Medical Devices Summit


February 2015
Boston, MA
THE 2015 CONFERENCE IS OPEN FOR PRE-REGISTRATION & SPONSORSHIP

Conference Details:
The 2015 conference is open for pre-registration & sponsorship!

With the current volatility of the health care industry, many medical device manufacturers are plagued with questions and concerns about their products. Opal Events' 6th Annual Medical Devices Summit strives to bring together industry and regulatory professionals frdaom across the country to address key issues in compliance, quality and innovation. Medical device manufacturers are tasked with staying on top of regulatory updiates, 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 many Medical Device OEM employees!

The conference is bringing together industry professionals and thought leaders to discuss some of the most pressing issues in the device industry today, including:
  • Reimbursement and Return: Getting a Bang for Your Buck
  • Combination Devices - what is the industry doing to meet the requirements?
  • Interactions with the FDA
  • Big in Japan
  • Understanding and Implementing Unique Device Identification (UDI)
  • Human Factors Engineering and Usability
  • Mobile Device Innovation
  • Security in Medical Devices
  • Requirements for effective design control
  • Healthcare informatics - database analytics

Join 400+ Medical Device industry professionals for panels, presentations, workshop and tons of networking opportunities with the industry's best!

Attend high level workshops hosted by industry service providers and learn about the latest solutions and industry developments.

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

"Opal's Medical Devices Summit West Event was second to none, delivered by a diverse group of top notch industry professionals about cutting edge technology changes."
- - Kim Nielsen RN, BSN (Medical Devices Summit West 2012 Attendee)

"The speakers have spent built successful careers bringing biotech products to market - you can learn a lot from their experience!!!"
- - Attendee, Rice University

"Great way of learning and networking with key decision makers in the medical device industry "
- - Attendee, Alfred Mann Foundation

"This was a very well run event. I was very impressed with the Opal staff and the support they provided throughout the conference as well as before and after the event! Great job and a terrific event. thanks! "
- -Attendee, Davis Companies

"This was an exceptionally well run event. The Opal staff was very attentive and helpful. We achieved the goals we had set out for the conference. We will have Opal at the top of our list for future events."
- -Attendee, HTI Plastics

More Testimonials
Target Audience:
Medical Devices Manufacturing Companies - Manager/ Engineers/Director/ VP of:
  • Compliance
  • Quality
  • Software Engineering
  • Research and 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:
Early Bird Rate

Standard Rate
Service Providers & vendors (including contract manufacturers, consultants, component and material providers)
$795
$995
Medical Device Companies*
First 100 free*, after $495

Register Now!

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.

*This group is exclusivelyfor companies which develop and manufacture their own devices. This does not include manufacturers of components, materials, or contract manufacturers.

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

Past Attendees
Device Quality Manager, AbbVie
Director of Human Factors, AbbVie
Senior Principal Engineer - Molding, AbbVie
Founder and Chief Scientific Officer, ActoKine Therapeutics
Product Business Manager, Acumed
Program Manager, Acumed
Engineering Manager, Acumed LLC
COO/CFO, Advanced Radiation Therapy
Chief Engineer, Advanced Radiation Therapy
Marketing Development Manager, AFL Global / Fujikura Ltd
Software Quality Insurance, AgaMatrix
Firmware Engineering Manager, AgaMatrix
Manager Clinical Affairs, AgaMatrix
Software Engineer, AgaMatrix
Quality assurance manager, AgaMatrix
Clinical research technician, AgaMatrix
Director Quality Assurance, AgaMatrix
Software Engineer, AgaMatrix
Senior Firmware Engineer, AgaMatrix
Regulatory Affairs Associate, Agamatrix Inc
Associate Manager Clinical Affairs, Agamatrix Inc
Director, Software Development, AgaMatrix, Inc.
Principle Packaging Engineer, Alcon Laboratories Inc
Founder ,CTO, Alfa Thermodiagnostics
Director, Strategic Planning, Alfred Mann Foundation
Senior Vice President Business Development and General Counsel, Alfred Mann Foundation
VP/CFO, American Health Care Professionals
Project Developer SE Asia App, American Health Care Professionals
Project Developer Diabetes 1 App, American Health Care Professionals
President- CEO, American Health Care Professionals
Principal Development Engineer, American Medical Systems
Principal Research Scientist, American Medical Systems
Senior Development Engineer, American Medical Systems
Senior Program Manager, American Medical Systems
QA Manager, Anchen Pharmaceuticals
Validation Engineer, Anchen Pharmaceuticals
Commercial Director, Anika Therapeutics
SVP Medical Devices, Aptiv Solutions
Director, Medical Devices, Aptiv Solutions
Vice President, Sales at Arbour Group LLC, Arbour Group
Director, Commercial Operations, Arteriocyte Medical Systems
CEO, Articulate Labs Inc
Program Chair, ASQ, Biomedical Division
Founder and President, ATR, LLC
CDO, Attogen
Global Regulatory Affairs, Pharmaceuticals, Bausch & Lomb Incorporated
Staff Engineer, Bayer HealthCare Medical Care
Staff Engineer, Bayer HealthCare Medical Care
Senior Engineer, Bayer HealthCare Medical Care
Senior Staff Engineer, Bayer HealthCare Medical Care
Senior Quality Systems Engineer, BD Medical – Diabetes Care
Principle Quality Engineer, BD Medical – Diabetes Care
Principal Quality Engineer, BD Medical – Diabetes Care
Principle Quality Engineer, BD Medical – Diabetes Care
Principal Quality Engineer, BD Medical – Diabetes Care
Sr System Engineer, Becton, Dickinson and Company
R&D Manager, Becton, Dickinson and Company
Licensing Associate, Beth Israel Deaconess Medical Center
Senior Licensing Associate, Beth Israel Deaconess Medical Center
Technology Transfer Specialist, Beth Israel Deaconess Medical Center
MD, Beth Israel Medical School/Harvard Medical School
President, Biochemical Diagnostics
Chief Science Officer, Biohot Technology Co
CEO, Biolom
CTO, Biolom
COO, Biolom
Regulatory Affairs Representative, Bio-Rad Laboratories
Regional Business Director, BioSense Medical Devices
Service Engineer, B-K Medical
Partner, Bookoff McAndrews
Partner, Bookoff McAndrews, PLLC
CFO, Boston Biomedical Associates
Director of Business Development, Boston Biomedical Associates
Co-Owner, Boston Biomedical Associates LLC
Executive, Boston Biomedical Innovation Center
Director, Boston Biomedical Innovation Center
Senior Safety Analyst, Boston Scientific
Principal Quality Engineer, Boston Scientific
Principal Analyst, Corp Medical Safety, Boston Scientific
Quality Engineer l, Boston Scientific
Quality Engineer, Boston Scientific
Senior Medical Director, Boston Scientific
Quality Engineer, Boston Scientific
Quality Engineer, Boston Scientific
Senior Manager of Global Medical Safety, Boston Scientific
Director, Boston Scientific
Sr. Software Quality Assurance Engineer, Boston Scientific
Quality Engineer, Boston Scientific
Medical Safety Reviewer, Boston Scientific
Software Quality Assurance Engineer, Boston Scientific
Director, Boston Scientific
Quality Engineer, Boston Scientific
Principal Medical Safety Analyst, Boston Scientific
Quality Engineer II, Boston Scientific
Sr. Quality Manager, Boston Scientific
Project Manager, Boston Scientific
Sr. Quality Manager, Boston Scientific
Executive Director, New Ventures, Boston University
Professor of Medicine and Pathology, Boston University Medical Center
Anesthesiologist, Engineer, Inventor, Brigham & Womens Hospital
Director of Marketing, BrownMed
Principal Engineer, Canon Virginia, Inc.
Senior Advisor Medical Device Development, Cardeas Pharma
Owner, Carlson Communications
Partner, Catenion
Dr., Catenion
Director of Manucfaturing  Engineering, CeQur
Director of Brand Development, CeQur
Senior Quality Engineer, CeQur
Production Supervisor, CeQur
Senior Product Designer, CeQur
Manager, Manufacturing Engineering, CeQur Corporation
Senior Biomedical Equipment Technician, Childrens Hospital Boston
Senior Biomedical Equipment Technician, Childrens Hospital Boston
President, Chrono Therapeutics Inc. (Cti)
Software Engineer, Cognition
CEO, Cognition Corporation
Sales Engineer, Cognition Corporation
President, Cognition Corporation
VP, Customer Success, Cognition Corporation
Application Engineer, Cognition Corporation
Application Engineer, Cognition Corporation
Senior Application Engineer, Cognition Corporation
Document Control Coordinator, Conformis
VP OpEx and Corporate Engineering, Covidien
Manager, RA Operations, Covidien
International Regulatory Affairs Specialist, Covidien
Regulatory Affairs Manager, Covidien
Regulatory Affairs Associate, Covidien
Regulatory Affairs Specialist, Covidien
Regulatory Affairs Manager, Covidien
Sr. Director Quality Assurance, Covidien
Sr. RA Product Specialist, Covidien Corporate
Vice President Regulatory Affairs, Covidien Corporate
Sr Program Manager, R & D, Covidien Corporate-Vascular Therapies
Sr. Development Engineer, R&D, Covidien Corporate-Vascular Therapies
Sr. Development Engineer, R&D, Covidien Corporate-Vascular Therapies
Sr. Manager, R&D, Covidien Corporate-Vascular Therapies
Vice President, Quality Assurance and Regulatory Affairs, Covidien Ltd.
Sr. Regulatory Affairs Manager, Covidien Plc
Sr. Regulatory Affairs Specialist, Covidien Plc
Sr. Principal Development Engineer, R&D, Covidien-Vascular
Systems Engineer, Cummins Inc.
CEO, Cynosure Biomedical
Franchise Director for Clinical Operation, DePuy
Program Manager, Clinical Research, DePuy
Regulatory Affairs Associate, Depuy Spine, Inc.
Group Manager, DePuy Synthes Spine
Group Manager, DePuy Synthes Spine
Director, Cervical Product Development, DePuy Synthes Spine
President, Devine Guidance
Sales Director, Digia
VP of Business Development, Dohmen
President, Dorchester BioMedical
Director of Regulatory Affairs, Draeger Medical
Information Security Engineer, Draeger Medical Systems Inc
Sr. Staff Software Engineer, Draeger Medical Systems Inc
Lead Human Factors Engineer, Draeger Medical Systems Inc
Clinical Engineer, Draeger Medical Systems Inc
Sr. Staff Clinical Engineer, Draeger Medical Systems Inc
Clinical Engineer, Draeger Medical Systems Inc
Staff Software Engineer, Draeger Medical Systems Inc
Sr. Staff Software Engineer, Draeger Medical Systems Inc
Staff Software Engineer, Draeger Medical Systems Inc
Staff Software Engineer, Draeger Medical Systems Inc
Software Project Manager, Draeger Medical Systems Inc
Senior Software Engineer, Draeger Medical Systems, Inc.
Sr. Software Engineer, Draeger Medical Systems, Inc.
Software Manager, Dreager Medical
Sr Staff Software Engineer, Dreager Medical
Sr Staff Software Engineer, Dreager Medical
Vice President, National Accounts, ECRI
Sr. Principal Project Manager, CC RA, Edwards Lifesciences
President, Electronic Control Concepts
Consultant-GQAAC, Eli Lilly & Co.
Product Development Manager, Embase
President, Endo-Lamina LLC
Senior Director Of Research & Development, Etex Corporation
Vice President Of Engineering, Eyegate Pharmaceuticals, Inc.
CEO, FallAWare Inc.
Consumer Safety Officer, FDA
Public Health Specialist, FDA
Biomedical Engineer, FDA Winchester Engineering Analytical Center
Analytical Engineer, FDA Winchester Engineering Analytical Center
Biomedical Engineer, FDA Winchester Engineering Analytical Center
Engineer. Supervisor, FDA Winchester Engineering Analytical Center
Regulatory Engineer, FDA Winchester Engineering Analytical Center
Biomedical Engineer, FDA Winchester Engineering Analytical Center
President and CEO, Fem-Medical LLC
Chief Executive Officer, FindCure.Org Inc
Scientist, Flow Forward Medical Inc
Intern, Flow Forward Medical Inc
Vice President Research & Development, Flow Forward Medical Inc
Compliance Officer, Food and Drug Administration
Investigator, Food and Drug Administration
Medical Device Specialist, Food and Drug Administration
Supervisor Consumer Safety Officer, Food and Drug Administration
Consumer Safety Officer, Food and Drug Administration
President, Franklin Street
R&D Development Engineer, Fresenius
Biomedical Engineer, Fresenius
Senior Document Control Manager, Fresenius
Senior Manager, Fresenius
Regulatory Affairs Associate I, Fresenius Medical  Care
Regulatory Affairs Associate, Fresenius Medical Care
Principal Regulatory Affairs Assoc, Fresenius Medical Care
Recall Coordinator, Fresenius Medical Care
Regulatory Affairs, Fresenius Medical Care
Regulatory Affairs Fellow, Fresenius Medical Care
Regulatory Affairs Associate, Fresenius Medical Care
Regulatory Affairs Manager - Device, Fresenius Medical Care
Regulatory Affairs Manager-Operations, Fresenius Medical Care
Regulatory Affairs Associate, Fresenius Medical Care
Regulatory Affairs Associate, Fresenius Medical Care
Sr. Quality System Manager, Fresenius Medical Care North America
Director Global Health Portfolio, GE Foundation, GE Corporate
Chief Medical Officer, GE Healthcare
CMO Ultrasound, GE Healthcare
QA Leader, GE Healthcare
Manager, Regulatory Affairs, GE Healthcare
Chief Technology Officer, GE Healthcare
RA Director, GE Healthcare
Medical Director Surgery, GE Healthcare
General Counsel, Vice President, GENO LLC
Database Adm., Genzyme
Senior Systems Engineer, GMTO
Director R&D Programs, Haemonetics Corp.
Design Quality Engineer, Haemonetics Corporation
Design Quality Engineer, Haemonetics Corporation
Design Assurance Manager, Haemonetics Corporation
Quality Associate / HR Manager, Hamilton Thorne, Inc.
Senior research engineer/QA Manager, Hamilton Thorne, Inc.
Scientist, Harvard Medical School/MGH
Medical Devices Specialist, Health Canada
Regulatory Director, HealthSTATS
Project Lead, HEMOVA MEDICAL
Systems Engineering & MDO Consultant, Homine Informatica
Director, Homine Informatica
Administrative Director, HTE@USC, Keck School of Medicine
Director of Sales, HTI Plastics
Principal, Hull Associates
Sr Account Executive, IBS America
Principal Product Consultant, IBS America
Events and Marketing, ICS Integrated Computer Solutions
Senior Consultant, Infosys
CEO, Innova Medical Design
Vice President, Inspirage
Solution Director, Inspirage
Project Intern, Institute for Pediatric Innovation
Project Intern, Institute for Pediatric Innovation
Project Intern, Institute for Pediatric Innovation
Project Intern, Institute for Pediatric Innovation
Project Intern, Institute for Pediatric Innovation
Medical Technology Intern, Institute for Pediatric Innovation
Project Intern, Institute for Pediatric Innovation
Director of Programs, Institute for Pediatric Innovation
CEO, Institute for Pediatric Innovation
Project Intern, Institute for Pediatric Innovation
Technical Advisor, Institute for Pediatric Innovation
R&D Systems Engineer, Instrumentation Laboratories
Quality Systems Manager, Instrumentation Laboratory
Director, Insulet Corporation
Scientist, Ipsen
Principal Research Associate, Ipsen
Senior Research Associate, Ipsen
Technology Analyst, Johns Hopkins University
VP Regulatory, Kaz, Inc
Director, KeepSight
Founder, KeepSight
Research Manager, Konica Minolta Laboratory USA
President, Labyrinth Devices
Business Development Manager, Lernia Training Solutions
Director, Clinical & Regulatory Affairs, LiveLeaf Inc
Chief Executive Officer, Lumos Catheter Systems
President, MAE Consulting Group LLC
Senior Research Scientist, Marine Polymer Technologies
QA Manager, Marine Polymer Technologies
QA Director, Marine Polymer Technologies
Founder & Executive Director, Mass Medical Angels
Member, Mass Medical Angels
Member, Mass Medical Angels
Executive Committee  Member, Mass Medical Angels
Member, Mass Medical Angels
Member, Mass Medical Angels
Member, Mass Medical Angels
Member, Mass Medical Angels
Member, Mass Medical Angels
Member, Mass Medical Angels
Anesthesia Clinical Engineering Department, Massachusetts General Hospital
Regulatory Scientist, MED Institute, Inc.
VP of Global Reimbursement, Health Policy and Health Economics, Medtronic
Senior Systems Engineer, Medtronic
Director, Software Quality, Medtronic
Sr Business Process Manager, Medtronic
Software Engineer, Medtronic
Principal Product Engineer, Medtronic, Inc.
Sr. Engineering Manager, Medtronic, Inc.
Product Engineer, Medtronic, Inc.
Principal Engineer, Merck
Associate Director, Merck & Co., Inc
VP, M-Files
Executive Director, MGH/Partners HealthCare
Director of Quality, MicroGroup
Senior R&D Engineer, Microline Surgical, Inc.
Scientist, MIT
Vice President, Product Development, MPR Associates
Director of Product Design, MPR Associates
Director of Product Design, MPR Associates, Inc.
AVP Compliance and Clinical Operations, Navix Diagnostix, Inc
Director of Operations, Neoventa Medical, Inc.
Co-founder, Head of Prod Dev, Neumitra
SVP for Research and Intellectual Property, Neurometrix, Inc.
Director of Clinical Affairs, Ninepoint Medical
Director of SW Development, Ninepoint Medical
Sr. Clinical Research Associate, Ninepoint Medical
Professor, Northeastern University
Director, Center for Research Innovation, Northeastern University
On-Staff Management Consultant, Nova Biomedical
Manager of Systema Integration, Novartis
, Novartis
Enginer 2, Ortho clinical diagnostics
Packaging Consultant - National Sales, Outlook Group Corp.
President and Founder, Pacific Bridge Medical
Associate, Pacific Bridge Medical
Regulatory Compliance Officer, Parsortix, Inc
CTO, Parsortix, Inc
Executive Director, Partners Healthcare
Research Director, Percepta Market Research Consultancy
Sr. Principal Scientist, Pfizer
Associate Research Fellow, Pfizer (formerly Wyeth Biopharma)
Director, Quality & Regulatory, Philips
Regulatory Affairs Specialist, Philips
Regulatory Affairs Specialist, Philips
Regulatory Affairs Specialist, Philips
Regulatory Affairs Specialist, Philips
Program Manager, Philips Healthcare
Sr Director, Phillips Respironics
CEO, PhotOral
COO, PhotOral
Chief Scientific Officer, PhotOral
CEO, Pilltek
Chief Development Officer, Pilltek
Director of Marketing and R&D, PLC Medical Systems
Office Administrator, Prisym ID
U.S. Business Development Manager, Prisym ID
Director of Product Management, PTC
Sales Business Transformation Manager, PTC
CEO, Pulmonary Apps, Pulmonary Apps
VP Commercial Excellence, Qiagen
Principal Owner, QualComp Consulting
Project Manager/Associate Consultant, QualComp Consulting
Associate Consultant, QualComp Consulting
Senior Vice President, Product Development, RainDance Technologies
Project Coordinator, Business Development, Reed Technology
, Reed Technology
Sr Manager, Information Solutions-Life Sciences, Reed Technology
Director of Business Development, Resolution Development
VP Engineering, Respiratory Motion, Inc.
Biomedical Bokhenik, Respiratory Motion, Inc.
Sr. Biomedical Engineer, Respiratory Motion, Inc.
Director of Product Development, Respiratory Motion, Inc.
MBA Candidate, Rice University
Mgr of Quality Assurance & Reg. Affairs, RMD Instruments/dba Dynasil Products
Research Fellow, Rothman Institute Orthopaedics
Grad Student, RPI
Business Development Manager, Sagentia
External Opportunity Leader, Sanofi
Global Head Medical Device Strategy, Sanofi
Life Sciences Business Development Manager, Seapine Software
Life Sciences Business Development Manager, Seapine Software
VP of Worldwide Sales, Seapine Software
Life Sciences Solutions Specialist, Seapine Software
Senior Regulatory Consultant, Shotwell & Carr LLC
Senior Research Scientist, Siemens Healthcare
Regulatory Affairs, Siemens Healthcare Diagnostics
Regulatory Affairs, Siemens Healthcare Diagnostics
Staff Scientist, Siemens Healthcare Diagnostics
Regulatory Affairs, Siemens Healthcare Diagnostics Inc
Market Manager | Advanced Surgical Devices Division, Smith & Nephew
RA Compliance Specialist, Smith & Nephew ASDD
Embedded Security Engineer, Southwest Research Institute
Group Leader Embedded Security, Southwest Research Institute
General Manager, SpineFrontier
Director, Quality, SpineFrontier
Director Operations, SpineFrontier
GC & Reguatory Manager, SpineFrontier
Chief Financial Officer, SpineFrontier, Inc.
North American Sales Manager, SpineVision
Director Health Sciences & Services, St. Louis Regional Chamber
Director, Recall & Retrieval, Stericycle ExpertSOLUTIONS
Recall Consultant, Stericycle ExpertSOLUTIONS
Project Lead Engineer, Sterling Medical Devices
Director of Sales, Sterling Medical Devices
President, Sterling Medical Devices
Regulatory Submissions Specialist, Sunovion Pharmaceuticals Inc
Director Business Development, Target Health Inc.
Director of Engineering, Telcare Inc
Systems Engineer, Tetra Pak
President, The celebration, Inc.
, The Law Offices of Jeoyuh Lin
VP, The RND Group, Inc.
Senior Manager, Technical Support & Field Services, Thoratec Corporation
Regulatory Affairs, Thoratec Corporation
Senior R&D Engineer, Thoratec LLC
Senior Manager, Toyota Tsusho America, Inc.
Creative Director, TR PRODUCTIONS
CEO, Triode - Product Strategy
Associate Staff Veterinarian, Tufts
Project Manager, Tufts Center for the Study of Drug Development
Environmental Services Program Manager, TUV Rheinland
Regional Account Manager, UL DQS
Medical Program Manager/Lead Auditor, UL DQS
Marketing Coordinator, UL DQS
Director, CTSA, UMass Medical School
Technology Licensing Officer, UMass Medical School
VP Corporate Quality & Regulatory, Unilife Corporation
Licensing Officer, University of Massachusetts Medical School
Sr. Licensing Officer, University of Massachusetts–Amherst
VP and Practice Lead – UDI, USDM
COO/CFO, Velocity BioGroup
CEO, Velocity BioGroup
Director, Business Development, Versicor
Research Fellow, Vertex Pharmaceuticals
Sr. Principal Quality Engineer, Vistakon
CEO, Vittamed
Quality Manager, Waters
Sr. Complaint Handling Specialist, Waters
Manager, Post Market Surveillance, Waters
Sr. Complaint Handling Specialist, Waters
Complaint Handling Specialist, Waters
Chair, BME & Professor, Wentworth Institute of Technology
Department Chair, Western New England University
CEO & Founder, WiCare
Director of Intelligence, Wind River
Technical Account Manager, Medical Device Solutions, Wind River
Engineering Specialist, Medical Device Solutions, Wind River
Account Manager, Medical Device Solutions, Wind River
Industrial & Medical Device Field Marketing Manager, Wind River
RAQA Director, Xeridiem
Senior Human Factors Engineer, Ximedica
Vice President , Global Medical and Regulatory Affairs, Zimmer Holdings Inc
2014 Agenda (current as of 2/20/14)
 Past Conference Day One: Tuesday, February 25, 2014
7:00 am
Continental Breakfast & Registration
QualComp Consulting Services
8:15 am
Chair’s Welcome and Audience Demographics: Learn who is in the room so that you can identify your peers and people with whom you would like to network.

David M. Cronin, CEO, Cognition Corporation
Cognition
8:30 am
Keynote: Disseminate the Economic Value of a Product to Internal and External Stakeholders
  • Understanding the impact that economic information can have for hospitals and healthcare systems
  • Developing a communication approach to demonstrate HEOR along with product advancements
  • Exploring reimbursement impact to payors and meeting their needs
Jeff Hersh, Chief Medical Officer, HealthCare Systems, GE HealthCare
9:20 am
Strategic Regulatory and Clinical Program Development

Lauren S. Baker, PhD, PE, President, Boston Biomedical Associates
Boston Biomedical Associates
10:05 am
Morning Refreshment & Networking Break in the Exhibit Hall
Talk with your peers, enjoy some light refreshments – all while learning about new and exciting services and technologies from our exhibitors.

Kindly sponsored by:
Boston Biomedical Associates
Track A - Premarket Focus
Track B - Product Development and Innovation
10:35 am
Bridging Points of Contention in University-Industry Licensing Deals

Dinesh Melwani, Partner, Bookoff McAndrews, PLLC
Les Bookoff, Partner, Bookoff McAndrews, PLLC
Ami Gadhia, Director- Physical Sciences & Engineering, Johns Hopkins Technology TransferBookoff Mcandrews
Overview of factors driving innovation
  • Manufacturing challenges and trends
  • Design and Test Risks which can slow you down
  • Important technologies being used for success
Erik Hilliard, Director of Sales, Sterling Medical Devices
Asmita Khanolkar, Manager, Manufacturing Engineering, CeQur
11:10 am
Requirements for strong design control process (with a software twist)

Eric Henry, Director, Software Quality, Medtronic
Special challenges and opportunities in developing pediatric medical devices

Donald P. Lombardi, CEO, Institute for Pediatric Innovation, and Adjunct Assistant Professor of Pediatrics, Tufts
Anwar Upal, Technical Advisor, Institute for Pediatric Innovation
11:40 am
Effective Early Interactions with the FDA: The Pre-Sub program

Dan Dillon,
MS, RAC, Senior Regulatory Scientist, MED Institute
Healthcare informatics - database analytics

Chris Larkin, Chief Technology Officer, GE Healthcare
12:10 pm
Networking Luncheon
1:10 pm
Understanding and Implementing Unique Device Identification (UDI)
  • Understanding UDI requirements and your responsibilities
  • What you need to consider to ensure compliance
  • Leveraging UDI to reduce risk and drive new operational efficiencies
  • Incorporating UDI into your overall quality, compliance and risk management strategy
Gary Saner, Senior Manager of Information Solutions for Life Sciences, REED TECHNOLOGY
Jay Crowley,
Vice President and UDI Practice Leader,USDM LIFE SCIENCES
Hal Plant, Business Development Manager, Prisym ID
2:00 pm
Conducting Medical Device Safety and Performance Assessments

Daan de Jong,
Product Development Manager, Elsevier Science & Technology, Embase
Embase
2:30 pm
Afternoon Refreshment & Networking Break in the Exhibit Hall
2:45 pm
Medical Devices Reach for the Cloud - Building a Scalable and Adaptable Software Platform for Connected Medical Devices

The medical industry is under siege to reduce costs. Medical equipment manufacturers are rapidly designing in connectivity capabilities that will mirror enterprise cloud computing and introduce more efficient ways to provide healthcare services. However, designing connected medical devices brings design challenges, complexities, and risk. And, with cost in mind, software platforms must scale and easily adapt to meet the changing needs of the healthcare industry.

Dean Chen, Director of Product Management, Intelligent Systems, Wind River
Ken Herold, Medical Engineering Specialist, Wind River Systems
Wind River
3:15 pm
Medical Devices Reach for the Cloud - Building a Scalable and Adaptable Software Platform for Connected Medical Devices Part 2

Ken Herold, Medical Engineering Specialist, Wind River Systems
Intel
3:45 pm
Roundtable Workshops Day 1

After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on different topic.

Remember to sign up for your workshop early at the registration desk to ensure your seat! 

Roundtable 1
Understanding the Plastics Medical Device Development Process

Identifying the key elements

  • 6 common phases that must be addressed
  • Why classification is important
  • Design
  • Materials


HTI Plastic
Rick Thomas, Director of Sales, HTI PLASTICS

Roundtable 2

How Portfolio Management can Support Innovation in MedTech

  • How to evaluate technology projects, life cycle projects and full blown innovative projects?
  • How to compare internal and external projects?
  • After assessing individual projects, how do you determine the portfolio's risk level?
  • Portfolio Management Best Practice - Where do you stand?
  • How can Portfolio Management contribute to innovation and corporate strategy?

Dr. Matthias Krings, Senior Partner, Catenion
Catenion

Roundtable 3 - Velocity BioGroup
Preparing Your Device for Funding or for Sale – What Does it Take?
You’ve got a great idea and an even greater product.  What secret sauce will entice the attention and deal making of potential investors, partners or acquirers?  This session will walk through the key performance indicators that will ensure the success of your medical device in the marketplace, explaining how to put these forward to investors.  Why? 

  • Investors understand that you need sound market metrics to win a divestiture
  • These potential partners can be experts in marketplace challenges, knowing more than you might know about the reality of your market worthiness
  • Market centricity during development increases your opportunity for a sound ROI
  • Market centric development is easier when you know the marketplace challenges and opportunities specific to your product

Michael DeWaal, COO/CFO, Velocity BioGroup
Patricia Trifunov,
CEO, Velocity BioGroup
Velocity BioGroup

Roundtable 4: How to Commercialize Overseas

Key advice from three seasoned experts on regulatory, reimbursement and market access to approaching foreign markets, determining which markets offer the best opportunities, and how to understand regulatory and reimbursement requirements.

Ilka  Bijoux, Market Manager, Advanced Surgical Devices Division, Smith & Nephew
Janet Kwiatkowski,
President, MAE Consulting Group LLC
Stephen Hull
, Principle, Hull Associates
Hull Associates LLC

Roundtable 5: Pacific Bridge Medical - How to Succeed in Asia’s Medical Device Market

Session A: Opportunities in India’s Medical Device Market

  • Best regulatory strategies
  • Sourcing and manufacturing
  • Opportunities and challenges

Session B: Opportunities in China’s Medical Device Market

  • Best regulatory strategies
  • Sourcing and manufacturing
  • Opportunities and challenges

Ames Gross, President and Founder, Pacific Bridge Medical
Pacific Bridge Medical

Roundtable 6: Protecting Your Brand - Pre, During and Post Recall

  • Ensuring you are sufficiently prepared for an effective recall to avoid one that negatively impacts your brand and bottom line
  • Developing the art of recall management throughout all levels of the organization
  • Minimizing the impact and maximizing the opportunity in the event of a recall
  • Compliance amidst a changing regulatory landscape

Kevin McAteer, Recall Consultant, STERICYCLE, INC.
Mike Davison, Director, Recall & Retrieval, STERICYCLE, INC.
Stericycle

4:45 pm
Day One Closing Remarks and Cocktail Reception (in the Exhibit Hall), kindly sponsored by
Cognition
Past Conference Day Two: Wednesday, February 26, 2014
8:15 am
Continental Breakfast & Registration
8:50 am
Opening Remarks from Opal- Wrap Up from Day 1 and Looking Ahead
9:00 am
Roundtable Workshops
  • After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on different topic.
  • Remember to sign up for your workshop early at the registration desk to ensure your seat! 

Roundtable 1 - Cognition
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.
Cognition
Roundtable 2 - TUV Rheinland
RoHS2 and Medical Equipment
  • What is RoHS 2?
  • Are standards available to help me demonstrate conformity to the requirements
  • Are there any changes to restricted substances?
  • What does the CE Mark cover?
Geoffrey Bock, Program Manager Environmental Services, TUV
TUVRheinland

Roundtable 3 - Internet of Things and Cloud-Connected Medical Devices Discussion

  • What are the challenges and opportunities you see today?
  • Get the chance to ask questions, and consider new opportunities
  • Debate hot topics with industry experts

Wind River

Roundtable 4 - IBS America
FDA Validation Roundtable – Demystifying Software Validation

Tisha Tomlinson, Principal Product Consultant, IBS America
Archie O’Leary, Vice President of Sales, Arbour Group

IBS America

Roundtable 5 - MPR
Session 1 – How to Design the Cost out of Healthcare
This 30 minute open discussion takes the always exciting subject of healthcare product cost reduction and looks at it from the perspective of the user as one effective approach for improving the bottom line. Join Chuck Luddy from MPR Associates Product Development team to explore how flexing your ‘empathy muscle’ to truly understand your product’s context and users can lead to decreasing the overall cost of your medical product while increasing overall value. Making the regulatory connection, Vicki Anastasi from Aptiv Solutions will piece together the links between user-centered design, risk reduction in your regulatory pathway, and increased effectiveness in clinical trials.

Chuck Luddy
, Director of Product Design, MPR
Vicki Anastasi,
Senior Vice President, Medical Devices, Aptiv Solutions

Session 2  - How to Make Sure Your Medical Device is Mobile Ready

Join Craig Mauch from MPR Associates for a look at the key issues facing Medical Devices Developers attempting to navigate the Mobile Health Arena.  With Cyber Security, Electronic Health Records and constantly changing FDA requirements at the forefront of most conversations, you won’t want to miss what the experts have to say about navigating this potentially complex landscape. Get actionable advice on latest regulatory positions for mobile health and cyber security along with practical system architecture guidance to maximize the benefits of mobile communication platform in your medical device project

Craig Mauch, Director of Product Design, MPR
Cynthia J.M. Nolte, Director, Medical Device Regulatory Services, Aptiv Solutions
MPR Product Development
Roundtable 6
Session A) Complying with the FDA UDI GUDID – How the UDI Rule and the GUDID will impact Quality and Global Product Development
Share your experiences and ideas in a highly interactive discussion.

  • What is the GUDID and how is the FDA going to use this data?
  • How does a tightly integrated pre-market approval and post-market surveillance system influence device quality and new product development?
  • Does your internal GUDID compliance strategy reflect the way the FDA will use the information?

Chris Piela, Sales Business Transformation Manager, PTC

Session B) How Connectivity and The Internet of Things Enables Continuous Software Innovation
Share your experiences and ideas in a highly interactive discussion.

  • How is the Internet of Things changing the dynamics of product development?
  • Review an Internet of Things scenario from an implantable device manufacturer. Do you see similar trends in your product area?
  • Discuss the challenges of continuous innovation in a regulated industry.  How is your organization responding to these challenges?
Ryan Lloyd, Director of Product Management, PTC
PTC
10:05 am
Supplier and Purchasing Controls

Supply Chain Musts:

  • Ensuring that you plan ahead translates into security later
  • Looking at it from the regulatory perspective
  • Examine case studies
  • FDA insight on purchasing controls and acceptance activities
Laurie Bem Frazier, Investigator, FDA
10:35 am
Overview of Human Factors- Raising the Bar
  • Domestic Human Factors standards
  • IEC/ISO - International Usability standards
  • Rising expectations from regulators for the use of best practice Human Factors methods in medical product design
Edmond W. Israelski PhD, Director Human Factors, Abbvie
Jeff Morang
, Senior Human Factors Engineer, Ximedica
11:20 am
Morning Refreshment & Networking Break in the Exhibit Hall
Talk with your peers, enjoy some light refreshments - all while learning about new and exciting services and technologies from our exhibitors.

QualComp Consulting Services
11:40 am
Organizational Impacts of Regulatory Change and Business Benefits
Leading an organization through change can be challenging.  Managing change in the medical device industry is particularly dynamic and complex due to constantly changing regulatory requirements and expectations.  This presentation depicts the pressures changes put on an organization, possible mitigations, and the business benefits to embracing regulatory change.

Mitch Hayes, VP Customer Success, Cognition
Cognition
12:10 pm
Big in Japan

Dr. Christopher Devine,
President, Devine Guidance
12:40 pm
Follow-Up on Current Combination Product Development:
  • At what point will regulations effect that grandfathering of products?
  • Post-market submissions, what is now required?
  • Applying your Supplier QMS: Risk Management is still important, as well as Design Controls in Device Development
Pedro Cruz, Project Manager, QUALCOMP Consuting Services
Victor Arriaran,
Owner and Principal, QualComp Consulting
QualComp Consulting Services
1:10 pm
Network Luncheon
2:00 pm
Successful commercialization of innovations in the new healthcare environment
Spin outs from research, the commercial engine and the need to understand insurance and reimbursement

Neelima Firth,
Director, Strategic Planning and Development, Alfred E. Mann Foundation for Scientific Research
2:30 pm
Security in Medical Devices

Joel C. Kent, M.S., RAC, Manager, Quality and Regulatory Affairs, GE HealthCare
3:00 pm
Reimbursement and Return: Getting a Bang for Your Buck

Shamiram Feinglass, MD, MPH, formerly of CMS & Zimmer
3:30 pm
Event recap, giveaways and closing remarks
Register:
Service Providers & Vendors, (Including contract manufacturers, consultants, component and material providers)
$995.00
Medical Device Companies*
$495.00
Pending Registrations
You have 1 registration pending.
Sub-Total: $537.00