In today’s competitive global health-tech landscape, entering new markets requires more than a regulatory checklist or a polished investor deck. It requires local traction, commercial validation, and trusted partnerships that can turn plans into performance. That’s where 360Disruption comes in.
At 360Disruption, we don’t offer advisory in a vacuum. We execute. Whether you’re a U.S.-based company seeking to expand to the UAE, or a visionary startup looking for a trusted partner to bring your solution to life, we offer a pathway grounded in reality and built for scale
Every company we work with is different. Some are still testing product-market fit. Others are ready to scale. A few simply need the right on-the-ground team to carry the commercial flag. That’s why we built our platform around three adaptable tracks:
We work with early-stage companies or first-time entrants into the region to de-risk market entry, validate local demand, and prepare for regulatory approval. This includes:
Tailored market validation and go-to-market planning
Regulatory advisory and stakeholder mapping
Pilot design with regional healthcare providers
Messaging, positioning, and regionalization support
Whether you're preparing a clinical pilot, navigating UAE compliance, or trying to understand how to localize your product, 360Disruption gives you a head start — minus the burn rate.
For companies with product readiness and validated traction, we act as the growth engine:
Commercial pilot execution
Strategic partner introductions (hospitals, clusters, investors)
Government-facing localization narratives
Co-investment structuring and deployment readiness
You’re not just getting warm intros — you're gaining a team that moves with you, negotiates on your behalf, and ensures long-term value capture.
In select cases, 360Disruption becomes the commercial face of a product in-market. We take on:
Distribution rights and sales representation
Channel development, partner onboarding, and demand generation
Local brand adaptation and market education
Recent example? Our distribution agreement with a leading U.S. based Health Sciences company, bringing their clinically backed cardiovascular support supplements into the UAE. This is real commercial work, not speculative advisory.
The 360Disruption Difference
We act, not just advise. From Vaccine patches to nutraceuticals, we’re executing go-to-market playbooks every day.
We build trust with regulators and investors. Because we live here, work here, and have long-standing relationships with government, free zones, and healthcare providers.
We focus on outcomes, not optics. We measure success in pilots launched, deals closed, and patients impacted.
A Better Way to Expand
If you’re a health-tech company looking to:
Enter the UAE or Gulf region
Secure localized partners and licensing
Launch with credibility and momentum
Or simply avoid the mistakes others have made…
Let’s talk.
360Disruption isn’t just your launchpad. We’re your local operating arm — ready to incubate, accelerate, or commercialize your innovation.
Reach out to explore how we can help bring your healthtech solution to life — the right way, the first time.
Let’s build your Gulf expansion the smart way.
Reach out to schedule a strategy call
Let’s talk strategy.
Let’s build something that scales.
Let’s make your business expansion as smart as your product.
Want to stay in the loop, please subscribe on our website, 360disruption.com
Or when you wish to discuss or need input for your Free Zone, send an email to info@360disruption.com
The United Arab Emirates (UAE) has quietly built one of the world’s most innovation-friendly pathways for medical device companies—and now, more than ever, U.S.-based healthtech startups and scaleups should take notice.
Unlike the FDA’s formal and risk-heavy classification system, the UAE’s Ministry of Health and Prevention (MOHAP) offers a flexible, product-specific, and internationally harmonized framework that accelerates market access, reduces cost, and creates entry into a health-conscious, tech-forward region.
This is not just an alternative to the U.S. regulatory maze—it’s a springboard into the broader Middle East, Africa, and Asia.
| Criteria | FDA (USA) | MOHAP / UAE |
|---|---|---|
| Classification | Class I, II, III | Class I, IIa, IIb, III (EU MDR aligned) |
| Approach | Risk-based | Risk-based + product-specific |
| Timeline | 12–36 months | Weeks to classification letter |
| Cost Burden | Clinical trials, PMA/510(k), extensive review | Streamlined, significantly reduced cost for non-drug devices |
| Formality | Highly structured | More adaptive, especially for emerging technologies |
A MOHAP-issued classification letter is not a final approval—but it provides early clarity on the product’s regulatory pathway, including whether full registration is required and under which class.
In some cases, such as a recent business case we managed for one of our clients, classification as a medical device rather than a pharmaceutical has eliminated tens of millions in development costs and shaved years off the go-to-market timeline.
This letter also opens the door for direct import, pilot deployments, and early commercial traction, even while the full registration process is ongoing.
Government investment: Aligned with Vision 2030/31, the UAE is prioritizing smart healthcare, digital infrastructure, and advanced manufacturing.
Gateway to Asia & Africa: Products approved or classified in the UAE gain credibility and regional access to larger, underserved markets.
Medical tourism hub: With Dubai and Abu Dhabi leading in healthcare services, the demand for innovative devices and therapies is rapidly growing.
Collaborative environment: Local authorities are not gatekeepers—they’re enablersENABLERS. The goal is safety, yes—but also speed, clarity, and impact.
Why 360Disruption Is Your Ideal Partner
At 360Disruption, we specialize in bringing U.S. healthtech companies into the Gulf through a structured, results-driven go-to-market framework:
If your product is FDA-cleared, CE-marked, or even in development, the UAE offers a faster, broader, and strategically vital opportunity. With 360Disruption by your side, you won’t just enter the Gulf — you’ll scale into Africa, Asia, and beyond.
Let’s build your Gulf expansion the smart way.
Reach out to schedule a strategy call
Let’s talk strategy.
Let’s build something that scales.
Let’s make your business expansion as smart as your product.
Want to stay in the loop, please subscribe on our website, 360disruption.com
Or when you wish to discuss or need input for your Free Zone, send an email to info@360disruption.com