# 129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-03-27
- Length: 32m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/129---Combination-Products--Infusion-Pumps-and-Recalls--Responding-to-Health-Disasters-with-Public-Health-Service--and-FDA-Rule-making-Process-with-Captain-Alan-Stevens-e2hjaj8

## Summary

Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie and former FDA official, explains why infusion pumps are highly susceptible to recalls due to reliability, software, and human factors issues in high-use hospital settings. He details the FDA's rule-making and guidance development processes, clarifying that while standards like ISO 11608 are influential, manufacturers must demonstrate safety and performance regardless of compliance. Stevens also discusses the application of reliability engineering to single-use combination products and the importance of systems thinking in public health safety.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste#t=1) Introduction: Subi Seday and Captain Alan Stevens
- [3:37](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste#t=217) Captain Alan Stevens and the Public Health Service
- [6:51](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste#t=411) Infusion Pump Recalls: Reliability, Software, and Human Factors
- [13:27](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste#t=807) FDA Rule-Making and Guidance Development Process
- [21:44](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste#t=1304) Reliability Engineering in Single-Use Combination Products
- [30:46](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste#t=1846) Systems Thinking and Nancy Levison's Book

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)

## Most relevant to

large enterprises

## Mentioned

- AbbVie (company)
- FDA (company)
- CDRH (company)
- Public Health Service (company)
- ISO 11608 (other)
- ISO 13485 (other)
- Systems Thinking in Safety (other)

## Related episodes from other shows

- [#385: The Trouble with Home-Use Devices, Pt. 1](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1) (Global Medical Device Podcast)
- [S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda) (Being an Engineer)
- [#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling) (Global Medical Device Podcast)
- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)
- [#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu) (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/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste. 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.