Monday, Feb. 11, 2013

Plenary Session: Opening Keynote Speech

Is there room for innovation in today's medical device industry?

Stanton Rowe
Corporate Vice President, Advanced Technology and Chief Scientific Officer
Edwards Lifesciences >More

Chair's Opening Remarks

Frank Pokrop, Director Regulatory Affairs, CareFusion

Applying 14971:2012 to achieve compliance with QSR  (21 CFR 820): Building an integrated QMS and implementing best practices in Risk Management

• Latest updates on QSR, cGMP requirements and the relationship with ISO 14971
• Implementing a 14971-aligned risk-based approach to device design and validation
• Identifying strategic criteria for driving critical component decisions and applying appropriate qualification standards
• Best practices in risk assessment through risk analysis, evaluation and control to achieve acceptability
• Understanding the relationship with EU MDD to improve "compliance efficiency"
• Developing a holistic view of risk management for the entire product lifecycle

Frank Pokrop, Director Regulatory Affairs, CareFusion

Implementing ISO 13845:2012 (Quality Management Systems) effectively and understanding  the new expectations from regulatory bodies

• Explaining the key differences between the 2003 and 2012 versions of the ISO 13845 standard
• Understanding the new expectations from Notified Bodies as specified by MDD with regards to ISO 13845
• Reviewing the Voluntary Audit Submission Pilot Program and how the 13845 audits can help achieve efficiency
• Exploring the benefit of implementing UDI in building Quality Management Systems

Marcelo Trevino, Sr Regulatory Compliance Manager – Heart Valves Center of Excellence, Medtronic

A simplified defensible approach to the Validation of Quality System Software

• De-mystifying the requirements for the validation of automated processes used in your quality system.
• Understanding the appropriate V&V strategies for OTS and SOUP software
• Understanding the FDA requirements for the validation of “non-product software” and implementing a practical and defensible approach to the validation of non-product software
• Understanding when “re-validation” of an automated system is required
• Learning to balance regulatory and business requirements

Thomas Bento, Sr. Regulatory Consultant, Certified Compliance Solutions

Risk Analysis technique workshop I

An interactive two-part workshop to walk you through all critical techniques necessary for risk analysis and when to use which technique to optimize your risk management system

• Preliminary Hazards Analysis (PHA)
• Fault Tree Analysis (FTA)
• Failure Mode and Effect Analysis (FMEA): Design, Process and Component

Pete Davis, VP R&D, Bard

Risk Analysis technique workshop II

An interactive two-part workshop to walk you through all critical techniques necessary for risk analysis and when to use which technique to optimize your risk management system

• Hazard and Operability Study (HOZOP)
• Hazard Analysis and Critical Control Point (HACCP)

James (Rusty) Lusk, Principal, Quality Systems International

Plenary Session: Keynote Speech

Innovation with ears: Designing a consumer-friendly medical device

Kim Blickenstaff
President and Chief Executive Officer
Tandem Diabetes Care >More

Chair's Opening Remarks

Michael Barile, Managing Parthner, Barile & Associates

How to Design a Better Reliability Test Program I

The medical industry is competing more on reliability and the FDA is requiring more from reliability programs through IEC 60601 3rd Edition, yet markets are requiring that products be developed faster. This leads to reliability test plans that are often generic or blindly following industry standards. Test plans must be tailored to fit customer use profiles. Also, reliability testing often occurs too late in the process. 

• Demonstrating the similarities between reliability and regulatory test programs
• Understanding unique differences between reliability and regulatory test programs
• Highlighting case examples to illustrate both

Mike Silverman, Managing Partner, Ops A La Carte

How to Design a Better Reliability Test Program II

A high level risk analysis review of each of the other risk analyses with the goal of pulling out the key risks in which you need to create a unique test strategy around (Risk Based Testing)

• Identifying key risks as input to a test program
• Understanding Early Reliability Testing (ERT)
• Developing Better Test Plans

Mike Silverman, Managing Partner, Ops A La Carte

General Lunch Break & Networking

RSVP Required: Lunch & Learn Session – Polymer Technology for Implantables: Devices and Excipients presented by Lubrizol

Process validation: Mastering the guidance and creating a total program

• Understanding the FDA and ISO approaches to process validation and different types of validation (prospective, concurrent and retrospective)
• Implementing IQ, OQ, OP, PPQ  measures and assessing the need for revalidation
• Documenting validation protocol, data analysis and validation reports as quality records

Karema W. Chantasirivisal, Process Validation Manager, Boston Scientific

Applying statistical methods to process validation

• Reviewing recommended statistical tools from GHTF guidance
• Understanding how to design a process validation study
• Developing process and tools for assessing data readiness and process stability
• Understanding how to assess process capability
• Case study: Applying statistical methods to an OQ or PQ study

Chris Wyman, Principal Quality Engineer; Corporate SME, Statistical Techniques, Boston Scientific

Materials process validation for medical devices

• Defining materials process validation
• Understanding the relationships between materials, processes and product quality
• Exploring the categories of materials for medical devices
• Identifying, quantifying and managing risks with materials, processes and products

Allan Kimble, Materials Process Validation Manager, DePuy Synthes – Johnson & Johnson

Plenary Session: Keynote Speech

The science (and art) of miniaturizing medical devices: A closer look at the CD technology in molecular diagnostics

Marc Madou
Chancellor's Professor and BioMEMS Lab Director
UC Irvine >More

Chair's Opening Remarks

Michael Barile, Managing Parthner, Barile & Associates

Updates/Implementation of IEC 60601-1 3^rd Edition: Electrical testing (FDA consensus standard)

• Overview of 3rd edition and Amendment 1
• Understanding some significant changes in amendment 1 to IEC 60601-1 3rd edition.
• ISO 14971 risk management process and the newly-addressed Essential Performance (EP) in amendment 1
• Outlining the collateral standards applicable to certain devices and their harmonization/implementation with IEC 60601-1
• TÜV SÜD's interpretations of some of the ambiguous areas in 60601-1
• Update on Timeline/Acceptance of IEC 60601-1 3rd edition by worldwide regulatory bodies
• Executing your transition to IEC 60601 in a timely manner

Uwe Degenhardt, Division Manager of Active Medical Devices, TÜV SÜD America Inc

Update on ASTM F2914: Shelf life testing for endovascular devices

• Standardizing the way to identify shelf-life attributes
• Utilizing fundamental engineering testing and principles to justify test attributes by age
• Understanding the benefit in saving validation cost and maintain quality control
• Exploring how the reviewer can use the standard as a road map for reviewing a company's justification

Fuh-Wei Tang, Research Advisor Polymer R&D, Bioabsorbable Vascular Solutions, Abbott Vascular

General Lunch Break & Networking

RSVP Required: Lunch & Learn Session – Portable Power Considerations for Medical Devices presented by Electrochem Medical

Featured Keynote Speech - EXPO FLOOR

The Future of Health and Medicine: Where Can Technology Take Us?

From the perspective of a leading physician, scientist, and innovator, this talk examines rapidly emerging, game-changing, and convergent technology trends and how they are and will be leveraged to change the face of healthcare, the medical device industry, and the practice of medicine in the next decade.

The talk will be a deep dive into how emergent fields such as low-cost personal genomics, the digitization of health information, crowd-sourced data, molecular imaging, wearable devices and mobile health, systems medicine, robotics, artificial intelligence, nanotechnology, 3D printing and regenerative medicine are transforming healthcare. The talk also will explain how these developments have the potential to enable clinicians, empower patients, and deliver better care and outcomes at lower cost.

Daniel Kraft, MD
Executive Director
FutureMed >More

Biocompatibility and Chemistry Testing Workshop

A comprehensive workshop to help you understand the newest biocompatibility testing standards in order to be in compliance and improve your in-house techniques

• An overview of ISO 10993 and requirements for medical devices
• Understanding how to evaluate biocompatibility by using material

Thor Rollins, Biocompatibility Specialist, Nelson Laboratories

Biocompatibility and Chemistry Testing Workshop (cont’d)

• Interactive case studies and hands-on applications of biocompatibility testing
• Understanding what happens if you fail "the test" and how to combat a chemistry failure

Thor Rollins, Biocompatibility Specialist, Nelson Laboratories

Bridging the gap between ideas and the marketplace for MedTech

David Gollaher
President and Chief Executive Officer
CHI-California Healthcare Institute >More

Chair's Opening Remarks

Marianne Gill, Director of Clinical Operations, CareFusion

Preparing Investigational Device Exemption (IDE) applications for clinical studies and understanding the new Pre-Submission Program

• Updating on the IDE submission process and best practices in IDE submissions
• Determining whether a device requires IDE and understanding all the requirements for clinical evaluation of the devices
• Developing an investigational plan and fulfilling IDE data requirements
• Reviewing how manufacturers benefit from the new Pre-Submission Program (in place of the Pre-IDE submissions) to obtain FDA feedback on IDE applications, including requesting meetings with CDRH and CBER

Denise McEachern, VP Global Regulatory Affairs, Bausch + Lomb Surgical

Pre-clinical test strategies through Product Development Process (PDP)

• Concept phase testing: Customer needs, proof of concept demonstration  and  specification development
• Design phase testing:  Regulatory submission pre-clinical test plan  and development of test methods for final specifications
• Validation and Verification testing: Bench tests, Simulated use tests, Animal studies and Biocompatibility studies
• Clinical Investigation:  Safety and efficacy pre-clinical studies to support IRB/EC submissions

Janie Mandrusov, Director or Preclinical and Clinical Development, SinuSys Corp

Designing a clinical trial strategy for success

• Updating on US and EU clinical data requirements for medical devices
• Applying ISO 14155:2011 for good clinical practice in conducting clinical trials
• Establishing criteria for a successful clinical trial, including human subjects and trial sites
• Controlling cost in clinical studies to still ensure feasibility of the device project

Michael A. Daniel, President, Daniel & Daniel Consulting

Applications of biostatistics to the design, execution and analysis of clinical trials for medical devices

• Understanding the role of efficient statistical design and sound analysis in the success of clinical trials
• Discussing statistical considerations in the design, execution and analysis of clinical trials
• Applying  novel approaches through two case studies: 1) The use of adaptive trial design strategy for sample re-estimation, 2) The issues and complexities that arise in medical device trials and analytical strategies for addressing them

Lei Peng, Associate Director of Biostatistics, Abbott Vascular

Cost savings in clinical trials: Practical strategies and tools

• Exploring best practices for controlling cost in clinical studies
• Identifying areas that could result in cost savings while continuing to support pre-market submission and product adoption
• Managing contract research organizations (CRO) to ensure cost-effectiveness and intended results: A case study

Mariam Mirgoli, Director of Clinical Solutions, Abbott Vascular