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# Unlock Funding and Market Confidence with Breakthrough Device Designation

**Your board, investors, and market need signals of regulatory momentum.**

Breakthrough Device Designation (BDD) from the FDA is the clearest signal you can send that:

- Your device addresses an unmet medical need - FDA has prioritized your review for expedited feedback and faster clearance - You\'re positioned to raise capital and close strategic partnerships

**The challenge:**

- **You need it done yesterday** - Your next funding round, board meeting, or strategic partnership depends on showing regulatory momentum now - **You need a full-service firm, not more tasks** - The last thing you need is a consultant handing you templates and adding to your team\'s workload. You need experts who own it end-to-end and deliver on autopilot

**You need certainty and speed.**

If we believe your device meets the criteria, we guarantee your Breakthrough Device Designation application will be granted.

![](/img/services/Guaranteed_Breakthrough_Device_Designation-75f5b4a92ee64e5e8d388961902113a2.jpeg)

## Our Speed and Certainty Promise **We guarantee your Breakthrough Device Designation application will be submitted to FDA in 4 weeks-or receive a partial refund.** **We guarantee your Breakthrough Device Designation application will be approved by FDA or receive a partial refund.** Unlike consultants who hand you templates, we own the entire process with our full-stack team of MDs, PhDs, regulatory experts, and engineers. ## Qualification Criteria Not all devices qualify. You need: 1. **A medical device that treats or diagnoses a life-threatening or irreversibly debilitating condition** 2. **An argument that your device provides more effective and/or more equitable treatment or diagnosis compared to standard of care** 3. **Early version of the device or algorithm** so we can articulate intended use and clinical benefit 4. **Organizational priority** - BDD should be a top strategic objective **Our selectivity protects you:** We only take on projects we believe have a strong likelihood of BDD approval. If we don't feel your device qualifies, we can help you get there!

See if you Qualify!

## Our Process: Battle-Tested. Guaranteed. We\'ve successfully secured BDD for multiple clients. Our process: ### What You Get: - **Eligibility assessment** against the eight BDD criteria - **Complete BDD application package** including: - Device description and intended use - Demonstration of unmet medical need - Evidence of potential clinical benefit over standard of care - Preliminary development and testing plan - Supporting literature and clinical rationale - **FDA eSTAR submission** prepared and filed - **Strategic guidance** on leveraging BDD for fundraising and partnerships **Timeline: Application submitted within 4 weeks of project start.**

Click for detailed BDD criteria and strategy

The FDA grants Breakthrough Device Designation to devices that meet all of the following criteria:

Core Requirements:

The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
The device meets at least one of the following:
- Represents breakthrough technology
- No approved or cleared alternatives exist
- Offers significant advantages over existing alternatives
- Device availability is in the best interest of patients

Our Process:

Week 1: Discovery and Eligibility Assessment

Kick-off meeting with your team
Review device specifications, clinical data, and competitive landscape
Assess eligibility against all eight BDD criteria
Identify gaps in available evidence or documentation
Deliverable: Eligibility assessment memo with go/no-go recommendation

Week 2: Strategic Positioning and Device Description

Identify strongest arguments for unmet medical need and clinical benefit
Map comparable devices and articulate differentiation points
Draft comprehensive device description and intended use statement
Develop breakthrough technology justification (if applicable)
Deliverable: Device description document and positioning strategy

Week 3: Evidence Compilation and Application Development

Compile supporting literature and clinical evidence
Document preliminary development and testing plan
Write comprehensive BDD request demonstrating:
- Life-threatening or irreversibly debilitating condition
- More effective treatment or diagnosis vs. standard of care
- Breakthrough technology argument
- Absence of alternatives or significant advantages
Deliverable: Draft BDD application for client review

Week 4: Finalization and FDA Submission

Incorporate client feedback on draft application
Prepare FDA eSTAR package and all required attachments
Quality review and final approval
Submit to FDA
Deliverable: Complete FDA submission with confirmation receipt

Post-Submission:

FDA typically responds within 60 days with grant or denial
If granted: We help you leverage BDD for investor communications and regulatory planning
If denied: We pivot to alternative regulatory strategies (covered under our guarantee)

# Why Innolitics? - **All we do is software as a medical device (SaMD) and AI as a medical device** since 2012 - **50+ SaMD and SiMD products** cleared through FDA - **Multiple successful BDD applications** across imaging, diagnostics, and therapeutic devices - **Full-time MDs, PhDs, software engineers, and regulatory experts** on staff - We are the only ones offering a **speed and certainty guarantee**

## **Case Studies**

## Testimonials

# Our Publications We are thought leaders in the AI/ML enabled medical device software space. Here are some of our [many articles and resources](https://innolitics.com/articles/):

# FAQs

How much does it cost?

Pricing depends on your device and scope. Contact us for a custom quote.

What is the FDA's timeline for BDD decisions?

FDA typically responds within 60 calendar days of submission with a grant or denial decision.

Can I publicly announce my BDD?

Yes. Many companies issue press releases upon BDD grant. It signals FDA prioritization and regulatory momentum-both strong messages for investors and strategic partners.

Does BDD guarantee FDA clearance?

No. BDD accelerates and prioritizes your review, but you still need to meet FDA's safety and effectiveness standards. However, the interactive review process significantly reduces regulatory risk.

What happens if my BDD application is denied?

If denied, you still have your standard regulatory pathway (510(k), De Novo, or PMA). We'll pivot immediately to optimize that strategy. Our guarantee covers this scenario.

We already have a regulatory consultant. Can you still help?

Absolutely. We frequently collaborate with in-house teams and external consultants, particularly on AI/ML and software-specific aspects of BDD applications.

Can BDD help with non-US markets?

BDD is US-specific, but it signals regulatory credibility globally. We focus exclusively on FDA to maintain deep expertise, though we have international partners for CE mark, Health Canada, etc.

What if I'm not sure we qualify?

Book a 30-minute assessment call. We'll evaluate your device against BDD criteria and recommend the best path forward-whether BDD or an alternative strategy.

# Let\'s Talk In a 30-minute call, we\'ll assess your device\'s BDD eligibility and provide a clear path to unlocking this strategic advantage.

Schedule Your Assessment