Bertrand Bordes: Integration into the Elkem group has been the occasion to reinforce our commitment to the healthcare market and our focus on customers. To ease their registration process, we are extending the number of our ISO 13485-certified sites, eventually covering all sites manufacturing medical-grade materials worldwide. We are also enlarging our regulatory team with local medical toxicologists and addressing with our customers the changes included in the latest ISO 10993 regulation, which aims at further limiting animal testing, and reinforces the chemical and physical evaluation of devices and materials. The safety for our employees, customers and end users, along with the involvement of all people - whether colleagues, customers or other stakeholders - are values strongly rooted in Elkem's DNA and strategic roadmap.
Not at all. We take time to understand our customers and their businesses; we acknowledge their constraints and identify opportunities for them to differentiate and grow. At a time when many companies, including in the healthcare sector, experience difficulties in sourcing their silicone materials, we continue to support existing and new customers by providing them with not only volumes, but with dedicated solutions, including technical studies, customised supply chain options and exclusive product references to enable them to implement their strategy.
For example, companies come to us with a request to re-engineer our wound-care, soft-skin adhesives in order to bring the improved wound healing associated with silicone technology to eye patches, first-aid bandages and wearable devices. We grasped the need for longer wear time, competitive manufacturing costs and breathable substrates, such as non-wovens. This resulted in the launch of Silbione RT GEL 4743 this year, which has various customisation options in terms of manufacturing and performance.
We certainly are, and have previously announced injection-grade, moulding-grade, compression-grade and extrusion-grade materials for over-30-days implantation under the Silbione Biomedical brand, all backed by master access files on file with US FDA. We continue to develop our offering by introducing, during MDM Minneapolis and Compamed, a latest-generation curable adhesive, Silbione Biomedical ADH1 M200. As usual, we have taken the opportunity with this development to not only provide an alternative material for companies that manufacture pacemakers, pacing leads and general devices for 30-days-or-more implantation, but to also provide them with an advanced solution. M200 is tin free, and though we are aware the regulatory bodies have validated devices using tin-catalysed silicones, we believe that a tin-free solution will help more patients benefit from such systems in the future. M200 is also faster to cure, and helps manufacturers to expand their options and business.
More customers and third-party audits have now confirmed that our South Carolina facility in the US - which manufactures all Elkem Biomedical-grade silicone materials following Elkem Silicones' quality management system and clean operation standard, which adhere to GMP and ISO 14949 guidelines - will enable implantable device manufacturers to meet the highest patient safety standards today and tomorrow.
Improving the outcome for patients is at the core of working in healthcare. We see the potential for mass customisation provided by additive manufacturing as a game-changer in this direction, and we take it as our responsibility to help bring this benefit to soft materials. We demonstrated the possibility to print medicalgrade silicone materials during the 'Rapid.Tech' and '3D Print' trade shows. In our case, we start from the material validated for long-term implantation and supported by master access file, and we discuss with machine and component manufacturers so as to be able to print it with no compromise on the accuracy of the part. Part of this work is supported by FASSIL cluster project. This will be for the benefit of our customers, as Elkem will remain a rawmaterial supplier for this application.
To discuss your projects and see how Elkem can help, come to its booth during Compamed, 13-16 November in Dusseldorf, Germany, Hall 8b booth C25.