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.

Enhancement of Construction Equipment Detection in Video Frames by Combining with Tracking

Vision-based object detection has been introduced in construction for recognizing and locating construction entities in on-site camera views. It can provide spatial locations of a large number of entities, which is beneficial in large-scale, congested construction sites. However, even a few false detections prevent its practical applications. In resolving this issue, this paper presents a novel hybrid method for locating construction equipment that fuses the function of detection and tracking algorithms. This method detects construction equipment in the video view by taking advantage of entities' motion, shape, and color distribution. Background subtraction, Haar-like features, and eigen-images are used for motion, shape, and color information, respectively. A tracking algorithm steps in the process to make up for the false detections. False detections are identified by catching drastic changes in object size and appearance. The identified false detections are replaced with tracking results. Preliminary experiments show that the combination with tracking has the potential to enhance the detection performance.

Physicians in leadership: the association between medical director involvement and staff-to-patient ratios

In a hospital environment that demands a careful balance between commercial and clinical interests, the extent to which physicians are involved in hospital leadership varies greatly. This paper assesses the influence of the extent of this involvement on staff-to-patient ratios. Using data gathered from 604 hospitals across Germany, this study evidences the positive relationship between a full-time medical director (MD) or heavily involved part-time MD and a higher staff-to-patient ratio. The data allows us to control for a range of confounding variables, such as size, rural/urban location, ownership structure, and case-mix. The results contribute to the sparse body of empirical research on the effect of clinical leadership on organizational outcomes.

Exploring an effective model of new product development in medical devices: A knowledge cluster approach

This study proposes a new product development (NPD) model that aims to improve the effectiveness of innovative NPD in the medical devices. By adopting open innovation theory and applying an in-depth investigation methodology, this paper proposes a knowledge cluster that improves the integration of interdisciplinary human resources and enhances the acquirement of innovative technologies. A knowledge cluster approach helps gather, organise, synthesise, and accumulate knowledge in order to become the impetus for innovation. Although enterprises are no longer the principals of research and development, they should still be capable of integrating professional physicians, external groups, and individuals through the knowledge cluster platform. However, in order to support an effective NPD model, enterprises should provide adequate incentives and trust to external individuals or groups willing to contribute their expertise and knowledge to this knowledge cluster platform. Copyright © 2013 Inderscience Enterprises Ltd.

Elevated levels of urinary 8-hydroxy-2'-deoxyguanosine in male electrical and electronic equipment dismantling workers exposed to high concentrations of polychlorinated dibenzo-p-dioxins and dibenzofurans, polybrominated diphenyl ethers, and polychlorinated biphenyls

To investigate the occupational exposure levels to polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs), polybrominated diphenyl ethers (PBDEs), and polychlorinated biphenyls (PCBs), indoor dust (n = 3) in workshops and hair samples from male workers (n = 64) were collected at two electrical and electronic equipment waste (E-waste) dismantling factories located in the LQ area in east China in July 11-13, 2006. Pre- and postworkshift urines (64 of each) were also collected from the workers to study oxidative damage to DNA using 8-hydroxy-2'-deoxyguanosine (8-OHdG) as a biomarker. The concentrations of PCDD/Fs, PCDD/F-WHO-TEQs, PBDEs, PCBs and PCB-WHO-TEQs were (50.0 +/- 8.1) x 10(3), 724.1 +/- 249.6, (27.5 +/- 5.8) x 10(6), (1.6 +/- 0.4) x 10(9), (26.2 +/- 3.0) x 10(3) pg/g dry weight (dw) in dust, and (2.6 +/- 0.6) x 10(3), 42.4 +/- 9.3, (870.8 +/- 205.4) x 10(3), (1.6 +/- 0.2) x 10(6), 41.5 +/- 5.5 pg/g dw in hair, respectively. The homologue and congener profiles in the samples demonstrated that high concentrations of PCDD/Fs, PBDEs, and PCBs were originated from open burning of E-waste. The 8-OHdG levels were detected at 6.40 +/- 1.64 mu mol/mol creatinine in preworkshift urines. However, the levels significantly increased to 24.55 +/- 5.96 mu mol/mol creatinine in postworkshift urines (p < 0.05). Then, it is concluded that there is a high cancer risk originated from oxidative stress indicated by the elevated 8-OHdG levels in the E-waste dismantling workers exposed to high concentrations of PCDD/Fs, PBDEs, and PCBs.

Development of a nanoporous and multilayer drug-delivery platform for medical implants.

Biodegradable polymers can be applied to a variety of implants for controlled and local drug delivery. The aim of this study is to develop a biodegradable and nanoporous polymeric platform for a wide spectrum of drug-eluting implants with special focus on stent-coating applications. It was synthesized by poly(DL-lactide-co-glycolide) (PLGA 65:35, PLGA 75:25) and polycaprolactone (PCL) in a multilayer configuration by means of a spin-coating technique. The antiplatelet drug dipyridamole was loaded into the surface nanopores of the platform. Surface characterization was made by atomic force microscopy (AFM) and spectroscopic ellipsometry (SE). Platelet adhesion and drug-release kinetic studies were then carried out. The study revealed that the multilayer films are highly nanoporous, whereas the single layers of PLGA are atomically smooth and spherulites are formed in PCL. Their nanoporosity (pore diameter, depth, density, surface roughness) can be tailored by tuning the growth parameters (eg, spinning speed, polymer concentration), essential for drug-delivery performance. The origin of pore formation may be attributed to the phase separation of polymer blends via the spinodal decomposition mechanism. SE studies revealed the structural characteristics, film thickness, and optical properties even of the single layers in the triple-layer construct, providing substantial information for drug loading and complement AFM findings. Platelet adhesion studies showed that the dipyridamole-loaded coatings inhibit platelet aggregation that is a prerequisite for clotting. Finally, the films exhibited sustained release profiles of dipyridamole over 70 days. These results indicate that the current multilayer phase therapeutic approach constitutes an effective drug-delivery platform for drug-eluting implants and especially for cardiovascular stent applications.

Biofunctionalization of PET/SiO2 surfaces for single molecule experiments and medical applications

PET/SiO2 layers were chemically modified to maintain immobilization of functional single molecules. GFP molecules provide an ideal system due to their stability and intrinsic fluorescence. GFP in vivo biotinylated within its NH2-terminal region and attached on the substrate via the biotinstreptavidin bond was further investigated with confocal microscopy, atomic force microscopy (AFM) and spectroscopic ellipsometry (SE). AFM revealed monolayered donut-like structures representing assemblies of biotinstreptavidinbiotinGFP immobilized onto PET/SiO2 surfaces via mPEG. In particular, regions with an approximate height of 12 nm, which approaches the molecular dimensions of the above complex given by molecular modeling, could be detected. The dimensions of the donut-like structures suggest a close-to-each-other positioning of the GFP molecules - which, however, retain their functionality, as evidenced by confocal microscopy. © 2011 World Scientific Publishing Company.

基于P2P技术的CSRe冷却装置控制系统设计；Design of Control System for CSRe Cooling Equipment Based on P2P Technology

HIRFL-CSR工程对CSRe冷却装置电子冷却部分的控制系统在实时性和可靠性方面提出了非常高的要求。电子冷却工作环境复杂,各种干扰难以预测。从电子冷却的控制系统改进出发,以实现电子冷却的自动调束为目标,以高端FPGA和ARM嵌入式系统为基础,采用P2P通讯技术和神经元网络算法来实现对电子冷却的自动控制。该控制系统对电子冷却控制的完善提供了先进的硬件平台和软件实现方案。

Hypothesis Formation and Evaluation in Medical Diagnosis

This thesis describes some aspects of a computer system for doing medical diagnosis in the specialized field of kidney disease. Because such a system faces the spectre of combinatorial explosion, this discussion concentrates on heuristics which control the number of concurrent hypotheses and efficient "compiled" representations of medical knowledge. In particular, the differential diagnosis of hematuria (blood in the urine) is discussed in detail. A protocol of a simulated doctor/patient interaction is presented and analyzed to determine the crucial structures and processes involved in the diagnosis procedure. The data structure proposed for representing medical information revolves around elementary hypotheses which are activated when certain disposing of findings, activating hypotheses, evaluating hypotheses locally and combining hypotheses globally is examined for its heuristic implications. The thesis attempts to fit the problem of medical diagnosis into the framework of other Artifcial Intelligence problems and paradigms and in particular explores the notions of pure search vs. heuristic methods, linearity and interaction, local vs. global knowledge and the structure of hypotheses within the world of kidney disease.

Intention and Causation in Medical Non-Killing: The impact of criminal law concepts on euthanasia and assisted suicide

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