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Process Validation

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Improved validation with automated camera equipment for measuring dental components

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.

Moving from manual labour towards automation and robotics

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.

Automated production processes allow for automated inspections

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.

Automated camera equipment for measuring dental components

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.

Meeting the market demands for detailed documentation and validation

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!

Also, read:

 

Swemac and the Hansson Pinloc System

Customer Case: Swemac and the Hansson Pinloc System

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Last year, we wrote a blog article about The Introduction of the Hansson Pin and the Olmed Screw, describing a pin and a screw that would improve the lives of patients suffering from femoral neck fractures. As you probably know, the development moves fast in the medtech industry. Since then, the Hansson Pin has gained further improvements, resulting in the Hansson Pinloc system. In this blog article, I will describe the Hansson Pinloc system and Elos Medtech’s involvement in the development process.  

Swemac offers solutions for fracture treatment and joint replacement

Swemac is a Swedish-based company, providing the medtech market with innovative and practical solutions for fracture treatment and joint replacement. The company dates back all the way to 1968 and has been developing and selling orthopaedic implants and medical equipment ever since. In addition, Swemac provides orthopaedic simulation training systems, as well as orthopaedic training programs that focus on surgical techniques and the characteristics of different orthopaedics implants. Swemac’s products aim to benefit the patients as well as professionals working with the implants. Quality, high performance and innovative competence were Swemac’s features in the past and most certainly will be in the future.

The Hansson Pinloc System is an evolution of the Hansson Pin System05

The Hansson Pin system was designed to offer secure, stable fixation for femoral neck fractures with reduced risk of healing complications, as well as to minimise surgical trauma to the patient. The Hansson Pin consists of two parts, an outer pin, and an inner sliding tongue. Fixation in the femoral head is achieved by pushing the inner sliding tongue out through the window of the outer pin. However, in some cases, the femoral head tilts back again to the same position it had during the fracture. This is the result of the screws not having the mechanical stability to allow the fracture to heal in its reduced position. To overcome the problem of fracture displacement after internal fixation, and still maintain the same features as the Hansson Pin System, Swemac designed the Hansson Pinloc System.

“When launching a new medical device, a successful cooperation with a development and production partner is crucial. To avoid bottlenecks and failure in deliveries, an optimal flow is required between the development phase, production phase and marketing phase. Basically, it all comes down to trust between the companies, says Lars Öster, responsible for Research and Development at Swemac.“  

High rotational stability with the Hansson Pinloc System

Skärmavbild 2016-11-24 kl. 14.48.15Swemac identified the need to further develop the Hansson Pin and make it even better, to provide the patients with even more benefits. Instead of the two isolated pins constituting the Hansson Pin, The Hansson Pinloc System consists of three Hansson Pins and a plate creating a dynamic unit, which has the ability to recreate the stability of an unbroken hip. The pins in the Hansson Pinloc System can not rotate in relation to each other, as often is the case when independent screws are used. This means that the femoral head can only rotate if the bone cuts through all pins simultaneously, which is very unlikely. Thus, the Hansson Pinloc System reduces the occurrences of complications during fracture healing and increases the quality of life for the patient.

Femoral neck fracture is a common fracture type,where around 30 to 40 % of the fractures are treated with osteosynthesis. The other 60 to 70 % are treated with arthroplasty. The surgery could result in symptoms like pain, limited ability to walk as well as tenderness. The Hansson Pinloc System aims to limit these symptoms to a minimum.

Elos Medtech started offering its expertise in the development phase

Swemac started collaborating with Elos Medtech early on in the development of the Hansson Pinloc System. Elos Medtech supported with production improvements to achieve an efficient and cost-effective manufacturing process. In addition, Elos Medtech was responsible for producing all the components, sterile validation, packaging and labelling the products. Elos Medtech was also Swemac’s development and production partner when manufacturing the Hansson Pin. Consequently, when manufacturing the Hansson Pinloc System, Elos Medtech contributed with an extensive understanding of the product, experience in producing similar devices as well as a unique know-how concerning the mounting, which was highly appreciated by Swemac.

Swemac puts high demands on a development and production partner

There were a lot of parameters Swemac took into consideration when choosing a development and production partner. High quality was on top of the agenda, as well as the prize, flexibility and delivery precision.

“I feel very safe letting Elos Medtech produce our products, and I have great confidence in them as our development and production partner. The manufacturing process was built on an open and tight dialogue between Swemac and Elos Medtech. Not all partners live up to the high level that Elos Medtech does, says Lars Öster, responsible for Research and Development at Swemac.“          

Elos Medtech is responsive to customer requirements

The medtech industry is characterised by tough competition and high-quality demands. Elos Medtech is an experienced and confident development and production partner, responsive to the customers’ requirements and market demands. On short notice, we manufacture products based on given specifications. We offer a unique flexibility during the design phase, which is highly appreciated by our customers. We provide valid and reliable instruments and products for clinical situations, and we take responsibility for your products throughout their entire lifecycles.

Are you more curious about the Hansson Pinloc System, or want to know more about Elos Medtech? Contact me directly or visit our website for more information. Don’t forget to visit Elos Medtech’s Blog for more interesting blog articles.