ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Role Of Psychological Principles In Med Device Training Design

  Explore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users.

• Fixtures And Surrogates For Combination Product Performance Testing

  The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

• Achieving EU GMP Annex 1 Compliance For Contamination Control

  Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

• Considerations In Design And Development Of Novel Combination Drug-Delivery Devices

  Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.

• Annex 1 – The Brave New World Of Regulatory Compliance

  The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

• Finding The Ideal Balance — Where Risk And Cost Of Quality Meet

  It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

• Achieving New Heights By Expanding Services, Talent, And Facilities

  As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

• Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization

  Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes. 

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• Data-Driven Innovation Is Drug Delivery's Next Evolution

  To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.