Medical Materials and Device Innovation: Choosing the Right and Relevant Biological Models

Abstract

The success of medical devices and biomaterials hinges on selecting biological models that truly reflect human physiology and disease. A well-chosen model is not just a scientific necessity; it is a clinical imperative. Academic biomedical research often relies on readily accessible models that yield affordable, convenient, and predictable results. However, rodent models of sepsis, cancer, and cardiovascular disease frequently fail in clinical translation. Likewise, optimizing a device or material to fit a specific model (“overfitting”) can create false confidence, leading to expensive setbacks. While in vitro systems offer ethical advantages and mechanistic insights, they lack the complexity of living organisms. Animal models, though capable of capturing systemic effects, face species differences, ethical concerns, and poor clinical translation. Advances in 3D tissue engineering, organ-on-a-chip, and humanized models overcome many of these shortcomings, improving predictive accuracy and complementing animal models. Clinician involvement is crucial to aligning preclinical models with real-world medical needs. Moreover, unnecessary animal experiments should not be conducted or required without a clear translational route. Prioritizing clinically relevant models enhances patient safety, reduces research waste, and drives ethical, impactful medical innovation.