Sterilization Modality Selection: Role of Sterility Assurance Subject Matter Expert

2021 ◽  
Vol 55 (s3) ◽  
pp. 67-77
Author(s):  
Jami McLaren ◽  
Joyce M. Hansen ◽  
Vu Le

Abstract Selection of a sterilization modality for a medical device is a critical decision that requires sterility assurance subject matter experts (SME)s to work collaboratively with various company functions. The sterility assurance SME is responsible and accountable for the sterilization modality decision for a product. The modality selection process starts with the sterility assurance SME partnering with research and development to ensure that the sterilization modality allows the device to deliver its intended function in patient care. After the sterilization modality is selected, the sterility assurance SME needs to work with other partners, including quality, supply chain/logistics, operations, and regulatory, to ensure that the selected sterilization modality is appropriately integrated into the end-to-end process. Collaborative partnerships between sterility assurance experts and key partners regarding sterilization modality selection reduce the potential for negative impacts within the end-to-end sterility assurance process, including impacts on product functionality, increased regulatory approval timelines, and inefficiencies and risks throughout the supply chain. This article describes aspects of a comprehensive approach to sterilization modality selection, including critical information necessary to address each of the key considerations.

Author(s):  
Ibibia K. Dabipi ◽  
Judy A. Perkins ◽  
Tierney Moore

Over the years the supply chain industry has been transforming to improve the end-to-end (production to delivery) process. Supply chain management (SCM) allows various industries to oversee and better handle how their product is manufactured and delivered. It allows them to track and identify the location of the product and to be more efficient in delivery. Integrating total asset visibility (TAV) technology into the supply chain structure can provide excellent visibility of a product. This kind of visibility complemented with various packaging schemes can assist in accommodating optimization strategies for visualizing the movement of a product throughout the entire supply chain pipeline. The chapter will define SCM, discuss TAV, review how transportation as well as optimization impacts SCM and TAV, and examine the role of packaging in the context of SCM and TAV.


Author(s):  
Lijo John ◽  
Anand Gurumurthy ◽  
Arqum Mateen ◽  
Gopalakrishnan Narayanamurthy

Abstract The uncertainty associated with the location, severity and timing of disaster makes it difficult for the humanitarian organization (HO) to predict demand for the aid material and thereby making the relief material procurement even more challenging. This research explores whether options contract can be used as a mechanism to aid the HO in making procurement of relief material less challenging by addressing two main issues: inventory risk for buyers and over-production risk for suppliers. Furthermore, a contracting mechanism is designed to achieve coordination between the HO and aid material suppliers in the humanitarian supply chain through optimal pricing. The options contract is modelled as a stylized version of the newsvendor problem that allows the HO to adjust their order quantity after placing the initial order at the beginning of the planning horizon. This flexibility helps to mitigate the risk of both overstocking and understocking for the HO as well as the risk of overproduction for the supplier. Our results indicate that the optimal values for decision parameters are not “point estimates” but a range of prices, which can facilitate negotiation between the two parties for appropriate selection of contract parameters under an options contract. The results imply that options contract can aid in the decentralized approach of fixing the prices between the HO and the supplier, which in turn would help in achieving systemic coordination.


1997 ◽  
Vol 185 (5) ◽  
pp. 893-900 ◽  
Author(s):  
Elizabeth W. Shores ◽  
Tom Tran ◽  
Alexander Grinberg ◽  
Connie L. Sommers ◽  
Howard Shen ◽  
...  

Immature thymocytes undergo a selection process within the thymus based on their T cell antigen receptor (TCR) specificity that results either in their maturation into functionally competent, self-MHC–restricted T cells (positive selection) or their deletion (negative selection). The outcome of thymocyte selection is thought to be controlled by signals transduced by the TCR that vary in relation to the avidity of the TCR–ligand interaction. The TCR is composed of four distinct signal transducing subunits (CD3-γ, -δ, -ε, and ζ) that contain either one (CD3-γ, -δ, -ε) or three (-ζ) signaling motifs (ITAMs) within their intracytoplasmic domains. A possible function for multiple TCR ITAMs could be to amplify signals generated by the TCR during selection. To determine the importance of the multiple TCR-ζ chain ITAMs in thymocyte selection, transgenes encoding α/βTCRs with known specificity were bred into mice in which ζ chains lacking one or more ITAMs had been genetically substituted for endogenous ζ. A direct relationship was observed between the number of ζ chain ITAMs within the TCR complex and the efficiency of both positive and negative selection. These results reveal a role for multiple TCR ITAMs in thymocyte selection and identify a function for TCR signal amplification in formation of the T cell repertoire.


2020 ◽  
Vol 12 (23) ◽  
pp. 10087
Author(s):  
Rafael Lizarralde ◽  
Jaione Ganzarain ◽  
Mikel Zubizarreta

The central role of R&D centers in the advancement of technology within industrial enterprises is undeniable and clearly affects their strategies, their competitiveness and their business sustainability. R&D centers assume responsibility for technology recognition, collection, acquisition, development and transition. Among their activities, the efficient choice of emerging technologies in the Technology Management Process is becoming a real challenge. In such heterogeneous scenarios, Multiple Criteria Decision Making (MCDM) models are commonly proposed as an appropriate decision-making approach. Multiple research works address the selection of particular technologies in industrial applications, but very few references can be found related to research institutions, and R&D centers in particular. Therefore, a decision-making model is provided in this study following the MIVES multi criteria method for the assessment of one or more technologies. The model is then applied to two case studies related to the selection process of new technologies at a Spanish R&D Center specialized in manufacturing.


Author(s):  
Christine Rutherford ◽  
Christian Konig

Critical to the success of any business is a supply chain capable of serving the end customer more effectively and more efficiently than the competition. Central to this premise is an understanding that in today’s global marketplace it is supply chains that compete, not individual firms. We explore the central role of logistics and the supply chain in gaining competitive advantage in a volatile global market by first defining the key principles of a market-responsive supply chain. Second, we discuss different supply chain strategies to improve the match between supply and demand, before dedicating two sections to the important subjects of logistics outsourcing and global sourcing. But first we begin by defining the supply chain, logistics and supply chain management.


2009 ◽  
Vol 21 (1) ◽  
pp. 28-49 ◽  
Author(s):  
Sami Farooq ◽  
Chris O'Brien

PurposeThe purpose of this paper is to present result obtained from a developed technology selection framework and provide a detailed insight into the risk calculations and their implications in manufacturing technology selection process.Design/methodology/approachThe results illustrated in the paper are the outcome of an action research study that was conducted in an aerospace company.FindingsThe paper highlights the role of risk calculations in manufacturing technology selection process by elaborating the contribution of risk associated with manufacturing technology alternatives in the shape of opportunities and threats in different decision‐making environments.Practical implicationsThe research quantifies the risk associated with different available manufacturing technology alternatives. This quantification of risk crystallises the process of technology selection decision making and supports an industrial manager in achieving objective and comprehensive decisions regarding selection of a manufacturing technology.Originality/valueThe paper explains the process of risk calculation in manufacturing technology selection by dividing the decision‐making environment into manufacturing and supply chain environment. The evaluation of a manufacturing technology considering supply chain opportunities and threats provides a broader perspective to the technology evaluation process. The inclusion of supply chain dimension in technology selection process facilitates an organisation to select a manufacturing technology not only according to its own requirements, but also according to the interest of its constituent supply chain.


Author(s):  
Swapnil Sawant ◽  
Avinash Sarode

The Indian manufacturing industry is growing rapidly, and supply chain management (SCM) plays the most important role in the industry. In SCM, customer satisfaction in terms of quantity, quality and on time delivery is the most important critical factor. To satisfy this requirement, the best third-party logistics (3PL) service provider is required.  Therefore, the selection of the best third-party logistics provider is one of the basic requirements in SCM. Logistics services are the backbone of an economy, providing the efficient, cost effective flow of goods and services on which other commercial sectors depend. The logistics companies work as the outsourced or third-party service providers and support the organization's logistics functions. In this study, we identified some important criteria for 3PL implementation in SCM in Indian manufacturing industries.  With the help of this study, supply chain managers from small to medium sized manufacturing industries can simplify the selection process for 3PL vendors. This study will help in the selection of the best vendor from such a competitive group and provide justification for the selection. 


2022 ◽  
pp. 24-50
Author(s):  
Kripanshu Vora

The purpose of this chapter is to explore the role of trust or confidence through the managerial lens. The chapter aims to acquire empirical evidence regarding the importance of factors that play a role in fostering trust during procurement decision making exemplified through a New Zealand-owned company, ContainerCo. This exploratory study scrutinises trust as perceived by SME managers in the supply chain of logistics and procurement in New Zealand. It uses the repertory grid analysis and is based on two interviews conducted through the repertory grid technique, a semi-structured method. Although different in every company and country, trust plays a major role during the selection of suppliers. Factors such as reliability and value are regarded as the most important ones for choosing the right supplier in the case of ContainerCo.


2018 ◽  
pp. 1688-1710
Author(s):  
Pradeep Kumar Behera ◽  
Kampan Mukherjee

Any selection decision of supply chain coordination schemes (SCCS) is essentially affected by the environment where the schemes are to be implemented, the necessary conditions required for their implementation, the risk associated with the implementation, and the impact on the performance of the supply chain. Because of the multi-dimensional characteristics; the selection of appropriate SCCS in a given situation remains a challenging task for supply chain managers. This study explores relevant factors that influence this selection process. A structural model is proposed to capture relationships among these factors for development of Impact Relationship Maps (IRM) by applying Decision Making Trial and Evaluation Laboratory (DEMATEL) and Maximum Mean De-Entropy (MMDE) algorithm. A study has been conducted and the outcome leads to add significant value to the decision making process with knowledge on the roles of the factors and inter-factor relations which helps in taking meaningful decision on SCCS selection and implementation.


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