disrupting.healthcareEach EU country has its own reimbursement process.
– 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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SaMD must show:
Use real-world evidence, literature, or clinical studies.
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Most SaMD is Class IIa or higher—requiring Notified Body involvement.
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Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk.
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To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485.
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.
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EU MDR’s Annex VIII, Rule 11 determines how software is classified:
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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).
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.
– AI-based radiology tools
– Depression treatment apps
– Software for detecting pneumonia in chest X-rays
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.
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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.
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.
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:
Source: ZS Associates
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:
Without this bridge, even groundbreaking technology risks commercial underperformance.
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).
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.
Commercial success in MedTech 2025 is not a matter of “build it and they will come.” It’s a matter of:
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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In July 2025, the U.S. FDA issued a warning letter to Whoop, Inc. for marketing its Blood Pressure Insights (BPI) feature without regulatory clearance. The agency concluded that Whoop’s sleep-based blood pressure estimation feature qualifies as a medical device, not a general wellness tool. This finding has implications far beyond one wearable band.
Whoop’s case highlights a growing issue in the digital health space: where exactly is the boundary between consumer wellness products and regulated medical devices? And what happens when that boundary is crossed?
See the Quantified Scientist test of Whoop below.
Hilo band is a clinically proven device that measures your blood pressure at specific times without your intervention – somewhat similarly to Ambulatory Blood Pressure Monitoring but without cuff. It does not provide other features
According to the FDA, Whoop’s BPI function, which estimates systolic and diastolic blood pressure based on biometrics collected during sleep, is not “low risk” and is intended for medical purposes. Therefore, it cannot be marketed without appropriate FDA clearance. This runs contrary to Whoop’s claim that the feature is designed to support general wellness and self-awareness.
The agency made it clear: any feature that measures or interprets physiological parameters in a way that could be used for diagnosis, monitoring, or treatment falls squarely under the medical device category — regardless of disclaimers or marketing language.
Further analysis from industry sources confirms that the FDA is reinforcing a long-standing but often misunderstood principle: intended use is inferred not only from claims, but also from function and context. (Source: Mintz Legal Analysis)
It is worth noting, that user reviews claim that Whoop’s readings are often misleading, and it is no surprise as wrist measurement is much harder than on the upper arm cuff. However, FDA did not even discussed the reliability of the device. The case is that it did attempt to measure and monitor blood pressure at all.
In stark contrast, Swiss MedTech company Aktiia pursued a fully regulated route for its cuffless blood pressure monitoring technology. The company’s flagship product marketed as the Hilo Band received 510(k) clearance from the FDA in July 2025. This made it the first-ever FDA-cleared wearable for over-the-counter cuffless blood pressure monitoring.
Unlike Whoop, Aktiia always positioned Hilo as a medical device. In Europe, it already holds a CE Mark under MDR as a Class IIa device, demonstrating compliance with EU Regulation 2017/745. It was developed in collaboration with clinicians, validated through peer-reviewed clinical trials, and built to meet regulatory requirements from day one.
Hilo’s strategy shows that it is possible to innovate in wearables while remaining on solid regulatory ground. That is if the product is clinically validated, and the claims are backed by science and cleared by regulators.
Under EU MDR (2017/745), any product that is intended to monitor or predict disease, or that provides data for diagnostic or therapeutic decisions qualifies as a medical device. This includes software, wearables, and connected apps. The CE-marking process requires clinical evaluation, conformity assessment, and continuous post-market surveillance.
Similarly, the FDA’s General Wellness Policy permits unregulated status only when features are demonstrably low-risk and not tied to medical decision-making. Estimating blood pressure, however, crosses that line.
Whoop’s mistake wasn’t in innovating — it was in positioning a potentially diagnostic feature as a harmless wellness insight. That approach may work in fitness marketing, but not under the scrutiny of regulators.
By contrast, Aktiia’s Hilo Band shows how a regulated, evidence-based strategy enables long-term success across global markets. Its path — from CE mark in Europe to FDA clearance in the U.S. — should serve as a roadmap for future wearable startups operating in the cardiovascular or digital biomarker space.
As a European expert in medical device commercialization, I believe this moment is a wake-up call: marketing and regulatory must be aligned from day one. Otherwise, companies risk more than compliance failures — they risk losing consumer trust and market access.
Read more on Scaling MedTech: From Product to Market – disrupting.healthcare
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Digital marketing has become a cornerstone of successful go-to-market strategies in the MedTech industry. Yet, marketing medical devices presents a distinct set of challenges, from navigating complex regulatory environments to building trust with clinical and procurement audiences.
This guide examines the unique aspects of medical device digital marketing, its evolution in 2025, and the key considerations companies operating in Europe must address to stay ahead.
Medical device digital marketing refers to the use of online channels and technologies to promote medical devices to healthcare professionals, procurement stakeholders, and, when allowed, patients or caregivers. These efforts must strictly comply with applicable regulations and ethical standards while communicating value, efficacy, and safety clearly.
Unlike traditional advertising, digital marketing enables real-time, measurable, and often personalized engagement across the buyer journey. From search engines to webinars and content hubs, medical device marketers use a blend of tactics to educate, influence, and convert target audiences.
Your website is often the first point of contact. A well-optimized, medically accurate, and user-friendly website is foundational.
Paid campaigns can amplify reach, especially when launching a new device or entering a competitive market.
Social media can support brand awareness and education. LinkedIn and YouTube are primary platforms for medical device marketing.
Email campaigns are effective for clinical updates, product launches, or training content.
Digital events remain vital in post-COVID medical marketing.
Medical device marketing in Europe is governed by strict laws and industry codes.
Always review country-specific requirements before launching any digital campaign.
1. iRhythm Technologies – UK Launch of Zio Service
In 2020, iRhythm partnered with Medico Digital to localize its Zio® ambulatory cardiac monitoring solution for the UK market. Key digital marketing strategies included:
The results were compelling:
Source: Medico Digital – Zio Case Study
2. NICE Evaluation of Zio XT – Market Credibility via Digital Validation
In 2020, the UK’s NICE (National Institute for Health and Care Excellence) issued guidance supporting the use of iRhythm’s AI-enabled Zio XT patch for long-term arrhythmia detection. This regulatory milestone:
Source: NICE Case Study – Zio XT
These verified campaigns illustrate how combining localized digital strategy with regulatory and clinical validation can powerfully support medical device adoption in competitive European markets.
Key performance indicators (KPIs) in medical device digital marketing may include:
Use compliant analytics tools that respect data privacy.
Key performance indicators (KPIs) in medical device digital marketing may include:
Use compliant analytics tools that respect data privacy.
Q: How is medical device marketing different from pharmaceutical marketing? A: Device marketing often targets a mix of HCPs, procurement teams, and hospitals, with more focus on technical features, usability, and health economic value. Pharma marketing is more focused on prescribers and patient outcomes.
Q: Can I advertise my medical device to consumers in Europe? A: For prescription-only devices, direct-to-consumer advertising is generally prohibited under EU MDR and national laws. Some Class I devices may be promoted if compliant with local rules.
Q: What budget should I allocate? A: Budgets vary widely. However, a McKinsey report suggests top-performing medtech firms often invest 5–10% of revenue in marketing, with digital increasing in share year-on-year (McKinsey MedTech Pulse 2023).
Medical device digital marketing in 2025 requires more than multichannel execution—it demands compliance, credibility, and clarity. As AI reshapes content creation and European regulations continue to evolve, marketers must remain agile and informed.
By grounding campaigns in strategic insight and verified best practices, digital marketers can drive meaningful engagement, support product adoption, and build long-term brand trust.
For ongoing updates, regulatory news, and tactical guides, follow Disrupting.Healthcare.
Note: This article is for informational purposes only and does not constitute legal advice. Always consult qualified regulatory experts before launching campaigns. This content has been enhanced using GenAI tools
Medical device digital marketing refers to the strategic use of digital channels: SEO, paid media, content, social, email, to promote medical devices. It must align with regulatory approvals, data privacy requirements like GDPR, and focus on educational, trust-building content tailored to healthcare professionals and patients.
Unlike pharma or general healthcare products, marketing medical devices demands higher emphasis on clinical evidence, compliance with device-specific regulations (such as EU MDR and UK ASA/MHRA guidelines), and precise messaging that reflects the product’s intended use. Medical devices are usually B2B and not B2C products.