Is your medical device
ready for Italy?
Get a free Italy Readiness Score. We review your evidence against what Italian hospital committees, regional HTA bodies and tender boards actually ask for — map who you will be competing against, and show you the gaps before they cost you a tender.
Get my free Readiness ScoreReviewed by a person, not just an algorithm. Delivered within 5 working days.
Entry possible — a few gaps to close
active in Italian tenders for your category
Reviewed by Clodio Caiola, CCi International Consulting
Good devices get stuck in Italy. Rarely because of the product.
75% of device purchases go through public healthcare.
That means committees, regional rules and tenders — each with its own way of judging clinical and economic value.
The tender base price is a ceiling.
Without documented evidence of clinical value and economic sustainability, you compete on price alone against suppliers who already know the system.
Procurement takes 12 to 18 months or more.
Missing evidence discovered late means starting the process over. The cost is not just time — it’s market position.
Around 60% of international market entries fail in the first two years. Most of those failures were visible on paper before launch — if someone had looked.
What your Italy Readiness Score tells you
Four areas reviewed against the Italian context — not a generic HTA checklist.
Your overall readiness level
Explained in plain words, not a pass/fail label. With a direct assessment of whether you are ready to enter, nearly ready, or need significant preparation first.
Your three most critical evidence gaps
For the Italian context specifically: regulatory status, comparators used in Italy, safety data, clinical effectiveness and economic evidence for the SSN setting.
Who you will be measured against
The likely comparator Italian evaluators will use, and the main competitors already active in Italian tenders for your device category.
A first read of the access route
Which decision-makers and procurement path your device is likely to face — regional tender, hospital committee, direct acquisition or a combination.
How it works
Tell us about your device
Fill in the form below. Ten minutes, with the basics you already have. No confidential documents required at this stage.
We analyse it
Using the CCi readiness method, built on Italian and European HTA frameworks and 20+ years of direct market experience.
You receive your score
By email, within 5 working days, with an optional 30-minute call to discuss the findings and next steps.
Built on 20 years inside the Italian MedTech market.
I’m Clodio Caiola, founder of CCi International Consulting. I’ve spent more than 20 years in Italian MedTech — working with hospitals, procurement directors, KOLs and clinical evaluators across every major region.
I’ve seen excellent technologies fail in Italy for reasons that had nothing to do with the product itself. This score is designed to surface those reasons early — while they can still be fixed before you invest in market entry.
Every score is reviewed personally before it is sent. Not by a junior analyst. Not by an algorithm.
Get your free Italy Readiness Score
Tell us what you already know about your device. Fields marked optional help us be more precise, but are not required to receive your score.
Frequently asked questions
Is it really free?
Yes. The Readiness Score is free and carries no obligation. If you want a full assessment afterwards, we will quote it separately.
Who reviews my device?
Every score is reviewed personally by Clodio Caiola before it is sent. Not delegated, not automated.
What if my device is not yet CE marked under MDR?
You can still apply. Regulatory status is one of the elements we assess — and knowing the gaps early is exactly the point.
What comes after the score?
If you want to go further, the full Italy HTA Readiness Check covers every evidence domain in depth, with a signed recommendation. Competitor prices and tender analysis are covered in our market assessments. There is no obligation at any stage.
Is my product information confidential?
Yes. All product details shared with CCi are treated as confidential. A signed NDA is available on request before you submit the form.
Book a free 30-minute call with Clodio — no form required.