Bristol Breakfast · Regulatory and Clinical
Cleared to sell, but is anyone buying?
Clearance lets you sell. It does not make anyone buy. Most of the regulatory and clinical problems MedTech owners run into trace back to that gap, and they surface long after the submission, when the product is approved and the pipeline is still empty. This is the morning on closing it.
For MedTech founders and commercial leads carrying a cleared or nearly cleared product.
Clifton Members Club · Ten seats · No fee
Start here, not with the form
The thinking is free. Take it now.
The five problems, how to spot each one in your own business and what good looks like, are free to read now in The Clearance Gap, written with Clearpath. The breakfast is the same argument around one table, against your product.
Read The Clearance Gap
Clifton Members Club, Bristol. One table, ten seats, one morning. Date follows demand.
The gap after clearance
A CE mark or a UKCA mark proves your device is safe and performs. It says nothing about whether a budget holder will buy it, whether the evidence you generated answers the question a payer actually asks, or whether anyone in the Trust knows the route by which your product could be purchased. Teams build for the regulator, then discover the buyer was never the same audience.
The five problems below are Andrew Dubowski's, the ones Clearpath sees most often. The commentary and the questions are AGENCY's. Each one is decided early, cheaply, and usually before anyone realises a decision is being made. General information, not regulatory or legal advice. Take advice specific to your device, your evidence and your markets.
The room
Nine or ten MedTech leaders. AGENCY runs the room, Andrew argues the regulatory half.
The breakfast is hosted jointly by AGENCY and Clearpath HealthTech. AGENCY runs the series and the room. Andrew Dubowski, Partner and Co-Founder of Clearpath HealthTech, where he leads commercial and engagement, brings the regulatory and clinical argument. Clearpath's work is the regulatory and clinical side of getting a device adopted: pathway diagnostics, evidence and health economics strategy, post-market surveillance, AI governance and NHS market access. He is a founding member of the MedTech Product Launch Collective alongside AGENCY.
Andrew Dubowski
Speaker. Partner and Co-Founder, Clearpath HealthTech
- Where
- Clifton Members Club, 22 The Mall, Clifton, Bristol BS8 4DS
- When
- Demand-led. We read the response to the September breakfast first, then set the date. Register and you hear before anyone else.
- Who it is for
- Senior life sciences marketing and commercial leaders within about an hour of Bristol.
- The table
- Kept to ten, so the conversation stays a conversation.
What happens
Ninety minutes. Three moves. You do the talking.
It is a conversation around one table, not a talk you sit through. Everyone in the room owns the same problem, so everyone has something to say.
01
Where is your product, and who has to say yes?
Everyone maps their own position: cleared, nearly there, or still choosing a pathway. The interesting version of the answer is always who signs the purchase order, and how few people in the room can name them.
02
The five gaps, against your own product
Pathway, evidence, surveillance, software and AI, procurement. Which of the five you have already closed, which you have not looked at, and which one is quietly setting your timeline.
03
What you would have to do differently
The one decision each person would take back and make again, and what it would cost to make it now rather than after the next submission.
Chatham House rule
No slides, no pitch
One table, no theatre layout
Bring a live example
The five gaps, and the question that finds each one in your business.
01
The wrong regulatory pathway
Misjudged classification, whether that is Class I or IIa versus IIb or III under the EU Medical Device Regulation, or 510(k) versus De Novo versus Premarket Approval in the US, derails timelines and investor confidence. The test in the room: can you point to the specific clause in the classification rules, not a slide, that justifies your device's class?
02
Evidence that satisfies the regulator, not the buyer
Evidence generated to win clearance often does not support reimbursement or a purchasing decision. The test in the room: can your current evidence answer what a budget holder actually asks, what does this replace, and what does it save?
03
Post-market surveillance as an afterthought
Vigilance obligations get under-resourced, which creates exposure at audit and again on market expansion. The test in the room: has anyone stress tested your vigilance system against next year's sales forecast rather than today's volume?
04
Software and AI devices under two rulebooks
Software as a Medical Device and AI-enabled devices sit under two regimes at once, medical device regulation and the EU AI Act, which are meant to be assessed together and rarely are. The AI Omnibus, in force since 27 July 2026, moved the high-risk requirements for AI inside regulated products to August 2028. That is a longer window to sequence the two properly, not a reprieve. The test in the room: does one team own both your device conformity work and your AI Act obligations, or do they meet only at the end?
05
NHS procurement mistaken for market access
A CE or UKCA mark gets read as permission to sell, and owners do not know the real buying journey. The test in the room: could you name the framework agreement your product needs to sit on to be purchased by an NHS trust?
Register interest.
Tell us who you are. When the date is set you hear first, and The Clearance Gap lands in your inbox today, so the morning starts before the morning does.
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