Michael Causey, Editor & Publisher, eDataIntegrityReport.com

That sound you heard last week was the device industry sighing and maybe even applauding lightly when the FDA announced  it was seeking the public’s input on a plan to identify and harness a web of outside experts who may help it speed device approval.

As Reuters reported, FDA formed a pilot committee of experts, which will run through December 30 and expand the pool of vetted sources the agency already has on tap. It’s all part of the FDA’s effort to reform the 510(k) medical device review process. Some say the agency isn’t tough enough in protecting the safety of device users; others say the agency is stifling innovation and sending more jobs overseas.

Device manufacturers we spoke to were guardedly optimistic about this and other recent FDA moves. “We support the creation of such a network, providing that the FDA ensures that the experts do not have any personal or professional ties or conflicts of interest with the products / manufacturers / specific device industries they oversee,” Kelly Roman, Vice President at Fisher Wallace Laboratories, told us.

“We are aware that current Panel members that the FDA works with on PMA and reclassification matters may have these types of ties and conflicts,” Kelly continues. “It is difficult to retain top experts who have no vested interest in the fate of the industries they oversee, but ensuring that the process is completely free of bias is essential to the FDA’s mission and to public health.”

She suggests that, as with Panel members, FDA should “provide the full professional biographies of network experts. “ She also called on the agency to provide a forum by which the public may raise concerns over potential conflicts of interest on a case by case basis, and provide some process by which these concerns are officially addressed.

“This will help provide transparency and resolution to conflicts of interest that will inevitably arise. As of now, there is no clear, prescribed way to address such issues.

But Charlie Chi, Ph.D., former CEO and co-founder of OtisMed (now part of Stryker Orthopaedics), is a medical device industry entrepreneur and inventor flat out thinks it’s a bad idea for the FDA to get involved in new medical technologies.

Chi doesn’t think any company would want the FDA to get involved in every step of the product development cycle. In addition, he thinks it would take longer and be more costly for companies to develop new medical devices even though the approval process might be faster.

Chi noted that most U.S. companies are now going to Europe/Asia first to launch their new products because the approval process is quicker and less stringent than in the U.S. Yet, the failure rate is actually less than here in the U.S. He thinks the FDA should follow a review and approval process similar to other countries around the world.

Doug Mowen, Accenture

Accenture’s Doug Mowen feels the pain of both sides and urged the medical device industry to take a “wait and watch” approach. “There has been so much noise around FDA and these issues, but I believe the FDA has now heard everyone loud and clear.” He and his team work with medical device firms to handle 483s and other FDA-related dealings.

Doug sees some reasons for optimism because the FDA does seem to finally understand the medical device industries concerns. “If the FDA is able to reform a few things in the 510(k) process and make it more transparent, that will be such a positive thing.”

With over 15 years of experience in the Life Sciences industry, Doug has worked broadly across the medical technology industry, assisting major MedTech companies with compliance in key areas including emerging markets, supply chain, and pricing and customer profitability. Most recently Doug developed a research paper “Achieving High Performance: Reinventing Medical Technology for a Dramatically Different Future,” addressing how global regulatory issues are changing the overall business landscape for MedTech.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Tyra Banks aside, not many 35 year olds look as pristine and buff as they did in younger days.

But if the new Institute of Medicine (IOM) report has its way, the FDA’s 35 year-old 510(k) process should be put out to pasture entirely.

I suppose there’s something to be said for the fact that IOM’s controversial new report seems to have made almost everyone mad.

FDA is reportedly not happy and surprised that it calls for scrapping the current 510(k) system.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), said industry isn’t happy with it, either. “The report’s conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”

Ulb goes on, “Numerous academic studies have shown that the 510(k) process is overwhelmingly safe. The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance. It even goes so far as to say that further investment in 510(k) process improvements would not be ‘a wise use of FDA resources.”

But IOM’s report seems to have surprised everyone with its stark view of the situation.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effective­ness of moderate-risk devices and, furthermore, that it cannot be transformed into one,” the report says.

IOM believes “the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

In other words, junk it. Start over.

Has the FDA’s 510(k) process hindered innovation (as much of the medical device industry maintains), or has it struck the best balance between protecting patients and spurring new ideas?

Sorry, IOM punted on that one. “It is unclear—and the committee concludes that it is indeterminable, given current information— whether the 510(k) process over the last 35 years has had a positive or negative effect on innovation. To answer this question, the FDA should commission an assessment to determine this effect.”

In other words, do another study.

Respected industry attorney and Hogan Lovells Partner John Smith tells us, “the report is extremely disappointing given the time and effort that has been dedicated to this process. The assumptions underlying the IOMs conclusions are fundamentally flawed and those conclusions are vague and highly questionable.”

Specifically, he faults the IOM report for saying the 510(k) process does not evaluate safety and effectiveness. “This is simply not true in FDA’s application of the 510(k) paradigm to new medical devices. Although the standard for clearance is ‘substantial equivalence,’ the agency routinely integrates an evaluation of both safety and effectiveness into its substantial equivalence determinations. In other words, the IOM analysis lacks a ‘real world’ perspective and appears to have relied upon on a very conservative reading of the Federal Food, Drug, and Cosmetic Act, and its implementing regulations to reach this conclusion.”

IOM says scrap the 510(k) system, but some say scrap the IOM report.

“The Institute’s primary conclusion that the 510(k) process should be abandoned completely ignores the considerable debate that lead to its creation and the successful applicable of the 510(k) paradigm over 35 years,” Smith says. “No specific, systemic shortcomings that would justify such a radical restructuring were convincingly identified. Simply put, establishing the 510(k) paradigm was a thorough, thoughtful process and the process served both FDA and industry well since its inception. The Institute also fails to offer concrete recommendations as to potential alternatives, likely reflecting how difficult it will be to improve on the existing 510(k) paradigm.”

Watch the IOM’s webcast unveiling the report here.

Comment period ends September 30. To comment, go here:

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Calling the recent GAO charges that the FDA is putting patients at risk by approving too many devices through the 510(k) process “silly and off base” leading medical device industry attorney Jonathan Kahan, Co-director of law firm Hogan Lovells’ Medical Device practice which represents about 700 medical device firms, says the current climate of misguided regulation is as bad for device firms as it was in the early 1990s.

Small device firms in particular are struggling to understand FDA’s confusing regulatory posture, and many are going out of business as a result, Kahan told us April 18. Kahan  has been practicing in FDA law for 35 years, and specifically focuses on assisting medical device companies navigate the FDA’s regulatory process.

During high-profile Senate  hearings last week the FDA heard from lawmakers that no one is especially thrilled with the agency’s performance in this arena  As reported in the Minneapolis Star-Tribune,  “Nobody is particularly happy with the FDA,” Sen. Bob Corker, R-Tenn said at the hearing.

Kahan acknowledges that some medical devices fail (“and NASA can’t always make a shuttle that doesn’t blow up”), but he stressed that the numbers are very low and that the GAO report wouldn’t address those failure problems anyway. “The problems occur more in the manufacturing side and not as a result of the 510(k) process,” he said.

“Congress and the White House have an astounding lack of understanding of this issue,” Kahan added. “The GAO emphasis is totally missing” the point.

Kahan stressed that the biggest issue is FDA inconsistency in its regulations and enforcement policy. He was echoed by at least one speaker at last week’s hearings.

The medical device industry is concerned that CDRH procedural and management problems have slowed medical device innovation. In his testimony last week, David Nexon, Senior Executive Vice President of the Advanced Medical Technology Association, criticized that there are, “inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology.”

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It sounds a bit like some 1960s futuristic ride at Epcot Center, but the FDA gamely today unveiled what it calls the “Innovation Pathway,” which is a fancy way of saying it’s a priority review program aimed at advancing breakthrough medical devices. As the agency seeks comment on how to use the “Pathway” more often, it also announced the first device submission: a brain-controlled, upper-extremity prosthetic.

The new program is highlighted in a report on the FDA’s website. It’s part of a broader effort from the Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers.

CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center’s White Oak campus.

The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science. Proposed actions include:

• establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages;
• creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the United States.

In addition, CDRH intends to engage in formal horizon scanning – or what is calls “monitoring medical literature and scientific funding in a systematic way to predict where technology is heading.” CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.

Formal horizon scanning? Didn’t science fiction great Philip K. Dick write something like that a few decades back? I’m thinking Minority Report or Blade Runner (the book is called “Do Androids Dream of Electric Sheep?” for you purists).

I suspect many in the medical device industry wish the FDA would focus more on the here and now when it comes to spurring medical device innovation. Namely, improving its 510k process so American medical device firms aren’t forced to play catch-up with their competitors in the European Union, as we’ve blogged about before.

But at today’s press event announcing the “Pathway,” CDRH Director Jeffrey Shuren accentuated the positive, “Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions…CDRH’s Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs.”

FDA even supplied some photos of its labs.

Cool!

In today’s announcement, the FDA said the Pathway includes these features:

• products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.

Maybe it’s just me, but the creation of a new “oversight body” doesn’t automatically sound like it will speed up the process.

At any rate, the FDA said it could ultimately conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.

I don’t think many people playing a free association game would link “FDA” with “innovation” just yet, but let’s make like Buzz Lightyear here with a little Formal Horizon Scanning of our own and cling to optimism in the face of any discouraging facts.

Hooray for the Innovation Pathway!

Under attack from consumers for being too lax and from industry for being too stringent, the FDA today unveiled its controversial and long-awaited 510(k) plan it hopes will improve the review process for “certain innovative, lower-risk medical devices.”

Like most government wonks, the agency focused on numbers from the start. Today’s plan contains not 24 or 26, but 25 specific actions it plans to take. Those include:

Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,

Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

An ambitious rollout plan is outlined here:

Publicly, most device industry groups are cautiously praising the FDA, with a few exceptions, such as AdvaMed’s Stanford University report. Privately, most device makers tell us FDA is going overboard and will stifle medical innovation.

Today’s actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), told reporters in a conference call this afternoon.

Before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission.

In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process — industry argued that the 510(k) process was unpredictable, inconsistent and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still underway.

Reported by Michael Causey – you can read his other posts here.