Depending on the device, there will be different levels of risk management.Â When thinking about risk and quality, companies should ask themselves, "Do we have effective controls?" The quality of the device must be absolute, and the processes must ensure that quality. ForÂ speed-to-market considerations, companies want to be aggressive, but they must also be realistic. When thinking about product performance, companies must make sure that their products deliver real benefits, and end-users need to be able to see the value of the product. Finally, cost must be considered. Companies must evaluate whether they can consistently produceÂ products that meet specifications, and whether they can make that process profitable for them. "The real question to ask," said Wrobel, "is how much risk you are willing to take for each item.Â Then plan your process with those decisions in mind."