MINNEAPOLIS, Minnesota– For months, the medical device community has been fretting over what they see as the Food and Drug Administration’s increasingly heavy-handed way of approving new technologies.
Now a newly formed grassroots group wants to fight back. The Minnesota Medical Device Alliance Steering Committee, made up of some of the state’s most prominent investors, attorneys and executives, is hosting a meeting in February to discuss ways to push back against critics of the 510(k) program.
They have a lot of work to do. The 510(k) program allows the FDA to approve devices that are similar to other technologies on the market. Yet under pressure from the Democratic-controlled Congress and Obama Administration, the FDA has made it increasingly difficult to win 510(k) clearance by imposing costly and unnecessarily strict testing requirements on start-ups who can least afford them, said Mark DuVal, a local attorney and FDA specialist seeking to mobilize Minnesota’s med tech industry.
The 510(k) scrutiny has received the same amount of attention as, say, the proposed $20 billion medical device tax to fund health care reform. But the issue matters far more to the med tech industry because toughening or even eliminating the 510(k), as some people fear, will stifle innovation by blocking companies from delivering promising technologies to market, DuVal said.
Not sure how the new alliance will differ from industry organizations like LifeScience Alley and Advanced Medical Technology Association. But judging from the group’s roster, it’s clear that some of Minnesota’s most prominent brains feel more needs to be done.
A Call-to-Action: Make Your Voice Heard on the 510(k) Program
Wednesday, Feb. 17, 2010
Brought to you by the Minnesota Medical Device Alliance Steering Committee
* Jim Bullock – Atritech
* Mark DuVal – DuVal & Associates
* Kris Johnson – Affinity Capital Management
* Tom Letscher – Oppenheimer Wolff & Donnelly LLP
* Rich Lunsford – Anulex Technologies
* Mark McKoskey – MedTech Resource Alliance
* Pete McNerney – Thomas, McNerney & Partners
* Dave Stassen – Split Rock Partners
* Eric Timko – NeuroVasx, Inc.
As we all know, the 510(k) program has been under siege for some time and is facing greater challenges than ever in the wake of proposed administrative and legislative changes. Because the end product will have an enormous impact on Minnesota’s medical device and investment communities, we must act now and make our voices heard at FDA and Congress.
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=2c7b75de-23bf-4e63-930f-2ad4c02a7a35)
Innovation, influence and business in America's medical cities.
Comments
Post a comment
The 510(k) process is awful, and NOT because the “poor companies” have to do actual research on their products in order to get them approved. It is horrible because if you can reasonably show that your product is “similar” to a product that was previously approved, the FDA has a very difficult task if it is a product that 1) should not have been approved in the first place or 2)is a product that was approved but then recalled or taken off the market. Further, companies try and sneak by products using this method (like a bait and switch). Why device manufacturers feel they should not have to do due diligence and research on the safety of new devices is beyond me. With the new materials (nano particles come to mind) MORE not less research is needed to determine the safety and effectiveness of new devices.
Comment by megphd — January 14, 2010 @ 2:22 pm
There absolutely needs to be a change in the 510(k) process…and not in the way of making it more cumbersome. Rather than paint all companies with a broad brush of maligned intent, it would be more accurate to take an exceptions-based approach to the 510(k) review process. The large majority of companies seeking FDA approval are already doing heavy amounts of research, and conducting multistage clinical trials before submitting their products for review. Even in the case of evolutionary innovation, most companies are doing their due diligence, knowing full well that substantial equivalence does not equate to safety and efficacy. These companies should be able to benefit from their upfront investment in their own due diligence, by having the FDA stick to its schedule. Rather, these companies are punished by being grouped with the few that operate with less internal controls.
Longer review times does not always equal a higher quality of review. Instead, the inefficient process costs taxpayers millions and delays therapies from getting to public who needs them.
Comment by Brad Ryba — January 20, 2010 @ 11:28 am
[...] newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and [...]
Comment by Minnesota med tech community on possible 510(k) overhaul: We’re not gonna take it…. : MedCity News — February 18, 2010 @ 11:30 am
Can we disconnect the FDA from politics somehow? After years of improvement, the FDA is moving back toward slower and costlier. How exactly does slower and costlier HELP the patients? It doesn’t. It helps the payor. And since the Fed gov’t will soon be the payor, they want to keep the new, expensive treatments off the market for as long as possible.
Comment by John Doe — April 26, 2010 @ 10:14 am
Post a Comment