Senior Account Representative, Western Region, 3M
Quality Assurance Manager, A Plus International
Senior Program Manager, Supplier Quality, Abbott Diabetes Care
Senior Project Manager- R&D, Abbott Diagnostics
Associate Director, Marketing, Abbott Laboratories
Global Service and Support Engineer, Abbott Laboratories
Senior Software Quality Assurance Engineer, Abbott Laboratories
Director of Market Intelligence, Abbot Vascular
Manager of Market Intelligence, Abbott Vascular
Principal Market Research Analyst, Abbott Vascular
Quality Engineer, Abbott Vascular
Senior Market Research Analyst, Abbot Vascular
Director of West Coast Operations, Accessible Bath Technologies
Director of Quality Assurance, Acumed
Quality Manager, Acumed
Regulatory Supervisor, Acumed
Senior Marketing Manager, Advanced Biologics
VP Sales & Marketing, Advanced Biologics
Senior Project Manager, Advanced Bionics
Chairman & Chief Executive Officer, Aethlon Medical
Chief Financial Officer, Aethlon Medical
Chief Science Officer, Aethlon Medical
Senior Scientist, Aethlon Medical
Vice President of Operations, Alere Health
Regulatory Manager, Alere San Diego
Regulatory Specialist, Alere San Diego
Regulatory Specialist, Alere San Diego
Senior Director, Global Home Monitoring, Alere San Diego
Senior Regulatory Specialist, Alere San Diego
Director, Allergan
Director, Device and Package Engineering, Allergan
Scientist, Allergan
Scientist, Allergan
Senior Scientist, Allergan
Director, Amgen
Director, Amgen
Manager, Anchen Pharmaceuticals
Senior Engineer, Anchen Pharmaceuticals
Marketing Associate, Aplicare
Director, Apnea Sciences Corporation
President/CEO, Apnea Sciences Corporation
Vice President of Finance and Administration, Apollo Endosurgery
President, Atmos
QA Sterilization/Micro Specialist, B. Braun
Chief Technology Officer, Bausch & Lomb
Depury Director, QA Biotech Development, Bayer
Staff Scientist, BD
Quality Assessment Specialist, Beckman-Coulter
CEO, Bio Research Funding Group
Director of Research, Bio Research Funding Group
CEO, BioElectric Research Corporation
Project Manager, BioElectric Research Corporation
Education Specialists II, BioTronik
Project Manager, Boston Scientific
Senior Engineer, Boston Scientific
Senior Engineer, Boston Scientific
Complaint Analyst, Cardiac Science Corporation
Vice President of Program Management, CareFusion
Assistant General Counsel- Litigation, CareFusion
Director of User Centered Design, CareFusion
Manager, CareFusion
Principal Software Quality Engineer, CareFusion
Principle Engineer, CareFusion
Senior Supplier Quality Engineer, CareFusion
Software Quality Engineer, CareFusion
Assistant General Counsel- Litigation, CareFusion
R&D Manager, Caymus Medical
COO, CenterVue
Director of Technology Transfer, Children's Hospital of Los Angeles
Innovation Project Manager, Children's Hospital of Los Angeles
Senior Engineer, City of Moreno Valley
Director, Cognition Corporation
Vice President of Customer Success, Cognition Corporation
Senior Manager, Portfolio & Strategy, Coloplast
Sales Representative, Cordis Corporation
Director of Global Marketing: BioSurgery, Covidien
Senior Research Scientist, Covidien
Staff Development Engineer, Covidien
Vice President of Global Operational Excellence, Covidien
Consultant, CTK Biotech
Product Manager, CTK Biotech
Quality Control, CTK Biotech
R&D Manager, CTK Biotech
Export Import Manager, Designed Mobility
Managing Director, Designed Mobility
CEO, Device Technologies of Australia
VP International Business Development, Device Technologies of Australia
President, Devine Guidance
Principal, Domain Associates
Program Manager, DTx
Representative, DTx
Director, EC Innovations, Inc
Director of Engineering and Technology, Electrochem
Director of Marketing, Electrochem
Engineering Manager, Electrochem
Strategic Accounts Manager, Electrochem
Clinical and Regulatory Affairs Specialist, EMD Millipore Corporation
Regulatory Affairs Specialist, EMD Millipore Corporation
CEO, Enano Health
Chief Scientist, Enano Health
President, Endo-Lamina
President, Epic Research and Diagnostics
Manager, Exel International
CEO, FAST Diagnostics 
Investigator, FDA
Investigator, FDA
Business Development, Finix Industrial
Partner, Finnegan
Partner, Finnegan
Quality Manager, Fisher & Paykel Healthcare
Account Executive, Flexiciser
Information Technology, Flexiciser
Product Manager, Flexiciser
Director of Business Development, Flexiciser
Director of Business Development, Flextronics
Quality Assurance Specialist, Audits, Gen-Probe
Research Associate, Gen-Probe
Vice President, PMO, Gen-Probe
Research Associate, Gen-Probe
Director, Giant Medical
Marketing Director, Global Healthcare
Business Development Manager, GlobalR/Arazy Group
Member, Handistander Products
Catheter Design Engineer, Hansen Medical
Control Systems Engineer, Hansen Medical
Senior Controls Engineer, Hansen Medical
Director, Healthline Medical, Inc.
President, HirLan Consulting
Principal and Director of Creative Services/ Account Management, HirLan Consulting
Senior Healthcare Director, HK America
Senior Verification Engineer, Hospira
Principal, I.D.E.A.S.
Consultant, ICAP Ocean Tomo
Vice President of Engineering, ImThera Medical
Independent Sales Specialist, Independent Medical Device Sales
Independent Sales Specialist, Independent Medical Device Sales
CEO, Infinite Medical Technologies
Senior Associate, Infinite Medical Technologies
CEO, Innometrix
Chief Scientific Officer, Innometrix
Platform Architect, Medical Segment, Embedded & Communications Group, Intel Corporation

Senior Project Manager, Intuitive Surgical
Compliance Leader, Invitrogen
Student, Iowa State University
Business Development Manager, ISIS
CEO and Founder, ISIS
Director, Client Services, ISIS
Group Leader, Johnson and Johnson
Scientist, Johnson and Johnson
President, Juno
Sales Manager, Juno
Quality and Regulatory Manager, Kaz
Senior Research Scientist, Kimberly Clark
CEO, Kinamed Inc
President and CEO, Life Connect Advantage
Business Development, Liftwave
Senior Operations Consultant, Lombard Medical
Account Executive, Lycron
Founder and Chief Scientific Officer, Lychron
Senior Direct of Business Development, Lychron
CEO, Matryx Group
Principle Engineer, Medical Device Safety Institute
Independent Representative, Medical Devices Sales and Business Representative
Business Development Manager, Medical Devices Consultants
Program Project Analyst, Medtronic
Business Development Manager, Medtronic
Field Clinical Engineer, Medtronic
Senior Design Assurance Engineer, Medtronic
Senior Program Manager and Master Black Belt, Medtronic
Vice President of Language Solutions, Merrill Brink Translations
Regulatory Affairs and Compliance Officer, MicroAire Surgical Instruments
Account Executive, Minnetronic
Account Manager, MKS
Application Engineer, MKS
Product Manager, MKS
Regional Director of Sales, MKS
Strategic Accounts Manager, MKS
Strategic Solutions Manager, MKS
Business Manager, Modulated Imaging Inc
Chief Engineer, Modulated Imaging Inc
CTO/Acting CEO, Modulated Imaging Inc
Director of Research, Modulated Imaging Inc
Executive, Myco Industries
CEO, Naviscan
Vice President of Business Development, NivaSonix
Hospital Account Manager, Nonin Medical
Chief Financial Officer, Obstetrics Solutions and Interventions
CEO, OCT Imaging
Engineer, OCT Imaging
Engineer, OCT Imaging
CEO, Ocutronics
Managing Manager, Omniport
Principal Software Quality Engineer, Omnyx
Client Relationship Manager, ORC International
Vice President, ORC International
CEO, OsteoInductive Technologies
Owner, Peace of Mind Alerts
Representative, Pedal Computer Mouse
Partner, Intellectual Property Group, Pillsbury Winthrop Shaw and Pittman
Senior Associate, Pillsbury, Winthrop, Shaw and Pittman
Director of Marketing, Pillsbury, Winthrop, Shaw and Pittman
Director of Marketing, Posey Company
Vice President, Sales and Marketing, Posey Company
CEO, Presbia
Vice President, Presbia
Regional Sales Manager, Prexion
Representative, Priamus System Technologies
Sales Consultant, Priamus System Technologies
CEO, Principio Technologies
Vice President of R&D, Procept Corporation
Principal, Process Control Services
CEO, PTM Consulting
Chief Medical Officer, Pulsecor
Director of Product Development, Pure Biosciences
Director of Regulatory Affairs and Microbiology, Pure Biosciences
Executive Vice President, Pure Biosciences
Manager of R&D, Pure Biosciences
Vice President of Operations, Pure Biosciences
Regional Sales Manager, QNX Software Systems
Senior Applications Engineer, QNX Software Systems
Scientist, Quidel Corporation
Senior Process Engineer, Quidel Corporation
Senior Process Engineer, Quidel Corporation
Chairman, RJG Inc
Consultant and Trainer, RJG Inc
Regional Sales Manager, RJG Inc
Vice President of Medical and Clinical Affairs, RS Medical
Research Scientist, Scripps Research Institute
Senior Consultant, SDLC Partners
Senior Manager of Manufacturing, Second Sight Medical Products
Healthcare Sales Manager, North America, SGS
Medical Auditor and Specialist/Sales Manager, SGS
Clinical Supply Manager, Shire Pharmaceuticals
Senior Human Factors Engineer, Sonosite
Associate General Counsel, Sonova
Staff Engineer, Sony
President, SoundElkin
Clinical Systems Engineer, St. Jude
Senior Design Engineer, St. Jude
Senior Manager Corporate Quality Audit, St. Jude
Senior Vice President of Global Quality, St. Jude
Senior Vice President of Regulatory and Quality Affairs, St. Jude
Quality Assurance Manager, Steril-Aire
Supplier Development Manager, Stryker
Supplier Development Manager, Stryker
Business Analyst, Sxminc
Co-Founder, Chair and CSO, Syncardia Systems
Vice President of Product Development, Syncroness
Marketing Manager, Tactician Corporation
President, Tactician Corporation
Engineer, Tandem Diabetes
Vice President of Quality Services and Regulatory Affairs, Teleflex
Senior VP of Product Development, Tengion
Vice President of Sales, Teleflex
Director of Supply Chain, Thoratec
Sales, Transitions Representative
Vice President of Sales, Triple Ring Technologies
Founder and CEO, TrueAngular
Product Manager, Ulthera
Senior Account Executive, Underwriters Laboratories
Senior Staff Engineer and Regional Lead Reviewer, Underwriters Laboratories
Student, University of California
Student, University of California Riverside
Technology Transfer Office, University of California- Irvine
Graduate Student of Biomedical Engineering, University of Southern California
Licensing Officer, University of California-San Diego
Vice President, Regulatory and Quality Assurance, U-Systems, Inc
COO, VirtuOx
CEO, Vital Fusion
Director of Catheter Engineering, Volcano Corporation
Director of Financial Planning and Analysis, Volcano Corporation
Account Manager, Wind River
Director of Global Marketing, Wind River
Director, Vertical Markets- Medical Devices, Wind River
Senior Vertical Solution Marketing Manager, Wind River
Solutions Architect, Wind River
Brand Manager, Zimmer Dental
Brand Manager, Zimmer Dental
Director of Marketing, Zimmer Dental

• Defining Risk by it's location in the total product lifecycle; where does risk exist?
• For every action there is an equal and opposite reaction; for each of these risks - what is the corrective action and the residual risk or return?
• Who is ultimately responsible for your product's overall risk strategy? How can departments cross coordinate their strategiesand establish complete traceability of risk through product design?

Jennifer Heraty, Senior Principal Quality Engineer, CareFusion
Daniel Gutherie, Director of Global Marketung: BioSurgery, Coviden
Ryan Lloyd, Customer Requirements Manager, MKS

• Learn to develop an effective Quality Systems Matrix to enable more comprehensive plan which will enable you to ensure compliance across borders
• Unpack such importance documents as 21 CFR 820, the Medical Device Directive, and ISO 13485
• Compare different QMS objectives; what is your goal? Reduced variation? Meeting regulatory requirements? Customer satisfaction? Maximize your ability to meet your goals, and learn how to develop a QMS system to efficiently meet them
• Identify effective metrics for monitoring a Quality Management System
• Understand the need and importance of maintaining Technical Files and Design Dossiers as "Living Documents" within a compliance quality management system
• Understand the importance and role of ISO 14971 within a quality management system in order to demonstrate compliance against global regulatory requirements
• Understanding the importance and methods of demonstrating central control and management of outsourced manufacturing, design, development or other critical process controls

Dr. Christopher J. Devine, President, Devine Guidance
Former Senior Manager of Corporate Quality Assurance, Boston Scientific
Pete Gonzalez, MBA, RAC, Medical Auditor & Specialist / Sales Manager, SGS

• If one is to fully allow the integration of a proactive problem prevention technique in an organization's culture for maximum efficiency of developing high performing products in a consistent method, one solution is a technological advanced software package which incorporates all aspects of product development into one database
• Software packages which operate in silos are opportunities for errors due to inefficiencies which could lead to FDA findings. One way to resolve this is to leverage a software package where cross-functional product development teams can collaborate in one database. This will improve efficiency and reduce the chances of errors potentially leading to FDA findings

Nathan G. Piland, Senior Design Assurance Engineer, Medtronic Endovascular Innovations

• When designing and implementing medical devices today, developers are faced with many challenges. 
• In addition to quality, reliability and efficacy of the product, connectivity and security must also be factored in, which adds to the design complexity.
• Virtualization and multi-core implementations offer an approach to help address these challenges and ease design complexity.  They allow the modality to run on one processor core while connectivity and security applications to run on another processor core.  This solves many design challenges and allows developers to concentrate on their area of expertise. 
• This session will discuss the tradeoffs of this approach.

Michael Preston Taborn, Platform Architect, Medical Segment, Embedded & Communications Group, Intel Corporation

• The evolving connected medical device landscape
• Separating applications from system software
• Understanding and leveraging embedded virtualization for different use cases
• Increasing performance while lowering power and cost with multi-core technologies

• Understand both sides of an investment relationship by investigating both sides of the coin: Investors and Start-Up Companies
• How do investors perform their due diligence? What are the factors and considerations in making an investment decision?
• Debate the efficacy and benefits of early stage versus late stage investing and the different types of analysis associated with either option
• Survive the rigors of investor searching; maximize your efforts to find money, educate and complete your due diligence- all while running your business
• Making your company attractive for acquisition/investment from an IT perspective

Dinesh N. Melwani, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Leslie I. Bookoff, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Nimesh Shah, Principal, Domain Associates
Jim Joyce, Chairman & Chief Executive Officer, Aethlon Medical

• Overview of key healthcare market drivers including infection control, autoclaving, wireless charging, continuity of care with portable devices & patient compliancy monitoring
• Advantages of using lithium ion chemistries and other emerging technologies and their future directions
• Asking the right questions to drive optimal product design, performance and cost effectiveness
• Delve deeper into these ideas at Electrochem's workshop this afternoon!

George Cintra, Director of Engineering & Technology, Electrochem Solutions

• Know when it is appropriate, (read- necessary!) to submit updates to the FDA
• Computerized System Life Cycle (SLC) Process; Risk Management from Controls to Review

Brad Ryba, Senior Consultant, SDLC Partners
Yuliya Kasminskiy, Senior Software Quality Assurance Engineer, Abbott Laboratories

• Choose 2 half hour long workshops to attend, and join other industry leaders as they host in-depth discussions on a variety of topics.
• To inquire about participating as a speaker please contact Kira O'Brien for more information at KOBrien@opalevents.org (Only 6 1 tables available for sponsorship!)

Use Web 2.0 templates to guide your team through:

• Hazard Analysis, FMEA, and Fault Tree Analaysis
• Requirements Flowdown and V&V
• Safety Assurance Case Studies

When combined together online by your development teams, these three critical aspects of design will have you sailing through 510k submissions!

With: Eric Charles Maass, Senior Program Manager and Master Black Belt, Medtronic

This workshop will focus on case studies of our customers and how they achieve a high degree of lifecycle traceability in their risk management process. We'll also demonstrate how they've been able to reduce the amount of manual effort in performing risk management activities

• Risk Management Compliance per ISO 14971 and IEC 62304
• Establish lifecycle traceability from Hazards through to product design
• Analyze coverage of risks to ensure adequate V&V
• Automate risk reporting to streamline the production of FDA and CE traceability and risk reports

With: Ryan Lloyd, Customer Requirements Manager, MKS

Dr. James Swick, Founder and Chief Scientific Officer, LyChron

Session A (4:15-4:45)
Navigating the Human Factors/Usability 510(k) Requirements

• What are the requirements?
• What is the difference between evaluation and validation?
• When is the optimal time to address the requirements?
• How are the requirements met?

Session B (4:45-5:15)
Managing Innovation and meeting the 510(k) Human Factors/Usability Requirements

• Managing Innovation
• User Centric Design and Evaluation
• Integration of Innovation and User Centric Design and Evaluation

Dr. Virginia Lang, Principal and Founder, HirLan

• Use this more intimate forum to continue your discussion, and focus more deeply on the idea of asking the right questions to drive optimal product design, performance and cost effectiveness
• Ask specific questions targeted to your specific needs- and get the answers you've been looking for!

George Cintra, Director of Engineering & Technology, Electrochem Solutions

Matt Klassen, Strategic Solutions Manager, MKS

• Hear from professionals at each step of the Total Product Life Cycle about how they identify risk; from product development, to quality, to marketing
• Get a broad range of perspectives from the panel; from product development, to quality, to human factors, to marketing
• Incorporate a sales and marketing perspective into your product life- from concept to customer application
• Participate in dialogue to build best practices that you will be able to take back to your organization

Devin Hughes, Senior Healthcare Director, NK America
John Sheets, Chief Technology Officer, Bausch & Lomb
Jason Fouts, Senior Human Factors Engineer, Sonosite
Georgette Belair, Global Platform Leader - International Infusion Products, CareFusion

• Cardiovascular disease is the leading cause of death in the U.S. Why and how has this spawned numerous medical device therapeutic strategies, companies and products?
• Understanding basic mechanisms of disease, therapeutics, and technology will ultimately reduce risk. Understanding timing/costs of development, regulatory and reimbursement approval are key to a successful business strategy
• How important are regulatory and reimbursement strategies? When should these enter the equation
• How should you bring forward platform technology? Do you cross-over to non-medical applications? How does this alter business strategeis?
• Mathematical modeling and in silico strategies- a new approach to reduce development time cost and risk.
• The role of the market and understanding of its complexities - vital to an effective business strategy. Should a "low-hanging fruit" market opportunity trump a higher return complex opportunity or vice versa? Can one be too far ahead? What are the consequences?

Dr. Marvin Slepian, Co-Founder and Chairman, SynCardia

Join this industry panel for a discussion of issues faced by medical device manufacturers. During this session we will explore:

• The supplier management environment of the global medical devices market and how it has changed over the past 5 years
• Regulatory expectations for supplier quality management programs
• Risk assessment and mitigation approaches
• Supplier monitoring, supplier report cards and web based supplier assessment and metrics
• Supplier Management Data Systems and administration

Eugene Hutchison, Senior Program Manager, Supplier Quality Management, Abbott Diabetes Care
Deborah Madsen, Senior Staff Engineer and Regional Lead Reviewer, Underwriter Laboratories

• Hear how by starting with the fundamentals of good part and tool design, and continuing with robust processes based on Scientific Molding principles that streamline process validation- injection molded parts can help device manufacturers deliver absolute quality at a reduced price
• Gain insight with case studies from a leading device manufacturer to show how you can make these strategies work for you

Bob Reese, South Central Sales Manager, RJG Inc

• Positioning for reimbursement and payment with good data and evidence based decision making
• The impact of the Affordable Care Legislation on Medical Devices and how to best operate within this new legislative framework
• Optimizing scientific and intellectual property opportunities with health information technology and comparative effectiveness research

Dennis A. Robbins, Ph.D., M.P.H.  Board Member, National Research Network
Richard Zaitlen, Partner, Intellectual Property Group, Pillsbury Winthrop Shaw Pittman LLP

• Gain awareness of harmonization issues early in your product development process to avoid issues downstream
• Unpack ISO 13485 in a US context- rather than doubling your efforts, how can you maximize your compliance to ISO 13485 and US QS Reg simultaneously

Lisa Scott, Vice President of Regulatory Affairs and Quality Assurance, U-Systems
Sam Mostafavi, Principal, Process Control Services And Former Vice President of Quality, Sonitus

• Learn about the Chinese Medical Device Market: history; current market; future projections; SFDA approval process and more!
• Hear about new and exciting opportunities for Medical Device Manufacturers
• Gain vital insights into the Pitfalls and Pathways to Success

John Choate, CEO, MYCO Industries