scholarly journals Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

Materials ◽  
2021 ◽  
Vol 14 (13) ◽  
pp. 3528
Author(s):  
Mauro Petretta ◽  
Giovanna Desando ◽  
Brunella Grigolo ◽  
Livia Roseti

Extrusion bioprinting is considered promising in cartilage tissue engineering since it allows the fabrication of complex, customized, and living constructs potentially suitable for clinical applications. However, clinical translation is often complicated by the variability and unknown/unsolved issues related to this technology. The aim of this study was to perform a risk analysis on a research process, consisting in the bioprinting of a stem cell-laden collagen bioink to fabricate constructs with cartilage-like properties. The method utilized was the Failure Mode and Effect Analysis/Failure Mode and Effect Criticality Analysis (FMEA/FMECA) which foresees a mapping of the process to proactively identify related risks and the mitigation actions. This proactive risk analysis allowed the identification of forty-seven possible failure modes, deriving from seventy-one potential causes. Twenty-four failure modes displayed a high-risk level according to the selected evaluation criteria and threshold (RPN > 100). The results highlighted that the main process risks are a relatively low fidelity of the fabricated structures, unsuitable parameters/material properties, the death of encapsulated cells due to the shear stress generated along the nozzle by mechanical extrusion, and possible biological contamination phenomena. The main mitigation actions involved personnel training and the implementation of dedicated procedures, system calibration, printing conditions check, and, most importantly, a thorough knowledge of selected biomaterial and cell properties that could be built either through the provided data/scientific literature or their preliminary assessment through dedicated experimental optimization phase. To conclude, highlighting issues in the early research phase and putting in place all the required actions to mitigate risks will make easier to develop a standardized process to be quickly translated to clinical use.

2013 ◽  
Vol 837 ◽  
pp. 16-21
Author(s):  
Nadia Belu ◽  
Daniel Constantin Anghel ◽  
Nicoleta Rachieru

Failure Mode and Effects Analysis is a methodology to evaluate a system, design, process, machine or service for possible ways in which failures (problems, errors, risks and concerns) can occur and it has been used in a wide range of industries. Traditional method uses a Risk Priority Number to evaluate the risk level of a component or process. This is obtained by finding the multiplication of three factors, which are the severity of the failure (S), the probability/occurrence of the failure (O), and the probability of not detecting the failure (D). There are significant efforts which have been made in FMEA literature to overcome the shortcomings of the crisp RPN calculation. Fuzzy logic appears to be a powerful tool for performing a criticality analysis on a system design and prioritizing failure identified in analisys FMEA for corrective actions. In this paper we present a parallel between the typical and the fuzzy computation of RPNs, in order to assess and rank risks associated to failure modes that could appear in the functioning of control equipment.


2013 ◽  
Vol 289 ◽  
pp. 93-98 ◽  
Author(s):  
Shu Zhong Zhang ◽  
Qin Da Zeng ◽  
Gong Zhang

The traditional failure mode, effect, and criticality analysis (FMECA) uses risk priority number (RPN) to evaluate the risk level of a failure mode. The RPN index is calculated by multiplication of severity, occurrence and detection factors. The most critically debated disadvantage of this approach is that various combinations of these three factors may produce an identical value of RPN. This paper reviews the drawbacks in traditional FMECA and proposes a new approach to overcome these shortcomings. The proposed approach evaluates risk of failure mode by encouragement-variable-weighted analytic hierarchy process (EVW-AHP) that can prioritize failure modes even if two or more failure modes have same RPN. An example is provided to show the potential applications of the proposed approach and the detailed computational process is presented. The results based on the case study show the proposed new methodology solves the limitations of traditional FMECA approach and is feasible.


Author(s):  
Anamarija Rogina ◽  
Maja Pušić ◽  
Lucija Štefan ◽  
Alan Ivković ◽  
Inga Urlić ◽  
...  

2016 ◽  
Vol 33 (6) ◽  
pp. 830-851 ◽  
Author(s):  
Soumen Kumar Roy ◽  
A K Sarkar ◽  
Biswajit Mahanty

Purpose – The purpose of this paper is to evolve a guideline for scientists and development engineers to the failure behavior of electro-optical target tracker system (EOTTS) using fuzzy methodology leading to success of short-range homing guided missile (SRHGM) in which this critical subsystems is exploited. Design/methodology/approach – Technology index (TI) and fuzzy failure mode effect analysis (FMEA) are used to build an integrated framework to facilitate the system technology assessment and failure modes. Failure mode analysis is carried out for the system using data gathered from technical experts involved in design and realization of the EOTTS. In order to circumvent the limitations of the traditional failure mode effects and criticality analysis (FMECA), fuzzy FMCEA is adopted for the prioritization of the risks. FMEA parameters – severity, occurrence and detection are fuzzifed with suitable membership functions. These membership functions are used to define failure modes. Open source linear programming solver is used to solve linear equations. Findings – It is found that EOTTS has the highest TI among the major technologies used in the SRHGM. Fuzzy risk priority numbers (FRPN) for all important failure modes of the EOTTS are calculated and the failure modes are ranked to arrive at important monitoring points during design and development of the weapon system. Originality/value – This paper integrates the use of TI, fuzzy logic and experts’ database with FMEA toward assisting the scientists and engineers while conducting failure mode and effect analysis to prioritize failures toward taking corrective measure during the design and development of EOTTS.


Biomaterials ◽  
2011 ◽  
Vol 32 (25) ◽  
pp. 5773-5781 ◽  
Author(s):  
Nandana Bhardwaj ◽  
Quynhhoa T. Nguyen ◽  
Albert C. Chen ◽  
David L. Kaplan ◽  
Robert L. Sah ◽  
...  

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