2010 Florida Medical Device Symposium

April 12 & 13, 2010
Tampa, Florida

Agenda At-A-Glance

Speaker Highlights

Thank you to our 2010 Florida Medical Device Symposium Sponsors!

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Agenda At-A-Glance

April 12, 2010

• Law Firm Perspective, the Medical Device Industry
  • Bob Dormer, Hyman, Phelps & McNamara, P.C.  
• FDA Topics Open Forum
• Paula Wilkerson, Intertek
• Clinical Investigator - Disqualification/Disbarment
  • Brian Donato, Hyman, Phelps & McNamara, P.C.
• FDA Topics Open Forum
• Networking Reception

April 13, 2010

• Networking Breakfast
• Risk Management
  • Paul D. Evers, Underwriters Laboratories Inc.
• Washington Review
  • Thomas Novelli, Medical Device Manufacturers Association (MDMA)
• Trends In Medical Device Outsourcing
  • Moderator: Chris Delporte, Medical Product Outsourcing (MPO)
  • Gaet Tyranski, Jabil, Inc
• Networking Lunch
• Supplier Audits Panel
• Moderator: Rick Davis, RCA, Inc.
• Lilian Eshem, Bovie Medical
• Eric Peterson, ConMed Linvatec
• Joan Rubendall, ASO LLC
• State Regulatory Issues Panel
• Moderator: John Ray, John Ray Consulting, LLC
• Dr. Rick Hunter, FTSI
• Shannon Hartsfield Salimone, Holland & Knight

Speaker Highlights

Chris Delporte of Medical Product Outsourcing (MPO) will lead a discussion panel on recent trends in medical device product outsourcing. An award-winning journalist, Christopher Delporte has 14 years of reporting and journalism experience, with 10 years in the healthcare and medical technology sectors. In July 2006, he was named group editor for Medical Product Outsourcing and Orthopedic Design & Technology magazines published by Rodman Publishing in Ramsey, NJ.  Prior to heading the editorial departments for MPO and ODT, Delporte was director of communications and member relations for the Medical Device Manufacturers Association (MDMA), a Washington, DC-based industry trade and advocacy group. Before leading MDMA’s communications activities, he served as Washington Editor for Medical Device Daily by Thomson/BioWorld, where he covered Capitol Hill and a variety of legislative, regulatory and general healthcare issues impacting the medical technology sector.

Brian Donato
Director
Hyman, Phelps & McNamara, P.C.

Before joining Hyman, Phelps & McNamara in 1991, Mr. Donato practiced law in firms he founded in Virginia and in Florida. He is the recipient of an FDA Commissioner's Special Citation for his work in helping FDA communicate with members of the regulated industries. He is also the recipient of awards from FDLI, RAPS and The Orange County Regulatory Affairs Discussion Group. Mr. Donato has made numerous presentations to a variety of trade associations including the Drug Information Association, American Society of Quality Control, FDLI, RAPS and CTFA about various regulatory issues affecting their membership. His practice includes providing information about various legal issues related to the Federal Food Drug and Cosmetic Act and FDA's regulations and similar laws and regulations of the State of California.

Bob Dormer
Director
Hyman, Phelps & McNamara, P.C.

Mr. Dormer is one of three founding members of the firm. Before entering private practice, Mr. Dormer was Associate Chief Counsel for Enforcement and Associate Chief Counsel for Radiological Health at the U.S. Food and Drug Administration. He served at the FDA from 1976 to 1979. Prior to joining FDA, Mr. Dormer served as an attorney for the White House Special Action Office for Drug Abuse Prevention and the National Institute of Drug Abuse.

Lilian Eshem
Plant Manager
Bovie Medical

Lilian Eshem is the Plant Manager at Bovie Medical. Ms. Eshem has been with the company for approximately 14 years. Bovie Medical is a Medical Device Manufacturer specializing in Electrosurgical generators and hand held, disposable cautery devices, among other items. Ms. Eshem’s responsibility for Supplier Audits ranges from my active participation as an auditee (FDA, ISO, JGMP, FL DOH and various Customers) as well occasionally performing supplier audits (domestically as well as overseas).  Ms. Eshem graduated from Marshall University in Huntington, WV with a B.S. Degree in Applied Mathematics. She worked in the Pharmaceutical industry for approximately 10 years.

Paul D. Evers
Staff Engineer – Medical Business Unit
Underwriters Laboratories Inc

Paul D. Evers is a Staff Engineer for the Health Sciences Business Unit. He has worked for UL for a total of 20 years and served in many different positions at the company. Paul presently works in the Health Sciences Business Unit performing product evaluations, reviewing the work of other project handlers, and teaching courses at private and public seminars. Paul will be discussing Risk Management during the second day of the program. 

Richard G. Hunter, Ph.D.
President and CEO
FTSI

Dr. Rick Hunter was named President and CEO of FTSI in September, 2001.  The Company is a contract sterilizer of food, medical products and consumer goods and operates a gamma irradiator in Polk County, FL.  FTSI is listed on the NASDAQ exchange (symbol VIFL) and is certified to ISO 13485 standards and FDA registered.  Prior to joining FTSI, Dr. Hunter served as Florida’s Deputy State Health Officer where he was responsible for overall direction of about 11,000 employees.Dr. Hunter has received several awards for his professional work and has served on numerous local, state and federal government advisory boards. 

Thomas Novelli
Director of Federal Affairs
Medical Device Manufacturers Association (MDMA)

Thomas Novelli is Director of Federal Affairs for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents nearly 200 research-driven medical technology companies. Thomas joined MDMA after working on the Committee on Finance for former Chairman and current Ranking Member, Senator Charles Grassley, for nearly four years. Thomas will present an extensive update of the expectations of the United States Congress as well as the national issues facing our industry. 

Eric Peterson

Quality Engineering Manager

ConMed Linvatec

Eric Peterson is the Quality Engineering Manager, CQE and CQA leading the supplier quality group at ConMed Linvatec.  He brings nearly 20 years experience in manufacturing quality and product reliability of commercial fiber optic test equipment and aerospace electronics. A student of Greg Hobb’s methodologies, Eric has developed and led highly accelerated life testing and stress screening programs for switched power conversion products and fiber optic test instruments bringing leading edge devices to market with increased reliability; earning him the South Florida Manufacturers Association’s Recognition of Excellence award in 1996. His career has included the management of all quality system aspects involved in corporate moves, company acquisitions, and the implementations of enterprise systems such as Oracle and SAP.

John Ray
President
John Ray Consulting, LLC

John Ray of John Ray Consulting, LLC will lead a discussion panel on state regulatory issues.
John Ray is President of the Tallahassee-based consulting firm, John Ray Consulting, LLC, focusing on economic development strategies and government relations.  John possesses more than 17 years of experience in Florida economic development and public affairs, particularly in the Life Sciences. 
 

Joan Rubendall
Corporate VP, QA/RA
ASO LLC

Joan Rubendall is Corporate VP, QA/RA for ASO LLC and has over 18 years experience in medical device regulatory affairs and quality assurance management.  Joan works closely with emerging medical device manufacturers and suppliers to address FDA premarket requirements and ongoing quality assurance for the wide range of medical devices offered to ASO’s global customer base.  She holds a B.S. degree in Food Science from North Carolina State University in Raleigh, NC and is a certified auditor trained to conduct QSR, ISO, CMDCAS and MDD audits. Joan is a member of the American Society for Quality (ASQ) and the Regulatory Affairs Professionals Society.

Shannon Hartsfield Salimone
Partner
Holland & Knight

Shannon Hartsfield Salimone is a partner in the Tallahassee office of Holland & Knight and is the Regulatory and Litigation leader of the firm's national Healthcare & Life Sciences Team. She practices in the area of health law, advising clients on state and federal healthcare regulatory matters including corporate and regulatory compliance, data privacy, licensure, prescription drug distribution and pharmaceutical pedigree requirements and telemedicine.

Gaet Tyranski
 Director - Medical Business Unit
 Jabil, Inc.

Gaet Tyranski assumed his current post with St. Petersburg, Fla.-based Jabil (www.jabil.com) in early 2008 and is charged with leading the contract manufacturer’s entrance into the medical single-use device sector. He is responsible for setting strategy, establishing a global footprint for the business and ensuring that Jabil meets the highest medical standards.

 
Paula Wilkerson
Senior Staff Engineer
Intertek Testing Services 

Ms. Wilkerson has global regulatory experience in drug, medical device, biotechnology, and combination products.  She is a former FDA Career Officer having worked as a reviewer in the Center for Devices and as an Investigator credentialed in Ionizing Radiation emitting devices.  Paula is a Chemical Engineer and a graduate of the University of Washington.  She holds credentialization from the Regulatory Affairs Professional Society in US FDA regulations and is also a credentialed Clinical Research Associate with experience in the clinical trials of both devices and drugs.  She is currently a member of the Institutional Review Board for Santa Fe College in Gainesville, FL.

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