It’s especially important to support startups from Series A to growth-stage; a crucial inflexion point for building the business. We see exciting, innovative digital health startups emerge, yet many struggle to make it beyond their initial breakthrough. How do we scale companies that are truly moving the needle for healthcare?

Step one: test the tech and establish a home base

Before even thinking about scaling, you need to be certain that your technology is robust, effective, and delivering measurable impact. Scaling prematurely, before ironing out technical kinks or proving real-world value, can set companies up for failure.

Start at home. Your first market should serve as both a launchpad and a testbed, where you refine your product, strengthen partnerships, and establish a strong foundation. Early traction in a home market provides credibility and operational insights, helping you adapt before venturing into unfamiliar territory. Too many companies rush expansion without truly understanding the nuances of their core offering.

Balance resources: expansion and product quality

Scaling isn’t just about entering new markets; it’s about ensuring your product and business model can support sustainable growth. Logistics must be mapped out early; whether that means direct sales, distributors, licensing agreements, or embedding with larger technology partners. But having a plan isn’t enough; execution requires the right talent, resources, and financial runway.

Healthcare is a long game. Companies often need buy-in from Key Opinion Leaders (KOLs) and clinicians to drive adoption, particularly if they are introducing a new standard of care. That means balancing speed to market with quality and credibility. Rushing expansion without evidence and support can backfire. It’s also critical to assess Customer Acquisition Cost (CAC) against Lifetime Value (LTV) – if your LTV is too low, can you survive long enough to make the economics work?

Navigate local regulations and clinical workflows

Once you start expanding internationally, expect differences in clinical practice and regulatory requirements and navigate this wisely. What works in the UK won’t necessarily work in Germany, and what works in Germany might not translate to the US. Every market has its own clinical workflows, systems and reimbursement structures. Regulatory landscapes will also vary; companies must have a clear regulatory strategy from the outset, working with experienced advisers to navigate evolving requirements across markets.

Companies need to assess market readiness – considering cost of entry, and importantly, factor in the time that navigating this may add. Some Middle Eastern, Asian and Latin American countries may accept CE-marked products – but replicating regulations across borders isn’t always the case. For digital health companies, the regulatory process can be even harder when the technology is completely new and previous examples don’t exist, for example with FDA 510(k) and De Novo pathways. 

Also consider what additional data or evidence may be required, for example, generating trial evidence for a specific patient population might be needed when seeking regulatory approval in the US.

Understand different healthcare structures

Structure, ownership, and funding of healthcare systems will be different from country to country, is there one provider, or many? These differences affect timelines, costs, and ultimately, market entry strategies. You may also need to consider health outcomes, diseases and patient groups which could change the priorities.

Technology readiness of the destination is also a consideration. Will you be able to integrate the platform effectively in this region or system, and do they have the infrastructure required? It’s important to understand the specific need for the technology or product in the context you are expanding into. Remember, you are not just selling but may be required to change mind-sets, and must identify the key-decision makers each time.

For European startups, expanding into neighbouring countries could be a logical first step to scaling – capitalise on the opportunities in your nearest markets. Getting this right builds the platform and agility needed to take on the bigger markets, with higher entry costs, such as the US.

Mobilise the right investors and partners

Startups need investors that understand healthcare and deeptech. Investors need to be willing to release capital for R&D and regulatory processes, before seeing revenue. Value-add investors will be those that know the funding-to-revenue journey, and can support and advise effectively. This should include market knowledge – scaling journeys across Europe, and globally – understanding the size of the opportunity and increasing willingness to fund. For example, the funding gap post Series A in Europe which can prevent digital health startups from progressing, and the steps required to support companies at this crucial stage.

Diversity and experience in partner teams is also important for long-term, sustainable growth. Have the team operated in these contexts before, and do they have capacity to consider different viewpoints necessary for scaling? Diverse teams will inevitably support more sustainable and equitable outcomes, an integral part of longevity in healthcare.

Conclusion: play the long game

Many startups underestimate how much time and capital it takes to truly scale. Regulatory timelines, funding clinical trials, and engaging KOLs are essential steps but resource intensive, and requires advance planning. Milestones must be mapped against the costs required to reach them. Scaling digital health startups is not about speed – it’s about sustainability. The most successful companies take a measured approach, proving their value at home, refining their business model, and expanding methodically with a clear understanding of the markets they enter.

There are no shortcuts. But with careful planning, strategic execution, and a deep understanding of both the opportunity and the obstacles, startups can move beyond disruption and become indispensable players in the future of healthcare. The challenges and opportunities for disruptive healthtech are immense – especially in Europe, where talent is abundant. Celebrate the small wins, each regulatory approval, every hospital adopting your technology, and keep focused on the shared vision of improving healthcare long-term.

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