FDA Regulation Impact on Early Stage Medical Device Innovation in Academia

The commercialization of medical products at the university level is a multilayered and challenging process. One barrier to commercialization is the difficulty of meeting Food and Drug Administration (FDA) regulatory requirements. Regulations and standards are undoubtedly necessary to maintain the highest product safety levels, but it creates many obstacles. This paper will analyze how researchers involved with early-stage medical device innovation in a university setting deal with FDA compliance issues and the implications of this engagement for innovation. I conducted an exploratory case study of ten medical product development projects at the Rochester Institute of Technology (RIT). Overall, I found that FDA approval pathways were challenging for project participants to navigate without proper resources; approximately half of the projects indicated a lack of confidence in their knowledge of and/or progress towards meeting FDA requirements based on the resources available. I offer several suggestions regarding how RIT and other universities can reduce barriers to innovation caused by FDA regulation through actions, both internal and external to the university

Pattern and distributon of pulse pressure from young to elderly hypertensives

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Evolution of non-stationary pulses in a cold magnetized quark-gluon plasma

We study weakly nonlinear wave perturbations propagating in a cold nonrelativistic and magnetized ideal quark-gluon plasma. We show that such perturbations can be described by the Ostrovsky equation. The derivation of this equation is presented for the baryon density perturbations. Then we show that the generalized nonlinear Schr{\"o}dinger (NLS) equation can be derived from the Ostrovsky equation for the description of quasi-harmonic wave trains. This equation is modulationally stable for the wave number $k < k_m$ and unstable for $k > k_m$, where $k_m$ is the wave number where the group velocity has a maximum. We study numerically the dynamics of initial wave packets with the different carrier wave numbers and demonstrate that depending on the initial parameters they can evolve either into the NLS envelope solitons or into dispersive wave trains

Energy transfer dynamics and thermalization of two oscillators interacting via chaos

We consider the classical dynamics of two particles moving in harmonic potential wells and interacting with the same external environment (HE), consisting of N non-interacting chaotic systems. The parameters are set so that when either particle is separately placed in contact with the environment, a dissipative behavior is observed. When both particles are simultaneously in contact with HE an indirect coupling between them is observed only if the particles are in near resonance. We study the equilibrium properties of the system considering ensemble averages for the case N=1 and single trajectory dynamics for N large. In both cases, the particles and the environment reach an equilibrium configuration at long times, but only for large N a temperature can be assigned to the system.Comment: 8 pages, 6 figure

Similarities between interstitial cystitis/bladder pain syndrome and vulvodynia: implications for patient management

Interstitial cystitis/bladder pain syndrome (IC/BPS) and vulvodynia are chronic pain syndromes that appear to be intertwined from the perspectives of embryology, pathology and epidemiology. These associations may account for similar responses to various therapies

Exploring the phase diagrams of multidimensional Kuramoto models

The multidimensional Kuramoto model describes the synchronization dynamics of particles moving on the surface of D-dimensional spheres, generalizing the original model where particles were characterized by a single phase. In this setup, particles are more easily represented by $D$-dimensional unit vectors than by $D-1$ spherical angles, allowing for the coupling constant to be extended to a coupling matrix acting on the vectors. As in the original Kuramoto model, each particle has a set of $D(D-1)/2$ natural frequencies, drawn from a distribution. The system has a large number of independent parameters, given by the average natural frequencies, the characteristic widths of their distributions plus $D^2$ constants of the coupling matrix. General phase diagrams, indicating regions in parameter space where the system exhibits different behaviors, are hard to derive analytically. Here we obtain the complete phase diagram for $D=2$ and Lorentzian distributions of natural frequencies using the Ott-Antonsen ansatz. We also explore the diagrams numerically for different distributions and some specific choices of parameters for $D=2$, $D=3$ and $D=4$. In all cases the system exhibits at most four different phases: disordered, static synchrony, rotation and active synchrony. Existence of specific phases and boundaries between them depend strongly on the dimension $D$, the coupling matrix and the distribution of natural frequencies.Comment: 26 pages, 10 figure