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Articles from 2010 In October


Scalable Silicon Photomultiplier Technology Could Enhance Imaging

Digital silicon photomultiplier technology could enable faster, more-accurate photon counting.

A fully scalable digital silicon photomultiplier technology could enhance such medical applications as PET imaging and analytical instrumentation, according to its manufacturer, Royal Philips Electronics (Eindhoven, Netherlands). The company recently announced significant progress in the development of the technology in the form of scaling it from a single-pixel to fully integrated, 64-pixel sensor.

Optimized for use in applications that require the measurement of ultralow light levels, the silicone photomultiplier technology can count single photons and detect their arrival time to within roughly 60 picoseconds, according to the company. It also maintains that the component will enable faster and more-accurate photon counting for these applications.

"Featuring digital detection of photon-induced avalanche breakdown in each individual photodiode, together with on-chip photon counting and time-stamping logic that eliminates the bulky power-consuming A/D circuitry associated with existing analog silicon photomultipliers, Philips' new digital silicon photomultiplier technology offers the 'solid-state' alternative to large-area sensors using photomultiplier tubes," according to the company.

The silicon photomultiplier features a sensing surface of more than 10 cm and low power consumption; the prototype has demonstrated consumption of less than 1 W. Insensitivity to magnetic fields and a high level of integration in the optical detection and associated readout circuitry are additional benefits of the technology, according to the company.

Philip will present details on the technology at the IEEE Nuclear Science Symposium and Medical Imaging Conference.

2010 Salary Survey - Job Security

Compensation

Salary


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

Data was collected via mail survey from July 1 to August 13, 2010. 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.

2010 Salary Survey - Compensation

Age

Job Security


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

Data was collected via mail survey from July 1 to August 13, 2010. 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.

2010 Salary Survey - Age

Acquisition

Compensation


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

Data was collected via mail survey from July 1 to August 13, 2010. 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.

2010 Salary Survey - Acquisitions

Salary

Age


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

Data was collected via mail survey from July 1 to August 13, 2010. 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 global wound care market is expected to reach $20.3 billion by 2015: PharmaLive Special Reports

The United States accounted for about 90% of the worldwide wound care market in 2009. However, markets in Europe, Japan, and other developed nations are forecast to grow at a significantly fast pace, especially in their use of advanced wound care treatments. While 80% of U.S. hospitals are using advanced methods, most hospitals in foreign markets are still using traditional therapies.

Companies are investing in products and therapies that can be used for a wide range of indications. Angiogenesis is an innovative therapy that restores the body’s natural ability to grow new blood vessels to heal wounds and restore blood flow to tissues after injury. This essential healing process is shared by diseases that affect more than 1 billion people worldwide, including all cancers, cardiovascular disease, blindness, arthritis, complications of AIDS, diabetes, Alzheimer’s disease, and more than 70 other major health conditions. More than $4 billion has been invested in the R&D of angiogenesis-based therapies, making this one of the most heavily funded areas of medical research in human history.

Wound Care Review and Outlook 2010, PharmaLive’s newest Special Report, examines the wound care market, companies involved, as well as products and therapies that are driving growth within the sector.

“There have been many research developments attributing to the acceleration of wound healing over the last decade,” says Andrew Humphreys, editor in chief of UBM Canon Data Products Group. “They are providing the healthcare arena with some truly sophisticated, highly effective wound care treatments and are positioning this market for continued growth.”

More information is available in Wound Care Review and Outlook 2010, including qualitative and expert analysis of the quickly advancing wound care market and its future outlook, technological advances that are contributing to growth in this sector, as well as the challenges and opportunities associated with operating in this sector. This report can be found at www.PharmaLive.com/specialreports.
 

Implantable LED Array Gets Under the Skin

Image of 8 x 8 balloon arrays illustrates LED technology that could function in a variety of medical applications, including monitoring devices and light-emitting sutures.

A team of scientists at the University of Illinois (UI; Urbana-Champaign) is developing a flexible and implantable LED array. Collaborating with researchers from China, South Korea, and Singapore, John Rogers, UI professor of materials science and engineering, is using ultrathin sheets of inorganic LEDs and photodetectors to fabricate the array. 

According to the researchers, the lights can bend and twist as much as 75%, preventing them from interfering greatly with movement. The LEDs are encapsulated in a thin layer of silicon rubber to allow them to function well when implanted or when immersed in liquids.

Potential applications include medical monitors and devices for activating photosensitive drugs. The researchers also believe that they can function in light-emitting sutures and implantable illuminated plasmonic crystals.

For more information on Rogers's research on LED technologies, see the Medtech Pulse blog "Researchers Combine the Advantages of Organic and Inorganic LEDs."

Manufacturer of the Year: Siemens—On a Quest for Excellence in Imaging

Siemens is recognized for its advances in the integration of imaging technologies and as a leader in the development of technologies that reduce radiation exposure from computed tomography (CT). The global company reached that position because imaging technology is not only at the heart and soul of the company—it's at the heart and soul of its people. More than 48,000 employees work for the company's worldwide healthcare ­business.
 
The imaging giant began its work on radiation dose reduction in the early 1990s when the concern over possible excessive dosing came to the forefront in other parts of the world. But the company’s focus on the problem was accelerated in recent years “because the way in which CT was being used began changing,” says Tom Miller, CEO of Siemens Healthcare’s Customer Business Unit. As CT technology became increasingly used to rule out disease in the United States, reducing the amount of radiation became a more important consideration, he says.
 
Moreover, says Miller, Siemens is a technology company. "Every photon contributes. You can always make a better device. It can be faster, higher resolution, or lower dose. He points to the company's recent launch of a program that focuses on advancing technologies and promoting education to the healthcare community on reducing CT radiation exposure. Through its Siemens Radiation Reduction Alliance (SIERRA), the company has established an expert panel to generate proposals for dose reduction in CT. Among its objectives are identifying ways for manufacturers to develop their technologies and to educate users on how to better adapt their procedures to improve dose reduction. The panel includes 15 specialists in radiology, cardiology, and ­physics.
 
Images captured on the SOMATOM Definition Flash CT (top and middle) and the Biograph PET-CT systems (bottom).
Miller says that the idea behind the initiative is to balance image quality with the need to keep a patient’s radiation exposure as low as possible. With SIERRA, Siemens has taken a clear leadership role in this field, working to reduce radiation exposure for all typical CT examinations below 2 mSv.
 
Recent incidents at several California hospitals prompted California to pass a law requiring radiologists to incorporate radiation dose levels in their reports. The measure calls for radiologists to include the dose length product or the CT dose index if the machine is able to calculate it. Other states will likely follow California’s lead. Miller says that such measures and initiatives are not necessarily bad, but he cautions that they may shift control away from manufacturers. In addition to its SIERRA program, Siemens worked closely with the Medical Imaging and Technology Alliance to ensure that the technology capabilities were fully understood. Siemens is also working to develop standards for training and education for hospital and imaging facility personnel.
 
Siemens Healthcare’s latest dose-­reduction technology, the Iterative Reconstruction in Image Space (IRIS), aides in the reduction of image noise without the loss of quality or detail visualization. The significant noise reduction provided by IRIS allows for up to a 60% radiation dose reduction in routine clinical use. “The efficient use and collection of information enables us to reconstruct and differentiate the signal from the noise more effectively,” says Miller. “If we can reconstruct it more effectively, we can amplify the signal. We can further reduce the dose needed and reduce time.”
 

The People Behind the Technology

 
Executives at Siemens are in healthcare technology for life, explains Miller. "We know how the technology works," he says. The reason? The majority of Siemens executives are engineers and physicists themselves. "We take our roles in developing the technology very seriously, and we are deeply involved with the equipment. We are all engineers who are narrowly focused on a subset of the technology or on the study of a particular disease."
 
Miller himself is a great example. For more than 25 years, Miller, who holds a degree in nuclear engineering a master’s from Harvard Medical School and MIT’s joint program in medical physics, started his Siemens career in 1982 as a product specialist with the Computed Tomography Business Unit. In 1997, he took the helm of Carl Zeiss, Inc. He also cofounded LightLab Imaging, a company that commercialized a new diagnostic imaging method called optical coherence tomography (OCT). After the sale of LightLab, he returned to Siemens, where he ran the business development function for healthcare and later managed the health services business unit of Siemens Healthcare. He joined the group executive management board of the healthcare sector in 2006.
 
The syngo iFlow provides a greater understanding of the contrast flow within the pathology.
Miller's entire professional life has been dedicated to the development of imaging technologies. He recently testified before Congress in an effort to dispel myths surrounding the use of imaging for diagnosis. As he summed up his points, his passion was clear—and personal:
 
  1. Diagnostic technologies support more cost-effective care by enabling earlier, faster, and more-accurate diagnosis, eliminating the need for expensive and invasive surgeries and inappropriate therapies, reducing hospital admissions, and, in many cases, avoiding costs of long-term chronic conditions.
  2. The growth in medical imaging can be attributed to its transformational effect on medicine for almost every facet of every disease. Physicians know that medical imaging is simply the best tool they have to diagnose disease with confidence. And, the great majority of physicians have one overriding interest: to achieve the best possible outcomes for their patients.
  3. The best means to reduce costs and overuse is by creating a more-efficient healthcare system through healthcare information technology and to manage medical imaging utilization through physician-driven appropriateness guidelines.
  4. Advanced diagnostic imaging technologies don’t just improve health—they save lives. Simply ask any woman whose mammogram detected breast cancer in its earliest stages to make her a survivor. Ask anyone whose coronary CT angiography found blocked arteries before he/she suffered a catastrophic—or fatal—heart attack. Or ask my father, who, after suffering a stroke, can now still converse with his grandchildren due to immediate access to critical diagnostic imaging technology.
 
Tom Miller, CEO of Siemens Healthcare’s Customer Solutions, is passionate about healthcare and has dedicated his career to developing the full potential of medical technology.

From Dose Reduction to Improved Work Flow

 
Siemens recently announced the next release of the ACUSON SC2000 volume imaging ultrasound system. "The ACUSON SC2000 integrates three different technologies. With ultrasound, the outcome is very user dependent, and the outcome can be slightly different each time. This uses a different work flow with as few steps as possible with the goal of ensuring consistency of quality for tests." Miller notes that ultrasound is the medical imaging technology requiring the most action and intervention on the part of the technician. "The work flow allows greater consistency but also reduces repetitive stress injuries to the technician," he says.
 
The system offers work flow improvements in conventional and real-time volumetric echocardiography. Manual measurements require time-consuming repetitive key strokes, which actually consume the majority of the exam time. This system provides semiautomated measurements for routine echo exams, decreasing scan time by 10–15 minutes per patient. The company says the system's protocols dramatically reduce the need for user interaction and the number of key strokes during the imaging process.
Siemens Healthcare’s portfolio addresses the entire healthcare continuum.
 

Prospering in a Tough Economy

 
Siemens responded quickly to the economic crisis. In July 2008, as part of a massive global restructuring, Siemens AG announced would cut a number of jobs from its healthcare unit, mostly in the United States. That helped the company remain strong through the economic downturn and maintain its commitment to its R&D efforts, says Miller.
"At this point, we are back in a growth initiative. That could not have happened without some restructuring. The growth we are seeing, though, is primarily in India, China, and the Middle Eastern markets," says Miller. "We are starting to see some regrowth in the United States, and we are rehiring." Most significant is that Miller says the company did not decrease its investment in R&D. "During this time, we treated R&D as sacred," he says. "We knew the crisis would not last forever, and we protected that [investment]."
 
MAGNETOM Aera MR scanner is the first 1.5 T system with total imaging matrix 4G technology and Dot (day optimizing throughput) engine.
Earlier this year, Siemens restructured its healthcare unit. Siemens Healthcare increased second quarter income year over year (to $651.5 million from $470.1 million), but it reported a slight ­decrease in revenues ($3.93 billion) in the second quarter, compared with $3.95 billion in the same quarter in 2009.
 
With the restructure, Siemens combined its imaging and ­therapy systems (angiography systems, linear accelerators, particle therapy systems, etc.) with large-scale diagnostic imaging and therapy devices such as CT, MRI, and PET systems. Bernd Montag is CEO of the new group. Norbert Gaus is CEO of clinical products, which includes ultrasound products as well. Diagnostics, which includes equipment and reagents, is headed by Michael Reitermann. Miller became the CEO of the new customer solutions unit.
 
According to the company's Interim Report for the first nine months, the healthcare sector "showed strong growth in profit, revenue, and orders in a more favorable market environment." The report notes that third-quarter profit rose to €506 million ($706.27 million) on higher revenue and strong execution, including continued cost discipline.
 
Ysio is a highly flexible digital radiography product that can be adapted to the patient and clinician’s needs.
Siemens says its third-quarter orders for healthcare climbed 18%, with revenue increasing by 10%. Orders came in higher in all three geographic regions compared with the same period in 2009, while revenue rose in Asia, Australia, and the Americas.
 

The Effects of Healthcare Reform

 
Miller says that the recent healthcare reform measures will not significantly change what Siemens does and how the company develops its products. "The only area that will be affected is the company's IT space for which we provided meaningful use criteria," he says. He is strongly in favor of comparative effectiveness initiatives, because, he says, these criteria will clearly play a role in technology. "There is one caveat: [comparative effectiveness] may create a dip in the acceptance of technology while people figure out what to do," he says. "But there is nothing wrong with comparative effectiveness. It is important to take the long view."
 

Imagining the Future of Imaging

 
The ACUSON S2000 Automated Breast Volume Scanner acquires full-field sonographic volumes of the breast.
"Medical imaging is such an exciting field," says Miller. When he says it, you can hear the excitement in his voice. As he talks about where imaging is headed in the future, he says it is difficult to point to just one significant trend. "The trends that are most exciting to me change from day to day. Today, the continued integration of technology is showing much promise," he says, citing the advances in MR-PET, an area that Siemens is pursuing as "a work in progress." MR and PET systems in combination enable images to be seen that have never been seen before simultaneously.
At 1.6 pounds, the ACUSON P10 is the first pocket ultrasound device.
Another area showing promise, he says, is functional MRI, which can enable advances in diagnostics for diseases such as Alzheimer's, depression, and what he calls other “societal burdens” that are emerging with the aging population. He says the integration of imaging with therapies to provide more minimally invasive options is also emerging as a major trend. "Integrating imaging with the therapy enables patients to leave the hospital faster than ever before," he says. "While there is a big technology investment up front, it decreases costs over the long term."
 

The Result is Clear

 
From the integration of imaging technologies to its dedication to dose reduction, Siemens Healthcare is clearly a leader in its pursuit of advancing technologies that improve the diagnosis and treatment of patients.

"The reason Siemens has attained its leadership position is twofold," says Miller. "We have a deep value system in which we foster an attention to the detail of the technology, and we work closely with our customers to understand the clinical trends. We are willing to listen and we implement what we have heard."

Facing the Long-Term Challenges of Economic Recovery

This finding is the conclusion of Ernst & Young’s “Pulse of the Industry: Medical Technology Report 2010.” The annual report on the industry’s performance says that the industry’s net income improved because  “companies realigned to achieve improved financial discipline.” So what’s next?


Realignment was implemented swiftly across the industry. Companies reported downsizing staffs, closing facilities, streamlining approved vendor lists, and allowing inventories to deplete. Companies with cash reserves fared best. But, as the report points out, even though the medtech industry performed better than many industries, “new challenges will put increasing strain on the industry’s long-standing business model.”


The report focuses on the effects of these issues as medtech companies forge strategies for the future. Throughout the past year, I’ve touched on some of these challenges in my editorials. Ernst & Young points to the continued tightening of capital markets, the implementation of comparative effectiveness research (CER), increasing regulatory approval costs and hurdles in many markets, and the impending device tax as the greatest challenges. In particular, the firm notes that the device tax could disproportionately impact smaller, preprofitable companies.


“The medtech industry showed impressive discipline last year by improving bottom-line performance even as revenues remained flat, but even bigger challenges lie ahead,” says John Babitt, Ernst & Young’s medtech leader for the Americas. “With the financing model under enormous strain, the industry will need new ways to fund innovation. As hospitals consolidate purchasing decisions and payors look to CER, companies will need to demonstrate value as never before.” 


The report finds that many of the medtech industry’s long-standing business model are being challenged in ways not seen in the past. That’s not surprising. But, the report goes on to say that these challenges raise concerns as to whether “important elements of this model will need to be revisited.” The report suggests that three key areas will need to be addressed differently going forward: sustaining innovation, delivering values and outcomes, and fueling growth.


Sustaining innovation may become more difficult, says Ernst & Young, as the traditional 510(k) pathway comes under scrutiny. “Each step along this cycle may result in a lengthier approval process.” The report notes that the proposed measures to increase transparency in physician interactions will affect the ability of medtech companies to use their insights to achieve postapproval product ­improvements.


CER will rise to a much higher level of importance as medtech companies must deliver value and outcomes greater than ever before. “Companies are finding the value proposition of their products under increasing scrutiny by payors, regulators, and customers,” says the report. “Trends expected to exacerbate this challenge include the adoption of CER.”


Fueling growth may be the toughest challenge of all. The report says that identifying a path for long-term growth will be an ongoing test for the industry. It says that companies “will need to emphasize diversification in all aspects of their business, from diversification into new product lines better aligned with delivering improved health outcomes, expansion into nonproduct offerings such as consulting services and solutions, and geographic expansion into emerging markets.”


 “Seizing the opportunity will require demonstrating the value of their products before someone else establishes their value for them,” says Heinrich Christen, Ernst & Young’s medtech leader for Europe, Middle East, India, and Africa.


Sherrie Conroy
sherrie.conroy@cancom.com

Editor’s Note: With this editorial, I wish you all a fond farewell. After more than 15 years, I am leaving
MD+DI to pursue a new opportunity in the medtech industry.
 

Scientists Make Bone in the Lab

Nico Sommerdijk from Eindhoven University of Technology has succeeded in growing bone in his laborabory. (Photo by Bart van Overbeeke)

Researchers at Eindhoven University of Technology (TU/e; Netherlands) have succeeded in mimicking the process of bone formation in the laboratory and in visualizing the process in great detail, ScienceDaily reports. The results will be published in the December edition of Nature Materials.

Bone consists of fibers of collagen in which calcium phosphate is deposited in the form of nanocrystals. Now, the team of scientists under Nico Sommerdijk from the department of chemical engineering and chemistry at TU/e have been able to mimic the growth of calcium phosphate inside the collagen, just as it happens in the human body.

It has long been thought that collagen was only a template for the deposition of calcium phosphate and that bone formation was controlled by specialized biomolecules. However, the images taken by the Eindhoven researchers show that the collagen fibers themselves control the mineral formation process and thereby direct bone formation. The biomolecules have proved to have a different role in the mineralization process: They keep the calcium phosphate in solution until mineral growth starts.

Whlie Sommerdijk's group itself does not intend to commercialize its findings, the Italian research institute ISTEC is already developing new bone implants based on the researchers' work. The newly gained knowledge about bone formation has opened the door to a new research area for Sommerdijk's group. He is confident that the same principles can be used to make various kinds of nanomaterials. Sommerdijk and researchers at ISTEC are starting with magnetite, a magnetic material that can be used as biomarker or for data storage. But their ambitions go even further. "I am seriously convinced that we can make all kinds of materials using these principles," says Sommerdijk. He is very enthusiastic about the new research direction. "The biomimetic formation of magnetic materials is a new area that is still completely unexplored."