FEEBEE: Your Design & Development Quality Tool for MedTech 🐝

 

What is it?

FEEBEE stands for the Framework for Ethical and Empowering Biodesign and Engagement Evaluation. It’s a practical design and development quality tool that helps medtech and consumer device teams, investors, and evaluators understand how design changes in their products impact people, society, and the market—not just technically, but ethically and socially.

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Who's it for?

Perfect ​for those evaluating an early-stage technology, FEEBEE is the perfect tool for:

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1. Design Teams – Receive actionable recommendations on design inputs/outputs, usability, and risk so your device is prepared for clinical trials, UX studies, and regulatory reviews.

2. Compliance Teams – Quickly spot missing documentation, alignment gaps, and ISO requirements without manual cross-checks.

3. Investors & Accelerators – Evaluate market-readiness, patient impact, and regulatory compliance at a glance to de-risk investments.

4. Laboratories– Transitioning from academia to commercial production? Maintain technical rigor while scaling and managing internal approvals.

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How it Works

1️⃣ Intake & Data Submission

Upload your pre-market design documents along with any context about device functionality, user scenarios, or target populations.

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2️⃣ Interdisciplinary Analysis

We review your materials against 30+ design, ethical, and regulatory factors. A brief interview explores team dynamics and hidden culture that influence innovation.

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3️⃣ Platform Integration & Scoring

FEEBEE generates:

• Empowerment Index – Measures patient/user impact

• Compliance Index – Highlights regulatory gaps (ISO 13485, ISO 14971)

• Market Viability Index – Evaluates readiness and investor appeal

• Overall Design Social Change Impact Factor – Summarizes actionable insights with clear next steps

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4️⃣ Optional Features for Beta Users

• Digital Sign-Offs – RACI-driven approvals make internal or client review smoother.

• Auto-Completed Documents – Generate draft DHFs, usability files, risk analyses, and other regulatory documents to save time and standardize outputs.

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Benefits

• Save time & reduce friction – Automate evidence gathering, version control, and documentation assembly.

• Align your team – Ensure design, compliance, and leadership are all working toward the same goals.

• Future-proof your processes – Prepare your team for ISO alignment and regulatory submissions.

• De-risk investments – Quickly evaluate market-readiness, patient impact, and compliance gaps.

• Empower iterative design – Provide actionable guidance without blocking the creative workflow.

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Invite Only: Tap here to explore our demo on figma to see the audit in action.

Ready to use it on your own technology? Sign up to pilot the audit here.