By Nikolaus Fecht
Medical technology raises ever new and challenging requirements for electronics in many products. The involves a broad spectrum of products, ranging from smart or wearable devices to cardiac pacemakers and computer tomography systems.
Listening to Professor Dr. Tim C. Lüth, head of the Institute of Micro Technology and Medical Device Technology (MIMED) at the Technical University of Munich, describe the trends in medical technology, it sounds a little bit like Industrie 4.0. According to him, these trends include customized and personalized products and services as well as interconnecting devices and care assistance systems. "We develop and build customized instruments and assistance systems using 3D-printing. These instruments are referred to as micro manipulators and are disposed of after the surgery," the long-term professor for medical robotics explains. "With regard to real-time networking, we participated in the OR.Net project initiated by the Federal Ministry of Education and Research (BMBF)." The flagship project, which was completed in 2016 and received funding to the tune of 15 million euros, brought together 80 partners from research, clinics and industry to come up with solutions for safely and dynamically connecting components in operating theaters and hospitals.
Computer-aided surgery for protecting eyes ...
"One research objective of this project is to investigate navigation systems that measure the exact position of surgical instruments with an accuracy of one-tenth of a millimeter and which can be networked with other systems," says Professor Lüth. "For example, surgical instruments can for example be coupled with a navigation system via a data bus." This way, it is possible to precisely monitor the position of all instruments used in surgeries. If a milling cutter or laser comes too close to a patient's eyes, for example, the interconnected system automatically switches off the instrument. To ensure that this is done quickly, the navigation system measures the instrument's position 20 times per second. The development is leaning towards to the fast real-time Ethernet data bus system, which ensures that large amounts of data can be transferred in real time. The system also includes functions for coping with network failures, enabling surgeons to restart the milling cutter using a foot pedal.
The electronic equipment needed for this is developed by suppliers from fields including sensor or drive technology and image processing. "The bar is very high, because for medical facilities to hold their ground in competition, it is more important than ever for them to act as commercial enterprises while at the same time providing high-quality treatment. This translates into considerable requirements in terms of efficiency, profitability and quality," summarizes Frederik Vogel, Managing Director (Production and Technology) at Hamburg-based seca GmbH. "For us as manufacturers of medical measurement systems and scales, this means that we need to develop solutions that help facilitate diagnostic processes and customize treatments." To increase safety and efficiency in day-to-day medical care, medical technology products should also come with automation capabilities. Additionally, the accuracy of more complex systems must be validated in a scientific manner.
Products must offer added value
"Our products must be capable of much more than 'just' weighing and measuring," states Vogel. "To ensure that our development activities are in line with our customers' needs, it is very important for us to ensure a constant dialog with users from various medical faculties." This includes topics such as connectivity and integrated products that assist users in quickly assessing the medical condition of a patient without medical intervention. "The products we have developed to meet these specific requirements communicate wirelessly, exchange data automatically and make data available for medical records," Vogel adds. "This makes it much easier to meet the high medical documentation requirements in clinics while also ensuring accurate and correct data."
Precise measurements at gold standard level
To make it easier for medical experts to assess the health and nutritional status of their patients, seca has developed measuring stations that precisely determine a patient's body composition using bioelectrical impedance analysis (BIA). Internationally acclaimed in the scientific community, this measurement method is based on a weak and impalpable current conducted through the patient's body. BIA measurement technology makes use of the phenomenon that the muscular system conducts electrical currents better than body fat. It is used to measure the flow resistance (bioelectrical impedance), which serves to determine the amount of water and fat in the body.
"This data is particularly valuable in nutritional medicine, facilitating early diagnosis and making it easier to select custom treatment," the Managing Director of seca explains. "The accuracy of this data was validated against the most precise reference measurement method, i.e. the gold standard (see information box), in a multi-center study. This makes our product truly unique in this field of application."
The benefits of these BIA measuring stations in routine medical care have been confirmed by a global specialist for outpatient nutrition counseling, which offers special diets for patients after their hospital stay. "Thanks to our mobile BIA measuring station, our customers are able to considerably improve the treatment and monitoring of their patients, thus ensuring better quality of life and optimizing their services," says Vogel.
The macio GmbH from Kiel has also noted that the pace of development and the demands for medical technology are increasing constantly. But it is not just about ergonomics anymore, as user motivation is increasingly coming to the fore. "Our customers ask for ever shorter development cycles and easy-to-use devices that offer a positive and safe user experience," says Alexander Friedel, Managing Director at macio GmbH. "The goal is to ensure that employees enjoy using the devices. And the devices should also give them assurance that they can do no wrong." Medical devices are not only used by experienced employees, but also by personnel who is less technically savvy. "The devices may neither be too boring nor too intimidating," summarizes Friedel.
A typical example for great implementation is the new monitor developed by seca for measuring vital data and body composition. The software and the interaction design was developed in close collaboration between seca and macio. "Shorter development times are often made more difficult by the fact that the certification date has to be set long before the final functionality has been defined," the managing director explains. "We are often facing a dilemma: We want to develop a highly creative concept (keyword: design thinking), but we are forced to specify the design as soon as in the prototype stage in light of the tight certification schedule." The trick is to ensure a reliable transition from the experimental to the implementation stage in a very tight and agile development process and in close cooperation with the device manufacturer. According to macio, it usually takes one to two years to develop sophisticated medical technology products.
Faster and improved recording of vital data
"The most exciting aspect about this project with seca was that we had to combine functionalities in a new way to develop a better instrument for recording patient data," explains Friedel. "These functions were defined together with the customer in the first stage." The considerations in this stage revolved around the question of what hospital staff actually need. Answers to this question were derived from customer experience and own research activities at a hospital. Geared towards subsequent practical use, this approach led to a concept that offers a completely new combination of functions. "Users are able to complete medical examinations much quicker and more efficient without having to worry about all the paperwork." Open EDP interfaces ensure that the monitor can be connected to other devices and systems that are used to further process the data.
The new monitor is the first of its kind, monitoring traditional vital data (e.g. blood pressure, oxygen saturation, pulse and temperature) and body composition (e.g. body fat, muscle mass and body water) using bioelectrical impedance analysis (BIA). Combining the data on body composition and vital information allows a much quicker and precise determination of the patients health and nutrition status than just looking at vital signs and body mass indicies. "Such a development requires understanding the user environment down to the very last detail," says Friedel. "You need to know what purpose the device serves and who uses it under which circumstances. So it is not about adding more and more functions to a device, but about developing a work process using the device."
Process-oriented working in a network
The monitors were equipped with a software that assists users in completing entire workflows, displaying the steps required for recording patient information on the monitor. This computer-aided recording of the patient's medical history and the related data is then used as the basis for further processes - for example in combination with additional connected medical technology products. Friedel emphasizes, "Our achievement in this process is based on the fact that, together with seca, we succeeded in transforming an idea into a product within a matter of about one and a half years. The result is a reliable and certified solution that brings software and design together."
In the challenging field of medical technology, there is a high demand for tailored solutions that match the company's corporate identity, a fact that has also been recognized by steute Schaltgeräte GmbH & Co. KG from Löhne. According to Julia Mönks, Product Manager for Human-Computer Interaction (HCI), "medical devices must be intuitive in order to ensure that doctors and staff are able to fully concentrate on the patient and the surgery they are performing." In addition, the devices must comply with very strict safety and hygiene requirements. One example of this are foot pedals that can be cleaned easily and reliably.
Steute's Meditec business field offers a broad range of control units and systems for this purpose that meet the highest standards for quality and usability and that are certified in accordance with the Medical Devices Directive 93/42/EEC. "Ergonomic comfort, meaning intuitive operation, takes top priority in developing the control units," says Mönks. But the hygienic design of the operating elements is equally important, meaning that frequent cleaning and disinfection cycles should not reduce the device's service life.
The Löhne-based company offers standard devices for a wide range of applications or for specific fields of application such as laser surgery, ophthalmology and diagnostic imaging (X-ray, MRI, CT). Steute also works in close cooperation with customers to develop tailor-made control units for applications with special requirements. "The demand for wireless technologies is increasing in both areas," says Mönks.
By participating in several research projects on connected operating theaters and developing innovative control units, steute is also keeping a watchful eye on the future. For about three years, steute Meditec has been gearing its development activities towards the interoperability of medical devices, which enables controlling several devices at the same time via a shared user interface.
Networking becomes increasingly dynamic
"Several renowned manufacturers of medical devices are already using steute user interfaces in relevant projects and in demonstrations of interoperability capabilities in the operating theater," the product manager says. "Thanks to our user interface and integrated foot switch, we can reduce the amount of foot switches: instead of six to ten different foot switches the surgeon than has one integrated foot switch. The surgeon can simply select the device to be controlled via a touchscreen." In addition to offering greater ergonomic comfort and increased user friendliness, the interoperability of medical devices also provides a better overview in the operating room and increased hygiene, she adds. "This creates an important prerequisite for the continuous flow of information from medical devices to hospital information systems. And from our perspective, this is exactly what the near future holds for human-machine interfaces in the medical technology sector," Mönks summarizes.
Electronic and electromechanical components and modules, system components, subsystems and stand-alone platforms will continue to be the central topics for future medical technology. Fields of application range from traditional medical technology in hospitals to outpatient treatment and diagnostics systems up to ambient assisted living, life sciences and healthcare wearables.
Short and concise
Gold standard: The term gold standard comes from the financial sector and was used in the past to denote a monetary system in which the monetary unit was defined based on a fixed quantity of fine gold. The term has been adopted by other sectors over the past years. In medicine, the gold standard refers to a generally accepted practice, such as for treating diseases. It is the generally accepted and normative standard that sets the benchmark for all newly developed methods and treatments.