LNAge has consolidated partnerships with companies in the sector to operate, through a young and dynamic team of experts, in Medical Device Technology, a sector in which it supports sponsors and other client companies in the design, development and marketing of medical devices, whether they are mechanical devices (such as, for example, a retractor or an ultrasound) or parapharmaceuticals, supplements or cosmetics.
The process of formulation, validation and marketing of a medical device involves several phases that imply specific skills and professionalism not only in the clinical and scientific field but also in the strategic and managerial field. For this reason, the professionals present in LNAge deal not only with the actual production process, which is carried out in compliance with strict quality standards and the most recent Italian and European legislation, but also with other activities such as obtaining specific certifications and CE marking, traceability, logistics and distribution that, in the pharmaceutical field, they must comply with specific rules and parameters (such as temperature, humidity, etc.) that may vary both according to the medical device and according to the individual stages of distribution (a parameter such as the temperature of a drug or parapharmaceutical, may, for example, be subject to specific restrictions and require the use of special refrigerating equipment, both in the loading phase, both in the unloading phase, and, finally, during the maintenance in the warehouse, in a hospital or in a pharmacy).
Medical Device Technology
the Italian and European scenario
LNAge performs the tasks related to Medical Device Technology also for sponsors and foreign client companies that intend to develop a new medical device in Italy or Europe. These partners are offered in-depth advice that allows them to understand if the medical device designed can actually be developed and manufactured in the countries of the European Community and if it is, effectively suitable, for the relevant target market not only from a regulatory point of view, but also in consideration of the specific production process that implies, the parameters that it will have to comply with to obtain the certifications required by the Ministry of Health and other health control structures and, finally, aspects related to logistics and distribution.
The in-depth knowledge of Italian and European pharmaceutical legislation has allowed LNAge professionals working in Medical Device Technology, to offer sponsors and partner companies also training courses on the latest updates of Community legislation in the field of clinical and health research.
Medical Device Technology
the services offered
LNAge professionals working in the Field of Medical Device Technology deal in particular with:
design of medical devices: whether they are devices of an electronic, mechanical or chemical nature; this function also includes the definition and formulation of new active ingredients;
development of new medical devices, through the coordination and monitoring of all the production processes that take place in the plant;
obtaining the AIC code (Marketing Authorization) and the CE marking (compliance with European directives) and monitoring of the related accreditation procedures at the Certifying Bodies;
preparation of the Technical File of the Device, according to the parameters established by Directive 2007/47/EC and the applicable standards; this document contains and describes the design schemes, the results of the risk analyses carried out, the technical standards and practices applied during the formulation and implementation of the technical device, the test reports, the clinical assessments, the design defined for the labelling and the instructions for use of the device by the technical staff and by the end users;
the negotiation activity and the actions envisaged by the validation process initiated with the Notifying Bodies and with the Ministry of Health;
surveillance during the post-marketing phase and reporting activity;
the practices of registration of the Device in the national repertoire;
the creation of the Brand and the registration of the trademark;
the preparation of information and promotional material;
distribution strategies (including the definition of specifications for logistics) and marketing;
the training of the sales network and industry experts;
Medical Device Technology
the professional figures involved
The professionals operating in LNAge who deal with the activities of Medical Device Technology monitor all the production phases of the product until its placing on the market: in addition to the technical requirements and process specifications, factors relating to purity and compliance with Good Manufacturing Practice (GMP) standards must be constantly maintained and verified.
In these activities, the action of the Production Manager is of fundamental importance who, possibly supported by a Project Manager, plans, organizes, controls and monitors the production processes that take place in the plant.
Upstream of the production activity is the basic research and the theoretical and experimental activity carried out to acquire knowledge on fundamental clinical phenomena, without providing for a particular application of the new medical device. In this context, pharmaceutical researchers develop and new knowledge, spreading it in the scientific community, from which they obtain feedback, indispensable for the formulation and design of new drugs and for the improvement of existing drugs compared to the golden standard.
Finally, the Product Manager is also involved in the Medical Device Technology activities, who operates in the field of corporate marketing and carries out actions aimed at the continuous growth of the product and the maximization of its value, compatibly with the needs of the reference market. The Product Manager analyzes the reference markets, plans the strategic production of the product, the management of distribution and sales activities and strategic and operational marketing activities, including the definition of the Brand, the care of the packaging and the design of advertising campaigns; finally, he manages the positioning of the product on the national and international market and participates in training opportunities and meetings for sales agents, so as to acquire all the elements necessary for the improvement of sales and to obtain maximum customer satisfaction.