Launch Your Business Product With a Bang
Jan 26th, 2010 by admin
The question is always: What is the purpose of my product or project? What you need my product? What are the needs / demands of my customers and what legal requirements must be implemented? What risks are associated with the use of my product? Have they been fully recognized and fully? Are defined and appropriate risk mitigation measures? How big is the cost resulting from a product hazard? Can this be adequately controlled?But back to the starting point of the inquiry into the “right” requirements. The problem is almost always, as stakeholders are properly taken into account with their respective requirements. This list of requirements should be designed to understand and easy to handle. This is related to the development complex medical devices are not always readily available. One approach is to divide the total product or project into modules. This change of requirements to be defined areas = modules limited. This in turn would facilitate the maintenance of job profile and change management of requirements very much. Similarly, the communication between those involved in the product could be better implemented. However, further challenges are thus not yet been resolved. Often many stakeholders are involved in a project that come from different areas and speak different “languages. This language is commonly understood and described in the form of” user stories “to the” ordinary “use of a medical device for the user, eg a doctor or a nurse . Therefore, a language for the description of requirements is necessary to understand them all. That is, the language is colloquial rather than technical, it is pictorial and uses analogies, its content is high and is not quantitative. level of technical development of a product the definition of requirements in a technical language, which is also useful only at the level of the modular components or components of the medical device. held by the level of the user of the developer must then be a translation of the conceptual description of requirements. How could this translation? Assistance can thereby provide the modular method of risk management. The method of risk assessment is a great way to get out measures to reduce the risk of a medical device, the requirements for its modules (= components derived components). These modules are “carriers” of these measures. For instance, provides a safe sterile as a component / module of a sterile medical product, the requirement of maintaining the sterility of the medical device. Ie, modular risk management thus also serves the generation of requirements for the respective modules from which the product exists. Each module can then be described in the “language” and specified that is suitable for its development and creating the best. But can such requirements in terms of their importance and their risk to be weighted? This can also be implemented with the methodology of risk assessment. The approach is that an unrealized demand represents a risk. First, is therefore a risk assessment of the degree of risk needed to distinguish acceptable from unacceptable risks to. Second, if a risk was not assessed as acceptable, appropriate and effective measures are defined to minimize risk. The goal of this methodology is to develop a comprehensive commitment to customers optimal product whose risks are evaluated and have been significantly reduced, with reduced development effort. Another challenge is that requirements linked to each other or the development of requirements can be tracked. E. g. this is the case in the development of medical software. Software applications that are sold as OEM products on – after they have been marketed under its own name on the market – have a similar or “related” but not identical requirements as the original product. The reason: The current contract still has several additional requirements for the product, the raw product is not possible. Often, these requirements for compatibility with a defined hardware partners, on which to run the software. Although it is nearly identical products, requirements management is often the one development project not tuned to the other. Rather, both are separated from each other. Changes to the requirements in a project are not necessarily communicated to other projects. Valuable knowledge and valuable insights for product development will not be considered if, despite this knowledge and insight within the company are available.