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Pediatric Urine Collection bag, or similar

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Pediatric Urine Collection bag, or similar

ABOUT THIS REPORT

Although this report focuses on the development of a Pediatric Urine Collection Bag, the insights and methodology are broadly relevant to a wide range of similar medical devices providing general principles and realistic planning assumptions to guide innovators through the development landscape, especially for devices that might appear simple but involve hidden complexities.

The assessment is based on our understanding of typical product development pathways and the points at which clients usually engage with us. In cases where specific project details were unavailable, we have provided informed projections to aid strategic planning.

DEVICE OVERVIEW

FDA Identification

 A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence. 

General Description

The pediatric urine collection bag is a very small, handheld, disposable diagnostic device designed to collect urine specimens from infants and young children in a hygienic and efficient manner. The device typically consists of soft, medical-grade plastic materials and includes a skin-adhesive receptacle that attaches externally to the perineal area to non-invasively capture urine.

Its primary role is to facilitate urine sample collection in pediatric diagnostic settings, especially where catheterization is neither feasible nor desirable due to age, discomfort, or clinical setting. It is classified under the FDA as a “urine collector and accessories” device, not intended for connection to indwelling catheters, and includes specific variants such as the pediatric urine collector, leg bag for external use, and paste-on incontinence-style collectors.

Unlike urinary catheters, which are invasive and carry higher infection risks, this device supports non-invasive collection while maintaining skin safety, minimizing contamination risk, and ensuring ease of use in outpatient, emergency, or home care environments.

This particular design is waterproof, contains no electronics or moving parts, and aims for simple, cost-effective deployment in clinical or field settings where rapid diagnostics are required. It supports short-term, single-use application and is disposed of after sample retrieval.

Strategic Takeaway

The pediatric urine collection bag fits a critical but underserved niche in early childhood diagnostics. Its non-invasive nature, small form factor, and straightforward construction open the door for rapid adoption and low-cost production, provided the design is optimized for comfort, leakage prevention, and ease of collection.

FEASIBILITY

Understanding Your Feasibility Score

The Feasibility Score bar provides an assessment of your project’s path to market, with higher values indicating lower complexity and fewer anticipated obstacles.

  • 0 - 39 (Low Feasibility): This range suggests that the project may face significant challenges due to high complexity or extensive requirements. Additional planning, resources, or risk mitigation strategies will be necessary.
  • 40 - 74 (Moderate Feasibility): Projects within this range indicate a moderate path to market. While the overall complexity is manageable, some areas may require refinement or further development to ensure project stability and success.
  • 75+ (High Feasibility): A score in this range indicates a relatively straightforward path to market, with low complexity and minimal additional work expected. This project is well-positioned to progress smoothly.

The Feasibility Score is a general guide, not an absolute measure of project success. We recommend using this score as part of a broader assessment and considering additional expert guidance for a comprehensive evaluation.

PROJECT OVERVIEW

Early Concept with Clinical Support

This pediatric urine collection bag is still in the conceptual phase, supported by a clinical champion who sees its value in pediatric diagnostics. While the product idea is defined, development activities like design for manufacturability (DFM), prototyping, and documentation have not yet begun. The presence of a patent-pending status and an existing patent show proactive IP positioning, which is promising, especially in pediatric health, where differentiation and safety drive adoption.

The current development status can be described as “idea to prove” where the problem is clearly understood and clinical need is validated, but engineering implementation and user feedback cycles are still pending. This is typical for first-time inventors or early-stage innovations with clear real-world use cases.

Positioned for a Low-Complexity Path

A notable strength of this project lies in its simplicity: no electronics, no software, no power requirements, and no moving parts. This makes it a more accessible first product to develop and commercialize, especially when compared to high-risk, high-cost electro-mechanical medical devices. The concept relies on plastic materials, many of which are readily available off-the-shelf, and the supply chain is expected to be straightforward.

The project is further simplified by being disposable, meaning it does not require sterilization for reuse or complex cleaning validation protocols. Combined with its classification as a Class II device with a 510(k) exemption, the project avoids many of the burdens associated with traditional premarket notification requirements; although compliance with general controls and selected special controls is still required, including documentation of safety, labeling, and quality system processes.

What Lies Ahead

Despite the simplicity, there are key steps that must still be tackled:

  • Designing an effective and comfortable adhesive or attachment method for pediatric skin.
  • Ensuring sample containment without leakage or contamination.
  • Demonstrating usability through benchtop testing and limited clinical feedback.
  • Preparing documentation to support regulatory clearance, labeling, and packaging.

This project is well-aligned with a phased development model, where low-risk technical validation can be completed quickly, allowing early iteration and feedback before full-scale production.

Strategic Takeaway

You’re in a strong position. Your idea addresses a clear clinical need with a low-risk product profile. But don’t let simplicity breed complacency; successful pediatric products require careful attention to fit, adhesion, comfort, and caregiver usability. Focus on refining the user interface, verifying materials, and gathering real-world feedback early in the process.

DEVELOPMENT PHASES & MILESTONES

Taking your pediatric urine collection bag from concept to commercial product will follow a clear series of steps. Each phase is designed to build confidence in the design, in performance, in usability, and in market readiness. While this device is lower in complexity, a structured process will still be essential to manage quality, cost, and adoption.

Phase I: Concept Development

Goal: Define core product functionality and align it with clinical needs.
Key Activities:

  • Clinical feedback review and use-case definition
  • Initial sketches or mockups of form factor and adhesive layout
  • Early risk identification (e.g., adhesion failure, skin irritation)
  • IP confirmation and refinement of existing patent(s)

Milestone: Clearly defined design concept with clinical validation of use case and patient fit.

Phase II: Prototype Development

Goal: Translate the concept into a working physical prototype for evaluation.
Key Activities:

  • CAD development and material selection
  • Construction of rough prototypes using adhesives and film materials
  • Fit and function trials on anatomical mannequins or test surfaces
  • Iteration to improve comfort, leak prevention, and removal process

Milestone: Functional prototype ready for benchtop evaluation and initial caregiver testing.

Note: The regulatory cost estimates in this section include expenses associated with an optional FDA 510(k) pre-submission (Q-Sub), which, while not required, can be a valuable tool for obtaining early feedback and reducing downstream submission risk.

Phase III: Design Output & Verification

Goal: Finalize design and demonstrate performance through basic testing.
Key Activities:

  • Benchtop leak testing, retention testing, and ease-of-removal studies
  • ISO 10993 biocompatibility testing initiation (cytotoxicity, sensitization, irritation)
  • Packaging integrity and shelf-life test planning
  • Documentation of design features and performance verification matrix

Milestone: Verified design outputs, initial test reports, and readiness for validation plan.

Performance Testing Matrix
Test Name Standard / Reference Purpose
Adhesion Retention Test Internal Protocol Ensures adhesive maintains contact on pediatric skin for the required duration.
Leak Containment Test Internal Protocol Confirms bag holds urine without leakage under typical volumes and conditions.
Usability Fit Test Formative Usability (FDA Guidance) Verifies the device fits a range of pediatric patients comfortably.
Peel Force Test ASTM F88 Measures the force needed to remove the device without discomfort or skin damage.
Biological Safety Testing Matrix
Test Name Standard / Reference Purpose
Cytotoxicity ISO 10993-5 Evaluates potential for cell damage due to materials.
Sensitization ISO 10993-10 Assesses potential for allergic skin reactions.
Irritation (or Intracutaneous) ISO 10993-10  Checks for local tissue response after short-term skin contact.

 

Phase IV: Validation & Regulatory Submission

Goal: Confirm usability and performance in representative settings; finalize regulatory readiness.
Key Activities:

  • Usability testing with clinicians or caregivers (if possible)
  • Labeling and IFU (instructions for use) development
  • Completion of required testing: packaging, shelf-life, biocompatibility
  • Quality system documentation and product traceability setup

Milestone: Validation complete with documentation package suitable for FDA Class I registration and production preparation.

Packaging and Environment Testing Matrix
Test Name Standard / Reference Purpose
Seal Integrity Test ASTM F1929 or ASTM F2096 Validates packaging remains sealed through shipping and storage.
Drop and Compression Test ASTM D4169 Simulates handling conditions to ensure the product and packaging aren’t damaged in transit.
Accelerated Aging Test ASTM F1980 Simulates long-term storage conditions to estimate shelf life.
Usability Testing Matrix
Test Name Standard / Reference Purpose
Formative Usability Study FDA Human Factors Guidance Identifies use errors and design improvements early in development.
Instruction-for-Use Evaluation Internal Protocol / Labeling Study Confirms that caregivers can use and apply the device correctly using only the packaging instructions.

 

Phase V: Full-Scale Production & Launch

Goal: Transition from prototype to mass production with reliable quality and market readiness.
Key Activities:

  • Supplier agreements for materials and adhesive patches
  • Manufacturing process setup (likely contract manufacturing for film cutting, sealing)
  • Final packaging design, barcoding, and labeling implementation
  • Distributor or direct sales preparation

Milestone: Launch-ready product with complete supply chain and quality system in place.

Each phase has its own technical and business challenges, but the biggest delays typically happen when design, testing, or regulatory planning are rushed or skipped early on. By following a phased model and closing out each milestone thoroughly, you set yourself up for a smoother regulatory path, stronger manufacturing handoff, and faster market entry.

Note: The tests above are provided as illustrative examples to reflect the expected level of complexity and rigor required during the development of the product. Final tests, plans and protocols may vary based on the finalized design, risk assessment, and regulatory strategy.

RESOURCE ALLOCATION & TEAM INVOLVEMENT

Although your device is relatively simple, successful development still requires focused contributions from a cross-functional team. At this early stage, resource planning is less about the size of the team and more about clarity in roles, timing, and coordination. Because there are no electronics, software, or powered components, the team structure can remain lean, but must still cover critical areas like mechanical design, clinical feedback, and regulatory compliance.

Core Functional Roles Required
  • Product Designer / Mechanical Engineer
    To lead CAD work, ergonomic shaping, and materials selection, especially around adhesive zones, bag volume, and collection flow.
  • Regulatory Consultant
    To confirm classification, labeling compliance, and testing expectations (biocompatibility, packaging).
  • Manufacturing Specialist or DFM Engineer
    To identify low-cost, high-quality production methods (e.g., film sealing, patch application) and help with vendor quoting.
  • Quality Assurance / Document Coordinator
    To prepare and maintain basic design documentation, supplier control forms, and records needed for compliance under 21 CFR Part 820.
  • Clinical Advisor
    To provide feedback on patient usability, skin contact safety, and situational challenges during urine collection in pediatric environments.
Specialty Support Needs
  • Adhesive Technology Consultant (if needed)
    If skin-safe adhesion becomes a sticking point (literally or figuratively), you may require guidance from a specialist in pediatric dermatology adhesives or material science.
  • Packaging & Labeling Expert
    To ensure pouch or blister packaging protects the product during transit, storage, and handling, especially in bulk distribution scenarios.
Phase Contributors
Concept Inventor, Clinical Advisor
Prototype Product Designer, Mechanical Engineer
Testing & Validation QA/Document Coordinator, Regulatory Consultant, Clinical Advisor
FDA Submission Regulatory Consultant, Document Coordinator
Production & Launch Manufacturing Specialist, Packaging Expert

This matrix will evolve over time. In early phases, the Inventor and Clinical Advisor play lead roles. As the device moves into prototyping and manufacturing, technical contributors become more central.

Strategic Takeaway

Even the simplest device demands a multidisciplinary effort. Success comes from clear delegation and sequencing: don’t try to solve engineering, regulatory, and supply chain all at once. Lean into your clinical backing and bring in the right specialists just-in-time, not all at once.

RISK MITIGATION STRATEGIES

Even with a simple device like a pediatric urine collection bag, risks can still arise across usability, performance, and compliance. Mitigating these risks early, ideally during the concept and prototype phases, helps avoid costly delays later. Because your device involves skin contact with infants, bodily fluids, and human handling, targeted strategies are essential to ensure safety, functionality, and user satisfaction.

Usability Risks
  • Risk
    Improper fit or difficult application by caregivers
    Mitigation
    • Conduct early usability testing with clinical staff or simulated mannequins
    • Focus on intuitive design features (alignment guides, peel tabs, color indicators)
    • Use caregiver-centered feedback to refine labeling and instructions
  • Risk
    Discomfort or distress for pediatric patients
    Mitigation
    • Choose skin-contact adhesives specifically rated for infants
    • Validate wear time duration to avoid skin irritation
    • Ensure painless removal through gentle adhesive formulations
Performance Risks
  • Risk
    Leakage, backflow, or poor urine containment
    Mitigation
    • Test various bag geometries and volumes during benchtop trials
    • Design flow paths to promote gravity-assisted collection
    • Integrate a one-way flap or chambering to reduce spillage risk (if needed)
  • Risk
    Adhesive failure or detachment during use
    Mitigation
    • Simulate real-use moisture and body movement conditions
    • Evaluate adhesives over time, especially with low-volume urine output
Regulatory Risks
  • Risk
    Overlooking required compliance steps due to 510(k) exemption status
    Mitigation
    • Maintain a checklist of general and special controls, including labeling, biocompatibility, and quality system procedures
    • Prepare design control documentation, including design verification and risk analysis, even without a formal 510(k) submission
    • Work with a regulatory advisor early to validate testing plans and documentation scope appropriate for a Class II, exempt device
Manufacturing and Supply Chain Risks
  • Risk
    Adhesive or plastic materials with long lead times or inconsistent quality
  • Mitigation
    • Source from vendors with medical-grade certifications
    • Identify secondary suppliers for critical components
    • Include tolerances and handling specs in drawings early
  • Risk
    Packaging that compromises hygiene or damages the product
    Mitigation
    • Perform drop, seal, and storage validation testing during Phase III
    • Use transparent packaging materials for easy inspection
Strategic Takeaway
Your biggest risks aren’t electronic, they’re human and environmental. Focus on making the device intuitive for caregivers, gentle on infants, and consistent in containment. By testing for real-world messiness, not just lab scenarios, you’ll build a product clinicians trust.

INVESTMENT & FINANCIAL OUTLOOK

Primary Cost Drivers
For your device, the largest cost areas typically include:
  • Prototype Iterations and Testing Supplies
    While there are no moving parts, expect several rounds of adhesive testing and fluid containment trials, especially to meet comfort and performance expectations. Iterative development is especially important for pediatric applications where fit, comfort, and leak prevention are critical to user satisfaction and clinical acceptance.
  • Biocompatibility Testing
    As a Class II skin-contact device, biocompatibility testing is required and non-negotiable. Per ISO 10993, you must evaluate:
    • Cytotoxicity
    • Sensitization
    • Irritation or intracutaneous reactivity
    These tests are standard for externally applied pediatric products and should be budgeted as early development milestones.
  • Packaging and Labeling Development
    Even without a 510(k) submission, labeling and packaging must meet FDA’s general and special controls:
    • Hygienic, sealed packaging that protects product integrity through transport and shelf life
    • Label design that clearly communicates proper use and safety
    • Bulk or unit-dose formats for clinical and home-use markets
  • Manufacturing Setup
    Tooling and early production infrastructure may include:
    • Low-volume bridge tooling for adhesive patch application and film cutting
    • Sample runs with contract manufacturing organizations (CMOs) experienced in pediatric disposables
    • Design-for-manufacture (DFM) consultations to ensure process scalability without overcomplication
Budgeting Tips for Early Inventors
  • Stay lean in early prototyping
    Use mock materials and benchtop tests before investing in expensive production adhesives or sterile packaging.
  • Bundle testing
    Group biocompatibility tests together to save time and money.
  • Limit SKUs
    Avoid customizing versions by patient size or gender until the primary design is validated and in demand.
  • Engage vendors early
    Getting quotes on adhesives and packaging now will clarify your manufacturing path and avoid costly surprises.
Funding Strategy Considerations
To fund development, consider these early-stage approaches:
  • Non-dilutive funding
    SBIR grants or pediatric-specific innovation challenges (e.g., FDA’s Pediatric Device Consortia).
  • Clinical partner pilots
    Partner with a hospital to support user feedback testing in exchange for first access or discounted units.
  • Strategic licensing
    If you don’t want to build a full company around this product, you may explore licensing to a diagnostics or incontinence brand already in the pediatric care space.
Revenue Potential Considerations
The device fits a repeat-use clinical need, so revenue is driven by:
  • Volume sales, especially to hospital systems, pediatric practices, and urgent care centers
  • Private label or bundling opportunities with diagnostic labs or pediatric testing kits
  • Global expansion into markets needing low-cost, hygienic urine collection methods, especially in mobile clinics or rural healthcare
  • Profit margins may be slim per unit but can add up quickly with consistent volume and streamlined manufacturing.
Financial Risk Mitigation
To control financial exposure:
  • Use pre-validation prototyping to test assumptions before tooling.
  • Ensure testing and labeling investments align with actual market needs; don’t overbuild.
  • Build a conservative forecast based on actual hospital purchasing behavior, not assumptions.
Strategic Takeaway
This is a low-cost, volume-based product with strong licensing potential. Keep your early investments focused on core performance: skin safety, adhesion reliability, and caregiver usability. These are the levers that drive both clinical adoption and future revenue.

Understanding Vendor Tiers and Impact on Project Cost and Time

Tier 1: Higher costs associated with comprehensive services complete system development, advanced technology, and the ability to manage complex projects. Design services may have shorter lead times due to ability to build a larger team however the scale of operations and the complexity of the more comprehensive supply chain may slow certain processes.

Tier 2:  Their cost and Time may vary based on their specialization allowing for efficient production of specific components, potentially leading to shorter lead times for those items. However, since they do not provide complete systems, the overall integration into larger assemblies may require additional coordination, potentially affecting timelines. 

Tier 3: Lower costs due to specialization in specific components or materials or limited staffing resources requiring additional coordination with other suppliers. This may slow the development time from both a design and supply chain perspective.

Considerations

  • Despite higher costs and longer lead times, Tier 1 suppliers may be more suitable for complex projects requiring integrated solutions.
  • For projects with budget constraints, engaging multiple Tier 3 suppliers could be more cost-effective, but may require more intensive project management.
  • Working with Tier 3 suppliers entails coordinating a robust supply chain to ensure timely delivery and quality assurance.

The choice between Tier 1 and Tier 3 suppliers involves trade-offs between cost, time, and supply chain management complexity. Careful evaluation of project requirements and resources is essential for making an informed decision.

Disclaimers & Limitations

  • Generalizations: This report provides a high-level overview based on standard assumptions and does not account for unique device characteristics. Actual costs, timelines, and risks may vary significantly depending on the device's design, use case, and target market.
  • Assumptions of Device Class and Use: Assumptions were made regarding the device's classification and intended use. These assumptions can impact regulatory requirements, costs, and timelines. Specific regulatory pathways, for instance, may differ based on the device's risk classification and market entry strategy.
  • Market and Regulatory Dynamics: Regulatory requirements and market conditions are subject to change. The report's cost and timeline estimates may be affected by evolving regulatory landscapes, standards, or unforeseen market dynamics, which could delay approval or require additional testing.
  • Risk Assessment Limitations: Risk levels and mitigation strategies are based on general device categories and may not fully address specific technical or operational risks unique to the product. Thorough risk assessments should be tailored to the device's complexity, materials, and usage.
  • Development Phases and Milestones: The development phases outlined here follow a typical medical device development pathway, but real-world project phases may overlap or require iteration due to unforeseen challenges or design changes.
  • Cost and Timeline Variability: The cost and timeline estimates are based on standard industry benchmarks but do not account for project-specific adjustments. Factors like unexpected technical challenges, prototype iterations, or regulatory re-submissions can significantly impact final costs and schedules.
  • Reliance on Industry Standards: The report relies on common industry standards for development and testing. However, additional standards specific to certain device features or regions may apply, affecting compliance requirements and associated timelines.
  • Testing and Validation Scope: Testing and validation requirements are generalized. Devices with novel materials, complex electronics, or unique features may require additional, specialized tests, potentially extending both cost and duration.