IMDMC Past Events

The IMDMC is dedicated to providing quality education opportunities for the Indiana medical device community. Below please find a listing of events held over the past few years.

2009	Program Type/Title	Speakers
January 29, 2009	Off-Label Use of Medical Devices	Doug King, Wooden & McLaughlin Jamie Young, Wooden & McLaughlin
February 4, 2009	AdvaMed Code of Conduct	Andy Van Haute, AdvaMed Ralph Hall, Baker& Daniels
March 25, 2009	Preemption & Other Hot Litigation Topics	Tom Shea, Barnes & Thornburg
April 22, 2009	Stimulus Bill's Impacts on Privacy and Security	Joan Antokol, Baker & Daniels
May 12, 2009	IMDMC's FDA Regulatory 101 Course	Ralph Hall, Baker & Daniels Rickie Kohne, Zimmer Colleen Hittle, Anson Group Suzanne O’Shea, Baker & Daniels Dale Miller, Zimmer Susan Reardon, Johnson & Johnson David Chadwick, Cook Medical Jeff Boone, Roche Diagnostics Danelle Miller, Roche Diagnostics
October 22, 2009	Annual Conference
November 2009	Reimbursement 101 / Cancelled

2008	Program Type/Title	Speakers
January 24, 2008	Human Factors Engineering	John Gosbee
February 27, 2008	Combination Products Roundtable	Suzanne O'Shea, Baker & Daniels
March 31, 2008	Perspectives on Regulated Software	Scott Thiel, Roche Diagnostics Joseph Katuin, Cicero Bioinstrumentation
May 22, 2008	Device Reimbursement: Planning for Value Based Payment	Edward J. Dougherty Kathleen A. Claessens Suzanne M. O'Shea Elizabeth Woody
Fall	FDA Clinical Trials	FDA Officials
October 2008	Annual Conference


2007	Program Type/Title	Speakers
February 28, 2007	Potential False Claims Act Exposure	Jim Utterback, Bose McKinney & Evans Dwight Miller, Hill-Rom
March 22, 2007	GAMP from a User’s Perspective	Rick Gunyon, Eli Lilly and Company Bob Banta, Eli Lilly and Company
April 24, 2007	Supplier Management	Frank Chapman, Product Action
May 30, 2007	Legal Issues Surrounding Grants & Contributions	Mike Bigelow, Eli Lilly Danelle Miller, Roche Diagnostics
June 27, 2007	Privacy & Security Issues Affecting Medical Device Companies	Joan Antokol, Baker & Daniels
August 22, 2007	IMDMC Recall Roundtable	Joann Givens, Director, Regional Office, FDA Sandra Williams, FDA Debbie Reece, Maetrics
October 17, 2007	Annual Conference

2006	Program Type/Title	Speakers
Feb. 1, 2006	Product & Clinical Trial Claims	Jill Wadlund, Chubb
Feb. 28, 2006	A Conversation with Thomas Gunderson	Thomas Gunderson
April 19, 2006	Recall Management	Mark Vare, Willie Bryant Jr., Stericycle Ralph Hall, Baker & Daniels
Sept. 26, 2006	Current CAPA Issues	Michael Southworth, Southworth & Associates Priscilla Hamill, Eli Lilly & Company
October 12, 2006	Annual Conference
November 15, 2006	Managing Records & Information in Gov’t Investigations and Litigation	JP Hanlon, Baker & Daniels

2005	Program Type/Title	Speakers
March 31, 2005	Understanding & Impacting What’s Going on In DC	Tom Connaughton, Cook Inc.
May 4, 2005	ISO 13485-A Facilitated Discussion on Transforming from a Process to a Procedural based Quality Management System	Larry Mager, Boston Scientific Mark Marley, Eli Lilly & Company
June 16, 2005	Clinical Trials	Dennis King, Statking Consulting
October 5, 2005	IMDMC Annual Compliance Conference	Featuring Joann Givens, Director, Regional Office, FDA

2004	Program Type/Title	Speakers
Jan. 27, 2004	Lunch-n-Learn How to Navigate the Medicare Coverage Process	Bradley Thompson, Baker & Daniels Ted Mannen, Aventor
February 17, 2004	Lunch-n-Learn Technology Transfer	Mark Long, Emerging Technology Center, IU Teri Willey, ARCH Development Partners
March 31, 2004	IMDMC University ISO 10993	Mike Hendershot, NAMS Jason Anderson, NAMSA
April 21, 2004	Roundtable China - Medical Device Market Opportunities and Regulatory Requirements	Mark Cisneros, LifePlus LLC Wei Zheng, LifePlus LLC Yongbiao Guan, Beijing Institute of Pharmacology & Toxicology
May 11, 2004	ISO 13485:2003 Training	BSI Management Program
July 15, 2004	Integrate your CAPA, DHR & Manufacturing Systems	Flexware Innovation
September 30, 2004	Plastics Failure Analysis & Prevention Workshop	Bodycote Materials Testing
October 26, 2004	IMDMC Annual Compliance Conference	Featuring Tim Ulatowski, Director, Office of Compliance, CDRH, FDA

2003	Program Type/Title	Speakers
Jan. 21, 2003	Lunch-n-Learn Data-mining & Modeling	Rob Damler, Milliman USA, Indianapolis
March 25, 2003	IMDMC University Part 11 Draft Guidance	Paul D'Eramo, Johnson & Johnson Keli Mcleod, DePuy Terry Spartz, Theoris, Inc. Bruce Klopfenstein, Theoris, Inc.
April 23, 2003	Lunch-n-Learn A Hospital CEO's Perspective	Vincent Caponi – St. Vincent’s Indpls., Tony Lennen – Major Hospital Shelbyville, Frank Byrne – Parkview Ft. Wayne
May 8, 2003	Reimbursement & Regulatory Roundtable Overview of Japanese Health Care System	Robert R. Fike, Ph.D., Aventor Regulatory Consultant
June 18, 2003	IMDMC University CAPA	Dennis Gwaltney, DePuy Kim Zinser, ProSource Consulting Jenny Kapper, Roche Diagnostics
July 15, 2003	Lunch-n-Learn A Payor's Perspective	Carolyn Cunningham, M.D., AdminaStar – Adrian Oleck, M.D., AdminaStar
August 14, 2003	Roundtable Accelerating Organizational Uptake: Driving Innovation in Clinical Trials	Doug Teany, Praxis Life Sciences, Boston Holly Smith, Praxis Life Sciences. Indianapolis
2002
1/9/02	Regulatory/Reimbursement Roundtable Medicare Reform and Restructuring	Tom Connaughton, AAHomecare
1/30/02	Lunch-n-Learn Bioterrorism and the Medical Device Industry	Sarah Archer & John Clark, Hudson Institute
2/26/02	Regulatory/Reimbursement Roundtable Medicare Reform and Restructuring	Congressman Steve Buyer
3/6/02	Lunch-n-Learn The 2002 Indiana Statehouse Update	Indiana State Senator Luke Kenley
3/26/02	Regulatory/Reimbursement Roundtable Dialogue with the New FDA District Diurector	Joann Givens, FDA District Director
4/16/02	Lunch-n-Learn Reimbursement 101--Just the Essentials	Carol Warnecke, Roche Diagnostics
5/9/02	Quality Systems ISO 13485 & ISO 17025	Christian Lupo & Win Wedeking, NSF-ISR, LTD
6/13/02	Lunch-n-Learn Encouraging the Entrepreneurial Spirit	Dr. Michael Goldsby, Ball State University
7/9/02	Lunch-n-Learn The Central Indiana Life Sciences Initiative	Indianapolis Mayor Bart Peterson
7/23/02	Regulatory Reimbursement Roundtable User Fees and Competitive Bidding	Shelagh Foster, AAHomecare Janet Trunzo, AdvaMed
9/10/02	Regulatory Reimbursement Roundtable Understanding & Working with HIPAA	Patrick Cross, Baker & Daniels Julie Cantor-Weinberg, Guidant Corp.
10/11/02	Annual Conference FDA/CMS Harmonization
10/30/02	Lunch-n-Learn Ways to Manage Innovation	Steve Ferguson, Cook Inc.