Hardware Podcasts

207 - What 99.999% Reliability Really Means

Let's Combinate · 24 Sept 2025 · 23m

What this episode covers

Alan Stevens, Global Head of Complex Devices at AbbVie and former FDA/CDRH leader, explains the FDA's 2020 draft guidance on 'five nines' (99.999%) reliability for life-saving drug-device combination products like epinephrine and naloxone injectors. He clarifies that this standard does not require testing 300,000 samples, but rather demonstrates reliability through fault tree analysis linking design requirements to manufacturing process controls and challenge testing. Stevens emphasizes that while traditional design verification (DV) remains necessary, manufacturers must use sequential challenge testing and robust process controls to meet the high reliability threshold for products where failure could result in death or serious injury.

Most relevant to

large enterprises

Topics

Mentioned

Companies
AbbVie, FDA
Products
epinephrine injectors, naloxone injectors
Also
ISO 14971

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