CGI, Inc, the leading manufacturer of custom gearheads and robotic solutions, today announced itsrecognition as a key supplier for the Freedom® portable driver, which won a 2012 Medical Design Excellence Award. Manufactured and submitted by SynCardia Systems, Inc., the Freedom portable driver was awarded a Bronze in the Critical Care and Emergency Medicine Products category. Weighing 13.5 pounds, the Freedom driver is the world’s first wearable power supply for the SynCardia temporary Total Artificial Heart, the only FDA, Health Canada and CE (Europe) approved Total Artificial Heart in the world. The Freedom driver is designed to allow stable Total Artificial Heart patients who meet discharge criteria to wait for a matching donor heart at home instead of in the hospital. The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
Presented by UBM Canon, and sponsored by Medical Device and Diagnostic Industry magazine, the MDEA program is the MedTech industry’s premier competition for medical device design and innovation. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA-winning products excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.
A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, clinical practice, diagnostics, human factors, industrial design, manufacturing, and medicine. Entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives. The 2012 MDEA Jury selected 25 winning products out of 41 finalists in 10 medical product categories. CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.