Infusion Drug Delivery Videos

1. An EDDO Identification Tutorial For A Metered Dose Inhaler (MDI) 4/23/2025

   In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.

2. Understanding How EDDOs Relate To CGMPs 4/23/2025

   How are EDDOs (Essential Drug Delivery Outputs) related to CGMPs (Current Good Manufacturing Practices) during the design of a drug-led or biologic-led combination product? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC establishes the connection between the two regulatory concepts.

3. Risk Management and the New QMSR 7/11/2024

   What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.

4. Understanding The Change From EPR To EDDO 10/9/2024

   Why does the FDA’s new guidance on drug-led or biologic-led device design include a change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs)?  In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, offers his perspective on how the change in terminology clarifies key concepts related to design controls.

5. DARPin-Delivered Radiotherapy With Molecular Partners And Orano Med 8/20/2025

   In this episode of In Combination, CEO Patrick Amstutz of Molecular Partners and CEO Arnaud Lesegretain of Orano Med join host Tom von Gunden in a discussion of using DARPins (Designed Ankyrin Repeat Proteins) as vector delivery platforms for high-affinity binding of radioisotopes to treat cancer. Using the example of small cell lung cancer. Patrick and Arnaud describe how DARPin-delivered radiotherapy can attack metastatic cancers while overcoming the targeting limitations of external beam radiation and of antibodies. 

6. Confirming EDDOs Based on "Device Dependence" 10/9/2024

   Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.

7. Regulating Drug Delivery Platform And System Development 1/12/2026

   In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Fran DeGrazio to comment on her front-of-mind topic of systems thinking and platform approaches to combination product development.

8. Preparing For Combination Product Regulatory Inspections 4/11/2025

   In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 9 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Kim Trautman.

9. Partnership And Clinical Trial Strategies For Digitally Connected Devices 5/23/2025

   In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.

10. Understanding Supplier Quality And Controls For Combination Products 5/12/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 10 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Fran DeGrazio. On the topic of supplier quality and controls, Susan and Fran discuss key considerations for using third-party suppliers of raw materials, constituent parts, and services in combination product development.