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When the maXYmos TL ML launched in May 2020, it entered the market as possibly the most advanced process monitoring and audit compliance technological device in the industry. With the tool offering extensive utility to manufacturers in the industry, it has grown particularly popular. Kistler, the manufacturer of the maXYmos TL ML, is moving forward in their vision towards efficient process monitoring, introducing new updates to improve the maXYmos TL ML’s functionality.
The maXYmos TL ML is a process monitoring tool that effectively meets Medtech’s regulatory requirements for quality assurance. It employs the process monitoring philosophy, ensuring that products are checked and validated throughout the manufacturing process. Based on the maXYmos TL (Top Level) system that already runs on other devices in the maXYmos family, the maXYmos TL ML visualizes process profiles for each manufactured device and offers a variety of interfaces where manufacturers can connect sensors.
With its sensors in place, the maXYmos TL ML integrates directly into the production line to monitor and evaluate the quality of each manufacturing step based on a curve. By monitoring and evaluating products on a step-by-step basis, the maXYmos TL ML can evaluate the entire product seamlessly and in real time.
The maXYmos TL ML is also adaptable to a variety of tasks. The Evaluation Objects (EOs) functionality allows users to modify or adapt the curve evaluation to specific monitoring tasks. By allowing users to specify monitoring specifications on a case-by-case basis, the maXYmos TL ML allows users to follow unique industry product standards. The maXYmos TL ML can be qualified for various products, enhancing its cross-cutting usability.
Each medical device manufacturer must meet important regulatory standards – they need to prove that they have a working quality management system, ensure that their products meet safety and quality standards, verify their suppliers’ quality management systems, and provide proof of quality assurance for all their tools, machine, and manufacturing process.
The new maXYmos TL ML continues in line with its predecessor’s strict guidelines of the FDA (U.S. Food and Drug Administration) and MDR (Medical Device Reporting) regulations. A collaborative effort between Kistler and partners in mechanical engineering and plant construction, the new release – the maXYmos TL ML 1.8 – offers important updates to both improve regulatory compliance and facilitate better process monitoring. Among the new features are the following:
New sensitivity correction functionality
Due to a number of reasons, measured values in systems tend to deviate from real-life values. This may arise due to the way sensors are mounted in machines, interferences from the internal environment of the machines, or adjacent cables. In medical devices where minute differences are significant, such discrepancies can lead to product quality and utility issues.
Because of how measured values can tend to deviate from real-life values, the Kistler 1.8 offers a sensitivity correction feature. Sensitivity correction on the maXYmos TL ML 1.8 compensates for the biasing factors in medical devices, allowing users to define up to 31 support points representing a real force’s swing. Users can then compare their results with those from the force sensors. From these measurements, users can fine-tune force ranges and match measurements to the actual environment.
Enhanced audit trail function
With end-to-end traceability of the manufacturing process as a further requirement in Medtech regulation, performing a seamless audit trail is an excellent advantage. Version 1.8 of the maXYmos TL ML features a revised audit trail functionality to improve tracking of product development. At the sensor level, the maXYmos TL ML 1.8 monitors and records all changes to the testing device, automatically indexing the time and user. The improved audit trail function allows for the mandatory archiving of log files. Data can be exported to different file formats or printed. A convenient search and filter function is included in the maXYmos TL ML, allowing authorized staff to quickly find who changed what, when they made the change, and why. Access to the audit trail is also restricted to users with administrator rights, ensuring a high level of security.
Master administration system
With each machine at a plant often demanding separate logins, getting access to monitoring for each device on an individual basis can be laborious. That’s why Kistler has developed and included an optimized log-in and administration system to go along with the maXYmos TL ML 1.8. With this master administration system, users can log into multiple machines at a plant with a single set of credentials. This makes the process smoother and more seamless, enhancing process monitoring with improved user convenience.
In the Medtech industry, quality assurance is an important aspect of the product pipeline. Multiple products are being developed every time, so keeping patient care as the primary focus requires deep work in understanding each product and ensuring it performs efficiently and consistently. Additionally, with new regulatory standards being developed and enforced across the industry to prioritize quality assurance, having a tech solution to make the process smooth is a breath of fresh air. According to Meticulous Research, the medical device testing market is growing at a pace of 4.7%, expected to reach $12.5 billion by 2027.
Typically, the quality assurance and design & development teams are separated in an organization, making real-time quality assurance difficult. That’s where a tool like the maXYmos TL ML comes in. With tools like the maXYmos TL ML, there’s no need to restrict quality assurance to a few random products at the end of the product development cycle. Kistler’s maXYmos TL ML ensures that product optimization is hard baked into the entire manufacturing process so that each product that emerges from the plant is 100% assured to be of the highest quality.
With less than one month to go, this is the best time to sign up for Med-Tech World! As part of SiGMA Group’s Malta Week, Med-Tech World 2022 will take place from 17 – 18 November at the Hilton Hotel in St Julian’s, Malta. For the latest updates, top-quality conferences and premium networking opportunities at the digital health summit of the year, register here.