[ad_1]
From pacemakers to insulin pumps, thousands of different medical devices help Americans every day. But the way this product arrives on the market is often unknown to the public.
"Frankly, patients do not have much visibility or transparency about the safety or quality of a device," he said. Dr. Archelle Georgiou, KSTP Medical Expert.
Currently, when a company, such as Medtronic, Boston Scientific or 3M, markets a new medical device, it only needs to prove that it is similar to devices currently on the market.
The medical device industry has been an important part of the Minnesota economy for decades. Below you will find the latest statistics from the Ministry of Employment and Economic Development on the number of people working for medical device manufacturers in Minnesota.
"Imagine buying a new cell phone and comparing the cell phone you buy today to the one that was designed and built 15 years ago … is this really the comparison you want to buy? "said Georgiou.
Now the FDA is able to compare new devices to more modern technology. This decision comes after an investigation revealed that over a 10-year period, more than 83,000 deaths were believed to be related to medical devices.
"The process of approving medical devices affects or will affect all Americans," said Shaye Mandle, president and CEO of Medical Alley Association.
Mandle works with some of the biggest names in the industry and believes that this change should have a beneficial balance for both patients and manufacturers.
"The announcement today, I think, creates an opportunity," Mandle said.
Dr. Georgiou thinks this is necessary but we have to wait and see how it all goes.
"It's a compromise between quality and safety, time to market and cost," Georgiou said. "But the FDA with this new regulation will help bring more safety to consumers."
The FDA plans to set guidelines for these regulations early in the year, but their implementation could take years.
Source link
