MD&M Minneapolis Conference Sessions

• Reviewing new draft guidance documents on clinical trials, evaluating de novo devices, developing and using product codes, and appealing decisions
• Understanding how the FDA determines whether a device is substantially equivalent to a device already legally marketed under the 510(k) program
• Highlighting the unique trial program, Triage, which involves a 30-day quick review for IVD products

• Discussing 510k reform and its impact on the medical device industry and meeting the FDA's expectation for high quality 510(k) submissions
• Reviewing the FDA's revised modification guidance
• Responding to FDA deficiency letters; best practices and red flags
• Navigating the requirements around PMAs and PMNs
• Clarifying FDA's definition of a "substantially equivalent" device and explaining Product Development Protocol in regards to class III devices that require PMA
• Understanding the FDA Humanitarian Device Exemption

• Clarifying the 'Least Burdensome Standard' for both PMAs and 510(k)s and the determination of 'substantial equivalence' through clinical information
• Discussing the withdraw of the FDA's draft guidance published in July 2011 on device modifications to 510(k)-cleared devices
• Underlining the FDA's requirement for manufacturers of certain class II or III devices to conduct post-market surveillance activities
• Reviewing new requirement for FDA to clarify standards for conducting checks on recall effectiveness, to establish detailed criteria for determining the effectiveness of correction active plans for recalls, and to document the basis for terminating a device recall

• Understanding the Unique Device Identification (UDI) requirements and implications
• Recent changes in Registration and Listing requirements
• New Draft Guidance related to submissions including:
• eCopy Program for Medical Device Submissions
• FDA and Industry Actions on Premarket Notification 510(k) Submissions: Effect on FDA review clock and goals
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect of FDA review clock and goals
• Refuse to Accept Policy of 510(k)s

• Overview of the pending EU legislation and key changes to the medical device regulatory requirements
• Strategies for implementation of key reforms including enhanced vigilance, clinical trial coordination, Member State market surveillance, product testing, and Notified Body auditing
• Highlighting new legislative reforms for in vitro diagnostics (IVDs)

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• Understanding FDA requirements and expectations to guide decision-making on when to take corrective actions
• Exploring the problems that can trigger FDA reports such as MDRs, Corrective Reports, and Removal Reports
• Implementing an effective and unified system, which integrates multiple processes relating to adverse events to improve regulatory compliance as well as reduce total costs

Introduction

• Define a technical performance problem
• Discuss common investigation mistakes
• Introduce the investigation template
• Introduce the case study

• Describe the problem in 8 dimensions
• Conduct Workshop A
• Describe the processes under investigation
• Identify the process inputs

Step 2: Collect Data

• Understand what data is needed
• Develop the measurement plan
• Conduct Workshop B
• Update the problem description

• Develop a timeline of changes
• Search for differences
• Search for changes
• Brainstorm

• Test the possible causes
• Documenting assumptions

• Verify assumptions
• Perform studies / experiments
• Identify technical root cause(s)
• Use the 3-Legged-5-Why Tool to identify systemic root cause(s)

• Consider mistake proofing techniques
• Consider variation reduction and optimization techniques
• Extending the 3-Legged-5-Why Tool

• Measure effectiveness and evaluate results of corrective and preventive actions
• Further extending the 3-Legged-5-Why Tool

• Train
• Implement
• Measure
• Celebrate

Tom Weaver, President, Weaver Consulting LLC

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This full day workshop will help guide the application of statistical methods throughout process validation for IQ, OQ, and PQ.

• Primer on Statistical Analysis
• Reviewing which statistical methods are recommended by the guidance documents
• Understanding where these statistical methods should be applied throughtout process validation

• Analyzing a hypothesis test and interpreting data intervals
• Determining appropriate sample sizes
• Learning to analyze relationships between continuous variables using regression

• Selecting the correct measurement and approach
• Assessing the measuring device, procedures and operators, assessing any measurement interactions
• Calculating the measurement uncertainty of individual measurement devices and/or measurement systems
• Learning how to interpret the results from an ANOVA

• Understanding the benefits of robust design methods
• Learning to generate and interpret process control charts and capability indices

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This Risk Management workshop will provide full-day, step-by-step guide to developing a comprehensive approach to risk management in medical device design and development.

• Reviewing risk management concepts and terminology
• Introducing the requirements of ISO 14971: 2009

• Covering the basics for conducting comprehensive risk assessment
• Determining methods for evaluating over-all device risk acceptability

• Using FMEA to identify potential failures and taking steps to counteract or at least minimize the risks from those failures

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• Critical Process Parameters
• Critical Quality Parameters

• Defining the Software Development Lifecycle (SDLC), as described in IEC 62304:2006 and coordinated with the FDA's General Principles of Software Validation
• Implementing a software development lifecycle as key to developing software for safe and effective devices
• Design verification vs. design validation
• Traceability vs. relationship between work products / deliverables
• Issues around identifying and using Software of Unknown Provenance (SOUP)
• Unit verification vs. unit testing
• Static (reviews/walkthroughs/inspections) vs. dynamic (test execution) verification
• Can I be agile and compliant?
• Impact analysis and change management

• Reviewing the FDA's Design Transfer requirement and what FDA expects
• Understanding the tasks and actions that need to occur within a given time-period to meet those requirements
• Highlighting different aspects/types of process validation requirements in design transfer
• Devising a DMR (device master record) and post-clinical surveillance strategies

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• Understanding the collaboration among suppliers, researchers, and manufacturers to realize innovation
• Overview of how the University of Minnesota and the Medical Devices Center interfaces with medical device manufacturers and examples of success
• Using clinical studies as a key source of information for continued innovation

• Anticipating the manufacturing process in the early stages of development to adapt designs to ensure manufacturability
• Translating lab skills and techniques into the manufacturing process when undertaking larger scale production
• Adapting manufacturing processes to maintain the properties of polymers and protect product quality and functionality
• Assessing the technological constraints in manufacturing and the level of cost required to scale-up
• Managing the additional challenges of scaling-up in the area of micro-processing and precision manufacturing
• Bridging the gap between R&D and supply chain strategies (make vs. buy)

• Reviewing new technologies and trends in rapid prototyping
• Best practices for incorporating rapid-prototyping into the manufacturing process

• Discussing new balloon manufacturing technologies to reduce product costs and improve quality and yields
• Extruded balloon tubing performance requirements
• Preformed parison requirements
• Balloon parameter development system
• High efficiency water jackets
• Automated balloon manufacturing and testing

• Realizing the capabilities of 3D printing technologies and their potential impact on the packaging design process
• Understanding the benefits and challenges of managing 3D technologies in house vs. outsourcing
• Identifying new technologies and processes being used for digital rendering, 3D mockups, 3D rapid prototyping, and prototype tooling

• Reviewing the standards for verification and validation
• Best practices for incorporating verification and validation strategies into product development lifecycle

• Highlighting the emerging technologies in virtual simulation for product design
• Using virtual prototyping for a better understanding of variables product reliability
• Conducting virtual testing in a simulated environment to reduce production costs and increase speed to market

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Discussing the different aspects of medical reliability testing, from FDA regulations to industry best practices, this seminar will cover different types of reliability tests used within the medical industry along with practical case studies and examples.

• Setting reliability goals early on in the development process
• Creating a comprehensive reliability plan
• Identifying effective execution strategies

• Addressing the challenges balancing regulatory testing with reliability testing
• Using HALT (highly accelerated life testing) to determine how robust a product with a margin of safety
• Using ALT (accelerated life testing) to determine life expectancy of a product within a margin of safety

• Combining testing for regulatory requirements with testing for reliability to achieve an optimal testing plan
• Satisfying FDA requirements while achieving your reliability goals

• Providing practical and applied learning examples of reliability programs implemented for medical devices, implantable devices, medical bionics
• Reviewing data collection and management strategies for reliability programs

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• Highlighting the trends and innovations in materials used in new and existing applications
• Evaluating the biological, physical, and chemical properties for device specific applications
• Determining biocompatibility and testing for optimal material selection
• Considering the impact of polymer selection on the fabrication process to ensure manufacturability
• Finding alternatives to banned and materials and in the event of a material change

• Performing biocompatibility testing and analyzing the results, when- what-and how  – determining the characteristics of new biomaterials
• Challenges and the use of additives and coatings to better achieve biocompatibility and device characteristics
• Identifying challenges with data analysis and the decision process in selecting the optimal material
• Reviewing safety considerations and requirements

• Determining the importance of patent protection for medical materials and improvements
• Establishing a robust patent strategy under patent reform
• Managing and mitigating IP risk when working both domestically and internationally
• Including necessary measures and terms in agreements and supplier contracts to secure patent protection and address ownership

• Introducing the fundamentals of bioresorbable polymers and understanding the unique complexities and requirements for bioresorbable implantable devices and controlled drug-delivery
• Comparing the dimensional stability, hydraulic stability, and mechanical property requirements among various bioresorbable materials
• Identifying key factors in material selection and processing considerations of bioresorbable materials for specific medical devices

• Highlighting the range of coatings available for today's medical device applications
• Discovering new coatings for enhanced material functionality
• Innovations in antimicrobial properties and drug-delivery

• Modification of silicone chemistry and its influence on release rates of active pharmaceutical ingredients (APIs)
• Reviewing the challenges faced in the development process and resulting solutions
• Realizing prescribed dose delivery rates over the prescribed amount of time
• Compatibility of silicone chemistry and API stability

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Power source technology is critical to design, performance and reliability of medical devices. This session will feature speakers who will address varied topics, including system requirements, emerging technologies and innovation in design and testing, pertaining to power sources.

Ultra-Long Life Implantable Rechargeable Battery Chemistries Enabled with Zero-VoltTM Capability

Alternative Power Sources for the Biomedical Horizon

Lithium/CFx - Spanning the performance spectrum from high energy to high power for implantable devices

Longevity and Reliability Evaluation for Implantable Medical Device Batteries

• Understanding how to quantify battery reliability through effecting testing techniques
• Mapping out performance reliability using long-term life predictions
• Applying accelerated aging test prediction models to determine lifespans

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The goal of this session is to highlight the challenges and opportunities in the design of bio-electronic systems. A primer of general considerations for bi-directional biological interfacing, packaging and electronic requirements, and regulatory considerations will lay a foundation for the topic. Detailed overviews of sensors, actuators, algorithms, and wireless systems from leading laboratories will then bring everyone up to date on the state-of-the-art and future trends. The day ends with demos of bio-electronic system prototypes, described throughout the tutorials, with sufficient time for networking.

• Overview of design and manufacturing challenges for developing SOCs, microprocessors, sensors, power supply, and wireless capabilities for emerging medical device technologies

• Addressing future demands and challenges in achieving miniaturization for embedded electronics in medical devices
• Developing and minimizing sensors, electrodes and systems for mission critical devices
• Understanding packaging requirements and challenges specific to medical device development

• Reviewing best practices for reliability testing for embedded systems technologies
• Understanding the safety and reliability requirements for implantable devices
• Designing embedded electronics to achieve size and reliability requirements

• Digital processor scaling (low voltage challenges)
• Designing in hardware specific sub-routines for biomedical applications
• Key areas for "smart sensing" technologies in the future

• Stimulation methods with electricity
• Emerging methods of stimulating the body: optogenetics, etc
• Considerations for sensing and stimulation compatibility in advanced systems

• Highlighting new sensor technologies (biochemical, hybrid sensing, etc)
• Reviewing the integrated design and development challenges in the application of smart sensor technology
• Pilot experiments in closed loop system development

• Reviewing the trends and demand for enhanced wireless capabilities in medical devices
• New wireless capabilities and future growth opportunities for medical devices
• Addressing the challenges of interoperability adapting wireless technology to meet multiple standards internationally