In the Beginning

A new medical device is usually developed in answer to a need. For example, patients die when their hearts develop an irregular rhythm or stop unexpectedly. Since resuscitation equipment and CPR is not always readily available, people expire before medical help arrives. So, someone has the bright idea to invent a pacemaker that gives the heart a little jolt, if regular beats cease.

Today, this small device implanted near the heart is responsible for saving many lives and improving quality of life. Maybe doctors went to the medical industry and asked for something that would solve the problem of electrical shorts in the heart. Maybe someone in the industry took on the problem and began searching for a solution. Either way, in the beginning, ideas for medical advancement are born from the need for better diagnostics and treatment.

Development

Unfortunately, a great idea is often years in the making. Through a series of trials and errors, someone or a group of innovative engineers and scientists work on making the perfect device to improve medical diagnostics or treatment solutions. In order to make sure the device is both safe and effective; a device is constantly tested and modified, until it is just right.

While no device is 100% perfect, the benefits must ultimately far outweigh any potential risks. While some devices, like tongue depressors, have little to no risk to the patient, if it is not perfect, other devices like the pacemaker can be the difference between life and death. The pressure to develop the best device possible means not rushing a good idea. It is vital to get it right before marketing it to the public.

Pre-Marketing

The device is as perfect as humanly possible. But, the medical industry cannot simply advertise the product and put it on the market. A lot of pre-marketing requirements must be met, before it actually gets into the hands of the medical community to help patients.

When the device is potentially responsible for a major consequence to life, the company must obtain an IDE, which is an Investigative device exemption. Without this important document, people dedicated to the medical industry cannot set up the clinical trials needed to prove safety and effectiveness of the product. Once the exemption is obtained, participants are often required to test the device. Sometimes, in order to collect the necessary data, these trials may last years. For instance, no one wants to undergo implantation of something like a pacemaker, unless it has been proven to last a significant length of time, before it begins to fail or needs replacing.

In addition, enough volunteers have to be available, in order to provide a measurable ratio of success and failure of a device. If only two people are willing to undergo the trials, a 100% success is no big deal. The results have to show an objective and realistic view of the potential for improving health care.

Gaining Clearance

After all of the tests have been run, and the data has been recorded, life and death types of medical devices must be approved by the FDA, before they can be marketed to the public. It is time to fill out a pre-market application to gain clearance for sale. The document must be meticulously accurate, and accompanied by all of the test results, so the regulatory agency can make a proper determination and decide whether the device is worthy of helping the patient, or the medical company must go back to the drawing board.

In short, a great idea for medical advancement may be years, and even decades in the making. After creating the device, medical trials are often required, in order to prove the product is both safe and effective for its intended purpose. Trials commence only after the FDA has issued an exemption to test the medical device. But, even after the tests are complete, there are still some more steps to follow, before the device is distributed and the company sees any profit. In the end, the whole arduous process is well worth the effort, because advancements in diagnostics and treatment have the potential of saving countless lives.