April 10, 2008
The Japan Market for Medical Devices-An Overview and More...
Market
Overview & Product Review Protocol
Ian Clements, Office of Japan, U.S. Department of Commerce
Understanding
Japan's Reimbursement Procedures
Paul Barry, Director, International Health Policy, Boston Scientific
Case
Study: Succeeding in the Japan Market
Gerard E. Puorro, President, CEO, Director, Candela Corp.
March 6, 2008
Intellectual Property Update: Maximizing Protection in the Changing
Patent Landscape
Overview
of the Changing Patent Landscape
David J. Dykeman, Greenberg Traurig LLP
Preparing
for Changes in the Treatment of US Patents
Chinh H. Pham, Greenberg Traurig LLP
Patent
Portfolios that Attract Venture Capital Investment
Omar Amirana, MD, Oxford BioScience Partners
Conducting
an IP Audit & Monetizing Non-Core IP
Mildred A. Hastbacka, PhD, TIAX LLC
November 29th, 2007
FDA Update
Operations
Report: Center for Devices and Radiological Health
Dr. Dan Schultz, Director
Center for Devices and Radiological Health, FDA
October 19, 2007
Medical Devices in Europe-A Market Overview and More...
The
European Market for Medical Devices
N. Gerard Zapiain
International Trade Specialist, Medical Devices
U.S. Department of Commerce, Int'l Trade Administration
Critical
Elements of Doing Business in Europe: Pros & Cons of Setting Up a
Legal Entity & Tax and Financial Strategies
Richard Hughes, President, HealthLink Europe
EU - Regulatory
Update
Gregor Dzialas, Certification Officer
TUV Rheinland of North America
Risk
Management for Labeling in the European Market
Marc Miller, President
Crimson Life Sciences
September 12, 2007
Point of Care Diagnostics: Challenges and Opportunities
Point-of-Care
Diagnostics: The Role of Clinical Utility
by Matthew Gombrich, MD, MS-Director of Clinical Research, Inverness Medical
Market
Perspectives on the Point of Care Industry
by Bruce Cranna, Analyst-Leerink, Swann & Co.
Genetics
and Genomics in Clinical Medicine
by Raju Kucherlapati, PhD-Harvard Medical School, Partners Healthcare
June 22
Building Better MedTech Companies-A Seminar for Entrepreneurs
Presentations by:
Jason
Harry, Afferent Corp.
John J. Schwartz,
Member, Boston Harbor Angels
John Hession, Partner,
McDermott Will & Emery
Rachael Scherer,
Vice President, Emerging Technologies Marketing, Medtronic, Inc.
June 5, 2007
Optimizing Sales and Services for Competitive Advantage
IBM Presentations
May 18, 2007
Medical Device Clinical Trials: Emerging Trends, Current Best
Practices
Best
Practices in Medical Device Clinical Trials
Susan Rockwell, Manager, Clinical Trials and Clinical Development
Medical Device Consultants, Inc. (MDCI)
Clinical
Trial Contracting issues: Managing the Outsourced Relationship
Linda Bentley, Member
Mintz, Levin Cohn Ferris Glovsky and Popeo PC
Strategic
Approaches to Outsourcing to CRO
Kate Giovino, Director of Clinical Operations
Organogenesis, Inc.
Launching
Clinical Trials: Small Company vs. Large Company Environment
Laurie Ridener, Senior Director, Clinical and Regulatory Affairs
Pervasis Therapeutics, Inc.
Bioresearch
Monitoring in Medical Devices: An Update
Michael Marcarelli, PharmD, Director, Division of Bioresearch Monitoring
Office of Compliance, CDRH
April 10, 2007
Nonotech for MedTech: Nanotechology's Impact on Medical Device
Innovation
Overview of Nanotechnology and Medical Devices
David Dykeman, Patent
Attorney, Greenberg Traurig, LLP
Chinh
Pham, Greenberg Traurig, LLP
Nano
& MedTech Research at UMass, Lowell
Stephen P. McCarthy, PhD, Director, Center for Biodegradable Polymer Research,
University of Massachusetts, Lowell
The Investment
Climate for Nano-MedTech Ventures
Omar Amirana, MD Investment Manager, Oxford Bioscience Partners
Deploying
Nanotech-A MedTech Company Case Study
Ed Ahn, Angstrom Medica
February 27, 2007
Collaboration for Innovation Models for MedTech Product Develpment
Samuel
Prabhakar, Director, New Business Development, IBM Technology Collaboration
Solutions
Collaborative Innovation Business Model for Medical Device Development
Scott
Nintzel, Director, Instrument Center of Excellence, Medtronic, Inc.
Case Study: How Collaboration for Innovation Works for MedTech
Michael
Davies, Chairman, Endeavour Partners, Senior Lecturer, MIT, Sloan School
of ManagementCase Study: Co-Creation Strategies at Nokia and Elsewhere
December 1, 2006
FDA Update-Current Trends in Postmarket Surveillance
Susan
Gardner, Ph.D., Director, Office of Surveillance and Biometrics Center
for Devices and Radiological Health- U.S. Food and Drug Administration
Mutahar
Shamsi, Director of Compliance- U.S. Food and Drug Administration
William
Boivin, Supervisory Consumer Safety Officer, Medical Devices New England
District Office, U.S. Food and Drug Administration
Sheila
Hemeon-Heyer, JD, RAC, Vice President, Global Regulatory Affairs- Boston
Scientific Corporation
October 12, 2006
Business Development in the Device Industry: Companies' Strategies
for Gaining Market Share, Expanding R&D Potential
Getting
Acquired-Strategies for Small Companies
Doug Adams, President & CEO, Solx, Inc.
September 19, 2006
Employment and Demographic Trends in the MedTech Industry
2006
Medical Devices Compensation Survey: Analysis and Results
David Weaver, The Survey Group
Benefits
Strategies in the MedTech Industry
Louisa Bolick, William Gallagher Associates
Finding
Talent: New Initiatives for Sourcing, Vetting and Hiring Employees
Ari Gordon, Tyco Healthcare, Inc.
Establishing
the Employment Relationship: A Legal Perspective on Important Do's and
Don'ts
Robert Shea, Morse, Barnes-Brown & Pendleton, P.C.
May 2, 2006
10th Annual Conference
Larry
Kessler, Sc.D.
Director, Office of Science and Engineering Laboratories
Center for Devices and Radiological Health, FDA
April 20, 2006
Evidence-Based Medicine Practical Application to Drive Reimbursement
Naomi
Aronson, Executive Director, Blue Cross/Blue Shield Association Technology
Evaluation Center
Brian
Carey, Foley Hoag LLP
Erica Bisguier, Director,
Boston Healthcare Associates
March 28, 2006
Combination Products: Who Regulates Them, What are the Market
Opportunities, and are They Worth It?
Mark
Heller, Partner and Chair of FDA Department
WilmerHale
Understanding the Evolving R&D, Regulatory,
and Sales Environment for Combination Products.
Janice
Hogan, Partner, Hogan & Hartson
Philip
Levin, President and CEO, Averion, Inc.
Pamela
Weagraff, Principal, Quintiles Consulting
Building a Company Around a Combination Product:
One start-up Story.
S. Eric
Ryan, MD, Chairman and CEO, CorNova, Inc.
March 9, 2006
From the Lab to the Living Room-Deploying New Technologies for
the Growing Home Healthcare Market
Rob Scheschareg,
President, Intuitive Care Advisors
Tomorrow's Home Environment: Evolving Product Design &
Technology Platforms
John Collins, Ph.D.,
President, TIAX LLC
Richard Lobovsky, Director,
Health Business Development, QUALCOMM
New Business Models: Reimbursement Strategies for an Emerging
Market
Erica Bisguier, Director,
Reimbursement Consulting, Boston Healthcare Associates, Inc.
Joseph
Kvedar, MD, Director, Partners Telemedicine
Risk Management: Legal and Liability Issues
with Home Healthcare Products
Ray
Zemlin, Partner, Goodwin Procter LLP
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