Insights
Market intelligence for people building medtech companies.
ScaleCraft Monthly — Spanish and EU medtech: what moved in regulation, funding, trials and tenders, what it means from someone who has sold into these systems, and a short closing note on care as a craft. Alongside it, longer analysis on the economics of scaling in regulated markets.
Where to start with AI in a MedTech company: one process first
Start with the one process closest to revenue, measure it, fix the flow, then add AI step by step — a MedTech playbook built on Deloitte, McKinsey, BCG and MIT data from 2025–2026.
ReadHow Spanish public procurement of medical devices works
Spain has no single health buyer: 17 autonomous communities plus INGESA, central frameworks and hospital call-offs. How specifications are shaped and where tenders are lost — BOE and Sanidad sources.
ReadISO 13485 and AI agents: what the notified body will ask
An AI agent that triages complaints or drafts CAPAs is QMS software under ISO 13485 clause 4.1.6. What auditors ask, what the validation file contains, where to start — Deloitte, ISO, EUR-Lex sources.
ReadMore revenue, fewer people: what AI means for MedTech companies
Gartner expects AI to decouple headcount from revenue. How MedTech producers and distributors will reorganise by 2030, and eight measures to get there.
ReadThe performance-learning paradox in the age of AI — and what it means for how you develop your people
OECD research shows AI can boost task performance while employee skill stays flat. Here's what that performance-learning paradox means for how growing companies should design AI-enabled training and L&D.
ReadThe €3M wall in medtech — and the distributor economics that break through it
Most device companies don't stall because demand dries up. They stall because the distributor model that got them to €3M is the same one that caps them there. Here's the fix.
ReadScaleCraft Monthly
What moved in Spanish and European medtech — and what it actually means.
Once a month: regulation, funding, clinical investigations and tenders — named and sourced — my read on what matters, and a short closing note.
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I have just written to confirm it. The first letter arrives next month — and you can reply to any of them, they come straight to me.