Tag: medical devices

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Digital Health MedTech

Investment Trends in European Digital Health

Where Capital Flows

Investors favor:

  • AI-powered platforms
  • Value-based care tools
  • Female health (menopause, hormones)

Valuation Benchmarks:

  • 4–6x revenue for most healthtech
  • 6–8x for AI/diagnostics
  • 10–14x EV/EBITDA for EBITDA-positive firms

Learn more at Scaling MedTech: From Product to Market

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Digital Health MedTech

Post-Market Surveillance for SaMD

Staying Compliant Post-Launch

Post-market surveillance (PMS) is required for all devices.

Requirements:

  • Plan for data collection
  • Trend analysis and signal detection
  • Regular updates to clinical files
  • Vigilance reporting (e.g. EUDAMED)

For Class IIa+, submit PSUR every 1–2 years.

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Digital Health MedTech

SaMD Market Access & Reimbursement in Europe

CE Mark ≠ Reimbursement

Each EU country has its own reimbursement process.

Highlights:

– Germany (DiGA): Fast track, 12-month provisional access

– France: Multiple programs (ETAPES, PECAN)

– UK: NICE approval + local commissioning (ICBs)

Evidence needs differ, it can be Randomized Controlled Trials (RCTs) or real-world evidence depending on system.

Learn more on Scaling MedTech: From Product to Market

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Digital Health MedTech

Clinical Evidence for SaMD in the EU

MDR Requirements

SaMD must show:

  • Clinical association (medical logic)
  • Analytical validity (correct processing)
  • Clinical validation (real-world benefit)

Documentation:

  1. Clinical Evaluation Plan (CEP) = how you’ll gather evidence
  2. Clinical Evaluation Report (CER) = full evaluation
  3. Post-Market Clinical Follow-up (PMCF) = follow-up after launch

Use real-world evidence, literature, or clinical studies.

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Digital Health MedTech

The CE Marking Process for SaMD

Get CE Mark

Most SaMD is Class IIa or higher—requiring Notified Body involvement.

Key Steps:

  1. Prepare tech documentation (Annex II, III)
  2. Implement QMS (ISO 13485)
  3. Create clinical evaluation plan (CEP) and report (CER)
  4. Work with a Notified Body

Class-specific routes:

  • Class I: self-certify
  • Class IIa-III: Notified Body review + ongoing surveillance

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

SaMD Cybersecurity and GDPR

Security = Safety

Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk.

Technical Steps:

  • Secure architecture and testing (MDCG 2019-16)
  • Access control, encryption, logging
  • Vulnerability management and patches

GDPR Considerations:

  • Health data = special category
  • Explicit consent and purpose limitation
  • DPIA (Data Protection Impact Assessment) required if high-risk AI involved

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

Building a Compliant QMS for SaMD

To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485.

What You Need

  • ISO 13485: General quality framework
  • ISO 14971: Risk management integration
  • IEC 62304: Software development lifecycle

Best Practices

  • Build your QMS, don’t buy a generic one
  • Ensure continuous documentation and audits
  • Tie QMS to real clinical risk management

Cybersecurity Integration

Use MDCG 2019-16 as a guideline for secure development. Cybersecurity is considered a safety issue under EU MDR, it is not just IT hygiene.

Learn More:

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Digital Health MedTech

Rule 11 Explained: Classifying SaMD in the EU

EU MDR’s Annex VIII, Rule 11 determines how software is classified:

  • Class IIa: Most diagnostic and therapeutic decision-support tools
  • Class IIb: Tools whose incorrect use may lead to serious harm
  • Class III: Life-critical functions (e.g., software controlling pacemakers)

What Determines the Class?

  • The intended use and severity of the condition it addresses
  • Whether the software makes decisions or just informs them
  • If a human-in-the-loop can reliably override the software

Example:

  • Software interpreting chest X-rays → Class IIa or IIb
  • Sepsis detection app triggering alerts → Class IIb or III

References:

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Digital Health MedTech

What Is Software as a Medical Device (SaMD)?

Software as a Medical Device (SaMD) refers to software intended for medical purposes that performs these functions without being part of a hardware medical device.

Under the EU MDR (Regulation 2017/745), it’s officially termed Medical Device Software (MDSW).

Key Definitions

MDSW under EU MDR aligns closely with the global SaMD concept defined by IMDRF.

A software must have a clearly defined intended medical purpose such as diagnosis, treatment, prevention, or monitoring of a condition.

Examples of SaMD/MDSW

– AI-based radiology tools

– Depression treatment apps

– Software for detecting pneumonia in chest X-rays

Regulatory Trigger: Intended Use

Your declared intended use is the most critical driver of classification. Even minor “call-to-action” features (e.g., “contact your doctor”) can elevate a wellness app into a regulated medical device.

Resources

– EU MDR text

– MDCG 2019-11 guidance

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MedTech

MedTech Marketing Strategy 2025: How FDA Wins and Commercial Innovation Drive Multi-Billion Dollar Growth

The MedTech landscape is evolving fast, and in 2025, the race to win in the market is no longer just about innovation. It’s about **how you commercialize**, how you adapt to shifting sites of care, and how you create measurable value for buyers. A timely example? Cambridge-based CMR Surgical is reportedly exploring a $4B sale just weeks after receiving FDA clearance for its Versius surgical robot in the U.S., highlighting how strategic regulatory milestones can turbocharge commercial outcomes.

Regulatory Wins as Commercial Catalysts

In July 2025, the FDA cleared CMR’s Versius system for gallbladder procedures, opening doors to the lucrative U.S. surgical robotics market. With over 30,000 procedures already performed globally, this milestone didn’t just validate the technology—it positioned the company as a prime acquisition target. Regulatory approvals are no longer just technical hurdles; they are strategic marketing events, reshaping brand credibility and attracting investor attention.

Site-of-Care Shifts: The ASC Revolution

Across MedTech, there is a structural migration of procedures into Ambulatory Surgery Centers (ASCs), especially in orthopedics and cardiology. This trend requires rethinking go-to-market strategies, from simplified contracting models to focused messaging for cost-conscious ASC administrators.

What you need to win in ASCs:

  • Leaner commercial models.
  • Product-service bundles tailored to ASC workflows.
  • Clear value propositions around speed, efficiency, and ROI.

Source: ZS Associates

AI Needs Commercial Proof, Not Just a Label

AI and machine learning are driving new MedTech approvals at record speed (see Clarivate report), but innovation hype is not enough. Marketing leaders must translate AI capabilities into proven outcomes:

  • Clinician training programs.
  • Real-world evidence supporting adoption.
  • Messaging linked to payer priorities and procurement KPIs.

Without this bridge, even groundbreaking technology risks commercial underperformance.

Direct-to-Consumer (DTC) Potential Beyond Pharma

Procurement teams now demand quantifiable value: cost savings, improved outcomes, reduced readmissions. Feature-heavy brochures won’t sell anymore.

MedTech marketers must deploy tools like ROI calculators, outcome dashboards, and peer-to-peer clinical advocacy to influence tender decisions (see also Icovy’s 2025 MedTech marketing trends).

M&A: The Commercial Integration Challenge

Finally, M&A activity is accelerating. As seen with large-scale deals across the sector, successful acquisitions hinge on fast alignment of sales forces, brand identity, and bundled offerings. Poor integration risks value erosion, while synchronized post-merger marketing can unlock cross-selling opportunities and expand market share.

Takeaway for MedTech Leaders

Commercial success in MedTech 2025 is not a matter of “build it and they will come.” It’s a matter of:

  • Using regulatory events as marketing springboards.
  • Adapting GTM strategies to changing care settings.
  • Backing innovation with hard evidence and ROI metrics.
  • Balancing B2B, B2B2C, and DTC pathways.
  • Mastering post-M&A go-to-market execution.

The Versius story illustrates how a well-timed regulatory win, coupled with proven clinical traction, can reshape commercial destiny. For MedTech executives, marketing is now a boardroom priority, directly tied to valuation and investor outcomes—not just brand awareness.

For more insights read also: Scaling MedTech: From Product to Market and Medical Device Digital Marketing: Expert Guide for 2025

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