Tech Validation Hub: Assessment of Custom Biomedical Devices and Hardware
Service Description
Overview
This service provides a structured technical assessment of biomedical hardware, custom sensors, and instrumentation prototypes for health applications. Conducted by SMAILE at Karolinska Institutet, the evaluation focuses on device design, integration, signal fidelity, power consumption, and suitability for clinical or field use. From wearable biosensors to lab instruments, our team helps ensure your innovations meet scientific, technical, and regulatory expectations.
We provide expertise and support in: • Biomedical device prototyping and test bench validation • Signal stability, hardware reliability, and functional safety • Pre-compliance testing and integration readiness
How can the service help you?
Innovators often struggle to identify design flaws or performance issues in early prototypes. This service accelerates development by identifying bottlenecks, verifying functionality, and preparing devices for clinical or usability trials.
How will the service be delivered?
Hybrid model: virtual consultations, remote analysis of schematics and performance data, and physical testing at SMAILE’s facilities. Duration: 2–6 weeks, depending on complexity.
Additional Information
Provider Description
SMAILE at Karolinska Institutet supports digital health and medtech innovation through technical validation services, regulatory support, and usability testing for medical technologies.
Technical Description
Assessments cover sensor calibration, signal noise analysis, data synchronization, power management, interface protocols, and durability under simulated use conditions. Testing follows ISO and IEC standards for electronic health devices, and supports both standalone and integrated system evaluations.
Service Customization
Clients may focus the service on device subcomponents (e.g., battery life, enclosure design), specific functions (e.g., HR monitoring), or integration with software/data systems.
Prices are indicative only and can change depending upon clinical expertise requirements (and affiliation); this service can be subsidised up to 100%. Additional data storage and handling costs can be added separately according to project requirements and SME needs. The average personnel cost is 115 EUR per hour (depending upon affiliation, personnel costs can be up to 100% subsidised).
Example price for a 200-hour project (including consultancy with a clinical expert, project management, data assembly and cleaning processes). Data storage is not included in this price). Full price: 23 000 EUR, Reduced price: 2 300 EUR (subsidisation of 90%, based on case study).