EDITORIAL ADVISORY BOARD

In the heavily regulated and increasingly competitive medical device world, executives must be vigilant to avoid running afoul of regulations governing the industry and laws protecting the intellectual property (IP) portfolios of competitors. Careful adherence to codes of conduct and professional help in navigating legal issues can help medtech companies avoid costly regulatory investigations and even-more-costly court battles.

Getting expert advice on governance and legal matters is as important for MX as it is for the magazine's readers. Throughout 2006, MX is announcing members of its new editorial advisory board. Members of the board include a variety of experts drawn from industry, government, finance, legal circles, and academic organizations, each with specialized expertise in the business of medical technology.

The overall advisory board will encompass a series of councils, each dedicated to a separate area and including several experts in the field. In this issue, MX is pleased to present the newly appointed members of the advisory councils for corporate governance and legal affairs.

Corporate Governance

John W. Brown is nonexecutive chairman of the board for Stryker Corp. (Kalamazoo, MI), a position he has held since January 1, 2005. Prior to that, he served as the company's chief executive officer.

When shaping and implementing good governance policies, Brown believes that the fundamental rules still apply. "Don't lie, don't steal, don't cheat," he says. "Those are pretty good standards for company boards and company leaders. They will go a long way in helping executives abide by all laws and regulations concerning business leader conduct."

Brown started his career as an engineer for the Ormet Corp., an aluminum manufacturer, and then moved to Thiokol Chemical Corp., where he worked on rocket propellants. In 1965, he joined Squibb Corp., where he worked in various middle management positions, including assistant to the president.

In 1972, Brown became president of Edward Weck & Co., a subsidiary of Squibb Corp. He held that position until 1977, when he became president and CEO of Stryker. He was appointed chairman of the board of Stryker in 1980.

"I sit on three company boards and, without exception, the shift in board activity has been to comply with the Sarbanes-Oxley Act and other securities laws," he says. "This burden has fallen particularly hard upon the governance and the audit committees. In turn, emphasis on business strategy has been diminished.

"The Sarbanes-Oxley Act was hastily conceived and enacted by an outraged Congress in response to angry investors," he adds. "The cause was a few individual executives who stepped over the bounds of securities laws and good ethical standards. The medtech companies are trying very hard to live up to both the spirit and intent of the act."

Brown says that corporate boards today are much more cautious and conservative than they were in years past. "Both corporate boards and management are focusing on clear and frequent reports to the investment community and an avoidance of risk-taking due to litigation fears," he says.

Brown is a director of InHealth: The Institute for Health Technology Studies (Washington, DC) and the American Business Conference (Washington, DC), a coalition of CEOs of midsize, high-growth companies. He is also a director of St. Jude Medical (St. Paul, MN) and Gen-Probe Inc. (San Diego). Brown serves as a governor-appointee on the Michigan Economic Development Committee, and is a board member of Southwest Michigan First and the Greater Kalamazoo United Way.

Brown is a graduate of Auburn University with a BS in chemical engineering.

Mary Cade is vice president and senior counsel for Medtronic Inc. (Minneapolis).

Cade joined Medtronic in February 1996 as a member of the legal department's litigation team. In 1997, she moved to Medtronic's international headquarters in Tolochenaz, Switzerland, where she served as European counsel, managing the legal team that provides services to the company's businesses in Europe, the Middle East, and Africa.

In 1999, she returned to Medtronic's headquarters in Minneapolis where, in her present position, she developed and now manages a shared-services legal team that provides counsel and training in regulatory areas that are core to Medtronic's businesses. These include FDA and healthcare laws and regulations. She also drafted and coordinated implementation of the Medtronic code of conduct and, along with her team, provides legal support to Medtronic's corporate compliance program.

Before joining Medtronic, Cade spent 10 years as a civil litigator in private practice in Minneapolis. She spent her first five years of practice at the Minnesota state public defender's office, where she represented defendants in criminal matters.

Kevin McAnaney is an attorney and a nationally recognized expert on healthcare fraud and abuse. He served as the chief of the industry guidance branch of the Office of Counsel to the Inspector General from its creation in 1997 until May 2003.

The industry guidance branch is responsible for issuing formal guidance to the regulated community through advisory opinions, fraud alerts and special bulletins, compliance guidances, and regulations related to the fraud and abuse authorities enforced by the Office of Inspector General, especially the antikickback statute and the Ethics in Patient Referrals Act (Stark statutes). McAnaney also worked closely with the Department of Justice in developing cases involving the antikickback and Stark statutes.

"There has been a tremendous amount of effort by the medical device industry to make regulatory compliance a top priority," McAnaney says. "Device companies are designating corporate compliance officers and giving them direct access to the board. Companies are revisiting their compliance policies and educating their employees. Although many medical device companies were late to the healthcare regulatory compliance party, they are catching up quickly.

"Investors, corporate boards, and company management have all taken notice of the effect that federal enforcement efforts have had on any number of healthcare companies," he adds. "To the extent that such information is important to investors, boards and management must stay on top of their compliance efforts."

According to McAnaney, top members of management set the tone for their entire company. "If management is not perceived as committed to compliance, the rank and file act accordingly," he says. "Public and meaningful support for compliance by management is the most important contribution top management can make."

Prior to joining OIG's industry guidance branch, McAnaney was a partner in the Washington, DC, office of the Dewey Ballantine law firm. From 1981 to 1983, he served as assistant counsel to New York Governor Hugh Carey, a position in which he was responsible for the governor's agenda in the health and human services area. McAnaney also served as the director of legal affairs for the New York Hospital.

McAnaney is a graduate of the University of North Carolina at Chapel Hill and the Columbia University School of Law. He is an adjunct professor of law at the University of Maryland Law School, a member of the board of directors of the American Health Lawyers Association, and a frequent speaker on healthcare fraud issues.

Kristine A. Rapp is vice president of ethics and compliance for Hospira Inc. (Lake Forest, IL). Before joining Hospira, Rapp served as associate general counsel and chief regulatory counsel for Baxter International Inc. (Deerfield, IL). Prior to that position, she served in a number of legal and general management capacities at Baxter, both in the United States and in Europe.

Rapp chairs the working group within industry association AdvaMed that is responsible for the development and support of AdvaMed's Code of Ethics for Interactions with Healthcare Professionals.

According to Rapp, the shift to a culture of compliance within a medtech company must start with "the tone at the top." She adds, "If the CEO and the senior leadership team make compliance a priority, there will be an added level of assurance that the company's culture will be one of compliance. Second, the code of conduct should be a visible, practical tool, almost like a mantra that employees at all levels of the company understand, use, and apply in their work. Reinforcing the messages in the code by visible reminders and by real-life examples communicated to employees helps.

"Third, the policies and procedures of the company must be straightforward, understandable by the average employee, and easy to locate and follow," she adds. "Fourth, making the tough decisions and, when appropriate, communicating those tough decisions sends a message to employees that this culture is one based on integrity and compliance."

Rapp says that setting the tone at the top through their words and actions is the most important role for the industry's executives in driving good governance. "Their interactions with their boards, their employees, their stakeholders—including investors, the community, and other companies in the industry—must be consistent and based on the highest integrity," she says. "Company executives must be living examples of integrity in order to expect the rest of the company and the rest of industry to act with integrity."

Rapp says that the recent emphasis placed on corporate governance has resulted in greater awareness among board members and management regarding their significant responsibilities for compliance. "The press has helped companies by making the cases of bad apples so visible," she says. "The interactions between companies and investors are more likely to be at arms' length than some companies and investors may have experienced in the past. It's a healthier situation today."

Rapp was the chairman of the Food and Drug Law Institute in 2003 and served on its board between 1998 and 2005. She received a BA from the University of Michigan, a JD from Northwestern University School of Law, and an MBA from the University of Chicago Graduate School of Business.

Legal Affairs

Mark D. Barrish is a partner at Townsend and Townsend and Crew LLP (Palo Alto, CA), where he is the practice group leader of the mechanical and medical device practice group. His practice concentrates on developing patent portfolios for growing companies, primarily in the medical device, fiber-optic, and robotic fields.

In addition to patent prosecution, Barrish provides strategic patent counseling, including identifying and reviewing competitors' patents, assisting in selection of disclosures for patenting, and presentations to product development teams.

"The single most common issue that has been driving my medical device clients to seek IP counsel is orphan patent publications," Barrish says. "Experienced medical device executives and engineers often understand and know how to deal with actual competitors and their issued patents. Orphan patent publications are those that are not related to any real product or continuing product development activity—they may have been filed by solo inventors, existing companies that were considering entering a field, or entrepreneurs that were seeking funding. These published patent applications are not yet patents and may not have been filed with patent troll intentions, but can produce considerably uncertainty.

"The two countervailing risks caused by failing to adequately analyze orphan patents are that a company will either be unnecessarily driven away from a promising market or technology for fear of a patent that has not even issued, or that the company will simply hope for the best and fail to take advantage of opportunities to reduce or even eliminate patent infringement liability risks," he adds.

Barrish has significant due diligence experience, including representing clients before potential investors, reviewing IP for potential investment, representing clients throughout the initial public offering process, evaluating potential mergers, and participating in successful discussions with venture capitalists. His current practice includes opinion work, licensing, and representing clients before the interference trial section within the U.S. Patent and Trademark Office.

Barrish says there are four effective strategies for addressing a medical device company's legal needs within a realistic budget. "First, get enough practical legal know-how to be able to handle the basics without having to run everything by counsel," he says. "Second, spend a little money up front where it will avoid spending more later. Get enough solid IP protection to discourage those that can be discouraged.

"Third, in any IP dispute—even in bet-the-company patent litigation—be strategic," he adds. "All-out, money-is-no-object, take-no-prisoners multijurisdictional patent wars can break any budget, and a company has to survive to win. Instead, pick and choose battles that are contained and that the company can win. Fourth, set the IP budget high enough to allow the CEO to get at least some sleep. When IP issues distract executives so much that the fundamental business suffers, consider reallocating funds."

Barrish is a member of the American Intellectual Property Law Association and the State Bar of California. He is admitted to practice before the U.S. Patent and Trademark Office.

According to Barrish, several versions of the recently proposed patent reform legislation before Congress include provisions for interparty oppositions in the U.S. Patent Office. "The devil is in the details, but the possibility of providing medical device companies a real opportunity to challenge a patent in a forum that is technically competent and familiar with patent law—at costs significantly lower than current patent litigation—could significantly reduce the cloud of uncertainty that has been growing over the ever-more-crowded medical device patent landscape."

Prior to entering the practice of law, Barrish was an engineer with Douglas Aircraft Co. He received a BS in mechanical engineering from the University of California, Santa Barbara, and a JD from the University of California Hastings College of the Law.

Genese Kay Dopson is special counsel at Sedgwick, Detert, Moran & Arnold LLP (San Francisco). She focuses her practice on the representation of clients in the medical device and pharmaceutical industries.

"Risk management and risk prevention are areas in which medical technology companies need legal guidance," Dopson says. "These areas have become the nuts and bolts of everyday business. Issues can be as basic as ensuring appropriate interoffice communications. Frequently, employees are either not schooled or they forget that interoffice communications can become evidence in a court of law.

"A written employment manual that clearly enunciates all company rules of etiquette, coupled with repetitive follow-up training can save a company millions of dollars in defense fees and costs in subsequent litigation," she adds "The attorneys drafting the employment manual must not only understand sound employment principles but must also have a grasp of the regulatory environment that controls the medical technology industry."

Dopson has served as lead defense counsel in numerous jury trials, and her representations include her role as national coordinating counsel for Vital Pharma Inc. in multistate medical device litigation.

Dopson was honored as Medmarc Insurance Company's Defense Attorney of the Year for 2005. She is a member of the California State Bar Association, Defense Research Institute, and Association of Defense Counsel. Prior to becoming an attorney, Dopson practiced as a registered nurse in an acute hospital setting.

Dopson is admitted to practice in state and federal courts in California. She obtained a BS in nursing from Mt. St. Mary's College and a JD degree from Loyola Law School. She has practiced as a litigation and trial attorney since 1982.

Arthur S. Hsieh, PhD, is patent counsel at Kyphon Inc. (Sunnyvale, CA). Prior to joining Kyphon, he practiced at Morrison & Foerster LLP (Palo Alto, CA) and served as outside counsel to various medical device companies. Hsieh's practice concentrates on intellectual property strategic planning and patent portfolio development through both prosecution and acquisition. He is also experienced in technology licensing and technology litigation.

Hsieh has advised both established industry leaders and early-stage companies. He has written and prosecuted patents in a wide range of technology areas, including medical devices, medical diagnostic systems, biomaterials, electronic devices, computer hardware and software, high-throughput chemical screening platforms, microarray technologies, and others. Hsieh is also experienced in structuring and financing of early-stage and start-up companies. He has worked both inventor-side and company-side on due diligence for venture capital financings.

"One of the most difficult and common legal issues that faces medical technology companies is the need to understand the company's exposure to potential patent litigation for operating in a particular technology area," Hsieh says. "Typically this legal analysis is characterized as a freedom-to-operate analysis during the venture capital financing phase. In addition, this type of risk analysis is often necessary prior to the introduction of a new product into the market."

Hsieh says that understanding the patent landscape and defining a viable path for technology and product development can be a daunting task. "However, failure to invest in the analysis of the patent landscape can lead to the company facing unexpected lawsuits, which can result in the demise of a complete product line," he says. "For an emerging company, a threat of patent lawsuit alone may prevent the company from raising further funding.

"The objective of a freedom-to-operate analysis is not to eliminate the risk of patent litigation, but to understand the risk profile related to a specific venture, such that senior management can manage the company's risk exposure effectively," he adds. "Working closely with an experienced patent attorney early on in a technology and product development cycle can allow the company to maneuver around major IP hurdles and minimize the likelihood that the company will face an unexpected lawsuit after millions have been invested in the development of a product."

According to Hsieh, there is a trend in both the U.S. Patent and Trademark Office and in the courts to limit patent owners' ability to obtain broad patent coverage and enforce patent rights against infringers. "The proposed rule change promulgated by the Patent and Trademark Office early this year and the recent Supreme Court ruling eliminating the Court of Appeals for the Federal Circuit's rule that injunctions should issue absent exceptional circumstances exemplify this continuing trend in the erosion of patent rights," he says. "These changes will likely affect early-stage companies the most, since many early-stage companies do not have products in the market and rely on the development of a strong patent portfolio as the primary means to increase company valuation."

The Patent and Trademark Office's proposed rule change has several significant implications for the patent examination procedure for both new and continuation patent applications. "It is expected that some form of these proposed rules will be adopted by the end of the year or early next year," Hsieh says. "The new rule change will likely make it much more difficult for a company to build a strong patent portfolio and at the same time increase the cost of obtaining patent coverage for a given technology. These changes will make it particularly hard for emerging companies with limited resources to pursue protection for the full scope of their inventions. In addition, the need to develop a solid patent filing and prosecution strategy becomes ever more important in the early stages of a technology development cycle."

Prior to his legal career, Hsieh conducted research in various technological areas, including semiconductor device fabrication, nanotechnology, plasma micromachining, signal processing, digital image processing, computer modeling, neuromuscular feedback systems, physiology, circulatory diseases, cellular biology, growth factors, medical instrumentation, orthopedic implants, and biomaterials.

Hsieh was a key member on a research team that developed the first generation of semiconductor tactile sensors at the University of Wisconsin-Madison's Center for Applied Microelectronics. He is experienced in various integrated circuit and microelectromechanical systems fabrication techniques.

In the biomedical engineering area, Hsieh has conducted research utilizing both in vivo and in vitro models. In particular, he has conducted in vivo studies of osteoblasts' and osteoclasts' role in bone remodeling, utilized absorbable polymers as carriers to deliver growth factors to facilitate bone remodeling, and applied image analysis techniques to study vascular growth and microcirculation.

Hsieh received a BS in electrical engineering and molecular biology from the University of Wisconsin-Madison, and a PhD in biomedical engineering from the University of Southern California. He received his JD from Boston University.

Hsieh is a member of the State Bar of California and is registered to practice before the U.S. Patent and Trademark Office. He is also a member of the Institute of Electrical and Electronics Engineers and the Biomedical Engineering Society.

Brooks R. Magratten is an attorney with the law firm of Vetter & White (Providence, RI). His practice focuses on the defense of commercial, product liability, insurance, and claims related to the Employee Retirement Income Security Act of 1974 (ERISA).

Magratten has represented a variety of manufacturers, insurers, and financial institutions in litigation in Massachusetts and Rhode Island. Magratten was appointed chair of the health and disability insurance law committee of the American Bar Association in August 2004. He also serves as program chair for the life, health, and disability committee of the Defense Research Institute (Chicago).

According to Magratten, class-action lawsuits are one of the most common reasons medical technology companies find themselves in need of legal counsel. "This phenomenon is not unique to medical device companies; it is a threat to a wide range of industries," he says. "New medical device companies may be particularly vulnerable to a class-action attack because they produce products that, if defective, can be harmful, and they may lack the experience and resources to withstand prolonged class-action litigation.

"Class-action litigation can be bet-the-company litigation," he adds. "Even large, more-experienced companies have floundered after plaintiffs' class-action lawyers have caught the scent of blood in the water."

Magratten says the recent Class Action Fairness Act (CAFA) has strengthened the ability of defendants to remove purported class actions to federal court and otherwise level the playing field. "Because of CAFA and courts clamping down on class certifications, class-action litigation may be considered less of a bonanza for plaintiffs' lawyers," he says.

Magratten has authored and coauthored a variety of publications concerning product liability, ERISA, and disability insurance topics. He is also a frequent lecturer on ethics, federal practice, and product liability trends.

Although emerging medtech companies may encounter a wide variety of needs for legal counsel, they generally cannot afford a large legal staff, and may also have limited resources for outsourcing such services. Magratten recommends that emerging medtech companies hire an experienced general counsel at an early stage of company development. "The in-house lawyer is often in a position to do the company's legal work, or can at least triage demands for legal work and match resources to those needs most efficiently," he says.

Magratten attended Hamilton College and the Dickinson School of Law, and obtained an MBA from Bryant College, where he has also served as an adjunct faculty member, teaching courses on business law and ethics.

Timothy J. Malloy is a founding partner and shareholder at McAndrews, Held & Malloy (Chicago). He specializes in trial litigation of high-technology matters, including patent, trademark, antitrust, unfair competition, contract, and other intellectual property law matters throughout the United States.

Malloy has obtained numerous multi-million-dollar verdicts, awards, and settlements for his clients. For defendants, he has obtained numerous verdicts and decisions of invalidity and noninfringement, and dramatically reduced damages.

In the medical device realm, Malloy obtained a $166 million damage award on behalf of Guidant Corp., an award that was listed in the top 10 IP damage awards of all time by Intellectual Property Today. In 1990, he argued before the Supreme Court regarding the medical device patent protection case of Eli Lilly and Co. v. Medtronic Inc.

According to Malloy, there are two primary legal questions that confront medtech companies when dealing with new technology. "The first—which is asked by all companies, small and large—is, 'Am I free to sell the new technology without fear of injunctive relief or massive damages resulting from patent infringement?'" he says. "The second question—more often asked by smaller medtech companies and start-ups—is, 'Is my technology exclusive to me?' In other words, do I have solid patent protection for the new technology?

"Failure to ask and resolve those two questions can lead to a world of trouble," he adds. "While the Federal Circuit has backed off the requirement that an accused defendant produce a legal opinion justifying its conduct, it is still prudent to seek competent advice before launch of a product. As for those seeking exclusivity, companies have a one-year window, which begins counting down from first publication or sale of the device, in which to file a patent application. To delay may be to lose any chance of exclusivity and thus sharply diminish a company's worth in the marketplace."

Malloy is admitted to practice in Illinois and is a member of the bars of the U.S. District Court for the Northern District of Illinois and others, the U.S. Court of Appeals for the Federal Circuit and others, and the U.S. Supreme Court. He is admitted to practice before the U.S. Patent and Trademark Office.

Malloy is widely published and has lectured to the Federal Circuit Bar Association on jury trial techniques. He has conducted the National Symposium on Patent Protection for Medical Devices and has presented multiple talks at the PricewaterhouseCoopers Intellectual Property Leadership Forum.

"In terms of improving the patent laws, all medtech firms engaged in serious research and development ought to give consideration to lobbying Congress for a law modifying the Federal Circuit's interpretation of the written disclosure-enablement requirements of 35 USC 112," he says. "At the present time, a number of panel decisions suggest that a pioneering invention—especially one in the field of genetics—will be given no broad protection unless the scope of the claim is no broader than the scope of enabled disclosures. What this means in plain English is that the broader and more pioneering a company's discovery, the less likely it may be able to protect it with valid patent protection."

Malloy holds BSEE and JD degrees from the University of Notre Dame. He has been elected to the National Register of Who's Who, Chamber's USA—America's Leading Lawyers, Strathmore's Who's Who, and was named as one of Illinois' 100 Super Lawyers in any field by Chicago Magazine in 2005.

Barbara A. Wrigley is a partner in the intellectual property practice of Oppenheimer Wolff & Donnelly LLP (Minneapolis). She is cochair of the firm's medical technology practice group, and client and industry group managing partner.

With more than 16 years' experience creating, enforcing, and defending intellectual property assets, Wrigley focuses her practice on providing service to clients—from start-ups to established Fortune 500 companies. She provides clients with a full range of patent counseling including opinions and advice concerning patentability, infringement, and validity issues; patent prosecution including ex-parte appeals, reissues, reexaminations, interferences, and foreign oppositions and appeals; risk analysis including assessment of the relative strengths of patent positions; and litigation strategy. She has broad experience in transactional intellectual property including intellectual property due diligence in complex corporate transactions, freedom-to-operate opinions, patent and technology licensing agreements, codevelopment alliances, and joint ventures.

"The need for counsel that arises most frequently is clearance opinions regarding the infringement or noninfringement of third-party rights by a new product under development, going to market, or already commercialized," Wrigley says. "The medical device industry is a high-stakes, multi-billion-dollar industry. Therefore, a product that has the potential to capture significant market share will catch the attention of most big competitors, which will then scour their patent portfolios looking for instances of potential infringement."

Wrigley says the cost of patent litigation can be between $500,000 and $4 million per party, depending on the product at stake and the loss of executive and management time in managing the litigation. "Further is the risk of an injunction barring the sale of the infringing device altogether, and treble damages for willful infringement," she says. "And, in some cases, the defendant will be liable for the plaintiff's attorneys' fees. So for a medtech business that ignores advice of counsel, the stakes are quite high relative to the cost of making modifications to a product."

"Most emerging medtech companies have sophisticated CEOs who understand the risks of infringement and engineering staff that monitor the patents of competitors while they are designing the company's products," she adds. "These patents are then brought to the attention of outside counsel, who can opine on infringement. Working with counsel on an ongoing basis can ultimately save money because the two resources—inside engineering staff and outside counsel—are working together as the product is being designed. On the other hand, engineering staff that wait until the design is frozen and then contact outside counsel, only to find that the product infringes third-party rights, are looking at an expensive redesign or the risk of litigation."

According to Wrigley, the most significant patent reform currently being proposed in the United States is the postgrant opposition procedure. "Currently, with the exception of the United States, most industrialized countries have a postgrant opposition procedure to challenge the validity of a patent proposed to be granted," she says. "The postgrant opposition procedure presently being contemplated in Congress would be modeled after the European system. The recent surge in filing applications for patents at the U.S. Patent and Trademark Office has created an increased patent office backlog, raising concerns among medtech businesses that patents are being granted that have had an inadequate search of prior art, and thus are invalid. Those patents are being asserted against competitors with challenges to validity now occurring in the courts. With concerns over the spiraling costs of litigation, proponents argue that the postgrant opposition procedure would move the determination of validity back to the patent office, thus lowering the costs of litigation and increasing patent quality. Opponents argue that small inventors would face the cost of validity challenges brought by big medtech companies that don't want the patent to issue and would tie up the issuance for years.

"The postgrant opposition procedure would enable any third party to file a request not more than nine months after the grant of a patent opposing the issuance of a patent," she adds. "The party requesting an opposition could raise any of the statutory requirements for patentability. Many proponents correctly argue that the economic benefits of the system would far outweigh the potential disadvantages to small inventors. In the specific case of the medtech industry, we would see stronger, higher-quality patents with, I believe, a concomitant decrease in spurious litigation."

Wrigley's broad technical expertise is in the mechanical, electromechanical, and applied chemical arts, and she has particular expertise in medical devices, processes, and systems. She has been involved with medical technologies in the fields of cardiosurgery, cardiovascular, ophthalmology, orthopedics, dialysis, MRI-guided surgical instrumentation, rehabilitative medicine, and urology and gynecology.

Before joining Oppenheimer, Wrigley served as executive vice president, general counsel, and chief intellectual property counsel for Minntech Corp. (Minneapolis), where she created a global intellectual property strategic plan for the company to aggressively seek worldwide patent protection for core technologies; built technology platforms; secured intellectual property rights in strategic alliances; and contributed to top-line growth through technology transfers, licensing, and technology acquisitions.

Wrigley received a BS from Villanova University and an MBA from the College of St. Thomas. She earned a JD from William Mitchell College of Law (St. Paul, MN). She is registered to practice before the U.S. Patent and Trademark Office and is admitted to practice before the state court of Minnesota and U.S. District Court, District of Minnesota. She has worked as an adjunct professor of law at William Mitchell College of Law and as an adjunct professor in the mini-MBA program at the University of St. Thomas, where she has taught more than 200 students the fundamentals of patent, licensing, and technology law, and the business of intellectual property.

MX looks forward to the contributions of these editorial advisers. In the November/December issue, MX will present its advisory board members in the areas of sales and logistics, marketing and advertising, and corporate communications. To nominate medtech industry experts in these or other fields, contact MX editor in chief Steve Halasey at 310/445-4274 or via e-mail at [email protected].

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