Conference Agenda At-a-Glance

Concept Ideation & Implementation

• Assumption Storming I: Experience the Design Problem

• Assumption Storming II: Learn to be Disruptive

• IDEO Creativity workshop: Using design thinking to solve development challenges

• Design for Six Sigma: Executing design concepts

• Consumerization of medical devices: Design and innovation opportunities

Risk Management & Quality Control

• Applying ISO 14971 to comply with 21 CFR 820

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

• A simplified defensible approach to the Validation of Quality System Software

• Risk analysis workshop I (PHA, FTA, FMEA)

• Risk analysis workshop II (HOZOP, HACCP)

Regulatory Updates & FDA Perspective

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

• 510(k) Triage and Quick Review pilot program

• FDA Los Angeles District Update / FDA Globalization Initiative

• FDA guidance for home use devices

• Panel discussion: Interacting with regulatory agencies and NBs

Sustaining Compliance

• FDA national strategy for post-market surveillance

• Medical Device Reporting

• Complaints handling system

• FDA device tracking requirements

• EU Vigilance Reporting

Special One–Day Conference Track

• Suture and fiber materials selection for cardiovascular components

• Mechanics of biomaterials: Principles for implant designs

• Bioabsorbable materials

• EFEP co-extrusion technology

• Advances in antimicrobial plastics technology

• Comparative radiopacity and mechanical properties of FDA-compliant radiopacifiers

• MEMS intraocular drug delivery device

• Chemical resistance of Eastman Tritan™ copolyesters and engineering polymers used in medical devices - oncology drug case study

• IDEO Prototyping workshop: Building to think

• Computational modeling and simulation

• Software design for Six Sigma: Best practices and Agile development

• COMSOL multiphysics: FEA and product development applications

• Motion capture of the heart: Cyberheart

• Process validation: Mastering the guidance and creating a total program

• Applying statistical methods to process validation

• Materials process validation for medical devices

• How to design reliability test program

• A high level risk analysis review to create a unique test strategy

Regulatory Submissions & Approval Process

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

• NanoScale: Regulatory opportunities and challenges

• 510(k) pathway: Submission and approval guide

• PMA pathway: Submission and approval guide

• Combination product pathway: Submission and approval guide

• Strategies for FDA inspections and NB assessments

• Responding to 483s, Establishment Inspection Report (EIR) and Warning Letters

• Devising a recall strategy: Dealing with Removals and Corrections

• Best practices in implementing Corrective and Preventive Actions (CAPA)

• Root cause analysis for CAPA

Separately Bookable Seminars On:

Design of Implantable Devices
Developing improved biomaterials

Bioresorable Polymers
Latest developments in resorbable polymers for medical devices

Innovations in Orthopedic Devices
Explore changes to the way existing materials such as PEEK are used, their successes and limitations, and the potential impact

Conference attendees have unrestricted access to MedTech Innovate Seminars for no extra charge on the day(s) they are registered for the conference.

Design Control for Quality, Safety & Effectiveness

• Optimizing medical device development via systems engineering

• FDA session: Human Factors Pre-market Review - Incorporating HF engineering into risk management

• IEC 62304:2006 Medical software processes

• Innovating with quality in mind

• Integrating pharmaceutical technology transfer practices into a design control system for combination/convergent medical products

• IEC 60601-1 3rd: Electrical testing

• ASTM F2914: Shelf life testing for endovascular devices and determining aging mechanism

• Biocompatibility and chemistry testing I

• Biocompatibility and chemistry testing II

• Biocompatibility and chemistry testing III

•Unique Device Identifier: FDA update and plan for the industry

• Industry implementation of UDI programs

• Panel discussion: Roadmap for UDI compliance

• Leveraging GS1 standards to comply with UDI

• Reviewing labeling and packaging solutions for UDI-compliant medical devices

• Scale-up strategies for high-volume production

• Cost control in medical device manufacturing

• Lean principles for medical device manufacturing

• Transition from rapid prototyping to rapid manufacturing

• 3D-MID technologies for miniaturized medical devices

Separately Bookable Seminars On:

Wireless Medical Devices
• Using risk management to deploy wireless medical devices
• Medical device integration using 802.11
• Preparing your wireless medical device system for acute care environments

Developing Medical Mobile Apps
Examining current and upcoming FDA regulations impacting mobile medical app approvals

Microelectronics and Sensors
• Background on bioelectronics systems
• Designing a MEMS-powered medical device 101
• Algorithm details: Developing integrated circuits for microprocessor

Conference attendees have unrestricted access to MedTech Innovate Seminars for no extra charge on the day(s) they are registered for the conference.

• Developing and implementing an effective and robust materials selection process for medical devices

• Selecting materials for implantable electronic devices

• Working with material suppliers to ensure quality and streamline CAPA systems

• Materials selection based on the new RoHS requirements: Selecting alternative lead-free alloys for circuit boards assembly

• Selecting materials for miniaturization

Success in Pre-Clinical Studies & Clinical Trials

• IDE applications for clinical studies (and the Pre-submission program)

• Step-by-step guide to pre-clinical studies and animal models

• Clinical trial design strategies: ISO 14155

• Biostatistics in design, execution and analysis of clinical trials

• Cost savings in clinical trials and managing CROs

Globalization: Compliance & Commercialization

• Internationalization: Product development, regulatory approval, commercialization and post-market surveillance

• Bringing medical devices to Japan

• Bringing medical devices to China

• EU Regulatory update: MDD, IVDD and AIMDD

• Fast track to CE marking

Outsourcing & Supplier Management

• Intellectual property (IP) issues and open innovation challenges when working with suppliers

• Panel discussion: Creating a successful partnership with suppliers and CMOs

• FDA perspective on purchasing controls and supplier controls

• Purchasing and supplier controls: Maintaining quality agreements to manage and minimize risk

• Establishing supplier performance management systems

Separately Bookable Seminars On:

Innovations in Cardio Devices
• Identifying innovation opportunities in new materials, design functions and process enhancement
• 3D printing and additive manufacturing in cardiovascular device design and development
• Customer Insights Panel: A review of latest cardio device innovations

Power Source Technologies
• Energy Harvesting: Considerations for implantable medical devices
• Methods for demonstrating reliability, testing and evaluations
• Alternative power sources for the biomedical horizon

Conference attendees have unrestricted access to MedTech Innovate Seminars for no extra charge on the day(s) they are registered for the conference.

One-Day Classroom Hosted by Nelson Labs

• Radiation & Ethylene Oxide Sterilization Validation

• Sterile Barrier Packaging Validation

• Cleaning Validations for Newly Manufactured Devices

• Biocompatibility