In regard to medical devices, I think in a majority of instances the risks taken are necessary because the devices are utilized as a medical necessity. I’m sure if there were alternative options to the device, then would the device even be necessary? Any medical device used in surgery or implanted or utilized outside of a medical facility has risks, we just have to weigh the risks vs. benefits. For instance, it’s necessary for people to have to get rods placed in their legs, or have to get pacemakers implanted, even those that have to use crutches are all at risk for something, but the benefits outweigh the risks. This is also relevant to medical device development, even if there are risks of potential new devices if the benefit is greater, then it would be useful and helpful.
It would be okay to accept the risks when it comes to medical devices if it is for the greater good it utilized by a professional. For example, certain medications are administered by injection and have to be injected by a physician. This is partially due to the risks of injecting yourself if you are not trained in it. But the medication itself is extremely beneficially and works best and fastest if injected intramuscular. So a medical device having risk shouldn't just negate it from being commercialized, especial if the benefits out way the risks.
Researchers charged with developing new medical devices have the difficult issue of making a medical gadget safe for human usage. Risk management entails identifying, comprehending, controlling, and preventing failures that can result in dangers when people use medical technology. The development of medical devices relies heavily on risk analysis. A risk analysis, also known as a hazard analysis, is a structured tool for evaluating potential difficulties associated with the use of a drug or a medical device. Manufacturers are obligated to identify potential design dangers in both normal and fault conditions. If a danger is deemed undesirable, it should be minimized to acceptable levels by suitable measures.
