Conference

Wednesday, October 22, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)

Session 203 - Effective Medical Device and Diagnostics Development

Chairs: John H. Linehan, Ph.D., Professor of Biomedical Engineering and Medicine, Northwestern University; and Jan Pietzsch, Ph.D., Co-Founder, President, and CEO, Wing Tech Inc. Welcome and Introductions John H. Linehan, Ph.D., Professor of Biomedical Engineering and Medicine, Northwestern University; and Jan Pietzsch, Ph.D., Co-Founder, President, and CEO, Wing Tech Inc. Device and Diagnostic Development: Road Map Overview John H. Linehan, Ph.D., Professor of Biomedical Engineering and Medicine, Northwestern University; and Jan Pietzsch, Ph.D., Co-Founder, President, and CEO, Wing Tech Inc. Phase I: Needs Assessment and Risk Analysis Mir Imran, CEO InCube Labs Clinical needs analysis Technical and regulatory risks Financial review Competitive assessment and IP Q&A Break Phase II: Formulation/Concept and Feasibility Julio Spinelli, PhD, Chief Technical Officer, Action Medical Inc.; formerly Head of Heart Failure Research at Guidant Corporation Customer input Concept selection Prototyping Development strategy Q&A Networking Luncheon Phase III: Design and Development/Verification and Validation Michelle Paganini, President, Michelle Paganini Associates Quality systems section for phases III and IV Verification and validation Q&A Phase IV: Final Validation/Product Launch Preparation Mark Ungs, formerly VP, Boston Scientific Corporation Product branding Manufacturing planning Supplier collaboration Market entry preparation Manufacturing and operations scale-up Q&A Networking Break Phase V: Product Launch and Post-Launch Assessment Russ Olson, Senior Principal Advisor, Regulatory & Clinical Research Institute, Inc. Product and process improvements Continued clinical and economic studies Post-market surveillance Product life cycle considerations Q&A Panel discussion on policy issues important to medical device development

Chairs: John H. Linehan, Ph.D., Professor of Biomedical Engineering and Medicine, Northwestern University; and
Jan Pietzsch, Ph.D., Co-Founder, President, and CEO, Wing Tech Inc.

About the Chairs

John H. Linehan, Ph.D., Professor of Biomedical Engineering and Medicine, Northwestern University
John H. Linehan, Ph.D. is Consulting Professor of Bioengineering in Stanford University’s Program in Biodesign and the Department of Bioengineering. Linehan was the Vice President of the Whitaker Foundation from 1998 - 2005. Prior to 1998, Linehan was the Rose Bagozzi professor and the founding chair of the biomedical engineering department at Marquette University and an adjunct professor of physiology and pulmonary medicine at the Medical College of Wisconsin. He is a founding fellow and past president of the American Institute for Medical and Biological Engineering, a fellow of the International Academy of Medical and Biological Engineering and a member of the National Academy of Engineering.

Jan Pietzsch, Co-Founder, President and CEO, Wing Tech, Inc.
Jan B. Pietzsch is Co-Founder, President and CEO of Wing Tech Inc., a technology consulting firm, and Consulting Assistant Professor in the Department of Management Science and Engineering at Stanford University. His work at Wing Tech focuses on early-stage technology assessment and strategic decision-support for manufacturers and investors, with primary application to medical devices. Before starting Wing Tech, Jan pioneered new approaches for the early evaluation of medical devices during his doctoral research at Stanford. During this period, he also worked as a research fellow with the FDA's Office of Device Evaluation. At Stanford, Jan is an Advisory Faculty member in  the Biodesign Program, where he teaches a graduate-level course on technology assessment and regulation of medical devices. He holds a Ph.D. degree in Management Engineering and a M.S. degree in Engineering-Economic Systems and Operations Research from Stanford University, as well as an Engineer degree from the University of Karlsruhe, Germany.

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Device and Diagnostic Development: Road Map Overview

Abstract

To be updated shortly

About the Instructors

John H. (Jack) Linehan, Professor of Biomedical Engineering and Medicine, Stanford University
John H. Linehan, Ph.D. is Consulting Professor of Bioengineering in Stanford University’s Program in Biodesign and the Department of Bioengineering. Linehan was the Vice President of the Whitaker Foundation from 1998 - 2005. Prior to 1998, Linehan was the Rose Bagozzi professor and the founding chair of the biomedical engineering department at Marquette University and an adjunct professor of physiology and pulmonary medicine at the Medical College of Wisconsin. He is a founding fellow and past president of the American Institute for Medical and Biological Engineering, a fellow of the International Academy of Medical and Biological Engineering and a member of the National Academy of Engineering.

Jan Pietzsch, Co-Founder, President and CEO, Wingtech, Inc.
Jan B. Pietzsch is Co-Founder, President and CEO of Wing Tech Inc., a technology consulting firm, and Consulting Assistant Professor in the Department of Management Science and Engineering at Stanford University. His work at Wing Tech focuses on early-stage technology assessment and strategic decision-support for manufacturers and investors, with primary application to medical devices. Before starting Wing Tech, Jan pioneered new approaches for the early evaluation of medical devices during his doctoral research at Stanford. During this period, he also worked as a research fellow with the FDA's Office of Device Education. At Stanford, Jan is involved with the Biodesign Program, and is teaching a graduate-level course on technology assessment and regulation of medical devices. He holds a Ph.D. degree in Management Engineering and a M.S. degree in Engineering-Economic Systems and Operations Research from Stanford University, as well as an Engineer degree from the University of Karlsruhe, Germany.

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Phase I: Needs Assessment and Risk Analysis

Abstract

To be updated shortly

About the Instructor

Mir Imran, CEO InCube Labs
Mir Imran founded InCube Laboratories in 1995 to focus on his passion: creating medical device solutions that change the standard of care in critical healthcare markets. Mir began his career as a med-tech entrepreneur in the late 1970’s, and has founded numerous game-changing companies since those early days. Over the decades, he has become one of the world’s most successful inventors, entrepreneurs and investors in healthcare.

Mir now holds more than 200 issued patents - and is perhaps most well known for his pioneering contributions to the first FDA-approved Automatic Implantable Cardioverter Defibrillator. However Mir has invented a number of breakthrough devices that set new standards of care for their industries. Mir''s current crop of inventions includes advanced treatments for neural aneurysms, epilepsy, ulcerative colitis, obesity and chronic pain, among others. Most of these will enter clinical trials in the 2008 to 2010 timeframe.

As an entrepreneur, Mir has founded over 20 medical device companies. As an investor, Mir serves as the Life Science Venture Partner for DFJ ePlanet, where he has led 9 investments in a range of promising ventures around the globe. Mir is also the founder and Managing Director of DFJ InCube Ventures, a life science vanture capital fund. In addition to his venture capital activities, Mir is an active angel investor, with a portfolio based around both medical and pharmaceutical ventures. Mir currently holds board seats with Bodymedia, nFocus, Intrapace, Egeen International, Spinal Modulation.

Mir holds an MS in Bio-Engineering and a BS in Electrical Engineering from Rutgers University.

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Phase II: Formulation/Concept and Feasibility

Abstract

To be updated shortly

About the Instructor

Julio Spinelli, PhD, Chief Technical Officer, Action Medical Inc.
To be updated shortly

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Phase III: Design and Development/Verification and Validation

Abstract

To be updated shortly

About the Instructor

Michelle Paganini, President, Michelle Paganini Associates
With over twenty years of corporate experience and six years as an independent consultant in the Medical Device field, Michelle Paganini has made her mark in all aspects of quality system training and auditing programs, and quality systems evaluation and improvement. Experienced in numerous regulations and standards, Ms. Paganini has successfully hosted FDA and ISO audits. She is experienced in improving and developing quality systems for both large established corporations and start-up companies. Michelle received a degree in quality and is a Biomedical CQA (Certified Quality Auditor.) Michelle has been a contributing member of numerous development teams.

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Phase IV: Final Validation/Product Launch Preparation

Abstract

One of the biggest determinates in a product’s commercial success is its launch execution. This presentation will review the most common mistakes that sap the potential  of a product as well as highlight the winning launch strategies that maximize commercial success.

About the Instructor

Mark Ungs, formerly VP, Boston Scientific Corporation
Mark Ungs recently served as the Vice President of New Business Development for Boston Scientific’s multi-billion dollar Interventional Cardiology division where he was responsible for leading the division’s growth outside its core businesses through internal development programs as well as external technology acquisitions into new therapies. Mr.Ungs has played key roles in launching the two largest commercial successes in the history of the medical device industry, the drug coated stent and cardiac resynchronization therapy for CHF, representing billions in incremental revenue for his employers. Mr. Ungs is the co-founder of ACTx, a startup that is developing a therapy that has the promise of redefining the science of tissue function recovery and regeneration.

Mr. Ungs has over twenty years professional experience in the medical device industry. He has a degree in Chemical Engineering from Oregon State University and an MBA from the University of California, Berkeley.

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Phase V: Product Launch and Post-Launch Assessment

Abstract

FDA’s postmarket initiatives and ongoing transformation efforts have resulted in the need for medical device manufacturers to provide more comprehensive and timely responses to field performance issues and adverse events for released product.  In addition to having established procedures for handling complaints, MDRs and change control, manufacturers should ensure they have a rigorous product launch and post-launch system, and risk management practices well integrated with the product life cycle systems.  Prompt receipt, analysis, and established communication management methods for responding to events should be augmented through company-wide awareness and training, such that appropriate measures may be readily implemented throughout the organization and to all stakeholders.

Attendees will learn:

• Product launch and postmarket synergies
• Inputs leading to and during commercial release
• Why postmarket surveillance is everyone’s responsibility
• How to “walk the talk; i.e., post-launch activities are risk management

About the Instructor

Russ Olson, Senior Principal Advisor, Regulatory & Clinical Research Institute, Inc.
Russell Olson is a Senior Principal Advisor for Regulatory Affairs and Quality Systems at RCRI, Inc. He has over 25 years of experience in the medical device industry, 15 years of which have been with venture funded companies, focusing upon the areas of research, manufacturing, product development, quality systems and regulatory affairs. He has successfully gained multiple facility and product approvals in the United States and Europe including a PMA, multiple 510(k)’s, IDE’s CE Marks and approvals for Quality Systems. Russ assists RCRI’s clients with determining domestic regulatory strategies, drafting submissions, and negotiating their approval with the FDA. In addition, due to his significant experience with notified bodies and CE marking products, he provides guidance to medical device clients for CE certification to the MDD and AIMD directives; Technical File and Design Dossier preparation; Quality System design, certification, auditing, and compliance; and international product registration. Russ holds a Bachelor of Science degree in Microbiology and Public Health. He has additional training in the areas of quality system auditing, and sterilization validations, sterile packaging testing, FDA and ISO compliance issues and negotiations. With his experience, Russ has acquired a complete understanding of product design/development, process validation, manufacturing, quality systems and regulatory requirements. He has a B.S. in Microbiology and Public Health from the University of Wisconsin, Oshkosh.