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.

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.

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.

scholarly journals The Relationship between Language Learning Strategies and Lexical Complexity Measures

2021 ◽  
pp. 37-52
Author(s):  
Ervin Kovacevic
Keyword(s):  
English Language Learners ◽  
Language Learning ◽  
Learning Strategies ◽  
English Language ◽  
Cognitive Strategies ◽  
English For Academic Purposes ◽  
Language Learning Strategies ◽  
Complexity Measures ◽  
Lexical Complexity ◽  
The Relationship

This study examines the hypothesis that language learning strategies (LLS) partly account for the level of L2 proficiency (i.e. the level of L2 lexical complexity produced in the written output of English language learners). To test the hypothesis, 152 English-proficient freshman students of Bosnian L1 linguistic background were surveyed utilizing the Strategy Inventory for Language Learning (SILL) designed by Rebecca Oxford (1990). Their lexical output was collected through short essays that were written during formal exams held in English for Academic Purposes undergraduate courses at the International University of Sarajevo. The written samples were converted to an electronic format and analyzed with the Web-based Lexical Complexity Analyzer (Lu, 2012; Ai & Lu, 2010). Relationships between six SILL subscales and twenty-five lexical complexity (LC) measures were assessed through applying the principles of correlational design. The results confirmed the hypothesis. Statistically significant correlations were found between memory strategies and three LC measures, cognitive strategies and twenty LC measures, compensation strategies and nine LC measures, and affective strategies and three LC measures. It is concluded that the relationship between LLS and LC levels is mostly conditioned by LLS types.

scholarly journals Implementation of Apriori Algorithm Data Mining for Increase Sales

SinkrOn ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. 17
Author(s):  
Reza Alfianzah ◽  
Rani Irma Handayani ◽  
Murniyati Murniyati
Keyword(s):  
Data Mining ◽  
Business Strategy ◽  
A Priori ◽  
Data Mining Algorithm ◽  
Sales Data ◽  
The Right ◽  
Or Organization ◽  
Product Sales ◽  
The Relationship ◽  
Confidence Value

Any company or organization that wants to survive needs to determine the right business strategy. The product sales data carried out by Lakoe Dessert Pondok Kacang will eventually result in a pile of data, so it is unfortunate if it is not re-analyzed. The products offered vary with a wide variety of products as many as 45 products, to find out the products with the most sales and the relationship between one product and another, one of the algorithms is needed in the data mining algorithm, namely the a priori algorithm to find out, and with the help of the Rapidminer 5 application, with a support value 2,4% and a confidence value 50%, products that customers often buy or are interested in can be found. This study used sales data for March 2020, which amounted to 209 transaction data. From the research, it was found that the item with the name Pudding Strawberry and Pudding Vanilla was the product most purchased by consumers. With knowledge of the most sold products and the patterns of purchasing goods by consumers, Lakoe Dessert Pondok Kacang can develop marketing strategies to market other products by analyzing the profits from selling the most sold products and anticipating running out or empty of stock or materials at a later date.

A Map Complexity Measure Based on Contact Surface

2013 ◽  
Vol 411-414 ◽  
pp. 1994-1997
Author(s):  
Yan Li ◽  
Wen Ju Zhao ◽  
Zhen Hua Zhou
Keyword(s):  
Contact Surface ◽  
Hamming Distance ◽  
Measurement Methods ◽  
Complexity Measure ◽  
Connectivity Map ◽  
Complexity Measures ◽  
The Relationship

This paper defined the full connect map and contact surface, and proposed a new map complexity measure, and compared with measurement methods based on Hamming distance and relative Hamming distance. We further research on the relationship between the complexity measure and the map connectivity. The complexity measures based on Hamming distance and contact surface are applicable to full connectivity map, and the new measurement can reflects the difficulty of the pathfinding algorithm more accurately, especially in a higher complexity.

The demoralization of society and the proliferation of organization

Kybernetes ◽  
2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Kurt Rachlitz ◽  
Benjamin Grossmann-Hensel ◽  
Ronja Friedl
Keyword(s):  
Social Systems ◽  
Historical Analysis ◽  
Modern Society ◽  
Alternative Possibilities ◽  
Content Type ◽  
Love Relationships ◽  
Social Forms ◽  
Or Organization ◽  
The Relationship

PurposeIn this paper, the authors aim to clarify the relationship between organization and society. They argue that the proliferation of organization in modernity has not yet been properly understood in light of the absence of organization in premodern times. The authors therefore ask: Why do organizations proliferate? Why do they proliferate in such manifold organizational forms? And how can these heterogeneous forms nevertheless be related to a common problem to which organizations provide a solution? A comparative historical analysis based on the theory of social systems reveals that organizations fill a gap which the decline of morality as an integrative success medium created.Design/methodology/approachThe paper develops a conceptual framework focusing on the theory of media within Luhmann’s theory of social systems as a point of departure. The authors discuss the concept of “interpenetration” to assess the relation between morality and organization. They raise several follow-up questions for future empirical research, most prominently pertaining to the relationship between organization and digitalization.FindingsThe main finding is that morality can be conceptualized as a specific success medium (alongside religion and symbolically generalized communication media) which used to structure premodern societies by means of social and interhuman interpenetration at once. Modern society instead employs two differentiated forms of interpenetration: Social interpretation through organizations and interhuman interpenetration through love relationships. These centripetal counterforces help to mediate the centrifugal forces unleashed by the full development of modern success media. Modern society critically depends on the proliferation of organizations.Originality/valueThis paper examines the relationship between morality and organization not from the perspective of interaction or organization, but from the perspective of society. This approach provides novel insights in that it opens up promising avenues of comparison between organization and other social forms. Understanding the distinctively modern “success story” of organization as a social form makes it possible to ask about corresponding potentials and limitations, but also alternative possibilities. In doing so, the authors depart from most studies of organizations grounded in social systems theory as the authors primarily focus on Luhmann’s theory of media (as opposed to the theory of differentiation).

Susceptibility of almond (Prunus dulcis) cultivars to twig canker and shoot blight caused by Diaporthe amygdali

Plant Disease ◽  
2022 ◽  
Author(s):  
Francisco Beluzán ◽  
Xavier Miarnau ◽  
Laura Torguet ◽  
Lourdes Zazurca ◽  
Paloma Abad-Campos ◽  
...  
Keyword(s):  
Agronomic Traits ◽  
Field Tests ◽  
Prunus Dulcis ◽  
Breeding Programs ◽  
Relevant Variables ◽  
Shoot Blight ◽  
Blight Disease ◽  
Cultivar Susceptibility ◽  
The Relationship ◽  
Selection Of

Twenty-five almond cultivars were assessed for susceptibility to Diaporthe amygdali, causal agent of twig canker and shoot blight disease. In laboratory experiments, growing twigs were inoculated with four D. amygdali isolates. Moreover, growing shoots of almond cultivars grafted onto INRA ‘GF-677’ rootstock were used in four-year field inoculations with one D. amygdali isolate. In both type of experiments, inoculum consisted of agar plugs with mycelium, which were inserted underneath the bark and the lesion lengths caused by the fungus were measured. Necrotic lesions were observed in the inoculated almond cultivars both in laboratory and field tests, confirming the susceptibility of all the evaluated cultivars to all the inoculated isolates of D. amygdali. Cultivars were grouped as susceptible or very susceptible according to a cluster analysis. The relationship between some agronomic traits and cultivar susceptibility was also investigated. Blooming and ripening times were found relevant variables to explain cultivars performance related to D. amygdali susceptibility. Late and very late blooming, and early and medium ripening cultivars were highly susceptible to D. amygdali. Our results may provide valuable information that could assist in ongoing breeding programs of this crop and additionally in the selection of cultivars for new almond plantations.

OP04 Cardiac Implant Registries: Systematic Review Of Global Practices

2018 ◽  
Vol 34 (S1) ◽  
pp. 2-2
Author(s):  
Peter Kolominsky-Rabas ◽  
Shixuan Zhang ◽  
Sebastian Gaiser
Keyword(s):  
Data Collection ◽  
Medical Device ◽  
Best Practice ◽  
Electronic Device ◽  
Data Entry ◽  
Joint Decision ◽  
World Picture ◽  
Regulatory Decision ◽  
Long Term Follow Up ◽  
Regulatory Decisions

Introduction:The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in post-marked surveillance has been recognized and approved, but there is a lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006–2016) and to provide recommendations on “best practice” approaches.Methods:A systematic search on CIR was employed in line with the PRISMA guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect, EMBASE and the Scopus database. After identifying the existing CIR, an inductive approach was used to explore key elements emerging in the identified registries.Results:The following eighty-two registries were identified: eighteen ICD registries, seven CRT registries, five pacemaker registries, and six Cardiovascular Implantable Electronic Device (CIED) registries which combined ICD, pacemaker and CRT implantation data; as well as twenty-two coronary stent registries and twenty-four TAVI registries. While seventy-one national or local registries are from a single country, forty-four are from European countries, and nine are located in USA. The following criteria have been summarized from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.Conclusions:For HTA as well as regulatory decision making, medical device registries provide a “real-world” picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and approval issues of medical devices; for payers CIRs provide evidence on the medical device benefits and drive the decision as to whether the product should be reimbursed or not; for hospitals data from CIRs are important for sound procurement decisions, and CIRs also help patients and their physicians to reach a joint decision on which of the products is the most appropriate. However, many current CIRs are still lacking standards to inform on patient safety and ensure transparency.

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