Director of Technical Operations, Abbott Labs
Human Factors Program Manager, Abbott Labs
Senior Quality Assurance Product Manager, Abbott Labs
Senior Quality Assurance Product Manager, Abbott Labs
Director of Quality and Manufacturing, AcelRX Pharmaceuticals
Director, Acumed
Regulatory Specialist, Acumed
Vice President, Adaptive Methods
Vice President of Research and Design, Adaptive Methods
Medical Device Testing Systems Sales Engineer, ADMET
Presidents, ADMET
Director, AgaMatrix
Director of Hardware Engineering, Agamatrix
Founder, AgaMatrix
CEO, Alandra Medical
Sales and Business Development Director, Alandra Medical
Senior Scientist, American Academy of Family Physicians
National Research Network
Mechanical Engineer, ANA Enterprises Inc.
CEO, ArcScan, Inc.
Manufacturing Engineer, Arteriocyte Medical
Quality Engineer, Arteriocyte Medical
Regulatory Manager, Arteriocyte Medical
Senior Manager Product Initiatives, Arteriocyte Medical
CEO, Artinis Medical Systems
Founder, CEO, AudioDontics
Marketing Manager, Stryrenics Division, BASF
Technical Development Engineer, BASF
Senior Manager, BASF
Head of Central Analytical Research, Global R&D, Baush & Lomb
Director, Global R&D, Baush & Lomb
Director, Baxter Healthcare
Engineering Specialist, Baxter Healthcare
Engineering Dept Head, TR, Baxter Healthcare
Engineering Specialist, Baxter Healthcare
Technology Integration Manager, Beckman Coulter
Regulatory Affairs and Compliance Director, Asia Pacific,
Becton Dickinson
CEO, BEO ITS inc
Faculty, School of Professional Studies, Berkeley College
Director, Beth Israel Deaconess Medical Center
Chief Executive Officer, BioMed CryoDevices
Analyst, Boston Scientific
Associate Medical Director, Global Medical Safety, Boston Scientific
Associate Medical Director, Global Medical Safety, Boston Scientific
Biocompatibility Specialist, Boston Scientific
Corporate Counsel, Boston Scientific
Corporate Counsel, Boston Scientific
Corporate Quality Assurance, Boston Scientific
Corporate SME Statistical Techniques, Boston Scientific
Director, Boston Scientific
Director and Corporate Counsel, Boston Scientific
Director of Corporate Toxicology and Biocompatibility Services,
Boston Scientific
Director of Global Quality Systems, Boston Scientific
Director of Quality Systems, Boston Scientific
Manager of Design Assurance, Boston Scientific
Manager, Global Shelf Life Quality, Boston Scientific
Medical Director, Global Medical Safety, Boston Scientific
Medical Director, Global Medical Safety, Boston Scientific
Manager Enterprise SQA, Boston Scientific
Principal SW Quality Engineer, Boston Scientific
Principal Financial Analyst, Boston Scientific
Principal Quality Engineer, Boston Scientific
Principal Statistician, Boston Scientific
Principal Supplier Quality Engineer, Boston Scientific
Principal Supplier Quality Engineer, Boston Scientific
Principal Supplier Quality Engineer, Boston Scientific
Principal Supplier Quality Engineer, Boston Scientific
Principal Supplier Quality Engineer, Boston Scientific
Principal Supplier Quality Engineer, Boston Scientific
Quality Assurance, Boston Scientific
Quality Director, Boston Scientific
Quality Engineer, Boston Scientific
Quality Engineer, Boston Scientific
Quality System Engineer, Boston Scientific
Quality System Engineer, Boston Scientific
Quality System Engineer, Boston Scientific
R&D Director, Boston Scientific, Boston Scientific
R&D Engineer, Boston Scientific
Regulatory Affairs Specialist, Boston Scientific
Senior Cash Specialist, Boston Scientific
Senior Engineer, Boston Scientific
Senior International Counsel, Boston Scientific
Senior Manager of Quality Systems, Boston Scientific
Senior Quality Engineer, Boston Scientific
Senior Quality Engineer, Boston Scientific
Quality Engineer - Risk Management Office, Boston Scientific
Senior Safety Analyst, Boston Scientific
Software Quality Engineer, Boston Scientific
Software Quality Engineer, Boston Scientific
Software Quality Engineer, Boston Scientific
Supplier Quality Engineer, Boston Scientific
Vice-President of Global Medical Safety, Boston Scientific
Engineering Graduate Student, Boston Univerisity
Anesthesiologist, Engineer, Brigham & Womens Hospital
Anesthesiologist, Engineer, Inventor, Brigham & Womens Hospital
Anesthesiologist, Inventor, Brigham & Womens Hospital
Anesthesiologist, Inventor, Brigham & Womens Hospital
Anesthesiologist, Medical Informaticist, Brigham & Womens Hospital
Biomedical Technician, Brigham & Womens Hospital
Chairman and CEO, BSP Biological Signal Processing Inc.
Vice President, Research, Cambridge Polymer Group
Director of Global Medical Devices Practice, Camstar Systems
Product Manager, Capsule Tech
Data Analyst, Caridian BCT
Marketing Coordinator, Carl Zeiss
Representative, Carl Zeiss
Strategic Accounts Manager, Carl Zeiss
Production Supervisor, CeQur
Associate Licensing Manager, Children's Hospital Boston
President (Portfolio Manager, Healthcare and Life Sciences), Chilton Capital Management
Director Operations, Clinical Instruments International, Inc.
General Manager, Clinical Instruments International, Inc.
President, Clinical Instruments International, Inc.
Vice President of Clinical and Regulatory Affairs, Clinquest
Partner & Director of Business Development, Code Refinery
Engineering Manager, Codman and Shurtleff
Application Engineer, Cognition Corporation
Customer Success, Cognition Corporation
Director of Business Development, Cognition Corporation
President, Cognition Corporation
Senior Engineer, Cognition Corporation
Technical Support, Cognition Corporation
Test Engineer, Cognition Corporation
VP Development, Cognition Corporation
Regulatory Affairs Director, ConMed Linvatec
Regulatory Affairs Manager, ConMed Linvatec
Regulatory Affairs Manager, ConMed Linvatec
President and CEO, Convergence Medical Devices
Vice President of Marketing and Business Development, Convergence Medical Devices
Category Manager, Covidien
Clinical Program Manager, Covidien
Clinical Research Associate, Covidien
Clinical Research Project Manager, Covidien
Clinical Research Project Manager, Covidien
Director Clinical Affairs, Covidien
Director Regulatory Affairs, Covidien
Global Operational Excellence Director, Covidien
Global OpEx Directo, Covidien
Global Senior. Director International Clinical Affairs, Covidien
Manager of Regulatory Affairs, Covidien
Manager of Regulatory Affairs, Covidien
Manager of Regulatory Affairs, Covidien
Program Manager, Covidien
Regulatory Affairs Associate, Covidien
Regulatory Affairs Specialist II, Covidien
Research and Development Project Lead, Covidien
Senior Associate of Regulatory Affairs, Covidien
Senior Manager Clinical Affairs, Covidien
Senior Software Engineer, Covidien
Strategic Marketing Manager, Covidien
Strategy & Portfolio Management, Covidien
Vice President of Quality Assurance, Regulatory Affairs, Covidien
Vice President of Operational Excellence, Covidien
Vice President Quality & Regulatory, Covidien
Vice President Regulatory Compliance, Covidien
Director, Critical Process Filtration, Incorporated
Engineer, Critical Process Filtration, Incorporated
Engineer, Critical Process Filtration, Incorporated
Business Development Manager, Crystal Global Information Technology
Vice President of Marketing and Business Development, CSA Medical
Director of Quality Assurance, Cytonome
Analyst, Field Assurance, Davol
Manager of Field Assurance, Davol
Senior Analyst, Field Assurance, Davol
Supervisor, Field Assurance, Davol
Representative, Davol
Vice President of Global Sales: Healthcare, DB Schenker
President, Device Design, Definitive Design Corporation
Sterilization Specialist, DePuy
Territory Business Manager, Dexcom
Administrative Assistant, Digital Prospectors Corp
Sales Representative, Digital Prospectors Corp
Associate Regulatory Affairs Manager, Draeger Medical
Director of Quality Assurance, Draeger Medical
Director of Regulatory Affairs, Draeger Medical
Program Manager Regulatory Affairs, Draeger Medical
Senior Staff Clinical Engineer, Draeger Medical
Test Engineer, Draeger Medical
Test Engineer, Draeger Medical
CEO, ECI Biotech
President, EDAC Medical, Inc.
Corporate Vice President, Quality, Edwards Lifesciences
Senior Director, HTV Quality and Product Development, Edwards Lifesciences
Mobility Consultant, Electric Mobility / Rascal Scooters
Accounts Manager, Electrochem Solutions
Strategic Accounts Manager, Electrochem Solutions
Strategic Accounts Manager, Electrochem Solutions
President, Electronic Control Concepts
Director, Global Regulatory Affairs, EMD Serono
Director, Global Regulatory Affairs, EMD Serono
Manager, Supply Chain, EMD Serono
Medical Director, EMD Serono
Medical Director, Neurology Medical Affairs, EMD Serono
Senior Director, Regulatory Affairs, EMD Serono
Senior Medical Director, Neurology, EMD Serono
Specialist, Global Regulatory Affairs, EMD Serono
Specialist, Global Regulatory Affairs, EMD Serono
CEO, Enano Health Limited
Chief Scientist, Enano Health Limited
Associate Director, Endo Pharmaceuticals
President, Endo-Lamina
Project Engineer, Enercon Technologies
Business Development, ErgoGenesis
Vice President, Ergonomic Products
Principal Scientist, Etex Corporation
Senior Director of R&D, Etex Corporation
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA

Supervisory Consumer Safety Officer, FDA
Supervisory Consumer Safety Officer, FDA
Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner
Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner
Research Scientist, Fraunhofer USA
Business Development Manager, Freescale Semiconductor
Manager, Quality and Regulatory Affairs, GE Healthcare
Associate Director of Regulatory Affairs, Genzyme
Central Files Librarian, Genzyme
Central Files Librarian, Genzyme
Principal Associate, Regulatory Affairs, Genzyme
Regulatory Affairs Manager, Genzyme
Senior Regulatory Affairs Specialist, Genzyme
Director - Business Operations, Geometric Americas Inc
Technical Consultant, Glemser Technologies
Senior Regulatory Advisor, Greenleaf Health
Senior Software Engineer, Haemonetics Corporation
VP, Customer Solutions Group, Haemonetics Corporation
Representative, Heidenhain
Director of Quality, Henke-Sass, Wolf
Enterprise Services, Hewlett Packard
Enterprise Services Manager, Hewlett Packard
Manager of Operations- Software Publishing Services, Hewlett Packard
Process Engineer, Hexagon Metrology
Press, HighTech Views
Press, HighTech Views
Product Manager, Hexagon Metrology
Product Manager-Vision Sytems, Hexagon Metrology
Executive Director of Electronics Platform, Hill-Rom
Director, Systems Engineering, Hill-Rom
Marketing Engineer, Hittite Microwave Corporation
Senior Design Engineer, Hittite Microwave Corporation
R&D Manager, Hologic
Associate, HRA Research
CEO, Hypo-Safe
Quality Assurance Manager, Hypo-Safe
Principal, I.D.E.A.S.
CEO, Image Engineering Laboratories
COO, Image Engineering Laboratories
Physician Liaison, Institute For Biomedical Innovation and Translation
Platform Architect, Medical Segment, Embedded & Communications Group, Intel Corporation
President, Iradimed Corporation
Technical Manager, Iskander Medical Group
Senior Project Manager, Johnson & Johnson
Clinical Systems Enginer, Kaiser Permanante
Partner, Kalypso
VP of Global Product Quality, Kaz, Inc
Founder, KeepSight
Director of Quality, KMC Systems
Marketing Manager, Surgical, Therapeutic and Diagnostic Imaging Instrumentation, KMC Systems
Program Manager, KMC Systems
Senior Manager, Marketing Communications, KMC Systems
Senior Principle Systems Engineer, KMC Systems
Senior Quality Engineer, KMC Systems
Senior, Principal Systems Engineer, KMC Systems
Systems Engineering Manager, KMC Systems
President, Labyrinth Devices
COO Medical Division, Levitronix
Director, Clinical Affairs, Levitronix
Quality System Manager, Levitronix
Specialist, Regulatory Affairs, Levitronix
Territory Sales Manager, Lychron
CEO, Magaw Medical
Systems Analyst, Magellan Health Services
Quality, Magistim
Quality Manager, Magistim
CEO, Founder, Makrocare
Senior Clinical Veterinarian, Mass General Hospital
Veterinarian, Mass General Hospital
Technology Licensing Associate, Massachusetts Institute of Technology
Technology Licensing Officer, Massachusetts Institute of Technology
President, Matrix Scientific
Chief Scientific Officer, Executive VP, Meagan Medical
Regulatory Scientist, MED Institute
Clinical Research Manager, MedEng
Strategic Business Development , Mediatek
Associate Manager, Regulatory Affairs, MedImmune
Project Manager, Medtech Innovation Center
Senior Quality Systems Specialist, Medtronic
SW/FW Quality/Reliability Engineer, Medtronic
Associate Director, Merck
Associate Director, Merck
Senior Engineer, Merck
Senior Principal Engineer, Merck
Senior Principal Engineer, Merck
DP Formulation, Millenium Pharmaceuticals
Director Customer Solutions, MKS
Strategic Accounts, MKS
General Manager, Namiki Precision Jewel Co. Ltd.
Director of Global Contracts, NAMSA
Director of International Sales, NAMSA
VP of Global Sales and Marketing, NAMSA
Chief of Technology Commercialization Office, National Cerebral & Cardiovascular Center
Program Manager, National Institute of Standards and Technology
Representative, NeuroDyne Medical
Vice President of Research, Neurometrix, Inc.
Senior Vice President, Client Services, NewCardio
Chairman, Next Safety (NSI)
President, Nexus Imaging Systems
Director of Systems Engineering, NinePoint Medical
Intellectual Property Counsel, NMT Medical
International Clinical Project Director, NMT Medical
Graduate Student, Northeastern University
On-Staff Management Consultant, Nova Biomedical
Systems Engineer, Novartis MDx
Head, Systems and Engineering, Novartis Molecular Diagnostics
Manager Systems & Engineering, Novartis Molecular Diagnostics
CEO & President, Novian Health
Director of Medical Development, Objective Interface Systems, Inc.
QA Representative, Ocular Systems
QA Director, Ocular Systems
Senior Application Engineer, Omnify
Vice President of Sales, Omnify
Vice President of Strategic Accounts, Omnify
Vice President, Ondamed Inc.
Director of Sales, OnProcess Technology
Senior Licensing Associate, Oregon Health and Science University
CEO, OrthoKinetic Technologies LLC
Associate, Pacific Bridge Medical
President and Founder, Pacific Bridge Medical
Vice President, Pacific Bridge Medical
Sr. Business Strategy and Licensing Manager, Partners HealthCare
Systems Architect, Philips Innovation Services
Team Leader, Philips Innovation Services
Business Development, Phillips Healthcare
Sector Senior Director, Phillips Healthcare
Director, Phthisis Diagnostics
Area Director, PLANVIEW
Product Line Manager, PLANVIEW
Vice President of Marketing, PLANVIEW
Chief Operating & Sales Officer, Poiesis Medical
President and CEO, Poiesis Medical
President & CEO, Portaero
President, Principio Technologies, Inc
Business Executive, Productividad Movil
CEO, Productividad Movil
CFO, Productividad Movil
Vice President of Business Development, Proven Process Medical Devices
Marketing, Proven Process Medical Devices
Sales Executive, Quadrite
Director Business Development, Ramot at Tel Aviv University, Ltd.
Senior Engineer, Ranfac
Engineering Manager, RMD Instruments
Manager of Quality Assurance and Regulatory Affairs, RMD Instruments
System Engineer, Roche
MBA Student, Rutgers Business School
MBA Student, Rutgers Business School
Director of Marketing and Sales, Saebo
Recall Program Manager, SCA Consulting
CEO, SciVolutions
Life Sciences Solutions Engineer, Seapine Software
North American Sales Manager, Seapine Software
COO, Sensiotec
CEO, SGL Group
Health Care Sales Manager, North America, SGS
Clinical Supply Logistics, Shire
GM, X-ray Products, Siemens Healthcare
Business Development, Silipos, Inc
Design Engineer, SleepNet
Director of R&D, SleepNet
President, SleepNet
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Senior Human Factors Engineer, SonoSite
President, SoundElkin
Director Corporate Quality Systems, St. Jude Medical
Senior Counsel, Stereotaxis
Clinical Research Manager, Stryker
Design Engineer, Stryker
Manager, Regulatory Affairs, Stryker
Senior Manager, Advanced Portfolio, Stryker
Director, SUNY Stony Brook
Founder and CEO, Syncardia Systems
Senior Product Manager, Synovis Surgical
CEO, Tal Medical
VP of QA/RA, Tayside Flow Technologies
Marketing Specialist, Teshima International
Professor of Medicine, Chairman of Cardiology, The Chicago Medical School
Director of New Business Development, The Jay Group
Business Development, The Medtech Group
General Manager, The Prometheus Group
Systems Engineer, Thermedical
Director of Business Development, Transperfect
Director of Business Development, Transperfect
President of the Crimson Life Sciences Division and Vice President of Quality Systems, Transperfect
Sales Associate, Transperfect
Vice President of Sales, Triple Ring Technologies
VP Regulatory Affairs, Tryton Medical, Inc.
Associate Director, Tufts University
Associate Director, Tufts University
Director, Tufts University
Licensing Associate, Tufts University
Senior Associate Director, Tufts University
VP, Clinical and Regulatory Affairs, Tyrx Pharma
Licensing Officer, UMASS Medical School
CEO, Unique Wellness
Assistant US Attorney, United States Department of Justice - Massachusetts
Assistant US Attorney, United States Department of Justice- Eastern District of PA
Office of Technology Development Director, University at Albany
Senior Technology Transfer Associate, University at Albany
Graduate Student, University of Connecticut
Assistant Vice Chancellor Research Development, University of Massachusetts Dartmouth
Program Director, University of Minnesota
Medical Consultant, Urobiologics
Vice President of Sales, UroMend
Director of Research and Development, ValenTx
CEO, VitalFusion
CEO, WaveGuide Corporation
Partner, White & Case LLP
Account Manager, Medical Device Solutions, WindRiver
Business Development Manager, WindRiver
Engineering Specialist, Medical Device Solutions, WindRiver
Industrial & Medical Device Field Marketing Manager, WindRiver
Solutions Architecht, WindRiver
Technical Account Manager, Medical Device Solutions, WindRiver
Director of Marketing, Xtract Solutions
Director, Strategic Partnerships, Yodle
Account Manager, Life Sciences, YourEncore
Client Services Director, YourEncore

• Examine the new landscape: what major mergers and acquisitions have happened since last year?
• A year in enforcement trends and strategy
• The Department Of Justices' perspective pertaining to evolving prosecutorial trends in the medical device industry

Dr. Gerald Sullivan, Assistant United States Attorney, US Attorney's Office, Eastern District of Pennsylvania
David Schumacher, Assistant U.S. Attorney, US Attorney's Office, District of Massachusetts

• Consolidating using multi-core and embedded virtualization technologies
• Standardize on open platforms for increased agility
• Build on a software foundation that can support change

Santhosh Nair, Director, Vertical Markets - Medical Devices, Wind River

• Learn about the latest technologies in metrology used to ensure product quality.
• New tools for process control; ways to improve throughput and reduce manufacturing costs

Hexagon Metrology

• Going beyond the basics of post market surveillance to a comprehensive method of risk analysis
• Mitigating supplier risk and the impact to finished medical devices
• Reducing supplier risk through effective supplier assessments
• Employing risk-based inspection techniques for supplier management

Dr. Christopher J. Devine, Corporate Quality Assurance, Boston Scientific

• The boom in China and India: Are you participating?
• Discuss case studies on quality assurance in China.
• Gain insight to the new quality regulations in China
• Develop a basic model for developing world
• Determining the diverse cultural issues in these markets; and how to use them to your advantage

Ames Gross, President and Founder, Pacific Bridge Medical

• What is the role of evidence in product promotion? How do we reduce uncertainty?
• Evidence, CPT and Product Adoption: Analyzing the interrelated nature of these processes
• A New Standard of Value: Practice based perspectives on increasing efficiency and reducing downstream costs and sequelae

Dennis A. Robbins, Ph.D., M.P.H.  Principal, I.D.E.A.S
Elizabeth Stewart, Senior Scientist, American Academy of Family Physicians National Research Network
William Carroll, Executive Vice President and Chief Scientific Officer, Meagen Medical

• Learn about the alternative methods of demonstrating substantial equivalence in device modifications
• Gain strategies for using third party teams for conformance assessment

Joel C Kent, M.S., RAC, Manager, Regulatory Affairs, GE Healthcare
Dan Dillon, MS, RAC(US), Regulatory Scientist, MED Institute
Heather Rosecrans, Senior Regulatory Advisor/Vice President of Regulatory Affairs, Greenleaf Health/Medical Device Manufacturers Association (And former Director of CDRH 510(k) Staff)

• Pros/Cons of systems engineering: is this approach right for your company?
• Taking engineering to the next level- gain skills for both your technical and human-centered processes
• Get ahead of the curve with a run-down of the most important aspects of systems engineering from industry trailblazers

Moderator:
David M. Cronin, Director, Cognition Corporation
J. Rusty Hitch, Technology Integration Manager, Beckman Coulter
Jason Fouts, Senior Human Factors Engineer, SonoSite

• Learn the processes necessary for making your pre-production design is compliant with the new 510(k)
• Ensure that your clinical trials are compliant not internationally by learning the details of ISO 14155, and the issues associated with multi-national device testing
• Integrate risk management strategies into your routine clinical studies- what strategies are applicable throughout the clinical trial process?

Margaret Hooker, Principle Quality Engineer, Boston Scientific
Dr. John McLane, Vice President of Clinical and Regulatory Affairs, Clinquest

• Choose 2 half hour long workshops to attend, and join other industry leaders as they host in-depth discussions on a variety of topics.
• After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on a while new topic
• Remember to sign up for your workshop early to ensure your seat!!!

Workshop 1 Product Development Lifeline Program for Medical Device Compliance
Located in the King Room

Hear from Cognition Corporation about their rapidly growing Product Development Lifeline™ Program for medical devices to include small business as well as larger corporations. The Lifeline Program creates requirements, test, and risk management documents, traces and reports to meet and exceed industry standards for medical devices.

This talk will show how the Product Development Lifeline Program teaches companies to:

• Identify compliance deliverables and formats
• Design working documents needed to generate deliverables
• Create documents and links between documents
• Set up web servicing to host documents
• Train teams how to fill our and export all documents/deliverables

Speaker:
David M. Cronin, Director, Cognition Corporation

Workshop 2 Risk Assessments in Clinical Studies- Continued
Located in the Longfellow Room

• Use this intimate setting to ask questions about making your process 510(k) compliant
• Ask questions about preparing and conducting clinical trials for 510k and IDE devices and some of the pitfalls in assessing risks
• Use the roundtable format to discuss more closely the ins and outs of risk management in the clinical setting
  

Speaker:
Dr. John McLane, Vice President of Clinical and Regulatory Affairs, Clinquest
Lisa Ferrara, CEO, OrthoKinetic Technologies

Workshop 4 Untangling The Web
Located in the Holmes Room

• Find out how Yodle solved the small business challenge to become the 35th fastest growing company in the country in 2010
• Learn how to increase sales, build customer loyalty and differentiate yourself from your competition by partnering with Yodle

Speaker:
Glenn Normoyle, Director of Strategic Partnerships, Yodle

Workshop 5 Adapting a Quality System to Include Usability
Located in the Lowell Room

• What's the Goal?
• Why is Usability Important?
• The Usability Engineering Process (UEP)
• The Usability Engineering File (UEF)
• Integration into a QMS
• Planning
• Execution/Interaction

Speaker:
Steve Moszka, Senior Quality Engineer, KMC Systems, Inc.

• What are some of the issues that doctors and hospitals face, and how can manufacturers help them- and the patient!
• Spotlight: ISO Standards for Instructions, writing to increase compliance and effectiveness

Dr. Rohit Arora, Professor of Medicine, Professor of Physiology and Biophysics, Chairman of Cardiology, Associate Chair of Medicine for Research, The Chicago Medical School
Dr. Marvin Slepian, Co-Founder and Chairman, SynCardia

• Discuss Concept Architecture validation for a given set of features/functions
• Hear about rational design concepts which reduce risk in product development costs and schedule
• Ability to evaluate and optimize key marketing product features and yield a feasible Product Requirement Document

Steve Moszka, Senior Quality Engineer, KMC Systems, Inc.

• Develop the most effective testing methodologies and procedures to strengthen your V&V process
• Bolstering the efficacy of your current software, and evaluating when it is time for change

Dr. Arnab Ray, Research Scientist, Fraunhofer USA
Dr. Mike Whalen, Program Director, Software Engineering Center, University of Minnesota

• Augment your predevelopment task analysis with detailed insight in context of use issues and user centered design
• Hear about the updates the FDA has planned for their guidance on human factors
• Gain vital risk management skills and update your FMEA to reduce use errors

Edmond Isrealski, Human Factors Program Manager, Abbott Laboratories
Diana Gunnarson, Senior Software Engineer, Covidien

• Gain the skills necessary to push yourself to look critically at your product development process; including streamlining your communication, effectively delegating tasks and resources, and having comprehensive planning
• Are you using your resources effectively? Do you realize exactly what resources you have at your disposal?
• Get the most out of social media opportunities with these top strategies from industry experts

David M. Cronin, Director, Cognition Corporation
Scafford Serron Ph.D., Senior Director- HVT Quality & Product Dev Practices, Edwards Lifesciences
Nanette J. Bulger, Senior Sector Director, Philips Healthcare
Ryan Foss, Project Engineer, Enercon Technologies

Speaker opportunities available

• Understand both sides of an investment relationship by investigating the perspectives of investors and perspectives of companies pitching to investors
• 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 for each
• Surviving the rigors of investor searching; maximize your efforts to find money, educate and complete your due diligence- all while running your business

Nhan H. Nguyen, MD, JD, MSF, Portfolio Manager, Healthcare & Life Sciences, Chilton Capital Management
Richard Hughen, Vice President of Sales, Marketing and Business Development, CSA Medical
Dinesh Melwani, Attorney, Finnegan LLP
Leslie I. Bookoff, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP