10.10.14
Maybe time really does forgive all transgressions.
Consider the love-hate relationship between the U.S. Food and Drug Administration (FDA) and the Advanced Medical Technology Association (AdvaMed). Several years ago, the two organizations were at odds over tougher and more complex regulatory scrutiny, patient access to medical devices, product approval times, and American medtech competitiveness, among other issues. “The decline in FDA performance began in 2007,” AdvaMed Senior Executive Vice President David Nexon said in 2011. “We really feel we want to be a partner with the FDA, we really want to produce improved treatments and cures. At the same time, people are very frustrated with FDA’s performance.”
How times have changed.
AdvaMed’s frustration with the FDA appears to have significantly declined in the three years since Nexon’s comment, becoming practically non-existent. It appears, in fact, that both parties have buried the hatchet and are learning to work through their differences for the greater good of patients. The couple’s improved relationship clearly was evident at AdvaMed 2014: The Medtech Conference, held earlier this week in Chicago, Ill. The three-day event—now in its eighth year—attracted more than 2,300 attendees, a 13 percent increase compared with last year’s conference. Participants from nearly 900 companies and stakeholder groups from 29 countries roamed the exhibit hall inside McCormick Place, forming new product development partnerships and exploring new areas (both geographic and clinical) to potentially expand their businesses.
Panelists and session participants at this year’s event praised the FDA for its efforts to streamline the device approval process, reduce regulatory red tape, better train its staff, and jump-start U.S. product launches. “The FDA climate has dramatically improved,” Edwards Lifesciences CEO Mike Mussallem said during a CEOs Unplugged session on Oct. 7. “If we go back just a few years ago, it seemed that we were at loggerheads on a pretty regular basis. I also think the FDA has become more sensitized in making sure that Americans actually get to benefit from some of the most innovative technologies.”
The agency has proposed creating an expedited approval process for medical devices designed to treat life-threatening or irreversibly debilitating diseases or conditions for which there are no other products available. In addition, the FDA is attempting to become more flexible and patient-centric in its decision-making, acknowledging the limitations of its current binary system.
Speaking at the Oct. 7 plenary lunch, FDA Commissioner Margaret A. Hamburg outlined specific steps her agency is undertaking to win back industry trust as well as companies that first seek product approval outside the United States. However, she admitted the FDA still has to overcome challenges in recruiting and retaining the right people to review products. “This is a work in progress,” she told midday diners. “We all know that change does not happen overnight…”
Certainly not, but the FDA’s Center for Devices and Radiological Health (CDRH) is doing its best to ensure the change that does occur is effective. During a “town hall”-style meeting on Oct. 8, CDRH Director Dr. Jeffrey Shuren delineated his organization’s efforts to return America’s medtech industry to its former glory. Changes to the agency’s de novo classification process, he said, has considerably reduced review times (from an average of more than 700 days several years ago to the current average of 166 days); also, pre-market approval (PMA) backlogs have been cut in half, and the percentage of PMAs with deficiency letters have fallen, too.
In a nod to industry concerns, the CDRH is tackling the troubling issue of clinical trials. A panel discussion on the “clinical trial crisis,” revealed some disturbing statistics on such studies: 15 percent of all clinical study sites fail to enroll a single patient. More than half of clinical study sites under-enroll patients and 45 percent of studies do not meet enrollment targets. The CDRH is attempting to address this discrepancy by increasing early feasibility studies, new draft guidance on adaptive innovative clinical trial designs, new development tools (biomarkers or computational models that potentially can be “game-changers”), a new policy on benefit risks and working with the Medical Device Innovation Consortium on improving clinical trial subject recruitment.
“If we can reduce the time and cost it takes to assess new technology, then we can make it easier getting new technology to the United States,” Shuren said. “We want to be able to talk to each other, interact and have a dialogue so we can figure out how to improve the process. The goal is to reduce the time and cost so the U.S. is the place to come first. If there is great technology out there, why not have it come to our [American] patients first? We don’t want it going somewhere else and then coming to us three or five years later.”
No company really wants to take its innovation elsewhere, but many have no choice. Many industry representatives said the lack of financing for early-stage medtech firms is forcing large multinationals to move clinical trials overseas, or even start subsidiaries in more business-friendly locales abroad.
While the number of new drugs approved has been on the rise, the number of medical devices entering the market under the FDA’s pre-market approval process tumbled from 41 in 2012 to 23 last year. The number approved under a separate process geared to improvements on products already on the market fell from 3,185 to 3,085 during that same period, according to market intelligence firm Evaluate MedTech.
“The horse has already left the barn,” warned Mark Deem, managing partner of the Foundry LLC, a medical device startup incubator in Menlo Park, Calif. “It’s gotten to the point where entrepreneurs are just moving all their early-stage medical device activities lock, stock and barrel overseas.”
Consider the love-hate relationship between the U.S. Food and Drug Administration (FDA) and the Advanced Medical Technology Association (AdvaMed). Several years ago, the two organizations were at odds over tougher and more complex regulatory scrutiny, patient access to medical devices, product approval times, and American medtech competitiveness, among other issues. “The decline in FDA performance began in 2007,” AdvaMed Senior Executive Vice President David Nexon said in 2011. “We really feel we want to be a partner with the FDA, we really want to produce improved treatments and cures. At the same time, people are very frustrated with FDA’s performance.”
How times have changed.
AdvaMed’s frustration with the FDA appears to have significantly declined in the three years since Nexon’s comment, becoming practically non-existent. It appears, in fact, that both parties have buried the hatchet and are learning to work through their differences for the greater good of patients. The couple’s improved relationship clearly was evident at AdvaMed 2014: The Medtech Conference, held earlier this week in Chicago, Ill. The three-day event—now in its eighth year—attracted more than 2,300 attendees, a 13 percent increase compared with last year’s conference. Participants from nearly 900 companies and stakeholder groups from 29 countries roamed the exhibit hall inside McCormick Place, forming new product development partnerships and exploring new areas (both geographic and clinical) to potentially expand their businesses.
Panelists and session participants at this year’s event praised the FDA for its efforts to streamline the device approval process, reduce regulatory red tape, better train its staff, and jump-start U.S. product launches. “The FDA climate has dramatically improved,” Edwards Lifesciences CEO Mike Mussallem said during a CEOs Unplugged session on Oct. 7. “If we go back just a few years ago, it seemed that we were at loggerheads on a pretty regular basis. I also think the FDA has become more sensitized in making sure that Americans actually get to benefit from some of the most innovative technologies.”
The agency has proposed creating an expedited approval process for medical devices designed to treat life-threatening or irreversibly debilitating diseases or conditions for which there are no other products available. In addition, the FDA is attempting to become more flexible and patient-centric in its decision-making, acknowledging the limitations of its current binary system.
Speaking at the Oct. 7 plenary lunch, FDA Commissioner Margaret A. Hamburg outlined specific steps her agency is undertaking to win back industry trust as well as companies that first seek product approval outside the United States. However, she admitted the FDA still has to overcome challenges in recruiting and retaining the right people to review products. “This is a work in progress,” she told midday diners. “We all know that change does not happen overnight…”
Certainly not, but the FDA’s Center for Devices and Radiological Health (CDRH) is doing its best to ensure the change that does occur is effective. During a “town hall”-style meeting on Oct. 8, CDRH Director Dr. Jeffrey Shuren delineated his organization’s efforts to return America’s medtech industry to its former glory. Changes to the agency’s de novo classification process, he said, has considerably reduced review times (from an average of more than 700 days several years ago to the current average of 166 days); also, pre-market approval (PMA) backlogs have been cut in half, and the percentage of PMAs with deficiency letters have fallen, too.
In a nod to industry concerns, the CDRH is tackling the troubling issue of clinical trials. A panel discussion on the “clinical trial crisis,” revealed some disturbing statistics on such studies: 15 percent of all clinical study sites fail to enroll a single patient. More than half of clinical study sites under-enroll patients and 45 percent of studies do not meet enrollment targets. The CDRH is attempting to address this discrepancy by increasing early feasibility studies, new draft guidance on adaptive innovative clinical trial designs, new development tools (biomarkers or computational models that potentially can be “game-changers”), a new policy on benefit risks and working with the Medical Device Innovation Consortium on improving clinical trial subject recruitment.
“If we can reduce the time and cost it takes to assess new technology, then we can make it easier getting new technology to the United States,” Shuren said. “We want to be able to talk to each other, interact and have a dialogue so we can figure out how to improve the process. The goal is to reduce the time and cost so the U.S. is the place to come first. If there is great technology out there, why not have it come to our [American] patients first? We don’t want it going somewhere else and then coming to us three or five years later.”
No company really wants to take its innovation elsewhere, but many have no choice. Many industry representatives said the lack of financing for early-stage medtech firms is forcing large multinationals to move clinical trials overseas, or even start subsidiaries in more business-friendly locales abroad.
While the number of new drugs approved has been on the rise, the number of medical devices entering the market under the FDA’s pre-market approval process tumbled from 41 in 2012 to 23 last year. The number approved under a separate process geared to improvements on products already on the market fell from 3,185 to 3,085 during that same period, according to market intelligence firm Evaluate MedTech.
“The horse has already left the barn,” warned Mark Deem, managing partner of the Foundry LLC, a medical device startup incubator in Menlo Park, Calif. “It’s gotten to the point where entrepreneurs are just moving all their early-stage medical device activities lock, stock and barrel overseas.”