In every industry, technological advancements are rapidly developing. Automation, computers, and software are just a few of the many improvements. Some industries are more cautious of this technological movement forward. One of these industries is medicine. The medical field constantly has scientists and technicians working towards the improvement of medicine. The only setback with these new inventions is testing them.
By Natalie Dodson, content writer for Do Supply Inc.
Technological inventions in the medical field often lack doctors and scientists that have the time to test and review them, especially when they are in the form of applications. Since apps now cover many areas of medicine, the FDA has become involved in regulating these apps.
The difficulty with regulation is that the FDA does not have a formatting process for this kind of management. The process of regulation requires the participation of the many different branches of the FDA, making it near impossible for the process to be efficient.
With thousands of apps being invented every year, it is expected that the FDA should be able to test and regulate many of them. Contrary to this belief, the FDA is only able to test about twenty of the apps each year. This complication means thousands of apps that potentially could be very useful are not out on the market because they are waiting to be tested by the FDA.
Apps ranging from diabetic uses to calculating when a person could relapse with cancer have been invented, but are not being used because of the FDA’s regulatory process. The FDA is quite possibly prohibiting lives from being saved because of these regulations.
Recently, the head of the FDA, Dr. Scott Gottlieb, announced plans to change the system of regulation. Dr. Gottlieb plans to limit the technology managed by the FDA; therefore enabling low-risk apps to be published without the FDA reviewing them.
As for higher risk apps, such as an app that records blood sugar levels and the amount of insulin a diabetic patient needs, companies will be provided more guidelines to enable the apps to pass the clinical tests efficiently. Furthermore, the FDA has partnered with Medical Device Innovation Consortium (MDIC), a public-private partnership, to focus on efficiency when to comes to approving medical apps.
Currently, the price to acquire the FDA to test one’s app is outrageous. Large medical companies are paying millions of dollars in order to have the FDA even look at an app, let alone approve it.
For smaller companies, the price makes it almost impossible to even enter an app for review. These prices are not only deterring small businesses, but they are also preventing life-saving apps from authorisation.
Mobile technology is the new face of medicine. Physicians are now recommending apps to patients, and patients are utilising apps that enable them to contact their doctors via webcams. With the strides that technology is taking, it is high time for medical officials and the FDA to embrace mobile technology, after all, lives could be saved.