Developing User Needs

Very many types of eddy current instruments available tend to look remarkably similar in much the same way as automobiles tend to look alike. This may be an inevitable trend since developments are converging on users needs, plus PC platforms are being used more and these too are tending to look more and more alike. In the way that the DSP has changed the inside of the instrument, the PC. is changing the outside. 

Focusing on the concept of the completely sealed system, the Sanyo Electric Co. developed sealed-type nickel-cadmium batteries in 1961. This type of battery enjoys a wide application range that is still expanding a large variety of nickel-cadmium batteries has been developed to meet user needs ranging from low-current uses like emergency power sources and semiconductor memories to high-power applications such as cordless drills. 

Research users need full access to the functional elements of the spectrometer system and require the most efficient and flexible tools for MR sequence and application development. If the measurement methods delivered with the software do not adequately address the specific investigational requirements of a research team, modem NMR software is an open architecture for implementing new and more sophisticated functionality, with full direct access to all hardware controlling parameters. After evaluation, the new functionality can be developed with the help of toolbox functions that allow rapid prototyping and final builds, to enable the new sequence to be executed by non-experienced personnel and then used in routine applications. These toolboxes provide application oriented definitions and connect to standard mechanisms and routine interfaces, such as the geometry editor, configuration parameters or spectrometer adjustments. 

A computer system is composed of software and hardware, equipment, a processor, and a user, and it is used to execute a specific procedure. Regardless of whether the computer system is developed in-house or by a contractor or purchased off the shelf, establishing documented end-user requirements is extremely important for computer systems validation. Without first establishing end-user needs and intended use, it is virtually impossible to confirm that the system can consistently meet them. Once established, it should obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications. It is important that the end-user requirements specifications take into account predicate rules [12]. 

High-performance liquid chromatography (HPLC) is one of the premier analytical techniques widely used in analytical laboratories. Numerous analytical HPLC analyses have been developed for pharmaceutical, chemical, food, cosmetic, and environmental applications. The popularity of HPLC analysis can be attributed to its powerful combination of separation and quantitation capabilities. HPLC instrumentation has reached a state of maturity. The majority of vendors can provide very sophisticated and highly automated systems to meet users needs. To provide a high level of assurance that the data generated from the HPLC analysis are reliable, the performance of the HPLC system should be monitored at regular intervals. In this chapter some of the key performance attributes for a typical HPLC system (consisting of a quaternary pump, an autoinjector, a UV-Vis detector, and a temperature-controlled column compartment) are discussed [1-8]. 

In the pharmaceutical industry, the level of user need varies tremendously. Some large global pharmaceutical manufacturers have very efficient research and development (R D), sourcing, and purchasing units, but this is by no means representative of the industry as a whole. The level of expertise and experience of customers... 

However, there are some lessons learned. It is very important to communicate the ideas and benefits of the agile iterative development process to the entire project team and have buy-ins not only from the developers, but also from business analysts, the QA team, and end users. We only have a small QA team that supports many projects and end users are busy with their priorities. It is important to have some rough iteration planning upfront and have some idea about when QA and end users need to be involved in testing. If the plan has to change, inform QA and end users as early as possible. 

Having a bad trip can cause the user to panic, which can lead to dangerous behavior. Paranoia and feelings of superiority sometimes develop. When a bad experience occurs, the user needs to be reassured or calmed until the immediate effects have passed, which can be eight hours or longer, depending on the dose. 

There exists a need for high-power pulsed CW radiation sources to enable fast switching times and high repetition rates for electromagnetic resonance experiments. In addition, commercial development of THz sources is needed so that this technology can be made more widely available to the research community. Furthermore, current detectors for THz spectroscopy have high cooling requirements to minimize noise in spectral data further developments are needed to provide inexpensive and user-friendly detector options. 

In general, the advantage of these response surface models is that they enable the description of nonlinear concentration-response relationships, and that differences in slopes and functional form of the individual concentration-response curves can be accounted for. The complete n + 1 dimensional concentration-response surface is fitted to the complete data set, which takes into account that the parameters of the individual concentration-response relationships are actually predictors for the complete mixture data set. Different likelihood functions can be used to adjust the analysis for different types of endpoints. Each approach has its own specific advantages, and response surface models for IA have also been developed (Haas et al. 1997 Jonker et al. 2005). The user needs to have some programming skills and statistical knowledge to judge the result. Specifically, the user needs to know how to... 

Bradshaw, D. R. S. (2006), Developing dose counters An appraisal based on regulator, pharma, and user needs, in Dalby, R. N., Byron, P. R., Peart, J., Suman, J. D., and Farr, S. J., Eds., Respiratory Drug Delivery 2006, Davis Healthcare International, River Grove, IL, pp. 121-131. 

Meet user needs Be easier to set up Be in production sooner Break down less often Be easier to repair Be easier to further develop Be used more efficiently Cheaper overall Preferred supplier... 

A common problem with COTS products is that access to product development documentation may not be available. The supplier may refuse to share its proprietary information, or it may be unavailable for some other reason. In such circumstances pharmaceutical and healthcare companies are expected by the regulatory authorities to compensate with additional black box testing to establish with sufficient confidence that the COTS products meet user needs. (Black box testing is... 

In design and development, validation concerns the process of examining a product to determine conformity with user needs. 

When a new test is developed or an old test is applied to a new clinical question, users need information about the extent of agreement of the test s results with the correct diagnoses of patients. For this purpose, researchers design studies in which results from the new test are compared with the results obtained with the reference standard on the same patients. The results of the comparison can be expressed in a number of ways, including sensitivity and specificity, predictive values, likelihood ratios, diagnostic odds ratios, and areas under receiver operating characteristic (ROC) curves (see Chapter 15). We will refer to such studies as diagnostic accuracy studies. 

The NLM developed PubMed as a user-friendly search tool to explore MEDLINE. For each citation listed in a search result, the user has the option to click on Related Articles, which takes the user to a listing of additional citations that are related to the search topic. Additionally, PubMed offers access to publisher Web sites for full-text articles, a citation matcher (service that assists a user in finding a complete citation), and access to the molecular biology databases of the NCBI. One of the newest features of PubMed is called Cubby, a page on the site that allows the user to store a search and update it in the future (users need to register for this free service). AIDSLINE soon will be added to PubMed. A user can search MEDLINE and 14 other NLM databases (e.g., AIDSLINE, AIDSDRUGS, TOXLINE) via Internet... 

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