Meeting regulatory requirements while maintaining a high-quality, cost-efficient service
This month’s blog comes from Francesco Bucciotti, Managing Director at Lincotek Medical (former Surface Dynamics LLC).
8 July 2019
Nowadays, it is becoming more and more challenging to remain competitive as a contract manufacturer of medical devices. ‘Price containment’, ‘cost reduction’, ‘quality and regulatory pressure’, ‘competitive service’ and ‘fast delivery’ are key phrases of integrated supply chain requirements that original equipment manufacturers (OEMs) want from their suppliers as the level of integration increases.
We aim to be in a leadership position as a contract manufacturer for Plasma Spray Coatings and Direct Metal Laser Sintering (DMLS) of medical devices, as well as to expand our offerings via our one-stop shop solution. The latter enables our customers to have the entire supply chain managed by just one contract manufacturer.
To be in a leadership position means that we need to be the choice strategic partner for our OEM customers, not only offering them a high quality of service and a cost-efficient product-to-service ratio, but also maintain a level of profitability that guarantees our Company’s growth and ability to invest in capital expenditure, R&D and new technologies, people, etc. To achieve this, we continually focus on the following key areas: knowledge; people & connection with local communities; FDA, quality and regulatory.
As part of medical division of the Lincotek (former UnitedCoatings Group) we have more than 45 years of experience in Plasma Spray technologies. This extensive experience allows our engineers to support our customers, when it’s requested, with indications and suggestions about how to design devices to make them ‘coating friendly’. Moreover, we have a long experience in optimizing the protection of devices that cannot be coated with our own masking techniques, design and procuring the most appropriate materials.
We have the capability to use machines with proprietary technology that guarantees robust process control, process monitoring and robot technology to guarantee the repeatability of all our automatic processes. Deep process knowledge allows us to offer a wide range of coatings that can be sprayed on to a large variety of substrates (from metals to plastic and ceramics) with large-scale, cost controlled production and the possibility to be very competitive on the market. The breadth of our knowledge and experience is evident from the fact that there are over 20 Master Files in place with the FDA and over 100+ different devices supported by these documents.
In our Additive Manufacturing (DMLS) department we have a dedicated team of engineers that can help our OEM customers during the device development phase according to the principles of design for additive manufacturing. This knowledge comes from more than 10 years of serial production of medical devices for OEMs within the medical division of Lincotek. In the past 6 months alone, we have helped different OEMs, of varying sizes, navigate through the FDA process by supporting them with validations and documents that address the FDA guidance document on Additive Manufacturing.
People & connection with local communities
We consider people our number one factor for success. We work in a niche market and with high tech manufacturing processes. Our Company invests significant energy in training all our new team members with the aim of reducing staff turnover to close to zero, even in a very competitive labor market like the USA. We have very specialist people working in production, with many of those with deep knowledge working in our Quality and Engineering department. Accountability and empowerment are key for our team. Since 2016, the American headcount has increased more than 100% and we are continuing to grow. Another strategic goal is to be very well connected with local communities in Tennessee and Ohio. particularly in Memphis, which is one of the largest medical and logistic districts in the world.
FDA, Quality and Regulatory
All our processes are designed to be ‘validation friendly’ and we have several Master Files for our coatings to help customers during the process of getting their product cleared by the FDA cleared or obtaining a CE Mark.
All of our products (coatings or devices printed with DMLS technology) and processes are in compliance with all FDA requirements. A cross-functional team within our Quality department continuously works across production and engineering to follow the customer’s parts on the floor during the entire manufacturing cycle. Our Quality department is also responsible for the inspection of any raw materials we used and process monitoring testing.
We hope that by considering all of these key areas together, mixed with passion for what we do, we will give our OEM customers satisfaction and ultimately, improve the quality of life of their device users more and more every day.
Please Contact Us to find out more about our US facilities.