While it may be true that some “current intervention practices de-incentive quality”, FDA regulations are intended to prevent harm to the device user, not to ensure quality. It is up to the discretion of the company to produce a product that Is not only safe and in compliance with regulation, but also one of good quality.

It is important to note that “Quality is defined as products and services that deliver intended performance, safety, and customer satisfaction, while compliance is defined as meeting regulatory requirements.” So even with regulation de-incentivizing quality, market competition should be sufficient motivation to make quality a priority along with compliance during device development.

I am however interested in what regulations de-incentivize quality and how.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf