The BIOMEDevice San Jose Conference 2011

The two day BIOMEDevice San Jose Conference focused on the product design and development process for medical devices. Industry experts addressed specific topics such as user needs and risk analysis, IP, regulations, 510(k), human factors, and supplier controls. Our mission is to ensure you leave the conference with new insights and practical information you can immediately apply to your job responsibilities.


Conference Agenda
TUESDAY, DECEMBER 6, 2011
Session runs from 9 a.m. – 4 p.m. with one-hour lunch break
Product Development and FDA Approval Process for Medical Devices
Chairs: H. Semih Oktay, Ph.D., CardioMed Device Consultants; and Nitin Salunke, Ph.D., Director, R&D, Cordis Corporation, a Johnson and Johnson Company
Product Development Process:
Carolyn Rice, R&D Manager, Cordis Corporation a Johnson & Johnson company

  • Overview of product development process.
  • How do you plan for a successful design process?
  • User needs and risk analysis.
Intellectual Property Considerations During Product Development:
Andrew I. Kimmel, Partner, Knobbe Martens

  • What should every product development professional know about the patent system?
  • How important is patent protection to a medical device company?
  • How to avoid accidental loss of patent rights?
  • How to efficiently integrate a patent strategy into a product development plan?
  • Is it better to patent or keep inventions as trade secrets?
  • Why is it important to include the IP team during the entire product design and development process?
  • How can patent and FDA strategies overlap and affect each other?
Panel Discussion
FDA Approval Process for Medical Devices:
H. Semih Oktay, Ph.D.

  • Overview of the FDA process for medical device approval
  • Pre-market Notification (510 (k))
  • Pre-market Approval (PMA)
  • Humanitarian Device Exemption (HDE)
  • Investigational Device Exemptions (IDE)
  • How to deal with FDA
  • Preparing for FDA meetings
Regulatory and Clinical Considerations: Industry Perspective:
Zachary J. Woodson, Sr. Regulatory Affairs Manager, Medtronic CardioVascular

  • Conducting clinical trials around the globe.
  • Managing information across geographies and vendors.
  • Regulations across geographies.
  • Understanding total product life cycle.
  • Challenges during the product development and regulatory approval process for the US and global markets.
Panel Discussion and Wrap-up

WEDNESDAY, DECEMBER 7, 2011
Session runs from 9 a.m. – 4 p.m. with one-hour lunch break
Design and Development of a Medical Device: From Concept to Production
Chair: Barrett C. Craner, CQE, CRE, Vice President QA/RA, Stellartech Research Corporation
Best Practices in Medical Device Design and Development Process: Using templates for need finding, due diligence and proof of concept:
Avi Roop, CEO, Miret Surgical

  • How to evolve from making observations, to understanding problems to defining unmet clinical need.
  • How the statement of unmet clinical need is key to raising money, reducing time to market and communicating with your customer.
  • How the integration of front end performance criteria, highly iterative prototyping processes and repeated customer interaction drive failure to occur earlier in the development life cycle and not in the more costly later development phases.
Human Factors in Medical Device Design:
Eric Bergman, Ph.D., Director, Human Factors Engineering, LifeScan Inc., a Johnson & Johnson company

  • A high level introduction to human factors engineering.
  • An overview of changing regulatory expectations.
  • Discussion of human factors as a risk management activity vs. its broader role in enhancing usability.
  • Interactive discussion/Q & A.
Supplier Controls:
John P. Haynes, Materials Manager, BioCardia

  • Integrating Supplier management work into the engineering team
  • Understanding the short time-frame engineering needs for the product development environment
  • Long-term needs of ramp-up and steady manufacturing
  • Small and large lot production
  • Finding obsolete or hard-to-find materials
  • Selling our suppliers on the company and the product (critical for a start up company)
  • Working with, controlling, managing, and approving suppliers
  • Considerations for 2nd tier suppliers (suppliers of your suppliers)
  • When to implement an ERP system
Polymeric Medical Device Design - Materials Selection and Characterization:
James P. Oberhauser, Ph.D., Manager, BVS Polymer R&D, Abbott Vascular

  • Polymeric medical device design requirements influence materials and manufacturing process selection.
  • Thermal and deformation history in polymer processing dictate microstructure and macroscopic material properties.
  • Polymer processing principles transcend the boundaries of medical device manufacturing, and learning from other industries can be instructive.
Panel Discussion – Speed to Market for Medical Devices:
Panelists: Mir Imran, Chairman & CEO, InCube Labs and Modulus; Joe A. Heanue, Ph.D., President, Triple Ring Technologies, Inc.; Stacey Chang, Healthcare Director, IDEO; and Roger A. Stern, Ph.D., President and CEO, Stellartech Research Corporation
Developing Medical Devices for Manufacturability
Software Verification and Validation: Implementing critical updates to IEC 60601:
Anura S. Fernando, Research Engineer, Underwriters Laboratories

  • Brief history of software safety and the role of Verification and Validation (V&V)
  • The role of IEC 60601-1-4 with Programmable Electrical Medical Devices (PEMS)
  • Changes to the structure of IEC 60601-1 Third Edition that reflect the growing importance of the V&V of software in medical devices.
  • Introduction of IEC 62304
  • Regulatory perspectives
  • Technology trends in device networking and “systems of systems”
Choices – IEC 60601-1 3rd Edition and Component Selection:
Mark Leimbeck, P.E., Program Manager, Health Sciences, Underwriters Laboratories Inc.

  • Background on the standard – the source of the risk management requirement and the intent.
  • Certification options in assessment and licensing of components.
  • The roles and responsibilities of both component and end-product manufacturers in risk management.
  • Conclusion
Panel Discussion and Wrap-up

For questions regarding conference, please call 310/996-9435 or email ubmcanonconference@ubm.com.