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8:00 am Morning Networking Coffee

8:50 am Chair’s Opening Remarks

Sustainability & Reusability of Injectable Devices

9:00 am Fit for Circularity as Measure of Medical Device Concepts Sustainability

  • Jesper Boegelund Program Manager of Device Design for Circularity, Novo Nordisk

Synopsis

  • Four levers for incorporating sustainability into medical device development
  • Three main dimensions of the circular economy
  • Two tools for directing and communicating
  • One overall KPI to compare concepts and gauge progress

9:30 am Beyond the Datasheet – Maximizing Your Drug Delivery Device Materials & Designs for Precision Friction Performance & Sustainability

  • Don DeMello Field Development Engineer – Medical Engineered Material, Celanese

Synopsis

  • Mechanical drug delivery devices for respiratory or injectable pharma can feature many sliding parts in high force, high pressure contact with one another where stick-slip or unexpected friction is a concern. Since friction is a system property between two material pairs and other conditions, this is difficult to capture on a datasheet
  • This presentation will highlight types of lab tribology testing and friction data available that can be used by mechanical engineers to mitigate risk in their designs. By plugging precision friction data into their models, engineers can optimize designs before mold steel is cut and increase opportunity for success
  • As devices slim down for human factors, cost reasons or require precise glide forces to push viscous biologics, this puts more performance needs on the materials used. System friction data is requisite for engineers designing precision dosing or other types of applicator devices
  • The good news is that low friction polymers are now available in grades to assist with medical device sustainability design goals

10:00 am Morning Speed Networking Break

Device Engineering & Control Strategies

10:30 am Can Behavioural Science be the Key to Unlocking Patient Adherence?

  • Andrea Pisa Usability Design Lead, Crux Product Design Ltd

Synopsis

  • The continued challenge of patient adherence and engagement to treatment – impact on patient outcomes and health system
  • Historic informational material – one size does not fit all
  • Two applied examples – development of digital solutions effective in on boarding users onto treatments and enabling successful self-management of their treatments over time
  • Key learnings – implementation lessons learned of applying Behavioural Science to instructional material development and technologies used to assess the intervention effectiveness
  • Project significance – Generation of medical solutions that better meet user needs and engage users with their treatments

11:00 am Supplier Engagement During a Drug Injectable Product Development

  • Emily Ho Associate Director, Merck & Co.

Synopsis

  • Understanding the quality management system requirements for an injectable device/combination product supplier
  • Determining the suppliers’ responsibilities and expectations for each design control phase/milestone
  • What are the benefits and challenges when developing a vaccine prefilled syringe combination product with a supplier?

11:30 am Building a Virtual Test Lab Delivering Results in 1 Hour

  • Martin Ebro Senior Innovation Lead, Bio Innovation Hub, Novo Nordisk

Synopsis

  • Reducing design iteration lead times from months to hours
  • Predicting the failure rate of 1.000.000 samples of a device – when variation is present
  • Expanding modelling capabilities to skin/tissue penetration, packaging, storage, and more

12:00 pm Panel Discussion: Next Generation Injectables Devices, Technologies & IoT Data Collection

  • Anthony Coston Director of Program Management, Biogen
  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals
  • Nick Song Director, Commercial Device Engineering, Takeda

12:35 pm Networking Lunch

1:35 pm Device Engineering & Design Control Strategies; The Important Aspects of Life Cycle Management

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals

Synopsis

  • How to manage component, manufacturing, assembly and/or analytical vendors through proper controls and common sense responsibilities
  • Design for manufacture benefits and criticality in today’s demanding economy
  • Lifecycle management: Thinking ahead and utilizing risk based manufacturing and device iterative design

2:05 pm Taking a Delivery System from Feasibility Through Development – Challenges & Opportunities with Progressing a Device Portfolio

Synopsis

  • Design control and how to take a device from feasibility into development
  • Challenges and opportunities and product development for pharmaceuticals
  • Understanding best practice around device injectable device development; aligning responsibilities and roles for injectable devices correctly
  • Making the best selection for each program; how difference diseases and the complications it gives patients and how they interact with the device
  • Creating devices with consideration to the medication going to be used

2:35 pm CMC Considerations Transitioning from Vial to Prefilled Syringe

  • Jamie Tsung Associate Director, Alnylam Pharmaceuticals

Synopsis

  • Identifying the key activities for developing prefilled syringe
  • Meeting and understanding the challenges for the vial-prefilled syringe transition.
  • Identifying the key factors to consider in primary packaging materials

3:05 pm Chair’s Closing Remarks

3:15 pm End of Conference