Home   |   About   |   Bill Text & Additional Materials  | Supporters

"Inefficiencies in the redundant federal approval process put our medical device companies at a competitive disadvantage. By eliminating duplicative requirements, we’ll speed up the rate of research into life-saving innovations and guarantee Indiana’s device manufacturing sector remains among the most competitive, fastest-growing in the world."   - Congressman Todd Young

Industry leaders cite skyrocketing development costs, complicated regulations and bureaucracy, and pressure to go offshore among the list of obstacles limiting the delivery of life-saving medical device technologies to patients in the United States. 

The unpredictable regulatory approval path coupled with an industry-specific tax increase levied to offset costs of the $1.1 trillion Affordable Care Act, have made it expensive to operate and develop new technologies here in the United States. 
 

For states like Indiana... 
.... the barriers to doing business represent a significant threat to the local economy as well as job creation. 

Indiana is home to...
.... the fifth largest medical device industry in the United States employing more than 20,000 Hoosiers.

As reported in November of 2015, the FDA medical device process can take years and cost companies anywhere from $30 million to $100 million. Prohibitive tax and regulatory costs stymie the development of innovative medical devices that improve quality of life for patients and help to drive down medical costs. 
 

One Hoosier medical device company...
...developed a device that generated 43% cost savings per patient per year.

Improved quality of life and reduced medical costs....
.... were achieved by reducing the number of treatments for patients from 3 or 4 each year down to only one. 

xxx