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[Early Stage] Intuitive Pelvic Floor Neuromodulation Device

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Derek

Project Timeline

Sep 2025 - Current

OVERVIEW

An empathy-driven device aimed at adapting TENS technology to the urology space for treatment of S2-S4 neurogenic pelvic floor dysfunction (PFD).

HighlightS

  • Leading design control efforts for an optimized TENS device to increase therapy accessibility for pelvic floor disorders (PFD)
  • Compiled design inputs, risk mitigation tables, and root cause analysis in accordance with 21.CFR.820 CGMP
  • Prototype expected to enter informed rapid prototype fabrication, assessment and design validation in spring 2026

SKILLS

Design InputsCompetitive AnalysisStakeholder CommunicationNeuromodulationRisk AssessmentDesign Empathy

Additional Details

Needs Statement

Patients experiencing neurogenic pelvic floor disorders (PFD) need a neuromodulation strategy that can be understood and implemented without instruction from a specialist to increase treatment compliance and reduce reliance on in-person physical therapy (PT) visits.

This project is aimed at understanding the specific user needs of patients experiencing pelvic floor dysfunction (i.e Urge Urinary Incontinence) and understanding how the existing TENS technology can best be modified in order to increase discretion, accessibility, and overall compliance. This is a 1 year development timeline with the first half being spent on user needs definition and competitive analysis to generate robust design inputs.

Screenshot 2025-10-16 225033.png

View the detailed mind map in supplemental attachments

Deliverables (ongoing)

  • 4 Design Reviews
  • Design History File (view in attachments)
    • Traceability Matrix
    • Root cause analysis 
    • Competitive landscape analysis

Relevant Experience

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Designing the Right Solution Through Robust Design Inputs

This project is one of my most empathy driven projects thus far, particularly because the development timeline is currently rooted in understanding the specific user needs of the end users who are currently using TENS to treat their PFDs. I correspond directly with pelvic floor physical therapists and a board of urologists, urogynecologists, and physicians and have gained valuable experience in clinical research as it relates to understanding designing the "right solution"

The course is developed directly in correspondence with CFR.820.21 deliverables and has thus has granted me experience in writing technical documents that are commonly used throughout industry.

Development Timeline

Winter 2025 

  • Fleshed out integration of top 3 ideas and assessment to design inputs
  • Fully formed committee board
  • Traceability matrix for all major design parameters

Spring 2025

  • Rapid prototype fabrication and development
  • Test fixture development for supporting benchtop testing
  • Risk mitigation and design validation of leading prototype
  • Final paper deliverable and conference presentation


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