How to deal with remanufactured single use medical device (R-SUD) business.

2018 ◽  
Vol 88 (6) ◽  
pp. 646-651
Keyword(s):  
Author(s):  
Shirzad Farhikhteh ◽  
Ali Kazemi ◽  
Arash Shahin ◽  
Majid Mohammad Shafiee

Purpose This paper aims to assess the contribution of competitiveness factors in how small and medium-size enterprises (SMEs) would access competitive advantage (CA) by focussing on industry structure and devise a conceptual model thereof. Design/methodology/approach The enterprises from three industries consisting of knowledge-based, single-use medical device producers and construction stone cutting each with different structures were assessed. The method is qualitative and quantitative where grounded theory and exploratory factor analysis (EFA) are applied. The initial survey involves 36 deep semi-structured interviews with some of the top managers of each of the three selected industries and a questionnaire distributed among 158 individuals with 46 structured questions. Findings The findings indicate that the micro-competitiveness factors are more contributive in achieving CA than macro factors as follows: in knowledge-based enterprises, customer relationship management (CRM), goods/services features and knowledge management are the most important variables. As to single-use medical device production industry, the sales force, sales promotion, and CRM are the most effective factors. Regarding construction stone-cutting industry, quality of the stone, sales promotion, and advertisement play the same role. The results of the EFA indicate that the three impressive factors, including capabilities of the enterprises, strategies of the enterprises and macro factors, are the extracted factors. Practical implications The findings here would assist SMEs’ managers in identifying the most essential factors in accessing CA. Originality/value The innovation of this study is that although there exist many studies on SMEs and their CAs, this study seeks the models of CA among SMEs in industries with different structures.


2021 ◽  
Vol 55 (s3) ◽  
pp. 35-44
Author(s):  
Brian McEvoy ◽  
Stacy Bohl Wiehle ◽  
Ken Gordon ◽  
Gerry Kearns ◽  
Paulo Laranjeira ◽  
...  

Abstract Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10−6 is typically achieved, with multiple layers of conservativeness delivered, using “overkill” approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care.


2019 ◽  
Vol 957 ◽  
pp. 409-416
Author(s):  
Elena Grossu ◽  
Constantin Gheorghe Opran ◽  
Lia Mara Ditu

In the medical industry the medical device sector is a domain dynamic and growing, that involved important efforts performance for imposing new material to support the development of new products. Manufacturers of medical devices for single use, are constantly looking for new products and new materials to expand their capabilities.


2004 ◽  
Author(s):  
Ibraheem S. Al-Tarawneh ◽  
Walter J. Stevens ◽  
Steven R. Arndt

2017 ◽  
Vol 65 (S 01) ◽  
pp. S1-S110
Author(s):  
C. Gestrich ◽  
J.E. Klein ◽  
B. Toctam ◽  
G.D. Dürr ◽  
J.M. Sinning ◽  
...  

2019 ◽  
Vol 01 (04) ◽  
pp. 74-77
Author(s):  
Thomas Gallmann

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.


2020 ◽  
Vol 64 (1-4) ◽  
pp. 1253-1259
Author(s):  
Minghui Wang ◽  
Hongliu Yu

Clamping devices with constant force or pressure are desired in medical device, such as hemostatic forceps and the artificial sphincter, to prevent soft tissues from injures due to overloading. It is easily obtained by stretching an SMA wire. However, studies with SMA bending round bar have seldom been reported before. This paper studied constant force characteristic of C-shaped round bar with shape memory alloys. Optimization designs of the components were carried out with computational simulation. Numerical results show that the phenomenon of constant force strongly depends on contour curve shape and geometric dimensions of the C-shaped round bar of SMA component.


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