Beneficiary 3

EKYMED medical device

BRIEF DESCRIPTION OF THE ORGANIZATION: 

Ekymed Spa (www.ekymed.com) was a spin-off company of SSSA, and now, form 2012, a small enterprise active in the development of novel medical devices for surgery, working with opinion-leader medics. Ekymed is able to lead the development of a medical product, from concept idea to certification and product release.

The research and development activity of the company is based on the day-by-day activity of the technical and commercial personnel, starting by the “participant observation” during a surgical procedure and directly listening the surgeons’ needs.

Any possible idea will be evaluated through several complementary parameters:

  • market potential;
  • patentability;
  • fabrication: methods, materials, sub-components, supply chain;
  • certification bottlenecks;
  • time to market.

Based on our experience a fundamental 1st step is the fabrication of a first prototype that gives to the physician / surgeon an initial feedback. Ekymed is constantly looking for commercial partners to jointly develop innovative ideas. Beside the R&D activity, Ekymed is also involved in the commercialisation of medical devices, both “Ekymed” labelled and also from other commercial partners.

MAIN TASKS WITHIN THE PROJECT: 

The main responsibilities of Ekymed within EndoVESPA, oriented on an industrial approach, are the following: i) industrial labelling pathway definition for CE mark, ii) pre-compliance testing for CE mark, iii) CE mark technical file compilation, iv) CE mark test, and v) exploitation plan of the EndoVESPA platform and derivative devices. Ekymed will be responsible, during the project, of the industrial approach and methodology that will cover the re-design / refinement of the EndoVESPA platform towards a clinical product.

PREVIOUS EXPERIENCE: 

Ekymed directly certified three medical devices (STAR System, STAR Light and Costamagna/Spera Floseal GI catheter) for laparoscopic surgery and one medical device for GI tract, completing autonomously the Technical File for CE approval by a selected Notified Body. In the recent past Ekymed was involved in the design of a teleoperated robotic console for eye surgery, keratoplasty in particular.

People

Dr. Bernardo Magnani received the Master Degree in Mechanical Engineering from the University of Pisa in 1995 with a thesis entitled "Experimental and theoretical study of a micropump for drug delivery system", with the supervision of Prof. Paolo Dario, Prof. Marino Marini and Dr. Maria Chiara Carrozza. In 1991 he joined the MiTech Lab of the Scuola Superiore Sant'Anna in Pisa. He was Project Manager of the BIOMED2/MIAS project, coordinated by MiTech Lab and aimed at the development of an integrated system for Computer Assisted Surgery for Minimally Invasive Arthroscopy. In 1999 he obtained the Ph.D. in Microsystems Engineering. From 1999 to 2000 he was the project manager of the EU project “Medical Micro-Instrument Competence Centre” in the framework of Europractice. In 2000 he became General Manager of MicroTech. His research interests are in the fields of micromechatronic technologies, microfluidic components and systems for medical applications, micromechatronic instruments for minimally invasive surgery and therapy. In 2012, he established the company Ekymed Spa, joining MicroTech with Ekyeria Srl. He is now the General Manager of Ekymed.