How Komax Medtech became a leader in production solutions for medical devices
The site in La Chaux-de-Fonds, Switzerland is the headquarters of Komax Medtech (a division of the Komax Group) and leads a team of over 330 employees at production sites located in Europe, Asia, and North America. Our origins go back to 1964, when Ismeca SA was founded by Jean-Pierre Pellaton with the mission to provide precision assembly and production tools for the watch industry. As our success grew during those early years we began to provide more and more automated production solutions – not only for watches but for motors, electronic connectors, and other devices. Our product line changed dramatically in 1973 when our main market collapsed with the arrival of the quartz watch. Ismeca responded by creating a line of products for the new industry of microelectronic manufacturing. We were soon providing systems to test, sort and package semi-conductors and other electronic components all over the world. Ismeca grew over the next twenty years through two activities – semiconductor handling, and automatic assembly.
In 2001 the company split in two, with the semiconductor and assembly automation business units becoming separate entities. At that time our assembly automation business provided equipment into many industries, including automotive, electrical goods, and healthcare. In 2005 Ismeca Automation joined the Komax Group – becoming the headquarters of the Medtech division in 2009. The many challenges of medtech
Our focus on medical devices began nearly two decades ago. We had realized that serving the needs of pharma and medical device manufacturers required highly specialized knowledge and adherence to standards that goes well beyond what is needed in other industries. We’ve since structured our products, our procedures, and our investments in research and development to meet the specific needs of this industry. Today medical devices represent the vast majority of our business, and Komax is among a handful of companies worldwide that are capable of engineering and manufacturing complete assembly lines for complex, high volume medical consumables such as insulin pens, inhalers, and diagnostic devices. Our employees have been trained on the laws and standards that govern medical device manufacturing, including adherence to FDA requirements (the US Food and Drug Administration) and our systems can be found in pharma and medical device factories all over the world.
With Komax, medical manufacturing companies can work with one automation supplier to provide solutions and support during the entire product development cycle. New devices always start as a “good idea” – a concept that must first be tested and refined before it can be brought to the market. Komax works extensively with our customers’ from the first design stages of a project, providing our know-how in high speed assembly and testing in order to benefit the overall development program. As the project progresses our involvement increases. We provide “Proof of Principal” studies, process qualification services, hand assembly tools for device field trials, semi-automatic (or low volume), and high volume production solutions. Komax has the experience and tools to serve our customers at every step in the process. Simultaneous engineering, together with ‘design for automation’ know-how, has lead to successful partnerships with many leading medical device suppliers.
Nearly every medical device assembled today has at least one manufacturing process that is critical to device quality. Processes can be either simple or complex, some examples include component feeding, UV curing, heat staking, and device testing. No matter the process, it will have variables (parameters) such as temperature, force, or time that need to be defined and often monitored. Process understand- ing is very often the key to successful high volume manufacturing and Komax takes special pride in having developed advanced know-how in many of the key processes related to medical device manufacturing. Our experience in areas such as needle feeding, needle coating, leak testing, and vision inspection allow us to provide our customers with robust, engineered solutions to the most challenging problems.
In the medical device world, even the best assembly machine can’t produce a device until it’s been validated – tested to provide documented proof that it meets the production specification. Komax understands this very basic premise, and has structured our company to insure that validation is at the very foundation of our engineering and project management processes. From day one our team is focused on understanding the whole picture – taking a GAMP (Good Automated Manufacturing Principles) based approach to all the steps involved in the creation of an assembly line. With our own staff of validation specialists working side by side with project managers, engineers, technicians and the customer, Komax insures the execution of all aspects of validation meets the customers’ requirements.
The costs to develop a new drug and its delivery system are measured in the hundreds of millions of Swiss Francs. When a product is finally ready to be put on the market the target is to amortize this investment as quickly as possible. Our customers look to serve as large a patient base as possible. As such, Komax needs to assure support for production sites that are located all over the world. Through the use of common standards used across all Komax Medtech factories we insure our service technicians will be able to work efficiently, no matter where the machines were produced or where they are installed. We provide not only emergency support, but long term service and maintenance services to our customers through our four production sites, and from other Komax Group sites (over 50 service points worldwide).
Personalising medical devices
The big trend in medical devices is the personalisation of medicine. Pressure is being put on healthcare spending by consumers and governments alike – and the biggest cost gains are being achieved by taking the treatment out of the hospital. The end result is that more and more treatments are being managed by the patient – self injection of many medicines, from drugs to treat diabetes, osteoporosis, and others is becoming the rule rather than the exception. In addition drug manufacturers are seeking to gain competitive advantage through user friendly and stylish devices that are personalized to different user groups. The result is a growing number of new devices being put on the market, and a continuing demand for automatic assembly lines to produce them. Komax Medtech is well placed to serve this dynamic and growing market through our four factories, a strong reputation and complete portfolio of assembly solutions.
En français dans le texte
De l’horlogerie à la médecine
A la Chaux-de-Fonds, l’ancienne Ismeca Automation, créée dans les années 60 pour servir l’industrie horlogère, est devenue le siège de Komax Medtech en 2009. L’entreprise s’est hissée parmi les leaders mondiaux dans la production de ligne d’assemblage automatisée pour l’industrie des technologies médicales grâce à ses savoir-faires mais aussi à la compréhension des besoins spécifiques de clients évoluant dans un environnement extrêmement régulé. Son activité est désormais dynamisée par les perspectives de personnalisation de la médecine qui va mettre plus de technologies médicales entre les mains des patients.