zewski-report-questionnaire

THE ZEWSKI REPORT

DEVELOPMENT QUESTIONNAIRE

Product Identification Generic device type
What you would call it in a catalog Product name / working trade name (optional)

Device Documentation Upload a document that describes your device (e.g., patent, specification, grant, design notes).
Supported formats: PDF (searchable-text), DOCX, or TXT. Scanned PDFs may not contain readable text.

Input below is used for early project modeling, not a formal quote or scope of work. Closest-fit answers are appropriate.

Device Category

Focus on the device’s primary function.

Respiratory / breathing device Carries, controls, supports, or delivers breathing airflow, oxygen, ventilation, or aerosolized respiratory treatment. Delivery / dosing device Actively meters, doses, pumps, or controls non-respiratory delivery of a substance or therapeutic input to the patient. Invasive / procedural device Used in a procedure, enters the body, or interfaces with sterile tissue or internal pathways. Monitoring / sensing device Measures physiological or environmental signals without delivering therapy. Support / containment device Holds, supports, collects, contains, or passively channels without sensing or powered control. Wellness / non-medical device Not intended to diagnose, treat, or prevent disease.

Electronics

Select what the electronics do.

No electronics Electronics measure, monitor, detect, or process information only Electronics actively control, power, or drive a function

Functional Subsystems

Count major functions, not individual parts. For example, fluid control and user interface are subsystems; housings and screws are not.

1 subsystem (single core function) 2 subsystems 3–4 subsystems 5+ subsystems

Materials

Focus on the main material combination used in the finished device.

Plastic-only Plastic + metal Plastic + electronics Metal-only Soft goods / laminates / adhesives

Intended Use Environment

Select the setting where the device will most commonly be used.

Hospital inpatient / ICU setting Clinical or outpatient setting Home-use by non-clinical user Both clinical + home use

Patient Contact Profile

Select the highest level of direct patient contact during normal use.

No direct patient contact Contacts intact skin only Contacts mucous membranes or internal fluid pathways Enters sterile tissue or bloodstream

Gas Pathway Exposure

Select whether the device carries inhaled or exhaled air during normal use.

Not part of the breathing pathway Forms part of the breathing pathway

Sterility Expectation

Select the sterility required at the point of use.

No sterility required Normal cleaning or handling is sufficient. Requires sterilization before use Not supplied sterile from the manufacturer – healthcare facility sterilizes before procedure. Supplied sterile Shipped with a sterile claim and sterile barrier packaging. Reusable, disinfected between uses Not sterile, but requires a validated disinfection method between patients/uses.

Regulatory Pathway

Indicate the expected FDA pathway.

Class I, Exempt Lower-risk device type that usually does not require a premarket submission. Class II, Exempt Moderate-risk device type that may still avoid a formal premarket submission. Class II, 510(k) Moderate-risk device that is usually cleared by showing similarity to an existing device. Class II, De Novo Novel device type without a clear existing predicate, but not high-risk enough for PMA. Class III, PMA High-risk device requiring the most rigorous FDA review. Not marketed as a medical device

Risk Level

Focus on the harm that could result if the device fails during use.

Failure does not create a safety hazard Failure could cause reversible or moderate harm Failure could cause serious injury Life-supporting or life-sustaining function

Product Variants

Count product versions that differ in size, features, or intended use.

One configuration 2–3 variants 4–5 variants More than 5 variants

Current Development Stage

Select the stage that best reflects the work completed so far.

Idea only (no designs yet) Early sketches / concepts Rough CAD model Basic prototype Functional prototype (core performance works) Integrated prototype (design + function aligned)