Post by arfanho7 on Feb 27, 2024 6:23:37 GMT -5
Indeed Stern found that small firms defined as non publicly traded companies with revenues under million made up percent of total entrants for follow on devices but only percent for novel devices—meaning they were only half as likely to pursue first in class technologies. Small firms that have less financial flexibility are less likely to take on these pioneer roles says Stern.
It s not that big firms are having all of the ideas. Bigger companies are just the ones that are more likely to take on the task of bringing a novel high risk product to market. The big question why Device Testing Is Different It s certainly true that Hungary Phone Number clinical trials for medical devices are not as straightforward as those for drugs. While drugs may have different effects or methods of action trials essentially consist of monitoring patients for proper dosage effectiveness and side effects. Medical devices meanwhile can differ from each other in almost every respect including how they work how they are applied to the patient and how their effectiveness is measured.
This forces the FDA to make ad hoc rules for the testing of each new device in order to properly gauge safety and effectiveness. at the numbers however she discovered a curious paradox. The FDA categorizes devices based on their function not their underlying technologies. She found that devices based on certain technologies placed in already existing product categories did not take as long to approve as devices using the same technologies that were placed in new categories. It wasn t wow we ve never seen this kind of product that led to the longest delays. Rather we observed many big regulatory delays for devices that are put in new product categories but built on technologies the FDA is already familiar with says Stern.
It s not that big firms are having all of the ideas. Bigger companies are just the ones that are more likely to take on the task of bringing a novel high risk product to market. The big question why Device Testing Is Different It s certainly true that Hungary Phone Number clinical trials for medical devices are not as straightforward as those for drugs. While drugs may have different effects or methods of action trials essentially consist of monitoring patients for proper dosage effectiveness and side effects. Medical devices meanwhile can differ from each other in almost every respect including how they work how they are applied to the patient and how their effectiveness is measured.
This forces the FDA to make ad hoc rules for the testing of each new device in order to properly gauge safety and effectiveness. at the numbers however she discovered a curious paradox. The FDA categorizes devices based on their function not their underlying technologies. She found that devices based on certain technologies placed in already existing product categories did not take as long to approve as devices using the same technologies that were placed in new categories. It wasn t wow we ve never seen this kind of product that led to the longest delays. Rather we observed many big regulatory delays for devices that are put in new product categories but built on technologies the FDA is already familiar with says Stern.
