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

Heather Thompson, Editor-in-chief, MD+DI

FDASIA Recap: Clarifying the review process and the benefit-risk determinations for PMA and de novo applications

• Understanding the clear guidelines on what FDA looks for when making benefit-risk determinations
• Identifying principal factors of the decision-making process for PMA applications, pathways for high-risk, to moderate and low-risk devices
• FDA guidance on how to deal with the unknown unknowns
• Demonstrating what constitutes "critical components" and what the FDA typically looks for in critical components
• Updating on electronic submissions and how to use the system

Randall Brockman, Chief Medical Officer, Acting, Office of Device Evaluation, CDRH / FDA

Reviewing the 510(k) Triage and Quick Review pilot program and an update on the new process, including the RTA policy change

• Highlighting results from the 6-month pilot program, Triage, which involves a 30-day quick review for IVD products, and understanding how to qualify for the pilot program
• Updates on electronic submissions and how to use the system
• Identifying potential new submission procedures and discovering plans to improve efficiencies
• Understanding how the FDA determines substantial equivalence to an existing legally marked device
• Discussing the Refuse-to-Accept policy change and how to complete the checklists

Don St. Pierre, Deputy Director for New Product Evaluation, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH / FDA

FDA Los Angeles District Update and the FDA Globalization Initiative

• A recap of the LA District Office’s activities in warning letters, 483s, inspections and audits
• Introducing the FDA Globalization Initiative and the impact for the global supply chain
• Outlining the LA District Office’s focus areas for 2013
• Updating on the new import program

Alonza Cruse, Director, FDA – Los Angeles District Office

Update on Los Angeles Import Operations Activities

• Port of LA Import Statistics for 2012
• Los Angeles Import Operations Activities in 2012
• Los Angeles Actions on stopping Counterfeits from coming through LA Ports
• Brief presentation on Import Provisions in the new FDA Drug/Medical Device Law - FDASIA (FDA Safety and Innovations Act)

Dan Solis, Director of Import Operations, FDA – Los Angeles District Office

The FCC's perspective on wireless connectivity in medical devices

• Overview of FCC regulations around radio communications in medical devices
• Exploring the impact of FCC rulemaking on the availability of frequency bands designated specifically for medical purposes and the implications for Medical Micropower Networks (MMN) and Medical Body Area Networks (MBANs)
• Understanding how medical device manufacturers can utilize the new spectrum to integrate their products better with the healthcare system and FCC recommendations for wireless medical devices

Mark Settle, Deputy Chief - Policy and Rules Division, Federal Communications Commission

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

Helene SpencerOrange County Regulatory Affairs Discussion Group (OCRA)

Regulatory strategies for 2013: The art of framing a successful submission

• Developing effective strategies for regulatory submissions and structuring a rationale that resonates with the FDA
• Understanding the reviewer's perspectives and requirements to document effective submissions
• Utilizing available resources and information about the latest requirements at the FDA to ensure a comprehensive submission
• Devising strategies to interact with the FDA

Michael Morton, Senior Director of Global Regulatory Affairs, Medtronic

Nanotechnology and nanomaterials in medical devices – The regulatory frontier

• Clarifying the definition(s) of nanotechnology/nanomaterials across different Health Authorities and understanding the standard definition
• Discussing the structure and function of the U.S. Nanotechnology National Initiative
• Understanding the FDA guidances and points-to-consider specific to nanotechnology/nanomaterials and how the agency plans to use the current processes to support products containing or manufactured with nanotechnology/nanomaterials
• Understanding the EU guidances and standards applicable to nanotechnology/nanomaterials and how the proposed changes to the EU regulations will affect devices
• Understanding Health Canada’s working definition and its current policy toward nanotechnology/nanomaterials
• Exploring other regulatory issues including potential environmental concerns with nanotechnology/nanomaterials
• Discussing the future of nanotechnology and nanomaterials in medical devices

Mary Gray, Manager of Regulatory Affairs, DePuy Synthes - Johnson & Johnson

General Lunch Break & Networking

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

Strategies for the 510(k) pathway: Submission & approval

Mr. DuVal on January 2, 2013 filed a Citizen Petition with FDA on behalf of the Minnesota Medical Device Alliance (MMDA), an unincorporated, voluntary affiliation of pre-revenue, small and mid-tier medical device companies, venture capitalists and some inventing physicians. The Petition was filed to challenge and force discontinuation of the administrative practices and definitional interpretations that FDA has put into practice since 2009 in reviewing 510(k)s which have dramatically changed the manner in which the 510(k) program operates. He petitions the FDA to suspend adoption of its proposed guidance entitled "Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," dated December 27, 2011, (hereinafter "the New 510(k) Guidance") and to revert to use of the 510(k) guidance documents currently in existence, until FDA has had the time to obtain additional input from the industry. The Petition chronicles many specific issues, some of which will be covered during this session, including:

• Mr. DuVal will discuss the specific issues in the Petition which explains how FDA is operating the 510(k) program today, including the use of the “stage-gated” approach to reviewing submissions
• This involves how FDA is interpreting same intended use, same technological characteristics and whether the device raises new questions of safety and effectiveness
• Establishing criteria for selecting a master device and grandfathering
• How FDA is pushing more devices onto the de novo path
• How FDA's Additional Information letters ask for information and data that exceeds the Least Burdensome requirements
• How FDA asks for data it wants but does not need (or which it cannot request)—how FDA requests for the information it would want in an “ideal” world
• How to negotiate with FDA on these matters
• A glimpse of the de novo path

Mark DuVal, President, DuVal & Associates

Strategies for the PMA pathway: Submission & approval

• Determining whether a device requires PMA and exploring strategies around establishing “reasonable assurance” of device safety and effectiveness
• Preparing summary of IDE data, preclinical and clinical studies and conclusions, and all study reports
• Identifying the criteria for establishing an Expert Advisory Panel review for original PMAs
• Addressing questions of safety and effectiveness based on scientific data and clinical information
• Discussing items to include in a PMA application
• A case study on PMA submission

Susan Petersen-Stejskal, VP Clinical Research, BioControl-Medical

Strategies for the combination product pathway: Submission & approval

• Determining whether a device is considered a combination product
• Understanding the Classification of Combination Products and the Request for Designation (RFD) process at the OCP
• Determining the regulatory requirements to initiate a clinical study involving combination products, including strategies around Significant Risk or Non-Significant Risk determination for Institutional Review Board (IRB) approval
• Interactive case study on Combination Products

Winifred Wu, President, Strategic Regulatory Partners LLC and former VP Regulatory and Medical Affairs, Medtronic

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

Session Chair's Opening Remarks

Steve Cochran, Chief Technology Officer, GHX

Unique Device Identifier: FDA update and plan for the industry

• Reviewing the proposed rule on UDI and future developments
• FDA-recommended critical action items for medical device manufacturers to take in order to comply with the UDI rule
• Understanding the implications for patient safety, electronic health records management and adverse events monitoring
• Exploring immediate solutions to achieve UDI compliance for on-going projects

Jay Crowley, Senior Advisor Patient Safety, FDA

Industry perspective: Where is the industry at in terms of implementation? The next steps

• Understanding how medical device manufacturers can benefit from UDI
• Best practices in implementing UDI standards
• Understanding UDI as the foundation to regulatory master data

Jackie Elkin, Global Process Owner - Standard Product Identification, Medtronic

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

Panel discussion: Creating a roadmap for UDI compliance from multiple perspectives

• Developing a transition plan to successfully incorporate UDI into internal quality control system
• Understanding the specifications of the automated identification system
• Implementing practical steps to prepare for UDI compliance
• Exploring the implications for supplier management

MODERATOR: Karen Conway, Executive Director, GHX

Jay Crowley, Sr. Advisor Patient Safety, FDA

Jackie Elkin, Global Process Owner - Standard Product Identification, Medtronic

Siobhan O’Bara, Vice President, GS1 Healthcare US

Joe Pleasant, CIO, Premier

Leveraging GS1 standards to comply with UDI

• Learning how GS1 standards fit with the UDI rule
• Understanding the enterprise-wide impact of UDI
• Reviewing the Common Comments on the proposed rule
• Implementing UDI in practice

MJ Wyllie, Sr. Director Healthcare, GS1 Healthcare US

Reviewing labeling and packaging solutions for UDI-compliant medical devices

• Understanding the key requirements for labeling and packaging  in accordance with the UDI rule
• Identifying different levels of packaging  (pallets vs. individual units) that require UDI for each medical device type
• Reviewing different labeling technologies such as AIDCT , linear bar codes, two-dimensional bar codes, RFID, etc. and determining the criteria for the best system
• Exploring best practices for labeling and packaging to achieve compliance and cost-efficiency
• Interactive case study on effective labeling and packaging systems for medical devices

Dawn Fowler, Sr. Manager of Global Labeling and Document Control, Endologix

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

Michael Morton, Senior Director of Global Regulatory Affairs, Medtronic

Internationalization of medical devices: Regulatory and commercialization challenges

• Understanding the globalization trend in medical device development and reviewing major market opportunities and challenges in key device markets such as EU, Japan, China and emerging markets
• Outlining the importance of reengineering certain device functionalities to meet local market needs and maximize commercial potential
• Addressing international regulatory challenges related to market entry, post-market surveillance, specific compliance requirements and documentation protocol
• Discussing best practices in bringing medical devices to foreign markets

MODERATOR: Michael Morton, Senior Director of Global Regulatory Affairs, Medtronic

Kirk Zeller, Director of International Market Development, Codman Neurovascular - Johnson & Johnson

Wenkai Ma, Director of Global Regulatory Affairs, Allergan China

Chris Sarner, Project Manager, DEKRA Certification B.V.

Gunjan Bagla, Managing Director, Amritt Inc.

Bringing medical devices to Japan

• Discovering commercial opportunities and understanding risks when entering the Japanese market for medical devices
• Understanding cultural differences to ensure successful business relationship
• Understanding the Japanese regulatory environment the approval process for medical devices and commercialization steps
• Understanding the clinical data evaluation process for “new to market” and “high risk” devices
• Addressing issues around designating a Marketing Authorization Holder (DMAH) and how to obtain PMDA approval in a timely manner

Kirk Zeller, Director of International Market Development, Codman Neurovascular – Johnson & Johnson

Yu Zhao, Director of Regulatory Affairs, Medtronic

Bringing medical devices to China

• Reviewing the Chinese regulatory environment and key market opportunities and challenges
• Updating on the latest regulatory issues around foreign medical device companies in China
• Practical steps for obtaining SFDA approval for commercializing medical devices in China – Case study on Class III devices
• Understanding cultural differences to ensure successful business relationship

Wenkai Ma, Director of Global Regulatory Affairs, Allergan China

EU Regulatory Update: MDD, AIMDD and IVDD

• Overview of current core EU directives: MDD, AIMDD and IVDD
• Highlights of Proposed Regulations
• Understanding the implications for medical device development and regulatory compliance
• Developing strategies for implementation of key reforms including enhanced vigilance, clinical trial coordination, Member State market surveillance, product testing, and Notified Body auditing

Chris Sarner, Project Manager, DEKRA Certification B.V.

Fast track to CE Marking: Strategies for timely compliance and commercialization

• Identifying the practical steps for achieving CE Marking
• Understanding the requirements of conformity assessment specific to the device governed by the relevant EU Directive
• Assessing the device according to the Essential Requirements and preparing the Technical File and Declaration of Conformity
• Working with Notified Body to meet all requirements for conformity assessments
• Understanding the translation requirements for IFU (instructions for use) in local EU market

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