ZR 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

Functions

What are the main things the device is designed to do? Count major functions.

1 core function 2 major functions 3–4 major functions 5+ major functions

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

Select the most likely FDA pathway based on current knowledge.

Need help choosing?

Class I, Exempt For lower-risk devices that generally do not require a 510(k) premarket notification. Class II, Exempt For moderate-risk devices that generally do not require a 510(k) premarket notification. Class II, 510(k) Premarket Notification For moderate-risk devices that can demonstrate substantial equivalence to a suitable predicate device. Class II, De Novo Request For novel, low-to-moderate-risk devices without a suitable predicate device. Class III, Premarket Approval (PMA) For high-risk devices requiring the most rigorous FDA review of safety and effectiveness. 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

Device Versions

Count the versions you plan to offer, such as different sizes or optional features.

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

Concept Maturity

Select the option that best reflects how developed the concept is today.

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