Costa Rica MedTech

Costa Rica MedTech Header
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.

Leave a Reply

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

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…

Vacuum Science

Vacuum is a process condition created by a system (surfaces + geometry + pumps + plumbing + gauges + sequencing) that you tune to get repeatable film chemistry, plasma behavior, transport, and cleanliness. There is no single spec or a single pump that can get you there. Vacuum in clean manufacturing is mainly about contamination…

From Sand to Silicon: Semiconductor Materials, Purification, Wafers, Films, and Dopants

Semiconductors are one of those fields where materials science and electronics meet in the most practical way: what a material is (and how clean, ordered, and intentionally “imperfect” it can be made) ultimately determines what circuits can do. I’m writing this series as an electronics engineer, and because earlier in my career I had the…

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.…

Laura López: The Economist Behind Costa Rica’s MedTech Boom

Laura López: The Economist Behind Costa Rica’s MedTech Boom You may know that Costa Rica has become a MedTech powerhouse but do you know that behind all these engineers and managers there is an economist thought leader helping shape the conditions for this economic miracle in the Americas? Laura López, CEO of PROCOMER (Costa Rica’s…

Something went wrong. Please refresh the page and/or try again.