scholarly journals The Complexity of Medical Device Regulations Has Increased, as Assessed through Data-Driven Techniques

Prosthesis ◽  
2021 ◽  
Vol 3 (4) ◽  
pp. 314-330
Author(s):  
Arthur Arnould ◽  
Rita Hendricusdottir ◽  
Jeroen Bergmann
Keyword(s):  
Medical Device ◽  
Response Times ◽  
Correlation Coefficients ◽  
Data Driven ◽  
Additional Time ◽  
Complexity Measures ◽  
Complexity Metrics ◽  
Regulatory Complexity ◽  
User Friendly

Medical device regulations are dynamic, as they need to cover an ever changing landscape. In Europe this has led to a new set of regulations (both for Medical Devices and In Vitro Diagnostics), which replaced the old rules. This study is interested in how the complexity of these medical regulations changed over time and if additional time-based metrics can be associated with any of the complexity metrics. Complexity is defined in terms of readability of the text and it is computed using established linguistic measures, as well as Halstead complexity scores. It was shown that the regulatory complexity of new EU medical device regulations was higher than their predecessors, especially when Halstead complexity measures were considered. The complexity metrics obtained for the new regulations were subsequently associated with the time it took to consider these regulations. Only very weak Pearson’s correlation coefficients were found between the complexity scores and the obtained response times for the new regulations. This could indicate that there are issues with how complexity is perceived by those that need to apply these regulations. Taking the complexity of regulations into account can greatly help with the development of more user friendly regulations. The results from the data-driven methods that are applied in this research indicate that governments could benefit from focusing on making regulations more accessible and utilitarian. This would improve the stakeholder adherence and facilitate effective implementation. This work also highlighted the need to develop more suitable methods to analyse regulatory text to further inform the wider research community.

An Analysis of Complexity Measures for Product Design and Development

2012 ◽  
Author(s):  
Josue R. Crespo-Varela ◽  
Gül E. Okudan Kremer ◽  
Conrad S. Tucker ◽  
Lourdes A. Medina
Keyword(s):  
Product Design ◽  
Medical Device ◽  
Consumer Products ◽  
Product Complexity ◽  
Design And Development ◽  
Complexity Measures ◽  
Device Development ◽  
Complexity Metrics ◽  
Development Costs

Complexity metrics have been developed for multiple applications such as consumer products, software, trajectory selection and assembly systems. Although existing complexity metrics were developed to reduce product design and development costs, their lack of simplicity in formulation and robustness has limited their applicability. This paper proposes a standard methodology for comparing and evaluating these metrics and introduces dimensions of complexity that should be considered towards the goal of developing a generalizable product complexity measure. To this end, this paper introduces variables that integrate multiple facets of complexity into a single metric. A medical device case study is used to compare the efficiency and robustness of existing complexity measures. The medical device case study also serves as the motivation for the proposed complexity metric due to the complexity of the domain itself and the increasing importance of mitigating healthcare costs. Overall, product complexity metrics can aid medical device development by increasing the understanding about the design and its implications regarding development time and FDA approvals.

Investigating the Relationship Between Product Design Complexity and FDA for Medical Device Development

2013 ◽  
Author(s):  
Lourdes A. Medina ◽  
Marija Jankovic ◽  
Gül E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Decision Time ◽  
Product Complexity ◽  
Complexity Measures ◽  
Design Complexity ◽  
Regulatory Decision ◽  
Complexity Metrics ◽  
Relevant Variables ◽  
Or Organization ◽  
The Relationship

Product complexity has been studied as an important factor to decrease the cost and time of the development process. With this purpose, prior research has included the development of design complexity metrics as a method to assess and decrease complexity. Recent studies have also focused on the comparison of complexity metrics for the particular case of medical devices development (MDD). However, the major issue relevant to MDD has not been addressed; the relationship between FDA regulations and the device complexity is not clarified. Therefore, to increase MDD safety and decrease the time to market, we must understand the regulatory decision process and rules. In this paper, we investigate the relation between different complexity metrics and FDA’s decision time using a sample of 100 hip replacement devices. Bayesian network learning is used to explore in detail local relationships between different variables, both complexity measures and product variables. This relationship was found significant for the first two clusters of the analysis. However, for a third cluster it is speculated that FDA decision time does not depend solely upon the degree of medical device complexity. Company or organization relevant variables could be playing a greater role than just complexity. Additional questions are drawn based on the results that must be investigated.

Monitoring Heparin Therapy: Relationships between the Activated Partial Thromboplastin Time and Heparin Assays Based on Ex-Vivo Heparin Samples

1990 ◽  
Vol 63 (01) ◽  
pp. 016-023 ◽  
Author(s):  
A M H P van den Bessekaar ◽  
J Meeuwisse-Braun ◽  
R M Bertina
Keyword(s):  
Partial Thromboplastin Time ◽  
Plasma Sample ◽  
Ex Vivo ◽  
Correlation Coefficients ◽  
Heparin Therapy ◽  
Thromboembolic Disease ◽  
Activated Partial Thromboplastin Time ◽  
Venous Thromboembolic Disease ◽  
Venous Thromboembolic

SummaryFive different APTT reagents, two amidolytic anti-ITa assays, one amidoiytic anti-Xa assay, and one coagulometric anti-Xa/ anti-IIa assay were used to assess the effect of heparin in patients treated for venous thromboembolic disease. Good correlations were observed between lug-transformed APYE> determined with the various reagents (correlation coefficients: 0.92-0.96).Nevertheless there were important differences in the slopes of the lines of relationship between the APTT reagents.Good correlations were observed between the anti-Xa and anti-IIa assay results (correlation coefficients: 0.92-0.97). However, the amidolytic anti-Xa activity was significantly higher (p <0.001) than the two amidolytic anti-IIa activities. Less good correlations were observed between the log-transformed APTTs and the anti-Xa or anti-IIa activities (correlation coefficients: 0.64-0.78). The correlations were improved by transforming the APTT into APTT-ratio, i.e. the ratio of the patient’s APTT to the same patient’s APTT after removal of heparin from the plasma sample by means of ECTEOLA-cellulose treatment. The correlation coefficients of log (AFTT-ratio) with anti-Xa or anti-IIa ranged from 0.76 to 0.87.For both APTT and amidolytic heparin assay, the response to in vitro heparin was different from the response to ex vivo heparin.Therefore, equivalent therapeutic ranges should be assessed by using ex vivo samples rather than in vitro heparin. Because of the response differences between the APTT reagents, it is not adequate to define a therapeutic range for heparin therapy without specification of the reagent.

Controlled Release of Metformin Hydrochloride I. In vitro Release from Physical Mixture Containing Xanthan Gum as Hydrophilic Rate Retarding Polymer

1970 ◽  
Vol 4 (1) ◽  
Author(s):  
Mashkura Ashrafi ◽  
Jakir Ahmed Chowdhury ◽  
Md Selim Reza
Keyword(s):  
Controlled Release ◽  
Xanthan Gum ◽  
In Vitro Release ◽  
Correlation Coefficients ◽  
High Ratio ◽  
Water Soluble ◽  
Metformin Hydrochloride ◽  
Model Drug ◽  
Very High

Capsules of different formulations were prepared by using a hydrophilic polymer, xanthan gum and a filler Ludipress. Metformin hydrochloride, which is an anti-diabetic agent, was used as a model drug here with the aim to formulate sustained release capsules. In the first 6 formulations, metformin hydrochloride and xanthan gum were used in different ratio. Later, Ludipress was added to the formulations in a percentage of 8% to 41%. The total procedure was carried out by physical mixing of the ingredients and filling in capsule shells of size ‘1’. As metformin hydrochloride is a highly water soluble drug, the dissolution test was done in 250 ml distilled water in a thermal shaker (Memmert) with a shaking speed of 50 rpm at 370C &plusmn 0.50C for 6 hours. After the dissolution, the data were treated with different kinetic models. The results found from the graphs and data show that the formulations follow the Higuchian release pattern as they showed correlation coefficients greater than 0.99 and the sustaining effect of the formulations was very high when the xanthan gum was used in a very high ratio with the drug. It was also investigated that the Ludipress extended the sustaining effect of the formulation to some extent. But after a certain period, Ludipress did not show any significant effect as the pores made by the xanthan gum network were already blocked. It is found here that when the metformin hydrochloride and the xanthan gum ratio was 1:1, showed a high percentage of drug release, i.e. 91.80% of drug was released after 6 hours. But With a xanthan gum and metformin hydrochloride ratio of 6:1, a very slow release of the drug was obtained. Only 66.68% of the drug was released after 6 hours. The percent loading in this case was 14%. Again, when Ludipress was used in high ratio, it was found to retard the release rate more prominently. Key words: Metformin Hydrochloride, Xanthan Gum, Controlled release capsule Dhaka Univ. J. Pharm. Sci. Vol.4(1) 2005 The full text is of this article is available at the Dhaka Univ. J. Pharm. Sci. website

scholarly journals Evaluation of Ceftaroline Alone and in Combination against Biofilm-Producing Methicillin-Resistant Staphylococcus aureus with Reduced Susceptibility to Daptomycin and Vancomycin in anIn VitroPharmacokinetic/Pharmacodynamic Model

2015 ◽  
Vol 59 (8) ◽  
pp. 4497-4503 ◽  
Author(s):  
Katie E. Barber ◽  
Jordan R. Smith ◽  
Cortney E. Ireland ◽  
Blaise R. Boles ◽  
Warren E. Rose ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Medical Device ◽  
Bloodstream Infections ◽  
Methicillin Resistant ◽  
Content Type ◽  
Elimination Half ◽  
Antimicrobial Protection ◽  
Mrsa Strains ◽  
Post Hoc

ABSTRACTAnnually, medical device infections are associated with >250,000 catheter-associated bloodstream infections (CLABSI), with up to 25% mortality.Staphylococcus aureus, a primary pathogen in these infections, is capable of biofilm production, allowing organism persistence in harsh environments, offering antimicrobial protection. With increases inS. aureusisolates with reduced susceptibility to current agents, ceftaroline (CPT) offers a therapeutic alternative. Therefore, we evaluated whether CPT would have a role against biofilm-producing methicillin-resistantS. aureus(MRSA), including those with decreased susceptibilities to alternative agents. In this study, we investigated CPT activity alone or combined with daptomycin (DAP) or rifampin (RIF) against 3 clinical biofilm-producing MRSA strains in anin vitrobiofilm pharmacokinetic/pharmacodynamic (PK/PD) model. Simulated antimicrobial regimens were as follows: 600 mg of CPT every 8 h (q8h) (free maximum concentration of drug [fCmax], 17.04 mg/liter; elimination half-life [t1/2], 2.66 h), 12 mg/kg of body weight/day of DAP (fCmax, 14.7 mg/liter;t1/2, 8 h), and 450 mg of RIF q12h (fCmax, 3.5 mg/liter;t1/2, 3.4 h), CPT plus DAP, and CPT plus RIF. Samples were obtained and plated to determine colony counts. Differences in log10CFU/cm2were evaluated by analysis of variance with Tukey'spost hoctest. The strains were CPT and vancomycin susceptible and DAP nonsusceptible (DNS). CPT displayed activity throughout the experiment. DAP demonstrated initial activity with regrowth at 24 h in all strains. RIF was comparable to the drug-free control, and little benefit was observed when combined with CPT. CPT plus DAP displayed potent activity, with an average log10CFU/cm2reduction of 3.33 ± 1.01 from baseline. CPT demonstrated activity against biofilm-producing DNS MRSA. CPT plus DAP displayed therapeutic enhancement over monotherapy, providing a potential option for difficult-to-treat medical device infections.

Developing annotation solutions for online Data Driven Learning

ReCALL ◽  
2009 ◽  
Vol 21 (1) ◽  
pp. 55-75 ◽  
Author(s):  
Pascual Pérez-Paredes ◽  
Jose M. Alcaraz-Calero
Keyword(s):  
Corpus Linguistics ◽  
Language Teaching ◽  
Language Education ◽  
Data Driven ◽  
Online Data ◽  
Analysis And Design ◽  
Language Classroom ◽  
Youth Language ◽  
User Friendly

AbstractAlthough annotation is a widely-researched topic in Corpus Linguistics (CL), its potential role in Data Driven Learning (DDL) has not been addressed in depth by Foreign Language Teaching (FLT) practitioners. Furthermore, most of the research in the use of DDL methods pays little attention to annotation in the design and implementation of corpus-based/driven language teaching.In this paper, we set out to examine the process of development of SACODEYL Annotator, an application that seeks to assist SACODEYL system users in annotating XML multilingual corpora. First, we discuss the role of annotation in DDL and the dominating paradigm in general corpus applications. In the context of the language classroom, we argue that it is essential that corpora should be pedagogically motivated (Braun, 2005 and 2007a). Then, we move on to deal with the analysis and design stages of our annotation solution by illustrating its main features. Some of these include a user friendly hierarchical and extensible taxonomy tree to facilitate the learner-oriented annotation of the corpora; real-time graphics representation of the annotated corpus matching the XML TEI-compliant (Text Encoding Initiative) standard, as well as an intuitive management of the different data sections and associated metadata.SACODEYL (System Aided Compilation and Open Distribution of European Youth Language) is an EU funded MINERVA project which aims to develop an ICT-based system for the assisted compilation and open distribution of multimedia European teen talk in the context of language education. This research lays emphasis on the functionalities of the application within the SACODEYL context. However, our paper addresses similarly the needs of potential multimedia language corpus administrators in general on the lookout for powerful annotation assisting software. SACODEYL Annotator is free to use and can be downloaded from our website.

scholarly journals Impact of COVID-19 Pandemic on COMPI Fertility Problem Stress Scale and the State-Trait Anxiety Scale in Patients Undergoing IVF/ICSI

2021 ◽  
pp. 1-7
Author(s):  
Arzu Yurci ◽  
Saban Karayagiz
Keyword(s):  
In Vitro Fertilization ◽  
Trait Anxiety ◽  
Correlation Coefficients ◽  
Anxiety Scale ◽  
Lower State ◽  
Cross Sectional ◽  
Vitro Fertilization ◽  
Stress Scale ◽  
Fertility Problem

OBJECTIVE: This study aimed to investigate the effect of the COVID-19 outbreak on infertile couples dealing with stress and anxiety during in vitro fertilization treatment. STUDY DESIGN: 252 infertile patients who applied for in vitro fertilization treatment were included in this cross-sectional study. Data were collected via four data collection tools including socio-demographic form, COVID-19 Inventory (COVID-I), COMPI fertility problem stress scale (COMPI-FPSS), and state-trait anxiety scale. Data analysis was conducted by SPSS statistical software included statistical analysis such as averages, standard deviations, correlation, regression, and t-test. RESULTS: Both negative and weak correlations were found between COMPI fertility problem stress scale and subscales of state-trait anxiety scale as well as the total score of state-trait anxiety scale. In terms of socio-demographic characteristics of the participants and their responses in state-trait anxiety scale and ISS forms, the correlation coefficients were also so low. The results also showed that public officials, health professionals, and educators showed lower state-trait anxiety scale (stress-related anxiety) scores. CONCLUSION: During the COVID-19 pandemic, there was an increase in spontaneous pregnancy expectations. Although participants were mostly stressed because of the COVID-19 outbreak, they didn’t change their in vitro fertilization treatment plans during the outbreak.

scholarly journals Microvessel Chaste: An Open Library for Spatial Modelling of Vascularized Tissues

2017 ◽  
Author(s):  
J.A. Grogan ◽  
A.J. Connor ◽  
B. Markelc ◽  
R.J. Muschel ◽  
P.K. Maini ◽  
...  
Keyword(s):  
Open Source ◽  
Tumour Growth ◽  
Spatial Models ◽  
3D Models ◽  
Tissue Growth ◽  
Coronary Perfusion ◽  
Analysis Model ◽  
User Friendly

AbstractSpatial models of vascularized tissues are widely used in computational physiology, to study for example, tumour growth, angiogenesis, osteogenesis, coronary perfusion and oxygen delivery. Composition of such models is time-consuming, with many researchers writing custom software for this purpose. Recent advances in imaging have produced detailed three-dimensional (3D) datasets of vascularized tissues at the scale of individual cells. To fully exploit such data there is an increasing need for software that allows user-friendly composition of efficient, 3D models of vascularized tissue growth, and comparison of predictions with in vivo or in vitro experiments and other models. Microvessel Chaste is a new open-source library for building spatial models of vascularized tissue growth. It can be used to simulate vessel growth and adaptation in response to mechanical and chemical stimuli, intra- and extra-vascular transport of nutrient, growth factor and drugs, and cell proliferation in complex 3D geometries. The library provides a comprehensive Python interface to solvers implemented in C++, allowing user-friendly model composition, and integration with experimental data. Such integration is facilitated by interoperability with a growing collection of scientific Python software for image processing, statistical analysis, model annotation and visualization. The library is available under an open-source Berkeley Software Distribution (BSD) licence at https://jmsgrogan.github.io/MicrovesselChaste. This article links to two reproducible example problems, showing how the library can be used to model tumour growth and angiogenesis with realistic vessel networks.

scholarly journals Feasibility Study and Direct Extraction of Endogenous Free Metallic Cations Combining Hemodialysis and Chelating Polymer

2021 ◽  
Author(s):  
Marco Natuzzi ◽  
Coralie Grange ◽  
Thomas Gréa ◽  
Thomas Brichart ◽  
Axel Aigle ◽  
...  
Keyword(s):  
Medical Device ◽  
Feasibility Study ◽  
Water Soluble ◽  
High Mass ◽  
Direct Extraction ◽  
Healthy Sheep ◽  
Chelating Polymer ◽  
Metallic Cations ◽  
Extraction Of Metals

Abstract In this article, we report the conception and the use of dialysis based medical device for extraction of metals. The medical device is obtained by addition in the dialysate of a functionnalized chitosan that can chelate endogenous metals like iron or copper. The water soluble functionnalized chitosan is obtained after controlled reacetylation and addition of DOTAGA. Due to the high mass of chitosan, the polymer cannot cross through the membrane and the metals are trapped in the dialysate during hemodialysis. Copper captation has been evaluated in vitro using an hemodialysis protocol. Feasibility study has been performed on healthy sheep showing no acute toxicity of the whole procedure and first insights of metallic extraction even on healthy animals.

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