Conference Agenda

8:00

Registration

8:50

Chair's opening remarks
Thomas J. Sommer, President, Massachusetts Medical Device Industry Council (MassMEDIC)

9:00

Best Practices in Medical Device Design and Development Process: Templates for Need Finding, Due Diligence and Proof of Concept
Milenko Masic, Principal Research Engineer, Covidien

• 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 late-development phases

9:40

Integrating Risk Management with Product Design
Ron Litke, Senior Project Engineer, Orchid Design

• Understanding why the value of this traceability is in measuring effectiveness of the risk management process and measuring the rework that is driven by risk management
• Requirements, design and software changes resulting from risk management activities as well as defects or problem reports that correlate to previously identified risks
• Analysing the risk management process implemented at different stages of the design process and the business benefits
• Assessing the business benefits of the integration with product/regulatory requirements and verification tests
• Defining roles, responsibilities and activities in the whole Product Risk Management Process

10:20

Coffee break

10:40

IP Strategy Under Patent Reform for Medical Device Design and Development
David J. Dykeman, Shareholder & Patent Attorney, Greenberg Traurig LLP
Roman Fayerberg, Patent Attorney, Greenberg Traurig LLP

• The IP challenges to be considered during product development - what should every product development professional know about the patent system?
• How important is patent protection to a medical device company?
• Avoiding accidental loss of patent rights
• Efficiently integrating a patent strategy into a product development plan amid US patent reform

11:20

PANEL DISCUSSION: Speed to Market for Medical Devices
Chair: Rich Nass, Director of Content, Medical Devices Group for UBM Canon
Panelists: Theresa W. Fossum, DVM and PhD, Texas A&M Institute for Preclinical Studies
Joseph A Heanue, Ph.D., President, Triple Ring Technologies, Inc.
José Colucci Jr., Director, Health & Wellness, IDEO

12:00

Keynote Presentation & Luncheon: Practical Guide to Using Post-Market Safety Data to Target Medical Device Innovation
Nora Illuri, CEO, Clarimed

Afternoon Chair's opening remarks
Rich Nass, Director of Content, Medical Devices Group for UBM Canon

1:30

Human Factors in Medical Device Design
Vicki R. Lewis, PhD, Scientific Director, National Center for Human Factors Engineering in Healthcare, MedStar Institute for Innovation, MedStar Health Research Institute

• High level introduction to human factors engineering
• Meeting the challenge of integrating human factors into established R&D processes
• An overview of changing regulatory expectations
• Discussion of human factors as a risk management activity vs. its broader role in enhancing usability

2:10

Meeting the Demands of the “Next Generation” Patient: User-Centric Design and Development, Current Design and Development Trends
Barb Huibregtse, Vice President Preclinical Sciences, Boston Scientific Corporation

• What does the evolving consumer require and expect?
• How can devices and materials best deliver

2:50

Coffee Break

3:10

From R&D to innovative medical device: The Role of Product Development Policy
Max Shurgalin, Senior Staff R&D Engineer, OmniGuide, Inc

• Learning to remove road blocks in project management
• Applying defect and process economics to decrease wasted effort
• Developing effective management of compliance processes including FDA

3:50

Mobile Medical Devices: A Risk-Based Approach
Sameer Jaiswal, Mgr, Enterprise Software Quality Assurance, Global Quality Systems, Boston Scientific Incorporated

• Unpack the FDA's Mobile Medical Device Draft Guidance and understand the FDA's definitions of Mobile Platform, Mobile Application and Mobile Medical Application.
• Investigate the grey areas of Mobile Platforms and Mobile Applications in the healthcare space – when does a Mobile Platform or Mobile Application require a 510(k) submission.
• Understand the politics of functionality vs cost vs culture when choosing a mobile technology.
• Review some of the issues surrounding validation of mobile technologies and how best to address them in the healthcare space.

4:30

Close of day one

8:00

Registration

8:50

Morning Chair's opening remarks
Shana Leonard, Editor-In-Chief, QMED/MPMN

9:00

Developing Medical Devices for Manufacturability
Vinny Sastri, Ph.D., President, Winovia

• Defining product requirements that meet end-user needs
• Translating product specifications to key process and raw material parameters
• Identifying sources of variation in process parameters and raw materials
• Controlling the right process an raw material parameters
• Conducting an effective design transfer
• Having an effective product development process with cross-functional participation

9:40

Polymeric Medical Device Design – Materials Selection and Characterization
Mary Beth Kossuth, Ph.D., Senior Staff Research Scientist, 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

10:20

Coffee break

10:40

The Roadmap for Materials – Upgraded Functionality and Flexibility; What’s Possible Now? What’s Coming Next?
Stephen McCarthy, Chairman, Polymer, Sciences and Biomaterials, Umass Lowell

• Change Control and device design
• Managing the effects of resin and material portfolio evolution
• Advances, diversity and related compliances
• Considering coatings, additives and advances in bioactive polymers
• Roadmap of material development to reflect end-user demand and lifestyle

11:20

Ensuring Proper Use of Low Cost Bench Testing to Optimize Medical Device Field Results
Lawrence T. Levine, P.E., Partner, Creative Services

• Identify scope of testing to generate reliable data
• Validate/refine predicted failure analyses
• Locate critical failure points and develop corrective action plans that can be tested and verified
• Find likely areas of part degradation and analyze implications
• Provide reasonable estimates on product life

12:00

Lunch

1:30

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 3rd edition that reflect the growing importance of the V&V of software in medical devices
• Introduction to IEC 62304
• Regulatory perspectives
• Technology trends in device networking and “systems of systems”
  

2:10

Choices – IEC 60601-1 3rd Edition and Component Selection
Mark Leimbeck, P.E., Program Manager, Health Sciences, Underwriters Laboratories

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

2:50

Coffee Break

3:10

Supply Chain Collaboration to Better Improve Cost Efficiencies - Compliance, Device Development, Design Transfer And Beyond
Kristen Grumet, Principal, Medical Device Quality Systems, Quintiles
Brad Dawson, Practice Leader, Process Optimization Consulting, Quintiles

• Selecting the best supplier for your needs
• Effective transfer of your product design to an outsourced supplier
• Monitoring methods to assure continued supplier quality throughout the product lifecycle
• Ways to optimize cost-savings without compromising quality or compliance
• Attributes of poorly performing supply chains
• Supply Chain Transformation Guiding Principles

3:50

Supplier Controls – Partnerships in Design through Transfer into Manufacturing
Ryan Sproul, Global Operations Supplier Quality, Smiths Medical & Director of Global Mfg Quality for Smiths Medical

• All types of materials and devices
• Short time-frame 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
• Controlling and approving suppliers
• Considerations for second-tier suppliers (suppliers of those who supply you)

4:30

Close of conference