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Pharma Marketing

Understanding AI in Pharma Marketing

What is Artificial Intelligence (AI) in a pharma commercial context?

In a pharma commercial context, AI primarily refers to generative AI, which differs from traditional “classical AI” or machine learning.

  • Classical AI / Machine Learning models perform specific tasks, like analyzing data for predictions or identifying patient groups, using very specific datasets.
  • Generative AI works with a foundational, large language model (LLM) trained on vast amounts of data, enabling it to be applied to many different problems. Its key characteristics include:
    •   Basic competences applicable to various problems.
    •   Ability to learn from structured and unstructured data.
    •   Generation of multiple outputs such as texts, images, speech, video, and designs.
    •     An intuitive, conversational user interface.

In pharma, generative AI is used for activities like writing marketing materials, generating webinars, building image and video libraries, spotting segmentation opportunities, and speeding up marketing processes. It is projected to grow faster in healthcare than any other industry, potentially generating between $60 billion and $110 billion a year in economic value for the pharma and MedTech industries, with most value going to commercial operations.

Categories
MedTech Pharma Marketing

Multichannel vs Omnichannel in Pharma Marketing

What is the difference between multichannel and omnichannel marketing in pharma and MedTech?

Multichannel marketing uses multiple independent channels (like television, social media, email, websites) to communicate with customers. In this approach, channels often operate as silos, repeating the same message, with the focus remaining on the product rather than the user. It lacks a connecting node between channels.


Omnichannel marketing also engages multiple channels, but they are all integrated and coordinated to provide a unified, seamless, and personalized experience for the customer, who is placed at the center of the marketing funnel. This approach ensures that information is available precisely when needed, encourages deeper content exploration, and reinforces messages across touchpoints, ultimately improving engagement and fostering trust.

According to McKinsey, correctly implemented omnichannel models can lead to 5-10% revenue growth and 10-20% marketing efficiencies and cost savings for pharma companies.

Categories
Digital Health MedTech

Why SaMD Launches Fail in Europe

Common Pitfalls

  1. Vague intended use leading to misclassification
  2. No QMS or weak cybersecurity
  3. Poor clinical evidence strategy
  4. Failure to engage clinicians or users

Fixes:

  • Start regulatory early
  • Build real clinical value
  • Design with adoption in mind

Learn more at Scaling MedTech: From Product to Market

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Categories
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

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Categories
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.

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Categories
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

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Categories
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.

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Categories
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.

This content has been enhanced by GenAI tools.

Categories
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.

This content has been enhanced by GenAI tools.

Categories
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:

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.