Costa Rica MedTech

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Gowned technicians assembling and inspecting medical devices in a clean, modern Costa Rica manufacturing lab.

2025-05-14-requirements-are-hard-just-state-what-you-need

Slide emphasizing that “just state what you need” hides the difficulty of specifying requirements

A slide reinforcing that ambiguity in requirements persists even if coding is accelerated, verification can only validate what is specified.

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Threat Modeling in MedTech: Turning Cybersecurity Regulation into Patient-Safety Evidence

TL;DR Who this guide is for This guide is for MedTech founders, product managers, systems engineers, software leads, cybersecurity engineers, QA/RA professionals, clinical engineering leaders, supplier-quality teams, and project managers. This guide moves from regulatory context to patient-safety impact, then into a practical threat-modeling workflow, a connected infusion pump example, attack modeling, DFD + STRIDE…

Managing Change in Regulated MedTech Software

🧭 TL;DR Who this article is for This article is for MedTech project managers, product managers, software leads, QA/RA, systems engineers, cybersecurity leads, and supplier-quality partners working with regulated software, SaMD and SiMD, connected devices, or hybrid medical-device programs. It is especially useful for teams trying to reconcile two pressures that often feel opposed: How…

Stakeholder Management in MedTech

Stakeholder management in MedTech is not a “soft skill.” It is part of the design-control and risk-control system that determines whether a product can be safely released, adopted, supported, and defended with objective evidence. This article is MedTech-first and experience-based. In regulated medical software, stakeholder management is not just communication. It is how expectations become…

Unpacking the Project Performance Domains in MedTech

Project performance domains are one of those concepts that sit quietly underneath everything in modern project management: they’re not a “method,” but they often determine whether the work is coherent, repeatable, and value-realizing. I’m writing this from the perspective of a program manager in high‑stakes engineering (MedTech and other regulated environments). I started learning with…

Agile in regulated medical device software: what TIR45:2023 really added

I believe in starting an Agile roadmap from an agnostic Agile perspective. I focus on the outcomes. I focus on flow. I focus on learning. I do this in any industry. I do it even more in safety-critical industries. That is why I paid close attention to the updates in AAMI TIR45:2023. This update matters.…

Prioritization tools: Pareto Analysis

Pareto Analysis is a prioritization method based on a simple observation: You don’t use Pareto to ignore the remaining issues, you use it to sequence work so the team earns the biggest satisfaction gains early. 🎯 Quick Takeaway: Pareto Analysis (the 80/20 rule) helps you focus improvement work on the small number of issues that…

Software Engineering in the Age of AI

Software Engineering in the Age of A.I. AI-assisted coding is here, and it’s improving fast, however software engineering still lives or dies by verification and validation discipline. Modern generative AI is fundamentally probabilistic, while many real systems demand behavior we can justify as provable (or at least defensible with strong objective evidence). The path forward…

Agile Progress Reporting Charts

How to read this article 🧭 TL;DR: Agile progress charts are not “status.” They’re a way to make scope volatility, flow constraints, and risk visible early enough to steer. Progress reporting in Agile Progress charts are not decoration. They are decision tools. In high-stakes engineering environments (including regulated work), “status” is cheap but predictability and…