Human-Centered Design & Risk Mitigation
In the product development process, our biomedical engineers specialize in designing with risk mitigation in mind. We consider the biomechanics of body movement, articulation of joints, and how that changes under ADLs (activities of daily life), with age and disease. Evaluating a design for the biggest risks includes considering installation, service, material choices, degradation, and failure modes. This may result in mitigations such as instructions and research to ensure instructions are followed, and biocompatibility testing respectively.
We focus on how products will impact and improve the health of the human body, designing with biocompatibility in mind. The careful selection of materials for a particular application is crucial to the viability of a device. We design by applying our knowledge of biocompatible materials suitable for surface contact, implantation, degradation, and more.
In addition, devices with electronics must meet regulations to ensure they can’t cause harm to the user. Electronics add a layer of risk that can range from minimal considerations for isolated system or core to patient safety when electronics directly connect to the human body. Our team has experience navigating both the risk assessment and implementation of electrical designs to meet safety and regulatory requirements across the full range from circuit design through systems integration.