Thanks to the access to POR 2014-2020 ERDF / INNOVATION AND COMPETITIVENESS funds, in the year 2020 ENKI was able to develop and equip itself with several new equipment and capabilities.
The submitted project is as follows:
The objective of the project is to strengthen the company in order to support customers in their need to have production cycles in view of 4.0, to facilitate the validation/certification procedures; this in order to reduce time and difficulties in the realization of prototypes and then the last product, accompanied by the appropriate documentation to obtain registrations as medical devices at the various certification bodies and therefore in the timing of market penetration. In addition, it is fundamental for ENKI to implement production facilities that allow a greater understanding of the behavior of materials, both to be able to treat those of “greater use” in all phases: from characterization to preparation, from extrusion to couplings in assembly, and to be able to test new potentially higher performance and suitable for the increasingly restrictive standards of biocompatibility.
The expected results, from an Industry 4.0 point of view, are therefore:
- -acquire new 4.0 systems able to achieve the set objectives of greater flexibility and ease of production and testing on new materials
- implement the current systems with sensors suitable to provide the big data that will be collected and analyzed to provide the necessary implementation commands to reduce the defect in production and replace those in which upgrades are not possible;</p>
- implement component measurement and cataloguing systems to improve the coupling of the many components in the assembly of catheters or other complex medical devices</p>.
- obtain further process certifications necessary to meet the requirements of several customers with very high quality standards.
- greater control and reliability in the phase of manual production in series through the aid of augmented reality and viewers that allow “in-line” and live control of such productions
Specifically, they have been made and installed:
- New compounder that allows a much higher product quality together with a quadrupled productivity, with predisposition to the interconnection in 4.0 prospective.
- New stretch blow moulding balloon machine, and related systems, with predisposition to the interconnection in 4.0 prospective.
- Machine for UV cured coating of catheters, with predisposition for interconnection in 4.0 prospective.
- New ISO 6 clean room for the production of permanence implantable class 3 devices
- New ISO 7 clean room for prototyping and R&D activity.
Project amount € 330,000.00 – Granted or liquidated € 33,000.00.