ADVANCES IN MEDICAL DEVICES DESIGN, PROTOTYPING AND MANUFACTORING

We have to divide the field between materials (to be used directly by patients or by clinicians) and devices (including custom made medical devices). The materials are dependent on intrinsic characteristics and properties that can be tested in a lab with significant preview of clinical performance. The medical devices are placed in activity by or according to instructions by the clinician. Furthermore the materials may be used in a custom made medical device made up by the clinician, while medical device is performing a function. Dental materials are a good example of such a difference: an elastomeric mass is a product to be used directly by the clinician in the mouth of the patient, but with a deep influence by manipulation and insertion. Even more relevant is alginate impression material or alloys to be cast by dental technician with accurate proportion of components and impossible detection afterwards if the final product is deficient because of poor quality of original ingredients or outcome misuse, with even infinite value for patient behavior. We also consider the difference in evolution and intended aim of the regional institutions. So the agreement between FDA and EU Medical device directive offices has become effective and the technical description required by manufacturers is equivalent, nevertheless EU is evolving towards the request to “Notified Bodies” to increase deep and frequent analysis and control by means of new Directives addendum, while FDA(U.S. Government Agency) is increasing internal controls with intensive use of references and previous clinical experience. Similarly EU is asking to insert more controls in the revision and annual recertification system, sometimes inclusive of quality assurance system, while FDA is devolving more relevance to its auditing in order to verify GMP in action. Also MERCOSUR is evolving in line with FDA, so the global perspective is inducing to conceive the proposal of new medical devices targeting the market, in particular as for as registration and clinical evaluation both time and costs. While standards and technical norms in some fields (like biocompatibility testing and re sterilization) are at a good level and allow a satisfactory level of confidence in most of the applications, clinical evaluation of most medical devices are still in a primordial status of harmonization and standardization. Dynamic and flexible aspects of trade, regulatory rules and surveillance post market are the main characteristics of the global perspective of medical devices around the world.