Good medicine - [control medical]

Developing a new medical device can be a minefield. You´ve completed the fundamental science and research, and enjoyed the first round of press attention. Now there are patients who need your new therapy or treatment and the competition is breathing down your neck so you need to get something to market fast. At the same time, quality is a key requirement because a failure could have catastrophic consequences. Your company also has to make a profit, so cost of goods sold (COGS) and other economics need to be considered. To manage the quality concerns, regulatory agencies such as the Medicines and Healthcare products Regulatory Agency in the UK and the US Food and Drug Administration (FDA) have been established to help guide and enforce best practices for the development of safe and reliable devices. The rest is up to you, the engineer, to work within those constraints and meet all of the requirements in the most timely and cost-effective manner. One of the first key engineering milestones is deciding how to implement the system´s primary controller. This decision can make or break the product because it serves as the foundation on which many other decisions are made. Not only do you need to consider processor architectures, operating system capabilities and other components, but you also must decide whether to produce a custom design or to buy off the shelf.