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Workshop Day: Monday, 1st March 2010
Come experience our Focus, pre-conference workshop day. You will hear from top leaders in the industry giving key talks about all of the “hot-button” issues and topics that are constantly brought up in discussion, and that face the Medical Devices landscape. These workshops will be set up in a classroom setting.
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10:30a
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Workshop A
From Design to Manufacturing: Improve Your Speed-to-Market while Maintaining Your Compliance Status
New product development of medical devices is pressured by both reliability and a tight time frame. Minimizing field problems is another challenge for the industry. To accommodate advances in sophisticated technology we must adopt highly sophisticated development methods. In the meantime, these practices will have to fit within the expectations of your quality assurance department, demanding consumers and regulatory agencies.
How You Will Benefit:
• Understand compliance requirements for design controls specified in the QSIT and QSR
• Maximize benefits and mitigate risks associated with the Canadian cascading water fall product design model
• Compare benefits and risks associated with other specified product design models
• Stay on top of current trends in the design and manufacture of medical devices
• Reduce lead time by utilizing Concurrent Engineering
What You Will Learn:
• Benefits of Concurrent Engineering in reducing lead time from design to market
• Tools used to cut cost and improve the profit margin
• Global trends in the design and marketing of medical devices
• Strategies to maintain compliance from design to market
• Mitigate risks associated with the design and manufacture of devices off-shore
• The importance of product launch plans
• Impact assessment of off-shore device manufacturing
David N. Muchemu, Founder and CEO, cGMP University Inc.
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11:30a
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Workshop B
Maximizing the Value of Your IP Portfolio and Safeguarding Product IP Ownership
In today's economic climate, effectively developing an intellectual property portfolio is becoming increasingly important. Filing, prosecution and maintenance costs represent a significant capital investment for many companies and universities and making strategic decisions regarding portfolio development will help maximize the protection and marketability afforded by this investment. This presentation will provide an overview of global IP filing options that maximize portfolio development and strength.
Multiple parties often collaborate in the conception, development and manufacturing of a medical device, which can lead to multiple claims of IP ownership based on inventive contribution to the device. For example, a device may be initially conceived at an academic institution, first reduced to practice at a small licensee company, further developed by a sub-licensee company, and manufactured by an OEM, each of which could potentially add an inventive contribution to the final product. Strategies will be discussed to effectively handle multiple claims of ownership that arise from typical product development collaborations and other issues associated with joint development efforts.
Peter F. Corless, Esq., Partner, Edwards Angell Palmer & Dodge LLP
Richard Smith, Esq., Partner, Edwards Angell Palmer & Dodge LLP
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12:30p
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Workshop C:
(Lunch Will Be Served)
Product Development and Post Market Compliance in the new era FDA
The FDA has changed and the medical device startup must adapt to that change. In this brief workshop learn some key ways you can apply immediately to adapt to those changes. The regulatory burden faced by startups is larger than ever and every advantage you can gain can help. Topics to be covered include:
• Lowering cost during product development
• Reducing risk associated with bringing a new product to market
• Shortening the time to market
Kristin Mortenson, Managing Partner & Founder, Acera Innovation
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1:30p
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Workshop D
Brazil: An Overview of the Market and Steps to Obtaining Regulatory Approval
Brazil is one of the hottest developing markets in the world, with more medical device companies expressing an interest in this market than any other according to a 2010 survey of 1,000+ device manufacturers conducted in November 2009 by Emergo Group. Dr. Loh will tell you what the research shows and will provide a complete overview of the steps required to get your medical device approved for sale in this fast growing market of nearly 200 million people
• Results of research on the outlook for the medical device industry in 2010
• ANVISA and other entities involved in medical device regulation in Brazil
• Classifying your medical device – how it differs from US and EU classification
• Obtaining the proper permits for importation
• Product testing requirements
• Complying with Brazilian Good Manufacturing Practice (BGMP)
• How the ANVISA Technical File compares to an EU Technical File and/or US FDA 510(k)
• Appointing a Brazilian Registration Holder to handle your submission
• Appointing distributors
Evangeline Loh, PhD, Vice President of Regulatory Affairs, Emergo Group Inc.
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2:30p
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Workshop E
Common FDA Regulatory Pitfalls and How Medical Device Companies Can Avoid Them
While most medical device firms intend to comply with FDA’s requirements, best intentions are not enough. Device companies can fall into practices or policies which undercut their compliance and business efforts, and they often miss or forego important compliance or due diligence steps due to a lack of knowledge. This workshop will:
• Describe and discuss common FDA regulatory pitfalls or oversights that can befall medical device companies
• Offer insights on how to integrate FDA regulatory and business efforts
• Provide recommendations on how to prevent or correct these pitfalls or oversights
Neil F. O'Flaherty, Principal, Olsson Frank Weeda Terman Bode Matz P.C.
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3:30p
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Workshop F:
Successful Change Management
Successful change management when it comes to medical devices is a collaborative change effort that can have complexity. The new management unit, will have to re-focus on transactional activities that can save money and also gain flexible, scalable, and improved processes for delivering new services, with new medical devices.
• How to inspire and win acceptance and support from your medical center team
• Getting buy-in from staff: Administration, Physicians, IT, Nurses and Biomedical team
• How to lead and inspire your IT department on an implementation project
• Getting your team to adapt to deploying new medical device products
• Explore critical aspects of successful implementation products
Wyatt W. Decker, MD, FACEP, Executive Board, Mayo Clinic Rochester, Professor of Emergency Medicine, Mayo Clinic College of Medicine
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4:30p
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Workshop G:
How to Achieve 100% Traceability & Process Visibility and More Easily Meet Compliance Requirements
This workshop is designed for medical device manufacturers who want to improve their quality and productivity through complete product and process traceability. The key is in the business processes and software solutions which enable you to not only better manage your overall operations but also more easily meet your stringent regulatory requirements. This workshop will help you take the best practices from other manufacturing industries and apply them to your operation, whether it is high-volume production or low-volume, custom manufacturing.
What You Will Learn:
• Processes and techniques to track and trace products and processes to achieve the highest quality levels
• Best practices from other manufacturing industries that can help you meet quality, traceability and compliance requirements
• Automated processes to easily achieve your data and document management needs so you minimize resources and maximize productivity
• How SaaS ERP systems enable you to achieve FDA validation
• Case study of how one growing medical device manufacturer used these tools to achieve world-class visibility
John Billings, Senior Account Executive, Plex Systems
Hosted by Plex System
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Conference Day 1: Tuesday, 2nd March 2010
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8:00a
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Breakfast and Registration
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8:30a
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Chairperson’s Welcome & Opening Remarks
David Cronin, Director of Business Development, Cognition Corporation
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8:45a
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Keynote Address: The Total Artificial Heart: Past, Present & Future
Dr. Marvin Slepian, world-renowned interventional cardiologist and co-founder and chairman of SynCardia Systems, Inc., will be presenting the history of the SynCardia temporary CardioWest™ Total Artificial Heart. SynCardia’s Total Artificial Heart is the result of 60 years of development and remains the first and only FDA, Health
Canada
and CE-approved Total Artificial Heart in the world. Similar to a heart transplant, the Total Artificial Heart eliminates biventricular failure by replacing both dying heart ventricles. It is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
Dr. Slepian’s presentation will focus on the efforts behind winning FDA approval and reimbursement by the Centers for Medicare & Medicaid Services (CMS) for the Total Artificial Heart. In addition to discussing the development and clinical use of this life-saving device, Dr. Slepian will also address the future of SynCardia technologies.
• 60 years of development by the giants of medicine
• Clinical use, FDA approval and CMS reimbursement
• The future of SynCardia technologies
Dr. Marvin Slepian, Co-Founder and Chairman, SynCardia
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9:30a
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Understanding Lean Six Sigma and the Importance of Quality Controls
• Cardinal Health highlights
• Lean Six Sigma History
• How can we improve our quality without impacting our speed?
• Controls; key of success
Ismael Villarreal, Director of Operations, Cardinal Health
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10:00a
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Panel Discussion: 510(k) Paradigm:Analysis of the Current Standard and Looking Toward the Future
• Does the 510(k) process need improvements?
• What are the specific components of 510(k) and what are the processes involved?
• Understanding various classifications of 510(k)
• Learn about critical requirements from the FDA
Stephen J. Northrup, Principal, Podesta Group
Brad Ryba, Senior Manager, Quality Engineering Labs, QA/RA, Philips Respironics
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10:45a
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Morning Networking & Refreshment Break
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11:15a
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Panel Discussion: CER (Comparative Effectiveness Research) Meeting the Standards of CER Through Product Design, Testing and Research
• What are the current updates in CER
• Integrating future standards of CER into product design
• Testing and research to meet the requirements of CER future standards
Maria Shepherd, Founder & CEO Data Decision Group
Charles Mathews, Director,
Boston
Healthcare
Philip T. Lavin, Founder & Vice Chair, Global Head of Medical Device & Strategic Consulting, Averion International
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12:00p
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Panel Discussion: ISO 14971 Risk Management: Understanding the Requirements and How These Requirements Apply To All Stages of the Lifecycle of Medical Devices
•Identifying the hazards associated with medical devices
•What makes this state-of-the art standard so widely recognized
•What are acceptable risks?
•Applying human factors engineering to reduce to risk of use error
Steve A. McRoberts, Principal Engineer for Medical Regulatory & Proprietary Compliance, Underwriters Laboratories
Ed Israelski, Program Manager, Abbott Laboratories
John McLane, COO & VP Clinical and Regulatory Affairs, CLINQUEST
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12:45p
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Networking Luncheon
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1:45p
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Panel Discussion: Manage Change and Risk to Enhance Safety and Avoid Defects
• Understand change control as a process within the medical device software lifecycle
• Develop strategies to address change from regulations
• Discuss methodologies for accessing the impact of change
• Obtain effective risk management techniques
Moderator:
David Cronin, Director, Business Development, Cognition Corporation
Mark Lex, Consultant & Business Development, Continuum, Former Director of Global Security, Abbott Laboratories
David N. Muchemu, Founder and CEO, cGMP University, Inc.
Tim Sullivan, R&D Manager, Systems Engineering BD Diagnostics
Matthias Buerger, Executive QA, GE Healthcare
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2:30p
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Panel Discussion: Interoperability of Products: Working Towards A Full Cycle of Care
• Why connectivity is a value-added service that helps ensure interoperability of products
• Document software and device network infrastructures for ongoing compliance
• Identifying all of your customer’s requirements across the board
• Discussing the need for intercommunication among medical devices and clinical information systems
• The guidelines and role that Bluetooth technology plays in the interoperability of medical devices
• What point-of-care medical device communications (POC MDC) standards could mean for plug-and-play medical device interoperability and all Healthcare IT once fully developed
Moderator:
Wyatt W. Decker, MD, FACEP, Executive Board, Mayo Clinic
Rochester
, Professor of Emergency Medicine,
Mayo
Clinic
College
of Medicine
Panelists:
George Walls, Senior Manager Connectivity, St. Jude Medical
Peter Cook, Specification Director, Bluetooth SIG
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3:15p
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Japan Quality Management Systems
• Riskier devices now require QMS audits for product registration
• Who will get audited
• Paper vs. onsite audits
• What documents are needed
• How to succeed when the PMDA does an on-site audit
Ames Gross, President and Founder, Pacific Bridge Medical
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4:00p
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Afternoon Networking & Refreshment Break
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4:30p
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Information Session: Legal Perspective: How To Interact and Avoid Potential Problems with the FDA
• How to steer clear of medical device pitfalls
• Why early stage due diligence is critically important
• Avoid bad practices that affect FDA regulatory compliance efforts
Moderator:
Melissa Gilmore, Senior Counsel, McGuire Woods
Neil O’Flaherty, Principal, Olsson Frank Weeda Terman Bode Matz, PC
Laurie A. Clarke, FDA Partner, King & Spalding
Tracy Palmer Berns, Esq., Associate General Counsel, Regulatory Affairs, Covidien
Paul T. Kim, Partner, Foley Hoag LLP
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5:15p
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Panel Discussion: Understanding Software Requirements and Conducting Effective V&V Within Challenging Development Schedules
• Establish effective V&V strategies that define adequate software requirements
• Exploring various and innovative testing methods for V&V process
• Developing the most effective testing methodologies and procedures to strengthen the V&V process
• The latest on the Part 11 update
• Learn the importance and understand how the IEC 62304 impacts software design and testing
• Explore the IEC 62304 relationship to other standards
Mikael Lindvall, PhD, Director Software Architecture and Embedded Systems Division, Adjunct Professor Computer Science Department UMD, Fraunhofer Center for Experimental Software Engineering, University of Maryland
Dr. Mike Whalen, Phd,
Program
Director
University
of
Minnesota
Software
Engineering
Center
Alexander Damisch,
Business Development, Medical Solutions
WIND RIVER
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6:00p
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Roundtable Best Practice Discussions
During each roundtable, the facilitator will present a short case study as a benchmark for a 30-minute discussion and question session. Attendees will be invited to attend 2 roundtable table discussions within this hour and get comprehensive review of the surrounding issues, technical capabilities and differing stakeholders’ views. Attendees will also get answers to many questions and innovative ideas to take back and apply to your medical device projects.
Table 1: Preclinical Evaluation of Medical Devices- Test Strategies, Clinical Relevancy and Pitfalls
• Designing test strategies to address risk analyses
• Designing testing to satisfy regulatory requirements
• Designing clinically relevant implant evaluations
• Understanding wear generation
• Pitfalls with regulatory testing and evaluations
Dr. Lisa Ferrara, President & CEO, OrthoKinetic Technologies
Table 2: Averion International
Statistical Trends in Medical Device Study Design.
Determining Sample Size:
• Design type (non-inferiority, quasi-superiority, superiority)
• Primary effectiveness (single, co-primary, composite)
• Minimum clinically meaningful difference
• Endpoint choice (patients, events, validated)
• Type I error (alpha) and power
• Interim looks alpha sending (superiority, non-inferiority)
• Computation (nQuery, EaSt)
Design Types:
• Non-inferiority (need a non-inferiority margin)
• Quasi-superiory (need a rationale for an advantage for the innovator product)
• Superiority (need a reachable alternative hypothesis)
Alpha Spending:
• Co--primary endpoints (both, either)
• Secondary endpoints (pre-ordered, no advance knowledge =>Bonferroni correction)
• Interim looks (sample size recalculation, hypothesis adjustment, futility/superiority, financial reasons)
Phillip Lavin, Executive Chairman, Averion International
Table 3: Is the EU Medical Device Directive (Council Directive 93/42/EEC) Coming to the US?
• Every medical device sold in Europe, regardless of its classification, must have a Clinical Evaluation Report in its technical file
• Risk management Plans Pre- and Post marketing
• Vigilance and MDR reporting
John McLane, COO & VP Clinical and Regulatory Affairs, CLINQUEST
Table 4: Understanding Software Requirements and Conducting Effective V&V Within Challenging Development Schedules (Continued)
• Continue the discussion in a more intimate setting and share ideas
Alexander Damisch, Business Development, Medical Solutions, WIND RIVER
Tim Kelleher, Chief Software Engineer, Design Mentor Inc
Table 5: Using The Latest Web 2.0 Technology To Create A Unified Model For Product Development
• Create a real time, dynamic Trace from inputs/voices to requirements to specs to tests to risks to complaints to costs, etc.
• Automated, standardized output of compliance documents
• Statistical analysis of requirements satisfaction
• CostBOM feedback throughout the R&D/Design process
• Real time, simultaneous uses, remote access worldwide to the entire unified model
• Automated process templates to guide users through the process to ensure consistency and completeness of each step in your process
David Cronin, Director of Business Development, Cognition Corporation
Mitch Hayes, VP of Customer Success, Cognition Corporation
Michael Cronin, CEO, Cognition Corporation
Table 6: How to Gather and Access Real-Time Information to Drive Traceability and Profitability
• Driving device manufacturing quality with SaaS ERP models
• Automating reporting and compliance
• Managing extremely tight tolerances electronically
• Production visibility
John Billings, Senior Account Executive, Plex Systems
Jason Howey, Executive VP & COO, OKAY Industries
Table 7: Lean Manufacturing
• Continuous improvement
• Employee involvement
David Burns, Manufacturing Team Leader, KMC Systems
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7:00p
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Closing Remarks & Cocktail Reception
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Conference Day 2: Wednesday, 3rd March 2010
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8:00a
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Breakfast & Registration
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8:45a
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Chairperson’s Welcome & Opening Remarks
Steve A. McRoberts, Underwriters Laboratories
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9:00a
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Panel Discussion Federal Investigation, Compliance and Enforcement Trends
• Challenges facing medical device companies in staying compliant
• Enforcement actions against medical device manufacturers
• DOJ perspective pertaining to evolving strategies that defend medical device companies
• Fraud investigations in medical devices
Gerald Sullivan, Esq. Assistant US Attorney, US Attorney’s Office, Eastern District of Pennsylvania
Jeremy M. Sternberg, Assistant U.S. Attorney. US Attorney’s Office, District of Massachusetts
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9:45a
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Panel Discussion: ISO 13485 – What is Being Done to Achieve Global Acceptance of the Harmonized Standard for Medical Devices Manufacturing QMS
• Hear about the importance and challenges of getting acceptance of ISO 13485 certification
• Learn about the work of the International Accreditation Forum’s (IAF) progress to achieve accreditation of ISO 13485 that is acceptable to regulators around the world
• Review the latest IAF and GHTF progress and discuss whether there is any hope of practical harmonization of QMS requirements
Casper E. Uldriks, JD, Assoc. Director, Regulatory Guidance & Government Affairs, CDRH, FDA
Paul Brooks, Vice President, Healthcare Solutions, BSI
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10:30a
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Morning Networking & Refreshment Break
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11:00a
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China Regulatory Update
• New product registration issues
• Clinical trial update
• Testing -- new local requirements
• Recalls/Adverse events
• Audits/GMP/quality systems
Ames Gross, President and Founder, Pacific Bridge Medical
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11:45a
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Security & Privacy for Wireless Implantable Devices
• Focus on ‘threat model’ for wireless implantable medical devices
• Experimental findings on the security and privacy properties of an implantable cardioverter defibrillator (ICD)
• Discuss future challenges and directions for wireless medical device security and privacy
Tadayoshi Kohno, Ph.D., Assistant Professor, Department of Computer Science and Engineering,
University
of
Washington
and the
Medical
Device
Security
Center
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12:30p
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Networking Luncheon
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1:30p
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Understanding Evolving Technology on Cochlear and Vestibular Implants
• Discussing algorithmic solutions
• Examining current problems and potential solutions of cochlear and vestibular implants
Gene Y. Fridman, Ph.D., Faculty, Department of Otolaryngology Head and Neck Surgery,
John
Hopkins
Hospital
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2:15p
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Panel Discussion: Quality System Regulation: 21 CFR Part 820
• Flexibility of Quality System Regulation
• Overview of Current Good Manufacturing Practices (CGMP)
• A look at GMP exemptions
Moderator:
Mitch Hayes, VP Customer Success, Cognition Corporation
Bob Mehta, Sr. Regulatory Compliance Manager, Edwards Lifesciences
Joanna Engelke, VP Corporate Quality Systems,
Boston
Scientific
Michael J. Cronin, CEO, Cognition Corporation
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3:00p
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Panel Discussion:
Dissecting the Total Product Life Cycle (TPLC): The Changing Face of Medical Device Product Development Through Validation
• The changing face of medical device product development
• Insuring the quality and integrity of devices from conception to realization through validation.
• The FDA’s TPLC approach
• Implications of reimbursement; when to develop a reimbursement strategy
• Reimbursement opportunities in the private sector
Randy Moog, Director of Quality Assurance, BioForm Medical
Barbara Grenell, President, Preferred Health Strategies
Kristin Mortenson, Founder-Managing Partner, Acera Innovations
Bob Evans, Marketing Manager, KMC Systems
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3:45p
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Afternoon Networking & Refreshment Break
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4:15p
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Panel Discussion:
Surviving the Post-Market Landscape: Tips for Negotiating Recalls, Quality Control, Risk Management and Surveillance
• Setting up comprehensive post-market surveillance
• Designing and using effective Corrective and Preventative Action (CAPA) strategies
• Understanding 21 CFR Part 7 and other recall regulations
Matthias Büerger, Executive QA, GE Healthcare
Sponsorship opportunities available
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