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Digital Health MedTech

Mistakes to Avoid in MedTech Commercialization (and How to Fix Them)

Even with the right product, market, and team — many MedTech startups fail. And the reasons often come down to avoidable commercialization mistakes: misjudging the buyer, skipping regulatory nuance, or assuming your tech will sell itself.

This final post in the Scaling MedTech: From Product to Market series lays out the most common missteps in MedTech go-to-market and how to avoid them — with real-world examples and corrective actions.


1. Building Before Validating the Buyer

Mistake: Launching development without confirming who pays, who uses, and who benefits.

Too many founders build based on clinical need or innovation potential — without validating demand, budget holders, or economic value.

Fix: Use the JTBD (Jobs-To-Be-Done) framework + early payer interviews to design with reimbursement in mind.


2. Relying on Pilots Without a Conversion Plan

Mistake: Dozens of pilots, zero sales.

Pilots are easy to get — but unless there’s a conversion path, they drain resources and confuse investors.

Example: Many DTx startups in Germany listed under DiGA saw high downloads but failed to convert to revenue due to unclear therapeutic ownership.

Fix: Design pilots with: – Pre-negotiated success KPIs – Budget source for scale-up – Procurement-ready documentation


3. Ignoring Procurement and IT Requirements

Mistake: Gaining HCP interest, but failing at hospital onboarding.

Even if clinicians love your product, procurement, legal, and IT may reject it due to data compliance, MDR classification, or lack of integration.

Fix: – Include procurement in early demos – Prepare GDPR/Data Processing documentation – Get listed in hospital or GPO vendor systems (e.g., GHX)


4. Misunderstanding Regulatory Signals

Mistake: Confusing CE marking or FDA approval with market readiness.

Regulatory clearance allows sales, but doesn’t guarantee adoption or reimbursement.

Fix: Align your commercial roadmap with regulatory + access strategy (e.g., CE mark + DiGA listing or NICE submission).

Resource: See MDR timeline & guidance from the European Commission.


5. Over-Investing in the Wrong Channel Early

Mistake: Hiring a large sales team before validating CAC or message fit.

Burning capital on outbound reps without understanding the sales motion leads to churn and stalled traction.

Fix: Run test campaigns with fractional reps, digital outreach, or advisor-led selling before hiring full-time field force.


Summary Table: Mistakes & Fixes

MistakeFix
No buyer validationConduct payer & JTBD interviews
Pilot fatigueDesign conversion-ready pilots
Procurement blockersInvolve early, prep documentation
CE mark ≠ market fitLayer regulatory + access planning
Premature sales hiresValidate channels first

Final Word

Commercialization in MedTech is not just execution — it’s sequencing. Avoiding these five traps increases the odds of landing not just pilots or press — but scalable, reimbursed adoption.


Explore more: – Why Pear Therapeutics failed despite FDA clearanceHow Bigfoot Biomedical sequenced product + payer strategy

This wraps our series on Scaling MedTech — let us know what topic you want next.

This content has been enhanced with GenAI tools.

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Digital Health MedTech

Commercial Channels That Actually Work in MedTech

For MedTech startups, success hinges not only on product quality, but also on how you reach, convince, and support stakeholders. Whether selling to hospitals, doctors, or patients, early-stage companies must design a channel strategy that reflects the healthcare buying process — slow, risk-averse, and influence-driven.

This post breaks down the most effective commercial channels in MedTech, based on what’s actually working in 2025.


1. The MedTech Sales Funnel Is Nonlinear

In traditional B2B, a sales funnel moves from awareness → interest → consideration → purchase.

In MedTech, it looks more like:

Clinical KOL → Hospital Committee → Procurement → IT → Payer → Rollout

Each stage requires a different communication style and sometimes different messengers. Sales success is more about building internal champions than pure outbound volume.

Insight: On average, a hospital sale in Europe involves 5–7 decision-makers (McKinsey MedTech Commercial Benchmark).


2. Channels That Work in Early-Stage MedTech

a. Key Opinion Leaders (KOLs)

  • Clinical influencers who help validate product utility
  • Invite early as advisors or co-authors of case studies
  • Ideal for high-specialty tools (robotics, diagnostics, DTx)

Example: Impulse Dynamics used KOLs to validate its cardiac neuromodulation tech pre-launch.

b. Medical Science Liaisons (MSLs)

  • Hybrid of sales and education
  • Often paired with clinical trials or early access programs

c. Virtual Selling Platforms

  • Tools like Veeva Engage or Showpad support rep-driven or rep-less demos
  • Crucial for digital products, AI tools, and DTx

Statistic: 75% of HCPs in Europe now prefer hybrid or remote interactions (Accenture HCP Preferences)

d. Peer-to-Peer Learning & CME Platforms

  • Hosting webinars, masterclasses, or contributing to Univadis and Medscape
  • Builds credibility and engagement in clinical communities

3. Choosing the Right Channel by Product Type

Product TypePrimary ChannelSecondary
Surgical toolsKOLs + in-hospital demosProcurement-led tenders
DTx & SaMDVirtual platforms + payersPrimary care orgs
Diagnostics (AI)MSLs + evidence portalsRadiology or lab heads
Monitoring devicesPeer-to-peer pilotsDistributors

4. Global Commercial Trends in 2025

  • Digital-first detailing is mainstream. COVID catalyzed a shift to Zoom-based product detailing and asynchronous video walkthroughs.
  • Field force is shrinking. Reps are more specialized, often scientific or hybrid profiles.
  • Channel orchestration is key. Companies using Salesforce, HubSpot, or Aktana orchestration outperform on conversion.

5. Building a Channel Strategy: Questions to Ask

  1. Who influences vs decides vs pays?
  2. Can you pilot the sales motion before full deployment?
  3. Can one channel (e.g. KOLs or CME) drive multiple buyers?
  4. Can data from pilots be repurposed for access and pricing?

Tip: In early-stage MedTech, channel feedback is often better than user feedback — it tells you what blocks growth.


Up next in the series: 📌 Mistakes to Avoid in MedTech Commercialization (and How to Fix Them)

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Digital Health MedTech

Cracking Reimbursement — Value-Based Pricing for MedTech Startups

Pricing in MedTech isn’t just a number — it’s your business model. In the EU, where public payers dominate and health systems are increasingly value-driven, getting paid requires clinical validation, health economic proof, and a clear story about long-term cost savings.

This post breaks down how to approach reimbursement and pricing for MedTech startups, with examples from DTx, devices, and AI diagnostics. We focus on the frameworks that matter and what early-stage founders must do to prepare.


1. Understand What Payers Actually Buy

Public and private payers (like insurers and national health services) don’t buy tech — they buy outcomes. Successful pricing strategies show how your product: – Improves health outcomes (efficacy) – Saves money (cost avoidance) – Improves workflow or capacity

Tip: Frame pricing in terms of cost per QALY (quality-adjusted life year) or ROI within 12–24 months.


2. Pricing Models That Work in MedTech

ModelBest forNotes
One-time saleCapital equipment, implantablesRequire large budget cycles
SubscriptionDTx, RPM, AI toolsCommon for digital health; easier for payers to adopt
Outcome-basedDigital diagnostics, chronic careReimbursed only if outcome achieved; harder to negotiate
Bundled with servicesMonitoring devices + clinical servicesEnables multi-stakeholder value delivery

Example: Kaia Health offers MSK therapy via reimbursed app + coaching in Germany, priced as monthly license.


3. EU Reimbursement Pathways to Know

Germany: DiGA Pricing

  • Startups can set their own price in the first year post-listing.
  • After 12 months, price must be negotiated with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).
  • Must show comparative evidence vs standard of care.

Caution: DiGA price averages dropped 30% post-negotiation in 2024 (IQVIA DiGA Report).

France: PECAN / LPPR

  • PECAN pilot covers early-stage pricing with proof-of-concept.
  • Long-term reimbursement requires HTA via HAS and inclusion on LPPR list.
  • Prices often benchmarked to existing therapies.

UK: NICE HTA and Value-Based Pricing

  • NICE uses cost-effectiveness models (e.g., ICER thresholds: ~£20k–£30k per QALY).
  • Pilots with NHS can inform real-world pricing.
  • Commercial frameworks like NHS England’s MIA allow negotiated price-volume deals.

4. Building Your Reimbursement Strategy Early

a. Collect Health Economics Evidence

  • Use budget impact models (BIMs)
  • Simulate payer scenarios: what happens if 1,000 patients adopt your solution?

b. Start Conversations With Payers

  • Germany: GKV associations
  • France: CNAM and HAS
  • UK: NICE and NHS regional leads

c. Use External Tools

  • Partner with health economics consultancies like Coreva Scientific
  • Validate models with HTA reviewers and KOLs

5. Common Pricing Mistakes to Avoid

  • Pricing too high without evidence → rejection by payers
  • Free pilots without contract conversion → unsustainable
  • Lack of cost comparator → HTA rejection
  • Misunderstanding budget holder (hospital vs insurer)

Insight: In France, even successful pilots stalled due to unclear budget responsibility between national and regional health bodies.


Quick Reference Table: National Pricing Characteristics

CountryNegotiation BodyModelNotes
GermanyGKVPost-listing price setDiGA pricing volatile post-year one
FranceHAS / CNAMCase-by-casePECAN pilots used for prep
UKNICE / ICSValue-basedUses QALY model and ROI thresholds

Final Takeaways for MedTech Startups

  • Start pricing strategy early — not after CE mark
  • Understand payer incentives and outcome expectations
  • Prepare BIMs and value dossiers during pilot phase

Up next in the series: 📌 Commercial Channels That Actually Work in MedTech

This content has been enhanced with GenAI tools.

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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 StandardsNHS 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.

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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 modelPear 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
Digital Health MedTech

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

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

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.

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Digital Health MedTech

The Top 10 Medical Devices Types Revolutionizing Digital Health in 2023

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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Digital Health

Germany leading in DTx reimbursement with 42 DiGA-approved apps

With four more Digital Therapeutics (DTx) added in January, Germany is a leader in reimbursing of prescribed digital health applications. The DiGA directory lists now 42 digital therapeutics available to be prescribed and reimbursed for German patients.

It has been almost two years since we have been discussing the approval of Deprexis, the 11th DiGA-approved digital therapeutics. The pace of the German regulator, the Federal Institute for Drugs and Medical Devices (BfArM) increased dramatically.

BfArM has so far received 165 applications. By the 22nd of February 2023, there were 43 positive decisions. Sixteen DTx are DiGA-approved permanently, 27 are approved provisionally (gathering additional RWE), and five were removed from the directory (two of them on developer request).

BfArM - DiGA assessment of digital therapeutics results
BfArM – DiGA assessment of digital therapeutics results

How to get a digital health application (DiGA) in Germany?

  1. Arrange a doctor’s appointment

    It is best to let your doctor advise you on your desired DiGA DTx.

  2. Get a prescription

    You get a red prescription. If you do not receive one, the health insurance company can also pay for the DiGA without a prescription.

  3. Submit

    Submit the prescription to your health insurance company (Krankenkasse). This can be done online. If in doubt, contact customer service.

  4. Receive code

    Your cash register will send you an activation code for three months (90 days) of DiGA usage. After that, you will need to submit a prescription again.

  5. Download the app

    Download the app to your mobile phone. Every DiGA is available in the google play store or app store. Some can also be used via browser.

  6. Enter code

    Where exactly you have to enter the code in the app depends on the DiGA. However, the application should query for the code itself.