8:00 Registration
8:55 Chair’s opening remarks
John P. Haynes, Materials Manager, BioCardia
9:00 Best Practices in Medical Device Design and Development Process: Templates for Need Finding, Due Diligence and Proof of Concept
Evan Anderson, Research & Development Manager, Spiracur
- How to evolve from making observations, to understanding problems to defining unmet clinical need
- How the statement of unmet clinical need is key to raising money, reducing time to market and communicating with your customer
- How the integration of front end performance criteria, highly iterative prototyping processes and repeated customer interaction drive failure to occur earlier in the development life cycle and not in the more costly late-development phases
9:40 Human Factors in Medical Device Design
Aidan Petrie, Chief Innovation Officer and Co-Founder, Ximedica
- High level introduction to human factors engineering
- An overview of changing regulatory expectations
- Discussion of human factors as a risk management activity vs. its broader role in enhancing usability
10:20 Coffee break
10:40 Supplier Controls – Partnerships in Design through Transfer into Manufacturing
John P. Haynes, Materials Manager, BioCardia
- All types of materials and devices
- Short time-frame needs for the product development environment • Long-term needs of ramp-up and steady manufacturing
- Small and large lot production
- Finding obsolete or hard-to-find materials
- Controlling and approving suppliers
- Considerations for second-tier suppliers (suppliers of those who supply you)
11:20 Polymeric Medical Device Design – Materials Selection and Characterization
Elizabeth Cosgriff-Hernández, Ph.D., Assistant Professor of Biomedical Engineering, Texas A&M University
- Polymeric medical device design requirements influence materials and manufacturing process selection
- Thermal and deformation history in polymer processing dictate microstructure and macroscopic material properties
- Prediction of long-term clinical findings from short-term laboratory studies
12:00 Lunch
1:30 PANEL DISCUSSION: Speed to Market for Medical Devices
Mir Imran, Chairman and CEO, InCube Labs and Modulus
Joe Heanue, President, Triple Ring Technologies
Fred B. Dinger, III, President and Chief Executive Officer, ENTrigue Surgical
Dennis Stone, MD, Chief Scientific Officer and Director, Remeditex Ventures
2:10 Designing Products Right-the-First-Time for the Best Cost, Quality, Compliance, and Time to Stable Production
Dr. David M. Anderson, PE, fASME, CMC, Management Consultant
2:50 Coffee break
3:10 Software Verification and Validation – Implementing Critical Updates to IEC 60601-1
Anura S. Fernando, Research Engineer, Underwriters Laboratories
- Brief history of software safety and the role of verification and validation (V&V)
- The role of IEC 60601-1-4 with programmable electrical medical devices (PEMS)
- Changes to the structure of IEC 60601-1 3rd edition that reflect the growing importance of the V&V of software in medical devices
- Introduction to IEC 62304
- Regulatory perspectives
- Technology trends in device networking and “systems of systems”
3:50 Choices – IEC 60601-1 3rd Edition and Component Selection
Mark Leimbeck, P.E., Quality and Training Program Manager, Health Sciences, Underwriters Laboratories LLC
- Background on the standard – the source of the risk management requirement and the intent
- Certification options in assessment and the licensing of components
- The roles and responsibilities of both component and end-product manufacturers in risk management
4:30 Close of day one |
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8:00 Registration
8:50 Chair’s opening remarks
9:00 Morning Workshop: Design for 510(k) Demystified
Cynthia J.M. Nolte, Ph.D., RAC, Principal Regulatory Consultant, Aptiv Solutions
This workshop is designed to provide R&D, design, engineering, manufacturing professionals with an update on 510(k) requirements and recent FDA guidance and initiatives that may impact their future 510(k) submissions. The program, divided into three sessions, will be interactive. Case studies will be presented to illustrate key concepts. Templates and outlines for critical documents will be provided.
Session I: Overview of Regulation and Guidance Documents from a Product Design Perspective
At this session, you will receive a high level overview of 510(k) requirements and understand the impact of FDA’s 510(k) retooling on your future 510(k) submissions. FDA has recently released guidance documents and launched initiatives that may affect your 510(k). During this session we will review the concept of safety assurance cases and discuss FDA’s focus on human factors. New requirements for reprocessing reusable medical devices and their impact on product labeling will be discussed.
Session II: Filing a 510(k) Premarket Notification for a Product Update
The fast pace of innovation and stiff competition require manufacturers to make continual improvements in their product design. In this session, FDA’s new draft guidance regarding when to file a 510(k) for a device modification will be discussed and we will look at the current status of Special 510(k) requirements and when you can use this type of 510(k) filing for your product update.
Session III: Using Design Control Documents to Support 510(k) Premarket Notifications
Many elements of FDA’s design controls find their way into 510(k) submissions. During this session we will discuss those design control documents – including risk assessments, design inputs and outputs, and verification and validation test plans – that are provided in total or extracted to support 510(k) premarket notifications.
12:00 Lunch
2:00 Afternoon WORKSHOP: Change Control: a Risk-Based Approach
Walt Murray, Director of Quality and Compliance Services
Kevin Marcus, Product Manager and Medical Device Expert, MasterControl
In this workshop track for change control the principles will be presented in a risk-based process model approach. Concepts for key components of change control will be reviewed including important considerations for good transfer of information leading to successful outputs.
The goal will be to avoid reactive control. The advanced quality planning model with will be used to show the cyclical loops necessary for closed methodology. The method will encompass a typical product lifecycle from supplier controls to post-market feedback (surveillance).
Two case study applications will be used to present an unplanned (reactive) and planned (proactive) context for thorough gateway change control.
Considerations for criticality and complexity will be included in the analysis of the cases and how to escalate process and team involvement based on level of risk.
Regulatory guidance regarding key aspects of a device will be discussed with consideration of effects due to cumulative change.
5:00 Close of conference
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