Medical Devices Summit

2013


March 2013
Boston, MA
United States

March 2013

Boston, MA

United States

Untitled Document

Conference Details:

First 100 Medical Device Companies Register Free!

With the current volatility of the health care industry, many medical device manufacturers are plagued with questions and concerns about their products. Opal Events' 4th Annual Medical Devices Summit strives to bring together industry and regulatory professionals from across the country to address key issues in compliance, quality and innovation. Medical device manufacturers are tasked with staying on top of regulatory updates, competitive designs and new opportunities- and can find them all in one place at this celebrated event! And to ensure that we have a diverse group of industry professionals ready to engage in thought-provoking discussion- we offer complimentary registration for the first 100 Medical Device OEM employees!

Join us for two days of panels, presentations and networking opportunities with high-level individuals from across the industry as we discuss such hot-button issues as:

Updates to the 510(k)
Legislation regarding such issues as: Electronic Health Records and the America Invents Act
Human factors in device design
Regulatory concerns internationally and strategies for bringing products to markets outside of the US
Integrating Process Excellence into Design Control
And get information specific to your needs by choosing from two tracks, focusing on Premarket & Postmarket issues!

Opal Events' Medical Devices Summits have grown by leaps and bounds since their launch, and are now held in Boston, San Diego and Minnesota!

Target Audience:

Medical Devices Manufacturing Companies - Manager/ Engineers/Director/ VP of:

Compliance
Quality
Software Engineering
Research and Development
Product Development

Product Development
Regulatory Affairs
And C-Level Managers

Join us and Experience:

25+ key leaders provide the latest and most critical insight into the medical device and larger health care industry
2 tracks specifically designed for manufacturers with premarket and post market needs
Special focus on regulatory updates, and insight into foreign markets
Choice of 2 roundtable discussions presented by industry service providers on new opportunities for growth and optimization
5+ hours of scheduled networking opportunities

Hotel Info:

TBA

Conference Registration Prices:

Standard Rate

Service Providers

$995

*Medical Device Companies, Academia, Government, Non-Profit

First 100 Free, after $495

Group Discounts:
Register 3 people and receive 10% off ***
Register 4 people and receive 15% off ***
Register 5 people or more and receive 20% off ***

If you'd like to be invoiced, please submit your contact details on the registration page and select "Please invoice me" at the bottom of the page.

If you are interested in sponsorship, exhibiting, or speaking opportunities, please call 212-532-9898 or email information@opalevents.org

* TERMS & CONDITIONS
Subject to approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by conference producer. Opal reserves the right to allocate places and to refuse applications.

*Health plans must be CMS approved as Medicare, Medicare Advantage or Medicaid health plans

***Registrations must be made online on the same date. Discount will be applied after all registrants have been received.

Registration price reflects $100 online discount

Untitled Document

2012 Attendees

Senior Licensing Associate, Beth Israel eaconess Medical Center
CEO, Bhinder Surgical
CEO, Bioelectric Research Corporation
CFO, Bioelectric Research Corporation
COO, Bioelectric Research Corporation
Partner, Biolog Europe
CEO & COO, Biolytical Laboratories Inc.
Director, MedTech Group, Boston Engineering
Associate Medical Director, Global Medical Safety, Boston Scientific
Corporate Counsel, Boston Scientific
Corporate Counsel, Boston Scientific
Corporate Senior Post Market Surveillance Manager, Boston Scientific
Corporate Senior Quality System Manager, Boston Scientific
Director, Boston Scientific
Dir, Corporate Post-market Surveillance, Boston Scientific
Director Quality Systems, Boston Scientific
Design Assurance Quality Manager, Boston Scientific
Manager of Corporate Quality Systems, Boston Scientific
Manager of Enterprise Software Quality Assurance- Global Quality Systems, Boston Scientific
Manager Global Audit Readiness, Boston Scientific
Manager Global Clinical Compliance, Boston Scientific
Manager II of Global Quality PMO, Boston Scientific
Medical Director, Global Medical Safety, Boston Scientific
Medical Director, Global Medical Safety, Boston Scientific
Medical Research Associate, Boston Scientific
Principal Business Process Analyst, Boston Scientific
Principal Financial Analyst, Boston Scientific
Principal Medical Safety Analyst, Boston Scientific
Principal Quality Engineer, Boston Scientific
Principal Quality Engineer, Boston Scientific
Principal Quality Engineer, Boston Scientific
Principal Quality Engineer, Boston Scientific
Principal Quality Specialist, Boston Scientific
Principal SW Quality Engineer, Boston Scientific
Quality Director, Boston Scientific
Quality Engineer, Boston Scientific
Quality Project Manager, Boston Scientific
R&D Manager, Boston Scientific, Boston Scientific
Safety Trial Manager, Boston Scientific
Safety Trial Manager, Boston Scientific
Senior Cash Specialist, Boston Scientific
Senior Counsel and Director of Clinical Services, Boston Scientific
Senior Field Inventory Resources, Boston Scientific
Senior International Counsel, Boston Scientific
Senior Manager, Clinical Process, Boston Scientific
Senior Manager of Global Medical Safety, Boston Scientific
Senior Quality Analyst, Boston Scientific
Senior Quality Analyst, Boston Scientific
Senior Quality Engineer, Boston Scientific
Senior Quality Manager, Boston Scientific
Senior Manager, Boston Scientific
VP & Chief Patent Counsel, Endoscopy & Urology/Women's Health, Boston Scientific
Postdoctoral Research Associate, Boston University
VP of New Business Development, Bridgemedica
Vice President of QA/RA, Bridgemedica
Anesthesiologist, Engineer, Inventor, Brigham & Womens Hospital
Owner and Executive Product Manager, Bristol Enterprises
Chief Consultant, Business Management Consultants International
President, Calmar Orthopaedics
Regional Services Manager, Cardiac Science Corp
Digital Product Line Manager, Carestream Dental
Software Product Line Manager, Carestream Dental
Vice President Product Line Management, Carestream Dental
Director of New Technology and Innovation, Carl Zeiss
Vice President of Marketing, The Celebration, Inc.
Medical Director, Celleration Inc.
Vice President of Reimbursement, Celleration Inc.
President, Clinical Instruments International Inc.
CEO, CytoSorbents Corporation
Professor of Medicine, Professor of Physiology and Biophysics, Chairman of Cardiology Department, Chicago Medical School
Founder & CEO, China-Centric Associates
Senior Advisor, China-Centric Associates
CEO, Cognition Corporation
VP of Customer Success, Product Development Software, Cognition Corporation
President & CEO, Compression Solutions
IP Counsel, ConforMIS
Vice President of Marketing, Convergence Medical Devices
Regulatory Scientist, Cook Medical
Associate General Counsel, Covidien
Associate Regulatory Affairs Specialist II, Covidien
Director of Regulatory Affairs, Covidien
Director of Regulatory Affairs, Covidien
Director of Regulatory Affairs, Covidien
IT Director, Covidien
Manager of Regulatory Affairs, Covidien
Vice President of Operational Excellence, Covidien
Vice President Quality and Regulatory Affairs, Covidien
Vice President Quality Assurance and Regulatory Affairs, Vascular Therapies, Covidien
Vice President, Research and Development, Covidien
Vice President, Regulatory Affairs, Covidien
Vice President, Regulatory Compliance, Covidien
Director of Sales, CSA Medical
Senior Director, CSA Medical
Vice President, CSA Medical
QA & Regulatory Affairs Manager, Dale Medical Products
Partner, Dar Expo
Manager, Field Assurance, Davol
President, DDN Medical Affairs
Life Carrier, DD&S
Endodontist, Dental Specialists of Maine
President, Devine Guidance
CEO, Digital Surgicals
Associate Director, Dr. Reddy's Laboratory
Director of Regulatory Affairs, Draeger Medical Systems
Regulatory Affairs Specialist, Draeger Medical Systems
Regulatory Affairs Manager, Draeger Medical Systems
Regulatory Affairs Program Manager, Draeger Medical Systems
Research Assistant, Drexel University
Research Assistant, Drexel University
Research Assistant, Drexel University
Research Assistant, Drexel University
Distributor Sales Manager, Dryan Medical
Director of Sales, Endoscopic Alternatives
Director of Engineering and Technology, Electrochem
Director of Sales, Electrochem
Engineering Manager, Electrochem
Strategic Accounts Manager, Electrochem
President, Electronic Control Concepts
Specialist, Global Regulatory Affairs, EMD Serono
CEO, Emerge Medical
Director of US Sales, Emerge Medical
President, Endo-Lamina
President & CEO, Endometix Corporation
Project Engineer, Enercon Technologies
Business Development Manager, Eigen
VP - Strategy & Operations, Eigen
VP of Quality and Regulatory Affairs, EpicOrtho
President, Epic Research and Diagnostics
Senior Director of Research & Development, Etex Corporation
CEO, FAM Sports
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
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Supervisory Consumer Safety Officer, FDA
President and CEO, Fem-Medical
Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner
Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner
VP of Software Development, Fluidnet
President, Foster Corporation
Head of Complaints, Fresenius Medical Care
CEO, Garana Industries
Manager of Regulatory Affairs, GE Healthcare
Principal Engineer, GE Healthcare
Product Marketing Manager, GE Healthcare
Quality Assurance Director, GE Healthcare
Quality Assurance Leader, GE Healthcare
Director Solution Design, Healthcare Logistics, Genco
Director, Regulatory and Quality Affairs, Genco
Vice President Business Development, Healthcare Solutions, Genco
Director of Marketing, Genzyme
Principal Associate, Regulatory Affairs, Genzyme
Principal Scientist, Genzyme
Director, German Healthcare Industries
Emerging Markets Growth Specialist, GFI Global
Director of Operations, GI Dynamics
Quality Specialist, GI Dynamics
VP of Engineering, GI Dynamics
VP of Quality, GI Dynamics
Senior Regulatory Advisor/Vice President of Regulatory Affairs, Greenleaf Health/Medical
Device Manufacturers Association
Principal/Founder, GSRD Architecture & Fabrication
Project Architect, GSRD Architecture & Fabrication
President, Guldmann Inc
Regulatory Affairs Specialist, Gyrus ACMI
Regulatory Specialist, Gyrus ACMI
QA Administrator, Hamilton Thorne, Inc
Director Global Marketing, Haemonetics
Senior Software Quality Engineer, Haemonetics
Senior Software Engineer, Haemonetics
Software Quality Manager, Haemonetics
Associate Counsel, Harvard Clinical Research Institute
Associate Director, Project Management, Harvard Clinical Research Institute
Associate Director, Project Management, Harvard Clinical Research Institute
Clinical Research Associate II, Harvard Clinical Research Institute
Medical Writer, Harvard Clinical Research Institute
Medical Writer, Harvard Clinical Research Institute
Quality Assurance Specialist, Harvard Clinical Research Institute
Senior Project Assistant, Harvard Clinical Research Institute
Senior Project Manager, Harvard Clinical Research Institute
Senior Regulatory Affairs Specialist, Harvard Clinical Research Institute
Trial Design Director, Harvard Clinical Research Institute
Trial Design Program Coordinator, Harvard Clinical Research Institute
Associate Director of Business Development, Harvard University
Associate Director of Business Development, Harvard University
Associate Director of Business Development, Harvard University
Business Development Associate, Harvard University
Business Development Associate, Harvard University
Director of Business Development, Harvard University
Executive Director, Harvard University
Principle V&V Engineer, HeartWare International
Software Engineering Manager, HeartWare International
Brand Manager, HemaCore
CEO, HemaCore
COO, HemaCore
R&D Engineer, Hemosphere
R&D Engineer, Hemosphere
Director of Quality, Henke-Sass Wolf of America
Applications Engineer, CT systems, Hexagon Metrology
Program Manager, CT Systems, Hexagon Metrology
President, Hood Laboratories
Managing Partner, Hope and Heal
CEO, Hospimed
Medical Device Risk Specialist, Hospira
Operations, Hospira
Director, Hugo Technology
Sales & Business Development Manager, Hugo Technology
Principal & Founder, Hull Associates
Director of Engineering, Hygieia
Senior Engineer, Hygieia
Vice President of Products, Hygieia
Chief Executive Officer, ICan DxRx
Senior Director of Business Development, IKARIA
Associate Director of Market Analytics, IKARIA
Vice President of Business Development, IKARIA
Manager, Iksander Medical Group
Technical Manager, Iksander Medical Group
Manager, Immunomedics Incorporated
Physician Liasion, Institute for Biomedical Innovation and Translational Medicine
Director, Instrumentation Laboratory
Director Regulatory Affairs, Instrumentation Laboratory
QA Complaints Manager, Instrumentation Laboratory
QA Manager, Instrumentation Laboratory
QA Manager Critical Care Systems, Instrumentation Laboratory

QA Manager Statistical Methods, Instrumentation Laboratory
R&D System Engineer, Instrumentation Laboratory
Software Test Manager, Instrumentation Laboratory
VP. Quality Insurance, Instrumentation Laboratory
Regulatory Affairs Specialist, Insulet Corporation
Director Regulatory Affairs, Integra Lifesciences
Director of Marketing, Integra Neurosurgery
Platform Architect, Medical Segment, Embedded & Communications, Intel
Associate Director, Research Administration, International Medicine Institute, University of Miami
Executive Director, International Medicine Institute, University of Miami
President, Intertech
Program Manager, Intertech
Regional Sales Director, IOP Ophthalmics
Student, Johns Hopkins University
Senior Project Manager, Johnson and Johnson
Vice President of Global Product Quality, Kaz
Clinical Research Physician, Kuros Biosurgery
COO, LAB Medical Manufacturing, INC.
Managing Partner, Long Life Surgical
President, Labyrinth Devices, LLC
Regulatory Affairs Associate, Lantheu Medical Imaging, Inc.
President, Lavin Inc
Owner, LED Crystal
Senior Vice President, Levitronix
COO Medical Division, Levitronix
Chairman, Founder, LifeConnect
Regulatory Affair Manager, LifeIMAGE
Biomedical Engineer, Life Instruments
Director of Global Quality, Life Technologies
Senior Manager, Quality Assurance, Life Technologies
Research Associate, Macrogen
Managing Partner, Market Ignition Group
Founder & Executive, Mass Medical Angels
CEO, Matrix Scientifics
CEO, MedCity News
Research Scientist, MED Institute
CEO, MediWiSe Ltd.
VP of Sales: Surgical Division, Medline Industries
Financial Director, Medical Development Group
Executive Director, Med-Rite Labs
Project Manager, MedTech Innovation Center
Clinical Process Owner, Medtronic
Senior Materials Engineer. Medtronic
Senior Principal Project Engineer, Medtronic
Senior Project Engineer, Medtronic
Senior Quality System Specialist, Medtronic
Senior Quality Engineer, Medtronic
Senior Systems Engineer, Medtronic
Vice President of Government Affairs, Medtronic
Biologic Project Lead, Merck
Senior Project Engineer/Scientist, Merck
Practitioner, Medical Office of Dr. David Sicard
Professor and Clinical Chairman, Medical University of SC
President, Mermaid Medical LLC
Regulatory Affairs and Compliance Officer, Microaire Surgical Instruments
Senior R&D Engineer, Microline Surgical Inc
CEO, Mindchild Medical
CMO, Mindchild Medical
COO, Mindchild Medical
Executive VP, Mindchild Medical
Business Development, Minnetronix
Senior Industrial Liaison Officer, MIT
CEO, Modulated Imaging, Inc.
Executive Director, MUSC Foundation for Research Development
Legal Counsel, MUSC Foundation for Research Development
Cardiovascular Technician, National Cardiac Monitoring Center
Clinical Manager, National Cardiac Monitoring Center
President, National Cardiac Monitoring Center
Sr. Cardiovascular Technician, National Cardiac Monitoring Center
Vice President Operations, National Cardiac Monitoring Center
Vice President, Strategic Planning, National Cardiac Monitoring Center
CEO, NeuroDyne Medical, Corp
Co-founder, Head of Prod Development, Neumitra
President, Neurotect
Medical Director, Neurovent
Business Development Manager, New Wave Surgical
Director of Quality Engineering, Nexis Vision
COO, NGX Corp
Professor, Northeastern University
Staff Management Consultant, Nova Biomedical
CAO/SR V.P. Product Development, NovaBay Pharmaceuticals
Manager, Engineering & Systems, Novartis
System Engineer, Novartis
Manager of Systems Integration, Novartis Molecular Diagnostics
Head of Engineering & Systems, Novartis Molecular Diagnostics
Director, Regulatory and Quality Engineer, NxStage Medical
Manager of Corporate Quality Assurance, NxStage Medical
Manager of, Quality Engineering, NxStage Medical
Senior VP, Quality/Regulatory/Clinical, NxStage Medical
Chief Operating Officer, NuOrtho Surgical inc
Nanotechnology Policy Advisor, OECD
Associate Director of Compliance, Olympus Biotech
Corporate Solutions Manager, Omnilingua
CEO, OncoRad Technologies
International Regulatory Affairs Manager, Otto Bock Healthcare Products
Director of Sterile Technology, Otsuka American Pharmaceutical
Quality Control Manager, OrthoMax Surgical
General Manager, Partners Healthcare
Senior Business Strategy and Licensing Manager, Partners Healthcare
Director of Marketing and Business Development, Pendar Medical
Founder, CEO, Perfuzia Medical
Director of Engineering and Marketing, PLC Medical Systems
President, PlenSat
Vice President of Business Development, PlenSat
Senior Director of Strategic Markets, Philips Healthcare
Senior Manager, Philips Healthcare
Senior Manager, Regulatory Affairs, Philips Healthcare
Vice President of Global Government Affairs, Regulations and Standards, Philips Healthcare
CEO, PhotOral
President & CEO, Poiesis Medical
SVP & Chief Operating Officer, Poiesis Medical
VP, CSO, Portable Therapeutix
CEO, Predisys
President, Principio Technologies Inc
Customer Solutions Director, PTC Reliable
CEO, CMO, Pulsecor
Regulatory and Compliance Officer, Pulsecor
President, QHeart Medical Inc
Process Development Lead, QiG
Co-founder-VP, Marketing & Administration, QuickCheck Health
President & CEO, QuickCheck Health
Vice President of Operations, QuickCheck Health
Director of Clinical Operations, Refectance Medical
VP & General Manager, REGENERON Pharmaceuticals
Graduate Program Director, Regis College
Regional Manager, RJG
Director of Engineering, RMD Instruments Corporation
General Manager, RMD Instruments Corporation
Manager of Quality Assurance and Regulatory Affairs, RMD Instruments Corporation
VP of Corporate Development, RNA Diagnostics
President, RTEmd
Director Devices, Sanofi Pharmaceuticals
Quality and Regulatory Consultant, SCA Consulting
VP Global Quality & Regulatory, General Counsel NA, Scapa Healthcare
Business Development Manager, Schlafender Hase GmbH
Managing Director, Schlafender Hase GmbH
Senior Consultant, SDLC Partners
Life Sciences Solutions Engineer, Seapine
North American Sales Manager, Seapine
VP of Worldwide Sales, Seapine
Chief Scientist, Sensorium Inc
CTO/COO, Sensus Healthcare
President/CEO, Sensus Healthcare
Health Care Sales Manager, North America, SGS
CEO, Shalatco
CEO, SharpsGoGreen, LLC
Senior Scientist, Siemens Healthcare Diagnostics
Director, Sales Operations, Smith & Nephew
Principle Regulatory Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Affairs Specialist, Smith & Nephew
Regulatory Specialist II, Smith & Nephew
Regulatory Specialist II, Smith & Nephew
Regulatory Specialist II, Smith & Nephew
Regulatory Specialist II, Smith & Nephew
Regulatory Specialist II, Smith & Nephew
Technology Transfer Officer, SOCPRA
CFO, SpineFrontier
Manager of Quality and Compliance, SpineFrontier
Regulatory Affairs Specialist, SpineFrontier
CEO, Spinofix
CFO, Spinofix
COO, Spinofix
Design Associate, Spinofix
Design Engineer, Spinofix
Engineer and Quality Specialist, Spinofix
Marketing Analyst, Spinofix
Business Development, Starfish Medical
Design Assurance Manager, St. Jude Medical
Manager, Advanced Portfolio Development, Stryker
Student, Syracuse University
Vice Chairman, Syringex Medical, Inc.
VP of QA/RA, Tayside Flow Technologies Ltd
Engineer, Technolas Perfect Vision
IT Specialist, Technolas Perfect Vision
Senior Specialist, Research & Clinical Operations, Technolas Perfect Vision
Senior Specialist, Technolas Perfect Vision
Specialist, Service Engineering, Technolas Perfect Vision
Mechanical Engineer, Teleflex Medical
Senior Director of Global Compliance, Teleflex Medical
Vice President of Global Regulatory Affairs and Quality Assurance, Teleflex Medical
Quality Manager, Tepha, Inc
Vice President of QS/RA, Teleflex, Inc
System Engineering, Thermedical
Director of Supply Chain, Thoratec
Senior R&D Engineer, Thoratec
Director of Product Development, Tomophase
Executive Chairman, Tomophase
Assistant Professor, Tufts Medical Center
Director, DLAM, Tufts Medical Center
Director, Business Development, Tufts Medical Center
Associate Director, Tufts University
Associate Director for Commercialization, Tufts University
Senior Associate Director, Tufts University
Instructor, UC Irvine
Senior Manager of Regulatory Affairs, Unilife Corporation
VP Quality & Regulatory, Unilife Corporation
Surgeon, United States Air Force
Associate Professor, University of Chicago at Illinois
Associate Director, University of Massachusetts–Amherst
Licensing Officer, University of Massachusetts Medical School
Assistant Vice Chancellor Research Development, University of Massachusetts Dartmouth
Research Assistant, University of Mississippi Medical Center
Director of Licensing, Physical Sciences, University of Pennsylvania
Graduate in Biomedical Engineering, University of Southern California
Vice President, UroMend
President & CEO, Urovalve, Inc.
Co-Founder, VacuPractor
VP, Sales and Business Development, Ventripoint Inc
CTO & Chairman of Scientific Advisory Board, Vertex Pharmaceuticals
Senior Research Scientist R&D, Vertex Pharmaceuticals
CEO, VitalFusion
Founder, VivaTechnics
Director of Supplier Quality Assurance, Volcano Corporation
Principal Mechanical Engineer & Manager, Volcano Corporation
Senior Quality Engineer, Volcano Corporation
Director, Regulatory Affairs and Quality Systems, VTS Medical Systems
Director of RA-QA, Warne Franklin
Regulatory Engineer, Welch Allyn
Department Chair, Western New England University
Director of Vertical Markets, Medical Devices, Wind River
CEO, Wireless MedCARE, LLC
Business Development Manager, WPI Corporate and Professional Education
Student, WPI
Strategic Change Management Operations, Excellence, Product Development, WTP Advisors
Senior Vice President, RA & CA, Ximedica

Conference Day One: Tuesday, March 6, 2012

7:15 am

Continental Breakfast & Registration

8:00 am

Chairs' Welcome

David M. Cronin, Director, Cognition Corporation

8:05 am

Chair's Welcome and Audience Demographics

8:15 am

Keynote Presentation:
The Impact of 2012: Updates on Congressional FDA Reform and the Reauthorization of User Fee Agreements

Unpacking the new draft agreements before congress through a comprehensive look at goals and objectives for performance enhancement
Research and Development in an age of instability: how can we preserve innovation
How will this reverberate throughout the industry, and when will you feel the effects

Keynote Speaker:
Peter Slone, Vice President of Government Affairs, Medtronic

9:00 am

Changes in the 510k- Adapting to Changing Criteria and Staying Ahead of the Curve

Addressing the series of 'Action Items' set out by the FDA; what is the proposed timeline? How will they impact the industry?
Learn how to interact most effectively with the FDA by having continuous dialog and providing feedback
What exactly are the new changes and how have they been impacting device companies?

Heather Rosecrans, Senior Regulatory Advisor/Vice President of Regulatory Affairs, Greenleaf Health/Medical Device Manufacturers Association (And former Director of CDRH 510(k) Staff)
Daniel J. Dillon, Regulatory Scientist, MED Institute of Cook Medical
Elisabeth M. George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare

9:45 am

Morning Refreshment & Networking Break
Talk with your peers; enjoy some light refreshments all while learning about some new and exciting services and technologies from our exhibitors

10:15 am

Interoperability: Overcome Barriers and Speed Adoption of mHealth

Interoperability is essential to the adoption of mHeatlh where multiple systems across health and mobile industries must be integrated to communicate and share information across multiple technology platforms.
Right now the medical device industry is building devices and gateways that offer little to no compatibility across systems.
Join Santhosh Nair, director, medical markets at Wind River as he addresses how medical device systems are beginning to be developed on common platforms to overcome these barriers to interoperability and accelerating the adoption of mHealth technologies.

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

11:00 am

Unpacking the America Invents Act: Implications for the Medical Device Industry

Preparing your patent portfolio for the legislative changes, including the change to a "First-Inventor-to-File" system
Understanding new mechanisms to challenge IP roadblocks and the business and strategy considerations in their use

Dinesh N. Melwani, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Leslie I. Bookoff, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Kurt Lockwood, VP & Chief Patent Counsel, Endoscopy & Urology/Women's Health, Boston Scientific

11:45 am

Moving from System Requirements to Hardware Requirements

Learn how to transition and 'breakdown' from system requirements to specifics for hardware development
Evaluate the associated leading metrics for performing this analysis

Chris Robinson, Senior Product Manager/Product Engineer/Operations Staff, Medtronic David

12:30 pm

Protecting Against Threat: Security Across Connected Devices

Security - it's more than about HIPPA
Malware concern around connected devices
Hardware features can be used to lower threat
Software and Hardware combinations to lower threat

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

1:15 pm

Luncheon Presentation
*After our luncheon, the event will be splitting into two separate tracks. Please feel free to attend the sessions that most pertain to you!

Track A - Premarket Focus

Track B - Postmarket Focus

2:15 pm

Getting Established in the Industry: Investments, Partnerships and Passion

Hear how life saving devices can go from a dream to a reality through critical research, business development strategy and effective partnerships
Getting away from the funding model and learning about new opportunities: partnerships, foundations and innovative ways to hunt for funding

Adam Wolfberg, Chief Medical Officer, Mindchild Medical
Chris Seper, CEO and Editor in Chief, MedCity News
Joseph V. Gulfo, President, CEO and Chairman of the Board of Directors, MELA Sciences, Inc.

Postmarket Surveillance and CAPA Strategies

How to set up an effective post-market surveillance program
How do you effectively deal with complaint handling?
Gain insight both on how industry responds to

Patrick Caines, Director of Global Quality Systems: Post Market Surveillance, Boston Scientific
Laurie Bern Frazier, Consumer Safety Officer, FDA
Stephen Smith, Consumer Safety Officer, FDA

3:00 pm

Premarket Pitfalls: Skill Building for Start-Ups

Gain the skills for taking your company to the next level with insight on such issues as how to manage subcontractors or where to look for regulatory approval guidance
Incorporate both human factors research and market analysis to see what medical device customers are looking for- and use this to push the envelope of innovation!
How do you identify possible partnership opportunities and develop sustainable partnerships?
Product commercialization: how to get ready to for the eventual FDA clearance while including not only sales and marketing, but clinical trials and regulatory departments as well

Edwin Lindsay, Vice President of Quality and Regulatory Affairs, Tayside Flow Technologies
Richard Hughen, Vice President of Sales, Marketing and Business Development, CSA MEDICAL
Sarah Kalil, Vice President, HOLOGIC

Optimizing Cost to Serve for Medical Device Manufacturers

Medical Device Industry challenges and how Cost to Serve is now a priority for this industry
Importance of Supply Chain and Aftermarket Services on addressing these challenges
New way of reducing/optimizing Cost to Serve – Integrated Process, Analytics and Technology solution
Success Stories

Gopalakrishnan VK, Vice President and Global Practice Leader, Genpact

3:45 pm

Afternoon Refreshment and Networking Break in the Exhibition Lounge
Talk with your peers; enjoy some light refreshments all while learning about some new and exciting services and technologies from our exhibitors

Courtesy of:

4:00 pm

Inspiring Innovation: Guidelines and Possibilities in Human Factors

Understand new FDA Guidance on human factors research
Gain skills for up front user research and usability testing through a special case study on HFE for a device
Learn how Human Factors / Usability Engineering can enhance product safety, effectiveness, acceptance and satisfaction
Hear about medical product users: how they are different than you and me and how can you understand them better
Hear about real-life examples of HF/U evaluation methods and how they can lead to key product improvements

Edmond Israelski, Human Factors Director, Abbott Laboratories
Thomas Varricchione, Senior Vice President, RA & QA, Ximedica

Understanding the Regulatory Pathways for the Introduction of Class IIa, IIb, and III Devices into Europe

Understanding the three Medical Device Directives in Europe: 93/42/EEC The Medical Device Directive; 98/79/EC The In-Vitro Diagnostic Device Directive; and 90/385/EEC The Active Implantable Medical Device Directive
Introducing Medical Devices into the EU through the Application of the MDD
Learn about regulatory processes unique to the EU, such as: Essential Requirements; The Declaration of Conformity, the CE mark, and Vigilance reporting

Dr. Christopher J. Devine, President, Devine Guidance
Former Senior Manager of Corporate Quality Assurance, Boston Scientific

4:45 pm

Roundtable Workshops

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 whole new topic
Remember to sign up for your workshop early to ensure your seat!
Each workshop will be hosted in a separate room.

Workshop One: Cockpit - Using Modern Tools to Win

Customer needs... user experience... stakeholder requirements...system features... safety... validation... and complete traceability, how in the world do you get it all done? Even harder, how do you get it all done efficiently and with the least pain? Whether you're a start-up or one of the big guys, modern tools are simplifying your burden. In this workshop, you will see what one of these tools looks like, and if you deal with the topics above and this example doesn't feel like it would simplify your life, then we'll buy you a beer.

Speaker:
David M. Cronin, Director, Cognition Corporation

Workshop Two: Increasing Medical Device Security with Mainstream IT Platforms and Technologies

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

Workshop Three: Advances in Medical Device Metrology

Speaker:
Jonathan J. O'Hare, Program Manager, CT Systems, Hexagon Metrology
Stephen Darrouzet, Applications Engineer, CT Systems, Hexagon Metrology

Workshop Four: Global Clinical Trials – Managing Adverse Event Reports for FDA Compliance

Your clinical trials last up to five years and more frequently are conducted globally. Adding to this complexity is the fact that companies are insourcing and outsourcing clinical trials. In this scenario, how can you improve the process and speed up translation and reporting of adverse events to the Institutional Review Board (IRB)? A customized clinical portal is an ideal way to securely manage Adverse Event Reports in a global multisite environment. Learn how your organization can benefit by linking all sites and streamlining the confidential transfer of documents requiring translation for global clinical trials.

Speaker:
Brenda Monney, Corporate Solutions Manager, OmniLingua Worldwide

Workshop Five: Electronic Device/Batch Records – Path to Next Level of Productivity and Proactive Quality Control

Ari Pihlajavesi, CEO, Presidys

Workshop Six: This workshop will have two separate discussions, one taking place for the first 30 minutes and the second taking place directly after.

Topic A) Sorting out the deadlines for Medical Equipment tests to 60601- 3rd Ed.
Different countries and regions have different requirements and deadlines for bringing products into compliance with 60601-1 3rd Edition. This roundtable will lay out the deadlines and share details of the requirements in the USA, Canada, Europe, and other markets.

Topic B) How to document Risk Management in order to meet 60601-1 3rd Ed.
ISO14971:2007 is commonly used as the risk management standard for electrical medical equipment. This roundtable will examine the best ways to document your conformity to both ISO14971 and IEC 60601-1 3rd. Ed.

Dale Hallerberg, Technical Manager, TUV Rheinland

Workshop Seven:
Medical Power Sources: Smart, Sterile & Wirelessly Charged.

Learn how smart batteries provide operators with enhanced performance information and longer run times.
Gain insight on how lithium batteries enable smaller, lighter and more powerful medical devices.
Discover sterilization techniques for batteries including autoclave, Sterrad/Steris and gamma irradiation.
Realize why wireless charging improves operational readiness and longer run times for medical devices.

George Cintra, Director of Engineering & Technology, Electrochem Solutions, Inc.
Jeffrey VanZwol, Vice President of Marketing, Micro Power Electronics

Workshop Eight: The Future EU Medical Device Regulation and Its Possible Effect on Your Company's Business
The European medical device directives have been undergoing intensive review by experts from member states and the draft of the next version is now expected by July 2012. Significant changes are likely including the following:

Change in Notified Body oversight
Audits of Notified Bodies
Requirements for importers and distributors
Reprocessing of devices labelled for single-use only
Replacement parts
Increased clinical study requirements
and more...

You will be briefed on the latest intelligence from Brussels, together with an assessment of how the changes may affect your business

Maria Donawa, President, Donawa Lifescience Consulting

Workshop Nine: Open Innovation in the Mobile Medical Device Space

Learn about Open Innovation and how it could deliver benefits in the mobile medical device space. Open innovation is a growing phenomenon across various markets, utilized by organizations as diverse as P&G, NASA, Dell, GSK and Life Technologies. It's about bridging internal and external resources and acting on those opportunities to bring better innovation to market faster. In addition to “better innovation”, benefits can include faster development cycles and lower costs. Let's discuss how your company might benefit from open innovation with respect to development efforts for mobile medical devices.

Todd Boone, Director of Open Innovation, Psion

5:45 pm

Day One Closing Remarks and Cocktail Reception (in the Exhibit Hall)

Join us and unwind with fellow industry professionals for refreshments during our last networking break of the day.

Conference Day One: Wednesday, March 7, 2012

7:15 am

Continental Breakfast & Registration

8:00 am

Chairs' Welcome & Day 1 Re-Cap

David M. Cronin, Director, Cognition Corporation

8:05 am

Chair's Welcome and Audience Demographics

8:15 am

A Year in Legal Insight: Developments to Meet a Rapidly Evolving Industry

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

Gerald Sullivan, Assistant U.S. Attorney, US Attorney's Office, Eastern District of Pennsylvania
David Schumacher, Assistant U.S. Attorney. US Attorney's Office, District of Massachusetts
Brent Gurney, Partner, WilmerHale: Washington, D.C. and Boston

9:00 am

Medical Device Innovation: Concept, Product, Practice: Case Studies in Cardiovascular Innovation

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 strategies?
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

9:45 am

Getting Established in the Industry: Investments, Partnerships and Passion- Part II

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?

Nanette J. Bulger, Senior Sector Director, Philips Healthcare
Adam Wolfberg, Chief Medical Officer, Mindchild Medical
Gavin Erickson, Senior Consultant, Bridgehead International

Track A - Quality Focus

Track B - R&D Focus

10:15 am

Integrating Process Excellence into Your Design Control Program

Defining process excellence
Mapping the product life cycle process
Ensuring the product life cycle process stays excellent

Peter Hennessey, Quality Assurance Director, GE Healthcare
Margaret Hooker, Quality Assurance Leader, GE Healthcare

Mobile Medical Devices: A Risk-Based Approach

Unpack the FDA's Mobile Medical Device Applications and understand their definitions for Mobile Platforms, Applications and Medical Devices
Investigate the grey areas of mobile medical devices- when is it a medical device requiring a 501(k) submission?
Understanding the politics of functionality vs. cost vs. culture and appearance when deciding on mobile technology

Sameer Jaiswal, Manager of Enterprise Software Quality Assurance- Global Quality Systems, Boston Scientific
Patricia Winston, Senior Software Quality Engineer, Boston Scientific
Fusun Tufan, Regulatory Affairs Manager, Boston Scientific

10:15 am

Integrating Process Excellence into Your Design Control Program

Defining process excellence
Mapping the product life cycle process
Ensuring the product life cycle process stays excellent

Peter Hennessey, Quality Assurance Director, GE Healthcare
Margaret Hooker, Quality Assurance Leader, GE Healthcare

Mobile Medical Devices: A Risk-Based Approach

Unpack the FDA's Mobile Medical Device Applications and understand their definitions for Mobile Platforms, Applications and Medical Devices
Investigate the grey areas of mobile medical devices- when is it a medical device requiring a 501(k) submission?
Understanding the politics of functionality vs. cost vs. culture and appearance when deciding on mobile technology

11:00 am

Morning Refreshment and Networking Break
Talk with your peers; enjoy some light refreshments all while learning about some new and exciting services and technologies from our exhibitors

11:30 am

Performing Effective Health Hazard Assessments

Use of Health Hazard Assessments in valuating quality or regulatory issues
Process and contents of a Health Hazard Assessment
Evolving roles of a Medical Safety team

Dr. Anna Chavez, Medical Safety Director, Boston Scientific
Dr. Arundhati Datye, Medical Director, Global Medical Safety, Boston Scientific

Creating a Framework and Mindset to Foster Innovation

Hear case studies from manufacturers on how they have broken down departmental barriers to deliver more innovative products to market
Gain skills for increasing cross-disciplinary communication and incorporating customer input
Learn about the most common internal and external issues with improving medical device product development

Steven Stanton, Software Engineering Manager, HeartWare International, Inc.
Dr. David Vogel, President, Intertech Engineering Associates, Inc

12:15 pm

Safety and Software: Understanding and Applying IEC 60601-1 & IEC 62304 standards for Medical Electrical Equipment

Understanding IEC 60601-1 criteria for evaluating the efficacy and safety of devices, including requirements under the third edition.
Discuss Essential Performance and Risk Management considerations within the standard
How to document safety compliance throughout the Software Design Lifecycle -IEC 62304
Using best practices to achieve efficient performance while complying with the standard

Brad Ryba, Partner, SDLC Partners

12:45 pm

Luncheon

1:45 pm

Navigating the Regulatory Waters of Medical Devices with Embedded Software

Understand the impact of software innovation on the future of devices, and the new regulatory challenges that this will bring to innovation.
Issues like heavy regulation from the FDA and other agencies, distributed development teams and time-pressure can result in costly issues and oversights. Gain strategies for ensuring an effective risk management program, utilizing available resources, and ensuring compliance and communication throughout the development and manufacturing process.

Stephen Denman, Product Marketing, PTC
John Hennessy, Director of Customer Solutions, PTC

2:15 pm

Medical Devices Going Global: Strategies and Pitfalls in International Development and Distribution

The medical device industry must prepare for the emergence of new markets, and the changing regulatory standards they will request: Use emerging markets such as Saudi Arabia and Latin American countries as a backdrop for this discussion of regulatory pitfalls and strategies
How are countries using the GHTF's STED as a way to prepare their regulatory documentation
Going Beyond Premarket Clearance: Obtaining Reimbursement Coverage in OUS Markets
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

Richard Russo, President & Chief Executive Officer, Endomedix
Joel Kent, Manager of Regulatory Affairs, GE Healthcare
Mindy McCann, Director of Health Care- North America, SGS
Mahendra Joshi, Deputy General Manager, Larsen & Toubro
Mahesh Sanzgiri, Joint General Manager, Larsen & Toubro

3:15 pm

Exploring Emerging Markets- Spotlight on China

China possesses the world's fastest growing and changing healthcare industry.
China has only been engaged in Western business practices with depth and breadth for fifteen years.
Understanding the differences in the institutions, consumer/provider drivers, channels to market, economics, insurance are all fundamental requirements for developing and executing successful business plans for China

Michael Corkran, Founder & CEO, China Centric

4:00 pm

Conference Debriefing and Refreshments

4:15 pm

Conference Adjourns

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