Processo Produttivo
Research and development
The critical factors in the success of the El.En. Group are the adequacy of the range of products which we offer and the capacity to innovate it continually in order to meet the requirements of the market and create new ones.
The position of the Group for hi-tech products and the global competitive context in which it operates comports a continuous and significant effort in terms of research and development of new products and new technologies; our strong point is the capacity to be single minded, to innovate considering the requirements of the doctor and the patient in the medical sector rather than the client in the industrial sector, starting with every intuition which may arise from the close and constant observation of problems that have not yet been solved.
It is the skills we have acquired and the enthusiasm of our employees that make the real difference; The El.En. Group and the people who work there in fact, possess a knowledge of physical, biomedical and technological phenomena that has evolved in almost forty years of experience and which is conducive to a great capacity for innovating one’s know-how, the production technologies, the processes, the products and the related services.
The Group organizes its activity of research and development according to mid- to long-term programs in order to prepare quickly and continuously products that are innovative in their performance and applications.
In our research activities conducted in our laboratories, as well as that made in collaboration with important research centers, hospitals and universities, both at a national and international level, we set no limits since we are driven by the desire and the passion for everything that is new or can become new. The kind of research that is conducted is of the applied type for most of the activities while it is theoretical for some specific subjects, usually related to activities regarding mid- to long-term innovative objectives.
The El.En. Group’s capacity for innovation is demonstrated also by the numerous patents that the Group has filed. In less than forty years they have filed 128 patents while at this time they have more than 80 pending.
Quality and safety of our products
The Group is aware that the complexity of its business requires high qualitative standards and for this reason the commitment that we have and we promote for the quality and safety of our products is essential in order to guarantee continued growth and success. We have always focused on the phases of design and development of our systems; in fact, our value is created through the study and application of methods that are increasingly selective, effective and safe.
Every day we are committed to supplying products of value to our clients in such a way as to create loyalty that is based on quality, reliability and safety and to guarantee these requirements for the product are recognized and appreciated and that every measure be adopted to make sure that they are in conformity with the law.
To this purpose, some companies of the Group have equipped themselves with an Integrated Management System Manual which is in compliance with TUSSL n. 81 of 2008, to describe the objectives and the policies of the Management System for Quality and the ways in which it should be applied. The manual defines the general criteria needed to satisfy the requirements for safety and performance of products during their entire life cycle, as well as the services supplied.
Depending on the geographic area in which they are located and the type of business they run, the different companies of the Group comply with the standards and regulations shown below.
ISO 9001;
ISO 13485 relative to quality control systems for medical devices
European directive MDD93/42/EEC (Medical Devices Directive);
National laws of the countries that are members of EU and the non-European countries like the United States of America(21CFR820/803/806), Japan, China (CCC- Certification for electronic components and Enterprise standard “CNC laser cutting machine”) and Brazil.
During the last two years, El.En. S.p.A., Deka Mela S.r.l., Quanta System S.p.A., Asclepion GmbH and ASA S.r.l. obtained the MDSAP (Medical Device Single Audit Program) certification. This certification makes it possible for institutions that are recognized and accredited by the Regulating Authorities of the five member nations (U.S.A., Canada, Brazil, Japan and Australia) to conduct a single audit for medical devices at the factory in order to verify that they satisfy the ISO 13485 requisites and the national deviations of the specific countries.
These same companies are now getting organized so that they can obtain the EU certification according to attachment IX of the new European Regulations regarding medical devices, UE 2017/745 MDR. This certification, which will enter into force before mid- 2021, will definitively replace the preceding Directive 93/42/ECC, which, in any case, will remain valid until 2024.
The new regulation will include severe and stringent requirements in relation to:
- Clinical evaluations of medical devices with demonstration of their clinical effectiveness through research or analysis of the available bibliography of similar products;
- Reprocessing of the medical devices (cleaning, disinfecting, sterilization, etc.)
- Post market surveillance (PMS) (identification of accidents and adverse events on the market);
- Post market clinical follow up (PMCF) (periodic re-evaluation of the safety and clinical effectiveness of the device).
Moreover, the Regulations include a new system for the traceability, the UDI (Unique Device Identification), which is similar to the American FDI, for all of the devices released on the market as well as the identification and traceability of all of the economic operators (manufacturers, importers, distributors). For the purpose of guaranteeing increased quality and conformity of the product, the new regulations introduce, and require the producer to appoint, a new manager in the company who is responsible for conformity to the regulations of the product released on the market and for its technical certification documents.
The Group is committed to achieving a continuous improvement in the quality of its products and services through the motivation and involvement of its staff; these objective is pursued through the optimization of the corporate processes, according to criteria of efficiency and univocal, homogeneous, effective and efficient working methods. Moreover, we are tending more towards a Quality Policy that is oriented to a risk management system as an instrument for evaluation and decision making, with an aim to pursuing a continual improvement through opportune corrective and preventive measures.
In a highly competitive environment like that of the medical industry, the competence of the experts working in the sector of Regulatory Affairs is of significant economic importance for the companies, especially when these latter are pursuing goals of internationalization in their marketing strategy. At the companies of the El.En. Group that operate in the medical sector the Regulatory function registers the compliance to the requirements of the government institutions which protect the public health and monitor the safety and effectiveness of the products produced in this sector. The companies that manufacture medical devices guarantee that their products are in compliance with all of the regulations relating to safety.
For this reason it is strategic for the company to equip itself with an office specialized in Regulatory Affairs so that they can keep the products updated with respect to the legislation, obtain and manage the certifications of the product, and guarantee the continual maintenance of conformity by acting as an intermediary between the requirements of the authorities and the needs expressed by all of the functional areas of the company, following the bureaucratic procedure and making themselves available in case that further documents or clarifications are requested by the institutions.
The Regulatory Activity requires the presence of people with different skills, possibly with different technical, scientific and administrative experience as well as a knowledge of different languages because it is necessary to know not only the national regulations but those of other European and extra- European countries.
The supply chain
In 2020 at a consolidated level the amount of spent for purchases was 255,2 million euros while the amount spent for outsourcing was 12,6 million euros. The El.En. Group believes that a close cooperation with the supply chain is essential in order to maintain a high standard of quality in the finished product and, in general, in the entire production process.
The final objective is that of establishing a long-lasting relationship that is characterized by transparency and cooperation. The suppliers must meet the minimum requirements for safety, quality and financial stability in order to minimize the risk of potential interruptions in the supply and unexpected costs. We continually conduct preventive analysis and evaluations in order to understand the market trends and monitor the evolution of the present suppliers and the potential ones, their technical up-dating and the regulations for the sector even in relation to the marketing of the products they sell to us.
The Group operates according to standards of fair competition and honesty, legality and correctness while respecting the legitimate interest of all of the stakeholders. the Ethics Code of the Group contains all of the principles and rules that all of those who are in contact with the Company are required to follow.
In the contracts for the sale of critical components that are underwritten by El.En. S.p.A., the other party must declare that they have received a copy of the Ethics Code and that they accept it. In relation to this, the suppliers are asked to meet certain requirements:
Financial soundness;
• Experience in the sector;
• Reliability;
• Technical and planning resources and capacity;
• Manufacturing capacity;
• Use of systems for the control of the quality and safety of the products, consistent with the requests of the Group.
In particular, for the manufacturing companies of the Group the selection of the suppliers follows a precise procedure of qualification and approval to guarantee the quality of the product and the respect of the delivery times. Once the supplier has been judged to be suitable from a qualitative point of view, periodic inspections are programmed to make sure that the standards of quality required have been maintained: these evaluations take into consideration aspects such as flexibility of the supplier, i.e. his capacity to adapt to the requirements of the organization, the speed of response to and the management of contingencies, the organizational structure and punctuality of deliveries as well as the evaluation of the merchandise delivered. Annual inspections are also conducted at some supplier's by specially trained internal auditors.
As stated in the Sustainability Plan, in the procedure for qualification and approval of the suppliers of critical components* we have included also an evaluation of some aspects related to sustainability issues so that these can also contribute to the overall evaluation of the supplier. The new qualification criteria came into force this year for the Parent Company El.En. S.p.A. and for the subsidiary Deka Mela S.r.l., where 43% of the suppliers of critical components were evaluated according to social and environmental criteria, while for the subsidiaries Asa S.r.l. and Quanta System S.p.A. these criteria will be included in the evaluation of suppliers of critical components starting in 2021.
*El.En considers suppliers of critical components to be all of those who supply components and/or assemblies which have an impact on the safety of the Patient and/or the Operator and which represent a high level of risk or offer services related to the quality of the product which have an impact on the safety of the Patient and/or Operator.