Public health pioneer and onetime Centers for Medicare & Medicaid chief Dr. Donald Berwick gave some props to the medical device industry ahead of a presentation at Harvard Medical School this week.
Despite a recent stream of high-profile recalls and the ever-present clamor among consumer groups calling for more stringent regulatory oversight, Berwick said he remains a fan of the industry.
"The medical device industry is doing a lot to protect patients," Berwick told MassDevice.com. "There are people who are alive today who wouldn’t be without medical devices."
Where Cleveland Clinic’s Dr. Steven Nissen sees "a consistent pattern of failure in medical devices," Berwick said he believes such tragedies are all-but-inevitable anomalies in an arena as large as the med-tech field.
Consumer groups such as Public Citizen and Consumers Union and well-known physicians such as Dr. Robert Hauser have called for more stringent oversight of medical devices and chided device makers and the FDA for insufficient post-market review amid a clutch of headline-grabbing recalls.
Johnson & Johnson (NYSE:JNJ) remains mired in a global recall of its metal-on-metal hip implants, St. Jude Medical (NYSE:STJ) just added a second product to its defibrillator lead recall, and firms like Boston Scientific (NYSE:BSX), C.R. Bard (NYSE:BCR) and J&J have been at the center of an ongoing controversy over transvaginal mesh implants.
Nevertheless, Berwick lauded the industry’s efforts and pegged recalls as the aberration, rather than the rule.
"This is an industry that will always have to look very closely at side effects," Berwick told us. "In a $2.7 trillion industry, there will always be bad eggs."
The policy expert has long championed patient issues, serving for more than 2 decades as CEO of the Institute for Healthcare Improvement. He landed the stop spot at CMS in March 2010 via a recess appointment that granted him the position without Senate approval until the summer of 2011, provoking strong Republican consternation.
GOP members jumped at the chance to grill Berwick and call for his removal when President Barack Obama re-nominated him in January 2011. Berwick resigned his position later that year, to be replaced by his 2nd-in-command, Marilyn Tavenner.
Berwick has long made waves with conservatives, who derided his lack of insurance experience and drummed up a controversy over statements he’d made about the British health care system. Last night, addressing a receptive audience at a Boston event sponsored by the free-market champion Pioneer Institute, Berwick stuck to his guns.
Health care is a human right, he said, but the health care system wastes way too much money – as much as 30% of health care spending is effectively going down the drain, Berwick said.
"There’s no discoverable relationship between the amount of money you spend and the quality of health care," he said. "Most of the areas that are spending the most have worse quality of care. It hints at waste."
In a conversation with MassDevice.com prior to his presentation, Berwick called on device makers to turn their eyes toward bringing down the cost of health care.
"There’s a lot of imagination there," Berwick told us. "The industry just needs to get more creative with cost-reduction."