7:30 am Registration & Welcome Coffee
8:30 am Chair’s Opening Remarks
Fortifying User-Centric Design Thinking in Your Injectable Device
8:40 am Understanding Injection Device Needs in Rare Disease Patients: A Holistic Approach for Early Stage Research
Synopsis
- Meeting and understanding the specific challenges for rare disease patients to design usable devices
- Approaches to prioritize patient experience over the solution; why usability and patient experience matters
- Case study: early findings from qualitative user research
- Value of patient needs research at the early stage of device development
9:10 am Presentation Title & Description – TBC
9:40 am Session Reserved for Emergo by UL
10:25 am Structured Networking & Morning Refreshments
Extending Your Product Lifecycle Management
11:10 am Leveraging Cutting Edge Technologies into Combination Product Lifecycle Management
Synopsis
- Identifying the needs to improve the launched injection system based on postmarket investigations
- Challenges from device design and manufacturing during design improvement
- Leveraging cutting edge technologies such as FEA, CFD and Moldflow simulation into the device improvement to mitigate risk, shorten lead time and reduce cost
11:40 am Usability Engineering Methods to Address Use Related Risk for Medical Devices
Synopsis
- Common methods to analyze use related risk including Use FMEA, URRA, Fault Tree Analysis; pitfalls and additional considerations in applying these risk management tools
- FDA regulatory expectations in using risk management methods and human factors for injectables
- Ensuring human factors are a part of design to fulfil product requirements and user needs; how new products are being developed and manufactured based on the user needs and clinical requirements
- Increasing patient medication adherence and improving onboarding for new patients, ensuring patients take their medication on time, stored properly and following correct application methods
12:10 pm Spotlight Session Reserved for Datwyler
12:25 pm Q&A: Extending Your Product Lifecycle Management
Updates of Evolving Global Regulatory Landscapes
12:40 pm Evolution of the Safety Organization to Support Post-Market Safety Reporting (PMSR) for Combination Products
Synopsis
- One year after implementation of FDA’s PMSR requirements for combination products how has it changed the world of safety and what does industry need to be aware of?
- How does FDA review and regulate combination product reporting?
- How can industry adapt to the global divergence of PMSR requirements?
- Challenges that still exist for PMSR compliance for injectable products
1:00 pm “Plug & Play”? Leveraging Established Device Platform for Combination Product Development
Synopsis
- Understand the regulatory agency’s expectation about devices for pivotal clinical trials
- When leveraging an existing device platform, how to decide what existing data can be leveraged and what extra steps to complete to satisfy the regulatory requirements
- How to communicate your development strategy to the regulatory agencies
- How to determine the development timeline
1:20 pm Case Study: Combination Products Bridging Study Landscape
Synopsis
- Industry strategies to ensure correct bridging of clinical trials
- Regulatory guidance of combination products bridging study; interpreting regulatory guidance to ensure successful submission
- Lessons learned from successful and unsuccessful submissions for injectables to regulatory agencies
1:40 pm Q&A Updates in Managing Evolving Global Regulatory Landscape
2:05 pm Networking Lunch
How ‘Smart’ Are Your Injectable Devices?
3:00 pm The Multiple Benefits of User Centered Smart Devices
Synopsis
- What are wearable technologies and how does the device developer maximize their benefits
- What patients want is comfort and convenience: How do device developers address these needs using biosensors and embedded sensor technology
- The evolution of human factors engineering and how the regulators are aligning
3:20 pm Leveraging Connected Health & Smart Devices
Synopsis
- Opportunities to enhance current treatment offerings with connected health and the role of data in benefiting patients, HCP’s and healthcare systems
- Development of the right solutions in connected health and impacting the user experience
- Overcoming challenges to bringing connected injectables to the market
3:40 pm Q&A: Smart Devices
High Viscosity & High-Volume Injection Device Design & Engineering
3:55 pm Technical & Human Factors Considerations for High Viscosity/High Volume Injection
Synopsis
- Future trends: market direction driving the move to high viscosity/high volume injection
- Addressing engineering and technical considerations in delivering these formulation and drugs through injectable format
- Understanding and fulfilling human factors challenges in these scenarios
- Decision making for high volume/high viscosity injectors; balancing pain and usability for patients
4:15 pm Afternoon Networking Break & Refreshments
4:30 pm Combination Product Development for Large Volume Delivery Device
Synopsis
- Patience tolerance to high volume injectables; Understanding the boundaries with high volume injectables
- Addressing the technical challenges for path injectors, wearables with higher volumes.
- Satisfying technical requirements for on-body high volume injectors
- Future trends: industry direction for large volume injections
4:50 pm Optimization & Patient Tolerance of a High Viscosity, High Volume Platform Technology Approach Towards Subcutaneous (SC) Injections
Synopsis
- Perceptions and facts associated with the current practice for SC injections
- New data that addresses user acceptability of multiple volume and viscosity permutations
- Strategies to optimize SC delivery systems
- Future trends: expanding the design and performance space for SC delivery devices