Use Scrum/Sprint development process to build highly reliable medical electronic devices (1)

Almost every person using the phone, there will be several times the call interrupt experience.

Although these products as well as other consumer products, system failures or problems will not be convenient, but they do not have disastrous consequences. However, medical electronics devices of a system failure will bring life-threatening, which is why medical equipment, as well as the integration of devices in the system and these devices run software must go through rigorous testing and comply with the United States food and Drug Administration (FDA).

To ensure that our new and useful to the ideal and reliable performance, smooth through the FDA approval process, we use a technique called "Scrum/Sprint development process" of highly structured design methodology.

In addition, by reducing software implementation of the function, you can reduce the chance of a software error occurred. We have by Xilinx FPGA implementation of these features. In order to be able to more fully understand this approach, we begin to examine medical device design process.

Three stages of the life cycle

FDA response to medical electronics developed strict rules, requirements and guidelines designed to ensure the personal safety of the community.

In these provisions, the FDA medical device (Figure 1) lifecycle developed strict requirements. In General, the electronics companies must be in the following ways to meet the above requirements, including medical equipment of all components, spare parts or spare parts, medical equipment manufacturing process using any of the software and equipment manufacturer quality system using all of the software, such as being able to record and preserve the history of the program.

Figure 1, FDA medical device design defined throughout the entire life cycle diagram.

We can use medical equipment throughout its life cycle is divided into three main phases.

First of all products throughout their life cycle in the early stages (Figure 2), the stage is all three phases of systemic worst stage, during the enterprise focuses on theoretical and conceptual aspects of research and development. The stage of continuous length from a few weeks to several years, and enterprise readiness development complexity of the system.

Figure 2, in the product lifecycle in the early stages of application design virtual instruments and HEI, you can clearly understand the need to resolve the problem.

Products the entire life cycle of the early stages of basic components of data gathering and analysis.

Generally, researchers and product design specification group will use a variety of tools to streamline the process. At this stage, often using HEI United States national instrument (NI) to the company's products to adjust the LabVIEW FPGA i/o. Once you fully understand the problem, we can design a solution. For device development and prototyping, we combine the intuitive graphical programming, repeat use math and signal processing capabilities to develop new algorithms. Then, by using a commercial Kit hardware, our real-world data with reference to the performance of the algorithm for authentication. In many cases, we can use the NI-based FPGA prototyping platform to achieve the final experimental prototype devices. Specifically, we are able to add LabVIEWReal-Time module and NI CompactRIO FPGA Module along with combining to algorithm design and device prototype stage between rapid iteration. Use hardware kit for prototype design, not only to significantly reduce hardware development and integration time, but also allows us to bring more focus to deliver powerful, reliable software design.

Figure 3, software designing audit and verify the work typically in products the entire life cycle of the medium.

The medical device lifecycle phase two is called the product the entire life cycle of the medium-term (see Figure 3), can fully meet the design of the equipment in the production, certification, audits, and manufacturing, and other needs.

This stage focuses on the development of accurate definition and clear set quantifiable requirements specification document. These specifications shall be defined in the specification document and the actual implementation of the code to establish a clear mapping between.

Figure 4, the traditional "waterfall" development processes in access to the next step before you complete each stage of development.