In a rapidly evolving healthtech landscape, regulatory adaptability is becoming just as important as technological innovation.  

DayOne recently hosted a webinar for the Accelerator’s current cohort with confinis, a Swiss-based regulatory consultancy specialising in medical devices, in vitro diagnostics and combination products. During the session, confinis’ Andrea Biasiucci and Claudio Alberti unpacked the growing layers of global regulation and offered practical advice for early-stage companies trying to navigate this complexity.  

Here are some of the key takeaways from the session…  

Regulations are increasing worldwide – not because authorities want to slow innovation, but because the number of users, devices and potential risks has grown dramatically. For companies operating (or planning to) in Europe, new frameworks like the EU AI Act, alongside existing ones such as the Medical Device Regulation (MDR), create a hierarchy of requirements that companies must understand and respect.  

Cybersecurity risks, in particular, are pushing regulators to tighten expectations for software-based and data-sensitive medical technologies. While this might seem overwhelming, founders should not be intimidated: staying informed, remaining flexible and being prepared for change are the best ways to stay compliant without losing momentum. 

Rather than seeing regulation as a burden, startup teams should treat it as a tool for building stronger companies. When planned early and properly, regulatory compliance can make operations more efficient, improve product quality and strengthen overall business performance. 

Startups often build on assumptions because resources are limited. The key is understanding what is legally required and planning for it in a way that is both practical and compliant. Good regulatory strategy doesn’t just avoid problems – it increases a company’s viability and long-term success. 

Early-stage startups often benefit from targeted, low-cost guidance – “an hour here, an hour there” – to avoid critical early mistakes. Experienced consultants or accelerators can help define the next right step, not the entire marathon. 

Raising capital is obviously important – not just for payroll, but as validation. If no investor is willing to take the risk, it may signal deeper issues in the business model that are better identified early. 

Founders can take a bootstrapped, client-first approach: finding an initial customer and iterating with them. But in regulated industries, this can be challenging and carries the risk of over-tailoring a product to a single customer rather than the broader market.

Founders must develop a strategic mindset – choosing carefully where to invest their energy and navigating constraints creatively. For example, exploring business ideas in herbal medicine, where regulatory barriers are significantly lower, enables faster iteration with limited resources. And the practical use of AI tools can support drafting early documentation. 

With the right mix of guidance, adaptability and market validation, even teams with minimal resources can make meaningful progress. 

Beyond is the regulatory AI solution developed by confinis and Zühlke and helps start-ups translate technical concepts into actionable regulatory plans. 

Many companies begin with a pitch deck, a prototype or a minimum viable product. The next challenge is understanding how to transform that concept into a fully compliant, market-ready medical device. Beyond addresses this by: 

• Generating regulatory strategy reports covering MDR, FDA, software-as-a-medical-device, cybersecurity and more 
• Presenting market pathway options (e.g., EU vs. US, 510(k) vs. de novo) with pros, cons and timelines 
• Highlighting how regulatory decisions impact the business model, whether as a service provider, OEM or full manufacturer 
• Providing realistic timelines for each phase – from initial classification to post-market obligations 
• Offering multi-step guidance for building required documentation, such as MDR-compliant device descriptions 

The tool iteratively guides users through each regulatory step, pulling from decades of confinis expertise. Its capabilities also include exporting full conversations for traceability, integrating with tools like Jira, and generating structured documentation that teams can continue refining. 

The message for innovators was clear: successful medical-device development doesn’t require massive budgets – but it does require clarity, adaptability and smart use of resources. 

Regulations will continue to grow more complex, but with the right strategy and tools, start-ups can navigate them efficiently and turn early prototypes into viable, compliant products. 

Learn more about confinis here. confinis is a partner of DayOne. 

Many early-stage healthtech and biotech startups aim to partner with large pharmaceutical and life sciences companies. But in a highly regulated industry, such collaborations can be challenging. To succeed, startups must demonstrate not only innovation – but also regulatory readiness, quality maturity, and a clear understanding of compliance expectations.

DayOne hosted a webinar for its current accelerator cohort and alumni, in collaboration with Entourage – a life sciences consultancy dedicated to supporting all contributors across the industry, from startups to global leaders. With a strong focus on regulatory affairs and a broad portfolio of expertise spanning development, quality, operations, and market readiness, Entourage equips organizations to grow sustainably and navigate complexity with confidence.

The session was led by Dominique Hoff, Managing Director Switzerland, supported by Kathrin Vernice (Business Development Director), Anastasia Wolf (IT & AI Systems Expert), and Simon Schulz (Regulatory Affairs Expert). Entourage, a trusted DayOne partner, shared how startups can position themselves as credible and compliant partners for collaboration with big pharma.

The key message was clear: readiness is not about bureaucracy – it’s about building trust.

Pharma and biotech partners expect control, consistency, and a mature approach to risk and quality. To build this foundation, the Entourage team presented the essential building blocks of becoming “Pharma-ready.”

Robust risk management is the first and most critical step. Startups should identify potential vulnerabilities early, assess their level of control, and define mitigation strategies. A clear, realistic remediation plan signals maturity and reliability – reassuring partners that the company can operate responsibly within regulated frameworks.

A structured QMS is non-negotiable in regulated industries. While early-stage startups aren’t expected to have a fully developed system, a lean or phased approach can make a real difference. Demonstrating control over key processes such as change control, CAPA, documentation and SOP management builds credibility and operational discipline. A functional QMS not only supports due diligence but also lays the groundwork for sustainable growth.

Regulatory strategy should never be an afterthought. Misalignment between market strategy and compliance planning can delay launches or even jeopardize partnerships. Startups should map regulatory pathways early – for example, deciding whether to pursue EU MDR or FDA approval will significantly shape documentation and design control efforts. A clear roadmap ensures resources are focused and timelines remain realistic.

With limited budgets, startups need to strike the right balance between outsourcing and building internal capabilities. Selectively engaging regulatory or quality experts can accelerate progress while keeping key know-how in-house. The goal is agility – staying lean without compromising compliance.

To streamline due diligence and investor discussions, startups should prepare a concise, standardized documentation set that demonstrates readiness. This may include quality policies, risk registers, process descriptions, and key SOPs. Such a package signals transparency, confidence, and preparedness – all factors that increase a startup’s attractiveness to potential partners.

Finally, startups should make their progress visible. Engaging in accelerator programs, applying for grants, and participating in ecosystem events like DayOne’s Innovation Showcase not only boosts exposure but also helps establish trust within the life sciences community.

Entourage concluded the session with three mindset principles that define successful pharma collaboration:

1. Structure builds trust. The more organized you are, the more credible you appear.

2. Prioritize strategically. Focus on what truly adds value to your goals.

3. Reflect pharma’s standards. Understand and adopt the mindset of a regulated partner.

The more structured you are, the more those companies will trust you. Structure builds trust – and trust opens doors.

Interested in learning more about how startups can become Pharma-ready? Meet Entourage and other innovators at the DayOne Innovation Showcase in Basel, December 2025.

Senseera is redefining what’s possible in precision medicine. With its AI-powered chromatin liquid biopsy platform, the company can read gene expression directly from blood, with no tissue biopsy required.

By analyzing cell-free chromatin, Senseera delivers genome-wide expression maps of tissues, tumors and immune cells. It’s a fully automated, clinically validated platform that has already processed more than 20,000 human samples. The result: powerful disease signatures, real-world clinical data and a foundation for both diagnostics and pharma collaborations.

Founded in 2020 from the groundbreaking research of Prof. Nir Friedman at the Hebrew University, Senseera set out to unlock a missing dimension in liquid biopsy gene expression. By combining chromatin epigenomics with advanced computation, its platform generates expression profiles that reveal how cells function, not just what mutations they carry.

Backed by $11M in funding, including a $7M seed round led by Lightspeed Venture Partners, Senseera has built one of the largest liquid biopsy expression datasets to date, a growing patent estate and a fully automated ISO-certified infrastructure ready to scale.

Senseera’s strategy blends pharma collaborations with an internal diagnostics pipeline. On one hand, it partners with drug developers to deliver blood-based expression biomarkers for discovery, patient stratification, treatment monitoring and more. On the other, it’s advancing safer, non-invasive tests for liver diseases, where diagnostics are urgently needed. Two clinical trials, focused on liver transplant rejection and MASH, are already underway.

Ronen Sadeh, CEO and co-founder of Senseera, led the company’s $7M seed round backed by Lightspeed and I-Next Capital, which successfully closed in early 2025. He holds a Ph.D. in Biochemistry and Molecular Biology and trained as a postdoc at Rockefeller University. His research has appeared in leading scientific journals and he’s an inventor on several patents in chromatin biology and diagnostics. Ronen is driven by a clear mission: make expression-based medicine accessible to every patient.

In 2024, Senseera joined the DayOne Accelerator. The program helped the team see Pharma’s world from the inside – how decision-makers think, what data they need and where chromatin liquid biopsy fits best.

With expert mentorship, Senseera refined its value proposition and sharpened its outreach and communication strategy. The results were impactful: more structure, stronger partnerships and increased traction across leading Pharma companies. Figure 1 shows the steep increase in business development activity over the course of the program.

During the program, Senseera deepened oncology collaborations, rebranded its visual identity to better reflect its core business and earned a special grant as one of the best 5 ventures from the yearly cohort. The acceleration program remains a model for how targeted mentorship, specific network, and strategic focus can turn startup innovation into industry impact.

Figure 1 – Senseera Pharma BD interactions (2021–2025)

For decades, cancer diagnostics revolved around mutations. But medicine has moved on. The biggest breakthroughs today – antibody-drug conjugates, checkpoint inhibitors and tumor-microenvironment modulators – depend on gene and protein expression. Around 2021, expression-based approvals began outpacing mutation-based ones, marking a clear tipping point in precision medicine. Figure 2 visualizes this shift.

Figure 2 – Mutation vs expression-based oncology therapeutics (FDA approvals 2001–2025)

Despite its power, expression data has been trapped in tissue biopsies – painful, invasive and unpractical to repeat. Plasma DNA sequencing can’t reveal which genes are active, while RNA and protein assays in blood are unstable and inconsistent.

Senseera’s chromatin liquid biopsy changes that. When cells die, fragments of chromatin enter the bloodstream, carrying epigenetic marks that show which genes were turned on. Senseera’s patented cfChIP-seq technology decodes those marks, providing a dynamic snapshot of gene activity across tissues and tumors.

Now, expression of key therapeutic drivers, like CEACAM5 or SEZ6, can be detected non-invasively, repeatedly and at scale. What once required tissue and Immunohistochemistry (IHC) can now be done with a highly sensitive and automated blood test.

Senseera is expanding its clinical collaborations and preparing for a $20 million Series A to accelerate global growth in 2026. The company is strengthening its U.S. presence, broadening into a CLIA-certified portfolio and forming new partnerships in liver disease and oncology.

Its vision is bold yet simple: make chromatin liquid biopsy the new gold standard for expression profiling. Within five years, Senseera aims for its technology to become integral to every clinical trial, every treatment decision and every monitoring program, reshaping precision medicine through the language of expression.

Learn more about Senseera here. 

DayOne, the launchpad for early-stage startups at the intersection of healthtech and pharma R&D, is proud to announce its partnership with the health.tech global summit, one of the world’s premier gatherings for healthcare founders and leaders. 

Taking place on 3-5 March 2026 at the Messe and Congress Center in Basel, the summit will bring together 5,000+ participants from 60 countries, including pharma, life sciences, hospitals, startups, investors and policymakers, to tackle key challenges and explore the transformative impact of technology on healthcare.  

Building on its success in Munich, the health.tech global summit now enters a new phase as a joint initiative by MCH Group and Bits & Pretzels and goes beyond a traditional conference, featuring exhibitions, keynotes, panels, curated matchmaking, startup pitches and innovation showcases. 

“We are excited to welcome health.tech global summit to Basel, supporting our mission to showcase the Basel Area as a leading European hub for healthtech innovation,” said Ursula Costa, Director, DayOne. “This partnership reflects our shared and long-term commitment to driving innovation across the health ecosystem – connecting innovators and key decision-makers to advance health through tech and shape the future of the industry.” 

As a partner, DayOne will power the startup competition at the summit. From a pool of 150+ healthtech startups worldwide, a selection committee will shortlist 15 companies to pitch on the first day, with 5 finalists advancing to present on the main stage on the second day. 

“We are delighted to welcome DayOne as a key partner,” said Andreas Nef, Managing Director, health.tech global summit. “Their experience in fostering collaboration between healthtech startups and industry stakeholders aligns perfectly with the summit’s mission to bridge the gap between technology and healthcare. DayOne’s deep roots in the Basel ecosystem and strong network across healthcare will allow the summit to expand its reach and strengthen engagement with pharma.” 

With a focus on collaboration and impact, the summit is set to become Europe’s key meeting point for healthtech innovation – connecting the ecosystem, inspiring breakthroughs and advancing the transformation of healthcare. 

Find more information about the DayOne Accelerator here and book your ticket to the health.tech global summit here. 

Innovation in healthcare isn’t just about creating new technology – it’s about building something that lasts. For startups in healthtech and life sciences, intellectual property (IP) can be the foundation that transforms great ideas into sustainable businesses. In an increasingly collaborative landscape where pharma, tech and startups intersect, a strong IP strategy is not only protection – it’s leverage. 

DayOne recently hosted a webinar for the Accelerator’s current cohort & alumni with Jean-Nicolas Longchamp, Founder & CEO of dynamXIP, an intellectual property law firm in Switzerland offering legal and technical services to protect, enforce and strategize clients’ patents, trademarks, designs and trade secrets. dynamXIP is a partner of DayOne and a resident at the Switzerland Innovation Park Basel at Novartis campus. 

Jean-Nicolas shared with us some valuable insights on the IP landscape in digital health and how to build an IP strategy for startups collaborating with pharma. Here are a few of the key takeaways. 

Every startup’s success ultimately depends on three factors: finding a viable market, ensuring the freedom to operate within it and maintaining a defensible competitive edge. Where these three elements overlap lies the “IP sweet spot” – the space where your innovation is both protected and valuable. 

An IP strategy should never start with paperwork. It starts with purpose. It’s not about filing patents for the sake of it but about understanding why your company exists, what makes it different and how that difference can be safeguarded. 

Startups with registered IP are statistically ten times more likely to secure funding and twice as likely to achieve a successful exit. Investors understand that IP isn’t just legal armor — it’s a signal of credibility, maturity and long-term value creation. 

Patents tend to get the spotlight, but they are only one piece of a broader toolkit. Trademarks secure your identity in the market; designs protect the appearance of your product, whether physical or digital; and copyrights automatically cover original software or creative work. Trade secrets, meanwhile, protect confidential know-how – provided you actively take steps to keep that information secure. 

In digital health, IP protection often overlaps with data protection. Exclusive access to a dataset can be just as valuable as a patent – and combining data ownership with protected algorithms creates powerful competitive advantage. 

An effective IP strategy always starts with your business model. Before thinking about what to file, define your goals: what value are you creating, who benefits from it, and how do you intend to grow?

Once you understand your business direction, identify what truly sets you apart. Is it your algorithm? Your access to unique data? Your user interface, device design or brand? Whatever your differentiator, protect it – strategically and selectively. Not everything needs a patent; sometimes a trade secret or a strong contract achieves more.

The key is balance. Layer protections where it makes sense and ensure your IP approach grows with your business rather than limiting it. 

For startups working with large pharmaceutical companies, as most startups from our DayOne Accelerator aim to do, IP becomes a form of currency. It’s what determines whether you’re seen as a replaceable vendor or a strategic partner. 

Before any collaboration, make sure you have clear ownership of your technology and that your agreements define what belongs to you and what will be co-created. Know your “background IP” (what you bring in) and “foreground IP” (what’s developed together). Clarify how data, AI models and results can be used and who owns derived outputs. 

These details might sound technical, but they are crucial. They protect your long-term interests and ensure you can continue innovating independently even after a partnership ends. 

Patents disclose, trade secrets conceal – and the smartest companies use both. Patent what must be public to attract investors or demonstrate innovation leadership but protect the rest as confidential know-how. 

However, trade secrets require discipline. They remain valid only as long as the information is genuinely secret. Limit access to key employees, enforce non-disclosure agreements and keep a record of your security measures. Once confidentiality is lost, so is your protection. 

A robust IP strategy evolves as your company does. In the early stages, focus on ownership – ensure founders and contributors have clear agreements and that provisional filings cover core inventions. As you grow, refine your patent claims, register your trademarks, and define your brand. 

At scale, monitor competitors, expand protection geographically and use your IP as a strategic asset – whether through partnerships, licensing or fundraising. 

The goal isn’t to collect IP rights, but to build a foundation that protects innovation while enabling agility, collaboration and long-term growth. 

Healthtech startups operate at the crossroads of science, data, and innovation. Their ideas have the potential to transform healthcare – but only if they can protect and scale them effectively.  

A smart IP strategy does more than guard innovation; it amplifies it. It allows startups to collaborate confidently, attract the right partners and shape the future of healthcare on their own terms.

Interested in learning more about practical IP strategies for healthtech startups? Join us at the DayOne Innovation Showcase in Basel in December 2025 and meet with dynamXIP. 

Galen Growth is a global leader in digital health actionable market intelligence, founded in 2016 by Julien de Salaberry to solve the challenge of biased or unreliable data hindering innovation. Through trusted data, AI-driven tools and domain expertise, Galen Growth helps HealthTech stakeholders – including startup ventures, Pharma and investors – navigate and accelerate meaningful change across the global digital health landscape. This is Galen Growth’s summary of the first half of 2025 for the European HealthTech sector…  

The first half of 2025 has marked a turning point for global digital health – and Europe is stealing the spotlight. While U.S. funding slumped to a five-year low, Europe’s share of global investment surged to a record 26%, cementing its role as a rising powerhouse in health innovation. 

This shift isn’t about hype anymore. Investors are demanding results, and European ventures are delivering. 

Funding restructured: From early bets to mega deals 

Europe saw $3.4 billion invested across 182 deals in the first half of 2025, a 52% year-over-year increase. More importantly, capital is shifting toward scale-ups – late-stage ventures experienced a 4.7x jump in deal value compared to last year. That appetite for maturity fueled seven mega deals, representing over half of Europe’s funding value. 

In short, the region has broken away from dependence on government grants, finding its footing in robust private investment. 

AI takes center stage 

Artificial intelligence continues to dominate healthcare innovation in Europe. AI-powered ventures drew 65% of total funding, or $2.3 billion, in just six months. The majority of that flowed into research solutions (40%) and medical diagnostics (23%), underscoring investor confidence in AI’s ability to transform drug discovery and disease detection. 

Top AI-driven clusters – including Research Solutions, Health Management Solutions, and Medical Diagnostics – captured 51% of all funding, indicating where the real momentum lies.  

Partnerships: Quality over quantity 

Partnerships have slowed, with 35% fewer in Q2 compared to Q1. However, this isn’t a sign of weakness – it’s a strategic move. Corporations and investors are now prioritizing focus and efficiency over “spray and pray” experiments. Medical diagnostics, research solutions, and patient solutions still account for nearly half of all collaborations, reflecting their central role in healthcare transformation. 

Therapeutic hotspots: Oncology still leads 

Oncology remains the top-funded therapeutic area in Europe, attracting $515 million in the first half of 2025 – a 66% increase year-over-year. Cardiovascular diseases and dermatology followed closely, while geriatrics experienced explosive growth, thanks to a $148 million mega deal for the home healthcare venture Cera. 

The bigger picture 

Europe’s digital health ecosystem is maturing fast. With 3,537 active ventures (growing at a 7% CAGR, outpacing global averages), the region is now home to nearly one-third of the world’s digital health startups. Notably, 42% of European ventures show strong clinical evidence, setting Europe apart in a sector where validation is everything. 

What’s next? 

Looking ahead to the second half of 2025, the winners will be those who use venture capital strategically – deploying capital not just to scale, but to prove real-world impact and cost savings. AI will remain the backbone, but ventures with strong evidence and operational efficiency will capture the attention of investors. 

Europe isn’t just catching up – it’s setting the pace.  

To read the full report, click here.  

Galen Growth is a supporting partner of the DayOne Accelerator for the third consecutive year.