Surface engineering strongly influences the performance, reliability, and safety of medical and biomedical devices, yet failures often originate at interfaces rather than in bulk materials alone. This review addresses the fragmented evidence base linking coating selection, interphase design, qualification testing, advanced characterization, and
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Surface engineering strongly influences the performance, reliability, and safety of medical and biomedical devices, yet failures often originate at interfaces rather than in bulk materials alone. This review addresses the fragmented evidence base linking coating selection, interphase design, qualification testing, advanced characterization, and data-driven durability analysis. The objective is to provide an integrative, failure-mode-based framework for implants, reusable instruments, inhalation systems, diagnostics, wearables, and implantable electronics. A narrative synthesis of the peer-reviewed literature in coatings, biomaterials, electrochemistry, reliability, standards, and materials informatics was conducted, with qualitative tables used only when protocols were too heterogeneous for numerical pooling. The review compares physical vapor deposition (PVD), chemical and plasma-enhanced chemical vapor deposition (CVD/PECVD), atomic layer deposition (ALD), sol–gel/organically modified silica (ORMOSIL) hybrids, plasma polymers, parylene, bioactive or antimicrobial surfaces, and electronic encapsulation strategies. The main finding is that no universally superior coating exists; reliable performance depends on matching architecture and characterization to the dominant failure pathway, substrate compliance, geometry, sterilization or physiologic exposure, and the standards-constrained endpoint. The review further shows how electrochemical diagnostics, interfacial mechanics, multiphysics models, survival/reliability statistics, and carefully governed AI workflows can be combined to support service-life prediction and decision-oriented qualification.
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