Conference Agenda

Tuesday, April 13

• The plastics role - a clinical view
• Safety and standards issues
• The future role for plastic in the operating room

• Injectable drug delivery today
• Large-volume parenteral drugs (LVPD)
• Small-volume parenteral drugs (SVPD)
• Where it's going
• Clinical and non-clinical settings
• Simplified administration
• Improved patient compliance
• Challenges and opportunities for plastics

• The design triangle — performance vs. manufacturability vs. cost effectiveness
• Mechanical considerations — relative strength, flexibility, frictional characteristics
• Compatibilities considerations — biocompatibility sterilization, inertness, etc.
• Multifunctional/multicomponent considerations
• Computer modeling in plastics and elastomers to estimate useful life
• Specific case studies

• Benefits of in-line automated production
• Inspection processes

• Micromolding in the medical field
• Material selection process
• Lessons from the thin-wall industry
• Computer integration
• Case studies

• Risk management
• Team member training
• Manufacturing environment
• Processing equipment
• Quality system
• Tooling considerations
• Lessons learned

• Identifying and overcoming conflicting demands of manufacturing and functionality

• Assessment techniques for new products
• Creative problem-solving techniques
• Conflict of originality and adoption
• Recognizing and prioritizing product features

• Polymer considerations in medical device design
• Designing to meet user needs
• Design for manufacture
• Critical steps in development process
• Case studies

• Simplifying the operating model
• Sustainable products and supply chains
• Organizational capability
• Building trust

• Meeting high-quality medical device standards
• Evaluating product, process and manufacturing attributes
• Advanced material selection for optimal medical device design and function

• Developing Class 1 and Class 2 medical devices

Wednesday, April 14

• What polymer characteristics do I evaluate?
• How to use ISO 10993-18 to make the right choice
• Is my polymer compatible and suitable for my medical device application?

• FDA regulation: overview
• Device classification
• Regulatory strategy throughout the product development process
• Plastic selection considerations: Performance, sterilization and biocompatibility
• Challenges in today's regulatory environment

• How can IP best be protected
• Why patent?
• What should be patented?
• When to file? (statutory bars and exceptions, including the CREATE Act)
• Where to file?
• Who owns or should own the IP?

• The development of inhalation products is difficult, costly and time consuming
• RBD has been employed to address and mitigate development risks
• Redundancy used in the development, providing multiple back-ups should the design fail
• RBD is a complete framework that handles parallel development
• RBD has proved successful and has helped projects deliver on time and on budget

• Mapping vs. configuring the supply chain's make vs. buy elements, including when to 'in-source' vs. 'out-source' plastics components, design, assembly, etc., globally
• The impact of healthcare reform on manufacturing within the medical device space and global ramifications it may (will) have
• The rallying cry to automate, leverage decoupled molding and other efforts to become very efficient and take out cost while improving quality of molded parts

• Criticality of supplier diversity as a business goal for corporations
• Link to customers
• How suppliers can support supplier diversity goals

• Product design
• Tooling considerations
• Beta prototyping phase
• DFM and DFA
• Transfer to production

• Targeting an appropriate level of validation effort to a new mold
• Risk assessment strategy
• Using flow simulation and solid modeling data to build the process before steel is cut

• Medical molding machine requirements in general
• Machine flexibility, integration of peripheral devices
• Mechanics, drives and general clean room design features
• Machine integration possibilities in conventional clean room technology

• Turnkey solution for high-volume disposable device production
• Case study with a fully integrated Pipette production system

• Requirements that will drive your choice of manufacturing process
• Case studies on process and resin selection
• How economics can be impacted by each decision

• Choice of correct molding technology
• Optimization of existing production
• Project management - 'The move to medical production'
• Case studies