How Software Methods Can Revolutionise The FDA

Drug discovery is currently a lengthy process that costs a great deal of money. However, approving drugs could soon become much quicker and cheaper.

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Drug Development Vs Software Development

In many ways, drug discovery and software development are very similar. They are both long, drawn out and expensive processes. Neither are released until their effectiveness has been proven and both will invariably be awaited by a group of desperate end users.

There is one difference, however. When it comes to software, it is one company building and making the decision regarding when to launch it. In the case of drug discovery, however, it is the FDA who decides at which point it is ready for release. While software development companies can strike a careful balance between release dates and adequacy, the same cannot be said for the drug industry.

How long does it take to get a FDA 510k approved?

The answer is “too long”, according to experts like Approval requires a huge financial investment. Furthermore, no matter how much time and effort has been invested into a particular product, it could be turned down by the FDA at any point, making it extremely high risk. Both factors effectively reduce the market to a small number of super rich corporations and, as a result, the drug development markets are unfortunately severely limited. What if the drug industry applied the same methods as the software development industry?

How could software methods work for drug approvals?

Software development doesn’t end with perfection. Once they have something in place that works to some extent, the program will be released, tested and then improved. The same could potentially work for the drug industry. Some people living with terminal diseases are looking for anything that might prolong or save their lives. They are willing to be guinea pigs and to be given one last chance, even if the risks are high.

Full disclosure and open source could also significantly improve the approval rates of new drugs. By sharing results with both researchers and patients, not only can patients make an informed choice about whether to try new treatments, but bright new minds can use the information available to create many more new treatments and cures. In effect, they won’t have to spend the time and money reinventing the wheel.