Market Research and Development for a Wound Healing Medical Device

BioMimir is a female-founded medical device company enabling healthcare providers to improve treatment outcomes for complex wounds. Our lead product is a liquid-to-solid wound filler designed to act as a wound sealant, wound filler, and tissue regenerator. BioMimir’s lead product is an FDA class II medical device and is projected to enter the US market in 2025 via an approval for a 510(k) based on substantial equivalence. We are in the process of establishing in-process and quality controls procedures to ensure the conformity of our medical device. These will also form the basis of our stability testing procedures. This project comprises both materials testing and quality control method development for our medical device.

Faculty Supervisor:

Roman Krawetz

Student:

Partner:

BioMimir

Discipline:

Engineering

Sector:

Manufacturing

University:

University of Calgary

Program: