Here’s an Idea: FDA Launches Device 'Innovation Pathway'

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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).

FDA LabsI 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!

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    More from the NYT’s today:

    “Medical Device Makers Shun United States”

    Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.

    http://www.nytimes.com/2011/02/10/business/10device.html?hp

  • Reply

    I for one am excited to see where this leads. I can see where you are right, FDA and “innovation” don’t seem to jive, but this could be the beginning of something great.

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