manufacturing readiness
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Metals ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 44
Author(s):  
Matthias Schneck ◽  
Max Horn ◽  
Maik Schindler ◽  
Christian Seidel

Additive Manufacturing (AM) allows the manufacturing of functionally graded materials (FGM). This includes compositional grading, which enables the allocation of desired materials corresponding to local product requirements. An upcoming AM process for the creation of metal-based FGMs is laser-based powder bed fusion (PBF-LB/M) utilized for multi-material manufacturing (MM). Three-dimensional multi-material approaches for PBF-LB/M are stated to have a manufacturing readiness level (MRL) of 4 to 5. In this paper, an advancement of multi-material technology is presented by realizing an industry-relevant complex part as a prototype made by PBF-LB/M. Hence, a multi-material injection nozzle consisting of tool steel and a copper alloy was manufactured in a continuous PBF-LB/M process. Single material regions showed qualities similar to the ones resulting from mono-material processes. A geometrically defined transition zone between the two materials was achieved that showed slightly higher porosity than mono-material regions. Nevertheless, defects such as porosity, cracks, and material cross-contamination were detected and must be overcome in further MM technology development.


Author(s):  
Ben Creelman ◽  
Collrane Frivold ◽  
Sierra Jessup ◽  
Gene Saxon ◽  
Courtney Jarrahian

AbstractMicroneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to identify both the current manufacturing readiness of the industry as well as how readiness varies by developer type and MAP type. Follow-up interviews identified barriers the industry faces in reaching full manufacturing readiness, including the perceived regulatory and investment risk of manufacturing MAPs at scale due to quality requirements and control methods, uncertain sterility requirements, lack of standard production methods (especially around dissolvable MAP drying methods), and the lack of available contract manufacturing organizations with MAP manufacturing capabilities. A Regulatory Working Group has been established to identify and address critical quality issues specific to MAP manufacturing with the aim of providing developers insight into what will be expected for MAP product approvals. Standardizing MAP production equipment and automatic, visual quality control could reduce the overall investment risk to developers and contract manufacturing organizations in pursuing pilot-scale manufacturing capabilities and ultimately lower barriers to the scale-up of full medical MAP product lines. Graphical abstract


2021 ◽  
Vol 13 (17) ◽  
pp. 9793
Author(s):  
Syed Radzi Bin Rahamaddulla ◽  
Zulkiflle Leman ◽  
B. T. Hang Tuah Bin Baharudin ◽  
Siti Azfanizam Ahmad

Manufacturing enterprises today are forced to face radical challenges in the disruptive concepts of Smart Manufacturing (SM) and Industry 4.0 to stay competitive. Most Multinational Enterprise (MNEs) have initiated their journey towards adopting SM. As a mainspring of many manufacturing economies, Small and Medium-Enterprise (SMEs) are still struggling to understand the complexity offered in SM, and many of them are not ready to embrace the concept of SM. To overcome this, SMEs first need to assess their readiness and maturity before embarking on an SM journey. The existing available readiness assessment model seems to be suitable for MNEs, and there is still a lack of tailored models that suit SMEs. This paper sought to pinpoint the conceptual framework from the review of the existing readiness-maturity assessment and identify the gap of existing model as well as proposed a tailored model framework that are suitable for SMEs. Ultimately, this model will be used to pursue a comprehensive scholarly study across Malaysia. The proposed model is enhanced with 4M attributes as the dimension and embedded with the characteristic of Industry 4.0 build component to help the SME’s overcome the possible uncertainties in adopting SM concept.


Author(s):  
M. Schneck ◽  
M. Horn ◽  
M. Schmitt ◽  
C. Seidel ◽  
G. Schlick ◽  
...  

AbstractIn this review paper, the authors investigate the state of technology for hybrid- and multi-material (MM) manufacturing of metals utilizing additive manufacturing, in particular powder bed fusion processes. The study consists of three parts, covering the material combinations, the MM deposition devices, and the implications in the process chain. The material analysis is clustered into 2D- and 3D-MM approaches. Based on the reviewed literature, the most utilized material combination is steel-copper, followed by fusing dissimilar steels. Second, the MM deposition devices are categorized into holohedral, nozzle-based as well as masked deposition concepts, and compared in terms of powder deposition rate, resolution, and manufacturing readiness level (MRL). As a third aspect, the implications in the process chain are investigated. Therefore, the design of MM parts and the data preparation for the production process are analyzed. Moreover, aspects for the reuse of powder and finalization of MM parts are discussed. Considering the design of MM parts, there are theoretical approaches, but specific parameter studies or use cases are not present in the literature. Principles for powder separation are identified for exemplary material combinations, but results for further finalization steps of MM parts have not been found. In conclusion, 3D-MM manufacturing has a MRL of 4–5, which indicates that the technology can be produced in a laboratory environment. According to this maturity, several aspects for serial MM parts need to be developed, but the potential of the technology has been demonstrated. Thus, the next important step is to identify lead applications, which benefit from MM manufacturing and hence foster the industrialization of these processes.


2021 ◽  
Author(s):  
Ben Creelman ◽  
Collrane Frivold ◽  
Sierra Jessup ◽  
Gene Saxon ◽  
Courtney Jarrahian

Abstract Microarray patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals. Yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to identify both the current manufacturing readiness of the industry as well as how readiness varies by developer type and MAP type. Follow-up interviews identified barriers the industry faces in reaching full manufacturing readiness, including the perceived regulatory and investment risk of manufacturing MAPs at scale due to quality requirements and control methods, uncertain sterility requirements, lack of standard production methods (especially around dissolvable MAP drying methods), and the lack of available contract manufacturing organizations with MAP manufacturing capabilities. A Regulatory Working Group has been established to identify and address critical quality issues specific to MAP manufacturing with the aim of providing developers insight into what will be expected for MAP product approvals. Standardizing MAP production equipment and automatic, visual quality control could reduce the overall risk to developers and contract manufacturing organizations in pursuing pilot-scale manufacturing capabilities and ultimately lower barriers to the scale-up of full medical MAP product lines.


2020 ◽  
Vol 311 ◽  
pp. 02008
Author(s):  
Pavel Drogovoz ◽  
Olga Yusufova ◽  
Alexander Gutenev

The features of the application of the system engineering methodology, technology and manufacturing readiness levels metrics when creating high-tech industrial products in the digital transformation of the economy are considered. The concept of manufacturing and economic feasibility of a perspective technical system is introduced. An approach to the economic and mathematical modeling of real options is proposed for a formalized description and decision support for managing multi-stage and interconnected processes for creating a goal technical system and supporting manufacturing system. The directions of further research are determined and the tasks of applied development of real options pricing models are posed.


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