Solutions clinicians carry in their heads, made real.
Kiventa Foundry is a medical device company built on one observation: the people who see the problem every day already know the answer. We take a clinician's idea through engineering, regulatory clearance, and manufacturing, and put the finished device on the shelf where it is needed.
For physicians, nurses, medics, and surgeons with an idea
You have carried it long enough.
Most clinical inventions never leave the notebook, not because they fail, but because their inventors are busy practicing medicine. The Foundry supplies what practice does not: design engineering, a regulatory strategy, a quality system, a contract manufacturer, and the capital to reach the market. You keep doing what only you can do.
Bring us an ideaFor investors
A repeatable path from bedside to cleared product.
Our first device, K-CAD, is a single-use chest access instrument invented by a thoracic surgeon and now moving toward FDA clearance on a defined predicate pathway. Behind it stands a pipeline of clinician-originated devices and a team whose experience is regulatory and manufacturing execution, which is where device companies succeed or fail.
Request investor information Meet the teamHow an idea becomes a device here
Every project moves through the same five stages. The sequence is fixed because the discipline is the product.
Listen
A conversation under a mutual confidentiality agreement. We want the clinical problem before the solution.
Evaluate
Clinical need, regulatory pathway, intellectual property standing, and market structure, assessed with sourced evidence rather than enthusiasm.
Engineer
Design controls, human factors, and verification testing with experienced device engineers and consultants.
Clear
FDA strategy led by former agency leadership; the submission is planned from day one, not discovered at the end.
Manufacture and place
Contract manufacturing, a quality system, and distribution into the sites that stock the device.
First casting: K-CAD, the Kinetic Cavity Access Device
Chest tube placement has not meaningfully changed in decades: a scalpel, blunt dissection, a finger into the pleural space. K-CAD is designed to replace that kit with a single device operated by one clinician, in the emergency department, the intensive care unit, and the transport environment where the procedure is hardest.
- Invented by a thoracic surgeon
- Jonathan Kiev, MD, FACS, after more than thirty years placing chest tubes and repairing the ones that went wrong.
- Regulatory position
- FDA has provided written pre-submission feedback on the proposed predicate-based 510(k) pathway. The device is in development toward that submission.
- Design intent
- Aspiration to confirm entry before any cutting, a covered trigger-actuated blade, a depth stop, and a cannula that accepts standard chest tubes. Performance figures are design targets to be demonstrated in verification and validation.
Investigational device. K-CAD has not been cleared or approved by the U.S. Food and Drug Administration and is not available for sale in the United States or elsewhere. Nothing on this page is a claim of safety or effectiveness. Descriptions reflect design intent and development status as of the date shown in the footer.