Insight. Innovation. Impact.

Turn device-feedback into design-ready insights—before your next recall

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Product Improvement Platform (PIP) Overview

Early Failure Detection

Spot critical device issues before they impact patients by surfacing risk signals across regulatory and real-world data.

Unified Feedback Pipeline

Automatically ingest and synthesize internal reports, FDA filings, social media, and patents into one intelligence platform.

Faster, Smarter Design Decisions

Accelerate innovation by matching failure themes with proven solutions from across the industry and IP landscape.

Collect

Aggregate MAUDE reports, Reddit posts, patents, and internal feedback

Analyze

Extract patterns and trends using domain-trained AI

Innovate

Generate design-ready insights with regulatory and technical context

Key Features

Automated Issue Extraction

Quickly detects recurring problems in unstructured data—like narrative MAUDE reports and Reddit posts—using NLP tuned for medical devices.

Cross-Source Risk Mapping

Connects the dots between internal complaints, regulatory filings, and public sentiment to uncover hidden risk patterns and emerging concerns.

Patent-Driven Design Discovery

Identifies relevant prior art and published solutions—so your team can move faster with confidence and regulatory alignment.

Traceable Reports & Templates

Export insights into structured documentation—like traceability matrices and user needs reports—with full source references for compliance and audits.



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Who We Serve

PIP helps innovators across the medical device ecosystem transform feedback into smarter design decisions.

Startups

Speed up regulatory learning and avoid known pitfalls using insights from real-world failures.

Established Device Manufacturers

Mine internal complaints, MAUDE data, and social feedback to continuously refine device design.

Academic & Research Institutions

Access structured design data to support funding applications, IP strategy, and early validation.

Regulatory & Quality Teams

Spot patterns, ensure traceability, and streamline evidence-based documentation for premarket planning.


Use Case Explorer

See how innovators across the medical device world use PIP to uncover insights from unstructured data like MAUDE reports and user feedback.

Quality Systems Manager – Cardiac Med Company

“Are our cardiac monitor battery issues an isolated problem or industry-wide?”
  • Inputs: 15 internal reports, device specs
  • Output: 37 MAUDE incidents categorized by failure mode, with trend analysis
  • Value: Showed the issue was systemic, prompting broader action

Implant Design Lead – Neuro Device Company

“Why are our spinal cord stimulator leads failing after implantation?”
  • Inputs: 10 device failure reports, design specifications
  • Output: Failure pattern linked to specific patient movements (e.g., bending, twisting)
  • Value: Identified real-world movement issues missed in internal tests

Director – Dialysis Company

“What user errors are causing our home dialysis machine alarms?”
  • Inputs: 14 customer support incidents, alarm logs, Reddit threads
  • Output: Identified confusing interface steps from patient phrases
  • Value: Led to UI/UX redesign to reduce critical user errors


Frequently Asked Questions

PIP (Product Improvement Platform) is an AI-powered tool that transforms fragmented feedback—like adverse events, user complaints, and regulatory data—into actionable design insights for medical devices. It helps teams uncover why device failures happen and how to prevent them before market launch, reducing R&D uncertainty.

Unlike other AI platforms, PIP is purpose-built for medical device design. It integrates semi-structured regulatory data, unstructured social media content, patent filings, and internal client data to generate tailored design, regulatory, and risk insights. While ChatGPT might answer questions, PIP synthesizes and surfaces critical issues relevant to your device and its market through integrations with essential datasources.

PIP focuses on the early-stage design and ideation phase—long before quality management or compliance documentation. It’s not just a documentation platform. It’s an intelligence system that helps R&D teams understand what to build and why, based on user needs, known failures, and competitor innovations.

No. Each client’s data is completely isolated. Internal data is never shared or visible to others. Privacy and security are core design principles.

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