07.28.10
In early July, during Congress’ Independence Day recess, the White House announced that President Obama would use his recess appointment prerogative to make Donald Berwick, M.D., administrator of the Centers for Medicare and Medicaid Services (CMS). The move quickly enraged Republicans who had opposed his nomination. Some Democrats were miffed by the president’s methods. The White House nominated Berwick in April.
“Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points,” the Obama administration’s communications director Dan Pfeiffer wrote on the White House blog. “With the agency facing new responsibilities to protect seniors’ care under the Affordable Care Act, there’s no time to waste with Washington game-playing. That’s why tomorrow the president will use a recess appointment to put Dr. Berwick at the agency’s helm and provide strong leadership for the Medicare program without delay.”
The U.S. Constitution requires that the most senior federal officers be confirmed by the Senate before taking office. However, while Congress is in recess, the president can act alone by making a recess appointment. To remain in effect, such an appointment must be approved by the Senate by the end of the next session of Congress, or the position becomes vacant again. That means, in current practice, that a recess appointment must be approved by the end of the next calendar year—which in this case, is late 2011. After that, Berwick would have to be re-nominated to continue in his job and likely would face even greater opposition in the Senate if the GOP makes the gains it expects in the midterm elections this fall.
The move fanned flames of an already heated battle over Berwick’s nomination, with advocates and opponents vying to frame the new CMS leader as an innovative healthcare leader or, alternatively, a dangerous advocate of healthcare rationing.
A pediatrician with three Harvard degrees, Berwick is known in the health policy world for founding the Institute for Healthcare Improvement, an influential think tank in Cambridge, Mass., in 1991. He has been a leading advocate for the idea that the quality of healthcare can improve while errors are reduced and costs decreased.
Medical societies, including the American Medical Association and numerous health reform advocates, lauded Berwick as a qualified and innovative leader.
CMS has not had a permanent head for four years. The Democratic-controlled Senate never took up the nomination of Kerry Weems, former President George W. Bush’s choice in 2007 to head the agency, and the CMS has cycled through a series of acting administrators who do not need Senate confirmation.
Response from Republicans was swift.
Republicans on the Ways and Means Committee in the House of Representatives asked Chairman Sander M. Levin (D-Mich.) to schedule a hearing for Berwick so they could grill him on his views and plans for implementing the health care overhaul law.
The Ways and Means Republicans said their concerns with Berwick were heightened because some Medicare spending faces cuts under the overhaul law.
They echoed concerns expressed by Senate Republicans that Berwick supports rationing of health care services. At issue is his support for comparative effectiveness research, which is aimed at determining which treatments—procedures, pharmaceuticals or devices—are most effective when compared with others.
This was the fourth request by Republicans on the committee for a hearing on the healthcare law since it was enacted in March, but, so far, Levin hasn’t acted.
“Members of Congress and the American people were denied the opportunity to hear Dr. Berwick’s testimony and learn how he intends to ensure seniors’ access to care is preserved,” the 15 committee Republicans said in a letter to Levin.
Levin countered by saying Berwick’s expertise is “especially needed to ensure that health reform is implemented in a timely and effective way.”
The tone from Republicans on the Senate’s Finance Committee—which oversees healthcare policy—was the same. They wrote: ”If (Berwick) is not provided the opportunity to present his qualifications for the position in the usual process, it casts a shadow over his legitimacy and authority to serve as administrator during a critical time for CMS.”
The surprise was from Finance Committee Chairman Max Baucus (D-Mont.).
Baucus said that he “fully expects” the new Medicare chief to testify before the panel “in the near future.” In addition, he called the recess appointment maneuver an evasion of the Senate confirmation process.
“I’m troubled that, rather than going through the standard nomination process, Dr. Berwick was recess-appointed,” Baucus said in a statement. “Senate confirmation of presidential appointees is an essential process, prescribed by the Constitution, that serves as a check on executive power and protects Montanans and all Americans by ensuring that crucial questions are asked of the nominee—and answered.”
Baucus’ criticism is notable, since he was a leading architect of the sweeping health care reform package championed by Obama. Baucus added that his criticism wasn’t with Berwick, simply with the manner in which he was appointed—a clear slap at the Obama administration.
The president said he had little choice in making the appointment.
“It’s unfortunate that at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes,” Obama said, noting that more than 180 other nominees are waiting for confirmation by the Senate.
Biomet Plans to Expand at Home, Adding Jobs Too
Biomet Inc. plans to invest $26 million in an expansion that will create about 280 new jobs at its headquarters in Warsaw, Ind.
During a recent Kosciusko County (of which Warsaw is the county seat) council meeting, a representative from Biomet requested economic development area status for parts of the company’s campus that will undergo expansion, according to local news outlets. The economic development status is one of the first steps to securing tax abatement for the project. The council approved the new designation, however, Biomet management will have to ask the council formally for the abatement at a
follow-up meeting.
The plan is to renovate existing property and add new equipment, according to the company. New jobs will be added over the course of two years.
The small borough of Warsaw, which only has a population of about 13,000, is home to three of the world’s largest orthopedic manufacturers—Zimmer Inc., DePuy Orthopaedics Inc. and Biomet.
NuVasive Inc. Goes Bicoastal
The San Diego, Calif.-based spinal implant manufacturer has negotiated a deal to lease a two-story office building in Paramus, N.J., a borough 20 miles northwest of Manhattan. The 65,000-square-foot structure, built in 2008, will include a training facility for doctors, and house research and development and sales personnel, according to The Record, a Hackensack, N.J.-based newspaper.
In a January presentation with analysts, NuVasive Chairman and CEO Alexis Lukianov said the company’s “New York” office would open July 1. He didn’t specify a location, saying only it would be in New Jersey “not far from Giants Stadium.” The Record reported that NuVasive’s new office would open by the end of July, though a real estate broker mentioned in the article did not know how many jobs would be created in the Garden State. The broker, however, said the company has leased the Paramus property for 11 years.
“They wanted to be near a lot of cutting-edge hospitals with this new technology that they have,” said Sam Buckley, a broker with the commercial real estate brokerage CB Richard Ellis. Buckley was referring to NuVasive’s XLIF technology, which allows surgeons to operate on the spine through small incisions in the side rather than a large one in the back.
The company’s XLIF technology helped boost profits in the first quarter of 2010. NuVasive earned $1.1 million, or 3 cents per share for the three-month period ended March 31, according to the firm’s first-quarter earnings report. Revenue rose to $109.1 million, a 36.3 percent increase compared with the $80 million in revenue the company reported during the first quarter of 2009 and a 2 percent rise compared with the $106.9 million the firm generated during the fourth quarter of 2009.
While the exact number of positions the company will maintain in New Jersey remains unknown, it already has begun advertising for some of the jobs that will be based in Paramus. Some of those positions include surgeon education manager, desktop support technician and office manager.
“The new facility outside of New York City will allow NuVasive to take the next step in revolutionizing spine surgery by extending our reach to Europe and the East Coast/Midwest of the U.S.,” read one posting on the job site Indeed.com.
Tornier Planning to Go Public
It hasn’t been the healthiest of markets for initial public offerings (IPO). Wall Street analysts most likely would accept that as an axiom. Though, given the number of recent acquisitions and a few IPOs in recent months, things may be turning around. With hopes of financial blue skies ahead, medical technology company Tornier Inc. recently announced plans for an IPO worth approximately $205 million, according to documents filed with the U.S. Securities and Exchange Commission.
Though the orthopedics firm is based in Edina, Minn., it has European roots, founded in France more than 70 years ago by Rene Tornier. The company was purchased by a group of private equity investors. Warburg Pincus is Tornier’s largest shareholder at the moment, owning roughly 63 percent of the company.
Tornier primarily has focused on the extremity and small-joint market. The company is one of the largest manufacturers of shoulder joint replacement products, as well as a leading producer of foot and ankle joint replacements. The company also has focused much of its recent research and development efforts on orthobiologics.
Tornier employs approximately 800 worldwide, with about a quarter located in the United States. The firm reported sales in 2009 of $202 million.
The company plans to list its stock on the Nasdaq under the symbol “TRNX.”
510(k) Still Valuable, CDRH Director Tells Industry Gathering
Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health, has been a one-man public relations machine lately. There’s no doubt he hit the ground running since taking the helm of the U.S. Food and Drug Administration’s (FDA) device office almost a year ago, but the push for positive spin and dialog has increased as the pressure also has grown regarding the agency’s 510(k) clearance program—not to mention the industry’s uncertainties surrounding the present and future shape of the review and submission processes.
He’s hit the road recently with a town hall meeting in Minnesota and Massachusetts, and California, slated for October. One of Shuren’s most recent stops was the annual meeting of the Medical Device Manufacturers Association (MDMA) in Washington, D.C. CDRH directors are no strangers to MDMA’s annual gathering, however, Shuren’s “presentation,” if you can call it that, was less podium and PowerPoint and more relaxed conversation talk-show-host style. He made brief remarks before strolling the ballroom lined with tables, microphone in hand, answering device makers’ questions.
His primary message? The 510(k) program isn’t going anywhere.
“First off, nobody’s going to scrap the 510(k) program. There’s a lot of value to the program,” he pointedly told the audience from the outset of his comments. “For the most part, the issues we’re encountering are for a smaller subset of devices. There are some broad issues, but for the most part, the challenges with devices pertain to a smaller minority. Most of the devices we deal with, at least form our perspective, just aren’t issues. The 510(k) program works very well.”
Shuren, a neurologist who also holds a law degree, did acknowledge that there has been “angst” regarding the program.
“We have heard concerns about the 510(k) program, although it has ratcheted up from what we hear and even from our own perceptions,” he said, adding that the concern led to an internal review and external analysis by the Institute of Medicine (IOM), which is expected next year.
“The value of [the IOM review] is that it is an assessment independent of FDA,” he explained, but said the results of an internal review of the 510(k) program also will provide clarity. “First, as a federal agency, we had an obligation to do self reflection and go back and look at our own programs. Secondly, 2011 is a long time. If there are things we should be doing now, we need to get those things underway before 2011.”
He acknowledged that the FDA is moving very quickly and that some people in the industry have voiced their concerns that the process of “introspection” may be moving too quickly. Even Shuren’s own CDRH staff has shared concern about the pace.
“I’m asking a lot of them and myself. And I’m asking for patience and understanding, but the concerns are so great that waiting a long time does not serve the interest of anyone,” he said, adding that they’re trying to get as much information as possible and digest it quickly and come out with preliminary 510(k) recommendations in a report expected to be released later this summer. Industry feedback to the internal findings will be solicited, and, if possible, debated and implemented before the end of the year.
An ongoing criticism of the CDRH review proces—both for 510(k)s and premarket approval—is a lack of consistency and predicability. Shuren acknowledged that the agency could be “a little more clear” when its expectations change. The agency also has begun an internal review of that process as well, he said.
“What should we base those decisions on, and how do we communicate them?” he asked. For example, at present, if the agency determines that there’s new safety information for a device, and it needs to amend the kind of assessment that is expected from the device sponsor, getting the message out to device companies isn’t always direct or efficient.
“How do we communicate it? Well, now we tend to do it on an ad-hoc basis,” Shuren admitted. He said companies may not find out until they visit or call the agency prior to submitting a device application. If a company already has a device in clinical trials, it may not find out about the new requirements until it has made its submission.
“That can lead to long delays and money spent,” Shuren said. “It doesn’t serve you well or us well. Another way is to issue a draft guidance, but this is resource intensive. There is a better way.”
Much of this activity is part of Shuren’s attempts to “change the culture” in the CDRH, he said. The mission of CDRH that Shuren articulated is to promote public health by helping safe and effective technologies to market, but it also has another side. Promotion of innovation is “a piece I found missing” he said.“For example, what can we do to help facilitate design changes that will reduce those risks? Why are we waiting for industry to go out and solve problems? What can we do to bring internal expertise to problems? We need to make our internal expertise available.”
A new council on medical device innovation is another priority for FDA, according to Shuren. The council will have participation from several government agencies, including the National Institutes of Health (NIH), the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention, the U.S. Department of Veterans Affairs, and the U.S. Department of Defense.
He said the different agencies will work together to examine where the latest medical technology might have the greatest impact on public health. “We would also look at reducing barriers to entry, where roadblocks could be reduced, for example, at CMS or FDA.”
Shuren compared his role at CDRH to that of a medical device CEO, noting that he manages a “company” with more than 1,300 employees. And like his fellow CEOs, he needs current and frequent intelligence.
“If I’m going to run this ‘business,’ I need to know what’s going on. I need signals, red flags,” he said, to address industry needs. He urged the audience to make an effort to stay in touch with CDRH, noting that open communication would be key to the success of initiatives currently being debated, though he recognized how trite that bit of advice sounded. “We have to get past this fear; we honestly have to get past it,” he said.
“Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points,” the Obama administration’s communications director Dan Pfeiffer wrote on the White House blog. “With the agency facing new responsibilities to protect seniors’ care under the Affordable Care Act, there’s no time to waste with Washington game-playing. That’s why tomorrow the president will use a recess appointment to put Dr. Berwick at the agency’s helm and provide strong leadership for the Medicare program without delay.”
The U.S. Constitution requires that the most senior federal officers be confirmed by the Senate before taking office. However, while Congress is in recess, the president can act alone by making a recess appointment. To remain in effect, such an appointment must be approved by the Senate by the end of the next session of Congress, or the position becomes vacant again. That means, in current practice, that a recess appointment must be approved by the end of the next calendar year—which in this case, is late 2011. After that, Berwick would have to be re-nominated to continue in his job and likely would face even greater opposition in the Senate if the GOP makes the gains it expects in the midterm elections this fall.
The move fanned flames of an already heated battle over Berwick’s nomination, with advocates and opponents vying to frame the new CMS leader as an innovative healthcare leader or, alternatively, a dangerous advocate of healthcare rationing.
A pediatrician with three Harvard degrees, Berwick is known in the health policy world for founding the Institute for Healthcare Improvement, an influential think tank in Cambridge, Mass., in 1991. He has been a leading advocate for the idea that the quality of healthcare can improve while errors are reduced and costs decreased.
Medical societies, including the American Medical Association and numerous health reform advocates, lauded Berwick as a qualified and innovative leader.
CMS has not had a permanent head for four years. The Democratic-controlled Senate never took up the nomination of Kerry Weems, former President George W. Bush’s choice in 2007 to head the agency, and the CMS has cycled through a series of acting administrators who do not need Senate confirmation.
Response from Republicans was swift.
Republicans on the Ways and Means Committee in the House of Representatives asked Chairman Sander M. Levin (D-Mich.) to schedule a hearing for Berwick so they could grill him on his views and plans for implementing the health care overhaul law.
The Ways and Means Republicans said their concerns with Berwick were heightened because some Medicare spending faces cuts under the overhaul law.
They echoed concerns expressed by Senate Republicans that Berwick supports rationing of health care services. At issue is his support for comparative effectiveness research, which is aimed at determining which treatments—procedures, pharmaceuticals or devices—are most effective when compared with others.
This was the fourth request by Republicans on the committee for a hearing on the healthcare law since it was enacted in March, but, so far, Levin hasn’t acted.
“Members of Congress and the American people were denied the opportunity to hear Dr. Berwick’s testimony and learn how he intends to ensure seniors’ access to care is preserved,” the 15 committee Republicans said in a letter to Levin.
Levin countered by saying Berwick’s expertise is “especially needed to ensure that health reform is implemented in a timely and effective way.”
The tone from Republicans on the Senate’s Finance Committee—which oversees healthcare policy—was the same. They wrote: ”If (Berwick) is not provided the opportunity to present his qualifications for the position in the usual process, it casts a shadow over his legitimacy and authority to serve as administrator during a critical time for CMS.”
The surprise was from Finance Committee Chairman Max Baucus (D-Mont.).
Baucus said that he “fully expects” the new Medicare chief to testify before the panel “in the near future.” In addition, he called the recess appointment maneuver an evasion of the Senate confirmation process.
“I’m troubled that, rather than going through the standard nomination process, Dr. Berwick was recess-appointed,” Baucus said in a statement. “Senate confirmation of presidential appointees is an essential process, prescribed by the Constitution, that serves as a check on executive power and protects Montanans and all Americans by ensuring that crucial questions are asked of the nominee—and answered.”
Baucus’ criticism is notable, since he was a leading architect of the sweeping health care reform package championed by Obama. Baucus added that his criticism wasn’t with Berwick, simply with the manner in which he was appointed—a clear slap at the Obama administration.
The president said he had little choice in making the appointment.
“It’s unfortunate that at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes,” Obama said, noting that more than 180 other nominees are waiting for confirmation by the Senate.
Biomet Plans to Expand at Home, Adding Jobs Too
Biomet Inc. plans to invest $26 million in an expansion that will create about 280 new jobs at its headquarters in Warsaw, Ind.
During a recent Kosciusko County (of which Warsaw is the county seat) council meeting, a representative from Biomet requested economic development area status for parts of the company’s campus that will undergo expansion, according to local news outlets. The economic development status is one of the first steps to securing tax abatement for the project. The council approved the new designation, however, Biomet management will have to ask the council formally for the abatement at a
follow-up meeting.
The plan is to renovate existing property and add new equipment, according to the company. New jobs will be added over the course of two years.
The small borough of Warsaw, which only has a population of about 13,000, is home to three of the world’s largest orthopedic manufacturers—Zimmer Inc., DePuy Orthopaedics Inc. and Biomet.
NuVasive Inc. Goes Bicoastal
The San Diego, Calif.-based spinal implant manufacturer has negotiated a deal to lease a two-story office building in Paramus, N.J., a borough 20 miles northwest of Manhattan. The 65,000-square-foot structure, built in 2008, will include a training facility for doctors, and house research and development and sales personnel, according to The Record, a Hackensack, N.J.-based newspaper.
In a January presentation with analysts, NuVasive Chairman and CEO Alexis Lukianov said the company’s “New York” office would open July 1. He didn’t specify a location, saying only it would be in New Jersey “not far from Giants Stadium.” The Record reported that NuVasive’s new office would open by the end of July, though a real estate broker mentioned in the article did not know how many jobs would be created in the Garden State. The broker, however, said the company has leased the Paramus property for 11 years.
“They wanted to be near a lot of cutting-edge hospitals with this new technology that they have,” said Sam Buckley, a broker with the commercial real estate brokerage CB Richard Ellis. Buckley was referring to NuVasive’s XLIF technology, which allows surgeons to operate on the spine through small incisions in the side rather than a large one in the back.
The company’s XLIF technology helped boost profits in the first quarter of 2010. NuVasive earned $1.1 million, or 3 cents per share for the three-month period ended March 31, according to the firm’s first-quarter earnings report. Revenue rose to $109.1 million, a 36.3 percent increase compared with the $80 million in revenue the company reported during the first quarter of 2009 and a 2 percent rise compared with the $106.9 million the firm generated during the fourth quarter of 2009.
While the exact number of positions the company will maintain in New Jersey remains unknown, it already has begun advertising for some of the jobs that will be based in Paramus. Some of those positions include surgeon education manager, desktop support technician and office manager.
“The new facility outside of New York City will allow NuVasive to take the next step in revolutionizing spine surgery by extending our reach to Europe and the East Coast/Midwest of the U.S.,” read one posting on the job site Indeed.com.
Tornier Planning to Go Public
It hasn’t been the healthiest of markets for initial public offerings (IPO). Wall Street analysts most likely would accept that as an axiom. Though, given the number of recent acquisitions and a few IPOs in recent months, things may be turning around. With hopes of financial blue skies ahead, medical technology company Tornier Inc. recently announced plans for an IPO worth approximately $205 million, according to documents filed with the U.S. Securities and Exchange Commission.
Though the orthopedics firm is based in Edina, Minn., it has European roots, founded in France more than 70 years ago by Rene Tornier. The company was purchased by a group of private equity investors. Warburg Pincus is Tornier’s largest shareholder at the moment, owning roughly 63 percent of the company.
Tornier primarily has focused on the extremity and small-joint market. The company is one of the largest manufacturers of shoulder joint replacement products, as well as a leading producer of foot and ankle joint replacements. The company also has focused much of its recent research and development efforts on orthobiologics.
Tornier employs approximately 800 worldwide, with about a quarter located in the United States. The firm reported sales in 2009 of $202 million.
The company plans to list its stock on the Nasdaq under the symbol “TRNX.”
510(k) Still Valuable, CDRH Director Tells Industry Gathering
Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health, has been a one-man public relations machine lately. There’s no doubt he hit the ground running since taking the helm of the U.S. Food and Drug Administration’s (FDA) device office almost a year ago, but the push for positive spin and dialog has increased as the pressure also has grown regarding the agency’s 510(k) clearance program—not to mention the industry’s uncertainties surrounding the present and future shape of the review and submission processes.
He’s hit the road recently with a town hall meeting in Minnesota and Massachusetts, and California, slated for October. One of Shuren’s most recent stops was the annual meeting of the Medical Device Manufacturers Association (MDMA) in Washington, D.C. CDRH directors are no strangers to MDMA’s annual gathering, however, Shuren’s “presentation,” if you can call it that, was less podium and PowerPoint and more relaxed conversation talk-show-host style. He made brief remarks before strolling the ballroom lined with tables, microphone in hand, answering device makers’ questions.
His primary message? The 510(k) program isn’t going anywhere.
“First off, nobody’s going to scrap the 510(k) program. There’s a lot of value to the program,” he pointedly told the audience from the outset of his comments. “For the most part, the issues we’re encountering are for a smaller subset of devices. There are some broad issues, but for the most part, the challenges with devices pertain to a smaller minority. Most of the devices we deal with, at least form our perspective, just aren’t issues. The 510(k) program works very well.”
Shuren, a neurologist who also holds a law degree, did acknowledge that there has been “angst” regarding the program.
“We have heard concerns about the 510(k) program, although it has ratcheted up from what we hear and even from our own perceptions,” he said, adding that the concern led to an internal review and external analysis by the Institute of Medicine (IOM), which is expected next year.
“The value of [the IOM review] is that it is an assessment independent of FDA,” he explained, but said the results of an internal review of the 510(k) program also will provide clarity. “First, as a federal agency, we had an obligation to do self reflection and go back and look at our own programs. Secondly, 2011 is a long time. If there are things we should be doing now, we need to get those things underway before 2011.”
He acknowledged that the FDA is moving very quickly and that some people in the industry have voiced their concerns that the process of “introspection” may be moving too quickly. Even Shuren’s own CDRH staff has shared concern about the pace.
“I’m asking a lot of them and myself. And I’m asking for patience and understanding, but the concerns are so great that waiting a long time does not serve the interest of anyone,” he said, adding that they’re trying to get as much information as possible and digest it quickly and come out with preliminary 510(k) recommendations in a report expected to be released later this summer. Industry feedback to the internal findings will be solicited, and, if possible, debated and implemented before the end of the year.
An ongoing criticism of the CDRH review proces—both for 510(k)s and premarket approval—is a lack of consistency and predicability. Shuren acknowledged that the agency could be “a little more clear” when its expectations change. The agency also has begun an internal review of that process as well, he said.
“What should we base those decisions on, and how do we communicate them?” he asked. For example, at present, if the agency determines that there’s new safety information for a device, and it needs to amend the kind of assessment that is expected from the device sponsor, getting the message out to device companies isn’t always direct or efficient.
“How do we communicate it? Well, now we tend to do it on an ad-hoc basis,” Shuren admitted. He said companies may not find out until they visit or call the agency prior to submitting a device application. If a company already has a device in clinical trials, it may not find out about the new requirements until it has made its submission.
“That can lead to long delays and money spent,” Shuren said. “It doesn’t serve you well or us well. Another way is to issue a draft guidance, but this is resource intensive. There is a better way.”
Much of this activity is part of Shuren’s attempts to “change the culture” in the CDRH, he said. The mission of CDRH that Shuren articulated is to promote public health by helping safe and effective technologies to market, but it also has another side. Promotion of innovation is “a piece I found missing” he said.“For example, what can we do to help facilitate design changes that will reduce those risks? Why are we waiting for industry to go out and solve problems? What can we do to bring internal expertise to problems? We need to make our internal expertise available.”
A new council on medical device innovation is another priority for FDA, according to Shuren. The council will have participation from several government agencies, including the National Institutes of Health (NIH), the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention, the U.S. Department of Veterans Affairs, and the U.S. Department of Defense.
He said the different agencies will work together to examine where the latest medical technology might have the greatest impact on public health. “We would also look at reducing barriers to entry, where roadblocks could be reduced, for example, at CMS or FDA.”
Shuren compared his role at CDRH to that of a medical device CEO, noting that he manages a “company” with more than 1,300 employees. And like his fellow CEOs, he needs current and frequent intelligence.
“If I’m going to run this ‘business,’ I need to know what’s going on. I need signals, red flags,” he said, to address industry needs. He urged the audience to make an effort to stay in touch with CDRH, noting that open communication would be key to the success of initiatives currently being debated, though he recognized how trite that bit of advice sounded. “We have to get past this fear; we honestly have to get past it,” he said.