May 29, 2017
Ask anyone in the medical device industry about validation, and they would stress the importance. This is not any less true for Elos Medtech. Over the years, automation and robotics have become an increasingly important part of our production. One of our investments is our automated camera equipment for measuring dental components. This piece of equipment snaps about eight pictures per second and helps us meet today’s high demands for detailed documentation and validation.
Let us begin with some background information to our automated camera equipment investment: In 2010, we made a strategic decision to move part of our turnover to China, where we established a new production site. At the same time, we took the opportunity to invest in automation and robotics as part of our strategy to drive innovation forward and meet the demands of the market, creating value for our customers.
We also saw an increasing demand among our customers for producing a wider range of medical devices in smaller batches. In a short period of time, we moved from having high production volumes and a small number of large batches, to having low production volumes and a large number of small batches.
This led us to rethink our entire production approach. We thought: If we are about to automate our production processes, it is not realistic to invest in dedicated robot cells for each process. Ultimately, we should invest in a system that is standardised – yet highly flexible.
Said and done! The solution was a modular system with standard workbenches where tools, robots and machines easily could be configured to carry out different tasks from day to day. The results spoke for themselves: We managed to double the number of efficient production hours!
But what we also found, was that automating our production and having robots carrying out the work instead of humans, meant that we could also validate our production processes by automating the inspections of the produced components. Unlike with manual inspections, it was possible to inspect all of the components, not only random samples.
This was a true advantage for our customers! Manual inspections are not only time consuming and costly, but there is also the risk of human error. With automated inspections, however, it is possible to improve the validation of the produced components and increase patient safety.
One of our investments in automation and robotics was our automated camera equipment. Before making the investment, we did careful research spending one year of scouting for the best solution on the market to fit our needs and another year of testing the camera. It was not until last spring that we started using the camera in production.
Today, we use the camera to inspect dental components as part of our validation process. The camera is used on a limited on limited number of components. The camera is mounted on top of a turning machine that has a built-in standardised robot as well as a cleaning system. The components are transported from the turning machine to the cleaning system, where they are cleaned from oil residues, and then presented to the camera.
The camera takes about eight pictures per second, and each picture is used to measure the outer dimensions of a component. The average value of all of the eight measurements is then calculated. If the dimensions are not approved, the component is automatically rejected. If there are several rejected components in a row, the machine stops. The measurement data is registered and stored in our quality system where we keep statistics over the validation process.
With our automated camera equipment, we are able to meet the increasing market demands for detailed documentation and validation of medical components. By replacing manual inspections with automated inspections, we will be able to replace random samples with between 50 and 80 percent. Moreover, our customer can be sure that their components are 100 percent inspected. This means not only improved validation of the components but also reduced production costs, shorter lead times, faster time to market, and never the less, increased patient safety.
I think that in the future, the demands on validation will only increase. In a few years, it will probably be unthinkable that one person has ever stood beside a machine to do a manual inspection of the produced components! What do you think? Let me know in the comments!
Head of R&D
Elos Medtech Pinol A/S