The FDA updated its Clinical Decision Support guidance on January 29, 2026. Most coverage will focus on what’s excluded from device regulation. The more important question is what isn’t. Navigating the Updated FDA CDS Guidance CDS software avoids device classification only if it meets four criteria. The first three are relatively mechanical: no image or […]

Why Failure Prevention Fails in Real-World Systems Most teams building critical systems optimize for failure prevention. Fewer outages. Fewer bugs. Fewer incidents. The goal sounds right. The engineering model behind it is wrong. Prevention assumes you can eliminate failure from a system. You cannot. Not in systems with external dependencies, human operators, network boundaries, or […]

AI Is Probabilistic by Design Deterministic AI systems are not about changing how models behave — they are about controlling how models are used. AI is inherently probabilistic. This is not a flaw to be fixed. It is a property to be governed. Why You Can’t Force Determinism Into AI The mistake most teams make […]

Most teams treat change control as friction — a review step, an approval process, a gate between engineering and production. Something to get through. The goal is to ship; change control is what slows you down. This framing is backwards. Change control is not the thing that slows delivery. Uncontrolled change is the thing that […]

Most compliance programs run parallel to the systems they describe. Documentation lives in one place. The software lives in another. The two are connected by human effort — someone writes the evidence, someone reviews it, someone attests that the system does what the document says it does. This works until it doesn’t. And it usually […]

I’ve talked before about BiTE’s completely distributed team, and how I think this is one of the keys to our success. Not only does it vastly open up the talent pool when looking for new team members but it decreases turnover while increasing productivity and flexibility. I’m often asked how we deal with the “inherent […]

  The first rule of great product development is: Don’t ask the customer what they want. But why? Well, customers have no idea what they want. More importantly, they can’t tell you why they really buy your product. I love the Henry Ford’s quote, “If I’d of asked people what they wanted, they would have […]

According to London Business School’s Annual Global Leadership Summit poll, over a third of surveyed companies project more than 50% of their workforce will work remote by 2020. That may seem like a surprising number until you realize how much a remote workforce could benefit your company. Here’s how it benefited ours: When Brant DeBow […]