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MEDTECH

DIGITAL HEALTH

PHARMA

IVD

Your Engagement Hubᵀᴹ
Build for Adoption.

Technical & regulatory success is only half the battle. We ensure your product isn't just approved - but embraced by the patients & professionals who use it every day.

3 of 4 HealthTech Innovations Never Reach a Positive ROI*

The reason isn't the technology - it’s adoption barriers. Whether you are in Clinical, R&D, or Commercial - non-adoption is your biggest risk.

* Sources: [1] Ghosh, Shikhar. "The Venture Capital Secret: 75% of Startups Fail." Harvard Business School Research, 2012. [2] Herzlinger, Regina E. "Why Innovation in Health Care Is So Hard." Harvard Business Review, Vol. 84, No. 5, May 2006.

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"Ensuring Insight Continuity."

  • The Challenge: Critical clinical insights are often lost during the complex transition from research to engineering.

  • The Non-Adoption Risk: Without this continuity, you risk missing market opportunities and developing features that lack real-world impact and perceived value.

THE CLINICAL CHALLENGE

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"Integrating Clinical Realities."

  • The Challenge: Fragmented workflows and silos often lead to solutions that pass technical validation but fail in actual practice.

  • The Non-Adoption Risk: Unclear clinical workflows result in "shelfware" - products that are technically sound but lack suitability within a provider’s existing environment.

THE R&D CHALLENGE

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"Activating Sales Evidence."

  • The Challenge: Design validation is frequently treated as a final regulatory hurdle rather than a strategic commercial asset.

  • The Non-Adoption Risk: Failing to generate adoption-ready evidence makes your product's clinical and economic value invisible to the payers and clinicians who drive procurement.

THE COMMERCIAL CHALLENGE

Your Lifecycle Engine

Build HealthTech That Truly Matters

The Problem

Dangerous Blind Spots. Clinical and marketing insights rarely survive into engineering. Design and development insights rarely empower sales.

The Solution

Integrated Translation. We unite the lifecycle by transforming upstream activities into an opportunity blueprint for engineering and R&D outcomes into a commercial value evidence pack.

The Result

Clinical & Commercial Success: Crystal-clear accountability, accelerated timelines, and solutions that are Fit for Purpose, Safe & Effective, and Commercially Successful.

ISO

13485 & 20252 CERTIFIED

PROJECTS ACCELERATED

GLOBAL

USER & MARKET ACCESS

USERS INTERVIEWED

CLIENT RETURN RATE

UPSTREAM SERVICES

Identify the Opportunity

Uncertainty-to-Clarity Transformation. We accept the inherent uncertainty of healthtech innovation - ambiguous needs, regulatory hurdles, and market competition - as our starting point, and transform it into testable requirements.

Market Strategy & Opportunity

Validate the commercial "Why" before committing to the technical "How" to ensure market fit and avoid costly missteps.

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Explore Market Strategy

User Research & Insights

Uncover latent behavioral needs and use-context friction in the real world to build an effective engineering blueprint.

See User Research
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Concept Definition & Requirements

Translate abstract user needs into tangible concept visions and traceable requirements ready for engineering.

Define Your Requirements
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CORE SERVICES

Engineer the Solution

Requirements-to-Design Validation. We translate requirements into robust specifications and validation-ready designs, creating a rigorous framework that ensures regulatory compliance from concept through tooling.

Human Factors & Design Validation

Safety is a science, not a checkbox. Execute rigorous, scientifically sound testing to prove safety and efficacy that withstands global regulatory scrutiny.

Explore V&V Services
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User Interface & Instructional Design

Compliance shouldn't mean complicated. Translate requirements into intuitive physical and digital interfaces that align with mental models for effortless compliance.

Design Your Interface
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Risk Management & Regulatory Advisory

Eliminate the friction between design, safety, and approval. Navigate the regulatory landscape with certainty, from strategic filings to complex remediation, to secure clearance without delay.

Control Your Risks
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DOWNSTREAM SERVICES

Accelerate Adoption

R&D Insights to Commercial Assets. We transform deep R&D insights into commercial assets for sales enablement, delivering audit-ready evidence that proves safety to regulators and value to payers.

Market Access & Value Evidence

Clearance is not coverage. Bridge the gap between regulatory approval and reimbursement by generating user-centric evidence for formulary inclusion.

Drive Market Access
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Commercial Enablement

Translate user study results and technical engineering assets into engaging sales training and adherence tools that empower commercial teams and users.

Enable Your Sales Team
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Post-Market Surveillance (PMS)

The launch is just the beginning. Deploy proactive monitoring to track real-world safety and identify innovation opportunities for your next generation product.

Secure Compliance
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Build for Adoption through Strategic Stakeholder Engagement

De-Risk Upstream. Integrate Core. Empower Downstream.

Traditional development is linear and fragmented, creating silos that blind R&D, Clinical, and Commercial teams to a shared goal. The Engagement Hub™ dissolves these gaps through strategic patient and stakeholder engagement, aligning your teams on solving adoption barriers. The result? You build for the market, not just the regulator.

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UPSTREAM

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Identify the Opportunity

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Identify the Opportunity

UPSTREAM

Uncertain User & Market Needs

Real-World Insight Loop

Clinical & Commercial Success

CORE

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Engineer the Solution

CORE

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Engineer the Solution

DOWNSTREAM

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Accelerate Adoption

DOWNSTREAM

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Accelerate Adoption

Our Partners

Trusted by Global Health Leaders.

From Startup to Fortune 500 - we partner with the world’s most ambitious Pharma, MedTech, and Digital Health organizations to translate bold ideas into indispensable, market-leading products.

Our Expertise

Mastering the Real-World.

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Medical devices
Combination products

Medical Devices

Robotics, Active Implants & Critical Care

Learn more

Digital Health

AI, DTx & Neurotechnology

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Combination Products

Connected Injectors, Inhalers & Infusion

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IVD & Diagnostics

Lab Automation, POC & Digital Pathology

Learn more

Deep experience across the full spectrum of health technology.

YOUR OPPORTUNITY

Innovation is Volatile.
Your Partner Shouldn't Be.

By identifying and eliminating adoption barriers, we protect your investment, accelerate your timeline, and ensure your product is built for real-world success.

30+

YEARS

Leverage our legacy.

Stability in Volatility. Decades of clinical lineage provide a steady foundation, ensuring your innovation roadmap is guided by seasoned expertise rather than trial and error.

100%

RETURN CLIENTS

Eliminate your risk.

Zero Churn, Absolute Trust. A perfect retention rate among global MedTech leaders proves that our strategic value compounds over time; we integrate directly into your long-term innovation lifecycle.

15,000+

ENGAGEMENTS

Ground your strategy.

Evidence at Scale. An unmatched volume of successful engagements provides the deep data pool required to ground your design decisions in proven human performance.

GLOBAL

ACCESS

Reach the unreachable.

Boundless Execution. Reach the unreachable with true global access, allowing you to validate products in any language, culture, and clinical setting to ensure readiness for the world's most demanding markets.

By identifying and eliminating adoption barriers, we protect your investment, accelerate your timeline, and ensure your product is built for real-world success.

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We Are Looking for Specialists

Join the Architects of Adoption.

We are a multidisciplinary team of psychologists, researchers, designers, engineers & strategists, united by a single purpose: bridging the gap between technical potential and human reality.

Common Questions & Answers

Technical Rigor Meets Strategy.

Still Have Questions?

Every innovation journey is unique.

You likely have specific complexities that require a more tailored discussion. We are here to help you replace uncertainty with evidence-backed clarity.

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