Introduction: Pediatric medical devices lag behind adult devices due to economic barriers, smaller patient populations, changing anatomy and physiology of patients, regulatory hurdles, and especially difficulties in executing clinical trials. We investigated the requirements, challenges, associated timeline, and costs of conducting a multi-site pivotal clinical trial for a Class II pediatric physiologic monitoring device.
Methods: This case study focused on the negotiation of clinical trial agreements (CTAs), budgets, and Institutional Review Board (IRB) processing times for a pediatric device trial.
A challenge in building the biomedical engineering human factors course at Malawi University of Business and Applied Sciences was integrating meaningful direct experiences with medical products. The instructor also noticed a significant gap between the topics in the course and their surrounding clinical context, a low-income setting. Recognizing that devices should be designed and evaluated in the context of the local users' needs and situations, new hands-on modules were created and implemented in this BME human factors course.
View Article and Find Full Text PDFObjective: We explore the relationships between objective communication patterns displayed during virtual team meetings and established, qualitative measures of team member effectiveness.
Background: A key component of teamwork is communication. Automated measures of objective communication patterns are becoming more feasible and offer the ability to measure and monitor communication in a scalable, consistent and continuous manner.
Introduction: A shortage of medical devices designed for children persists due to the smaller pediatric population and market factors. Furthermore, pediatric device development is challenging due to the limited available funding sources. We describe our experience with pediatric device projects that successfully received federal grant support towards commercializing the devices that can serve as a guide for future innovators.
View Article and Find Full Text PDFAm J Physiol Regul Integr Comp Physiol
March 2017
Muscle shortening and volume displacement (VD) are critical determinants of the pressure-generating capacity of the diaphragm. The present study was designed to test the hypothesis that diaphragm VD is heterogeneous and that distribution of VD is dependent on regional muscle shortening, posture, and the level of muscle activation. Radioopaque markers were sutured along muscle bundles of the peritoneal surface of the crural, dorsal costal, midcostal, and ventral costal regions of the left hemidiaphragm in four dogs.
View Article and Find Full Text PDFThe fabrication of scaffolds for tissue engineering requires elements of customization depending on the application and is often limited due to the flexibility of the processing technique. This investigation seeks to address this obstacle by utilizing an open-source three-dimensional printing (3DP) system that allows vast customizability and facilitates reproduction of experiments. The effects of processing parameters on printed poly(ε-caprolactone) scaffolds with uniform and gradient pore architectures have been characterized with respect to fiber and pore morphology and mechanical properties.
View Article and Find Full Text PDFThe goal of this area of research is to manipulate the pore space of scaffolds through the application of an intelligent design concept on dissolvable microparticles. To accomplish this goal, we developed an efficient and repeatable process for fabrication of microparticles from multiple materials using a combination of rapid prototyping (RP) and soft lithography. Phase changed 3D printing was used to create masters for PDMS molds.
View Article and Find Full Text PDFMinimization schema in nature affects the material arrangements of most objects, independent of scale. The field of cellular solids has focused on the generalization of these natural architectures (bone, wood, coral, cork, honeycombs) for material improvement and elucidation into natural growth mechanisms. We applied this approach for the comparison of a set of complex three-dimensional (3D) architectures containing the same material volume but dissimilar architectural arrangements.
View Article and Find Full Text PDFAm J Physiol Regul Integr Comp Physiol
July 2011
During physiological spontaneous breathing maneuvers, the diaphragm displaces volume while maintaining curvature. However, with maximal diaphragm activation, curvature decreases sharply. We tested the hypotheses that the relationship between diaphragm muscle shortening and volume displacement (VD) is nonlinear and that curvature is a determinant of such a relationship.
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