In the course of new product development, a medical device must pass stringent tests to prove that the product performs as intended in terms of functionality and efficacy before being certified for clinical use.
New product development efforts need small series production capabilities. STI’s small series production services are sought by startup companies that do not have adequate manufacturing capabilities and by R&D teams of incumbent medical device companies that do not wish to interrupt their own production lines.
STI allocates prototype laser machining or serial manufacturing resources according to the specific needs of a small series project. In addition to manufacturing, STI works closely with companies offering regulatory support services and therefore has become familiar with the specific conduct and documentation requirements demanded by the regulatory process.
Pre-clinical bench tests
Material tests: Metal fatigue, break elongation, tensile strength, grain size, composition, bio-compatibility, corrosion resistance, etc.
Functional tests: Maneuverability, x-ray visibility (radiopacity), traceability, torquability, shape memory, crush resistance, etc.
The results of the pre-clinical bench tests may trigger additional design modifications. Pre-clinical and clinical tests require small series manufacturing of 30-50 units per test run. STI manufactures the actual units needed for each test while providing customers with a single-source for both in-house and complementary testing capabilities.
The approval of an innovative medical device for clinical use entails passing a regulation process (CE mark, FDA approval, etc.). The regulation process involves a series of Validation and Verification tests (V&V), similar to the bench tests, run at the required number of repetitions for statistical validation, and clinical trials, initially in animals and then in human beings.