Meddesign

Meddesign is an interdisciplinary field that focuses on creating medical devices, health technologies, and care products with an emphasis on safety, usability, and patient outcomes. It combines elements of industrial design, user experience design, human factors engineering, biomedical engineering, and regulatory science.

Practitioners address the full product lifecycle, from early concept through prototyping, testing, regulatory approval, manufacturing, and post-market support. The field prioritizes patient- and clinician-centered design to ensure devices perform reliably in real clinical environments and integrate with healthcare workflows.

Core activities include user research, requirement specification, iterative prototyping, formative and summative usability testing, and risk management guided by ISO 14971. Design controls and validation plans align with regulatory standards to demonstrate safety and effectiveness.

Regulatory frameworks shape meddesign practice. In the United States, devices are regulated by the FDA with device classes and premarket submissions; in the European Union, CE marking under the Medical Device Regulation applies. Quality management per ISO 13485 and risk management per ISO 14971 are common requirements worldwide.

The field aims to reduce user error, improve adoption, and enhance patient safety, but faces challenges including regulatory complexity, high development costs, cybersecurity, data privacy, interoperability, and ensuring equitable access.

Career paths span design engineering, human factors engineering, regulatory affairs, clinical engineering, and quality assurance. Education often combines biomedical engineering, industrial or interaction design, and regulatory studies, with collaboration among clinicians, patients, and manufacturers.