Paediatric Medical Devices Development Services

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End-to-End Design and Development of Paediatric Medical Devices

This set of services provides comprehensive support for the design and development of paediatric medical devices, including orphan and breakthrough devices, from concept to prototype. It ensures devices meet children’s physiological, developmental, and safety needs while complying with regulatory and usability requirements. It integrates iterative co-design activities involving patients, families, and clinicians to ensure usability, safety, and acceptance. Methods include workshops, focus groups, and semi-structured interviews. These co-design activities also support the development of in vitro and in vivo models.

Prototype Testing

We provide specialised services for the systematic testing and validation of paediatric medical device (MD) prototypes, ensuring they meet safety, performance, interoperability, and regulatory requirements. It helps developers de-risk devices prior to clinical evaluation or market entry. Services includes safety risk analysis, performance evaluation against established standards, (bio)mechanical and electrical testing, electronic system assessment, and non-clinical toxicological testing for material safety and biocompatibility. By providing structured testing pathways. It ensures that prototypes are technically robust, regulatory-ready, and supported by strong evidence to facilitate successful clinical translation and market adoption.

End-User Usability Assessment

This service provides evaluation how end-users, including patients, caregivers, and clinicians, interact with paediatric medical devices. It integrates systematic usability assessment activities to ensure safe, intuitive, and effective interaction for children and caregivers. By applying human factors engineering and usability testing, it ensures devices are intuitive, safe, and effective in real-world settings. Activities include structured usability testing, interface and control system evaluation, risk and error analysis, ergonomic and cognitive optimisation, and benchmarking against existing market solutions and standards.

Technology Transfer and Exploitation

This service ensures the translation of paediatric MDs from research and prototype development into clinical and market applications. It builds directly on co-design insights, prototype testing data, and usability assessments to define regulatory, IP, and business strategies. It supports users in protecting innovations, defining value propositions, and enabling sustainable exploitation pathways. Deliverables include IP reports, regulatory strategy documentation, business models, and dissemination plans.

Advice on Regulatory Procedures for MDs of Paediatric Interest

This set of services provides regulatory guidance for paediatric medical device developers, ensuring strategies are evidence-based, aligned with performance, and tailored to children’s needs. It integrates outputs from design, prototype testing, and usability to support eligibility for mechanisms such as orphan designation or priority review, and provides advice on device classification, compliance, and testing requirements. Services include regulatory pathway mapping, preparation and review of applications with scientific and clinical justifications, and support for direct dialogue with authorities. Benchmarking against past approvals and best practices further strengthens applications and improves success rates.