# 137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-05-22
- Length: 18m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/137---The-3-Levels-of-Reliability--Fault-Tree-Analysis--Needle-Safety--Emergency-Use--and-Risk-Management-with-Capt--Alan-Stevens-e2jsnlp

## Summary

Capt. Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie, and former FDA CDRH official, explains the three levels of reliability in combination products: verification data, component reliability, and system reliability. He details how Fault Tree Analysis (FTA) is used to quantify system reliability, particularly for emergency use injectors and needle safety devices, where the FDA sets specific targets like 95% or 99%. Stevens discusses the regulatory expectations for these high-risk functions and how manufacturers should determine acceptable risk levels when no specific FDA guidance exists, emphasizing the role of risk culture and design assessments.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use#t=0) Introduction: Capt. Alan Stevens and AbbVie
- [2:40](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use#t=160) The 3 Levels of Reliability: Verification, Component, and System
- [8:55](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use#t=535) FDA Reviews, Component Jurisdiction, and Design Philosophy
- [11:04](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use#t=664) Fault Tree Analysis (FTA) in Risk Management and Emergency Use
- [14:17](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use#t=857) Specific Reliability Targets: 95%, 99%, and Needle Safety
- [15:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use#t=932) Establishing Risk Culture and Acceptable Risk Levels

## 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)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

large enterprises

## Mentioned

- AbbVie (company)
- FDA (company)
- CDRH (company)
- QMSR (other)
- FTA (tool)
- FMEA (tool)

## Related episodes from other shows

- [Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know) (Global Medical Device Podcast)
- [3 Systems of Risk for Medical Devices from FDA](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda) (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)
- [#325 The Role of dFMEAs in Risk Management for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices) (Global Medical Device Podcast)
- [Human Factors & Risk Management: What's Needed & Why?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why) (Global Medical Device Podcast)

## Citing this page

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