“In the financial industry, I think it’s added a new layer of uncertainty for the public and private companies,” said Amit Bhalla, director at Citigroup Investment Research (New York City). “In concept, comparative effectiveness is great—who doesn’t want more data? The question is how it’s going to be implemented: Is it going to be truly clinical effectiveness, or is it going to be cost effectiveness?”

For physicians, the one-size-fits-all approach doesn’t work. Neal Cayne, MD, expressed concern that if only devices that are more cost effective and proven medically effective than others are reimbursed, he could be limited in what devices he can use on patients. “There is clinical judgment when you’re making decision about patients,” said Cayne, the director of the endovascular surgery program at NYU Langone Medical Center. “I’m really concerned that I might not have the best treatment [option] for the patient.” Aside from potentially inhibiting innovation, Cayne’s point is amplified by the fact that comparative effectiveness and the direction of the economy could change the kind of healthcare people receive in the United States. “It’s hard for me to look at a patient with a problem that I know I can fix and the technology is out there, and my hands are tied. It’s very frustrating, and hopefully we can somehow adjust the monetary problem and have the care available for the individual patient that we need. But it’s not going to be easy to do.”

Minnesota Public Radio says that some politicians believe that the fee is still too high. Minnesota governor Tim Pawlenty and Rep. Erik Paulsen want the fee completely eliminated. As we’ve chronicled on this blog, Minnesota, home to many medical device manufacturers, is just one of the states with leaders that have actively opposed the tax.

UPDATE: Medtronic chairman and CEO Bill Hawkins commented on the revised medical device industry fee proposal today. In a statement on Medtronic’s Web site, Hawkins thanked the Minnesota congressional delegation for minimizing “the negative effects such a tax could have on the medical device industry.”

He also said: “While we are encouraged by this progress, we should not lose sight that this approach will come with a cost to our healthcare system. This tax, though reduced, will invariably impact our investment decisions on new therapy development, jobs, and global competitiveness. Most importantly, this can serve to diminish patient access to new, live-saving medical technologies. While we will work our level best to minimize these impacts, they are real, and they should not be overlooked.”

“We had a sense that these smaller devices were going to have better long-term outcomes, and this trial proves it,” Alfred A. Bove, MD, president of the American College of Cardiology, said in an e-mailed statement. He was not involved in the research. “These devices have come a long way in five years. I expect that technology will continue to move things forward and they will be even better five years from now.”

GE earned two silver Clios with television spots for medical equipment. In one, a doctors uses a travel-sized electrocardiogram in a rural India. In the other, a man falls (literally) for a women when she reads his x-rays in a small Chinese village.

Another silver Clio went to NuvaRing’s ad for a contraceptive vaginal insert. The ad features synchronized swimmers to illustrate repetition of swallowing birth control pills.

The print campaigned for Vibe hearing aids from Siemens also won a silver. The device comes with interchangeable covers in different bright colors and patterns.

A complete list of the winners in the Healthcare Clios can be found here.

1. Genetic testing. Aggressive marketing has sparked interest in some tests without supporting evidence. In addition, there are gaps in monitoring the quality of the tests.

2. Electronic health and medical records, and personal health records. Clarity related to the roles of these types of electronic records as well as responsibility for verifying patient data, access, and costs need to be established.

3. Premium computed tomography (CT) and ultrahigh field magnetic resonance imaging. Questions have been raised concerning the benefits that each imaging technique offers and when they make a difference.

4. Orthopedic physician preference items. Payers and hospitals are working to figure out how much reimbursement and payment should be made to certain devices, along with whether there is clinical evidence that demonstrates the benefit of one brand over another.

5. Radiation oncology’s competing modalities. ECRI names proton beam therapy, Cyberknife radiosurgery, intensity-modulated radiation therapy, accelerated partial-breast irradiation, and accelerated whole-breast irradiation as modalities to keep watching.

6. Robotic-assisted surgery. There have been undeniable improvements to surgical robots, however payers are taking different approaches to coverage and reimbursement.

7. Therapeutic hypothermia. This technique uses technologies to rapidly cool a patient’s core temperature following a life-threatening situation. Barriers for adoption include a lack of proper equipment in ambulances and a lack of knowledge about the technique.

Sign up for a free download of ECRI’s list, along with an analysis of the technologies here.

Hamburg also mentioned that FDA is currently in the process of hiring a new head of CDRH.

“DuraSeal is a great example of how we develop solutions at Covidien,” says Michael Tarnoff, MD, Coviden’s chief medical affairs officer in the surgical devices division. “We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics, and are intuitive for surgeons and their teams to use.”

“Recognizing that the economy has caused many challenges, our fund is awarding more grants for programs that provide basic needs such as food, shelter and clothing this year,” said Michael A. Mussallem, Edwards Lifesciences’ chairman and CEO in a press release. “I’m proud that during these tough times, we have been able to increase both the amount of funding and the number of organizations that receive grants from The Edwards Lifesciences Fund.”

Edwards Lifesciences was recently featured in an MD&DI cover story. Read the article here.

But the Advamed chairman also says that he hopes the tax will be less than the $40 billion that the Senate is proposing.

Mussallem recently sat down with former president Bill Clinton to discuss the device industry’s role in reform. Read the transcript here.

To address this possibility, researchers at the Swiss Federal Institute of Technology and the French National Institute for Research in Computer Science and Control are working on an ultrasound-based security measure. This scheme would determine the distance between an implantable device and the device trying to access it. Devices more than 10 meters away would have to complete a series of authentication procedures. Other than in emergency situations (in which any device in close proximity would be granted access), devices trying to access personal data or give commands would basically have to be in the same room with the implantable device user.