scholarly journals TOWARDS A VERIFICATION AND VALIDATING TESTING FRAMEWORK TO DEVELOP BESPOKE MEDICAL PRODUCTS IN RESEARCH-FUNDED PROJECTS

2021 ◽  
Vol 1 ◽  
pp. 3199-3208
Author(s):  
Emanuel Balzan ◽  
Pierre Vella ◽  
Philip Farrugia ◽  
Edward Abela ◽  
Glenn Cassar ◽  
...  
Keyword(s):  
Medical Devices ◽  
Early Stage ◽  
Design Stage ◽  
Concept Design ◽  
Proof Of Concept ◽  
Detailed Design ◽  
Testing Framework ◽  
Medical Products ◽  
Manufacturing Technologies ◽  
Validation Testing

AbstractResearch funded projects are often concerned with the development of proof-of-concept products. Consequently, activities related to verification and validation testing (VVT) are often not considered in depth, even though various design iterations are carried out to refine an idea. Furthermore, the introduction of additive manufacturing (AM) has facilitated, in particular, the development of bespoke medical products. End bespoke products, which will be used by relevant stakeholders (e.g. patients and clinicians) are fabricated with the same manufacturing technologies used during prototyping. As a result, the detailed design stage of products fabricated by AM is much shorter. Therefore, to improve the market-readiness of bespoke medical devices, testing must be integrated within the development from an early stage, allowing better planning of resources. To address these issues, in this paper, a comprehensive VVT framework is proposed for research projects, which lack a VVT infrastructure. The framework builds up on previous studies and methods utilised in industry to enable project key experts to capture risks as early as the concept design stage.

Study on Design Support Method Considering the Interaction Among Multi-Variables

2008 ◽  
Author(s):  
Junya Noda ◽  
Qiang Yu
Keyword(s):  
Graphical Model ◽  
Simulation Models ◽  
Hierarchical Cluster ◽  
Design Stage ◽  
Concept Design ◽  
Design Quality ◽  
Detailed Design ◽  
Design Support ◽  
Characteristic Values ◽  
Design Factors

Recently, a remarkable shortening of the development and design period becomes possible by the development of CAE and the optimization technologies, and efficient improvement of design quality in the detailed design stage has been achieved. Nevertheless, it is thought that there is a limit to for this kind of improvement in the near future, no matter how much the upgrade of the detailed design stage will be attempted. Therefore, the technology requested in the next step should be a new approach that can improve the quality of design concept and the efficiency of the concept design processes. For the engineers to improve concept design efficiency, they are requested that they should have very good understanding about the physics of their objectives and special experience about know-how for forming the answers to a very complicated problems. Thus, it is necessary to know the complicated physical relation between the design factors and the evaluation characteristic values to upgrade the concept design stage. It is thought that it can make a further improvement on the efficiency of design process if the technique, which can help the engineers to grip this relation, is established. However, it is very difficult for the engineers to understand a real complicated problem by few experiences. There are a lot of reasons for this kind of problems. For example, there will be a various patterns of design factors that achieve the similar design results, if the design factors have strong interacting relation between each other. In this study, the authors proposed a design support method for extracting the relation between the design factors and the evaluation characteristic values by using the results obtained by simulation models, and it was applied to the vehicle design problems in considering the interaction among the multi-variables by using a hierarchical cluster analysis and a graphical model. It was shown that the results given by the proposed approach can help the engineers to find and understand the essence of the phenomena involved.

Physician-Developer Interaction in Medical Device Design

2010 ◽  
Author(s):  
Lauren A. Shluzas ◽  
Larry J. Leifer
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Early Stage ◽  
End Users ◽  
Device Design ◽  
Financial Outcomes ◽  
Medical Device Design ◽  
Medical Products

Industry-physician relationships have been widely reported throughout the medical device community. However, there is limited research that describes how device developers effectively interact with physicians throughout the development of new medical products. There is also limited research regarding how the process of physician-developer interaction influences the clinical and financial outcomes of early stage companies. Knowledge of such interaction is particularly relevant to the large and growing number of complex and high-risk medical devices, in which physicians are the primary end users and patients are the recipients of care.

Early-Stage Analysis for MEMS Structural Optimization II: Its Application to Microrelay Reliability

2005 ◽  
Author(s):  
Koji Ishikawa ◽  
Takahiro Miki ◽  
Hiroki Mamiya ◽  
Q. Yu
Keyword(s):  
Structural Optimization ◽  
Mechanical Performance ◽  
Early Stage ◽  
Design Stage ◽  
Design Parameters ◽  
Total System ◽  
Concept Design ◽  
Restoring Force ◽  
Electrostatic Actuators ◽  
The Impact

This paper discusses a new structural optimization methodology for MEMS and its application to reliability evaluation of micro relays. Clarifying the relationship between system characteristics and design factors, our new design optimization method (called MESA) enables numerical evaluation of MEMS structures at the concept design stage. The relation is defined as sensitivity, which is calculated based on the system governing equations with an experimental method technique and a FEM analysis. The sensitivities show not only the effect of design parameters for the system performances but also the system tradeoffs. The MESA allows designers to obtain “rough” total system performance and create a new concept. The MESA is successfully applied to evaluate an electrostatic microrelay for DC/RF signal switching. With the aid of the MESA, we define existing problems of current cantilever-shape MEMS switches and propose new mechanical approaches in order to enhance the mechanical reliability. The MESA clearly shows us that there are tradeoffs in the switching phenomenon of cantilever microrelay. Based on the MESA information, a new switching concept, which has tri-state multi-finger lateral contacts, is established and the MEMS structure is designed and fabricated. The tri-state switching concept reduces the number of contacts and also disperses the impact energy, which aggravates adhesion. In addition, bi-electrostatic actuators increase the adverse force to prevent stiction without the increase of restoring force, which causes degradation or cracks of the contact surfaces. Furthermore, a new push-pull switching structure is designed as a second generation by means of the MESA. The MESA shows that the second concept will provide superior mechanical performance with keeping the high RF isolation.

Tailoring Design Development and Ideation in Catering To Industry Demands

2017 ◽  
Vol 14 (1) ◽  
pp. 67
Author(s):  
Fadila Mohd Yusof ◽  
Azmir Mamat Nawi ◽  
Azhari Md Hashim ◽  
Ahmad Fazlan Ahmad Zamri ◽  
Abu Hanifa Ab Hamid ◽  
...  
Keyword(s):  
Teaching And Learning ◽  
Industrial Design ◽  
Protocol Analysis ◽  
Early Stage ◽  
Idea Generation ◽  
Learning Processes ◽  
Design Stage ◽  
Design Development ◽  
Conceptual Design Phase ◽  
Industry Practice

Design development is one of the processes in the teaching and learning of industrial design. This process is important during the early stage of ideas before continuing to the next design stage. This study was conducted to investigate the comparison between  academic  syllabus  and  industry  practices  whether  these  processes  are  highly dependent on the idea generation and interaction related to the designer or to the student itself. The data were gathered through an observation of industry practice during conceptual design phase, teaching and learning process in academic through Video Protocol Analysis (VPA) method and interviews with industry practitioners via structured and unstructured questionnaires. The data were analysed by using NVivo software in order to formulate the results. The findings may possibly contribute to the teaching and learning processes especially in the improvement of industrial design syllabus in order to meet the industry demands. Keywords: design development, industrial design, industry demands

scholarly journals Methodology for the Concept Design of Locally Reinforced Composites

2021 ◽  
Vol 11 (16) ◽  
pp. 7246
Author(s):  
Julius Moritz Berges ◽  
Georg Jacobs ◽  
Sebastian Stein ◽  
Jonathan Sprehe
Keyword(s):  
Cost Estimation ◽  
Structural Design ◽  
Early Stage ◽  
Parameter Study ◽  
Great Effort ◽  
Concept Design ◽  
Cost Weight ◽  
Reinforced Plastics ◽  
Fiber Reinforced Plastics ◽  
The Cost

Locally load-optimized fiber-based composites, the so-called tailored textiles (TT), offer the potential to reduce weight and cost compared to conventional fiber-reinforced plastics (FRP). However, the design of TT has a higher complexity compared to FRP. Current approaches, focusing on solving this complexity for multiple objectives (cost, weight, stiffness), require great effort and calculation time, which makes them unsuitable for serial applications. Therefore, in this paper, an approach for the efficient creation of simplified TT concept designs is presented. By combining simplified models for structural design and cost estimation, the most promising concepts, regarding the cost, weight, and stiffness of TT parts, can be identified. By performing a parameter study, the cost, weight, and stiffness optima of a sample part compared to a conventional FRP component can be determined. The cost and weight were reduced by 30% for the same stiffness. Applying this approach at an early stage of product development reduces the initial complexity of the subsequent detailed engineering design, e.g., by applying methods from the state of the art.

scholarly journals SIMULTANEOUS DEFINITION OF KEY CHARACTERISTICS IN ORDER TO FACILITATE ROBUST DESIGN IN EARLY PRODUCT DEVELOPMENT STAGES

2021 ◽  
Vol 1 ◽  
pp. 2691-2700
Author(s):  
Stefan Goetz ◽  
Dennis Horber ◽  
Benjamin Schleich ◽  
Sandro Wartzack
Keyword(s):  
Product Development ◽  
Robust Design ◽  
Language Processing ◽  
Design Stage ◽  
Concept Design ◽  
Clear Definition ◽  
Implicit Information ◽  
Key Characteristics ◽  
Associated Functions ◽  
Definition Of

AbstractThe success of complex product development projects strongly depends on the clear definition of target factors that allow a reliable statement about the fulfilment of the product requirements. In the context of tolerancing and robust design, Key Characteristics (KCs) have been established for this purpose and form the basis for all downstream activities. In order to integrate the activities related to the KC definition into product development as early as possible, the often vaguely formulated requirements must be translated into quantifiable KCs. However, this is primarily a manual process, so the results strongly depend on the experience of the design engineer.In order to overcome this problem, a novel computer-aided approach is presented, which automatically derives associated functions and KCs already during the definition of product requirements. The approach uses natural language processing and formalized design knowledge to extract and provide implicit information from the requirements. This leads to a clear definition of the requirements and KCs and thus creates a founded basis for robustness evaluation at the beginning of the concept design stage. The approach is exemplarily applied to a window lifter.

scholarly journals Skeletal muscle PGC-1β signaling is sufficient to drive an endurance exercise phenotype and to counteract components of detraining in mice

2017 ◽  
Vol 312 (5) ◽  
pp. E394-E406 ◽  
Author(s):  
Samuel Lee ◽  
Teresa C. Leone ◽  
Lisa Rogosa ◽  
John Rumsey ◽  
Julio Ayala ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Exercise Training ◽  
Early Stage ◽  
Peroxisome Proliferator ◽  
Disuse Atrophy ◽  
Proof Of Concept ◽  
Peroxisome Proliferator Activated Receptor ◽  
Muscle Disuse ◽  
Training Response

Peroxisome proliferator-activated receptor-γ coactivator (PGC)-1α and -1β serve as master transcriptional regulators of muscle mitochondrial functional capacity and are capable of enhancing muscle endurance when overexpressed in mice. We sought to determine whether muscle-specific transgenic overexpression of PGC-1β affects the detraining response following endurance training. First, we established and validated a mouse exercise-training-detraining protocol. Second, using multiple physiological and gene expression end points, we found that PGC-1β overexpression in skeletal muscle of sedentary mice fully recapitulated the training response. Lastly, PGC-1β overexpression during the detraining period resulted in partial prevention of the detraining response. Specifically, an increase in the plateau at which O2 uptake (V̇o2) did not change from baseline with increasing treadmill speed [peak V̇o2 (ΔV̇o2max)] was maintained in trained mice with PGC-1β overexpression in muscle 6 wk after cessation of training. However, other detraining responses, including changes in running performance and in situ half relaxation time (a measure of contractility), were not affected by PGC-1β overexpression. We conclude that while activation of muscle PGC-1β is sufficient to drive the complete endurance phenotype in sedentary mice, it only partially prevents the detraining response following exercise training, suggesting that the process of endurance detraining involves mechanisms beyond the reversal of muscle autonomous mechanisms involved in endurance fitness. In addition, the protocol described here should be useful for assessing early-stage proof-of-concept interventions in preclinical models of muscle disuse atrophy.

Quantifying Design and Manufacturing Robustness Through Stochastic Optimization Techniques

1996 ◽  
Author(s):  
David Kazmer ◽  
Philip Barkan ◽  
Kosuke Ishii
Keyword(s):  
Manufacturing Process ◽  
Process Variation ◽  
Optimization Techniques ◽  
Design Stage ◽  
Tool Geometry ◽  
Detailed Design ◽  
Process Dynamics ◽  
Molded Parts ◽  
Industry Practice ◽  
End Use

Abstract Critical design decisions are often made during the detailed design stage assuming known material and process behavior. However, in net shape manufacturing processes such as stamping, injection molding, and metals casting, the final part properties depend upon the specific tool geometry, material properties, and process dynamics encountered during production. As such, the end-use performance can not be accurately known in the detailed design stage. Moreover, slight random variations during manufacture can inadvertently result in inferior or unacceptable product performance and reduced production yields. These characteristics make it difficult for the designer to select the tooling, material, and processing details which will deliver the desired functional properties, let alone achieve a robust design which is tolerant to process variation. This paper describes a methodology for assessing the design/manufacturing robustness of candidate designs at the detailed design stage. In the design evaluation, the fundamental sources of variation are explicitly modeled and the effects conveyed through the manufacturing process to predict the distribution of end-use part properties. This is accomplished by utilizing optimization of manufacturing process variables within Monte Carlo simulation of stochastic process variation, which effectively parallels the industry practice of tuning and optimizing the process once the tool reaches the production floor. The resulting estimates can be used to evaluate the robustness of the candidate design relative to the product requirements and provide guidance for design and process modifications before tool steel is cut, as demonstrated by the application of the methodology for dimensional control of injection molded parts.

Applying Spring Security Framework with KeyCloak-based OAuth2 to Protect Microservice Architecture APIs for a Health eCoach System: A Proof-of-Concept Study (Preprint)

2021 ◽  
Author(s):  
Ayan Chatterjee ◽  
Andreas Prinz
Keyword(s):  
Open Access ◽  
Medical Devices ◽  
Data Protection ◽  
Experimental Testing ◽  
Virtual Private Network ◽  
Security And Privacy ◽  
Secure Socket Layer ◽  
Proof Of Concept ◽  
Private Network ◽  
Microservice Architecture

UNSTRUCTURED The Internet of Medical Things (IoMT) combines medical devices and applications connected to healthcare information technology systems using network technologies. With the flourishing adaptation rate of Internet-enabled medical devices in healthcare applications, we need to guarantee the security and privacy of electronic health records (EHRs) and communications among these IoMT devices, exposed web services, and the underlying infrastructure. This research is a proof-of-concept (PoC) study for implementing an integrated security solution with Spring Security and KeyCloak open-access platform (SSK) to safeguard microservice architecture application programming interfaces (APIs). Subsequently, we extended the security solution with a virtual private network (VPN), Bcrypt hash, API key, network firewall, and secure socket layer (SSL) to build up a digital infrastructure following the Norwegian data protection policies and General Data Protection Regulation (GDPR). In this study, we have not proposed any new security solution; however, we have focused on accomplishing a hybrid security solution based on the established frameworks (e.g., Spring Security) and open-access software product (e.g., Keycloak) to protect microservice APIs for a health eCoach system as a PoC study. This study describes the methodological, technical, and practical considerations to protect REST interfaces only and ensuring the privacy of data in the system. We validate our SSK security implementation by theoretical evaluation and experimental testing. In addition, we compare the test results with related studies qualitatively to determine the effectiveness of the hybrid security solution (SSK).

scholarly journals Standard manual reprocessing of angiographic systems in the hybrid OR

2017 ◽  
Vol 3 (2) ◽  
pp. 405-407
Author(s):  
Sebastian Buhl ◽  
Carina Werner ◽  
Clemens Bulitta
Keyword(s):  
Pilot Study ◽  
Medical Devices ◽  
Initial Assessment ◽  
Hybrid Operating Room ◽  
Medical Products ◽  
Fda Guidance ◽  
Microbiological Examination ◽  
Artis Zeego ◽  
Cleaning And Disinfection ◽  
A Current

AbstractA current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.

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