# 143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-07-03
- Length: 29m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/143---New-FDA-Draft-Guidance-Essential-Drug-Design-Outputs-with-Alan-Stevens-and-Rumi-Young-e2ljh5f

## Summary

Alan Stevens, Global Head of Complex Devices at AbbVie, and Rumi Young, Director of Regulatory Policy at Novo Nordisk, discuss the FDA’s new draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices. They explain the distinction between EDDOs, system-level design outputs, and device-dependent design outputs, emphasizing that this framework applies to both combination products and standalone drug delivery devices like infusion pumps and auto-injectors. The guests highlight the guidance's value in providing concrete examples and clarifying the identification process early in development to ensure consistency across FDA review teams and industry sponsors.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=0) Introduction: Subi Sedate and the Complexity of Combination Products
- [1:21](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=81) Alan Stevens on the EDDO Pyramid and Identification Process
- [3:20](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=200) Rumi Young on Exhaustive Examples and Industry Feedback
- [4:30](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=270) Defining EDDOs vs. System and Device-Dependent Outputs
- [7:05](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=425) Timing of EDDO Identification: Novel vs. Established Devices
- [10:48](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=648) IND vs. Marketing Application Standards for EDDOs
- [13:21](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=801) Preconditioning, Storage, and Home Use Contexts
- [17:24](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=1044) Scope Clarification: Infusion Pumps and Standalone Devices
- [23:02](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=1382) Post-Market Changes and Established Conditions
- [27:05](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r#t=1625) Comment Period, Timeline, and Final Thoughts

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

large enterprises

## Mentioned

- AbbVie (company)
- Novo Nordisk (company)
- FDA (company)
- Genentech (company)
- AstraZeneca (company)
- CDRH (company)
- auto injector (product)
- infusion pump (product)
- syringe (product)
- pen injector (product)

## Related episodes from other shows

- [#343: Recent FDA Draft Guidances](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances) (Global Medical Device Podcast)
- [How Jon Speer Met His Most Frequent Guest: Mike Drues](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [The Best of Jon & Mike Through the Years](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years) (Global Medical Device Podcast)
- [Setting the Record Straight on Usability & Human Factors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.