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Articles from 2012 In October

New Adhesive Technology Prevents Lesions, Scarring

A new bandage technology developed by MIT researchers peels off easily, preventing skin irritation and scarring. (Image by Bryan Laulicht)

Lacking an epidermis, infants can suffer skin irritation and scarring when a bandage is removed. And with fragile skin, the elderly can also be injured by common bandages. Coming to the rescue is a team of researchers at the Massachusetts Institute of Technology (MIT; Cambridge), who have developed a new medical tape that incorporates a third layer sandwiched between the adhesive side of the bandage and the backing. This quick-release middle layer allows easy removal of the backing without removing skin.

Consisting of Jeffrey Karp, an associate professor of medicine at Harvard Medical School and codirector of the Center for Regenerative Therapeutics at Brigham and Women's Hospital; Bryan Laulicht, a postdoc at MIT's Institute for Medical Engineering and Science; and MIT Institute professor Robert Langer, the team has developed a wound-care technology that incorporates existing adhesive and backing materials, ensuring that it is strong and sticky. While standard medical tape backing is made from a thin sheet of polymer such as polyethylene terephthalate (PET), the new middle layer features a thin silicone layer coated on the side that contacts the adhesive, forming a release liner. This liner is similar to the strips of slick paper that are peeled off of bandages before use.

Discovering that this layer did not adhere well to the skin, the researchers etched grid lines into the silicone with a laser, exposing some of the PET backing. Because this backing adheres to the adhesive layer more strongly than the liner, the researchers can control the adhesiveness of the release liner by altering how much of the PET is revealed by the grid lines.

Because the adhesive and the backing are made from materials already used in medical tapes, the researchers believe that ramping up production of the new tape should be straightforward.

Medtech in an Election Year Digital Edition

Medtech in an Election Year Digital Edition

The 2012 election is of special importance to the medical device industry. At stake is everything from the future of the Affordable Care Act (and the fate of the medical device tax) to the progress (or lack thereof) made at FDA. 

To help our readers make an informed choice at the polls, MD+DI's editors have put together a special digital edition focusing on issues of importance to the medtech industry. The digital edition covers topics including the medical device tax and regulatory reform. It also features a slideshow of key races that could impact the industry and includes a feature story about what issues medtech voters should be paying attention to at the polls.

Click here to access MD+DI's "Medtech in and Election Year" digital edition on your computer or mobile device.

Happy voting!

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Everything You Need to Know about Medtech in the Elections...and More

Our colleagues at Medical Device and Diagnostic Industry have just published a snazzy digital publication devoted to the medical device sector in the context of the 2012 election season. Medtech in an Election Year includes:

  • Politics Takes Center Stage at SoCol Event
  • How to Repeal the Medical Device Tax: Lessons from Massachusetts
  • The Impact of Regulation on MedTech Innovation in the U.S. and Europe
  • Republican Platform Pledges FDA Reforms
  • FDASIA Is More than Just User Fees
  • Voices of Frustration, Uncertainty Heard in Medtech Election Perspective
  • Hot Topics in Medtech for 2012
  • Key Issues in the Presidential Race
  • Key Issues in the Massachusetts Senate Race
  • Key Issues in the Minnesota Senate Race
  • Key Issues in the Utah Senate Race
  • Key Issues in the Minnesota Congressional Race
  • Key Issues in the Michigan Congressional Race
  • Medical Device Tax 101
  • Who's High-Fiving the Medical Device Tax?
  • When the U.S. Medical Device Industry Wins, America Wins
  • By the Numbers: Medtech Topics Reflected in Statistics

Sandy's Effect on Medtech

Medical device companies from Massachusetts to New Jersey have been forced to shutter facilities today as a result of Sandy, the massive storm system that pummelled the East Coast Monday night and into Tuesday.

Johnson & Johnson closed its offices in New Jersey, New York, and Philadelphia today due to the storm, according to The drug and device maker also canceled a medical devices and diagnostics business review for investors set to take place Wednesday in New Brunswick, NJ. The meeting will be rescheduled for early 2013, according to a press release.

Boston Scientific closed two offices, a factory, and a distribution center near Boston, according to the Associated Press.

The Wall Street Journal reports interruptions at Covidien, which closed its Boston-area headquarters as well as an office and a factory in Connecticut.

Are your facilities closed? If so, let me know at or via Twitter @readMED.

Jamie Hartford is the associate editor of MD+DI.

Siemens Extends Three-Week Manufacturing and Delivery to Servomotor Products

A supplier of production products for the medical industry offers three-week lead time manufacturing and delivery of its servomotor products. Using a configurable options menu to build the motor required, customers can now place an order for any first generation 1FK7 servomotor and have it drop-shipped in three weeks. This new service applies to over 100,000 possible configurations. All compact (CT) and high-dynamic (HD) servomotors in the 1FK7 family are included. With a total of 6150 option pairings and 18 color choices, Simotics servomotors in the 1FK7 family can be configured to 110,700 possible designs. Options include stall torque and RPM rating, encoder style, and bit resolution, holding brake functionality, shaft style, IP rating, ac line supply voltage, and electronic nameplate recognition via Drive-Cliq. 1FK7-geared motor options and second-generation 1FK7 servomotors are not included in this program.

Ocean Thin Films Introduces PixelTec High-Precision Bandpass Filters

A company now provides its patented patterned optical coating process for high-precision bandpass filters, opening up new possibilities for application-specific cameras. The extended capability enables optical devices to be micropatterned with multiple narrow-band filters, creating even greater contrast and resolution for multispectral applications from cellular microscopy to factory vision systems. By combining state-of-the art sputtered coating expertise with exclusive microlithography technology, PixelTec coatings deliver accurate geometric and spectral performance across the ultraviolet (UV), visible, and near–shortwave infrared ranges (NIR–SWIR). The optical coatings are increasingly used for purpose-fit performance in a multitude of medical applications, enabling more compact, robust, and cost-effective devices.
Golden, CO

LPL2 Solenoid Pump From The Lee Co.

A new inert solenoid pump has been engineered to offer design flexibility and cost economies to medical device manufacturers. The pump’s distinctive port-head design allows tubing connections and manifold mounting that enable the designer to test the fluidic system using connections to soft 1⁄16-in. tubing. Once the system design is finalized, the same pump can be manifold-mounted by means of standard O-rings. The LPL2 pump additionally has a contoured end cap that is compatible with standard AMP electrical connectors, providing secondary connector retention. Consuming just 2.5 W in 12- or 24-V-dc operation, it has a standard dispense volume of 50 µl ±6% per shot, although other volumes are available.
Westbrook, CT

Strong Growth in Healthcare Market Will Continue Regardless of Election Outcome, Analysts Predict

Medical device companies may have painted too gloomy of a picture of how the industry will be impacted by the medical device tax, recent reports suggest. The same week the presidential candidates met in the last debate, several analysts predicted that healthcare stocks will continue to do well regardless of the outcome of the election. Today, executives from orthopedic device maker Zimmer Holdings said in a conference call with investors that the tax will have less impact on the company than it previously predicted. 

"The tax is not going to be that expensive, it's not going to be quite as significant as the $40 million to $50 million that I've referenced in 2013," Executive Vice President of Finance and Chief Financial Officer James Crines said, according to MassDevice.

Healthcare stocks are trading near all-time highs, says Marc Lichtenfeld, Senior Analyst on the Investment U website. The increasing aging population and poor nutritional habits will continue to drive growth, Lichtenfeld predicts.

The health IT market especially will grow rapidly, as social health networks and health apps become more popular, said Raj Prabhu, Managing Partner of Mercom, commenting on the company's recently released Healthcare IT News report. Health IT companies could also see a boost as a result of the plans for state exchanges in the Affordable Care Act, comments Susan Aluise for Investor Place

— Camilla Andersson

This Week In Devices [10/26/12]: Medical Devices Aren't Responsible for Healthcare Costs; Verdict in St. Jude v Volcano; Senate Charge Medtronic With Manipulation

An AdvaMed study shows that medical devices aren't contributing to rising healthcare costs. U.S. senators allege that Medtronic manipulated product studies. Volcano receives a verdict in its countersuit against St. Jude Medical

AdvaMed Study Finds Medical Devices Not Responsible For Rising Healthcare Costs
A study released this week by AdvaMed shows that prices for medical technology have remained consistently low over a 21-year period, growing at less than half the rate of overall prices in the economy and only one-fifth the rate of prices for other medical goods and services. Device and diagnostic prices have increased at an average annual rate of 1%, compared to the Consumer Price Index (CPI) increase of 2.7%, the Medical Care CPI increase of 4.7%, and the Medical Care Services CPI increase of 5% [AdvaMed].
Senate Alleges Medtronic Manipulated Studies
Leaders with the Senate Finance Committee are charging Medtronic with manipulating studies on its spine-fusion product and failing to disclose significant financial ties to the studies' authors. Senators have alleged that Medtronic substantially edited articles on its own products. In one incident, it is alleged that details on the adverse effects of Medtronic's InFuse product may have been omitted from a article in Journal of Bone and Joint Surgery after the recommendation from a Medtronic employee. Between 1996 and 2010 the company is alleged to have paid “consulting fees” to various article authors to the total of roughly $210 million. [The Hill]
Jury Verdict says St. Jude did not Infringe Volcano Corp. Patents
A Delaware federal district court has issued a verdict in favor of St. Jude Medical in the company's ongoing legal battle with Volcano Corp., a developer and manufacturer of guided therapy tools for coronary and peripheral vascular disease. The court has found that St. Jude's PressureWire products do not infringe on three of Volcano's patents. Volcano has, however, announced that St. Jude has agreed that previous versions of the PressureWire did infringe on another of Volcano's patents. Proceedings on damages have not yet been scheduled. [PR Newswire]

Cuts to User Fees and CDRH Funding Threaten Medical Devices

Cuts to User Fees and CDRH Funding Threaten Medical Devices

On October 22, President Obama made a passing remark in response to criticism on defense spending. “The sequester is not something that I’ve proposed,” he said. “It is something that Congress has proposed. It will not happen.”

For those of us watching the debate this statement brought on a brief a moment of excitement. In addition to applying to defense, sequestration budget cuts would apply to the user fees paid by the device industry, as well as appropriations for CDRH

But despite the clear language Obama used, it seems sequestration has not been downgraded to threat level green just yet. Following the debate, White House senior adviser, David Plouffe, worked to clarify Obama’s remark on sequestration. According to Reuters, Plouffe said that the president meant that no one in Washington “wants it to happen. . . .No one thinks it should happen.” Well, that sounds more like a politician.

The cuts are part of a fiscal cliff that would signal automatic spending reductions going into effect on January 2, 2013. The goal is to sequester government-wide budget items in an effort to prevent the United States from eventually defaulting on its financial obligations. A Congressional Joint Select Committee on Deficit Reduction was charged with reporting legislation to reduce the deficit by at least $1.5 trillion by November 23, 2011. The Committee was unable to reach agreement, thereby triggering automatic reductions to be spread evenly from fiscal years 2013 to 2021.

While appropriations for CDRH has always been at risk—and might involve a $26 million loss of funding under sequestration—it was only in September that it became evident that sequestration might apply to medical device user fees. According to Alliance for a Stronger FDA, the federal Office of Management and Budget considers user fees “non-voluntary payments to government,” and therefore subject to sequestration. The Alliance estimates that about $1.367 billion in FDA user fees would be subject to sequestration by OMB. The Alliance has provided a very preliminary estimate on the impact, concluding that about $5 million–$6 million would come from medical device user fees.

Simply put, sequestration of CDRH funding and medical device user fees stymies FDA’s ability to function efficiently and unravels the user fee system set up through the passage of FDASIA. And, since more than 80% of user fees goes to personnel,-related costs, the effect on FDA’s employment could be devastating.

Much of the industry criticism leveled at FDA centers around its lack of certainty and consistency, coupled with long decision times. FDA’s argument—and it’s a compelling one—is that the Agency can’t meet industry needs if it doesn’t have the funding to s to draw and keep talented people in sufficient numbers to meet the agency’s commitments.

“There is no way you can take an 8% cut and not have it affect jobs. And, if you are an FDA employee and you have three jobs instead of one, you are struggling every day,” says Steven Grossman of the Alliance for a Stronger FDA. “It hurts innovation—and the medtech community needs to appreciate that a strong FDA is their best interest.”

If FDA cannot use its funds to the fullest, patients, caregivers, and industry suffer. At Advamed’s annual meeting in October, chairman David Dvorak said that sequestration stands in opposition to the promises FDA has made to industry. “We want to come back to the substance of the argument, which is increased transparency for the regulatory process, better timetables, and a consistently improving processes,” Dvorak said. That can’t be done properly if FDA doesn’t get full use of its funds.

Despite Obama’s debate promise, the threat of sequestration has not abated. But let’s be fair, he really doesn’t have the power to fix it. And what happens next is unclear. “There is no secret plan for dealing with the sequester and the fiscal cliff,” Grossman says. “Anyone who tells you they know how it’s going to work out is trying to look good to voters.”

A lame-duck session of Congress, highly influenced by the presidential election, will decide how sequestration will proceed. Members of Congress, who have thus far been unable to come to an agreement, will be pressured to put differences aside and act fast. “The hardest part will not be figuring out the budget, but figuring out the politics,” Grossman says. A likely scenario is that Congressional leadership will do what they have done before and simply kick the can down the road.

In the short term, “FDA has assured us that it does have reserve funds, even if it cannot get user fees in full,” Steve Ubl of AdvaMed explained to reporters in October. FDA officials keep a surplus for an orderly shutdown of the user fee program. Let’s hope it doesn’t come to that.

Related Content

Medical Device Tax Update from Advamed, Plus User Fees Under Threat