The Biomedical Engineering division has been able to successfully develop many products accepted as golden standard within their areas. The key to this success is above all the constant focus on knowledge combined with 35+ years of clinical experience. Our understanding of what solutions that will work in actual clinical environment is a necessity for the development of market leading healthcare products.
Over time we have been involved in numerous clinical applications, ranging over a wide area of clinical specialties. This clinical experience is an absolutely invaluable asset in the development of new medical products. Besides giving us precious knowledge, we have also been capable of establishing a lot of useful clinical connections making it possible for us to verify ideas, get marketing input and giving us the possibility to validate and test new products.
Handling biological signals in a proper way is not a trivial task. It involves thorough understanding about the signals origin, features and clinical significance to be able to restore, analyze and present them in an optimal way. We have successfully done that over a wide range of different types of biological signals and clinical environments.
Software is our business. There are very few of our projects that do not involve software development in some form. Producing reliable medical software for the world market is a Judex foundation. But it is not enough, our service can be extended both to clinical validation, user interface design as well as regional customization.
We take great pleasure in working with hardware, from the development of new medical devices to writing device drivers for existing hardware. We can fulfil the demands for real time and reliable operation that so many medical devices requires.
Deploying medical devices into the clinical routine is a challenge. Even if the device performs just as specified it is not a guarantee that it will become a success. There are so many other things that need to be accounted for.
For this there is no shortcut, no matter what solution is to be developed it must be validated clinically. It must be verified in all the stages of the development, from the specifications, the beta testing to the final release.
To account for this we have a wide range of clinical contacts that we are continuously involving in our product development.
Some clinical areas that we have developed products for:
- Electromyography, (EMG), muscle examination.
- Electroneurography, (ENeG), nerve examination.
- Electrocardiography, (ECG), examination of the hart.
- Polysomnography, (PSG), sleep examination.
- Intra operative monitoring, (IOM), monitoring of vital functions during surgery (Scoliosis, Carotid etc.)
- Vestibular evoked myogenic potential, (VEMP), diagnosis of the vestibular system.
- Electroretinography, (ERG), examination of the eye.
- Auditory evoked potential, (AEP), examination of the ear.
- Visual evoked potential, (VEP), examination of the visual system.
- Somatosensory evoked potential, (SEP), examination of the sensory system.
- Mismatch negativity, (MMN), higher cognitive brain function.
- Cognitive evoked potential, (P300), higher cognitive brain function.
- Electroencephalography, (EEG), examination of the brain.
- Galvanic skin response, (GSR), autonomous nervous system examination.
Biological signals are electrical or magnetic signals generated by some biological activity in the human body. Biological signals have widely different sources, like the ECG originating from the hart or the EEG generated by the brain, making them very heterogeneous. Some have high amplitude and frequency where the clinical importance lies typically in the morphology of a few simultaneously collected signals, preferably analyzed in the frequency or time domain. Or it could be hundreds of signals with extremely small amplitudes where the clinical information is of a spatial nature calling for localization and 3D reconstruction. Our long clinical experience within this field has given us ample opportunities getting acquainted with the whole spectrum of biological signals.
The Clinical Environment
Signal analysis is one of our core competencies. We are well acquainted with the different signal analysis techniques and have long experience in digital filtering, wavelet analysis, artefact rejection etc. But it is in the real life clinical environment that signal analysis becomes a true challenge. Trying to analyze a nerve conduction signal in the operation room while the surgeon is using a cautery knife is where our skills come to their right. We know how important it is for the clinicians that we treat the signals with outmost care, using nondestructive filtering and always with the possibility to display the original non manipulated raw signal. And doing this on-line in real time with limited computational resources is just another obstacle that we have learned to overcome.
Throughout the years we have been able to collect an extensive library holding different types of biological signals. This is a crucial asset both when developing new types of analysis and validating changes to existing algorithms ensuring correct analysis results and backwards compatibility.
We could boast with being Microsoft Solution Providers, that we have a profound knowledge of a whole number of software languages like Assembly, C, C++, C#, VB, Java, JS, PLM etc. Or the fact that we are working with the newest technologies. But having been in this business for more than 35 years we know that these are not the important issues.
What matters is the craftsmanship - the combination of the ability to model a problem correctly, the know-how to select the proper technology, the experience to realize it in the best possible way and above all the ambition to only develop software that one can be proud of!
Now this is something that we do boast about!
An important reason behind our success in turning projects into successful software products is our extensive library containing firmly tested software components. These components range from data collection, interfacing devices, through user interface components to network and hospital connectivity functionality. The component library allows us to quickly assemble the right components into the desired functionality, cutting down on development time and cost.
User Interface Design
It takes a lot of knowledge to develop successful user interfaces for the medical environment. It is a stressful environment where non-technical staff relies on the equipment to perform its task flawlessly, often in a life and death situation. The software should aid the user in every possible way, having a simple and clear interface with high level of visibility and forgiveness (user mistakes should be protected against or recovered from in a simple way). A clear indication of workflow and current position is a must, simple ways to restore the interface to a well-known and functional state is another demand. This is a knowledge that we have acquired through our long experience developing clinical user interfaces.
We have been delivering software to many different countries around the world and know how important it is to develop localized, world-ready, Unicode based software directly from the start of an implementation. We work closely with translators early in the development cycle allowing for minimal testing and release time of the localized software versions.
Our different projects have included developing software for a multitude of platforms, from firmware for dedicated medical devices, Pads and Smart Phones, to standard PC both client as well as server applications.
It was hardware development that was the basis for the startup of Judex as a company and it still provokes the same childish enthusiasm amongst our engineers whenever a new piece of hardware is to be developed or interfaced.
We work within the whole range of development areas: from in-house development, developing drivers for existing devices, to doing specifications for totally outsourced production.
Real Time Solutions
Developing hardware for medical devices frequently involves real time requirements. To implement a system that can perform well in high demanding real time surroundings where the execution of the right tasks at the right time is a matter of life and death is something that needs both skills and experience. A hallmark for real time solutions is that it involves the complete technological pathway, from the first circuitry in the front end of the hardware, the logicware, through the firmware, the operative system and to the user interface, making it necessary to master all techniques involved. A know-how that we encompass.
Safety and Security
Safety and security is obvious in the world of medical devices but it is maybe not so obvious that the concept expands far beyond any regulations and standards. Users must feel safe and comfortable with the equipment, they need to trust it. This means that the device must be reliable (e.g. always start up), reproducible (deliver same output in same environment), insensitive to failures (if the network goes down switch over automatically to local hard disk without data or functionality loss), consistent over firmware versions (keep the most recent version together with the newest available and let the user compare and verify output between them at any time) etc. All these considerations are included from day one in a Judex project.