest quality standards. Each unit is subjected to a 100% functional test of touch function and display before delivery. In order to be able to trace all components even after delivery, the serial data is automatically recorded.
The personal contact during the development process was important for inomed. Florian Neumeister, Marketing Manager at IOM, looks back with satisfaction on the collaboration with SCHURTER: “The prototype was further developed in good consultation until it was suitable for series production and has since been extensively tested at inomed and in external test laboratories. The HMI is a bull's eye in terms of both design and functionality. We have received consistently positive feedback since its market launch. The HMIs supplied have been of consistently high quality from the start. The product is now available internationally and is used daily in the outermost regions. In addition, many international approval procedures for use in other medical devices are still ongoing.”
Developing such leading customized solutions requires specific expertise combined with unique innovation capacity; characteristics that SCHURTER and inomed have in common. A productive collaboration has resulted in a groundbreaking medical application of the highest quality. Florian Neumeister: “We are very satisfied with the collaboration during the development and look forward to further cooperation with SCHURTER.”