Medical Devices Summit West 2015

Reducing Risk and Increasing Return through Cutting Edge Business Strategy and Technological Innovation
June 25-26, 2015
San Jose Marriott
San Jose, CA

Conference Details
Today most medical devices are part of a larger system and they no longer work as stand-alone items. Information platforms are built into medical systems, wireless tools are rapidly evolving, and connectivity and interoperability have increasingly become an integral part of health systems.

Join industry professionals for this year's Medical Devices Summit West! The only way to push the envelope of innovation is by sharing new ideas, promoting novel technologies, and working together on strategies for fostering development. Join us for discussions on the most cutting edge software and devices on the market, and most importantly- learn how they got there, and what they're doing to stay ahead!

Attendees will be given the opportunity to work closely with thought leaders to share ideas, experiences and strategies- while working towards a common goal of truly revolutionizing the medical devices industry.
Target Audience:
Medical Devices Manufacturing Companies- Manager/ Engineers/Director/ VP of:
  • Product Design
  • Marketing
  • R&D
  • Business Development
  • Engineering
  • Software
  • And anyone who is truly interested in the future of Medical Devices!
Testimonial from Past Event:
“The Medical Device Summit West provides an ideal forum for the industry to come together to discuss the evolving connected healthcare landscape. It provides an opportunity to explore topics that continue to be top of mind for medical device manufacturers, such as connectivity and security in this Internet of Things era,”
--- Dean Chen, Director of Product Management, Wind River
Hotel Info:


Conference Registration Prices:
Early Bird Rate
Standard Rate
Service Providers & Vendors
Medical Device Manufacturers, Academia,
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
Subject to approval. *To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by Opal. Opal reserves the right to allocate places and to refuse applications or to charge a normal attendance fee once the number of complimentary places has been exceeded.

Registration price reflects $100 online discount
Gold Sponsor:

Boston Biomedical Associates

Media Partners:
OR Manager (Access Intelligence)    CanBiotech Innovations  Contract Biotechnology  Cutting Edge Information  Extension Media  FierceBiotechFierceMedicalDevicesFiercePharmaPharmaLicensing JSB Market Research  Labroots  Markets and Markets Market Wired  Medical Design Briefs  Medical News Today OpenSystems MediaTechnology Networks

Past Attendees
Principal Scientist, Abbott ADD
Software Manager Informatics, Abbott Diabetes Care
R&D Program Manager, Abbott Diabetes Care
Software Engineer, Abbott Diabetes Care Inc
Software Engineer, Abbott Diabetes Care Inc
Software Engineer, Abbott Diagnostic Care
Software Manager, Abbott Diagnostic Care
R&D Program Manager, Abbott Diagnostic Care
Quality Engineer, Abbott Laboratories
Engineer, Abbott Medical Optics
R&D Engineering Manager, Abbott Medical Optics Inc
Reg Affairs PM, Abbott Vascular
Global IT Director, Abbott Vascular
Sr. Quality Engineer, Abbott Vascular Structural Heart
President, Advanced NeuroSystems
Director, Software Development, AgaMatrix, Inc.
Management Analyst, Alameda County Public Health Commission
Founder, CTO, Alfa Thermodiagnostics
CEO, Alfa Thermodiagnostics
CEO, Alfred Mann Foundation for Scientific Research
Director of Regulatory Affairs, Andover Healthcare
Director, Animas Corp
M.Sc. of Bioengineering, Aurora Engineering Ltd.
Director of Innovation and Advanced Technology, Bard Access Systems
Sr Scientist, Beckman Coulter
President, BioKey Engineering
Global Software Methods & Tools, bioMerieux
Partner, Bookoff McAndrews
Partner, Bookoff McAndrews, PLLC
Principal Consultant, Boston Biomedical Associates
Director of Business Development, Boston Biomedical Associates
Quality Engineer, Boston Scientific
Senor Manager, IS, Boston Scientific
VP of IT, Boston Scientific
Quality Assurance, Boston Scientific
Regulatory Document Specialist II, Boston Scientific
Senior quality engineer, Boston Scientific
Sr. SW Quality Engineer, Boston Scientific
Manufacturing Engineering Manager, Boston Scientific
Director, R&D, Boston Scientific
Quality Engineer, Boston Scientific Corporation
Project Engineer, Boston Scientific Corporation
Sr Legal Counsel, Boston Scientific Corporation
R&D Engineer, Boston Scientific Corporation
STEM Program Coordinator, Boys and Girls Club of the Silicon Valley
Director of Business Development, BRTI Life Sciences
Partner, Cambridge Design Partnership
Manager, Cambridge Design Partnership
Sr Mfg/Mech Engineer, Care Innovations
Sr. Principal Engineer, Hardware Quality, CareFusion
Professor, CareFusion
Adjunct Professor, Carrington College
Associate Director of Surgical Safety, Cedars Sinai Medical Centre
CEO, CenterVue
Director worldwide market development, Cepheid
R&D Engineer, Cervel Neurotech
VP R&D, Cervel Neurotech
Engineer, Cervel Neurotech
Vice President QA/RA, Clarity Medical Systems Inc
Vice President QA/RA, CoaguSense Inc
Principal QE / Auditor, Cordis / J&J
Principal Engineer, Engr. Programs & Systems, Cordis Corporation
Staff Engineer, New Product Development QE, Cordis, Johnson and Johnson
Sr. Manufacturing Engineer, Covidien Ltd.
Information  Technician, CSC Laboratories
Marketing Graphics, CSC Laboratories/ CSC Group
President, Devine Guidance
Professor, DeVry University
Business Development, Doctor on Demand
Quality Director, Draeger Medical Systems Inc
President, Edison Nation Medical
MD, Edward Manougian, B.S., M.D.
Product Marketing Manager, Embase, Embase
Director Product Development, Embase (Elsevier)
Customer Consultant, Embase (Elsevier)
R&D Project Director, Ethicon
Commissioner's Fellow, FDA
Scientist, Fibrogen Inc
Business Development Manager, Flextronics International Kft
President & COO, Freedom Meditech
Director - Corporate Development, Freedom Meditech
Device Engineer, Genentech
Biomedical Engineer, GluMetrics Inc.
Owner, Goldenbuffalo
Owner, Goldenbuffalo
Manager, Goldenbuffalo
Sr. Software Quality Engineer, Haemonetics Inc.
Sr. Project Manager, Halozyme Therapeutics Inc
Software Engineering Manager, Hansen Medical
Regulatory Director, HealthSTATS
General Manager - USA, HealthSTATS
Senior Director of IT Security,, HealthSTATS
Chief Scientific Officer, Hemotek
Scientist, Hengkang Medical Group
Medical Equipment Coordinator, Hospital Universitari de Girona
Medical director, Humana
Post-Doctoral Research Associate, Incube Labs
CEO, Innova Medical Design
Sales and Marketing Manager, Introtek International
VP of Marketing, Jama Software
Solutions Architect, Jama Software
Technology Analyst, Johns Hopkins University
Production Planning Lead, Johnson & Johnson
R&D PROGRAM MANAGER, Johnson & Johnson
Assistant Professor, Kennesaw State University
R&D Manager, Konica Minolta Laboratory USA
Scientist, Lawrence Berkeley National Laboratory (LBNL)
Business Development and Marketing, Lift Labs
CEO, Lift Labs
Technical Advisor, MedDev Corporation
QA Manager, MedDev Corporation
Regulatory Compliance Consultant, Medicines 360
Quality Assurance Consultant, Medicines360
Senior Director Device Development, Medicines360
Quality Assurance Device Consultant, Medicines360
General Manager;VP of Clinical Affairs, Medicines360
Electrical engineer, Medtronic
Regulatory Affairs Specialist, Medtronic
Director of Regulatory Affairs, Operations & Compliance, Medtronic Vascular
Associate Reg Ops Specialist, Medtronic Vascular
R&D Engineer, MID Labs
International Rep, Ministry of Economic Development
CEO, Mitre Medical
Chief Business Officer, Mitre Medical
Director, Finance and Admin, Modulated Imaging Inc
Director of Research, Modulated Imaging Inc
CEO, Modulated Imaging, Inc
Vice President, Modulated Imaging, Inc
Associate Director, Software Development, Neuronetics Inc
Board Member, NeuVerus Health Inc.
Principal, Nexus
, Nexus
Owner, Noel Medical
Professor, North Carolina Central University, School of Law
SVP of Product Development, Novabay Pharmaceuticals, Inc.
Quality Assurance Associate  I, Novabay Pharmaceuticals, Inc. (FKA: Novacal Pharmaceuticals)
Associate Director, Quality Assurance, Novabay Pharmaceuticals, Inc. (FKA: Novacal Pharmaceuticals)
Chief Executive Officer, Nutek Corporation
Business Development Manager, Nutek Corporation
Creative Director, Ophardt Hygiene Technologies
Engineer, Ortho Clinical Diagnostics
Sr. Project Engineer, Ouroboros Medical
Research Scientist, Pacific Science & Engineering Group
Clinical Documentation Analyst, Precision Healthcare Systems
Owner, Prestige Health Care Technologies
Sr Director, PRI
PHD/VP of Science & Research, Propeller Health
Director of Business Development, Propeller Health
Sr. Director, Program Management, Proteus Digital Health
Associate Director, Product Development, Proteus Digital Health
Sr. Manager, Software Development, Proteus Digital Health
Director, Pulsecor
Chairman, Pulsecor
CEO, Pulsecor
Vice President, Pulsecor
Manager, Pulsecor
President, Rand-Scot, Inc
Project Coordinator, Business Development, Reed Technology
Sr Manager, Information Solutions - Life Sciences, Reed Technology
Sr. Scientist, ReLIA Diagnostics
Director (Biomedical Engineering Program), San Jose State University
Asst. Professor of Bioengineering, Santa Clara University
Manager of Laboratory, Santa Clara University
Research Assistant, Santa Clara University
Research Assitant, Santa Clara University
Health Services Administration, Savin Medical Center
M.D. (graduated medical student -pursuing residency), Savin Medical Center
Operation Manager, Savin Medical Center
Product Marketing Manager, Seapine Software
Life Sciences Business Development Manager, Seapine Software
Life Sciences Solutions Specialist, Seapine Software
Life Sciences Solutions Specialist, Seapine Software
Regulatory Specialist, Siemens Healthcare Diagnostics
R&D consulting Engineer, Silk Road Medical, Inc.
Embedded Security Engineer, Southwest Research Institute
Group Leader Embedded Security, Southwest Research Institute
Senior Director , Marketing and Business Development, Spinal Kinetics Inc
MEDICAL DOCTOR, St luke's hospital wusasa
Medical Director, St luke's hospital wusasa
Design Assurance Engineer, St. Jude Medical
Design Engineer, St. Jude Medical
V.P Global Client Solution, St. Louis Regional Chamber
Research Associate, Stanford University
Sr. Design Engineer, Stryker
Senior Design Engineer, Stryker
Chief Engineer, Stryker
Principal Architect/Engineer, Stryker
Design Engineer, Stryker
General Partner, Sue Rowinski Group
Director of Operation - Western Region, Sunrise Labs, Inc.
Executive Vice President for Interoperability and Research & Development, The Center for Medical Interoperability
Sterility Assurance Engineer II, Thoratec Corporation
Environmental Services Program Manager, TUV Rheinland
Event Manager, TUV Rheinland
ICT Director, TUV Rheinland
Regional Sales Representative, TUv Rheinland
Sales Executive Medical, TUV Rheinland of North America, Inc.
Associate Professor of Emergency Medicine and Vice Chairman, UC College of Medicine
Associate Director, UC San Francisco
Program Representative, UCSC Extension in Silicon Valley
Advisory Board Member for Medical Devices, UCSC Extension in Silicon Valley
UCSC Extension Program Chair, UCSC Extension in Silicon Valley
UCSC Extension Instructor, UCSC Extension Silicon Valley
UCSC Extension Instructor / Advisory Board Member for Medical Devices, UCSC Extension Silicon Valley
Assistant Professor, University of California San Francisco
Research Scientist, University of Washington
Editor, US China Healthcare Information Exchange
Eng Manager, U-Systems , Inc.
Director Technology Office, Varian Medical System
Manager, SW Engineering, Varian Medical Systems
Director, Cloud Solutions, Varian Medical Systems
Sr Manager, Translational Research, Varian Medical Systems
VP of Quality & Regulatory, Vascular Flow Technologies
RN,MSN/ED, TAN, Veterans Hospital of Fresno CA
Director of Worldwide Sales & Marketing, VORTRAN Medical
VP Quality Assurance, VORTRAN Medical
Vice President of Operations, VORTRAN Medical
General Counsel, VP of Business Strategy, Vortran Medical
VP/COO, VORTRAN Medical technology 1, Inc
Business Change Director, WellPoint
Associate Professor, Wentworth Institute of Technology
Chair, BME & Professor, Wentworth Institute of Technology
Chief Medical and Science Officer, West Health
Director of Intelligence, Wind River
Engineering Specialist, Medical Device Solutions, Wind River
CEO, Wireless Medical Monitoring
VP Hardware, Wireless Medical Monitoring
Sr. Regulatory Affairs Specialist, ZELTIQ Aesthetics
Director,Regulatory Affairs, ZELTIQ Aesthetics
Quality Manager, Zonare Medical Systems
2014 Agenda (current as of 6/30/14)
Past Conference Day One: Thursday, July 10, 2014
8:15 am
Continental Breakfast & Registration
9:00 am
Opening Remarks
9:05 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.

Mack D. Rubley, Director of Business Development, Boston Biomedical Associates
Paulette Niemyski, Principal Consultant, Boston Biomedical Associates

Boston Biomedical Associates
9:15 am
Keynote Speech - Meeting the Unmet Need: Product Development Planning and Execution

David Hankin, CEO, Alfred E. Mann Foundation
10:00 am
Bridging Points of Contention in University-Industry Licensing Deals

Ami Gadhia, Director- Physical Sciences & Engineering, Johns Hopkins Technology Transfer
Dinesh N. Melwani,
Leslie I. Bookoff, Partner, BOOKOFF MCANDREWS, PLLC

Bookoff Mcandrews
10:30 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
Boston Biomedical Associates
11:00 am
Implementing Unique Device Identification (UDI)

Gary Saner,
Senior Manager of Information Solutions for Life Sciences, REED TECH
11:30 am
Clinical Study Execution: Planning around the Pitfalls
  • Selecting the right trial designs for First in Human and IDE studies that lead to product approval
  • Key factors that improve ability to meet study timelines
  • Data management tips and hints
  • Having the right team in place
  • How to mitigate risks during trial execution

Paulette Niemyski, Principal Consultant, Boston Biomedical Associates

Boston Biomedical Associates

12:15 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 Systems
Ken Herold,
Medical Engineering Specialist, Wind River Systems

Wind River
12:45 pm
Networking Luncheon
1:45 pm
Leveraging Mobile and Digital Health Devices to Promote a Behavioral Symphony of Wellness

Dennis Robbins, Director of Translational Ethics and Policy, Pearl Translational Network and NYU, Chief Business Development officer, CINA and KPN Management Partners
2:30 pm
Human Factors Usability, Efficiency and Safety
  • Human Error in Healthcare
  • Human Factors & Systems Design
  • Usability and FDA 510K Human Factors Considerations

Ken Catchpole, Associate Director of Surgical Safety, Cedars Sinai Medical Centre

3:00 pm
Conducting Medical Device Safety and Performance Assessments

Daan de Jong, Director Product Development, Elsevier Information Systems, Embase 
4:00 pm
Afternoon Refreshment & Networking Break in the Exhibit Hall
4:15 pm
Getting from Connected to Seamless Interoperability

Ken Fuchs,
Executive Vice President for Interoperability and Research & Development, The Center for Medical Interoperability
Joseph Smith, MD, PhD, FACC, Chief Medical and Science Officer, West Health
5:00 pm
Day One Closing Remarks and Cocktail Reception (in the Exhibit Hall)
Past Conference Day Two: Friday, July 11, 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 - Wind River

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

Dean Chen, Director of Product Management, Wind River

Wind River

Roundtable 2 - TUV Rheinland

Session A: Regulatory Changes in Environmental Compliance Discussion

  • Overview of Major Changes to the RoHS Directive (RoHS2)
  • RoHS2 Timelines
  • Proving Compliance
  • Articles under the REACH Legislation

Geoffrey Bock, Environmental Services Program Manager, TUV Rheinland

Session B: Wireless Platforms

  • TUV Rheinland compliance platform software solution
  • Data collection through GreenSoft

Ivaylo (Val) Tankov, ICT Director, TUV Rheinland

Roundtable 3 - Real Time Innovations (RTI)

How to increase the scale and connectivity of medical devices
Imaging, robotics and radiotherapy devices incorporate more software and microcontrollers. Patient monitors and anesthesia machines are expected to better integrate with electronic health records and third-party applications. With the Data Distribution Service (DDS) standard, you can more quickly develop these distributed control systems and interoperable devices.

David Barnett, Vice President of Products and Markets, RTI
10:00 am
Using a Case Study Approach to Describe How Telemedicine is Reinventing Healthcare Delivery and Reimbursement Approvals
Telemedicine and Medical Mobile Apps (MMA) are quickly emerging as a critical way to increase patient access to healthcare.  To be commercially successful in this developing market, companies may want to consider incorporating early in the development process the patient experience design and healthcare provider reimbursement. Typically, these two items are addressed just prior to or after product launch.
  • How telemedicine and MMAs devices are changing healthcare delivery.
  • Why commercial success is inexplicitly linked to provider reimbursement and the patient’s experience during the telemedicine clinical session.
  • A key strategic decision that will help to define the scope of your reimbursement plan for your telemedicine or MMA medical device.

Lena Cheng, MD,
Business Development, Doctor on Demand
Susan Rowinski, MSE, President, Rowinski Group LLC
10:30 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.
11:00 am
Wireless Robustness and Security: Protecting the Patient, User and Manufacturer

Vasudev Nambakam, Principal Architect/Engineer, Stryker
Emmet McCarthy
, Chief Engineer, Stryker

11:30 am
Implementing Tools for Effective Supplier Management in the Medical Device Industry

Dr. Christopher Devine,
President, Devine Guidance
12:00 pm
The Sell-Build Model: Maximizing Product Acceptance
  • How to co-design products with the intended users
  • Method for bringing the best product to market the first time
  • Steps to stop a bad choice before it is too late
  • Leveraging the latest technologies and market research techniques

Jonathan Honiball, Senior Director, Customer Research, Pacific Consulting Group

12:30 pm
Networking Luncheon
1:30 pm
An Apple a Day? Really?  - Collaborative Design of Medical Devices
  • Understand how physicians, nurses, and allied health professionals work together and can affect product design
  • Discuss the application of human factors engineering to the design of new products as well as to postmarket evaluation of currently marketed products
  • Invite the opinion that design can be better when properly placed within an end-to-end medical care experience
  • Show how industry can work with medical providers to develop novel devices and mitigate user error

Andra L. Blomkalns, MD, Associate Professor of Emergency Medicine and Vice Chairman, University of Cincinnati

2:00 pm
Responding to observations from FDA
  • Observations/483 Warning Letter related regulations
  • Real life Observations/483 Warning Letter
  • How to respond to observations/warning letters from FDA
  • How to avoid FDA observations and warning letters
Bill Kurani, MSRA, MSEE, BC, Advisory Board Member for Medical Devices, UCSC
2:30 pm
Conference adjourns
Service Providers (including contract manufacturers, consultants and legal groups) Early Bird
Medical Device Manufacturers, Academia, Government
First 100 FREE
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