Olivia
Online
Jón I. Bergsteinsson
@joningib
Voice of MedTech | Industry Truth-Teller | MP @ | Chair of IceBAN
Iceland
Joined April 2009
475 Following
223 Followers
403 Posts
I'm getting really tired of hearing HealthTech VC funds talk about how they want to change healthcare, and then a few messages later they tell me they only do digital health 🤦
What they usually mean is that they don't want to touch hardware, they don't want pre-revenue, they don't want to deal with a notified body.
But then maybe don't call it healthtech - stick to wellness or lifestyle or even just b2b saas.
No software has ever stopped a bleed or replaced a heart valve, and no LLM has ever kept a premature baby breathing (not yet at least)
Software can inform a clinical decision, sometimes brilliantly, but someone still has to deliver the actual care with something physical.
And this is not some shrinking legacy business we should be moving away from. The global device market is around $570B today and is expected to pass a trillion within a decade, we'll have 1.4 billion people over 60 by 2030, and chronic disease is already behind roughly 74% of all deaths. Every one of those patients will need something physical at some point in their journey, and that is not going to change because we built better dashboards.
Many investors are just funding the paperwork around care and calling it a revolution.
And by the way, a lot of what these digital health solutions ends up being a medical device anyway. If your software informs diagnosis or treatment, you are regulated under EU MDR whether you planned for it or not. You didn't avoid the hard part, you just haven't met it yet...
Yes, devices are hard. EU MDR is hard. Pre-revenue hardware is BRUTAL and it takes years. But that IS the point. Hard is what creates the moat. If it was easy you wouldn't need a specialist fund, you'd need a landing page.
Digital health is not an alternative to MedTech, it's a layer on top of it 🩺
#MedTech #MedicalDevices #HealthTech #VC #Nordics #Startups
🫠Do we honestly believe that the FDA can turn this around in 12 months with 2k+ new hires?
CDRH lost roughly 22% of its workforce. The result: every device pathway slowed in H1 2026.
PMA approvals now average 599 days, up 49% on last year. An that's with access to ai tools!!
Meanwhile, the EU just bolted hard clocks onto notified bodies. Prepared CE files are clearing in sub 9 months for class III.
New reviewers take years to train.
The question isn't US or EU anymore. It's which clock your runway can survive with the most appropriate GTM plan 🥸
#MedTech #MedicalDevices #FDA #eumdr
⏳ Stop waiting until your product is "ready" to show up at industry events.
MedTech founders tend to hide until they have a finished product. Then they walk into a conference expecting the industry to care.
Or even worse, try to sell it into healthcare expecting the buyer and users to care
It doesn't work like that.
The real value of niche medical events isn't the pitch. It's everything you do before
🩺 Get to know the clinicians who'll actually use your device
👩⚕️ Collect KOL interest and honest input while you can still change or pivot
📌 Validate the problem before you've spent two years building the wrong solution
Clinically impactful solutions only work if you're open to sharing early, and being told you're wrong.
Show up before you're ready. That's the point.
#MedTech #MedicalDevices #HealthTech #KOL #Founders
⏳ A sub 12 month CE mark for Class II and III is now real - thanks to:
⌛ hard clocks on notified bodies
🎨 improved operations and offerings by notified bodies
I'm seeing this in real time - from conversations with startups, investors and regulatory advisors in the industry.
Notified Bodies are also reporting much shorter application timelines... could this be the key to improving the medical device startup scene in Europe?
#MedTech #eumdr #MedicalDevices
Failing to raise a big round can also kill your company. A big round isn't a milestone. Sometimes it's a mistake. 🌊
Why do so many argue about round names. Pre-Seed, Seed, bridge, extension. Nobody agrees. And honestly? It doesn't matter.
What matters is knowing exactly how much capital it takes to reach your next milestone, and can you show investors why, and when?
Raise too little, you stall before you de-risk.
Raise "extra" just because it's on the table, and you've handed away equity at a valuation you now have to outgrow.
Neither is efficient.
Funding efficiency isn't raising the most. It's raising precisely what the next milestone demands, no more, no less.
The best MedTech founders don't raise the biggest rounds. They raise the right ones.
#MedTech #MedicalDevices #Fundraising #Startups #HealthTech #Nordics
💡 The future of MedTech is being built around the LLM universe.
Software. Embedded software. Electronics. RA/QA. Manufacturing readiness. Fundraising.
All of it will run on LLM infrastructure, and for that, you need skills.
So we built a curated index of the AI agent skills and MCP servers that actually matter for MedTech founders: devices, diagnostics, SaMD.
We've reviewed it, flagged the founder-relevant bits and noted every licence. It's mostly free. No gate. We'll try to keep this updated as we can - things move super fast in this space these days.
The bottleneck is never access to these tools. It's knowing which ones actually matter. Find the latest updated "MedTech Startup Tool" on our https://t.co/EeANEfTxZJ
#MedTech #MedicalDevices #HealthTech #SaMD #Nordics
@dadikr Einmitt þessvegna sem ég er að betta öllu á MedTech 😁
I have reviewed so many MedTech clinical study protocols and almost all of them have the same problem...
The sample size "justification" looks something along these lines:
❝... using a power of 0.8 and an alpha of 0.05, a sample size of 104 patients was determined to be sufficient.
This is not a justification, that's a sentence.
Before you even open claude code (or a calculator - if you're more into the classics) or call a biostatistician, there are 4 decisions only you can make. Get those wrong, and the math means nothing.
Made a quick reference for this. Save it. Bookmark or whatever you like :)
#MedTech #ClinicalTrials #MedicalDevices #Founders
🤦 Your PI is collecting data for their research paper. Not for your regulatory submission or marketing needs.
After a decade in the EDC industry, the single biggest mistake I saw in early MedTech studies was this👇
Founders defer to their clinical investigator on study design because "they're the expert." And they are. But they're not YOUR expert.
A PI's job is to publish and with their incentives reward novel findings, clean comparators, and academic impact.
Your job is to get the device approved. Reimbursed. Funded.
Those goals overlap and don't match.
⚠️ When PI-driven data collection takes over we see
🔘 Beautiful publications, weak regulatory dossiers
🔘 Endpoints that excite reviewers but don't satisfy payers
🔘 "Statistically significant" results, no commercial story
🔘 A great paper, a stuck company
And this is just one piece... 90% of what determines whether your clinical evidence actually means anything sits below the waterline, operator effects, device drift, study design, endpoint validity.
The trophies above the surface get the headlines. The work below decides whether you ship.
💪 Founders: Own your study design. Your PI is a partner, not the decision-maker.
💰 Investors: When you see a glossy first-in-human result, ask who designed the data collection. The answer probably predicts the next 18 months.
A successful pilot is easy. But creating a reproducible device (and putting it to market) is hard.
What you tested isn't always what you ship.
#MedTech #MedicalDevices #clinicaltrials #HealthTech
💡 The unicorn obsession in VC is actively hurting MedTech startups and their founders.
MedTech needs companies that survive long enough to change patient outcomes.
Yes, some do turn into $1B+ companies, but most don't.
And yet, I keep seeing MedTech SaaS decks. Infinite TAM. Hockey stick projections. Unicorn exit narratives...
It doesn't land. And it shouldn't, because that's the "investment banker VC fund" speaking.
Here's the reality of MedTech fundraising that nobody says clearly enough
🔵 Exits are bounded. Strategic acquirers, Medtronic, Stryker, J&J, Abbott, buy on clinical proof and regulatory clearance. Not on storytelling.
🔵 Valuations move on de-risking milestones. CE mark changes your number. FDA clearance changes your number. A reimbursement pathway changes your number.
🔵 Generalist VCs will apply SaaS logic to your company. That's not a fit problem. That's a category mismatch. Stop answering questions about CAC and LTV it's irrelevant for most pre revenue MedTech.
🔵 The fundraising timeline is longer. Not because investors are difficult. Because the risk profile demands it. Decisions on investments aren't made in two weeks. The best industry investors do thorough DD upfront.
📌 MedTech M&A hit around $80B in 2025. The exits are happening, but the path to them just looks nothing like software.
The bounded return model isn't an industry weakness. It rewards execution over narrative. De-risking over growth hacking. Clinical evidence over pitch polish.
Which is actually a better game for founders who build real things.
Stop apologising for not being a unicorn. Start showing investors exactly which milestone de-risks their capital next.
Because in MedTech, the story doesn't build value. Traction and evidence does.
#MedTech #MedicalDevices #HealthTech
⚠️ If your medical device only works inside a hospital, you are already limiting your market, the impact, and your investor pool.
And most MedTech founders don't realise until it's too late.
There's one signal in Europe worth paying attention to right now👇
♦️Healthcare is moving closer to the home.
♦️Ageing populations. Overburdened hospital systems.
♦️Remote communities. Post-pandemic infrastructure gaps.
The next wave of MedTech innovation isn't solely inside the ICU. It's in the living room. The rural clinic. The disaster zone. The battlefield.
And here's the best part... A medical device built to function in resource-limited environments doesn't just serve defence applications.
It serves everything!
This is the dual-use angle many European investors are actively funding right now. Not because defence is the end goal.
But because resilience IS the product!
IMO, most medical devices should design for the edge case. The hospital will still be there 👊
Those who do, will have a larger investor universe.
#MedTech #MedicalDevices #DualUse
⏰ It's never too early to reach out to a Notified Body. I mean it. Never.
I just got off a call this morning with one of Europe's most well-known and respected Notified Bodies, who shared their experience with me.
"MedTech startups approach us too late. They should knock on our doors much sooner in their regulatory process, and get the dialogue started."
AKA, founders who plan to contact their NB at submission are too late. That's not a regulatory strategy, that's more like a prayer (full respect though).
NBs can't consult you (by law). But they CAN engage in a "Structured Dialogue" 📝.
You present your de-risking plan. Your clinical strategy. Your regulatory pathway. And your NB signals whether they concur. That's not consulting. That's alignment. And it's worth everything.
What early NB engagement gives you is...
🔹 Alignment on classification before you build the wrong technical file (which is by the way one of the most common issues with delays)
🔹 Confirmation of your clinical evaluation strategy before you run the wrong study
🔹 A slot in their pipeline (NB capacity is constrained, this alone is worth the call)
🔹 Investor confidence that your regulatory pathway is real, not assumed
⚠️ A Notified Body cannot tell you what to do. But they can tell you if what you're planning "makes sense".
Start the conversation today. Before you think you need to 👊
#MedTech #MedicalDevices #CE #MDR #IVDR #FDA
🛠️ We're building a free cap table simulator for MedTech founders.
Not just to show dilution math but to help founders understand how investors actually think.
Something most MedTech founders miss... VC ownership thresholds aren't arbitrary.
A €50M fund needs to return €150M to its LPs. If they own 10% of a company that exits at €80M, that's €8M back. Meaningful. Not fund-returning. That's why VCs push for 15–20% entry ownership and why high early-stage valuations create friction, it's math, not greed.
Four things that consistently trip founders up:
👉 Option pools dilute you before the round closes, not new investors
👉 Convertible notes delay valuation but reward early backers with discounts at conversion
👉 Stacking 3+ convertible notes makes your cap table genuinely scary to Series A investors
👉 Liquidation preferences mean investors get paid first — know exactly where you sit at €50M vs €100M
Last week's post on bridge rounds got an unexpected reaction. Founders doing the math wrong. Misreading 20% discounts. Surprised by their ownership at exit.
On convertible notes. When used right, they're founder-friendly, they push the valuation conversation to when you have more leverage. Used wrong, they quietly wreck your next round.
What we're building:
✅ Cap table simulation across multiple round scenarios
✅ Convertible notes modelled with discount and cap, see exactly how they convert
✅ Real dilution at every stage. grants, angels, pre-seed, bridge, seed, Series A
✅ Exit scenarios, what you own at €20M, €50M, €100M, €250M
✅ Built for MedTech funding reality, not SaaS
🆓 For MedTech founders. A founder who understands investor math raises better and builds a better company 👊
#MedTech #MedicalDevices #Startups #Fundraising #HealthTech
🍾The bottleneck in MedTech R&D (or any industry) is no longer software.
And I'm speaking from experience.
That screenshot? Our actual LIFA Ventures CRM. 79 deals in pipeline. Built from scratch in a few weeks.Then a few other internal tools we now use daily.
No 10-man dev team. No €200k software contract. No 6-month vendor timeline.
Just me, Claude Code, and a few weeks.
So when a founder tells me "I tried vibe coding and it doesn't work". I don't take that seriously anymore.
Because here's what a small MedTech team can now build in weeks:
*️⃣ Custom patent landscape tools (scrape, analyze, summarize competing IP in real time)
*️⃣ KOL mapping engines (identify and track key opinion leaders by specialty and influence)
*️⃣ Research aggregators (pull and synthesize latest clinical evidence for your indication)
*️⃣ Early product validation and ROI/Payment tools (collect structured feedback from surgeons and clinicians)
*️⃣ Competitive intelligence dashboards (monitor competitor filings, publications, regulatory submissions)
*️⃣ Regulatory document workflows (automate the painful first drafts)
*️⃣ Your own custom data room platform
Not generic. Not off-the-shelf. Custom. Yours. Built in weeks.
This used to cost €200-500k in software contracts and 12 months of vendor dependency. But in 2026? One sharp engineer and an AI coding subscription.
Bye bye expensive 10-man dev teams. Welcome the 10x leveraged single software engineer.
The real bottlenecks in MedTech R&D remain: capital to execute validated commercial and clinical strategies.
Software just left that list.
If you're still using slow software development as an excuse, you are way behind.
#MedTech #MedicalDevices #AI #HealthTech #Startups
💼 The ideal early-stage VC used to be (still is for many FoF) MBA, Wall Street, financial wizards and large angel portfolios.
In early-stage MedTech, that's probably the worst possible background.
The classic VC playbook works great for SaaS (scale fast, exit fast), or at least used to before claude code broke everything, consumer apps (growth metrics matter), and later-stage MedTech (post-approval scaling).
But early-stage MedTech is completely different. It's not a matter of placing the best bets.
Before you can scale, you have to survive three brutal phases:
1️⃣ Prove it works (clinical validation, not just prototypes)
2️⃣ Get payment/commercial/reimbursement clarity
3️⃣ Navigate FDA/notified body approvals
You can't spreadsheet your way through this.
A finance-minded VC can't read clinical data and spot problems. They don't know when to pursue a 510(k) versus De Novo or EU MDR. They've never navigated a hospital buying committee, created a CPT code, or understood what commercial adoption clarity actually means.
The valley of death kills most early-stage MedTech companies, not because they run out of money, but because they run out of operational expertise.
The data backs this up 👉 Healthcare specialist VCs show higher median returns versus traditional finance generalist VCs - a 5.2% point gap over 20 years. For VC - that's huge!
In early-stage MedTech, it's wider.
Finance VCs are genuinely good at later-stage MedTech scaling. But from prototype to first revenue? You need someone who's actually done it.
In early-stage MedTech, I believe that lived experience beats financial modeling - every time.
#MedTech #HealthTech #MedicalDevices #Startups
⏰ Today at 9 AM ET / 15:00 CET
"Is my clinical data strong enough to fundraise?"
If you’ve ever asked yourself this question, join me and my good friend Páll Jóhannesson from Greenlight Guru, LIVE in a few hours.
We're unpacking the difference between:
⌍ Statistical significance (gets you published) ⌌
⌍ Clinical significance (gets you prescribed) ⌌
⌍ Commercial significance (gets you funded) ⌌
Most people confuse these. And it can kill deals.
We'll walk through a real case and why I'm skeptical. Why are other investors excited? What does this reveal about how investors actually evaluate clinical data?
This is conversational, practical, and based on data we're seeing right now.
📌 Registration still open! ⬇️
#MedTech #ClinicalEvidence #MedicalDevices #HealthTech
💰 As promised, 'The https://t.co/gTD6q3L3lG MedTech Budget Template' is now live.
Last week I talked about the need to provide a structured budget template for early stage MedTech companies.
What's inside:
👉 Pre-built categories for MedTech-specific costs (regulatory, clinical, QMS, notified body fees, post-market surveillance)
👉 "Realistic" cost ranges based on real Class II device development (highly varies though between continents)
👉 Milestone-based budgeting (tie spending to de-risking events)
👉 Runway calculator (know exactly when you’ll run out of money)
I've seen too many founders present a round believing that it will get them to market, only to realise their budget doesn't hold water.
Or worse, they allocate it wrong. Spending on regulatory before early commercial validation. Hiring sales before they have a validated product to sell.
This template helps you build a budget that matches MedTech reality, not SaaS.
Common costs founders forget are e.g.
👀 Translation/localization for multi-market labels (IFUs)
👀 Notified body annual fees (€10k-25k/year, not one-time)
👀 Post-market surveillance setup (€20k-50k)
👀 Insurance (product liability + clinical trial)"
This template catches them before they become €50k surprises.
Free. No email required. No gate.
Link in first comment 👇
#MedTech #Startups #MedicalDevices #HealthTech #Nordics
We’ve been building this for months. The Founder Readiness Questionnaire is just the third piece.
Today we're publishing our core investment evaluation framework, the same one we use to assess companies that we believe can be a good fit to LIFA Ventures.
But we're not stopping there.
We're building https://t.co/EeANEfTxZJ - a suite of professional tools and educational content designed specifically for MedTech founders. Check it out!
More coming soon 👊
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