High-quality transparent production of medical devices thanks to integrated process monitoring from Kistler

Winterthur, October 2020 – Application-specific solutions from Kistler help medtech manufacturers to combine the very highest quality with maximum cost efficiency. Precise data from sensors provides the basis for optimizing production processes while ensuring compliance with the industry's regulatory requirements and delivering the necessary transparency.

Manufacturers of medtech devices find that their production lines must simultaneously meet a diverse set of requirements and expectations. The healthcare sector is witnessing a growing trend towards self-administration of medications – especially among patients with chronic conditions. For a long time already, standard treatments have included combination drug-device products consisting of the medication together with the medtech device: insulin pens and inhalers are just two examples. This requires manufacturers to produce devices that can be relied on to operate safely. But at the same time, they are confronted with fierce competitive pressure in the growth market for self-medication. There are also some pharmaceutical companies who aim to step up their production massively and rapidly so they are ready to meet demand on the same day as the medication gains approval. Their sights are fixed on recouping the millions they have already invested in research as quickly as possible, before patent protection expires. And last but by no means least, manufacturers are also under pressure from the authorization agencies. From 2021 onwards, for instance, the European Medical Device Regulation (MDR) obligates manufacturers to ensure end-to-end traceability of their medical devices throughout the entire supply chain. It is obvious that reliable data quality and complete documentation of all processes are crucial factors in meeting this requirement.

Process transparency and traceability are the top priorities

The coronavirus pandemic has ratcheted up the already high requirements for quality, productivity and cost-efficiency, confronting the industry with yet another set of hurdles. To take one particular example: manufacturers and suppliers of diagnostic tests found themselves faced with an abrupt upswing in demand for test kits, triggered by acute medical requirements and compounded by huge expectations on the part of the public. Florian Pichl, Strategic Business Development Manager Plastics at Kistler, explains: 'All of a sudden, manufacturers were required to complete process validation that would usually take months in a matter of just a few weeks.'

For instance, one manufacturer of kits for antibody tests faced a daunting challenge at shop-floor level: to step up production of test kits at speed, he had to call on several suppliers of plastic parts. ComoNeo, the process monitoring system from Kistler integrated directly in the production line, proved to be extremely helpful in this situation. It allows injection molding manufacturers to see what is happening as each individual part is being produced.

High-resolution sensors measure the cavity pressure – an informative variable that allows deviations in product quality to be identified at an early stage of the process. 'ComoNeo opens the way to zero-defect production, and it significantly boosts the overall efficiency of injection molding production,' Pichl notes. And with end-to-end documentation of the data, ComoNeo also meets the regulatory requirements for process transparency and traceability. 'All the suppliers used ComoNeo and the related sensor technology from Kistler; the same product specifications were available to them, and they all generated the same data quality – so the complete product met the applicable requirements.' In short: measurement technology from Kistler played a decisive part in enabling the manufacturers to meet the quality requirements and rapidly increase production volumes – despite the extraordinary pace.

Standard-compliant monitoring with maXYmos TL ML

When it comes to joining and assembling the finished single parts, manufacturers can count on a new process monitoring system that was recently added to Kistler's maXYmos family. maXYmos TL ML is an application-specific solution: the world's first process monitoring system that is specifically tailored to the strict quality assurance regulations in the medtech sector, enabling FDA- and MDR-compliant monitoring. Like ComoNeo, this new system offers the major benefit of speeding up processes. 'maXYmos TL ML makes it far easier to validate production processes,' Stephan Vogel, Business Development Manager at Kistler, explains. 'In the best-case scenario, 100 percent inspection of a manufacturing step can even eliminate the need for mandatory process validation in production.' The result: manufacturers can bring their products to market in considerably less time.

During discussions with manufacturers in recent months, the vital role that high-performance process monitoring can play in pandemic periods turned out: because of the widespread restrictions that were imposed, many production facilities were only allowed to operate with emergency staffing. But thanks to automated processes with transparency ensured by continuous monitoring, manufacturers were able to continue reliably producing parts of impeccable quality. 'Manufacturers have learned a lot about process monitoring of cavity pressure, and it will increasingly become a factor that makes them stand out from their competitors as time goes on,' Florian Pichl concludes. 'Experience has shown that the dynamic pace of development in this industry requires even greater efforts – pandemic or no pandemic!'