Navigating the challenges of initiating pediatric device trials - a case study.

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.

Incorporating a Hands-On Device-Based Activity in a Human Factors Biomedical Engineering Course in Sub-Saharan Africa.

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.

Objective Communication Patterns Associated With Team Member Effectiveness in Real-World Virtual Teams.

Objective: 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.

Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding.

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.

Regional diaphragm volume displacement is heterogeneous in dogs.

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.

Open-source three-dimensional printing of biodegradable polymer scaffolds for tissue engineering.

The 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.

Scaffold pore space modulation through intelligent design of dissolvable microparticles.

The 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.

Computer-aided tissue engineering: benefiting from the control over scaffold micro-architecture.

Minimization 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.

Diaphragm curvature modulates the relationship between muscle shortening and volume displacement.

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.