If you want to see where European MedTech actually ships, go to the RDS Simmonscourt at the end of May. The National MedTech & Biotech Summit isn’t the flashiest show on the calendar, but it’s one of the most instructive: procurement leads, QA heads, device founders and contract manufacturers comparing notes on how to design, validate and build medical devices that can survive audits and hit margins. The 2025 edition had a clear leitmotif: software‑native MedTech. Whether you’re selling hardware, reagents or services, your competitive edge now lives in software quality, data governance and lifecycle control.
Three currents you could feel on every stage
1) SaMD maturity (finally) looks like a moat, not a hurdle. Teams that once treated software as a bolt‑on now lead with IEC 62304 discipline, post‑market surveillance loops, and model cards for anything with AI inside. Buyers and notified bodies are rewarding suppliers who can prove version control, drift monitoring and change‑impact analysis—particularly as more devices ship with embedded models for triage, image analysis or control.
2) QA and manufacturing are going digital—without becoming theater. Instead of demo‑ware dashboards, line managers showed work‑instruction systems with step verification, inline vision pumping defect tags straight into the eQMS, and electronic batch records that actually reduce CAPA panic. The proof was in process capability indices, not pitch decks.
3) Sterilization and sustainability graduate from afterthoughts to design inputs. Capacity in EtO/gamma/e‑beam remains the pacing item for many programs. The smart teams arrived with dual sterilization validations, energy‑aware HVAC for cleanrooms, and mono‑material packaging that hits sustainability targets without violating dose delivery or tamper evidence.
Why Ireland still punches above its weight
The cluster effect is real: OEMs, contract design shops and CDMOs cross‑pollinate talent, while universities and testing houses create a deep bench in human factors, biocompatibility and software validation. The Summit’s co‑location with wider manufacturing events means MedTech taps adjacent expertise—automation, robotics, and sustainability—fast. If you’re an overseas founder looking for an EU foothold, the pattern is clear: set up clinical and regulatory brains here, manufacturing where it makes sense, and wire the two with quality systems that survive audits on both sides of the Atlantic.
Buyer questions that closed (or killed) deals
- “Show me your FMEA and what has changed since the last audit.” If your risk file is a PDF, it’s dead. If it’s living and mapped to complaints and field actions, you’re credible.
- “How will you ship software changes?” Release cadence, validation evidence, rollback plans and how you’ll notify customers. Bonus points for SBOMs and cyber bills of materials.
- “Where’s your sterilization slot?” Vague answers got polite nods; purchase orders for time on line got handshakes.
- “Prove your UDI/serialization can talk to my ERP/LIMS.” Open protocols and references beat “we’re integrating soon.”
The human factors turn
Summative testing used to be an end‑of‑project tax. In 2025 it’s part of agile, with formative cycles closing in weeks. Teams brought quick‑change tooling so the insights could land in the next build, not the next quarter. Hospitals buying at scale demanded inclusive design (glove use, low‑light usability, multilingual labelling) with fewer assumptions about training and environment.
The deal landscape
Startups that led with a narrow clinical beachhead (cardiac rehab, wound care, home infusion) and clear reimbursement roadmaps got the love. The bigger cheques flowed to platforms bundling hardware + remote services + analytics with outcomes‑linked pricing and clean procurement stories for hospitals and home‑care providers.
Founder playbook for Dublin
- Evidence before adjectives. Bring bench + formative + summative data, and if you’re claiming AI, bring external validation and a plan for post‑market vigilance.
- Book your steri slot. Even if you’re pre‑market, a conditional allocation signals adulthood.
- Industrialize your documentation. eQMS configured to your process (not the other way round), supplier qualification depth, and EU MDR readiness if you want to cross the Channel.
- Integrate with reality. EHR interoperability (FHIR), UDI, and service plans that work outside Dublin.
Dates & place:May 28–29, 2025, RDS Simmonscourt, Dublin.
