Maßgeschneiderte Embedded Systeme für die Medizintechnik
Medical technology is one of the key technologies of the 21st century. Nowadays, it is impossible to imagine medicine without electronics and embedded systems. Whether as wearables on the body, heart-lung machines in hospitals, diagnostic equipment, laboratory equipment or treatment devices for dentists. Electronics and software are ubiquitous. Major advances in medical technology are increasing the quality of healthcare and reducing medical management costs.
Electronics and embedded systems are core components of today's medical technology, reduce costs and enable completely new areas of application. Design, development and production of embedded systems and electronics in medical technology requires know-how in many disciplines:
Standards & Certification
The use of technology in medicine requires strict measures to exclude malfunctions and to permanently ensure quality. These measures must be adhered to and documented throughout the entire product life cycle. It starts with the specifications through its development to the discontinuation of the product. Medical technology systems must not pose a risk to life and limb.
For this reason, many standards and regulations must be taken into account for the development of medical technology devices. Numerous certifications have to be passed before the devices can be used. Over the life cycle of a medical device, the quality of the production and the product are continuously monitored by authorities and authorized institutions.
Some important medical device guidelines and standards that developers need to know:
Medical Device Regulation MDR of the EU
IVDR - In-vitro Diagnostic Device Regulation of the EU
EN ISO 13485 - Management system for the design and manufacture of medical devices
EN 60601 - set of standards on medical electrical equipment and systems
Easy operation and optimal use
Simple, intuitive and error-free operation is important in medical technology. Last but not least, the user interface is also an important design element of a device and a basis for decision-making for the potential buyer. The optimal user experience increases acceptance and reduces the learning effort and error-proneness of the operator.
In critical environments in treatment rooms or laboratories, care must be taken to keep HMI user interfaces and switch elements germ-free. Today, the operation of medical devices is supported by means of voice input and output. Artificial intelligence provides support when used, for example, to make suggestions for interpreting images or measurement results in diagnostics and to relieve the user of important decisions.
Measurement technology, sensors and actuators
A wide range of sensors are used in medical technology to record vital data or analyze substances in laboratories. Pulse, blood pressure or body temperature can be recorded directly on a patient's body. Complex spectroscopic methods can be used to determine the composition of tissues and fluids in a laboratory device. The technical challenge here is very often the continuous acquisition and processing of minute signals in interference-prone environments. Experience with analog technology and digital signal processing are important tools for the developer. Optical systems are often integrated with the electronics, which in turn requires specialist knowledge. ###IMAGE5###
The highest possible safety standards must be observed for all measurements on a patient's body. This naturally also applies to active intervention by a medical device. The actuators used, such as pumps for transporting body fluids or drives for drilling or cutting bones or tissues, must function reliably. The developer of a medical device must ensure and demonstrate that use on the patient can be performed with minimal risk.
Mobility, energy management and computing power
Increasing miniaturization and computing power of electronics and embedded systems now enable medical devices that are small and compact to collect data and make control decisions directly on the patient. This combines microcontrollers with minimal power requirements and sophisticated power management for long-lasting and low-battery operation. Today, pacemakers can be operated with a battery for up to 10 years. The computing power of the processors used enables extensive signal pre-processing and evaluation up to the use of algorithms from the field of machine learning and artificial intelligence.
Developers of medical devices must be as familiar with battery technology and its safe application as they are with the possible energy-saving levels of different microprocessors. The use cases of the device must be analyzed in detail in order to calculate an accurate energy balance.
Connectivity and security
We are also experiencing a digital revolution in medicine, which is fundamentally affecting all areas of life and the economy. Medical devices are becoming increasingly intelligent and rarely run in isolated operation. Vital data from patients and diagnostic data from laboratories are seamlessly transmitted to medical IT systems and analyzed.
Different network and wireless standards are used, and the integrity and security of the data must be guaranteed at all times. Patient data is extremely sensitive and the highest data protection standards must be considered for this. Devices are operated with medically certified cloud systems. Data transfer must be encrypted and secured. Manipulation and unauthorized access must be prevented.
The development of modern medical devices therefore requires expertise in network technology, network security and encryption.
Security and reliability
Medical devices must function permanently and reliably. The risk of malfunctions during operation must be minimized as early as the development stage. To this end, comprehensive risk analyses must be carried out on an ongoing basis. Based on these analyses, measures must be derived to further minimize potential threats. Redundant systems, sophisticated monitoring functions in hardware and software, and modules that meet the prescribed standards are used. Furthermore, long-term maintenance and care of a medical device over its entire life cycle must be ensured in order to permanently guarantee the highest possible level of security. ###IMAGE6###
Special requirements must also be taken into account when it comes to the materials used in the medical environment. Surfaces, buttons or touch displays should be disinfectable. Some components should be able to withstand a certain number of sterilization cycles in an autoclave without damage over their lifetime. Biocompatible or breathable materials must be used in contact with the patient.
The developer of medical devices must always focus on safety and be familiar with the regulations and procedures required for this.
Stability over many years
In order to create a robust hardware & software platform for series production, the expenses for integration, ongoing maintenance and expansions must be considered from the very beginning and over the entire product life cycle. Despite rapidly changing requirements, medical technology demands a long service life for its devices. Changes in hardware or software entail lengthy approval procedures.
Even during device design, care must be taken to ensure that durable components, preferably from multiple sources, are used and validated. The embedded software must be designed to be extremely stable, fault-tolerant and robust. Updates, e.g. for new threat scenarios or for new functions, must be able to be applied quickly and securely. In any case, beyond development, a long-term stable partnership with the development partner is essential.
Examples from practice
Ginzinger electronic systems offers complete solutions for the development and production of electronics and embedded systems for medical technology. The company is certified according to EN ISO 13485. Some examples of solutions:
W&H Dentalwerk Bürmoos GmbH
W&H Dentalwerk, headquartered in Bürmoos, develops, produces and markets precision instruments and equipment for dental, surgical and dental technology applications for the benefit of mankind.
The international company clearly trusts in Ginzinger and its embedded Linux solutions. W&H Dentalwerk Bürmoos GmbH
DMU GmbH ###IMAGE2###
It all began with the invention of the world's smallest 5-axis milling machine for dental medicine. The Salzburg-based start-up company DMU GmbH, which now has around 30 employees, developed this to production readiness in 2015.
In order to make the adjustments from prototype to finished industrial-grade product, modifications to the previously used proof-of-concept electronics were necessary. Read more: DMU Ltd.