In the previous year, we launched Factory 319’s support service for medtech and biotech projects trying to escape the lab and actually reach people who need them. Honestly? We’re tired of seeing brilliant science get locked away in university drawers, never to see the light of day.

The path from discovery to market is brutal. It’s expensive, slow, and littered with good ideas that never made it. We draw inspiration from what Flagship Pioneering and others have built, but we think there’s a real leading role for European venture builders like us in fixing this broken pipeline.

Here’s what we’ve learned from watching others try and sometimes succeed.

The real obstacles between lab and market

Let’s be honest: turning scientific breakthroughs into actual products is where dreams go to die.

That proof of concept that worked perfectly in your lab? It’ll probably break the moment you try to scale it. I’ve seen this over and over. What looks bulletproof under controlled conditions becomes a nightmare when you need to make it work reliably, repeatedly, and cost-effectively.

But here’s what most researchers miss: they’re building for the lab, not for users. There’s no user research, no validation that anyone actually wants or needs what they’re building. Brilliant tech that solves the wrong problem is still undervalued tech. The mindset shift from « does this work? » to « do people need this and will they use it? » is something most academic teams almost never make.

Then there’s regulation, which is like playing a video game where the rules change mid-level. In Europe, you need CE marking for medical devices, and most manufacturers follow ISO 13485 quality standards to get there. In the US, the FDA runs its own Quality System Regulation (soon harmonized with ISO 13485). For biotechs? Good luck. You’ll need toxicology studies, GMP batches, and an IND application before you can even start human trials. Each step takes years and burns millions. But here’s the thing: researchers rarely understand these constraints early enough. Most teams discover regulatory requirements way too late, when pivoting costs millions and delays launch by years.

Clinical development is where things get really ugly. Seven to ten years before approval isn’t unusual, and that’s if everything goes right. Which it usually doesn’t.

But here’s what really kills projects: the « valley of death » funding gap. VCs prefer later-stage deals where the risk is clearer and lower. Public grants help, but they’re scattered and insufficient. So you’re stuck. Too risky for private money, too commercial for academic funding.

And nobody talks about this enough: no single lab has all the expertise needed. You need regulatory specialists, IP lawyers, engineers, clinicians, business strategists. But more fundamentally, you need people who understand the whole ecosystem. How does your product fit into existing workflows? Who are the real decision-makers? What are the reimbursement models? Most research teams have zero visibility into these questions.

What venture builders actually do (and why it might work)

 

A venture builder isn’t just an investor writing checks and hoping for the best. They’re more like a startup factory. They create companies from scratch and embed the expertise from day one.

The smart ones hunt for technology in universities, hospitals, and corporate R&D labs. They’re looking for that sweet spot where solid science meets genuine commercial potential and real user demand.

Here’s where it gets interesting: they provide shared infrastructure. Connections to regulatory consultants who understand the approval landscape. Process development labs where you can test manufacturing at scale. Access to CROs and CMOs who’ve done this before. It’s not just advice. It’s partnership with people who’ve navigated these problems.

They also do something crucial. They bring in user research and product validation from the very beginning. Not just « does this work in the lab? » but « do real users want this, and will they actually change their behavior to use it? » This sounds obvious, but it’s where most academic projects fail. They also create structured milestones that mean something. Validated product-market fit, user feedback loops, and regulatory strategy documents. Things that make investors pay attention.

Most importantly, they’re willing to get their hands dirty early. They’ll co-develop prototypes, validate regulatory strategies, talk to end-users, even co-found companies. They’re taking on the translational risk that scares everyone else.

Case studies that actually worked

BioGeneration Ventures proved this can work at scale. In 2012, they helped create Acerta Pharma around a cancer therapy called acalabrutinib. Within a year (which is lightning speed in oncology), Acerta was in clinical trials. By 2016, AstraZeneca bought a majority stake for up to $7 billion. Today, that drug (now called Calquence) generates over $2 billion annually.

That’s not luck. That’s systematic venture building.

Flagship Pioneering took this model and ran with it. Sure, everyone knows about Moderna and the mRNA COVID vaccines. But Moderna is just one success in their portfolio of dozens. Flagship systematically scouts breakthrough science, builds companies around it, and nurtures them through the brutal early years. By the time external investors show up, these companies already have validated IP and clear development plans.

But here’s what interests me more: Jaza Rift Ventures is trying this in Africa. They’re investing in healthcare innovations across the continent while providing hands-on support for regulation, product development, and networks. Africa’s medtech market was worth $4.2 billion in 2022 and should nearly double by 2032. Yet most equipment is imported, and regulatory systems are fragmented. Jaza Rift is betting they can help build local capacity while making money doing it.

The GCC is just getting started. Gulf countries are sitting on massive sovereign wealth funds and finally realizing they need to diversify beyond oil. The pharma and biotech market there was $17 billion in 2023, growing 7-8% annually. But it’s almost entirely import-dependent. With Saudi Vision 2030 and UAE healthcare strategies pushing innovation, there’s real opportunity for venture builders to accelerate local medtech and biotech development.

The capital is there. The question is whether they can import the expertise fast enough.

Where this actually adds value (and where it doesn’t)

After looking at these examples, the pattern becomes clear. Venture builders work best when they can advance technologies from early proof of concept to something investable. Pilot production, early trials, regulatory clarity, and validated user adoption.

They excel at integrating regulatory planning from the start instead of treating it as an afterthought. They understand scale-up challenges, whether for biologics under GMP or devices under ISO standards. They know how to design clinical trials and user studies that generate useful evidence for both regulatory bodies and future investors.

Most importantly, they tie financing to technical milestones that make sense to later investors.

But let’s not kid ourselves about the limitations.

The hard truths nobody mentions

Even the best venture builders can’t fix everything. Life sciences is capital intensive in ways that would make a real estate developer weep. Toxicology studies and GMP batches cost tens of millions before you see a penny of revenue. For medtech, manufacturing scale-up and regulatory certification require significant upfront investment. Builders can’t carry that burden alone.

Failure rates are still brutal. Projects die from toxicity, lack of efficacy, regulatory rejection, or simply because users don’t want what you built. All the usual suspects. Venture builders improve the odds but can’t eliminate the risk.

Timelines remain painfully long. Five years to reach a pilot clinical trial is normal. For medtech, getting through regulatory approval and into the market can take just as long. That requires patience that most people don’t have.

And here’s the kicker: specialized talent is incredibly scarce. But it’s not just about finding regulatory experts (though that helps). The real scarcity is people who understand how to build businesses around science. How to talk to hospital procurement teams. How to navigate reimbursement models. How to design a go-to-market strategy that actually works in healthcare. Someone who can bridge the gap between brilliant research and commercial reality.

Venture builders’ real value isn’t being compliance gatekeepers. It’s having people who’ve actually built things before. People who know what questions to ask, what assumptions to test, and what partnerships matter. They understand the whole ecosystem, not just the regulatory checkbox

The ecosystem matters more than we admit. In regions with fewer labs, regulators, or supply chains, venture builders often end up importing expertise and building networks from scratch.

Why now might actually be the right time

Despite all these challenges, several things are aligning that make me optimistic about venture builders expanding their role.

Platform technologies are opening new doors. AI in drug discovery for biotech. Advanced manufacturing and 3D printing for medtech. Synthetic biology for both. Governments are finally investing seriously in translational research. The European Innovation Council’s venture building program is one example, and the GCC’s healthcare strategies are another.

Investors are showing renewed interest in deep science, especially when risks are managed through clear milestones and validated learning. And let’s face it: healthcare demand is exploding worldwide. We need innovation not just to improve outcomes but to make care affordable and accessible.

What this means for us at Factory 319

For Factory 319, this isn’t academic analysis. It’s directly relevant to what we’re trying to build.

In France, SATTs (Sociétés d’Accélération du Transfert de Technologies) already do excellent work moving academic discoveries toward commercialization. But they’re focused on early technology transfer. Where the gap opens up is after that. Once you’ve got promising tech, who helps you figure out if anyone actually needs it? Who brings in the business expertise, the market knowledge, the operational chops to turn it into a real company? That’s where venture builders come in.

We’re not just creating companies on paper. We embed business expertise from day one. We validate assumptions with real users before you’ve burned through your funding. We help you avoid the costly mistakes that kill most research projects. We understand the ecosystem. Regulators, manufacturers, hospital procurement, and reimbursement models. We help you navigate all of it.

This collaborative approach respects what SATTs do well while filling a real gap in the pipeline. It’s less glamorous than the Silicon Valley model but potentially more sustainable.

The final take

For Factory 319, this is our shot. We’re starting carefully, learning from what works and what doesn’t elsewhere. We believe there’s real demand for venture builders who understand how healthcare actually works and who can help researchers stop building in the dark and start building for actual markets.

The key is staying honest about what we can and can’t do, and not promising more than we can deliver.