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SOFTWARE
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Discover

Visualize rapid, validated insights through real-world data.
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Activate

Streamline data preparation with guardrailed workflows.
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Substantiate

Transform real-world data into decision-grade evidence.
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Generate

Safeguard privacy and ensure utility with AI-driven technology.

SERVICES

PARTNERSHIPS

Aetion has entered into an agreement to be acquired by Datavant, a leading health data platform company.   Learn more → 

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Catalyze a scalable RWE strategy for MedTech

Unlock the promise of RWE

Real-world evidence (RWE) is transforming how MedTech companies demonstrate product value, improve patient outcomes, and accelerate innovation. Through our platform and scientific services, we partner with you to:

  • Support regulatory submissions for label expansions using RWE
  • Strengthen understanding of product safety, performance, and patient outcomes
  • Deliver innovative products and life-changing interventions faster and more efficiently
  • Build infrastructure to scale RWE efforts across devices and therapeutic areas

 

Leverage RWE in MedTech

Aetion partners with MedTech industry leaders to drive scalable RWE excellence through strategic partnerships and proven frameworks.

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Generate RWE across the product lifecycle
Aetion provides scientific expertise to medical device and diagnostic manufacturers to facilitate the generation of RWE across the product lifecycle.
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Accelerate innovation and scale
Aetion partners with organizations to accelerate RWE innovation via RWE playbook offerings.
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Design regulatory-grade studies

Aetion collaborates with NESTcc and the US Food and Drug Administration's (FDA) Center for Devices and Radiologic Health (CDRH) to generate regulatory-grade RWE for label updates and expansions for medical devices and diagnostics.
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Demonstrate the value of RWE
Through our workshops, Aetion educates medical device manufacturers on the value of RWE across the medical device total product lifecycle.

Our impact

How our strategic partnerships and scientific solutions drive real-world results.

Partner to transform the role of RWE in MedTech

Through their strategic partnership, the National Evaluation System for Health Technology Coordinating Center (NESTcc) and Aetion, along with the FDA’s Center for Devices and Radiological Health (CDRH), are on a mission to advance the use of RWE in the medical device and diagnostic ecosystem.

Learn more -> 

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Expert-led RWE playbooks for the medical device ecosystem

“The Aetion team delivered best in class thought leadership and content in how RWE studies should be designed across the product life cycle and drove great engagement amongst the participants. Aetion was able to balance the complex “theoretical principles” behind RWE, which can be overwhelming and complex, with this company's diverse product portfolio and evidence generation needs.”

 

Top 15 Medical Device Company, on Aetion-led workshops advancing RWE across business units

Benefits

Aetion offers generous benefits to its full-time employees, which currently can include:

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Array of options for Medical, Dental, and Vision Insurance
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Free membership to OneMedical
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Flexible Spending Accounts for Healthcare and Dependent Care
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Commuter Benefits for Parking and Transit
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4% 401(k) match on Retirement Savings Plan
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Unlimited paid time off
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16 weeks of paid parental leave
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One month paid sabbatical after five years at Aetion
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Stipend towards wellness related expenses like gym memberships, fitness classes, and more
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Company activities including happy hours, annual rally, summer social, lunch ‘n learns, and more!

The benefits offering may differ based on geographies where employees are based, when outside of the United States.

RWE for label expansion

Label expansion powered by RWE is creating seismic change across the MedTech industry by accelerating timelines and unlocking new value from existing products.

Aetion brings deep regulatory expertise and scientific rigor to support label expansion submissions with RWE.

Aetion recently partnered with FDA, NEST, and Intuitive to successfully support a product labeling modification using fit-for-purpose real-world data. Read the full press release ->
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Develop a scalable PMCF solution

Medical device manufacturers are required by the European Union (EU) Medical Device Regulation (MDR) to conduct Post-Market Clinical Follow-up (PMCF) analyses to assess the safety and performance of their products when used as intended. Through its scientific and platform offerings, Aetion:

  • Builds a complete suite of services that includes PMCF strategy, device identification and labeling, study protocol, database connection, study execution, and a PMCF report for a single device
  • Uses its Aetion® Substantiate application as an accessible and transparent repository of study design and analytic decisions, generated cohorts and results  
  • Supports efficient scaling of PMCF activities across devices via expansion of its services to include an additional device or multiple devices and multi-year scientific support

Experts in providing real-world evidence solutions

Connect with us to work with the team advancing critical decisions in healthcare.
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