Bien-Air Surgery optimises its control efficiency with Ellistat's CES software solution 

Bien-Air Surgery, founded in 2000 and now part of the Swiss Bien-Air Group, specialises in the production of surgical instruments renowned for their exceptional precision and reliability. Used by surgeons all over the world, these instruments are dedicated to the most sensitive areas of the human body (otology and rhinology, cranial, spinal). In 2018, the company undertook a reorganisation to improve responsiveness and traceability and meet the growing demands for excellence in this cutting-edge sector. As part of a strategy to digitalise and redefine its processes, it is investing in production equipment and control. It chose the Ellistat software suite (CES and SPC modules), capable of managing all the controls linked to the validation of production batches and drastically reducing control times and returns to the workshop.

Bien-Air was founded in 1959 in Bienne by David Mosimann, a precision mechanic and entrepreneur at heart, specialising in rotary instruments used by dentists. An innovator, it created electric micro-motors that quickly became a great success. Since 1994, the company has been run by Vincent Mosimann, son of the founder, who continues the family spirit and remains faithful to the original philosophy of simplifying the work of practitioners. The know-how and cutting-edge technologies developed by the company are also proving useful in the manufacture of other medical instruments. In 2001, the company became the Bien-Air Group, comprising two separate entities: Bien-Air Dental (300 employees) and Bien-Air Surgery (100 employees).

The market for surgical instruments is largely occupied by large, internationally renowned groups. However, Bien-Air Surgery is well established in this market. It stands out for the flexibility of its size, the quality of its Swiss-made products, its cutting-edge after-sales service and, last but not least, its open and transparent communication.

As David Scarpino, joint managing director and operational director, explains: "Bien-Air Surgery's policy is to fully satisfy surgeons with high-quality tools. Of course, we provide every guarantee in terms of standards, with more than 10 audits every year. But innovation and cutting-edge technologies enable us to go even further and, for example, produce tools that don't heat up, don't vibrate, aren't noisy and have a life expectancy of 8 to 10 years.

The production site is equipped with around ten machining machine tools - machining centres, CNC lathes, bar turning machines - and the latest generation systems for checking parts (dynamic 3D vision, for example). As part of its process improvement and digitalisation drive, the company wanted to replace the three software packages it was using for incoming, in-process and outgoing workshop checks with a single package capable of managing all checks.

It is then necessary to check that the software meets the stringent standards imposed in the medical sector, particularly under the recent European MDR (Medical Device Regulation), with which all manufacturers will have to comply by May 2024 in order to be able to place their products on the market. The main areas of change, compared with the previous MDD, concern technical documentation, clinical evaluation and post-market clinical follow-up, as well as increased traceability of devices. The main objective is to ensure that nothing is delivered that poses a risk to patients. 

I'm very satisfied with the work we've done in partnership with Ellistat," comments David Scarpino. The flexibility of the software and the developments carried out by Davy Pillet's team mean that we can work with software that is perfectly adapted to our company's needs and not the other way round, which is a real luxury. We enjoy working with a young team that develops the latest generation of software, based on web technology. Their solutions are innovative, easy to use, modular and ergonomic. The team is attentive, responsive and always available, even though it is increasingly in demand due to its success. What's more, they take our requests into account when updating the software.

Developments are still underway, but Bien-Air Surgery has already seen a significant reduction in inspection time and also in the number of inspections. It has seen a gain of 10% in yield (or man capacity) and expects to achieve 30% in the short term. This is thanks to the use of a single software solution (instead of three) and the elimination/digitisation of manual operations. Not forgetting that, depending on the initial inspection results, Ellistat's CES module automatically adapts the number of inspections required to guarantee optimum results.  

To take this a step further, Bien-Air Surgery is deploying the SPC (Statistic Process Control) module from Ellistat's software suite, designed to monitor manufacturing processes in real time. The solution is also user-friendly and easy to use, particularly when it comes to setting parameters - and fortunately so, because the company produces around 5,000 surgical instruments. 

At this stage, Bien-Air Surgery has noted a reduction of 50% in workshop returns for quality problems. The company is aiming for a maximum of 2% when the developments become effective, and even 0% when the APC module of Ellistat (Automated Process Control), dedicated to the automatic correction of machine tools, is implemented. 

David Scarpino concludes: "In my opinion, if you want to optimise control efficiency in your company, the only software solution to use is Ellistat. This is thanks in particular to the artificial intelligence built into the software, which enables only what is necessary to be controlled automatically. If I had to do it all over again, I'd go back to Ellistat.