Keeping an Eye on Medical Device Technology

Medical technology is evolving rapidly. New devices are hitting the market at a furious pace, but this may not be for the best. Some devices are being rushed to the market while others are sitting stagnant due to stringent testing standards. Despite some of the setbacks in medtech, it's safe to say that we are currently benefiting from such technology.

In July 2016, the Food and Drug Administration placed a two-year ban on Elizabeth Holmes, founder and CEO of Theranos, preventing her from owning a lab. This was after extensive scrutiny was placed on the company's testing products with numerous sources, citing the tests as unreliable. While this was a victory for patients who ultimately want the most accurate medical technology, it also raised questions about the current state of medical technology.

Can we bring the technology to the market in a safe manner? Is medical technology moving quicker than we can adapt? Will doctors rely too much on technology?

Bringing safe technology to market all depends on the meaning of the word "safe." It is sad to say, but ultimately it comes down to the level of regulation put on a particular product or device.

Some companies are not putting in the time to develop technology because of stringent regulation. A survey conducted by the Advanced Medical Technology Association found that "unpredictable, inefficient, and expensive regulatory processes are jeopardizing America's leadership position in medtech innovation."

The U.S. is not the only market that may suffer because of regulations. Britain manufacturers are scared that the county's exit from the European Union may cause them to face new regulations for both the U.K. and E.U. markets.

So, when we talk about safe, we really man does a device meet the testing standards as implemented by the U.S. government? We have seen devices that have done so, only to be recalled at a later date.

According to the website Drug Lawsuit Source, one third of the 140 manufacturers affected by device recalls in the second quarter of 2012 actually faced multiple device recalls during a 90-day period. This shows that sometimes rushing products to market can wind up affecting the work on other devices by the same manufacturer.

An article in Fortune Magazine by Vinod Khosla predicted that technology will eventually replace 80% of what doctors are currently trained to do. This sounds great except technology must match or exceed the intimate care we currently receive from physicians. While artificial intelligence has made great strides, it is not currently at the point where we will see doctors being put out of work.

Some also say that technology will cause doctors to start losing their ability to properly examine patients. This type of reliance on technology can cause people to become misdiagnosed.

"The consequence of losing both faith and skill in examining the body is that we miss simple things, and we order more tests and subject people to the dangers of radiation unnecessarily," wrote Abraham Verhgese in a New York Times op-ed. "In my experience, being skilled at examining the body has a salutary effect beyond finding important clues...it is a ritual that remains important to the patient."

So even if technology replaces 80% of what doctors can do, the intimacy is still needed at least for the benefit of the patient.

Unfortunately, I cannot answer any of the questions I propose in this article, only bring them more to light. Hopefully by the time I am in need of such technology, those bringing it to market have done the due diligence to cause more good than harm.