Wednesday, May 1, 2013

The FDA is killing the Medical Device Industry in the US

The US has always been at the forefront of innovative new products and we pride ourselves on staying with the cutting edge of technology. In the Civil War we had doctors amputating legs with saws that were not sterilized. We have come a long way from the civil war, and pride ourselves on being the country that provides the best health care in the world. However times are changing. Due to stifling regulation, and increased taxes on Medical Devices, many entrepreneurs are unable to get the funding they need to develop their products.

To start with the guidelines were integrated one at a time in an attempt to guarantee any new medical devices that would go out to commercial world were safe for the end customers. This essentially keeps with the “first do no harm”. This is really noble, and it does make sense. And to be sure we are free from a lot of medical devices that are laminated with lead paint or the like. The caveat is that as each and every new procedure and specifications was added, it ended up being more and more difficult to get any of these medical devices through the system, also to market.

It follows that if we have now a system into position that makes it so that any innovative medical device must past numerous qualifications, medical tests, animal testing, or review organizations, that we will provide the best and safest products or services available on the free market. Unhappily this is obviously just a wrong conception. A good number of our most innovative cutting edge medical devices are not even doing a showing in the United States since the exclusions, and the timeframe it takes to pass the reviews and legal guidelines mean it is an unreasonable and unprofitable risk. Probably the most rapid growth of markets in India is new medical devices.

Investors and Venture Capitalists are the engine that drives originality. In this area of advanced technology, Silicon Valley is a stunning example of what one can deliver on when awarded the best suited funding. With venture capitalists backing the brightest young minds in our continent the breakthroughs that got their start in Silicon Valley are well known. Those entrepreneurs changed the face of our planet over the course of 2 whole decades.

Innovations such as this are attainable in the medical field by creating essentially the most ground breaking medical devices in our historical past. The change is that different than Silicon Valley, Investors and Venture Capitalists have begun to look at investing in medical devices as an unfavorable financial investment. The timeframe it requires to see profit is far too long. And the likelihood that the project may get stamped out by a principle or regulation is starting to become increasingly more unreasonable as the years remain on.

A decline in brand new medical devices has been a year to year occurrence. Both the last two years has seen a 13% decline in medical devices. The new medical devices taxations have put an acute damper on the market too. The taxes is not on profits, it is strictly calculated on revenue. This unjust practice is putting suffering businesses and organizations out of business.

Our innovators are forced to sell their devices to other markets. One developer created an iPhone app that can detect heart beats and diagnose arrhythmias from a smart phone device. Due to regulatory committees, the producer is now selling the App to veterinarians. The regulations are much leaner in the field of veterinary care. In this case our animals have a better chance at quality, innovative care than we do.

While it is frightening that we are forcing our best and brightest to take care of our animals, the worse news is that most new innovative medical devices are going directly to India. We are robbing Peter to pay Paul, and drowning in a sea of red tape.

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