Dr. Jeff's Travelling Medicine Show | Orthopedics This Week
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Dr. Jeff’s Travelling Medicine Show

RRY Publications LLC

Never let it be said that the new FDA device boss Jeff Shuren, M.D., doesn't have a sense of humor.

Shuren, the Director of the FDA's Center for Devices and Radiological Health (CDRH) brought his FDA Traveling Medicine Show to a Town Hall Meeting in Minnesota May 18. He got an earful from about 400 attendees from Minnesota's medical technology community about the dysfunctional PMA and 510(k) processes that are chasing innovation to overseas.

Minneapolis attorney Mark DuVal compared the FDA's role of protecting the public's health to that of a parent trying to do everything they can to keep their kids safe, but alas must eventually let them face the risks of the real world.

Shuren replied that he once considered parenting, but learned that he would be PMA'd and decided it wasn't worth it.

But, he added, he's considering parenting in Europe.

This humorous exchange between Shuren and DuVal perfectly crystallized the underlying complaints from the Town Hall attendees. Shuren’s predecessor at the FDA, Dan Schultz, M.D., told attendees at the 9th Annual MedTech Investing Conference in Minneapolis two days later that the U.S. is in danger of shipping innovation overseas.

AdvaMed President and CEO Stephen Ubl told the investors that over the past few years the number of clinical trials conducted in the United States has declined while the number overseas has increased. Today, the percentage of clinical trials conducted outside the U.S. (OUS) is roughly double from a few years ago and he estimates that the United State’s portion of overall clinical studies has fallen from 80% to 40%.

Investor Inability to Calculate Risk

What Shuren and his colleagues heard in Minnesota is exactly what we have heard from orthopedic industry executives and surgeons at many society meetings. The FDA regulatory process has become a onerous burden that is increasingly unpredictable and inconsistent. The FDA is exerting a chilling effect on innovation.

Pete McNerney, a senior venture capitalist speaking at the Town Hall meeting, summed it up best.                                                                    

"We have lost our ability to evaluate regulatory risk, " said McNerney

McNerney told Shuren that venture capital is usually the only source of capital for companies with, "No sales, no profits and few fixed assets. The primary assets they have are passionate people and intellectual property. Without venture capital they would not exist."

"I am here because the venture community is moving away from investing in medical technology, " said McNerney.

He backed that up by noting that venture capital investment in medical devices in the U.S. has declined by greater than one-third over the last two years, a decline that is more dramatic for companies raising their first round of capital.

FDA Town Hall Meeting in Minnesota/Orthopedics This Week
The Town Hall meeting in Minnesota was the first of three big shows scheduled for Minneapolis, Boston in June and Los Angeles in October. If you're going to try the show out on the road, Minnesota is a good place to start. The audience was polite, well mannered and finished on time. The Boston and LA crowds may not be so well behaved.

It’s asking a lot of someone who has business before the FDA to be critical in a public forum. Imagine a small town where the local constable is the licensor, inspector, prosecutor, judge and jury. Such is the power of the FDA.

One brave spine surgeon, John Sherman, M.D., lectured Shuren about inconsistent reviewer requirements that sank Disc Dynamics.

Shuren’s Quest

In a marked departure from past CDRH directors, Shuren invited his audience to join him in a no-holds-barred discussion and appeared to this writer to be engaged, open and communicative. Shuren’s road show released frustrations that have been pent up for years.

Jeff Shuren, M.D., CDRH Director/Orthopedics This Week
Shuren told his audience that he is taking this show on the road to acknowledge that recent changes at the agency have created uncertainty. He wanted to give people outside the Washington Beltway a "brief sense of what CDRH is up to...and where we're headed, so that perhaps you will understand that this period of change at the Center will end with a greater sense of predictability and transparency, " said Shuren.

He told attendees that reevaluating the agency's decision making processes, particularly the premarket review programs, and to assure as much predictability as is feasible, is one of the agency's top priorities.

CDRH Strategic Priorities

He outlined the Center's four strategic priorities for 2010:

    • Fully implement a total product life cycle approach
    • Enhance communication and transparency
    • Strengthen the Center's workforce and workplace
    • Proactively facilitate innovation and address unmet public health needs

      Implementing a total product life cycle approach means making "well-supported regulatory decisions that take into consideration all of the relevant information available to the Center."

      A major component of the life cycle approach is to complete the assessment of the 510(k) program being conducted by the Institute of Medicine by mid-year 2011. Shuren also established an internal 510(k) Working Group to evaluate the program and expects to see their report by the end of May and release the report for public comment thereafter. Industry can expect to see changes in the program as early as September.

      “The agency has no intention of scrapping the 510(k) program, ” added Shuren.

      Shuren noted the recent posting of the agency's "pivotal" IDE (investigational device exemption) checklist—which identifies important components of the FDA’s review of a clinical trial protocol—as an example of his move to more transparency. He also said that over the "next few years, " the agency will increase its ability to capture "meaningful data on marketed devices, " in part, by establishing a Unique Device Identification or UDI system. He said the UDI is "essential for linking information about the device with information about a patient's experience with the device."

      Over the next two to three years, CDRH will develop mechanisms to exchange and make better use of medical device information from "trusted foreign authorities, " such as supplementing the FDA's inspections with Quality Systems/GMP inspections conducted by other countries under the ISO 13485 Audit Report.

      The goal is to have a program where an inspection conducted in one country would serve in lieu of an inspection by the FDA and vice versa.

      Use of a Science Task Force

      The agency established an internal task force to incorporate new scientific information into the decision making process in a transparent and predictable manner. That task force's report will go out for public comment this summer.

      The Center recently established the position of Deputy Center Director for Policy whose function is to engage in strategic policy development and coordination. Shuren said that they are staffing that center up and expect to announce the new Director’s name later this summer.

      Shuren:  “I have no bench”

      Shuren commented on his staffing needs and made it clear that in several important categories he has “no bench”. When a reviewer leaves the Center, there is often no back-up staff member to step in. Shuren did not offer details as to how he plans to address this problem and certainly, as he mentioned in the meeting, the range of new medical technologies makes it harder and harder to find reviewers with the specific expertise necessary to properly evaluate applications.

      Innovation to Promote Health

      The mission of the FDA and CHRD is to protect the public's health and promote patient access to innovative medical products.

      Those two FDA mission statements have often moved in different directions. The public outcry, for example, that occurs when an approved product harms a patient is, said Shuren, far greater than when an unknown class of patients is not getting timely access to a new technology.

      Shuren, however, linked the two missions in his talk. He said that access to new technologies is important in order to protect the patient’s health. 

      "At certain times in the past the pendulum has swung far to one side or the other. To fulfill our mandate, we must embrace both parts of our mission."

      A Whiff of Change

      One banker at the MedTech meeting said he was beginning to sniff a change in the wind. He pointed to recent discussions with Deans of prestigious medical schools who are upset that innovations developed at their institutions are not finding their way to market due to the FDA's slow and inconsistent pace of approvals.

      Shuren said the agency has a "breadth and depth of knowledge about device design that is not available to industry, the venture community, the healthcare community." That experience, he said, has often been used to only tell companies they have a problem. 

      To harness that agency knowledge in a way to help manufacturers solve problems and develop new devices to address "unmet public health needs, " the FDA recently established a Council on Medical Device Innovation. The Council will identify the most important unmet public health needs and to minimize barriers to the development or redesign of devices to alleviate, prevent, or diagnose these illnesses.

      Make no mistake about it, Shuren is a man on a mission. In Minnesota, the medical device audience seemed to give him the benefit of the doubt. We’ll see how the audiences shape up when Dr. Jeff’s Travelling Medicine Show hits Boston and LA. 


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