Enlil Introduces the Industry's First Evidence-Based Milestone View for Medical Device Companies to Streamline Development Phases and FDA eSTAR Prep

New capability delivers end-to-end traceability across all product development data, connecting milestones, decisions, and evidence across every phase of the medical device lifecycle.

CAMPBELL, Calif., Feb. 3, 2026 /PRNewswire/ -- Enlil, Inc., the unified product lifecycle traceability platform for medical device innovators, today announced the launch of Milestone View, a new capability designed to help MedTech teams replace fragile, siloed timelines with traceable, execution-ready development milestones. Milestone View will be previewed at MD&M West 2026, February 3–5, in Anaheim, California, at Enlil's Booth #1090.

In an era of increasing product complexity, FDA scrutiny, and compressed development cycles, medical device teams rely on milestones to guide progress. Yet too often, those milestones are managed in isolation, tracked in spreadsheets, slide decks, or project tools disconnected from the systems where regulated work happens. The result is predictable: misalignment across teams, documentation drift, incorrect revisions, late-stage surprises, and avoidable delays during FDA submission and review.

Milestone View addresses this industry-wide problem by directly connecting development milestones to the underlying requirements, design outputs, risk controls, change histories, and regulatory evidence that determine actual readiness.

When Milestones Drift, Risk Follows

FDA's eSTAR program was designed to standardize and streamline submissions, but many MedTech companies, particularly high-growth startups and lean teams, continue to struggle with execution. Typical challenges include milestones and documentation falling out of alignment, manual tracking across functions leading to version confusion, and weeks of rework to assemble submission-ready packages.

These gaps don't stem from scientific shortcomings. They stem from organizational fragmentation, where teams can see milestone dates, but not whether the work behind them is complete, traceable, or defensible.

"Milestones fail when they're treated as calendar events instead of evidence-based checkpoints," said Chiratana Pot, Senior Director of Product Management at Enlil. "MedTech teams need to know whether a milestone is achieved based on completed, approved work, not just whether a date is approaching. Enlil built Milestone View to replace assumptions with traceability, giving teams a clear, shared understanding of readiness."

From Timeline Tracking to Traceable Execution
Milestone View is embedded within Enlil's unified platform, allowing teams to manage milestones directly connected to the regulated data that matters most.

Key features and benefits include:

End-to-End Traceability Across the Lifecycle: Links milestones to requirements, design artifacts, risk files, changes, and evidence across all phases, from concept through clearance.

Real-Time Milestone Readiness: Reveals whether supporting documentation and dependencies are complete, aligned, and inspection-ready.

Unified System of Record: Ends spreadsheet-driven tracking and version confusion by consolidating all product development data on one platform.

Structured, FDA-Aligned Workflows: Supports audits and eSTAR preparation with pre-formatted templates and traceable outputs, reducing submission preparation from weeks to days. Show auditors that you have everything under control with released documents, records, and a frozen snapshot of the phase at that time.

Earlier Risk Detection and Fewer Surprises: Flags gaps and inconsistencies before they surface during audits, submissions, or FDA review.

Change Impact Analysis Agent (coming Q3 2026): Ability to analyze proposed changes and predict impact across all phases. Identifies which milestones need to be reopened or reverified, saving you significant time and preventing mistakes for regulatory submissions.

By grounding milestones in traceable data rather than static plans, Milestone View enables teams to move faster without introducing downstream regulatory risk.

A Strategic Shift for MedTech Leaders

For product, quality, and executive leaders, Milestone View is more than operational visibility; it enables better decision-making.

"Medical device development doesn't break down because teams aren't working hard enough," said Nader Fathi, CEO of Enlil. "It breaks down when organizations lack a shared, factual view of progress across functions. Milestone View changes that by unifying strategy, execution, and regulatory readiness in one place so that leaders can make informed decisions earlier from a single pane of truth."

Preview at MD&M West 2026

At MD&M West 2026, Enlil will show how Milestone View transforms milestones from static dates into evidence-based checkpoints grounded in traceable product data. Attendees will see how development milestones are dynamically linked to requirements, design outputs, risk files, and regulatory evidence, offering a real-time view of readiness across every phase of development.

Live demonstrations will highlight how teams can identify gaps earlier, prevent documentation drift, and accelerate eSTAR preparation by working from a single, unified system of record. Visitors will also learn how evidence-based milestones enable tighter cross-functional alignment and reduce late-stage rework, audit risk, and FDA information requests.

Medical device leaders can experience Milestone View firsthand at MD&M West 2026, February 3–5, in Anaheim, California, at Enlil's Booth #1090.

About Enlil, Inc.

Enlil is a cloud-native development traceability platform built for medical device and life sciences organizations. Designed to support regulatory readiness across the product lifecycle, Enlil connects quality, regulatory, R&D, manufacturing, and operations teams around a unified system of record.

By structuring product data for traceability, auditability, and real-time visibility, Enlil helps MedTech innovators manage complexity, reduce risk, and scale compliance from concept through commercialization.

Learn more at enlil.com.

MEDIA CONTACT:
Sandra Schwartzman, RMR & Associates
(201) 704 – 8583, [email protected]

SOURCE Enlil, Inc.