Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in-vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
- and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
2. The Complexities in the Development of Medical Devices for Children
3. Addressing the Market Need for Pediatric Medical Devices
4. Addressing the Regulatory Needs for Pediatric MDs
5. 3D Printing for Pediatric MD
6. New Materials for Pediatric Medical Devices
7. Delivery Devices for the Administration of Pediatric Formulations
8. Diagnostic Imaging Devices for CYP
9. Patient and Public Involvement in Medical Devices’ Research
10. Towards a European Infrastructure to Support Pediatric Medical Device Development
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
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|Age||Approximate Weight (kg)||Systolic Blood Pressure (mmHg)||Heart Rate (Beats per Minute)||Respiratory Rate (Breath per Minute)|
|17 years +||70||95–140||60–120||14–26|
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Dimitri, P.; Pignataro, V.; Lupo, M.; Bonifazi, D.; Henke, M.; Musazzi, U.M.; Ernst, F.; Minghetti, P.; Redaelli, D.F.; Antimisiaris, S.G.; et al. Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities. Pharmaceutics 2021, 13, 2178. https://doi.org/10.3390/pharmaceutics13122178
Dimitri P, Pignataro V, Lupo M, Bonifazi D, Henke M, Musazzi UM, Ernst F, Minghetti P, Redaelli DF, Antimisiaris SG, et al. Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities. Pharmaceutics. 2021; 13(12):2178. https://doi.org/10.3390/pharmaceutics13122178Chicago/Turabian Style
Dimitri, Paul, Valeria Pignataro, Mariangela Lupo, Donato Bonifazi, Maria Henke, Umberto M. Musazzi, Floris Ernst, Paola Minghetti, Davide F. Redaelli, Sophia G. Antimisiaris, and et al. 2021. "Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities" Pharmaceutics 13, no. 12: 2178. https://doi.org/10.3390/pharmaceutics13122178