[3] In The Bleeding Edge, Academy Award-nominated investigative filmmakers Kirby Dick and Amy Ziering turn their sights on the $400 billion medical device industry,[4] examining lax regulations, corporate cover-ups, and profit-driven incentives that put patients at risk daily.

[6] The film also explores the FDA's 510(k) process, which allows a medical device to be fast-tracked onto the market with less clinical study and without human testing.

[8] Frank Scheck of The Hollywood Reporter called the film "a terrifying eye-opener", and noted that it "concludes by informing us that no one from the FDA or any of the companies involved agreed to be interviewed.

"[9] Owen Gleiberman of Variety stated that "Kirby Dick's disturbingly powerful exposé nails a corporatized America.

"[12] April Wolfe of The Village Voice analyzed how Ziering and Dick continued their "legacy of equally infuriating and enlightening documentaries"[13] with the film, while the Los Angeles Times declared that "The Bleeding Edge can already be called an agent for change.