Evaluation of a new medical device or procedure, prior to first-in-human Stage 1 studies.
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.
| SUMMARY DESCRIPTION OF STAGE | RECOMMENDATIONS FOR RESEARCHERS | RESEARCH ENIVIRONMENT | |
| Purpose: | Feasbibility and definition of procedure | All predictable risks to patients should be investigated before human studies begin. | Journals: Encourage or require registration of the innovation when considering for publication (E.g. IJS: Case Reports and www.researchregistry.com) |
| Number & Types of Patients: | Pre-clinical | Guidelines on best scientific practice and ethics specific to the types of study should be followed where available. | Regulatory/legal: Provide public interest defence from legal discovery for registries specifically for first-in-human studies. Ensure local hospital policy on innovative procedures groups foster innovation (i.e., IRB or new procedure committee) |
| Number & Types of Surgeons: | Very few: innovators | A minimum dataset describing technical consistency should be made public before first-in-human testing. | Ethical aspects: Multiple strategies required to minimise harms to patients, including formal human research ethics approval for selected planned interventions |
| Output: | Description addressing: • whether intended goal of procedure is accomplished • level of difficulty of performing procedure or using device as compared to standard of care • Safety risks • Desirability of intervention | ||
| Method: | Various, including simulator, cadaver, animal, modelling and cost-effectiveness studies | ||
| Stage Endpoint | Any studies that could avoid predictible risks of failure or harm to the first human should have been conducted. | ||
| RELEVANT LITERATURE | |||
| Marcus, H.J., Bennett, A., Chari, A., Day, T., Hirst, A., Hughes-Hallett, A., Kolias, A., Kwasnicki, R.M., Martin, J., Rovers, M. and Squire, S.E., 2021. IDEAL-D framework for device innovation: a consensus statement on the preclinical stage. Annals of surgery, 275(1), p.73. | |||
| Khan, D.Z., Luengo, I., Barbarisi, S., Addis, C., Culshaw, L., Dorward, N.L., Haikka, P., Jain, A., Kerr, K., Koh, C.H. and Horsfall, H.L., 2021. Automated operative workflow analysis of endoscopic pituitary surgery using machine learning: development and preclinical evaluation (IDEAL stage 0). Journal of Neurosurgery, 137(1), pp.51-58. | |||
| MacCormac, O., Noonan, P., Janatka, M., Horgan, C.C., Bahl, A., Qiu, J., Elliot, M., Trotouin, T., Jacobs, J., Patel, S. and Bergholt, M.S., 2023. Lightfield hyperspectral imaging in neuro-oncology surgery: an IDEAL 0 and 1 study. Frontiers in Neuroscience, 17, p.1239764. | |||
| Yokota, T., Kameda, T., Sasaki, N., Sekiguchi, M. and Matsumoto, Y., 2025. Development of a Novel Surgical Method for Endoscopic Flexor Tendon Repair: Stage 0 (Preclinical) Cadaveric Case Report and Study Protocol Following the IDEAL-D Framework. Cureus, 17(5). | |||
