Category: MedTech

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Digital Health MedTech

Market Access in Europe — What Founders Need to Know

Getting into the hospital is no longer the endgame. For MedTech startups in Europe, getting reimbursed — and doing so consistently across fragmented markets — is what separates hobby projects from scalable businesses.

In this second post of our series, we dive into the European market access landscape for medical devices and digital health, with a founder-focused lens on systems in Germany, France, the UK, and Nordic/CEE markets.

1. Germany: DiGA and the Fast Track for Digital Health

Germany remains Europe’s most structured digital reimbursement market thanks to the DiGA Fast Track, launched in 2020 by the Federal Institute for Drugs and Medical Devices (BfArM).

What qualifies: Apps or software-based interventions classified as low-risk medical devices (Class I or IIa under MDR).
Who pays: Statutory health insurance (covers 73M+ Germans).

Key Steps: 1. CE Marking as a medical device 2. Apply for DiGA listing (provisional or permanent) 3. Submit evidence (clinical, economic, usability)

Success story: Selfapy — a digital mental health therapy platform — was listed in 2022 and now reimbursed nationally.

Caution: Only 55 apps were listed as of mid-2025, with >40% later withdrawn due to insufficient evidence or pricing issues.

2. France: PECAN Pathway and Public Evaluation

France doesn’t have a DiGA equivalent yet, but the new PECAN pilot launched in 2023 offers early funding for digital therapeutics.

Agencies involved: – HAS (clinical evaluation) – CNAM (payer negotiations)

Key routes for market access: – PECAN for DTx and AI diagnostics (pilot program) – LPPR for physical devices (Listing for reimbursement)

Tip: Leverage French Tech Health20 status to speed up access via Bpifrance support.

3. United Kingdom: NICE, NHS Pathways, and DTAC

In the UK, access is driven by public health pilots and evidence-based appraisals.

Key frameworks: – NICE DHT Evidence Standards – NHS DTAC (Digital Technology Assessment Criteria)

Best path for startups: 1. Pilot with NHS via accelerators like NHS Innovation Accelerator 2. Gather local data and enter NICE appraisal 3. Align with Integrated Care Systems for regional deployment

Example: Huma has scaled UK pilots into global expansion after evidence-driven adoption in NHS settings.

4. Nordics: Digital-First, But Decentralized

Sweden, Denmark, and Finland lead in digital infrastructure but lack a unified reimbursement track.

Approach: – Run local hospital pilots (funded by Vinnova, Business Finland) – Engage with regional procurement bodies

Tip: Nordic health systems value co-creation and evidence transparency over hype.

5. Central & Eastern Europe: EU-Backed Access with Cost Advantage

In Poland, Romania, and Czechia, adoption is slower but aided by EU structural funds.

Tactics that work: – Partner with local CROs or academic hospitals – Position for structural fund-backed pilots – Focus on affordability + clinical value

Note: EIT Health plays an active role in startup acceleration and validation across CEE.

Summary Table: Market Access Pathways by Country

CountryKey FrameworkEntry PointReimburses Digital?
GermanyDiGABfArM application✅ Yes
FrancePECAN / LPPRHAS + CNAM⚠️ In pilot
UKNICE / DTACNHS pilot + ICS✅ If evidence exists
SwedenLocal procurementRegional pilots❌ No central track
Poland/CEEEU-backed pilotsAcademic/hospital use❌ Not at scale

Takeaways for Founders

  • Don’t treat Europe as one market — the access frameworks are radically different.
  • Start with pilots and evidence in 1–2 strategic countries.
  • Use programs like DiGA and PECAN if applicable, but expect pricing pressure and compliance overhead.

Up next in the series: 📌 Cracking Reimbursement — Value-Based Pricing for MedTech Startups

This content has been enhanced with GenAI tools.

Categories
Digital Health MedTech

The MedTech Go-to-Market Playbook (2025 Edition)

Breaking into healthcare is hard. Breaking into MedTech is harder — thanks to complex regulations, long sales cycles, and conservative procurement paths. For early-stage medtech startups, choosing the right go-to-market (GTM) strategy can be the difference between scaling and stalling.

This guide breaks down the GTM playbook for MedTech in 2025, with a focus on startups launching in Europe and beyond. Based on real-world cases and regulatory insights, it’s built for those bringing medical devices, diagnostics, SaMD, or digital therapeutics (DTx) to market.

1. Choosing Your Commercial Model

Startups typically consider three primary go-to-market approaches:

1. Direct Sales (Field Reps, Clinical Liaisons)

  • Best for: High-margin products requiring clinician education (e.g. surgical robotics, diagnostics)
  • Challenges: Expensive ramp-up, long hiring timelines, regulatory training

2. Distributor & Channel Partnerships

  • Best for: Physical devices, CE-marked products in new geographies
  • Challenges: Less control over brand, data access, or customer experience

Example: Aidar Health used local channel partners to launch its multi-parameter diagnostic device in the EU before expanding direct.

3. Hybrid Model (Digital + Field, Centers of Excellence)

  • Best for: DTx, connected devices, AI-enabled diagnostics
  • Combine inbound marketing, centralized KOL outreach, virtual demos, and sales hubs

Example: Kaia Health built its GTM around remote clinical onboarding + digital HCP engagement, reducing cost-per-acquisition in Germany.

2. B2B vs B2C vs B2B2C in MedTech

MedTech isn’t one market — it’s multiple buyer archetypes:

ModelBuyerExampleRisk
B2BHospitals, GPOsSurgical robots, AI diagnosticsLong cycles, tender processes
B2CPatientsWearables, chronic disease appsAcquisition cost, compliance
B2B2CEmployers, insurersDTx, remote monitoringValue-based outcomes required

Key takeaway: Align GTM strategy to your reimbursement model and data capture capabilities.

3. Launch Sequence: What Comes First

Here’s a 4-step playbook most successful medtech startups follow:

Step 1: Identify Use Case + Early Adopter Segment

  • Focus on a narrow clinical pathway (e.g. remote respiratory monitoring in COPD)
  • Validate with 3–5 pilot sites

Step 2: Secure Certification or Reimbursement Milestone

  • EU: CE Mark under MDR, DiGA listing in Germany
  • UK: NICE DHT Evidence Standards
  • US: FDA 510(k) or De Novo

Step 3: Establish Clinical + Economic Credibility

  • Publish real-world evidence or observational data
  • Prepare short HTA dossiers (see EUnetHTA)

Step 4: Build Repeatable GTM Engine

  • Onboard 2–3 KOLs as advisors
  • Launch pilot-to-procurement playbook
  • Invest in sales enablement tools (e.g. Showpad, Veeva)

4. The Rise of Digital-First MedTech GTM

  • Virtual engagement is now table stakes. Over 70% of HCPs prefer virtual or hybrid touchpoints post-COVID (Accenture Life Sciences Report).
  • AI-powered reps, modular education, and asynchronous demos are outperforming live-only tactics.
  • Tools like ExplORer Surgical are now used in complex OR sales motions.

5. Budget Benchmarks for GTM Readiness

For pre-Series A startups, GTM budgets vary by model:

GTM ModelTypical Budget (Year 1)Headcount
Direct sales€300K–€1M3–5 reps
Distributor€100K–€250K1–2 BD FTEs
Hybrid/Digital€150K–€500KGrowth + Med affairs + digital comms

Up Next in the Series

📌 Post 2: Market Access in Europe — What Founders Need to Know
We’ll explore DiGA (Germany), PECAN (France), NICE (UK), and how early-stage companies can position for public system adoption.

Explore related reading: – Bigfoot Biomedical’s GTM model – Pear Therapeutics: Why commercialization failed

This content has been enhanced with GenAI tools.

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Digital Health MedTech

EU Digital Health Funding Landscape 2025: Where and How to Raise Capital in Europe

With over €20 billion in public and private capital flowing into digital health ventures since 2020, the European Union has become a strategic launchpad for healthtech founders. But where exactly does this capital come from? And what’s the smartest path for early-stage startups looking to digital health funding?

This in-depth guide breaks down the EU digital health funding landscape in 2025 — covering both EU-level grants (like Horizon Europe, EU4Health, and the EIC Accelerator) and national innovation programs (from France’s Bpifrance to Germany’s HTGF). We also map out the private funding scene, spotlighting active VCs and corporate funds, and show how EU regulations like MDR and GDPR influence access to capital.

Whether you’re applying for your first public grant, looking to raise a blended round, or building a scalable platform for regulated care — this guide is for you.

The Big Picture: Why EU Digital Health Funding Matters in 2025

In 2024 alone, startups in Europe raised $4.8 billion in digital health VC — a 27% YoY increase (Galen Growth). Mega-rounds like Alan (€193M), Ōura (€200M), and Flo Health ($200M) highlighted the growing maturity of the region.

Public funding is also expanding. The European Commission committed over €14 billion to digital health via Horizon Europe, EU4Health, and the Digital Europe Programme. Countries like France, Germany, and the Nordics doubled down on national programs for startups, especially those focused on regulated innovation (e.g. DTx, AI diagnostics, RPM).

But with increased capital comes increased complexity: understanding how to access the right programs, meet regulatory expectations, and position your startup for both grants and venture capital is essential.

EU-Level Public Funding: Key Programs for Startups

1. Horizon Europe

The EU’s flagship R&D program with a €95.5 billion budget, Horizon Europe funds large-scale innovation consortia. While not startup-specific, early-stage digital health ventures can access funds by partnering in consortium projects (e.g. under Cluster 1: Health).

Pro tip: Join a consortium via national contact points or through platforms like CORDIS.

2. EIC Accelerator

For high-risk, high-impact innovation, the EIC Accelerator offers up to €2.5M in grant + €15M in equity. In 2024, only 71 out of 1,211 applicants (≈5.9%) were selected (EIC Results).

Eligible: single startups incorporated in the EU.
Selection: based on scalability, scientific merit, and impact.

3. EU4Health

A €4.4 billion program supporting digital infrastructure, health data, and cross-border health services. Includes funding for the upcoming European Health Data Space (EHDS).

Best fit: startups providing EHR, interoperability, cybersecurity, or public health software.

4. Digital Europe Programme

Targets adoption of digital capabilities like AI and cybersecurity. Useful for startups bridging research and deployment.

National-Level Public Funding: Country Breakdown

France – Bpifrance and France 2030

  • Over €2.3B deployed into health innovation via Bpifrance since 2021.
  • Grant programs: i-Lab, i-Nov, French Tech Emergence.
  • Digital Health Acceleration Strategy under France 2030.

Germany – High-Tech Gründerfonds (HTGF)

UK – Innovate UK

  • Smart Grants up to £2M.
  • Health-specific challenges (e.g. mental health, aging tech).
  • Access to NHS pilots via NIHR, NHS Innovation Accelerator.

Nordics (Finland, Sweden, Denmark, Norway)

  • Innovation agencies (e.g. Business Finland, Vinnova) offer R&D grants, public co-investment.
  • Highly digital healthcare systems ideal for pilots.

CEE (Poland, Estonia, Czechia, etc.)

  • Heavy use of EU structural funds via EIT Health and local programs.
  • Lower VC volumes but rising interest from pan-European funds.

Private Capital: VC and Corporate Investors in Digital Health

Top early-stage investors active in EU digital health (2024–2025):

VC/InvestorHQNotes
BpifranceFRPublic VC, top deal count in Europe
Octopus VenturesUKHealthtech-focused team, 7 deals in 2024
Heal CapitalDEBacked by German insurers
MTIPCHDigital health scale-up investor
Nina CapitalESSpecialized in early-stage health tech
Khosla VenturesUSActive in EU AI health rounds
Wellington PartnersDEKnown for Temedica, Kaia Health

EU Regulations and Their Impact on Fundraising

MDR (Medical Device Regulation)

If your product qualifies as a medical device (e.g. AI diagnostics, digital therapeutics), you must comply with MDR to enter the EU market.

Pro tip: CE-marked startups are more likely to receive both VC and public funding.

GDPR (General Data Protection Regulation)

Strong privacy and data governance are mandatory. Consider external audits, ISO27001 certification, and working with GDPR Sandboxes in countries like France or Spain.

EHDS (European Health Data Space)

Coming 2025, EHDS will define interoperability and data-sharing standards across Europe. Compliance could unlock access to new tenders and cross-border pilots.

2025 Outlook: Trends and Opportunities

  • AI dominance: ~60% of 2025 funding so far went to AI-driven health ventures (CB Insights).
  • Public-private blending: More startups combining EU grants + VC in same round.
  • Reimbursement as ROI: Germany (DiGA), France (PECAN), and Nordics offer clear digital reimbursement paths — critical for Series A+ readiness.
  • CEE Rising: Low costs + EU funds = surge of new startups in Poland, Romania, Hungary.

FAQs

What are the best EU digital health funding programs for early-stage startups?

Top options: EIC Accelerator, EU4Health, national innovation agencies (Bpifrance, HTGF), and Digital Europe grants for AI/infra.

How competitive are EU public grants?

Highly. For example, the EIC Accelerator had ~5.9% success in 2024 (source). “Seal of Excellence” can still unlock national funds.

Which EU country is best for starting a digital health company?

France (strong grants), Germany (DiGA reimbursement), UK (private VC and NHS pilots), Nordics (public adoption), and Poland (cost and EU access).

Want to go deeper into commercialization, regulatory strategy, or fundraising? Explore our insights on how Bigfoot Biomedical built a commercial model around a digital-first insulin delivery system and why Pear Therapeutics failed to secure sustainable revenue despite FDA-approved DTx.

This content has been enhanced by GenAI tools.

Categories
MedTech

What Is MedTech? A Beginner’s Guide to Medical Technology

The intersection of medicine and technology is rapidly transforming healthcare worldwide. If you’ve ever wondered, what is MedTech?, you’re not alone. This beginner’s guide explores the definition, industry scope, and the latest trends shaping medical technology today.

What Is MedTech?

MedTech—short for medical technology—refers to the vast range of products, services, and solutions that leverage technology to diagnose, monitor, treat, and improve patient health outcomes. MedTech encompasses everything from simple tools like thermometers and bandages to complex innovations such as MRI machines, surgical robots, and AI-powered diagnostic platforms.

“Medical technologies are products, services or solutions used to save and improve people’s lives.”
MedTech Europe

Key MedTech Categories

  • Medical Devices: Instruments and machines used in diagnosis, treatment, or monitoring (e.g., pacemakers, CT scanners, insulin pumps).
  • In Vitro Diagnostics (IVD): Laboratory tests and equipment for analyzing blood, tissue, or other samples.
  • Digital Health Solutions: Software and connected devices for remote monitoring, telehealth, and electronic health records.
  • Implantable Devices: Artificial joints, stents, and other devices placed inside the body.

Industry Scope

The MedTech industry is a cornerstone of modern healthcare, serving hospitals, clinics, laboratories, and home care settings. Its scope includes:

  • Patient Diagnostics: Tools for early and accurate disease detection (e.g., imaging systems, point-of-care diagnostics).
  • Therapeutic Devices: Equipment for surgical procedures, rehabilitation, and chronic disease management.
  • Monitoring & Wearables: Devices for continuous tracking of vital signs, glucose levels, or cardiac rhythms.
  • Connected Care: Integration of devices and data for seamless patient management and improved outcomes.

MedTech is distinct from HealthTech, which focuses more on consumer-facing digital health apps and telemedicine. MedTech primarily empowers healthcare professionals with advanced tools for clinical care.

Global Impact

The MedTech sector demonstrated resilience and growth in 2024, achieving a robust 5–7% annual growth rate despite global economic pressures. Demand is surging for wearable devices, AI-enabled diagnostics, and minimally invasive procedures, especially in emerging markets where access and affordability are critical priorities.

The MedTech landscape is evolving at an unprecedented pace. Here are the most influential trends shaping the industry:

1. Artificial Intelligence (AI) and Machine Learning

AI is revolutionizing diagnostics, imaging, and workflow automation. AI-powered tools help clinicians detect diseases earlier, improve diagnostic accuracy, and streamline administrative tasks. The adoption of AI in healthcare operations is projected to grow at an annual rate of over 30%.

2. Connected Devices and Home Healthcare

Wearable devices and remote monitoring solutions are empowering patients to manage their health at home. Edge computing and IoT-enabled devices provide real-time data to clinicians, supporting proactive care and reducing hospital visits.

3. Minimally Invasive and Patient-Centric Solutions

Technologies that reduce recovery times and improve patient comfort—such as robotic surgery and advanced imaging—are in high demand. The market for minimally invasive devices is expected to grow at a CAGR of 12-15% through 2025.

4. Data Security and Regulatory Compliance

With the expansion of digital health platforms, cybersecurity and regulatory oversight are top priorities. Investments in AI-powered threat detection and compliance tools are rising to safeguard sensitive medical data and meet evolving industry standards.

5. Global Expansion and Access

Emerging markets are driving growth through investments in healthcare infrastructure and affordable medical technologies. Companies are focusing on scalable, cost-effective solutions to reach underserved populations worldwide.

Conclusion

MedTech is at the forefront of healthcare innovation, blending advanced technology with clinical expertise to enhance patient care. From AI-driven diagnostics to connected home health devices, the industry is shaping a future where healthcare is more precise, accessible, and patient-centered than ever before.

Whether you’re a healthcare professional, industry stakeholder, or curious newcomer, understanding what is MedTech is essential for navigating the evolving landscape of modern medicine.

References

  1. MedTech Europe – What is Medical Technology?
  2. FDA – What Are Medical Devices?
  3. Mayo Clinic – Wearable Technology in Healthcare
  4. Deloitte – 2024 Global MedTech Industry Outlook
  5. McKinsey – MedTech in Emerging Markets
  6. Nature – Artificial Intelligence in Medical Devices
  7. Statista – AI in Healthcare Market Size
  8. Forbes – The Rise Of Connected Medical Devices
  9. MarketsandMarkets – Minimally Invasive Surgical Instruments Market
  10. Healthcare IT News – Cybersecurity in MedTech
  11. PwC – Medical Device Regulation
  12. WHO – Medical Devices: Managing the Mismatch

This content has been enhanced with GenAI tools.

Categories
MedTech

How to Build a Medtech Unicorn in Europe: The 2025 Founders Playbook

Introduction: Medtech Unicorns on the Rise in Europe

The medtech unicorn phenomenon is transforming healthcare in Europe. As one of the world’s largest industries—nearly 20% of U.S. GDP (about $5 trillion)—healthcare has long been ripe for disruption. Yet, medtech unicorns (startups valued at $1 billion or more) have historically represented only about 8% of all unicorns globally. This is changing rapidly: the European digital health market reached €64 billion in 2024 and is growing at over 20% CAGR, driven by medtech founders leveraging AI, digitalization, and urgent healthcare needs.

Why Medtech Unicorns Are Emerging Now

  • AI & Data Revolution: The AI healthcare market is projected to grow 40% in 2025, reaching over $208 billion by 2030. Medtech unicorns like Neko Health (Sweden) and Abridge (U.S.) are using AI for diagnostics, workflow automation, and drug discovery.
  • Systemic Pressures: Chronic disease, workforce shortages, and aging populations are driving demand for digital solutions and automation.
  • Market Growth: The European digital health sector is expanding rapidly, with innovation hubs in the Netherlands, Belgium, Switzerland, and the Nordics.

What Problems Do Medtech Unicorns Solve?

DomainExample CompaniesProblem Tackled
Access & ConvenienceDoctolib, CeraOnline booking, telehealth, elder care
Chronic Disease MgmtDexcom, Sword HealthWearable monitoring, remote coaching
Data & DiagnosticsTempus, Better MedicineGenomics, AI-driven early diagnosis
Workflow & EfficiencyAbridge, DoctolibAutomated documentation, scheduling
New Therapies & R&DInsilico MedicineAI-driven drug discovery

Key Insight: Medtech unicorns in Europe address big, costly, and pervasive healthcare pain points, often reimagining processes with technology for a 10x improvement.

How Do Medtech Unicorns Make Money?

  • B2B SaaS: Selling software to hospitals, clinics, and pharma (e.g., Doctolib, Tempus).
  • B2B2C: Partnering with employers/insurers for broader coverage (e.g., Cera).
  • Direct-to-Consumer: Selling directly to patients (e.g., Dexcom, Neko Health).
  • Device Sales: Hardware, wearables, and consumables (e.g., Dexcom).
  • Data Licensing: Monetizing unique health data via partnerships (e.g., Tempus, Insilico Medicine).

Europe vs. US: Medtech Europe startups often face centralized payers and tougher regulatory hurdles but can access broad markets through national schemes, while U.S. startups may scale faster but face fragmented payers and state regulations.

The Founder Blueprint: Traits of Medtech Unicorn Leaders

  • Experience Matters: 70% of medtech unicorn founders have over 10 years of professional experience before launching their company.
  • Team Composition: Over 80% of unicorns are built by teams, not solo founders, and more than half of the founders hold advanced degrees.
  • Centaur Teams: Winning teams blend domain experts (clinicians, pharma, medtech) with tech-native outsiders (AI, software), creating “bilingual” cultures.
  • Mission-Driven: Medtech founders are deeply passionate about impact, often with personal stories fueling their drive.

Navigating European Medtech Hubs

CityStrengthsNotable Companies
LondonCapital, NHS, researchCMR Surgical, BenevolentAI
BarcelonaInvestment, clinical infrastructure, digital focusImpress, Aortyx
Zurich/BaselPharma proximity, deep tech, elite talentMindMaze, SOPHiA GENETICS
BerlinDigital health, policy access, support networkAmboss, Doctorly
WarsawAI talent, cost-effective, emerging VC sceneDocplanner, Jutro Medical

Medtech Europe clusters are thriving in Western and Northern Europe, with strong support in Switzerland, the Nordics, and key EU capitals.

Regulatory and Market Challenges for Medtech Unicorns

  • EU MDR/IVDR: New regulations have increased costs, extended approval times, and created higher complexity for startups. Small medtech companies are disproportionately affected, with some shifting focus to the U.S. market due to regulatory hurdles.
  • Fragmented Reimbursement: Each EU country has its own system; medtech founders must design trials and health-economic evidence for specific markets.
  • Data Privacy: GDPR and local laws require robust data protection and compliance from day one.
  • Long Sales Cycles: Hospitals and payers move slowly; founders must be prepared for up to 18-month sales processes.

Funding the Journey: Key Investors and Strategies

  • Venture Capital: Top European healthtech VC funds include V Health Investors, Calm/Storm, Index Ventures, Nina Capital, and Octopus Ventures. In 2024, digital health investments in Europe reached $3.5 billion, a 19% YoY increase.
  • Corporate VC: Pharma and medtech giants such as Novartis, Roche, and Bayer provide capital, expertise, and access to distribution.
  • Public Funding: EU programs and national grants remain vital, with over €16 billion allocated to healthcare digitalization between 2014 and 2027.
  • Strategic Mix: Combining equity, grants, and partnerships is key for surviving long development cycles.

Actionable Steps: Your Medtech Unicorn Roadmap

  1. Identify a Painful, Funded Problem: Validate with clinicians, patients, and payers. Focus on “must-have” needs.
  2. Build a Bilingual Team: Combine domain (clinical, regulatory) and tech expertise.
  3. Leverage Your Ecosystem: Tap local accelerators, universities, and health systems for pilots and validation.
  4. Design for Regulation: Map out regulatory needs (e.g., CE mark, FDA) early; consult experts from the outset.
  5. Validate Clinically and Economically: Run pilots, publish results, and build a health economics model for each target market.
  6. Strategize Funding: Target VCs and public grants aligned with your market and stage; consider corporate partnerships.
  7. Plan Go-to-Market by Country: Tailor your approach for each market’s regulatory and reimbursement realities.
  8. Prepare for the Long Haul: Set milestones, cultivate resilience, and stay adaptable as regulations and markets evolve.

Conclusion: The Future of Medtech Unicorns in Europe

Building a medtech unicorn in Europe is challenging but increasingly achievable. Success demands a unique blend of technical and clinical excellence, regulatory savvy, and strategic ecosystem navigation. By focusing on real, validated problems, assembling a centaur team, leveraging Europe’s maturing hubs, and planning for regulatory and funding complexity, medtech founders can reach billion-dollar valuations and make a lasting impact on healthcare.

References

  1. SignalFire Health & Pharma Tech Unicorn Founders Analysis
  2. Vestbee: European Unicorns and Tech Hubs
  3. European Parliament: Digital Health Market in the EU
  4. Fortune Business Insights: Medical Devices Market

This text was enhanced with Generative AI models.

Categories
Digital Health MedTech

What Happened to 23andMe? The Rise, Fall, and Future of a Consumer Genetics Pioneer

Understanding the 23andMe Journey

23andMe was founded in 2006 by Anne Wojcicki, Linda Avey, and Paul Cusenza with a bold vision: to put the power of genetics directly into the hands of consumers. The startup pioneered the direct-to-consumer (DTC) genetic testing market, offering affordable at-home DNA test kits that could reveal ancestry roots, inherited traits, and potential health risks.

The company made headlines early on with its $999 saliva-based DNA test, which later dropped to $99—making it accessible to millions. For the first time, individuals could decode their DNA without going through a doctor or lab. This democratization of genetic data made 23andMe a household name and a Silicon Valley darling.

But with innovation came regulatory friction. In 2013, the U.S. Food and Drug Administration (FDA) halted the marketing of 23andMe’s health reports, citing concerns over accuracy and consumer safety. After years of negotiations, the company received FDA clearance in 2017 for specific health risk reports, such as predispositions to Parkinson’s and Alzheimer’s.

The Business Model Shift

23andMe wasn’t just selling DNA kits—it was building a data-driven biotech engine. Over time, it accumulated one of the largest genomic databases in the world. This treasure trove of anonymized genetic data became a valuable asset for pharmaceutical research.

Image: GSK’s 2018 partnership with 23andMe marked a major turning point for the company’s therapeutics ambitions.

In 2018, 23andMe announced a high-profile partnership with GlaxoSmithKline (GSK), aiming to develop new drugs using its consumer data. The move signaled a pivot from consumer health to therapeutics.

The company went public in 2021 via a SPAC merger, reaching a valuation of nearly $3.5 billion. It was a landmark moment, but also the peak of its trajectory.

Why Did 23andMe File for Bankruptcy?

In early 2025, 23andMe filed for Chapter 11 bankruptcy protection—a stunning development for one of health tech’s most iconic players.

The reasons behind the collapse are multifaceted:

  • Declining demand for consumer DNA tests as the novelty wore off
  • Privacy concerns and increased scrutiny over genetic data usage
  • Limited success from the GSK partnership, with no therapies reaching late-stage trials
  • Rising operational costs amid a tougher funding environment for biotech startups

The consumer genetics market matured and contracted. With fewer new customers and limited revenue from therapeutics, 23andMe faced an unsustainable business model.

The Chapter 11 filing offers a path to restructure. However, it remains unclear whether the company will recover, pivot again, or sell off its most valuable asset—its genomic database.

Who Is Anne Wojcicki?

Anne Wojcicki, born in 1973, is the co-founder and CEO of 23andMe. A biology graduate from Yale, Wojcicki began her career as a healthcare investment analyst before disrupting the world of genomics.

She envisioned a more transparent, consumer-centric healthcare model—one where individuals could access and understand their own genetic code. Her leadership helped push personalized medicine into the mainstream.

Wojcicki is a prominent advocate for digital health, women in STEM, and healthcare innovation. She was formerly married to Google co-founder Sergey Brin and is the sister of former YouTube CEO Susan Wojcicki.

Even as 23andMe faces restructuring, Anne Wojcicki remains a powerful voice in biotech, known for challenging traditional healthcare and betting on the future of data-driven medicine.

Subscribe to Disrupting.Healthcare for more insights into MedTech, digital health trends, and the companies shaping the future of care.

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MedTech

Early Cancer Detection: The Promise of Protein Biomarker Analysis

Cancer detection has seen a revolutionary transformation, thanks to the emergence of a technique known as Protein Biomarker Analysis using Proximity Ligation Assays (PLA). This novel approach is a game changer in identifying cancer at its nascent stages, improving the chances of successful treatment and recovery. But what exactly is PLA, and how does it contribute to early cancer detection? Let’s delve into this promising frontier of medical technology.

Understanding Protein Biomarker Analysis

At its core, Protein Biomarker Analysis is about studying specific proteins – called biomarkers – that are often associated with the presence of cancer. Unlike the conventional methods which rely on identifying genetic mutations, this analysis focuses on proteins, offering a real-time glimpse into the presence of cancer.

A proximity ligation assay identifies complexes (red) containing the Notch1 receptor and the heparan sulfate proteoglycan Syndecan-3 in skeletal muscle satellite cells stained for Syndecan-4 (green). Pisconti et al. show that Syndecan-3 is required for Notch1’s cleavage by the metalloproteinase ADAM17 and downstream signaling controlling satellite cell proliferation and differentiation.
 
This image is available to the public to copy, distribute, or display under a Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported license.
 
Reference: Pisconti et al. (2010) J. Cell Biol.190, 427-441.
Published on: August 9, 2010.
doi: 10.1083/jcb.201003081

Some of the innovative approaches and technologies in Protein Biomarker Analysis are:

  1. Multiplexed Proximity Ligation Assays: A high throughput protein biomarker discovery tool has been developed that utilizes multiplexed proximity ligation assays in a homogeneous format. This innovative platform comprises four 24-plex panels profiling 74 putative biomarkers with sub-picomolar sensitivity, each consuming only 1 μl of human plasma sample​​.
  2. TaqMan® Protein Assays: TaqMan® Protein Assays represent an adapted form of PLA technology, invented by Ulf Landegren, Simon Fredriksson, and colleagues. This technology melds antibody-protein binding with real-time PCR-based detection of the reporter nucleic acid sequence. It’s an illustrative example of how PLA technology can be adapted and expanded for varied applications in protein analysis​.
  3. Multiplexed Protein Detection Procedure: A proximity ligation-based multiplexed protein detection procedure has been presented wherein several selected proteins can be detected via unique nucleic-acid identifiers. This method holds promise for a more comprehensive understanding and detection of protein complexes associated with cancer​​.
  4. Nanoparticle-Based Proximity Ligation Assay: This method enhances the traditional PLA by replacing antibody–DNA conjugates with nanoparticles. These nanoparticles create ultradetectable PCR templates by capturing biotinylated oligonucleotides and catalyzing ligation, thus potentially offering a more sensitive and quantitative assay for protein analysis​​.
Applied Biosystems™ TaqMan™ Protein Assays Core Reagents Base Kit
Source: fishersci.se

The Role of Proximity Ligation Assays (PLA)

Proximity Ligation Assays are the tools that enable this intricate analysis. They help in measuring and visualizing protein complexes, which in turn, provide critical insights into the presence and progression of cancer. The beauty of PLA lies in its ability to offer real-time information, which is crucial for early detection and subsequent treatment of cancer.

Advantages Over Traditional Methods

  1. Early Detection: As mentioned earlier, one of the standout benefits of PLA is its potential for early cancer detection. By identifying protein biomarkers, it’s possible to spot cancer long before symptoms surface.
  2. Real-Time Analysis: Unlike genetic mutation tests that might not provide a current status of cancer, PLA offers real-time information, which is invaluable in determining the most effective treatment plan.
  3. Enhanced Accuracy: By honing in on specific protein complexes, PLA tends to have a higher degree of accuracy compared to traditional testing methods.

The Future of Cancer Detection

Integrating Proximity Ligation Assays in routine cancer screening could herald a new era in oncology. By enabling early and accurate detection, PLA empowers healthcare professionals and offers hope to individuals and families affected by cancer.

Concluding Thoughts

The journey towards a cancer-free world is laden with numerous challenges, yet with innovative technologies like Protein Biomarker Analysis via Proximity Ligation Assays, we are inching closer to that goal. As research advances, there’s an optimistic outlook that PLA will become a cornerstone in cancer diagnostics, offering a beacon of hope for millions affected by this dreaded disease.

This exploration into the world of Protein Biomarker Analysis is a testimony to the relentless human endeavor to combat cancer. It’s a significant stride towards not only understanding this complex disease better but also combating it with more precision and effectiveness.

Note: this content has been created using experimental Generative AI features.
While edited, authored, and reviewed by humans it may include some biased or incorrect statements.

Categories
Digital Health MedTech

Pear Therapeutics: The Rise and Fall of a Digital Therapeutics Pioneer

Pear Therapeutics bankruptcy (https://peartherapeutics.com/)

Pear Therapeutics, once a leader in prescription digital therapeutics (PDT or DTx), has recently filed for bankruptcy. In this blog post, we’ll explore the history of the company, its milestones, and the reasons behind its unforeseen downfall, while also shedding light on its competitors in the digital therapeutics market.

Pear Therapeutics: History

Established in 2013 by Dr. Corey McCann, Pear Therapeutics aspired to revolutionize the treatment of various disorders by merging the power of software and medicine. Based in Boston, Massachusetts, the company aimed to develop, manufacture, and distribute FDA-approved software applications that would work in tandem with conventional medications to enhance their effectiveness.

Pear Therapeutics’ Key Achievements

FDA Approvals

Throughout its existence, Pear Therapeutics managed to obtain three FDA approvals for its products, establishing itself as a significant player in the digital therapeutics industry:

  1. reSET (2017) – The first FDA-approved PDT, reSET is designed for treating substance use disorder. This groundbreaking achievement demonstrated that software could be clinically effective in treating patients.
  2. reSET-O (2018) – A follow-up to reSET, this PDT is aimed at helping patients with opioid use disorder as an adjunct to outpatient treatment. It includes buprenorphine and contingency management, a behavioral therapy approach.
  3. Somryst (2020) – The first FDA-approved PDT for chronic insomnia, Somryst offers cognitive behavioral therapy for insomnia (CBT-I) through a digital platform, making it more accessible for patients who might not have access to in-person therapy.

Partnerships and Collaborations

Throughout its journey, Pear Therapeutics partnered with several industry giants to develop and distribute its PDTs. These collaborations included deals with Novartis, Sandoz, and Blue Cross Blue Shield, among others.

The Path to Bankruptcy: Crucial Factors

Market Penetration and Adoption Challenges

Despite the groundbreaking nature of its PDTs, Pear Therapeutics faced significant challenges in gaining market traction. The healthcare industry is often slow to adopt new technologies, and the novel concept of PDTs faced resistance from both physicians and insurers.

Reimbursement Issues

One of the most significant hurdles for Pear Therapeutics was obtaining adequate reimbursement from insurance companies. Many insurers were hesitant to cover the costs of the treatments, which made it difficult for patients to access them.

High Development and Marketing Costs

Developing PDTs is a time-consuming and costly process. Pear Therapeutics had to invest heavily in research, development, and clinical trials to bring its products to market. Additionally, the company faced considerable marketing expenses to promote its PDTs in a market dominated by traditional pharmaceuticals.

Management Missteps

Some critics argue that Pear Therapeutics’ management made a series of missteps that ultimately contributed to the company’s downfall. This includes an overemphasis on partnerships at the expense of product innovation, and a lack of clear, focused strategies to address the challenges faced in the market.

COVID-19 Pandemic Impact

The COVID-19 pandemic brought about significant challenges for Pear Therapeutics, particularly in the area of patient access. As healthcare providers struggled to adapt to the new normal, digital therapeutics adoption was deprioritized, and this further impeded the company’s growth.

Competitors in the Digital Therapeutics Space

While Pear Therapeutics was a pioneer in the prescription digital therapeutics (PDT) field, it wasn’t the only company trying to make its mark. Some of the key competitors in the digital therapeutics market include:

Akili Interactive

Akili Interactive is a Boston-based company that has developed EndeavorRx, the first FDA-approved video game for treating attention deficit hyperactivity disorder (ADHD) in children. EndeavorRx is a digital intervention that aims to improve attention function in pediatric patients with ADHD.

Voluntis

Voluntis, a French digital therapeutics company, specializes in creating software to assist patients in managing chronic conditions. Their flagship product, Insulia, is an FDA-cleared digital therapeutic designed to help patients with type 2 diabetes manage their insulin dosages.

Big Health

Big Health, a UK-based company, focuses on developing digital therapeutics for mental health. Their two major products are Sleepio, a digital CBT-I program for insomnia, and Daylight, a digital CBT-based program for anxiety. While not FDA-approved like Pear’s Somryst, Sleepio has demonstrated clinical effectiveness in multiple studies.

Omada Health

Omada Health is a San Francisco-based digital health company that offers a suite of digital programs aimed at chronic disease prevention and management. Their flagship program, the Omada Diabetes Prevention Program, is a CDC-recognized digital intervention to help patients with prediabetes make lifestyle changes to prevent or delay the onset of type 2 diabetes.

Click Therapeutics

Click Therapeutics, a New York-based digital therapeutics company, is focused on developing software as a prescription medical treatment. One of their most prominent products, Clickotine, is a digital smoking cessation program designed to help users quit smoking. The company is also working on a digital treatment for major depressive disorder called CT-152, currently in clinical trials.

Conclusion

Pear Therapeutics was a trailblazer in the field of prescription digital therapeutics, achieving FDA approvals and forging partnerships with industry giants. However, the company’s inability to overcome market penetration, adoption, and reimbursement challenges, coupled with high development costs, management missteps, and the impact of the COVID-19 pandemic, ultimately led to its bankruptcy. With multiple players such as Akili Interactive, Voluntis, Big Health, Omada Health, and Click Therapeutics still in the game, it remains to be seen how the digital therapeutics landscape will evolve and what future innovations may emerge.

Categories
Digital Health MedTech

Bigfoot Medical: Pioneering Diabetes Management Solutions & Their Future Prospects

BigFoot Unity (www.bigfootbiomedical.com)

Beginning of March 2023 Bigfoot Medical announced it has FDA clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with Type 2 diabetes. Bigfoot Unity has been compatible with iOS devices since May 2021. 

The medical device landscape is continuously evolving, with companies like Bigfoot Medical revolutionizing diabetes care through cutting-edge technology and artificial intelligence. In this post, we explore the history, achievements, and future prospects of Bigfoot Medical, an industry leader in diabetes management solutions.

Early Days: Laying the Groundwork for Success

Founded in 2014 by Jeffrey Brewer and Bryan Mazlish, Bigfoot Medical was driven by a personal connection to the challenges of diabetes management. Their goal is to create an integrated system that simplifies and enhances diabetes care using advanced technology and AI.

From day one, Bigfoot Medical focused on patient-centric solutions, which has been instrumental in their success and significant progress in the diabetes care sector.

Achievements: Transforming Diabetes Care with Bigfoot Unity™

Bigfoot Medical’s flagship product, the Bigfoot Unity™ Diabetes Management System, is an innovative solution that combines a continuous glucose monitor (CGM), insulin pen caps, and a mobile app to provide a seamless, data-driven experience for those living with insulin-requiring diabetes.

Key achievements of Bigfoot Medical include:

  1. FDA Approval: In 2021, Bigfoot Medical received FDA clearance for the Bigfoot Unity™ System, a major milestone in their journey.
  2. Enhanced Patient Outcomes: The Bigfoot Unity™ System has demonstrated improved glycemic control, reduced hypoglycemic events, and enhanced quality of life for users.
  3. Strategic Partnerships: Bigfoot Medical has formed alliances with industry leaders like Abbott, ensuring technology integration and broader patient reach.
  4. Awards and Recognitions: The company has garnered numerous accolades, such as being named one of Fast Company’s Most Innovative Companies in 2021.

Competition and Market Size: Navigating a Dynamic Industry

The global diabetes care devices market is substantial, with a value of $20.0 billion in 2020, and is projected to reach $38.3 billion by 2030, growing at a CAGR of 6.6% from 2021 to 2030. This significant market size is attributed to the increasing prevalence of diabetes, the need for better management solutions, and rising awareness about diabetes care. In such a dynamic industry, Bigfoot Medical faces competition from various established and emerging players, such as Medtronic, Dexcom, Insulet, and Tandem Diabetes Care, which offer insulin pumps, CGMs, and other diabetes management solutions.

Despite the competitive landscape, Bigfoot Medical differentiates itself through its unique, integrated approach to diabetes care, focusing on providing a seamless, data-driven experience for users. Additionally, the company’s commitment to leveraging AI and machine learning for personalized treatment plans offers a competitive edge that could attract patients seeking tailored solutions for their diabetes management. By continuing to innovate and staying ahead of the curve, Bigfoot Medical aims to secure a significant share of this growing market, providing millions of diabetes patients worldwide with advanced, user-friendly, and effective diabetes care solutions.

Future Prospects: Embracing Continued Innovation

With a strong foundation and proven success, Bigfoot Medical is poised to keep transforming diabetes care. Their future prospects encompass:

  1. Diversified Product Line: Bigfoot Medical plans to expand its product offerings, addressing a broader range of patient needs.
  2. Global Market Reach: The company aims to make its groundbreaking solutions accessible to patients worldwide.
  3. Personalized Medicine: Bigfoot Medical is committed to harnessing AI and machine learning to develop tailored treatment plans for diabetes patients, further enhancing outcomes and quality of life.
  4. Research and Collaborations: The company will continue to work with research institutions, healthcare providers, and industry partners to drive innovation and uncover new ways to improve diabetes care.

Bigfoot Medical’s dedication to enhancing the lives of diabetes patients is evident in their history of innovation and promising future. As they continue to evolve and expand, Bigfoot Medical will undoubtedly remain a leader in the medical device industry, shaping the future of diabetes management for millions around the globe. With a unique approach to diabetes care and a commitment to delivering personalized solutions, Bigfoot Medical is well-positioned to make a lasting impact on patients’ lives and redefine the standards of diabetes care in the years to come.

Categories
Digital Health MedTech

The Top 10 Medical Devices Types Revolutionizing Digital Health in 2023

Photo by Darlene Alderson on Pexels.com

Digital health in 2023 continues to advance rapidly. Medical devices that utilize digital technology are becoming increasingly popular and offer a wide range of benefits, including improved accuracy, increased convenience, and greater efficiency. In this post, we’ll take a look at the top 10 medical devices revolutionizing digital health in 2023.

Smart Inhalers

Smart inhalers are innovative medical devices that can help patients manage their asthma and other respiratory conditions more effectively. These devices are equipped with sensors that can track the usage of the inhaler, monitor patient symptoms, and provide feedback to help optimize treatment plans.

Wearable Glucose Monitors

Wearable glucose monitors are becoming increasingly popular for individuals with diabetes. These devices provide continuous monitoring of blood glucose levels and can alert the wearer when their levels are too high or too low, allowing for more timely and effective management of the condition.

Remote Patient Monitoring Systems

Remote patient monitoring systems enable healthcare providers to monitor patients remotely, reducing the need for in-person visits and improving patient outcomes. These systems typically involve wearable devices that can track vital signs, medication adherence, and other health metrics.

Virtual Reality Therapy Devices

Virtual reality therapy devices are a new and innovative way to treat a range of mental health conditions, including anxiety and PTSD. These devices allow patients to immerse themselves in a virtual environment, providing a safe and controlled space to address and overcome their fears.

Portable Ultrasound Machines

Portable ultrasound machines are an exciting development in medical imaging technology, allowing for easier and more accessible imaging in a range of clinical settings. These devices are also more cost-effective than traditional ultrasound machines, making them valuable tools for healthcare providers.

  • Philips CX50
  • Chison Sonobook 9
  • Mindray M7
  • GE Logiq e

AI-Powered Diagnostics Tools

AI-powered diagnostics tools are changing the game when it comes to early disease detection and diagnosis. These devices can analyze large amounts of data to detect patterns and anomalies that may indicate a health condition, enabling earlier intervention and improved patient outcomes.

Smart Pill Bottles

Smart pill bottles are an excellent tool for medication adherence, particularly for patients with chronic conditions who need to take multiple medications. These devices can track medication usage, remind patients to take their medication and alert healthcare providers if medication is missed

Robotic Exoskeletons

Robotic exoskeletons are a new and exciting development in the field of physical therapy. These devices can assist patients with mobility issues, providing support and assistance with movement and helping to reduce the risk of falls and other injuries.

Wireless ECG Monitors

Wireless ECG monitors are a convenient and effective way to monitor cardiac health. These devices can be worn for extended periods, providing continuous monitoring of heart rate and rhythm, and alerting healthcare providers to potential issues in real time.

Smart Contact Lenses

Smart contact lenses are an exciting new development in digital health, allowing for continuous monitoring of a range of health metrics, including glucose levels, intraocular pressure, and other vital signs. These devices could have a significant impact on patient outcomes, particularly for those with chronic conditions. We have seen early pioneers (Alcon+Verily, Mojo) failing to deliver on their promises, but the platform has its potential and the research continues. The most recent advance was when the Ulsan National Institute of Science and Technology (UNIST) scientists led by Dr. Seol Seung-Kwon and Professor Lim-Doo Jeong made a significant step forward in 3D-printed smart lenses.

Medical devices are revolutionizing digital health in 2023, offering patients and healthcare providers new tools to improve patient outcomes, reduce costs, and increase access to care. From wearable glucose monitors to smart inhalers and AI-powered diagnostics tools, the future of digital health looks bright. Are you working on any of the trends above? Do you have a new disrupting healthcare technology in mind? Let us know!

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