Toshiba Implements Corporate Environmental Initiative

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

As part of a global environmental initiative being undertaken by its parent company, Toshiba America Medical Systems (Tustin, CA) is introducing environmental programs to help reduce its energy-oriented carbon dioxide emissions and non-carbon dioxide greenhouse gas emissions by 2010. To date, the company reports that its green efforts include the following.

  • Reducing power use and emissions from its headquarters: Toshiba is retrofitting its headquarters; introducing electronics with the Energy Star logo, which is used to promote energy-efficient products; and publishing interoffice communications that offer energy-conservation tips.
  • Reducing emissions in logistics: Over the next three years, the company is replacing its entire fleet of sales and service sedans with hybrid cars.
  • Recycling: The company is recycling or reusing products that are either defective or being replaced by customers. It is also working toward a goal of sending zero waste to landfill from its headquarters. Toshiba has put into place recycle containers and has promoted their use through employee educational materials.
  • Green shipping materials: Equipment and repair parts received from Japan are shipped with packaging that meets standards put forth by the European Union's Restriction of Hazardous Substances (RoHS) directive. Repackaging and shipping of parts from Toshiba is also accomplished with RoHS materials.
Copyright ©2008 MX

Greening Medtech

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Sidebars:
In recent months, trade journals and business magazines have been flooded with articles and advertisements focusing on eco-friendly products, green buildings, sustainable practices, and energy-conservation techniques. Hybrid cars, biodegradable plastics, and biofuels are rapidly evolving from grassroots movements to mainstream culture. Phrases such as climate change, post-consumer waste, and certified organic have become marketing buzz words. Many companies are beginning to embrace sustainable business practices and, accordingly, are reaping the financial rewards.1

For years, regulatory programs around the world have required manufacturers to reduce certain discharges and emissions from industrial facilities. However, regulatory mandates have been less focused on addressing long-term sustainability of products and the processes used in their production.

Recently, however, it has been corporations—not regulations—that are driving certain industries to adopt more sustainable business models.2 Companies are discovering that managing their carbon footprints and determining their impact on the surrounding environment is not just good environmental stewardship—it is also good business. Although consumer-based markets have been the primary proponents of this business model, the medical technology industry could benefit greatly from embracing the notion of sustainability.

Photo by JUPITER IMAGES
Although many sustainable business practices occur at the product design and development stages, a company's commitment to embracing such strategies starts at the executive level. Companies' cultures and missions must be conceived in such a way that sustainable practices are embraced for both their environmental and financial benefits.

Sustainability and Its Barriers

In 1987, the World Commission on Environment and Development published a report titled Our Common Future, which later came to be known as the Brundtland Report.3 This report established the guiding principles for sustainability by defining sustainable development as "development that meets the needs of the present generation without compromising the ability of future generations to meet their needs."

This principle can further be defined as a framework of three overarching objectives based on meeting environmental, economic, and social needs. The goals of sustainability are to balance these three objectives to the greatest extent possible and to avoid exploitation of one for the benefit of another.

Throughout history, entire societies have succeeded or failed based on their ability to live within their social, economic, or environmental means. Just as the choices made by a society dictate its likelihood of survival, the choices made by a designer or engineer can determine the survival of a product or its manufacturer. The act of balancing environmental, economic, and social factors not only builds sustainable businesses, but also efficient, effective businesses.

Historically, the medical device industry has been slower than consumer-based industries to adopt new product design philosophies, new technologies, and alternate manufacturing methods. Strict FDA regulations, legal liability, and rigorous device performance requirements promote an adherence to proven methods and the status quo. Requirements such as biocompatibility, high-temperature or caustic sterilization modalities, and long-term stability restrict the use of new or innovative materials. In addition, desires to mitigate contamination, avoid reprocessing, and derive continuous revenue have impelled numerous medical device companies to espouse disposable products as their primary source of revenue.

Hospitals in the United States alone produce 2 million tons of waste per year, of which 85% is nonhazardous and potentially recyclable.4,5 Much of this waste can be traced to device packaging and disposable plastic parts used for surgical, drug-delivery, or patient care applications. And although disposable medical devices constitute a large volume of waste, electronics and diagnostic devices tend to supply the majority of the toxic waste. For example, lead and mercury are still commonplace in printed circuit boards, blood-pressure monitors, and fluorescent lighting used in surgical electronics and operating room capital equipment.

While consumer industries are promoting sustainable products as market differentiators and key selling points, many medical device manufacturers see sustainability as another set of regulatory requirements, not as a revenue opportunity. In fact, this perception is well on its way to becoming a reality, as the time for medical device companies to voluntarily pursue sustainable initiatives is waning. Such practices may soon become a necessity, as indicated by evolving international requirements.

Overseas Regulatory Drivers

A variety of drivers is beginning to coax the medical technology industry toward more sustainable design and operation practices. The majority of these drivers can be categorized as internal or external forces. Internal drivers may include company decisions related to issues such as efficiency, time-to-market, shareholder returns, business goals, corporate policies, stewardship, or the company's corporate vision or mission. While many of these internal drivers are voluntary in nature, external drivers are typically imposed on the business by customers, regulators, trade requirements, product requirements, energy costs, or new technology.

Several external drivers have the potential to dramatically affect the business practices of medical device companies, particularly those with products classified as electrical or electronic devices. For example, the European Union's Waste Electrical and Electronic Equipment (WEEE) directive requires compliance with specific labeling, reclamation schemes, registrations, and instructions for end-of-life dismantling and recycling.6 The directive affects medical devices meeting the definition of electrical and electronic devices in most EU nations.

In addition, the EU's Restriction of Hazardous Substances (RoHS) directive requires manufacturers of electrical and electronic equipment to remove certain toxic metals, specifically mercury and lead, as well as certain flame retardant materials commonly found in flexible polyvinylchloride (PVC) products.7 Although medical device manufacturers are currently exempt from the EU RoHS regulations, the exemption is under review and could be lifted as early as 2010.8

There is no RoHS exemption for medical devices in China, where a more restrictive regulation referred to as China-RoHS became effective in 2007.9 China-RoHS does not yet restrict the use of the EU RoHS toxic metals and flame retardants. However, it does require self-disclosure and imposes strict labeling requirements when electronic and electrical products contain these toxic metals and flame retardants.

Regulatory drivers are not limited only to electronics and electrical products. The EU is also moving to ban many hazardous materials, promote large-scale recycling, and encourage energy efficiency by passing further legislation. The EU's Registration, Evaluation and Authorisation of Chemicals (REACH) regulation, which went into effect in 2007, calls for the regulation of more than 30,000 chemicals.10 Meanwhile, the Energy-Using Products (EuP) directive will pose further restrictions on wasteful or hazardous products and manufacturing processes.11 While currently in place as a voluntary directive, some European nations are expected to adopt EuP legislation as law over the next year. Loss of market share in Europe due to noncompliance would be devastating to the bottom line of device manufacturers operating in this key market.

U.S. Drivers of Green Design

Although the United States has lagged in the passage of similar directives, many experts agree that the adoption of environmental requirements in the U.S. market is only a matter of time. As the product development cycle for medical devices tends to be considerably longer than in many other industries, devices under development now may be subject to such regulations when they are launched to the market. Designing new products and preparing current products to meet impending environmental regulations will provide significant cost savings in retooling, redesigning, and retrofitting products in the long term.

Regulations aside, medical device manufacturers operating in the United States are already feeling pressure to adopt sustainable design practices. In the U.S. healthcare system, group purchasing organizations (GPOs) and large hospital conglomerates are beginning to encourage the use of healthier, greener medical products. Desires to reduce waste, mitigate liability, improve safety, and publicly support the theme of environmental stewardship have driven GPOs to use their buying power to influence the medical device industry to embrace sustainability. Many GPOs gear their purchasing preferences toward eco-friendly design factors—such as mercury-free, PVC-free, or lead-free products—and products that conform to EU standards. Device companies that can meet the challenges of GPOs' purchasing preferences will have a greater chance of winning lucrative, long-term contracts.

The Value of Green Practices

Preparation for future environmental regulations and opportunities is imperative for medtech manufacturers. However, many device companies see the previously described regulations and factors as distant concerns that have little effect on their current bottom lines. Nevertheless, advanced and active employment of sustainable design practices can provide significant rewards and savings immediately.

For example, reductions in product size and weight, lowering of assembled part counts, and minimization of packaging are all considered sustainable improvements—but they also have a direct effect on lowering product cost. Meanwhile, improving manufacturing efficiency, reducing or eliminating hazardous materials, and minimizing waste will save on disposal costs, raw materials, and energy usage. The tenets of good quality systems management and environmental management are inextricably linked.

As fuel prices continue to rise to record levels, understanding and evaluating transport and logistical costs as part of the product design process are also becoming critical considerations. Evaluating the product life cycle—from concept through manufacture, transport, use, and disposal—can expose inefficiencies, unintended waste, and hidden costs that quietly erode profitability. Implementation of life-cycle analysis methods, development of formal environmental management systems, and performance of supplier audits can provide valuable insight into the true costs of a finished product, not just those present on a bill of materials.

Life-cycle analysis and tracking tools can be valuable to both device manufacturers and their customers. Understanding the origins of raw materials; the input, output, and byproducts of manufacturing processes; and final product composition can mean the difference between a successful device launch and the arduous process of revalidation or even product recall. Furthermore, product life-cycle design techniques can provide higher quality and lower cost products to customers by minimizing manufacturing waste, streamlining supply chains, and improving product reliability.

Sustainability in Practice

Whether sustainability drivers are internal or external, they all have the potential to negatively or positively affect medical device manufacturers. How companies choose to respond to such drivers may make the difference between grasping market opportunities and losing them to competitors.

A number of major consumer product companies have embraced the tenets of sustainable design in recent years. Nokia, Toyota, Nike, and many others are adopting them into their overall missions and philosophies, thereby improving profits and public relations in the process.12 Direct financial benefits of embracing sustainability can be seen in the booming hybrid car industry. Within the past year, Toyota has overtaken General Motors as the world's largest car manufacturer. Experts surmise that much of this success is derived from increasing sales of hybrid and fuel-efficient vehicles and a drastic decline in sales of fuel-inefficient sport utility vehicles.13

Although sustainable design is still emerging as a business strategy in the medical device and pharmaceutical industries, several major manufacturers have already committed to employing sustainable practices in their design and manufacturing (see sidebars). End-of-life equipment reclamation programs such as those instituted at GE Healthcare, the development of product life-cycle management software at Siemens, and voluntary compliance with a variety of environmental standards by Novartis and Philips are just a few of the tactics being used by corporations to differentiate their devices from the rest of the industry.

Conclusion

Sustainable design is not just design for the environment; it is a business strategy that promotes the creation, manufacture, and management of well-engineered products that benefit a manufacturer's bottom line in the short term and lay a foundation for continued success in the long term. Such a philosophy holds true not just in consumer-driven markets, but also in the highly regulated medical technology industry. Although many of the environmental requirements that govern consumer and industrial products do not yet apply to medical devices, companies that choose to see sustainability as a business opportunity, rather than a barrier, will be leading the market—not just scrambling to keep up.


References

1. P Engardio, K Capell, J Carey, and K Hall, "Beyond the Green Corporation," Business Week (29 January
    2007); available from Internet: www.businessweek.com/magazine/content/07_05/b4019001.htm.
2. M Borden, "50 Ways to Green Your Business," Fast Company no. 120 (2007): 90; available from Internet:
    www.fastcompany.com/magazine/120/50-ways-to-green-your-business.html.
3. Report of the World Commission on Environment and Development: Our Common Future (New York City: Oxford
    University Press, 1987).
4. L Brannen, Preventative Medicine for the Environment: Developing and Implementing Environmental Programs
    that Work
(Concord, CA: Center for Health Design, 2006); available from Internet:
    www.healthdesign.org/research/reports/CHD_Brannen.pdf.pdf.
5. "Reusable Totes, Blue Wrap Recycling and Composting: Environmental Best Practices for Health Care
     Facilities" (Washington, DC: Environmental Protection Agency, 2002); available from Internet:
     www.epa.gov/region09/waste/p2/projects/hospital/totes.pdf.
6. "Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on Waste
     Electrical and Electronic Equipment (WEEE)," Official Journal of the European Union L37 (February 13,
     2003): 24-38.
7. "Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the
     Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment," Official
     Journal of the European Union
L37 (February 13, 2003): 19-23.
8. "RoHS Exemption for Medical Devices is Under Review," Green Supply Line [online] (August 25, 2006);
     available from Internet: www.greensupplyline.com/howto/19230028.
9. "Management Methods for Controlling Pollution by Electronic Information Products," (Ministry of
     Information Industry Order #39) (Beijing: China Ministry of Information Industry, National Development
     and Reform Commission; Ministry of Commerce; General
     Administration of Customs; General Administration of Industry and Commerce; General Administration of
     Quality Supervision, Inspection, and Quarantine; and State Environmental Protection Administration,
     2006).
10. "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
      Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
      Establishing a European Chemicals Agency, Amending Directive 1999/45/EC and Repealing Council
      Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive
      76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC,"
      Official Journal of the European Union L136 (December 18, 2006): 3-280.
11. "Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 Establishing a
      Framework for the Setting of Ecodesign Requirements for Energy-Using Products (EuP) and Amending
      Council Directive 92/42/EEC and Directives 96/57/EC and 2000/55/EC of the European Parliament and
      of the Council," Official Journal of the European Union L191 (July 6, 2005): 29-58.
12. "The Global 100," Business Week (29 January 2007); available from Internet:
      http://bwnt.businessweek.com/interactive_reports/g100/index.asp?sortCol=name&
      sortOrder=ASC&pageNum=3&resultNum=25.
13. "Toyota 'World's Largest Carmaker,'" BBC News [online] (26 April 2007); available from Internet:
      http://news.bbc.co.uk/2/hi/business/6586679.stm.

Christopher Kadamus is a principal design engineer with Cambridge Consultants Inc. (Cambridge, MA). Wayne Bates, PhD, PE, is engineering manager at Capaccio Environmental Engineering Inc. (Marlborough, MA).

Copyright ©2008 MX

Spit-Sample Test Quickly Identifies Breast Cancer

R&D DIGEST

An array of the silicon nanobiochips developed by the McDevitt research team. The bead ensembles in the center of each chip are sensor sites for a saliva diagnostic test that can detect early signs of breast cancer.
Thanks to a nanobiochip, a woman could know in minutes whether she has breast cancer by spitting into a cup. A team of researchers at the University of Texas (UT) developed the saliva-based test, which could detect breast and other types of cancer in the future.

The lab-on-a-chip system miniaturizes a test that is traditionally conducted in large labs. Its concept was born more than a decade ago at UT with the help of professors John McDevitt, PhD, and Charles Streckfus. DDS. They were working independently on different elements of saliva-based diagnostics at separate campuses of UT.

At the UT dental branch at Houston, Streckfus was conducting research from a clinical perspective to look for proteins in saliva that would indicate the early stages of breast cancer. Streckfus is a professor of diagnostic sciences.

McDevitt, professor of chemistry and biochemistry at UT's Austin campus, was examining the test's mechanical aspect. This involved developing next-generation diagnostic tools.

About a year ago, the professors began talking about Streckfus's work in saliva diagnostic studies of cancer patients and how McDevitt's group could adapt its sensor to breast cancer diagnosis.

“Through this collaboration, we're beginning to reprogram our miniaturized sensor,” says McDevitt. “We've jointly been developing this effort, but the miniaturized platform that we're using has a longer history.”

Charles Streckfus (left) has been work­ing for a decade to develop the saliva-­based cancer diagnostic.
McDevitt's team is building the plumbing and the subcomponents of the technology. “We want to pull some of the best features of microfabrication and the electronics industry—the things that have made computer chips so powerful—and bring those concepts into this miniaturized system,” says McDevitt. “You might think of it as a marriage between microelectronics and in vitro diagnostic devices.”

McDevitt likens the test's operation to an automated teller machine system. Its main components are a nanobiochip, which contains the sample, and an analyzer that identifies the proteins. The miniaturized chip is packaged in a structure that is about the size of a credit card (2 × 3.5 in.) but twice as thick. The way in which the test processes samples is straight forward. After a patient spits into a cup, the saliva is transferred onto a card that is fed into an analyzer. About the size of a toaster, the analyzer contains a series of mechanical actuators, optics, and a computer.

The inexpensive test has global potential. It could be used as a primary test in developing nations that don't have mammography centers, or as an adjunct to a mammography in wealthier countries.

Because results are produced in just 15 minutes, the patent-pending test could be conducted during one visit to a doctor's office. It's also expected to minimize the occurrence of false-
positive and false-negative results. The technology could serve as a comfortable alternative to the mammogram, which means that women might opt to be tested more frequently. Regular testing is key to early detection.

The microchip used as a sensor system in a saliva diagnostic test as seen with a scanning electron microscope.
The researchers looked at several places where the test could be conducted. They found the dental setting to be a good option, because people generally visit their dentist about twice a year.

In the future, the test could be used to detect oral and cervical cancer, and even heart disease. Streckfus also suggests that a universal test to detect cancer could be designed with subsets of markers. Theses subsets would provide information about a tumor's location.

The researchers need about another year to identify the specific biomarkers that must go into the final system. “We have some good results on some initial biomarkers, but with the paper [Streckfus] just published, there's a series of about three dozen other candidates that we want to look at carefully,” says McDevitt.

Streckfus's work that examined identifying protein markers in saliva to diagnose breast cancer was published in the January 10, 2008 issue of the journal Cancer Investigation.

After establishing the biomarkers, the group will begin looking for commercial partners. McDevitt estimates FDA approval, manufacturing, and distribution will take about three years. He hopes to have the device on the market in four years.

Copyright ©2008 Medical Device & Diagnostic Industry

Four Device Pioneers Earn Hall of Fame Induction

NEWS TRENDS

The 2008 inductees into the National Inventors Hall of Fame include four men whose inventions radically changed the medical device industry. The inductions, 18 in all, were announced on February 14.

Sir John Charnley is the father of modern hip-replacement surgery. He was honored for his invention of low-frictional torque arthroscopy, a method that was much more effective and less painful for patients than previous procedures. In 1962, he unveiled his invention, which combined a thick plastic socket and a small-diameter, highly polished metal ball to replace the head of the thigh bone. It solved the problem of pain due to pressure on nerves in the hip socket and poor lubrication of the joint. He also developed a clean air enclosure, total body exhaust suits, and an instrument tray system that go along with the replacement procedure.

Willem Einthoven produced the first reliable electrocardiogram. He designed the first instrument, the string galvometer, to accurately record the electrical activity of the heart and detect abnormal heart function. He did it by putting a quartz wire under tension in a magnetic field. It moved when exposed to an electrical current, and he photographed the movements. He was also a pioneer in the study of heart sounds, retinal currents, and acoustics.

William P. Murphy Jr., who founded the company that became Cordis Corp. (now part of Johnson & Johnson), invented a number of medical devices and packages. Among his brainchildren are the disposable medical procedure tray, the modern blood bag, the physiologic cardiac pacemaker, the angiographic injector, and the hollow-fiber artificial kidney.

Based on his observations from the Korean War, Murphy created a compression system for sealed blood bags that allowed for efficient and safe pressure transfusions. And when he noticed that reprocessing often damaged reused medical devices, he designed inexpensive trays of drugs and sterilized instruments that could be discarded after one use.

David Pall was credited with more than 181 patents related to filtration, most notably the leukocyte filter, which makes blood transfusions safer. The invention helped prevent the rejection of transfused blood and the transmission of bloodborne diseases by transfusion.

He founded Pall Corp. to develop filtration systems for aerospace, but eventually turned his efforts to healthcare. The firm makes fluid management systems used in the manufacturing and administering of medical devices.

Murphy is still living. Charnley died in 1982, Einthoven in 1927, and Pall in 2004.

Copyright ©2008 Medical Device & Diagnostic Industry

Cleanroom Addition Boosts Options for Hiemstra Customers

The addition of a cleanroom enables
Hiemstra to shorten time to market.
Hiemstra Product Development has added a cleanroom to help its customers meet their product development and manufacturing needs. The San Francisco–based company recently received approval to manufacture Class I, II, and III medical devices in its Class 10,000 cleanroom.

With the approval, Hiemstra can provide additional resources for companies seeking support for clinical trials, low- to mid-volume production, or manufacturing.

“Hiemstra is now better equipped to [shorten] time to market by offering not only product design and development, but also manufacturing, in a one-stop-shop facility,” says Patrick Owens in a company statement. He is director of operations at Hiemstra.

The 750-sq-ft cleanroom supports devices such as catheters and their delivery systems, implants, and surgical tools. Depending on the medical product, the cleanroom provides the option of manufacturing volumes from a few hundred to 30,000 units.

The company's engineers can also help clients choose the appropriate resources when moving to a high-volume production facility.

Hiemstra is a product development firm that focuses on industrial and mechanical design, usability, and rapid commercialization. The company received the cleanroom approval from the Food and Drug Branch of the Cali­fornia Department of Health Services' Division of Food, Drug, and Radiation Safety.

Copyright ©2008 Medical Device & Diagnostic Industry

Continued Innovation

COVER STORY

Across all three of its business units, Advanced Medical Optics Inc. (AMO; Santa Ana, CA) continues to roll out a range of new technologies designed to position the company for future growth. Noteworthy product developments and launches over the past year include the following.

Cataract and Implant Technologies. In late 2007, AMO launched three new refractive technologies to the European market. The Tecnis one-piece intraocular lens (IOL) and the Tecnis multifocal acrylic IOL were introduced for the first time in any market. Meanwhile, the WhiteStar Signature phacoemulsification system, launched in the United States in April 2007, made its debut on the European market.

"These products are excellent examples of our investment in research and development producing innovative new technologies, whether building off of an existing platform such as with the WhiteStar Signature system and Tecnis multifocal IOL, or in developing a brand-new technology like the Tecnis one-piece IOL," says James V. Mazzo, AMO chairman and CEO.

In 2007, AMO's intraocular lens sales rose 8.8% to $317.2 million. Phacoemulsification sales rose 3.6% to $90.7 million for 2007.

The IntraLase femtosecond laser
Laser Vision Correction. In April 2007, AMO completed its $808 million acquisition of IntraLase Corp. (Irvine, CA). "The addition of IntraLase's state-of-the-art femtosecond laser technology to AMO's unmatched portfolio of corneal and cataract products allows us to forge a new path for vision care with a full suite of technologies to address a lifetime of refractive needs," says Mazzo.

Use of IntraLase's femtosecond laser is increasingly seen as the standard of care in many ophthalmic surgery suites around the world. The laser replaces traditional handheld blades and enables surgeons to provide greater accuracy and patient safety in creating a corneal flap, which is the initial step in the laser-assisted in situ keratomileusis procedure.

For 2007, AMO's U.S. femtosecond procedure volumes grew 41.5% on a pro forma basis. Internationally, pro forma femtosecond procedure sales grew 84.2% during the year.

Eye Care. Following a widespread contact lens solution recall in the spring of 2007, AMO's eye care business relaunched its Complete Easy Rub multipurpose solution last August. The relaunch helped partly offset multipurpose solution sales declines. For 2007, multipurpose sales declined 59.8% to $59.2 million, which included about $41.5 million in returns and an estimated $84 million in lost sales related to the recall.

In addition, AMO's eye care business recently launched a new over-the-counter dry-eye drop, which represents a completely new category for the company—one in which AMO was not allowed to compete for three years following its spin-out from Allergan. Mazzo estimates that the market for such products stands at $500 million or more.

Copyright ©2008 MX

Roundtable Participants

ADVERTISING, DISTRIBUTION, & SALES

Mark Adams was appointed vice president of sales and marketing for CryoCor Inc. (San Diego) in November 2007. He is responsible for leading CryoCor's commercialization efforts for its cardiac cryoablation system, which was approved by FDA in August 2007 for the treatment of right atrial flutter.

Adams has served at the management and executive levels with several electrophysiology companies, including EP Technologies, prior to its acquisition by Boston Scientific; Irvine Biomedical, prior to its acquisition by St. Jude Medical; EP Medsystems; and Instromedics. Throughout his career, Adams has been involved in a number of strategic alliances, including relationships with Boston Scientific, Guidant, Medtronic, Philips, and St. Jude Medical. Prior to joining CryoCor, Adams served as a business consultant providing sales, marketing, operational, and staffing expertise to a range of organizations primarily in the medical device industry. He can be reached via e-mail at madams@cryocor.com.

Dale Hagemeyer is a research vice president for the manufacturing sector of industry advisory services at Gartner Inc. (Stamford, CT). His area of expertise is in customer-facing processes and applications for the consumer goods and life sciences industries, including the biotech, pharma, and medical device sectors. His work includes vision and strategy development, business case development, vendor evaluation and selection, and implementation and support strategies.

Hagemeyer has 17 years' experience in sales, marketing, and finance, including an international assignment in Mexico from 1995 to 1996. He holds a bachelor's degree in finance and in Spanish from the University of Utah, and an MBA from the University of Chicago. He can be reached via e-mail at dale.hagemeyer@gartner.com.

Mark M. Miller has served as vice president of sales and marketing for Zonare Medical Systems Inc. (Mountain View, CA) since March 2003. Prior to joining the company, Miller served as vice president of ultrasound sales at Siemens Medical Solutions (Malvern, PA) from March 2001 to March 2003. He holds a BA in business management and history from Albion College (Albion, MI). He can be reached via e-mail at mmiller@zonare.com.

Marshall C. Solem is managing principal of ZS Associates' headquarters office in Evanston, IL, and until 2008 was the leader of the firm's medical products and services practice. His primary focus is working with medical device and diagnostics companies on issues of sales and marketing effectiveness, including go-to-market strategy, sales force effectiveness, and incentive compensation. He has consulted with companies ranging from start-ups to the Fortune 500, and throughout his career has worked in industries ranging from medical devices and pharmaceuticals to consumer products and utilities. His assignments at ZS have included projects in the United States, Canada, and several countries in Latin America. Solem has been a featured speaker at a number of industry-sponsored conferences and has had articles published in various industry journals.

Solem holds a master of management degree from the Kellogg School of Management at Northwestern University (Evanston, IL), and a bachelor of business administration degree from the University of Wisconsin at Madison. He can be reached via e-mail at marshall.solem@zsassociates.com.

Copyright ©2008 MX

Boston Scientific Loses Stent Patent Case

NEWS TRENDS

A Princeton, NJ, radiologist has won his patent-infringement lawsuit against Boston Scientific. Bruce Saffran, MD, claimed Boston Scientific's drug-eluting stent technology infringed on a patent he was awarded in 1997. A jury in federal court in Texas awarded $431 million to Saffran.

The suit did not ask Boston Scientific to stop selling its stents. The company said it would appeal, first in posttrial motions in the Texas court, then, if needed, at the U.S. Court of Appeals for the Federal Circuit in Washington. The company says it expects to win on appeal and has not set money aside for a loss.

Saffran's patent did not relate to stents, but to healing of fractures.

To find out how a fracture-healing patent could affect stent technology, click here.

Copyright ©2008 Medical Device & Diagnostic Industry

Agreement on IVD Technologies Could Help Unify IVD Standards

Two European companies have agreed to cross-license their in vitro diagnostic (IVD) technologies. Epigenomics (Frankfurt) has obtained worldwide nonexclusive rights to DxS's (Manchester, UK) proprietary technology for use in research kits, and possibly in cancer IVD kits.

The DxS technology is known as Scorpion. It consists of a system of highly sensitive, sequence-specific molecules that contain polymerase chain reaction (PCR) primers, which are covalently linked to a probe. The probes can be used for quantitative, real-time PCR analysis, according to DxS CEO Stephen Little.

In return, DxS gets license and options to certain Epigenomics intellectual property covering the use of Scorpion technology for DNA methylation applications. Methylation is the process by which enzymes catalyze heavy metals into methyl groups. The process is thought to play a role in cell differentiation. Diagnosticians can measure methylation to study cancer.

The two companies hope that their agreement will move beyond simple exchange and enable them to influence industry more effectively.

“Through this strategic technology cross-licensing, [we've taken] an important step towards establishing a unified industry standard for DNA methylation detection,” says Kurt Berlin, CEO of Epigenomics.

Copyright ©2008 Medical Device & Diagnostic Industry

Editorial Advisory Board

EDITORIAL ADVISORY BOARD