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Michael Bell, Managing Member
R-Squared
Michael is the Founder and Managing Member of R-Squared, a reimbursement and regulatory compliance consulting and solutions firm. With the assistance of a Chief Technology Officer and a team of coders/developers, Michael consultatively designs affordable and effective technological solutions for operational and compliance improvement. A lawyer by training, he is a nationally recognized compliance expert who frequently consults, publishes, and presents on topics of healthcare corporate compliance, privacy, and third party coverage and reimbursement. Michael currently serves on manufacturer, health system, and health plan compliance committees, and on several Advisory Boards, including those for BNA’s Medical Device and Law and Industry Report, Matthew Bender/Lexis Nexis Healthcare, AIS Report on Patient Privacy, and Seton Hall University School of Law’s Corporate Compliance Officer Certification Program. Michael is the chief designer of R-Squared’s Arrangements KeeperSM, a compliance and contract management tool designed specifically to evidence compliance with requirements related to manufacturer/physician relationships, and Spend TrackerSM, a highly scalable and interoperable program that automates tracking and reporting of physician marketing/gift expenditures.

Shawn Bishop, Professional Staff Member
Senator Baucus, Chairman of Senate Finance Committee
Shawn Bishop is a Professional Staff member to Senator Baucus, Chairman of Senate Finance Committee. Her responsibilities on the committee staff include Medicare Parts C and D, which encompass the new Medicare Advantage and prescription drug programs. Prior to her current position, she was a Principal Analyst at the Congressional Budget Office (CBO) where she developed models to estimate the cost of legislative proposals related to Medicare health plans and competition. Shawn has worked in federal health payment policy at the Centers for Medicare and Medicaid Services, CBO, the Prospective Payment Assessment Commission (now MedPAC) and in the private sector at Price Waterhouse, LLC. She has a master’s degree in public policy from the University of California, Berkeley.

Les Bookoff, Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
Les Bookoff is a partner and the current leader of Finnegan’s Mechanical Practice Group. His practice involves most aspects of patent-related work and has an emphasis on the medical device field. He provides a full range of patent services to clients with a particular focus on developing patent strategies in concert with the client’s business goals. He has considerable experience building and managing patent portfolios, from start-ups to larger companies.

Les analyzes patent portfolios of competitors to counsel clients regarding acquisition of technology, licensing, contemplated products, and potential design-arounds. He studies competitor products to advise clients on enforcement of their patent portfolios and often prepares validity, infringement, patentability, and clearance opinions. He also prepares and prosecutes foreign and domestic patent applications, including practice according to the Patent Cooperation Treaty. Les also has considerable experience in district court litigation and Patent Office interference proceedings.

David Cassak, Managing Partner
Windhover Information
One of the leading experts on the medical device industry, David Cassak writes and speaks extensively on trends and company strategies focusing on all aspects of the medical device industry. He is a frequent presenter before companies and industry groups, including, for the past several years, the featured interviewer at the Stanford University BioDesign Program’s Innovator’s Workbench series.

David was for almost 20 years Managing Partner, running the medical device business, of Windhover Information Inc., which he founded in 1989 with his partner Roger Longman. In 2004, Windhover acquired MedTech Insight, an information provider specializing in the medical device industry, and in 2008, Windhover was acquired by Elsevier Life Sciences Inc. Under Elsevier, David will run a newly-created business unit that features several leading publications serving medical device executives, including IN VIVO, Start-Up, MedTech Insight, and the Gray and Silver Sheets.

Chris Chavez, President
ANS Inc., A St. Jude Medical Company
Christopher Chavez is president of Advanced Neuromodulation Systems (ANS) (www.ans-medical.com), a division of St. Jude Medical. Joining ANS as president, CEO and director in 1998, Mr. Chavez guided ANS through a nine-year period of successful growth and through its acquisition by St. Jude Medical. Mr. Chavez started his career in the medical device industry with Johnson & Johnson Medical, Inc. in 1981 and progressed through several cross-functional roles to become vice president and general manager of the infection control business unit, with approximately $500 million in worldwide revenues. Prior to ANS, he served as vice president of worldwide marketing and strategic planning at Eastman Kodak’s health imaging division, where the division’s five worldwide business units reported to him. He holds an MBA from Harvard University and currently serves as a board member for the Medical Device Manufacturers Association and Advanced Medical Optics.

Kate Cook, Associate Director, Regulation and Policy
Center for Devices and Radiological Health
Catherine M. Cook, J.D., is Acting Associate Director for Regulations and Policy at FDA's Center for Devices and Radiological Health. She previously served at FDA as Associate Chief Counsel for Biologics and Associate Chief Counsel for Enforcement, where she concentrated on criminal matters. Ms. Cook received her J.D. from the New York University School of Law.

Thomas S. Crane, Member
Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.
Tom Crane is a Member at Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C. where he co-coordinates the firm's Health Care Fraud and Abuse and Corporate Compliance practice group.He is a nationally recognized authority on fraud and abuse. He provides comprehensive fraud and abuse services in defending clients against false claims, whistleblower and anti-kickback allegations, with this work including internal investigations, voluntary disclosures, negotiating settlements and Corporate Integrity Agreements (CIA's). He has appeared before numerous offices of U.S. Attorneys, the FBI and OIG around the country. He served as counsel to a hospital executive and his management company in United States v. Jones (5th Cir. January 16, 2007), a criminal related party cost report fraud case reversing District Court’s sentencing and restitution order based on a failure of the government’s proof. He also assists clients in structuring complex transactions to comply with the anti-kickback and Stark laws as well as other regulatory requirements. He received his undergraduate degree from Harvard College (1972), a masters degree in health administration from the University of Michigan (1976), and his law degree from Antioch School of Law in Washington, D.C. (1983).

Daniel F. Donovan III, Counsel
King & Spalding
Dan Donovan joined the firm as Counsel after serving as Senior Investigative Counsel to Senator Charles E. Grassley, Chairman of the Committee on Finance in the United States Senate from 2003 to 2007. In that role, he directed investigations of pharmaceutical, medical device, and other healthcare companies on a broad range of regulatory compliance issues, including matters of drug and device safety, and fraud, waste and abuse in Medicare and Medicaid and other federal government programs. His practice focuses on representing clients being investigated by Congressional committees and on other compliance and enforcement actions by federal and state healthcare enforcement and regulatory agencies.

Ames Gross, President and Founder
Pacific Bridge Medical
Ames Gross is President and founder of Pacific Bridge Medical (PBM). Mr. Gross is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross founded PBM in 1988 and has helped over 200 medical companies with business development and regulatory issues in Asia. Mr. Gross is a frequent contributor of articles on Asian medical issues for Clinica (England), Medical Device and Diagnostic Industry (Los Angeles), and other medically oriented journals. Mr. Gross has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences.

Steve Jensen, Partner
Knobbe Martens Olson & Bear LLP
Stephen Jensen is a partner with Knobbe Martens, one of the largest intellectual property firms in the U.S. with offices nationwide. His practice emphasizes intellectual property litigation, negotiation, licensing and strategic counseling matters. He has handled extensive and diverse cases, involving virtually all aspects of intellectual property, and has negotiated and drafted diverse license and other technology related agreements between companies worldwide.

Mr. Jensen represents clients in a wide range of technologies, with a particular emphasis in the medical device industry He has extensive experience building patent portfolios for companies like Masimo and the members of MDMA to enhance the likely success of their innovative technologies coming to market and protecting their position within the marketplace. He also counsels clients in other technological areas such as semiconductors, computer hardware and software, and telecommunications and was named by the Daily Journal as one of the top 20 lawyers under 40 in California.

Patric Kallman, CEO
Vasco Advisers
Patric Kallman is CEO of Vasco Advisers, a small European consulting company working with business and strategy development in the healthcare sector. His work involves developing business and strategies for a range of players in the healthcare area including medical technology and biotech companies, private and public healthcare providers, pharma, private equity and VC companies. Patric has a background from both academy and the medical industry. He holds a PhD, a M.Sc., Bachelor of Medicine and MBA. Before founding Vasco Advisers in the year 2000 he held different leading positions in the healthcare industry.

Joe Kiani, Chairman & CEO
Masimo Corporation
Joe E. Kiani is the founder, CEO and Chairman of the Board of Masimo Corporation. Mr. Kiani has held these positions since Masimo’s inception in 1989. Mr. Kiani is an inventor on more than 50 patents related to signal processing, sensors, and patient monitoring, including patents for the invention of motion and low-perfusion tolerant pulse oximetry. Prior to founding Masimo Corporation, Mr. Kiani served as regional technical manager for Anthem Electronics, and field applications engineer for Bell Industries, which distributed advanced semiconductor components. Mr. Kiani was also Product Engineer at Unisys. He serves on the Board of SABA, a publicly traded software company focused on Human Capital Development and Management solutions, Orange County Section of March of Dimes, and the Medical Device Manufacturers Association (MDMA). Mr. Kiani has a B.S.E.E. degree and an M.S.E.E. degree from San Diego State University.

Mark B. Leahey, Executive Director
Medical Device Manufacturers Association
Mark Leahey is the Executive Director for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents research-driven medical technology companies. Mr. Leahey's responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies, worked to open access to the hospital marketplace by challenging the exclusionary and anti-competitive nature of certain large group purchasing organizations (GPOs), as well as ensure that medical device technologies are reimbursed adequately. Mr. Leahey currently sits on the Medical Devices Committee for the Food and Drug Law Institute (FDLI) and the Editorial Advisory Board of Medical Product Outsourcing. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business.

Michael Lefkowitz, Technical Advisor
Division of Acute Care, CMS
Miechal Lefkowitz is a Technical Advisor in the Division of Acute Care at CMS. She has been at CMS for almost 9 years, and has worked on a variety of Inpatient PPS policy issues, including DRG weights, charge compression, graduate medical education, and wage index. Miechal received an MBA with a concentration in Health Care Management from Loyola College in Maryland.

Jennifer Loffredo, International Trade Specialist
U.S. Commercial Service, U.S. Department of Commerce
Jennifer Loffredo is an International Trade Specialist. She joined the US Commercial Service in 1997. Over the course of her career with the US Commerical Service, she has focused on the Medical and Information Technology firms in Michigan. In 2005 and 2006, Jennifer was the domestic recruitment lead for the US Commercial Services’ MEDICA CEO program. In the fall of 2007, Jennifer was appointed to be the US Commercial Service’s Global Healthcare Team Leader. In this position, she manages a worldwide team of domestic and international trade specialist that cover the medical industry.

Before relocating to Michigan, Jennifer was a native to Arkansas. Jennifer earned her B.A. in Psychology with a focus in Neuroscience from Vanderbilt University in Nashville, Tennessee.

John Manthei, Partner
Latham and Watkins
John Manthei is a partner in the firm’s Washington, D.C. office and the global co-chair of the firm’s Health Care and Life Sciences Practice. Mr. Manthei’s practice focuses on regulatory matters involving the FDA for the medical device, pharmaceutical and biotechnology industries. His practice includes assisting clients with all aspects of the FDA-regulated product life cycle in both the US and the EU. Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives’ Committee on Commerce. He also served as the primary congressional staff contact in the House with the FDA Commissioner’s Office and Center Directors, in developing FDA policy. Currently, Mr. Manthei serves as outside FDA counsel to MDMA and is a member of the Food & Drug Law Institute’s Advisory Committee for Drugs and Biologics. In 2006, Mr. Manthei was named by Washingtonian Magazine one of the top “40 Lawyers under 40.”

Diane Mitchell, Associate Director, Postmarket Transformation
Center for Devices and Radiological Health
Dr. Diane Mitchell is on detail to the Office of the Center Director in the Center for Devices and Radiological Health. She is working on the postmarket transformation, specifically on turning the Center into a Matrix organization. Her tenure with CDRH began 1998 in the Office of Device Evaluation where she has been both a reviewer and a manager. In 2006 she went on a detail to the Office of Surveillance and Biometrics and learned about CDRH’s postmarket regulatory responsibilities and last year she was detailed to the Office of the Center Director to work on the Center’s postmarket transformation initiatives. Prior to joining the FDA she practiced medicine full time with the Indian Health Service in Oklahoma. Dr. Mitchell is a board certified obstetrician gynecologist. She did her residency training at Walter Reed Army Medical Center. She received her medical degree from the Uniformed Services University of Health Sciences where she is now an Assistant Professor. She is also a Captain in the Public Health Service.

Guy Nohra, Co-Founder and Managing Partner
Alta Partners
Guy Nohra is a co-founder of Alta Partners, and was also a partner at Burr, Egan, Deleage & Co., which he joined in 1989. Guy has been involved in the funding and development of notable medical technology and life science companies including Cutera, Innerdyne, R2 Technology, deCODE genetics, and Vesica. Previously, Guy was Product Manager of Medical Products with Security Pacific Trading Corporation. He was responsible for a multi-million dollar product line and traveled extensively in Korea, Taiwan, Hong Kong, China and Southeast Asia.

Currently, Guy serves on the board of directors of several private companies, including AcelRx, ATS Medical, Carbylan Biosurgery, Coapt Systems, Paracor Medical, PneumRx and Vertiflex, and is the Chairman of the Board of USGI Medical. He also serves on the board of directors of the Medical Device Manufacturing Association (MDMA). He was named to the 2007 Forbes "Midas List" of dealmakers in high-tech and life sciences.

Blake Rodgers, President
Spine Midwest Research, Inc.
W. Blake Rodgers, M.D. is a board certified orthopaedic spinal surgeon. Dr. Rodgers is President of Spine Midwest, Inc. and Director of the Spine Center at St. Mary’s Health Center. He serves on the Boards of Directors of the ARGOSpine, SOLAS, St. Mary’s Health Center, and the Columbia Independent School. He graduated summa cum laude in Molecular Biophysics from Yale where he received the Mendell Prize. He completed his medical degree and his orthopaedic training at Harvard. Dr. Rodgers completed a fellowship in adult spinal surgery at Massachusetts General Hospital and was the Ober Fellow in Pediatric Spinal Surgery at Boston Children’s Hospital. He is a member of the Yale University Development Board and the National Board of Advisors of the Eiteljorg Museum.

In addition, Dr. Rodgers is a member of NASS, AAOS, SMISS, and numerous other medical associations; he has published extensively in various peer-reviewed journals and has presented at academic meetings throughout North America, Europe, and Asia.

Allison Weber Shuren, Partner
Health Care Practice Group, Arent Fox LLP
Allison Weber Shuren is a Partner of the Health Care Practice Group. She serves on the Life Sciences Steering Committee, focusing on issues involving medical devices and emerging technologies, and focuses her practice on a variety of regulatory and legislative health care issues. Ms. Shuren advises a diverse group of clients, including pharmaceutical, medical device and biotechnology companies, hospital and academic medical centers, physician practice management companies and physician practices, ambulatory surgery centers, diagnostic imaging centers, health care professional societies, ambulance companies and Internet-based health care companies. She regularly interacts with representatives from CMS, OIG and FDA.

Mr. Tommy G. Thompson
Health and Human Services Secretary 2001 - 2005
Tommy G. Thompson, the former Health and Human Services Secretary and four-term Governor of Wisconsin, is Senior Advisor and Founding Independent Chairman of the Deloitte Center for Health Solutions and a partner at the law firm of Akin Gump Strauss Hauer & Feld. He also serves as Chairman of AGA Medical Corporation.

At Deloitte and Akin Gump, Secretary Thompson is building on his efforts as HHS Secretary and Governor to develop innovative solutions to the health care challenges facing American families, businesses, communities, states and the nation as a whole. These efforts focus on improving the use of information technology in hospitals, clinics and doctors offices; promoting healthier lifestyles; strengthening and modernizing Medicare and Medicaid; and expanding the use of medical diplomacy around the world.

Secretary Thompson served as HHS Secretary from 2001 to 2005 and is one of the nation's leading advocates for the health and welfare of all Americans. Secretary Thompson has dedicated his professional life to public service and served as Governor of Wisconsin from 1987 to 2001. Secretary Thompson made state history when he was re-elected to office for a third term in 1994 and a fourth term in 1998.