Some fractures can’t be treated using plaster casts, in which case pins, plates and screws are required to reposition and consolidate the bone. In France, Newclip Technics designs and manufactures just such anatomical orthopaedic implants and plates for the upper and lower limbs. For almost 20 years the company has been developing new innovative products designed to solve a range of problems. However, in the field of medicine, inventiveness is not always enough. The implants have to meet strict standards if they are to be approved for market release. For example, when it comes to their mechanical characteristics, a range of values has to be measured and compared with those specified in the relevant standards.
Standards that are difficult to apply
Some standards, such as those relating to fatigue and wear testing, are particularly difficult to apply. They simply set out in schematic terms the tests to be carried out and give the tester complete licence as to how this is done. “That’s why we ask Cetim to carry out these tests. As well as having a Cofrac-accredited biomechanics laboratory, they have the right testing facilities and the expertise required to devise and implement the test protocols necessary to ensure our products meet the requirements set out in the standards. Their engineers can also develop the protocols we need to achieve our target performances for complex implants. And their know-how is equally valuable when it comes to deciding on a test procedure for an assembly (plate and screws) for which there are no established standards.”, explains Renaud Rougé, Head of R&D at Newclip Technics. As a result, the protocols are devised according to the specific needs set out by the company in order to reproduce the in vivo conditions of the implant on our static and fatigue test benches while applying any necessary constraints in a reproducible manner.
