Wolfgang Renner
Heads the health market and medical technology department of KUMAVISION and is also responsible for quality management in this function
Not every Internet of Things application is highly complex. These use cases show how medical device manufacturers can cleverly solve industry-specific problems in manageable IoT projects - for example, when they monitor the particle density in clean rooms with IoT support, document storage and transport conditions, or develop new service offerings.
Many medical products and medical technology devices are manufactured or processed in clean rooms. The documentation of the production and environmental conditions in the clean room is an integral part of quality assurance. These include, for example, monitoring room temperature, humidity and, above all, particle density. The DIN EN ISO14644 standard distinguishes between nine classes. In the highest class, ISO1, only a maximum of 10 particles with a size of 0,1 microns are permitted per cubic meter of air. For comparison: a human hair is about 500 times thicker. Manufacturers use particle counters to measure the particle density. The measuring devices continuously check the air in the clean room and save the measured values on the device. Typical portable particle counters take 10.000 or more readings. Optionally, the devices print out the measured values as standard-compliant reports on paper. In both cases, there is a media break from the point of view of IT. Because the measured values have to be assigned manually to the respective production orders, for example in order to be able to prove compliance with the environmental conditions in the event of complaints.
Automated acquisition of measured values
With IoT-based sensors, the particle density and other measured values can be continuously recorded and logged. At the same time, they are transmitted to the ERP software via the Internet of Things and stored with the production order. Quality assurance in the company is relieved of routine tasks that are sometimes prone to errors and can prove compliance with the relevant standards, such as those required by the Medical Device Regulation (MDR) or Good Manufacturer Practice (GMP), at the push of a button during audits. If a customer complains about a product, customer service is able to identify the product in the ERP software using the serial number and call up the environmental conditions at the time. It is also possible, for example, when the delivery notes are printed by the ERP software, to automatically create a standard-compliant log of the environmental conditions during the manufacture of the item. Another advantage: If limit values are exceeded, the employees in the clean room can be notified in real time and production management and quality assurance can be informed via a reporting chain in order to eliminate the causes. In the same way as in the clean room, the machining processes of CNC machines or 3D printers can also be recorded - including exact accounting according to the actual material and time expenditure and standard-compliant documentation of the materials used (RoHS/REACH).
Transport and storage conditions
IoT-based transport loggers enable end-to-end monitoring of logistics processes. The compact devices have a GSM modem and transmit the measured values to manufacturers or carriers via mobile communications. In addition to temperature or humidity, particularly sensitive medical devices can also be used to monitor vibrations and shocks. In this scenario, too, the measured values are transferred to the ERP software and automatically assigned to the respective product or batch. If the service technician puts a device into operation, he can see in the electronic device file on his tablet whether the specified transport conditions have been complied with. In the event of major deviations, automated workflows could be triggered that lock the device in the ERP software or notify the recipient by email.
New digital business models
More and more companies no longer sell devices and machines, but offer their functions as a service. Then the medical technology device is in the clinic or practice. However, these are no longer the owners of the devices, but pay per operation or examination. The manufacturer or service provider takes over the technical service and the delivery of consumables via automated workflows, which are triggered by the operating data transmitted via IoT. A wide range of billing models is possible, ranging from flat rate subscriptions and prepaid cost models to pay-per-use scenarios. Billing can be based on processes created, units produced, hours of operation performed or consumption.
Supported Service Processes
Equipping devices with networked sensors also simplifies service - keyword predictive maintenance. If the operating times, useful times or the volume of a device exceeds a limit value, this can indicate impending failures. IoT solutions embedded in workflows help to notify qualified service technicians when limit values are exceeded, and at the same time to create a service order in the ERP software, to order the required material from the warehouse and to initiate route planning. The use is also documented digitally - including photos, digital signature and transmission of the required spare parts and working times to the ERP software for billing and tracking in the device file. The product management receives anonymous data about the behavior of the devices in practice, which provide information for the prescribed post-market surveillance as well as optimization and further development.
additive manufacturing
Additive manufacturing with 3D printers offers the opportunity to produce individual medical products such as implants, prostheses or aids quickly and, above all, economically. IoT makes it possible to seamlessly map the entire process from measurement to production to use. Whether exact billing according to actual material and time expenditure, standard-compliant documentation of the materials used (RoHS/REACH) or automatic reminders of inspection dates: medical technology manufacturers are able to control the entire product life cycle efficiently and within one software environment.
Universal technology platform
In order to implement IoT-based use cases, KUMAVISION relies on the Microsoft technology platform Microsoft Dynamics 365. The globally unique offer provides all relevant business applications such as ERP, IoT, Business Intelligence CRM for sales, service and marketing, Office and Azure Cloud-Services for artificial intelligence, deep learning and big data on a unified platform. The advantage for customers: consistent processes, no data silos and therefore no problems with interfaces. Companies can thus fully concentrate on the implementation of ideas and business processes.
Flexible problem solvers
IoT-based processes are recommended as versatile problem solvers: They relieve employees of time-consuming routine tasks, increase process reliability and lay the foundation for complete traceability. The Microsoft technology platform Dynamics 365 enables seamless IoT integration into the digital architecture and processes of your company and ultimately increases efficiency. We would be happy to advise you and show you how to profitably network IoT, ERP, CRM and other solutions based on your specific requirements.
