Another factor to consider when making benefit-risk determination suggested by FDA in this guidance document is whether the device is a novel technology addressing an unmet medical need. This means that the device has a breakthrough technology by providing a clinically meaningful advantage over existing technologies, posing less risk than an existing treatment, or providing a treatment where no other alternative is available. I think this is an important assessment when it comes to experimental drugs for cancer. The risk may be high, but if there is no other alternative, it may be determined that the potential benefits may outweigh the potential risks.