Innovative paths: Industry 4.0 as a catalyst for progress and efficiency

Digital twins act as virtual representations of physical systems, such as medical devices, and transmit data about these devices in real time to enable simulations and analyses. Cobots, so-called collaborative robots, are used in cooperation with medical staff and already provide support during operations, among other things. Modular production also plays a major role in the automation of processes in medical technology. The aim here is to become more efficient and flexible in the production of medical devices. This technology makes it possible to react more quickly to changing requirements.

How digital twins help with process optimization

Technical products used in medtech require highest quality, safety and proven benefits. The development of medical technology follows strict regulations. A digital twin helps with optimization. Digital twins of medical devices are a virtual replica or a digital prototype of the actual device that precisely reproduces all the important properties, functions and behaviors of the real device. This makes it possible to virtually test, analyze and optimize the device before it is actually manufactured or used.

Niklas Kuczaty, VDMA       © Team Uwe Nölke

This enables detailed simulation and analysis of production processes. In medical technology, this opens up a wide range of opportunities for fine-tuning and improving manufacturing processes. For example, precise simulation allows potential bottlenecks and sources of error to be identified and also enables parameters to be optimized for maximum efficiency. "One obvious advantage is the geometry," says Niklas Kuczaty, Managing Director of AG Medizintechnik at VDMA, the Medical technology network of the supplier industry. "How can I design the product? The medical professional has an idea, but it is often necessary to check beforehand whether the production technology is even available. Simulation is of course helpful for this. However, this requires greater cooperation between manufacturers, production technology suppliers and medical professionals, because the needs of medicine have to be compared with what is possible in terms of production technology."

Digital twins are not only used to optimize processes for one product. Production lines can also be planned based on digital twins. According to Stefan Pflaum, Head of Product & Lifecycle Excellence Global at Siemens Healthineers, digital twins of manufacturing processes are already being used successfully in many areas. For example, the new technology and production center for X-ray emitters and generators at their site in Forchheim was developed comprehensively on the basis of digital twins. This enabled the complex manufacturing processes to be optimized and coordinated in the computer even before the factory was built. Among other things, this allowed the space requirements of the production lines to be flexibly designed for the planned future capacities.

Stefan Pflaum, Siemens Healthineers

In addition, digital simulation, based on exact digital modeling of medical device functions in the computer, allows much more knowledge to be gained in a shorter period of time, which can be validated against reality to provide equivalent information. "On the one hand, this can shorten the development time of medical devices, bring valuable innovations to market faster and thus make them available to clinical users and ultimately patients earlier. On the other hand, fewer prototypes, samples, resources and materials are used during the development phase. This leads to a positive balance in development costs and greater sustainability while ensuring the highest quality," says Pflaum.

Another example is virtual sensing. "Vacuum ovens that heat the raw material to over 1,000 °C are used in an important cleaning step in production. Achieving the exact temperature is an important quality parameter. However, it is not economical to use a physical thermometer. Virtual sensing can be used during production to draw conclusions about the actual temperature reached by indirectly measuring the current and using a model," explains Dr. Oliver Welzel, Senior Key Expert Digital Twin Product Lifecycle Management at Siemens Healthineers. Virtual sensing works by analyzing existing data about a system and drawing conclusions from this data about unknown variables, such as temperature. This is usually done with the help of mathematical models or algorithms that describe the thermal behavior of the system. These models can take into account existing data and parameters such as ambient temperature, heat radiation, air flow and other influencing factors. This is usually done with the help of mathematical models or algorithms that describe the thermal behavior of the system. These models can take into account existing data and parameters such as ambient temperature, heat radiation, air flow and other influencing factors.

Dr. Oliver Welzel, Siemens Healthineers

Digital simulation, based on exact digital modeling of medical device functions in the computer, can provide much more knowledge in a shorter time, which can be validated against reality to provide equivalent information. "On the one hand, this can shorten the development time of medical devices, bring valuable innovations to the market faster and thus make them available to clinical users and ultimately patients earlier. On the other hand, fewer prototypes, samples, resources and materials are used during the development phase. This leads to a positive balance in development costs and greater sustainability while ensuring the highest quality," says Pflaum.

However, digital simulations are also very valuable after the development phase of medical devices. This is because many medical devices - especially large diagnostic devices - are usually still digitally networked with the manufacturer when they go into operation in hospitals or medical facilities. "This means that digital monitoring provides us with early indicators of malfunctions or the need to replace wearing parts," says Welzel. "With digital twins of the respective medical devices on site, we can carry out a fault analysis and an effective, efficient repair even faster, or proactively arrange a service appointment with the customer before a defect occurs and also plan the appointment in such a way that patient operations are disrupted as little as possible. This enables us to better ensure the availability of our products in hospitals and medical facilities."

From the development of new medical devices to the production of complex individual products, digital twins help to increase quality, shorten production times and optimize costs. This technological advancement not only promises improved performance in medical technology, but also paves the way for more precise and reliable solutions. Overall, the advancement of process optimization through digital twins enables a progressive development in medical technology from which both the industry and patients can benefit directly. And the application possibilities go far beyond the fields of use described: "Our so-called "Digital Transport Twin" allows us to identify the most cost-effective logistics route and means of transport based on customer orders and delivery commitments, thereby also optimizing the carbon footprint," says Pflaum.

Man and machine working together: cobots in medical technology

 The integration of collaborative robots, also known as cobots, into medical technology marks a groundbreaking advance for the industry. Cobots enable safe collaboration between humans and machines, and their areas of application extend across the entire field of medical production and research. A distinction is made between robots that perform medical activities - they are a medical device - and robots that assist in the production of medical devices. The latter do not require certification.

In manufacturing, cobots help to automate repetitive tasks, which not only increases efficiency but also improves the working environment for staff. "Areas of application can include lifting heavy components or assembling very small elements. Monotonous tasks are also suitable for the cobot in production: Anything where a part has to be placed from A to B several times for hours on end, as well as tasks that do not require constant human intervention," says Kuczaty.

Jennifer Schlichting, Stäubli Tec-Systems  © Stäubli

As a medical device, cobots show their potential when performing precise and sensitive tasks, again supported by human control. For example, in surgery, where cobots can position instruments or aids very precisely. According to Jennifer Schlichting, Business Developer Medical Robotics at Stäubli Tec-Systems, their robots can achieve an accuracy of 0.3 mm - something that a human cannot achieve, as even with high concentration their hands always tremble slightly. "This benefits patients because it results in fewer complications, less pain and faster recovery," says Schlichting. "Robots can also be used for imaging, for example by connecting high-resolution camera systems to the robot. The Stäubli robot was connected to a camera by the BHS company from Innsbruck, making it easier for doctors to see into the surgical field without having to bend forward."

In the operating room, the robot can then move to a position very precisely. This position can be checked using a navigation system and combined with imaging such as an X-ray system or ultrasound system. The medical staff can therefore specify exactly at which angle which point should be approached and control or monitor this using imaging. "Robots receive the target coordinates and can then automatically follow the sequence of movements, such as the exact placement of a biopsy channel, so that the medical staff only have to place the needle," explains Schlichting. This position can be checked using a navigation system and combined with imaging such as an X-ray system or ultrasound system. The medical staff can therefore specify exactly at which angle which point should be approached and control or monitor this using imaging. "Robots receive the target coordinates and can then automatically follow the sequence of movements, such as the exact placement of a biopsy channel, so that the medical staff only have to place the needle," explains Schlichting.

Cobots can be equipped with various sensors: For example, with force-torque sensors that enable the user to move the robot to a certain point by hand or to position an instrument on an exact line a little further back or further forward, as is the case with the robot from Stäubli Tec-Systems. In addition to their "eyes", their camera, robots as medical devices will also have a sense of touch in the future. In recent years, the start-up company SURAG, a spin-off from Magdeburg University Hospital, has developed a system that uses vibration to support navigation during needle interventions. For example, in the case of epidural or spinal anesthesia without imaging, the needle must be inserted into an area of the spine where many nerve tracts run and where there are other anatomical structures that should not be injured. It takes a great deal of experience and practice for a doctor to be able to do this. "Vibrations are generated when a needle interacts with tissue. Each layer of tissue has different mechanical properties, so each layer generates a different vibration when you pierce it with the needle. We have therefore developed a sensor that is so sensitive that it can detect and interpret vibrations that humans do not perceive. It can then provide feedback on which structure you have reached. This could be the spinal space, for example. It is surrounded by a layer that generates a certain type of vibration," says Moritz Spiller, CEO at SURAG.

Moritz Spiller, SURAG

This sensor technology is suitable for neurology or anesthesia. The aim is to reduce the number of puncture attempts and save time. In some cases, for example, a CT image has to be taken, which is not part of the hospital's schedule and also incurs additional costs. "There are already many robots with image recognition algorithms that are being used in various areas. A camera may have 120 images per second, whereas our touch technology can capture 44,000 values per second. This allows processes to be recorded that are not visible. The hardware requirements are minimal and the amount of data to be processed is also small compared to HD video," says Spiller. There have already been attempts with Da Vinci, the world's most frequently used robot-assisted surgical system. In the future, SURAG's sensor technology will autonomously detect pulsating blood vessels that are currently difficult to recognize for the surgeon. In open surgery, this was previously felt with the hands before cutting, which is of course no longer possible with the robot without a sense of touch.

Last but not least, collaborative robots can take on a variety of tasks in medical rehabilitation. Here, cobots support medical professionals in carrying out various therapeutic exercises and activities for patients. Their precise and safe operation makes it possible to control movements and resistances accurately, which is particularly important when it comes to restoring muscle strength and mobility. Cobots also help to automate repetitive tasks in rehabilitation, relieving the burden on medical staff and allowing them to focus more on the individual needs of patients. They can also be used as assistance devices to help patients manage their everyday lives, for example when walking or gripping objects. "In rehabilitation, for example, a robot can help to bring a glass to the mouth if a patient can no longer do this themselves," says Schlichting. Overall, cobots help to increase the effectiveness and efficiency of medical rehabilitation and enable patients to improve their recovery and quality of life.

The flexibility and extremely high accuracy of cobots therefore enable them to adapt to changing requirements in many medical fields, which is of crucial importance in dynamic medical technology. In addition, their use in long operations offers the advantage of reducing break times, as the machine has a constant "concentration".

These collaborative robots therefore not only help to increase efficiency, but also open up new horizons for innovative solutions in medical technology. Their use promises a transformative development that will steer the industry towards advanced technologies and patient-centered innovations.

Modular manufacturing processes for more efficiency and flexibility

The introduction of modular manufacturing processes in medical technology ensures more efficient and flexible production processes. By using such manufacturing technologies, companies in the industry can react more quickly to changing requirements. Modularity allows individual components to be flexibly combined and adapted, which improves adaptability to individual customer requirements. According to media reports, for example, the coronavirus pandemic has increased the need to manufacture disposable products such as pipette tips as efficiently as possible. As a specialist in automation, MA Micro Automation GmbH has therefore launched a modular solution for up to 64 cavities: the Centauri IVD. In 24/7 operation, machine downtimes can be avoided. MA Micro Automation is currently expanding several of these automation lines for the USA and also plans to serve the Asian market.

"In metal processing, let's say in the manufacture of implants, the quantities are relatively small. And a modular production line also makes sense for personalized medical technology, when the product is tailored to the patient," says Niklas Kuczaty. A lot is conceivable with modular production lines - but in the end, of course, it also has to be economical. A production line like this is more economically viable in the automotive industry, where much higher quantities are produced. "Most of the costs in medical technology are in certification and not in production - so saving a few cents in production often doesn't add much value. Although manufacturers want to become more automated, it often doesn't pay off. 

According to Trumpf, one of the technology leaders in machine tools, medical technology manufacturers face enormous challenges in terms of production conditions and legal regulations. Among other things, this is due to the very high quality standards, as patient safety is naturally the top priority in this industry. And since the introduction of directives such as the MDR (Medical Device Regulation), the development of medical devices has become even more complicated. According to the online magazine healthcare-digital, this means more work for device manufacturers, particularly in terms of documentation and approval. The team at Solectrix, a design house for embedded systems, has therefore decided to increasingly rely on a modular system approach for the development of medical devices in future. System development will be carried out on the basis of modular individual systems. The primary aim is to reduce development time and costs in the interests of the customer. The results of this strategy are extremely convincing, such as the development of the first lateral flow test devices, mobile IPL (Intense Pulsed Light) devices and other versatile medical tablet applications.

The basic idea of such a modular system is based on so-called "building blocks". These are independent modules with specific functions. In addition to the purely technical implementation in hardware and software, all regulatory requirements must be recorded for each of these blocks from the outset, suitable measures implemented and the technical documentation created. Each of these "building blocks" must be comprehensively specified and, above all, verified.

This development benefits medical technology where precision and customized solutions are of crucial importance. These advances promise an accelerated market launch of new technologies and products. Overall, the integration of modular production technologies in some areas represents a significant step.

Synergies and outlook for the future

All these combined technologies not only open up more efficient production paths, but also shape the future of the industry. The integration of modular processes enables flexible adjustments and accelerated development cycles, while digital twins and simulations optimize precision and quality. Cobots are setting new standards in collaborative cooperation between man and machine, revolutionizing manufacturing and research processes.

A look into the future shows that the synergies of these technologies will not only reduce costs, but also make medical technology faster and more innovative. This combination promises progress in patient care and accelerated development of new technologies.

"The latest developments in automation in medical technology will also be of great importance at this year's MedtecLIVE from June 18 to 20 in Stuttgart. Technologies such as robotics are crucial for the further development of the industry. At MedtecLIVE, experts, companies and innovators will come together to discuss the potential of these developments and present solutions. This event offers an opportunity to look into the future of medical technology," says Christopher Boss, Managing Director of MedtecLIVE.

Christopher Boss, MedtecLIVE

Overall, these approaches will make medical technology more effective, precise and patient-oriented, which represents a promising outlook for future developments in Industry 4.0.