Getting your medical device approved shouldn’t take years of trial and error

I help early-stage MedTech founders get a clear EU MDR, UKCA and/or FDA regulatory strategy in just 30 days so they can move forward with confidence, reduce delays and get to market faster

The problem:
Many founders are unsure which pathway applies, what documents are required or how to avoid months of regulatory back-and-forth. Without a clear plan, they risk burning runway, missing opportunities and losing investor confidence

How I help:

- Map the exact regulatory pathway (CE, UKCA, 510(k), De Novo, PMA)
- Define intended use & classification to align with regulators
- Build a step-by-step submission readiness plan
- Provide hands-on support for technical documentation, QMS & audits
- Guide devices including SaMD, AI/ML, hardware and IVDs through IEC 62304, IEC 82304, applicable ISO standards and emerging AI frameworks

Full capabilities:

Regulatory consulting: CE marking under MDR/IVDR, UKCA certification, FDA pathways (510(k), De Novo, PMA). PRRC & UKRP services. Gap assessments, submission support & strategic planning

Quality assurance: Implement & remediate QMS to ISO 13485 & MDSAP. Lead audits, manage CAPAs & complaints, support risk management (ISO 14971), process validation (IQ, OQ, PQ) & sterilisation (ISO 11607). Certified ISO 13485 Lead Auditor (CQI/IRCA)

Digital health / SaMD: Compliance with IEC 62304, IEC 82304 & AI/ML frameworks. Software validation & CSV for regulatory alignment

eQMS platforms: Implement Greenlight Guru, Qualio, MasterControl, JIRA & Confluence, with CSV to ensure audit readiness

Due diligence: Regulatory & QMS assessments for investors, accelerators & M&A. Identify red flags in technical documentation & submissions before they become costly

Training & microconsulting: For teams & founders building internal capability. CQI/IRCA-registered tutor for MDR, IVDR, ISO 13485, ISO 14971 & MDSAP

I’m a startup advisor and competition judge for MedTech Innovator, Springboard Enterprises and MassChallenge. As a trainer and host of The MedTech Podcast, I work with founders, investors and accelerators worldwide to deliver regulatory clarity and practical strategies

I combine regulatory expertise with a practical, execution-focused mindset. Clients value my ability to cut through complexity, reduce time to market, pass audits and scale confidently, whether launching a first product or expanding internationally

If you’re navigating regulatory uncertainty or preparing for growth, let’s connect

🎙️ The MedTech Podcast | 📺 YouTube: @KarandeepBadwal

Karandeep Badwal

Hakeem Adebiyi - (Accelerating Your Healthcare Export journey)

✅OUTCOMES DELIVERED TO YOU!✅

𝗠𝗮𝗿𝗸𝗲𝘁 𝗘𝘅𝗽𝗮𝗻𝘀𝗶𝗼𝗻 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲: Hands-on guidance to help navigate difficult export landscapes and establish a strong international presence.

𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀𝗵𝗶𝗽𝘀: Connecting you with key industry players and decision-makers to drive business development.

𝗖𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗦𝘂𝗽𝗽𝗼𝗿𝘁: From strategy sessions to my signature online programme through to  full-scale consultancy, I am committed to your success.

✅ 𝗠𝗬 𝗨𝗡𝗜𝗤𝗨𝗘 𝗩𝗔𝗟𝗨𝗘 𝗣𝗥𝗢𝗣𝗢𝗦𝗜𝗧𝗜𝗢𝗡✅

✔️𝗣𝗿𝗼𝘃𝗲𝗻 𝗦𝘂𝗰𝗰𝗲𝘀𝘀: I work with my copyrighted Healthcare Export Acceleration Formula which is the process that helped me take a stagnant, SME medical device export business from 5M to 20M over 6 years increasing profitability from 40% to 53% . Which is the same process used to a grow a medical device start up from no sales into 24 markets, and an eight figure offer to buy the business, all within 12 months. 

✔️𝗧𝗮𝗶𝗹𝗼𝗿𝗲𝗱 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀: Offering bespoke solutions that address the unique challenges and opportunities in the medical device export industry.

✔️𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗘𝘅𝗽𝗼𝗿𝘁 𝗔𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗼r: An online program designed to share my successful process with a broader audience, empowering businesses to enter new markets successfully and achieve significant growth.

✅️𝗪𝗛𝗬 𝗖𝗛𝗢𝗢𝗦𝗘 𝗠𝗘?✅️
- Over 30 years of experience and a proven track record of transforming businesses. 
- Over 11 years of experience in the medical device export sector, I am passionate about helping startups and SMEs achieve rapid market expansion and unlock their full potential. 

As the Owner and CEO of Hands Associates Ltd, I leverage my extensive industry knowledge and proven methodologies to guide companies through the complexities of international markets.

𝗟𝗲𝘁'𝘀 𝗖𝗼𝗻𝗻𝗲𝗰𝘁!
If you are a CEO or decision-maker in a startup or SME looking to expand your medical device exports, let's connect. Together, we can definitely unlock new opportunities and drive your business towards significant growth.

EMAIL ME: hakeem@handsassociates.com

Chief Commercial Officer (CCO)

Brought in to help build the business globally so that every women can have gold standard postpartum care, wherever they may be in the world.

Hakeem - Global Market Strategist

Today I had the privilege of judging at the Pf Awards 2026 Assessment Day for the Account Manager – Primary Care category.

It’s always a good feeling to be in a position where you can give back to the profession that’s shaped so much of your own journey.

And it was even better to see so many familiar faces on the judging panel. 

People who genuinely understand the complexity of primary care and what “good” really looks like in the NHS. Paul Dermody, Sarah Stewart (Swinyard), Nyambe Sumbwanyambe Kerry Bambrick-Sattar Brian Bambrick-Sattar Caroline Wilcher to name but a few.

The candidates had to be structured.
Understand stakeholder dynamics and system pressure
Understand the reality that primary care account management is influence-led, not pitch-led.

Primary care is not an easy environment.

Well done to everyone who put themselves forward. 
Assessment days aren’t comfortable. 
Growth rarely is.

#PfAwards #PrimaryCare #AccountManagement #NHS #HealthcareLeadership

Hakeem Adebiyi - Global Market Strategist

Helping Medical Device Startups and SMEs Expand Globally | CEO - Hands Associates Ltd | Creator of The Healthcare Export Accelerator Programme | Host of the Clinician to CEO Podcast | Author

Thanks for joining our exclusive live broadcast. Feel free to share your questions and interact with other participants in the chat.

Tomorrow at 10am UK, I’m breaking down why most MedTech distributor partnerships stall.

It’s rarely a market issue.

It’s usually a structure issue.

We’ll get into:
• What must be defined before outreach
• How to identify who deserves your time
• What actually drives performance after signing

If international growth is on your agenda this year, it’ll be practical.

(Event link in comments.)

Regulators Say Yes… Buyers Say No.  Here's Why 75% of Medical Devices Still Fail After Approval.👇🏽

According to DeviceLab, 75% of medical device startups fail, even after getting regulatory approval.😱

AND

Just 2% of digital health products actually make it to market successfully. (Nope not making these numbers up, and every time I see them it still makes me wince!😱)

BECAUSE

After all that effort, you’ve got a technically brilliant product, the regulatory boxes are ticked... 

BUT

so many still fall flat when it comes to real commercial traction!

Having spent more than a decade working with medical device companies breaking into new markets, I’ve seen this story play out just about everywhere. 

And let me tell you, it’s rarely the product quality that’s the issue.

Usually, it comes down to these pitfalls I see time and time again:

❌ Too many teams leave the market planning until the regulatory approval’s already done.

❌ They send the same pitch to surgeons, CFOs, and nurse leads (when each group has completely different things keeping them awake at night!)

❌ They forget to show the evidence around workflow impact, integration, training costs, and don’t make it easy for the real gatekeepers.

❌ Supply chain teams, IT/security get ignored until it’s too late and everything slows to a crawl.

❌ Pricing models that just don’t line up with the realities of hospital buying.

Want to know the difference between those that stall and the ones that smash it?

The ones that succeed:

✅ Test pricing, messages and claims with real buyers BEFORE the thing has even got a CE mark or FDA sticker

✅ Map the decision making unit, instead of hoping a single surgeon or champion will do it all

✅ Build up market recognition and lay the groundwork while the regulatory machine is still spinning

Every time I work with teams wrestling with this stuff, the same lesson jumps out: 

technical brilliance isn’t enough on its own. 

You need a deliberate, joined-up approach to market entry, one that treats the commercial side as mission-critical, not an afterthought.

If any of these headaches sound familiar, you’re definitely not alone. 

Always happy to share what’s worked for me, just reach out or drop a comment if these challenges are stopping your product from breaking through.

#medicaldevices #healthcare #export #linkedin

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