Tuesday, November 10
7:30 - 11:30 a.m.
7:30 - 8:20 - Medical Device Design
8:30 - 9:20 - Mock IP Due Diligence
9:30 - 10:20 - The Regulatory Road Less Traveled
10:30 - 11:20 - European Opportunities for Medical Device Companies
Medical Device Design - How to Deliver Technology that People Value
Sponsored by:
Breakthrough technologies are being developed in labs and universities around the world everyday. Doctors, nurses, patients, and caregivers value technology that combines improved outcomes with a clear, enhanced user experience. Their satisfaction is the key to your success. This session will focus on the activities that are essential to bridging the gap between the user and technology for business success.
Allan Cameron, Principal - Industrial Design, Continuum
Allan is a integral member of the medical design practice in Continuum’s Health and Medical Group. At Continuum, he has managed and designed a diverse group of medical devices from a pediatric sedation headset to a POC respiratory product to a revolutionary device to treat depression. He has also lead several large laboratory instrumentation projects for the clinical, microbiology, and life sciences field. These projects have included intensive work on architectural design, user interaction and disposables, their life cycle and packaging.
Before coming to Continuum, Allan Cameron worked in the Southern California design community for over 23 years, acquiring a broad range of experience in medical device design. His seasoned view brings a wealth of knowledge to the programs he manages. He has developed a wide spectrum of products but his focus is in the field of medical device design. Mr. Cameron’s medical projects have included surgical tools and controls, heart/lung machines, dialysis equipment, laboratory instrumentation, handheld and diagnostic devices with their accompanying disposables/packaging. Some of his clients have included Bayer, Baxter, Dade-Behring, Cobe, Dura Pharmaceuticals, Birtcher Medical Systems, Allergan, Micro-Scan and BioRad.
Mr. Cameron balances the voice of the user with the needs of the client and the project. He has a strong mechanical background, holding many patents, which allows a seamless mating of both the Industrial Design and Engineering disciplines. Mr. Cameron received his BFA from the Cleveland Institute of Art.
Stuart Perry, Director - Electrical Engineering, Continuum
Stuart Perry is responsible for electrical engineering and design in both implementation and project leadership roles. He has experience in diverse aspects of systems engineering and product development with technical strengths that span motion control, instrumentation, testing, simulation, analog and digital signal processing, analog and digital circuit design, wireless system design and software.
Prior to joining Continuum, Mr. Perry worked for eleven years at the Eastman Kodak Company in the R&D laboratories for optical disk recording. He led a team of mechanical, optical, electronic, and software engineers as the system architect and project leader for a DVD-R optical disc recorder. His responsibilities included systems-level and detailed engineering design, systems modeling, technology assessment, hardware/software partitioning, DSP and microprocessor selection, and standards activities. In previous assignments at Kodak, he developed control strategies from concept through implementation for next generation optical disk drives. These control strategies were applied to such diverse subsystems as objective lens positioning, optical head positioning, laser power control, and actuator design. He has developed an array of skills in testing, measurement and analysis of dynamic systems, and complements the theoretical work with hardware and software design experience including analog and digital circuits and DSP-based acquisition systems for real-time control.
Mr. Perry also has product development experience leading the electronic design of a broad array of products, including an advanced infusion pump, a three dimensional printer, a medical-grade audiometric amplifier, an ultrasonic cleaner, a PC-based analog telecommunications device, and a low-cost avionics instrument.
Mr. Perry received an MS in Electrical Engineering, and a BE as a double major in Electrical Engineering and Math from Vanderbilt University. His Master's studies were concentrated in advanced control theory and his thesis work resulted in two published papers. He holds six patents in the areas of power amplifier design, computational methods for control systems, and resonant load stabilization.
Mock IP Due Diligence
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Learn about the IP issues facing investors, acquirers and companies through a mock IP due diligence. Panelists role-playing both sides of a potential investment, including investor and company representatives and IP counsel, will walk through common due diligence issues and problems using the example of a hypothetical medical device company seeking financing and positioning itself for acquisition.
Vito Canuso, In-house IP litigation counsel for Medtronic-CoreValve
Vito Canuso is in-house IP litigation counsel for Medtronic-CoreValve, responsible for handling IP litigation matters involving cardiovascular technologies. He was previously responsible for both litigation and prosecution for a start-up cardiovascular company before and during its acquisition by Medtronic.
Prior to May of 2008, Mr. Canuso was a partner with Knobbe Martens Olson & Bear, where he has been practicing as an IP lawyer since early 1990, having become a partner in 1995. His practice historically focused boardly on IP litigation and IP prosecution matters for various types of clients, from billion-dollar international comglomerates to small garage inventors. He has litigated IP issues involving a wide variety of technologies, including consumer electronics, semiconductor processing equipment, medical devices, pharmaceuticals, telephony, motorized watercraft, controllers, and circuit board devices. Mr Canuso has litigated cases before district courts throughout the United States and before the ITC, and has prepared and argued appeals to the Federal Circuit. While at Knobbe, Martens, his patent prosecution docket focused primarily on medical devices for numerous life science applications in the cardiovascular and pulmonary fields, and clean technology, including electrochemical applications. Mr. Canuso spent a great deal of his latter career advising start up companies in IP strategy, primarily in the medical and clean tech fields.
Mr. Canuso received his Juris Doctor degree from the University of San Diego. He earned a master's of science degree in Environmental Health Engineering from the University of Notre Dame and a bachelors of science degree in Mechanical Engineering from Villanova University.
Sabing Lee, Partner, KMOB
Sabing H. Lee is a partner in the Orange County office of Knobbe Martens Olson & Bear LLP. Mr. Lee received his Bachelors Degree in Materials Engineering, Phi Beta Kappa and summa cum laude, from UCLA, and also received his Masters Degree in Materials Science and Engineering from UCLA. He received his J.D. from the University of California, Berkeley School of Law (Boalt Hall), where he was an Articles Editor and Executive Editor for the Berkeley Technology Law Journal.
Mr. Lee’s practice includes strategic patent procurement, patent portfolio management, intellectual property due diligence, general counseling on infringement and licensing, interferences, reexaminations, and other related issues. Mr. Lee currently represents clients in a wide range of technologies, including medical devices, nanotechnology, and semiconductor fabrication.
Mr. Lee joined the firm in 1997 and became a partner in 2003. He has been named as one of Southern California's "Rising Stars" in intellectual property law in a survey of his peers, published in Los Angeles magazine and Super Lawyers magazine, consistently since 2004.
In the medical device field, Mr. Lee has worked extensively with cardiovascular and orthopedic technologies. He has been involved in the intellectual property strategy and acquisitions of PercuSurge, Inc. (acquired by Medtronic, Inc.), Flex-Foot, Inc. (acquired by Össur hf.) and Endius, Inc. (acquired by Zimmer Holdings, Inc.).
Ryan Siemens, Managing Director, Waveland Technology Partners
Mr. Siemens has over 14 years of experience in investment banking, mergers and acquisitions, and business evaluations, with primary industry focus in the technology, healthcare, energy and manufacturing sectors.
As Manager of Waveland Technology Partners, he is also instrumental in the management of three Waveland-sponsored technology funds. Prior to joining Waveland, Ryan served as Director of Research for Taurus Capital Group, LLC, where he was responsible for the firm’s due diligence on private equity transactions and was actively involved in marketing the firm’s M&A clients to financial and strategic buyers throughout the U.S. Prior to Taurus, Ryan served for over three years as an analyst and M&A advisor with Kibel Green Issa Inc., ranked by ‘Turnarounds and Workouts’ as one of the top turnaround consulting groups in the U.S. and prior to that, he was a financial analyst for Nearon Enterprises, a $300 million private investment fund. He has substantial experience in conducting valuation analyses of businesses in many industries as well as on non-corporate investments such as real estate and energy exploration.
Ryan received his BA in Political Science from the University of California at Berkeley and his MBA from the Thunderbird School of Global Management. He is also a director of Fertile Earth Corporation, a Waveland portfolio company.
Gerard von Hoffmann, Partner, KMOB
Gerard von Hoffmann is a partner in our Orange County office, where he specializes in intellectual property strategies, financings and strategic transactions in the medical device industry. Mr. von Hoffmann holds an A.B. in Chemistry from Rice University and Occidental College and received a J.D., cum laude, from the University of San Diego School of Law. Mr. von Hoffmann attended the Institute on International and Comparative Law at Oxford University, England, and served as a law clerk for the Honorable Helen W. Nies, Circuit Judge, United States Court of Appeals for the Federal Circuit. Mr. von Hoffmann has served as an Adjunct Professor of Patent Law at the University of San Diego School of Law, and also on the Board of Directors of several private and public medical device companies including CardioVascular Dynamics, Inc. (angioplasty products), Radiance Medical Systems, Inc. (intravascular brachytheraphy), Triage Medical, Inc. (orthopedic fixation devices), NeoMatrix, LLC (breast cancer screening), and ValenTx, Inc. (implants for morbid obesity).
His technical experience involves a wide variety of diagnostic and therapeutic cardiovascular interventions, throughout the peripheral and coronary vasculature, intracranial access devices and procedures, and various coronary implants and procedures. He has also been involved in a variety of orthopedic projects, including total hip revision systems, bone fracture fixation systems, various joint replacement and repair technologies, and fixation and mobility preservation devices and procedures relating to the spine. His activities have also involved a variety of intraocular, gastrointestinal, OB/GYN and respiratory technologies.
Mr. von Hoffmann joined the firm in 1986 and became a partner in 1989.
The Regulatory Road Less Traveled: de novo 510(k)s and HUD/HDEs
Sponsored by:
For many companies there may be regulatory alternatives to pursuing conventional pre-market FDA approvals. The presenter - Alquest CEO Linda Alexander - will cover justifications for lesser-used, yet important approval strategies known as de novo 510(k)s and HUD/HDEs. Alexander will address considerations involving product design, steps, costs and timelines, as well as regulatory “fall back” options if these approaches are not supported by regulators.
Speaker: Linda Alexander, CEO, Alquest, Inc.
Linda Alexander founded Alquest, Inc. in 1993 after working in management and director-level positions in regulatory and clinical affairs for Brennen Medical, Bioplasty and Medtronic. During her career, Linda established worldwide regulatory and clinical strategy and requirements for over 50 devices, including cardiovascular, audiology, interventional vascular, dental, neurovascular, orthopedic, plastic surgery, general surgery, neurology, gastroenterology and urology devices. Linda has obtained clearance/approval for more than 50 premarket notifications; 15 IDE applications; and six PMA applications. Linda is a nationally-recognized and sought expert and presenter on clinical and regulatory strategy for medical device companies. She earned a B.S. degree in biology and chemistry from Iowa State University, and M.S. in Technical Communication from the University of Minnesota.
European Opportunities for Medical Device Companies
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International experts will discuss how Europe is driving growth and innovation for many American medical device companies. A case study outlining a recent international expansion project will be analyzed and experts will be available to share information on incentives, research and development opportunities, and overall global industry trends.
Douglas K. Ebert, Executive Director North America, Development Economic Western Switzerland
For nearly two decades Doug Ebert has represented Switzerland, most particularly the Canton of Neuchatel and most recently DEWS, the combined economic development regions of the Cantons of Neuchatel, Vaud, Valais and the Jura (Western Switzerland) in the area of Economic Development and Direct Foreign Investment. As the Executive Director of North America for DEWS, Development Economic Western Switzerland, Doug is the team leader of the DEWS development organization in the US and Canada. Prior to his work with Neuchatel and DEWS, Doug was Sr. Vice President for Consulting and Client Services for an international outplacement firm where he had oversight for over 50 offices nationwide.
Nanci Govinder, Head of Medtech Coaching at the EPFL (Ecole Polytechnique Federale – Lausanne) Science Park.
Nanci Govinder has worked for more than 12 years in the medical device industry as a researcher, senior business manager and international marketing manager for companies such as Johnson & Johnson and Medtronic. She works as a business consultant at the Parc-Scientifique, EPFL, coaching startups from idea generation to go-to-market, and is the CEO of a medical device startup in Geneva, Switzerland. Nanci is also a guest lecturer and facilitator at IMD, one of Europe’s leading business schools. She has a Bachelor of Science degree in Chemistry and Applied Chemistry and an MBA. She is a member of the Worldwide and European Medical Device Networks.
Gerry Hammarth, Vice President, Finance, Masimo Corporation
Gerry Hammarth has served as Vice President, Finance for Masimo Corporation, a publicly traded medical device manufacturer, since June 2002. From April 1997 to June 2002, Mr. Hammarth served as Controller for Powerwave Technologies, Inc., a publicly traded manufacturer of telecommunications equipment. Previously, Mr. Hammarth has served in various finance positions in the computer manufacturing, retail, food and fashion apparel industries. Mr. Hammarth holds a B.A. in Psychology from the State University of New York at Stony Brook and an M.B.A. in Finance from the Wharton School of the University of Pennsylvania.
Pierre Ihmle, Head of Partnership Development, EPFL (Ecole Polytechnique Federale – Lausanne)
Pierre Ihmle has a dual scientific and management career in top institutions in the USA and in Europe. Pierre worked several years as a project manager for an internationat management consultancy. In 2002, Pierre Ihmle founded VPI Management consulting. In 2005, he co-founded Cinetis SA, a start-up in Martigny devoted to film digitization technologies. Pierre is regularly involved in teaching programs at IMD, and teaches strategy, entrepreneurship, innovation and finance classes at various universities and programs (VentureLab). He is Chairman of the Board of Cinetis SA. He is on the Advisory Board of Spectraseis, a geophysical start-up in Zurich. Pierre is on the Board of two non-for profit organizations. Pierre Ihmle holds a degree in natural sciences from the ETHZ in Zurich (summa cum laude) and a Ph.D. in geophysics from M.I.T. in Cambridge, USA. He has been active as a senior research scientist at the Institut de Physique du Globe de Paris and at Institute of Geophysics at ETHZ.
