On the one hand, any first-in human studies carry obvious risks. On the other hand, only 10% of medical devices make it from development to stage 1. Stage 0 provides a framework for robust and transparent evaluation of devices, following the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies.
The stage 0 framework is based on three steps:
The device classification is a 3-tiered descriptive taxonomy, based on what the devices do, and therefore, provides a reflection of the potential harm a device may pose:
The studies that may be conducted to evaluate a device fall into 4 perspectives: device, patient, clinician, and system.
The risk a device may pose may be assessed using a Failure Modes and Effects Analysis (FMEA). For each risk, it can be categorized according to its probability and severity. The results of this FMEA analysis can be used to achieve a ‘proportionate’ evaluation that balances innovation and patient safety.
The extent of this proportionate evaluation can be guided by the figure below, which higher risk devices requiring a more thorough evaluation prior to Stage 1 studies.
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