The FDA’s New Initiative for Medical Devices – Hidden Under a Bush

The FDA announced yesterday a Medical Device Innovation Initiative  (MDII) reflective of the Critical Path Initiative and designed to act as a catalyst to speed advancements and innovation with the device industry. 

As pointed out in a recent speech by Scott Gottlieb at Northwestern University, this is a time in the history of medical development when we could be at the precipice of advances on many fronts of medical research and advancement.  Therefore, anything that can enhance the communication between industry and the agency to catalyze innovation is extremely important. 

But one has to wonder whether or not the FDA has the gravitas at this time in its history to pull off this sort of ambitious undertaking.  It leads one to ask whether or not the Critical Path Initiative (CPI) has gained enough footing to signal success of a sister effort.

As noted in a prior posting, the communications around the CPI has not been optimal.   Communications about the CPI is fraught with jargon.  Some are skeptical that it means anything at all substantively.  The initiative contains an ambitious set of opportunities, but if you look at accomplishments, the agency lists only West Nile Virus, mammography and vaccine manufacturing – the last having a grain of salt attached given the flu vaccine mess up of 2004. 

According to the press release for the MDII, the agency inability to break out of jargon has not gone away.  Here is a quote:

"As part of this initiative, FDA also announced today a critical step forward in modernizing the medical development process by issuing new guidelines to outline the use of adaptive clinical trial designs.  The draft guidance titled, "Bayesian Statistics in Medical Device Clinical Trials", provides FDA’s recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials." 

Whoa, hold the presses.  Did you read that second sentence? 

Ambition is expressed in the subheadings of the press release which state that the agency will:

  • provide regulatory clarity through guidance development
  • invest in the critical path
  • conduct stakeholder outreach and improve communications
  • engage in laboratory research to support efforts to improve the device development process
  • implement a quality review program
  • leverage information technology solutions, and
  • expand clinical and scientific expertise at FDA

Hopefully you understand how that relates to your life and the future of device development.  If you do, translate it into messaging for the agency that will make this look more relevant and less bureaucratic.   

J0387733 But perhaps most importantly, there are issues beyond lackluster communications.  Key to any such effort in moving research forward is the issue of leadership – whether we are talking about the CPI or the MDII. 

Leadership carries vision.  During the past 64 months of the Bush Administration, there have been Acting Commissioners of the FDA for 45 months, over two-thirds of the Administration’s responsibility.  The first Commissioner, Mark McClellan took off after only 17 months for the presumably greener pastures of CMS.  That kind of tenure is not long enough to have made any real and lasting impact, either positive or negative, upon the agency.  Following that, after a long acting commissioner tenure, the new commissioner, Lester Crawford resigned after two months.  Now President Bush has entered a nomination that has little hope of advancing because of the politicization of the Plan B over-the-counter decision (or lack of one). 

The goals of the CPI and the MDII are without question necessary and admirable.  But until the FDA, Secretary Leavitt and the Administration deal with leadership issues, even better communications doom these efforts to some level of obscurity.  The ambition they represent deserves better. 

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