It’s the final countdown of ’25, another year of remarkable highs, deep complexities, and everything in between.

Before we all drift into our well-deserved holiday break, let’s take a moment to look back, breathe, and reflect on the last 365 days.

Because one thing is unmistakably clear:
2025 was a monumental year for MedTech.
A turbulent year.
A historic year.
And above all: a year dominated by AI.

At Flinn, we had a front-row seat to it all:
the regulatory pressure, the AI hype, the shifting tone in customer conversations, the resource struggles, and the deep transformation of how MedTech teams think about automation, compliance, and risk.

So let’s unpack what shaped this year and what 2026 is likely to bring!

A Regulatory Year Like No Other

Europe: A system under strain

From a regulatory perspective, 2025 felt like someone pressed the accelerator… and then welded it to the floor.

Across the EU, the reality was painfully consistent:

• Manufacturers struggled (really struggled) to keep up.

• Documentation workloads exploded again.

• Many still haven’t re-certified legacy devices under MDR.

• And now the inevitable is approaching: Massive notified-body bottlenecks starting in 2026.

RA/QA teams described the year in three words: exhausted, overloaded, out of breath.

United States: More scrutiny, less oxygen

Across the ocean, the FDA tightened its grip:

• Cybersecurity requirements became tougher.

• Documentation expectations ballooned.

• And then a rather unusual and historical moment: the FDA was essentially closed for a month, creating a backlog still felt today.

If you felt that the world became more regulated in 2025… you weren’t imagining things.

Global trend: No relief in sight

As if MDR/FDA workloads weren’t enough, 2025 added:

• EU AI Act (partially active)

• Biotech Act (emerging)

• Accessibility Act (introduced)

Or, as Tibor, our Head of Quality & Regulatory, summed it up:

It is hard to catch a breath; as soon as one regulation is complied with, a new one is already waiting around the corner.

And Then Came AI – Everywhere, All at Once

The regulatory pressure had a very clear side effect:
AI went from curiosity → necessity.

Remember 2022/23?
Talking about AI in MedTech got you polite smiles:
“Sure… maybe one day.”

Fast forward to 2025:
Every conference = AI.
Every LinkedIn thread = AI.
Every RA/QA roundtable = “AI, AI, AI.”
Every internal meeting = “Can we automate this with AI?”

Why?
Because the industry has reached a simple conclusion:
“We can’t keep up without AI.”

• Hiring is difficult, especially in Europe.

• RA/QA specialists are scarce.

• Budgets are tight.

• Teams are tired.

• Workloads have tripled.

AI didn’t become popular, it became essential.

2025: The Wild West of AI

We often called 2025 a year of experimentation, excitement and creativity.
A year of “what can’t we automate?”
A year of proof-of-concepts, prototypes, pilots, and… let’s be honest, a fair bit of chaos.

Everyone wanted to try AI. Many rushed in. Few had a strategy.

Which brings us to the next phase.

2026: The Year of Consolidation

The hype is cooling. The questions are getting sharper.
Companies now ask:

• Where does AI help right now?

• Where does it help in 1–2 years?

• Where is it not the right tool (yet)?

• And how do we validate all of this properly?

Manufacturers are no longer impressed by a simple “we use AI.”
They now expect proof. Transparency. Validation. Explainability. Documentation. Auditable processes.

For us at Flinn, this shift was the defining change of 2025.
Because it means one thing:
Customers are becoming more critical and that’s a very good thing. Critical customers are informed customers.

And informed customers are ready for the next chapter!

But First Things First: Fixing the AI Misconceptions

Across 2025 (in audits, workshops, customer sessions etc.) we noticed the same recurring patterns:

Misconception #1: “AI is AI.”
Deep Learning ≠ Large Language Models ≠ Machine Learning.
Using these terms interchangeably is like calling every vehicle a “car.” Technically not wrong, but dangerously imprecise.

Misconception #2: “AI is a truth engine.”
AI predicts plausible answers from patterns.
It can sound confident... and still be wrong. (Hello hallucinations.)

Misconception #3: “We don’t use AI.”
Completely understandable, the landscape is overwhelming.
But often teams were already using: DeepL for translations, AI-driven voice generation for training material, Speech-to-text in Teams or Zoom & Automated transcription and summarization tools. Modern AI often hides inside tools we use every day.

Misconception #4: “There must be one checklist to validate AI.”
Sadly: no.
Instead, companies must navigate:

• MDR / IVDR

• EU AI Act

• QMS (ISO 13485)

• Risk (ISO 14971)

• Validation (ISO/TR 80002-2)

• AI Standards (BS 34971, ISO TR 24028)

• FDA CSV

• Scientific literature

There is no silver bullet. AI literacy is essential and a responsibility for every MedTech leader.

The Polarising AI Debates of 2025

2025 also brought several highly public AI debates: the kind that spread fast, sparked strong opinions, and showed how diverse (and sometimes divided) our understanding of AI still is.

One example came from the UK:
When the NHS suggested that certain AI scribe tools might fall under medical-device regulation, a global discussion erupted.

Suddenly everyone asked:
“Is this a medical device? Who decides? What does this mean for other AI tools?”

Another ongoing debate:
Could ChatGPT itself ever become a medical device?
Opinions ranged from “absolutely yes” to “absolutely impossible.”

But these debates were not distractions, quite the opposite. They reminded us how quickly AI blurs traditional boundaries and how essential clear thinking will be in 2026.

The Viral “80% AI ROI Fail” Debate

You probably saw those viral LinkedIn posts:
“McKinsey says 80% of companies fail to see AI ROI.”

Sounds dramatic, but context matters.

What these viral posts didn’t mention:
ROI rarely appears in the first year.
ERP, CRM, cloud: they all took years.

Most AI “failures” are caused by:

• weak data foundations

• vague use cases

• poorly scoped projects

• unrealistic expectations

What we actually see is much simpler:
AI fails when the use case is unclear.
AI succeeds when workflows are well-defined and purpose-built.

So What Does This Mean for 2026?

Three big trends are already visible:

a) Integration > Tooling
We’ve moved past “AI can help.”
2026 will be about:
Connected systems, Cross-module automation, Interface thinking & End-to-end AI workflows.

b) Higher quality expectations
More AI = higher expectations for: Validation, Monitoring, Documentation & Transparency.

c) Expansion into new areas
AI-first solutions will grow across:
Risk Management, Complaint Intake, Complaint Handling, Vigilance Trend Analysis and beyond.

And something we’re especially excited about:
2026 will be a year of MedTech AI education!

And since it is the season of giving, here’s a little Christmas spoiler for you!
At Flinn, we plan to expand:

• AI literacy initiatives

• EU AI Act training programs

• Webinars & Workshops

• And yes… possibly the first Flinn Conference!

Because if 2025 taught us anything, it’s this:
MedTech doesn’t just need tools, it needs understanding first!

Final Reflection: 2025 Was a Turning Point

The industry changed. Teams changed. Expectations changed. AI changed.
And so did we.

2025 proved that AI is no longer a side topic.
And as we close out the year, one thing feels clearer than ever:
The future of MedTech belongs to those who understand AI, not just use it.

Now, from all of us at Flinn:
Thank you, from the bottom of our hearts, for this incredible year.
Everything we build is only possible because of you: your trust, your feedback, your high standards, your challenging questions, your curiosity, and your courage to rethink what’s possible.

If you’d like to discover how these trends impact your organisation, our team is always happy to connect – just reach out to us.

Let’s enjoy these very last days of 2025!
Take a breath. Recharge. Rest. You’ve earned it!

We can’t wait to build 2026 with you.
Happy Holidays & see you in January!