Among the many smart comments made by panelists who spoke yesterday at the InHealth 510(k) survey results conference, my favorite quote came from Peter Barton Hutt, a senior counsel in Covington & Burling. Hutt was Introduced by moderator Robert Rudin as "the go to guy in Washington for medical device advice."
Although Hutt spoke late in the conference, his succinct and pragmatic advice caught my attention. Amid a long conversation about the future of FDA, 510(k)s, and what should be done about both, Hutt had only two pieces of advice. " Step one," he said, "find out what FDA wants. Step two—do it. It doesn't matter if what they ask for is stupid or brilliant. It doesn't matter if the request is reasonable. If you don't give FDA what they ask for, you aren't going to get your device approved."
With that, Hutt brought the conversation down to a basic "...
Update: Edwards Lifesciences clarified a few points in its statement this morning. The device manufacturer mentions that the devices did have appropriate regulatory clearance and that FDA has stated that the firm “made a good faith effort” and an “honest attempt” to follow guidance when Edwards used FDA’s Justification to File (JTF) process in 2006 to introduce its 5100 ring. That FDA asked for additional review and eventually cleared the ring is a normal part of the process of navigating the regulatory landscape.
Edwards also calls into question the MAUDE database, which was the Tribune reporters' source. It maintains that MAUDE data cannot be relied upon for an analysis of injuries and deaths. The Web site says...
On May 19, 2011 the MedTech Investing Conference tackled a sticky issue in device development: the lack of funding for early stage medical device and diagnostics companies.
StarTribune blogger, Wendy Lee reported on the event, saying that VCs continue to chafe at the expense of investing in medical device companies at an early stage. "The panel said that the cost and risk of bringing medical device start-ups to market has gotten so expensive, it has caused at least one of them to change their business model."
According to Lee, Jan Garfinkle (Arboretum Ventures), said her firm used to be 75% focused on medical devices and diagnostics. Arboretum has now modified that to 60%, with the remainder to go toward healthcare services and other life science tools.
Garfinkle estimates it takes about $20 million to get enough clinical data...
Your next car might come with a significant upgrade: health monitoring.
Ford Motor Co. is working on smartphone-like apps that could be integrated in the display panel in modern vehicles. These applications will contain health-related data, such as pollen count and air quality, and Bluetooth synchronizers for blood glucose meters.
A press release from the automobile company explains the technology for both allergen sufferers and diabetics.
“For people with diabetes and their caregivers, constant knowledge and control of glucose levels is critical to avoiding hypoglycemia or low glucose, which can cause confusion, lightheadedness, blurry vision and a host of other symptoms that could be dangerous while driving. Many now depend on a portable continuous glucose monitoring device to track their levels.
Hot on the heels of those Guardian and Telegraph op-eds (and a British Medical Journal report) that called into question European device regulations, the European Society of Cardiologists (ESC) has released a report in the European Heart Journal advocating for a stricter approach to the approval process. Among their recommendations, the authors want "a single regulatory authority" to be created in the EU to coordinate device approvals. They also call for mandatory company-run clinical trials for all Class II and Class III devices.
The heartwire section of theheart.org has an excellent breakdown of this report and what it means, focusing on the ESC's message to physicians to be actively involved in whatever the European Commission decides to do about revising regulations after its evaluations are complete.
But what I'm most interested in is the report's favorable stance toward increasing...
Although it sounds crazy, two groups of scientists at Berkeley Lab and UC Berkeley have shown that chemical analysis with nuclear magnetic resonance (NMR) can be performed without using any magnets whatsoever. NMR is essentially the same thing as MRI—the primary distinction being that it is used to study materials instead of human tissue.
The research is the brainchild of UC Berkeley physics professor Dmitry Budker and Berkeley chemistry professor Alex Pine. Research groups led by the two professors have progressively extended the use of NMR by eliminating the use of magnetic fields at various stages of NMR measurements. Now, they have succeeding in doing away with external magnetic fields entirely.
Budker acknowledges that using low- or zero-field NMR has a number of drawbacks: small polarization, low detection efficiency, and no chemical-shift signature. But, by doing away with the large, costly magnets used in conventional NMR and MRI setups, the technique...
George W. Bush is going to close out his third year of freedom—er, retirement—by speaking at AdvaMed's conference in September. Jamie Hartford has the details over on the MED blog.
She has it right when she says, ever so diplomatically, that one either loves or hates him. I'm assuming that most device makers loved him, or a least his ostensibly business-friendly positions. Do any of you have less than fond feelings for him?
— Thomas Blair
Did Medtronic make a mistake by ditching a group purchasing organization (GPO) in February?
That's what an article recently published by Dow Jones Newswires is suggesting. Apparently, after the device maker canceled some of its contracts with GPO Novation, competitors like St. Jude moved in. This is surprising because, the reporter notes, many thought that Medtronic would be a trendsetter in moving away from GPOs, which have been a controversial topic for device makers, who grumble about the fees they have to pay for doing business with them. Instead, it looks more like Medtronic has isolated itself.
From the article (emphasis added):
J.P. Morgan analyst Michael Weinstein believes Medtronic lost some implantable defibrillator market share in its recent fiscal quarter due in part to the effects of merging its cardiovascular sales organizations and cancelling with Novation. Medtronic wouldn't comment on recent market share...