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Articles from 2011 In September


Cutting Touch Screen and Solar Costs With Copper Nanowire Film

With the use of mobile devices with touch screen displays on the rise, engineers have been trying to find lower-cost alternatives to the expensive indium tin oxide (ITO) films currently used to connect pixels in electronic screens. At Duke University (Durham, NC), researchers have developed a technique to organize copper atoms in water, resulting in long, thin, non-clumped nanowires that can be transformed onto transparent conductive films. In addition to touch screens on tablets and handheld devices, the technology may also help engineers build improved solar cells or foldable electronics.


Film made from ITO, an expensive rare earth element costing as much as $800/kg, is highly transparent, which helps it to transfer information well, but the film cracks easily and must be deposited from a vapor in an extremely slow process. An alternative process of using inks containing silver nanowires has found its way into electronics, with the first cell phone with screen made from this material due out this year, but the cost is still high, with silver at $1,400/kg. However, copper is a thousand times more abundant than silver or indium, and at a cost of $/kg, is about 100 times less expensive.


Duke University chemist Ben Wiley and his graduate student Aaron Rathmell were able to form a layer of copper nanowires on glass, creating a transparent conducting film in 2010, but the wires clumped together so the film wasn't good enough for practical applications. They developed a new technique  to grow the copper nanowires and coat glass surfaces that eliminates the clumping. The copper nanowires also can maintain their form and conductivity when bent back and forth 1000 times, unlike the ITO films that break after just a few bends.


The results were published Sept. 23 online in Advanced Materials. Wiley believes that the high-performance, low-cost, flexible copper nanowires make them an ideal choice for use in solar cells and in lighter, more reliable displays. And taking both expense and weight out of medical device components is a development that will be welcomed by many design engineers.
 

California Breast-Screening Bill Creates Controversy

California Senate Bill 791, a piece of legislation recently vetoed by governor Jerry Brown, would have been worth millions of dollars for breast ultrasound technology firm U-Systems, according to the L.A. Times. The bill would require clinics to inform women if they have high-density breast tissue, which can make imaging cancerous tumors difficult with mammography. In an article titled “Eleventh-hour lawmaking with morning-after questions,” the L.A. Times questions the motives behind the regulation’s sponsorship—as well as the method with which it was passed in the state senate.
 
The bill was supported Joe Simitian, a senator representing California’s 11th Senate District—in which U-Systems happens to be based. After the bill was passed, the senator reported to the L.A. Times that he had never heard of the company, which has lobbied to pass similar breast-tissue notification bills in other states. In lieu of lobbying directly, the company recruits breast cancer survivors to campaign on its behalf. 
 
Adding to the controversy is the method that was used to pass the legislation, which is known as “gut and amend,” in which, late in a legislative session, the content of a prior bill is stripped out and replaced with new legislation. In this case, a bill regarding local gas taxes was “amended” to caution women about breast cancer risks.
  
Simitian was persuaded to support the legislation after he was approached by Amy Colton, a nurse and breast cancer survivor, who came to him with the idea to force doctors to warn women if they have dense breast tissue.
 
Colton told the L.A. Times that such a law would have helped her:
 
"The radiologist knew I had dense breast tissue, my primary care physician knew," she told the senator. "The only one who didn't know was me."
 
Simitian had sponsored a “There Ought to Be a Law” contest, in which he solicited recommendations for proposed legislation. Colton, who had been encouraged by U-Systems to support such notification legislation, entered it and won.
 
More information on the breast-screening legislation is available in from the L.A. Times.
 
Update: This article was updated on October 10, when I received news that it was vetoed.
 
Amy Colton, who had originally brought the idea for the bill to Senator Simitian wrote a touching letter explaining her disappointment that the bill was not passed. In that letter, Colton writes, addressing the governor:
 
In your veto message, you cite the “unnecessary anxiety” that breast density notification would cause. I ask you for a moment to consider the “anxiety” of a late stage cancer diagnosis. As if that isn’t devastating enough, imagine learning that your cancer might very well have been detected at an earlier stage had you received notice that you have a condition that masks breast cancer. There is no comparison between the speculated “anxiety” that breast density notification would cause and the “anxiety” of a late stage cancer diagnosis.
 
In an earlier update, I had updated the text here after Simitian wrote a letter to the editor to the L.A. Times about their coverage. The text the paper published is below:
 
The Times' story regarding my legislation to improve breast cancer detection (SB 791) suggests the bill received "little scrutiny;" not so.

The two-sentence notice to patients at the heart of the legislation was debated in six committee hearings and three floor sessions between Feb. 7 and Sept. 9, when the Legislature took final action.

That debate resulted in clear consensus that the effectiveness of mammography alone for women with dense breast tissue is limited and that women with this tissue should be given notice of that fact.

After seven months and extended debate, the Legislature voted (66 to 6 in the Assembly, 35 to 1 in the Senate) to require this two-sentence notice. Two sentences can save thousands of lives. Let's hope the governor signs SB 791.

Sen. Joe Simitian
(D-Palo Alto)

This Week in Devices: FDA's Suppport of 510(k), Biomaterials Research, and More on the Device Tax

This Week in Devices

Here's the scoop on devices this week: FDA commisioner Margaret Hamburg expressed her support for the 510(k) process, EMDT reports on award-winning biomaterials research, Massdevice ran an article on how the device tax would likely affect employment, Medtronic won a big patent settlement, and recent report from Ernst & Young found that medtech markets are mostly flat.

Brian Buntz

Weekly Vitals: Sony Buys Micronics, Exclusive AdvaMed Coverage, and More

This week in medical device industry news, Sony announces that it has purchased Redmond, WA-based Micronics for an undisclosed amount. Micronics specializes in developing portable devices that can be used to perform tests on body fluids such as blood and saliva. Also, at the AdvaMed Medtech Conference, held September 26-28, topics ranged from the importance of innovation, FDA reform, and exports to the Affordable Care Act, opportunities in India, and the pros and cons of the contract manufacturing agreement process.

Sony Buys Medical Device Maker, Eyes New Business Line (Qmed)

Exclusive Coverage of AdvaMed 2011 (MD+DI)

Medical Device Makers Push Congress to Repeal Excise Tax (Miami Herald)

FDA: Sebelius Lobbies Medical Device Industry to Increase User Fees (MassDevice Network)

Biology-Inspired Coating Shows Promise for Catheters (MPMN)

Why Startup Medical Device Companies Should Enjoy Patent Reform (MedCity)

Boston Scientific Subsidiary Guidant Pays U.S. $9.25 Million to Settle False Claims Act Allegations (Qmed)

FDA Releases Draft Guidance on De Novo Classification Process

FDA has issued draft guidance on the de novo device classification process, indicating that the agency will allow manufacturers to submit devices for de novo classification at the same time as they are submitted for 510(k) approval. 

This move could shorten the approval process by as many as 90 days, according to a news release. Under the present framework, devices must be rejected for 510(k) approval before they can be submitted for the de novo process. 

“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” CDRH director Jeffrey Shuren said in the release. “Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients.”

The de novo program is for "low- and moderate-risk devices" that do not have a predicate device and thus can't be approved through the 510(k) process. 

In response to the draft guidance, Janet Trunzo, executive vice president for technology and regulatory affairs for AdvaMed released a statement supporting optimizing the de novo pathway. 

From the statement:

AdvaMed is concerned that, if the de novo process is not streamlined, these low- to moderate-risk devices will not be marketed in the U.S. because the current de novo process takes too long, and the PMA process is inappropriate for these devices.

Medical technology manufacturers are particularly frustrated with the current process’ requirement that a 510(k) must be submitted and receive a “not substantially equivalent” (NSE) determination before a de novo classification can be requested. FDA’s proposed option for a “one-step” process in addition to the current two-step process – with the manufacturer having the choice of pursuing either the one-step or two-step process – may be a good start to streamlining the de novo process.

We believe the under-utilized de novo process has the potential to play a key role in the regulation of medical devices lacking a predicate for which general or special controls provide a reasonable assurance of safety and effectiveness. We look forward to working with the agency to ensure the proposed guidance helps facilitate timely patient access to these devices and diagnostics.”

View the draft guidance, titled "Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)," on the agency's Web site. FDA will accept comments on the document for 90 days. The AdvaMed statement is also available online.  

Pressures to Cut Medtech Spending Build

Pressures to Cut Medtech Spending Build

Everyone seems to agree that healthcare costs in the United States need to be reined in. As for how to do that, that’s a different matter entirely.

Two professors from a prestigious university had a take on the issue that Advamed didn’t especially like: slash technology spending.
 
Health costs have steadily risen, even during the recession, greatly outstripping inflation. Or at least that was a common interpretation of the report for those in the medtech industry. “Our recommendations are not anti-device,” explains Katherine Baicker, one of the report’s authors explains and a Harvard professor of health economics. “Our main conlusion is that healthcare payments should align with value. There are some high-value medical devices out there and others that aren’t.”
 
The researchers’ paper is titled “Aspirin, Angioplasty, and Proton Beam Therapy: The Economics of Smarter Health Care Spending.” It was co-authored by fellow Harvard professor Amitabh Chandra.
 
In the paper, the authors also question the assumption that it is necessarily a bad thing for healthcare spending to go up over time. As they explain in the intro of the paper, as “societies grow richer, it would seem natural that an increasing share of their resources should be devoted to ‘purchasing’ health and longevity.” (Whether the U.S. society is gaining wealth at an appreciable rate at present is another matter).
 
The paper goes on to stress, however, that one of the main reasons most people in the United States balk at the high costs of healthcare here is the waste and inefficiency built into the system. And they later argue that the high price of new medical technologies is not justified in every case. As the paper explains, “there is as yet little evidence on comparative effectiveness for a vast array of treatments.” They cite proton beam therapy as one example of such an “exorbitantly unproven” technology.
 
When asked about the likely broad implications of healthcare reform on healthcare policy, Baicker says “the policy levers that are most likely to succeed are those that reform the reimbursement system. Moving to more-coordinated care will help control costs,” she adds. “That is a more promising way to reform the delivery to promote less fragmented care—than any sector specifically.”
 
She explains that “payment reform is a challenge because it inherently means that public programs can’t reimburse for all care that might possibly benefit all people There is a virtually unlimited amount of things we could do but there is only a limited amount of funding that can be allocated to spending on healthcare.” Baicker explains that there are a number of things that can be done to cut costs but cutting out fraud and abuse of Medicare won’t be sufficient. Expensive healthcare technology that is of questionable value to the patient would be a logical place to cut, she argues.
 
In their paper, the authors add that many physicians often select costly procedures that rely on expensive technology.
 
Describing their scheme to reduce healthcare spending, they explain that “some specialists will see their incomes fall and are unlikely to take these cuts quietly.”
 
They cite patients with heart disease as an example of how costs could be contained. Inexpensive options such as prescribing aspirin for heart attack patients are underused. “Many expensive technologies are used more extensively in the U.S. than in other countries, such as cardiovascular procedures, at 587 per 100,000 in the U.S. compared with 207 in Denmark,” they explain in the report.
 
An earlier paper from the researchers that was published in 2009 came to similar conclusions. Titled “Improving Health Care Quality and Values,” the paper cites researchers done by John Wennberg and colleagues in the Dartmouth Atlas of Health Care, who have shown large disparities in the quality and cost of care delivered across the U.S.
 
A report from the Hastings Center also backs up the authors contention that medical technology, in one way or another, contributes to the cost inflation. “New or increased use of medical technology contributes 40–50% to annual cost increases, and controlling this technology is the most important factor in reducing them.”
 
“Largely due to the use of medical technology, those costs are now increasing at an annual rate of 7% a year,” that report explains. “That’s because cost control will mean that just about everyone will be forced to give up something and accept a different, more austere kind of health care.”
 
Conclusions such as those will likely be difficult for many Americans to swallow—the logic behind them notwithstanding. Many involved in healthcare are infatuated with new medical device technology and the incentives to use it whenever possible are strong.
 
Support for these views, however, has come from an unexpected place. The new Medtronic CEO Omar Ishrak was quoted by the Economist earlier this year as saying medical device companies “do not present comprehensive evidence of value.” Instead, he believes they rely on “an emotional kind of sale.” Owing to depressed healthcare spending, that might change. And there’s a real likelihood that use of technology in the United States could be reduced for at least as long as the economy continues to falter.
 
As for the likelihood that the U.S. healthcare system will be truly revamped with efficiency in mind, that likely won’t happen any time soon. “I’m not optimistic about what Congress will do about the growth of health-care spending,” Amitabh Chandra was quoted as saying in Bloomberg.
 
AdvaMed came out against the report, citing a previous report that found medical device spending is flat as a percentage of national health expenditures.
 
—Brian Buntz 

Sony Expands its Involvement in Healthcare

While the company now makes items such as printers, cameras, and data recorders that are used for medical applications, it has not yet developed products that would be marketed directly to hospitals. The company has no firm timetable for sales of point-of-care devices, citing the regulatory approvals process as an uncertainty.
 
Last year, Sony acquiried iCyt Mission Technology, a producer of devices that sort cells for stem cell applications and disease research.

Brian Buntz

Salary Survey Sneak Peek 2011: Regions

MD+DI is getting ready to publish its annual salary survey in December 2011. But we wanted to give you a sneak peek at the data we've collected on salaries in the industry.

What region are you in?

Number of Employees

Salaries


Methods: The survey sample of 1,635 was selected from MD+DI's domestic circulation in the categories of finished medical device manufacturers and in vitro diagnostic manufacturers, representing 29,986 recipients at the time of sample selection.

Data were collected via mail survey from July 1 to August 13, 2011. The survey was closed for tabulation with 517 usable responses, a 32% response rate. The findings highlighted in this report are based on the 441 individuals who indicated they are involved in the industry and work full time in firms manufacturing finished medical devices and/or in vitro diagnostics,
representing approximately 25,000 MD+DI recipients.

The margin of error for percentages based on 441 usable responses is ±4.6 percentage points at a confidence level of 95%.

Salary Survey Sneak Peek 2011: Number of Employees

MD+DI is getting ready to publish its annual salary survey in December 2011. But we wanted to give you a sneak peek at the data we've collected on salaries in the industry.

How many employees do you supervise?

Average Age

Regions


Methods: The survey sample of 1,635 was selected from MD+DI's domestic circulation in the categories of finished medical device manufacturers and in vitro diagnostic manufacturers, representing 29,986 recipients at the time of sample selection.

Data were collected via mail survey from July 1 to August 13, 2011. The survey was closed for tabulation with 517 usable responses, a 32% response rate. The findings highlighted in this report are based on the 441 individuals who indicated they are involved in the industry and work full time in firms manufacturing finished medical devices and/or in vitro diagnostics,
representing approximately 25,000 MD+DI recipients.

The margin of error for percentages based on 441 usable responses is ±4.6 percentage points at a confidence level of 95%.

Salary Survey Sneak Peek 2011: Age

MD+DI is getting ready to publish its annual salary survey in December 2011. But we wanted to give you a sneak peek at the data we've collected on salaries in the industry.

What is your age?

Years of Experience

Number of Employees


Methods: The survey sample of 1,635 was selected from MD+DI's domestic circulation in the categories of finished medical device manufacturers and in vitro diagnostic manufacturers, representing 29,986 recipients at the time of sample selection.

Data were collected via mail survey from July 1 to August 13, 2011. The survey was closed for tabulation with 517 usable responses, a 32% response rate. The findings highlighted in this report are based on the 441 individuals who indicated they are involved in the industry and work full time in firms manufacturing finished medical devices and/or in vitro diagnostics,
representing approximately 25,000 MD+DI recipients.

The margin of error for percentages based on 441 usable responses is ±4.6 percentage points at a confidence level of 95%.