Case Study Overview

Medtech companies across the US, UK, EU, and Asia seek innovative strategy and pathways to bring safe, innovative devices to market faster while navigating increasingly complex FDA requirements, including for premarket notification (510(k)) submissions.

Value for Global MedTech Stakeholders

• Accelerated device development

• Reduced confusion, rework and cost and dependence on ad-hoc consultants

• Higher submission quality for AI-assisted FDA reviews

• Global collaboration on US market entry

The Challenge: Manual Predicate & Product Code Search

 

For medtech innovation customers, challenges that can slow down development include:

• Locating regulatory databases to classify devices and identify suitable product codes and predicates for 510(k) submissions.

• Regulatory and R&D functions can often be siloed; development teams make early design decisions without clear regulatory pathways, creating costly redesigns later.

• Smaller and mid-sized companies struggled to scale regulatory expertise globally, across US, UK, EU, and Asian teams working on US market.

• Companies faced higher costs due to rework, delayed submissions, and reliance on external consultants.

Solution: MedCompass AI

 

To solve this, we launched MedCompass, an AI-enabled regulatory planning tool designed to streamline FDA product code and predicate selection for 510(k) submissions.

 

MedCompass uses AI to structure regulatory intelligence, surface relevant product codes, and suggest potential predicate devices aligned with indications for use and technological characteristics—key criteria for substantial equivalence under 510(k).

 

MedCompass is designed as an empowerment tool for early product and regulatory planning: device teams can input key attributes (intended use, technology, target indications), and the AI rapidly points them to candidate product codes, guidance, and relevant cleared devices to consider as predicates along with an output accuracy confidence score.

 

This shifts regulatory strategy upstream, so design decisions and evidence plans are aligned with the likely FDA pathway from the start.

 

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