Technology confidence in early stage development of medical devices

Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.

Maturity grids as tools for change management

One method to assess organizational capabilities is a maturity grid. MATURITY GRIDS AS TOOLS FOR CHANGE MANAGEMENT A maturity grid assessment is typically structured around a matrix or a grid. It consists of a series of cells where ...

HTGR fuel element depletion benchmark: Stage three results

Recently, a new numerical benchmark exercise for High Temperature Gas Cooled Reactor (HTGR) fuel depletion was defined. The purpose of this benchmark is to provide a comparison basis for different codes and methods applied to the burnup analysis of HTGRs. The benchmark specifications include three different models: (1) an infinite lattice of tristructural isotropic (TRISO) fuel particles, (2) an infinite lattice of fuel pebbles, and (3) a prismatic fuel including fuel and coolant channels. In this paper, we present the results of the third stage of the benchmark obtained with MCNP based depletion code BGCore and deterministic lattice code HELIOS 1.9. The depletion calculations were performed for three-dimensional model of prismatic fuel with explicitly described TRISO particles as well as for two-dimensional model, in which double heterogeneity of the TRISO particles was eliminated using reactivity equivalent physical transformation (RPT). Generally, good agreement in the results of the calculations obtained using different methods and codes was observed.

HTGR fuel element depletion benchmark: Stage one results

In this paper, we reported the results of the first stage of HTGR fuel element depletion benchmark obtained with BGCore and HELIOS depletion codes. The results of the k-inf are generally in good agreement. However, significant deviation in concentrations of several nuclides between MCNP based and HELIOS codes was observed.

Stakeholder engagement in early stage product-service system development for healthcare informatics

This paper presents the findings from four case studies on stakeholder engagement in new health information and communication technology (ICT) product-service system (PSS) development. The degree of connectivity between the new health ICT PSS and its intended operating environment has emerged to be an important contextual factor that may impact the decision of stakeholder engagement in the early stage development process. Along with the proposition of a four-level framework to guide stakeholder identification for new PSS development, three stakeholder engagement propositions that are based on the degree of connectivity are developed. Analysis has shown that there can be two types of connectivity: data and process. Moreover, each connectivity type can be characterized by how much the new PSS is connected with its environment: independent if there is no linkage, linked if it interfaces with, or incorporated if it is embedded into. Furthermore, depending upon whether and to what extent the PSS has data and process connectivity with its intended operating environment, the stakeholder engagement needs in early stage development vary. The propositions presented in this paper provide important directions for future work exploring PSS characterization and stakeholder engagement decision in early stage new PSS development in the healthcare industry. © 2013 PICMET.

DEVELOPMENT OF EUSTRONGYLIDES IGNOTUS (NEMATODA: DIOCTOPHMIDA) IN DOMESTIC DUCKS (ANAS PLATYRHYNCHOS DOMESTICA (L.))

Investigating the development of Eustrongylides ignotus in its definitive host would enable us to trace the complete life cycle of this nematode. Fourth-stage larvae isolated from naturally infected swamp eels (Monopterus albus) were used to infect domestic ducks (Anas platyrhynchos domestica [L.]). We observed that male and female worms exhibited different developmental patterns in host ducks. In males, the fourth molt occurred at day 1-2 post-infection (PI), after which they attained maturity on day 4 PI and died between day 7 and 9 PI. However, females underwent the fourth molt at day 2-4 PI, produced eggs from day 9 to 17 PI, and then degenerated and died. When compared 10 fourth-stage Female larvae, adult females demonstrated a considerable increase in total body size with a 151% increase in average body width and a 17% increase in average body length. However. the increase in size of the male larvae was not its significant as that in females. The average body width in adult males exhibited only a 45% increase over that in the larval stage.

Effects of pure microcystin-LR on the transcription of immune related genes and heat shock proteins in larval stage of zebrafish (Danio rerio)

Microcystins (MCs) are cyanobacterial toxins in water blooms that have received increasing attention as a public biohazard for human and animal health. Previous studies were mainly focused on the toxic effects on adult fish, rather than juvenile or larvae, and the response of fish immune system were usually neglected. This paper presents the first data of the effects of microcystin-LR (MC-LR) on transcription of several genes essential for early lymphoid development (Rag1, Rag2, Ikaros, GATA1, Lck and TCR alpha) and heat shock proteins (HSP90, HSP70, HSP60, HSP27) in zebrafish larvae. Relative changes of mRNA transcription were analyzed by real time PCR. The transcription of Rag1, Rag2, Ikaros, GATA1, Lck and TCR alpha were up-regulated when following exposure to 800 mu g/L MC-LR, which may indicate that specific lymphocytes differentiation and TCR/lg arrangement are induced to counteract the toxic effects of MC-LR. It was also interesting to note the dramatically increased transcription of HSP90. HSP70, HSP60 and HSP27, which may indicate their important roles as molecular chaperones under oxidative stress. (C) 2009 Elsevier B.V. All rights reserved.

Identification of Differentially Expressed Genes Between Cloned and Zygote-Developing Zebrafish (Danio rerio) Embryos at the Dome Stage Using Suppression Subtractive Hybridization

Comparative analyses of differentially expressed genes between somatic cell nuclear transfer (SCNT) embryos and zygote-developing (ZD) embryos are important for understanding the molecular mechanism underlying the reprogramming processes. Herein, we used the suppression subtractive hybridization approach and from more than 2900 clones identified 96 differentially expressed genes between the SCNT and ZD embryos at the dome stage in zebrafish. We report the first database of differentially expressed genes in zebrafish SCNT embryos. Collectively, our findings demonstrate that zebrafish SCNT embryos undergo significant reprogramming processes during the dome stage. However, most differentially expressed genes are down-regulated in SCNT embryos, indicating failure of reprogramming. Based on Ensembl description and Gene Ontology Consortium annotation, the problems of reprogramming at the dome stage may occur during nuclear remodeling, translation initiation, and regulation of the cell cycle. The importance of regulation from recipient oocytes in cloning should not be underestimated in zebrafish.

Production planning of multi-stage multi-option seru production systems with sustainable measures

With the concerns over climate change and the escalation in worldwide population, sustainable development attracts more and more attention of academia, policy makers, and businesses in countries. Sustainable manufacturing is an inextricable measure to achieve sustainable development since manufacturing is one of the main energy consumers and greenhouse gas contributors. In the previous researches on production planning of manufacturing systems, environmental factor was rarely considered. This paper investigates the production planning problem under the performance measures of economy and environment with respect to seru production systems, a new manufacturing system praised as Double E (ecology and economy) in Japanese manufacturing industries. We propose a mathematical model with two objectives minimizing carbon dioxide emission and makespan for processing all product types by a seru production system. To solve this mathematical model, we develop an algorithm based on the non-dominated sorting genetic algorithm II. The computation results and analysis of three numeral examples confirm the effectiveness of our proposed algorithm. © 2014 Elsevier Ltd. All rights reserved.

Reproductive seasonality and maturity of male Neophocaena phocaenoides asiaeorientalis in captivity: A case study based on the hormone evidence

To provide hormone evidence on reproductive seasonality and maturity of the Yangtze finless porpoise, the authors monitored the monthly variations of serum reproductive hormones of a male Yangtze finless porpoise in captivity via radioimmunoassay from 1997 to 2003. It was demonstrated that the immature animal had a serum T level of 28-101ngdL -1 (6552ngdL -1 ), reached puberty with the serum T concentration ranging between 250 and 590ngdL -1 (390130ngdL -1 ), and attained reproductive maturity when the serum T level went beyond 1120180ngdL -1 in the breeding season. The body length growth of the animal showed a pattern similar to the serum T variations during its adolescent period from the age of 4 to 6 years. Moreover, the serum T concentration of the male porpoise exhibited significant seasonal variations, indicating that its breeding season may start as early as March and end as late as September.