Lupine Medical was founded in 2013 to help product developers design, test, and gain FDA approval for their game-changing medical devices.
We are a contract research organization offering research and development as well as GLP testing to the medical device industry. Specializing in combination device technologies, our focus is improving patient outcomes by reducing the two most common medical device complications: infections and thrombosis.
We are constantly adapting our testing to meet the ever-changing and growing list of requirements for combination products. With our in-house blood testing laboratory, we can perform in vitro tests to demonstrate the reduction of platelet adhesion, platelet activation, and other markers in the clotting cascade. Our existing repertoire of blood compatibility tests is just a starting point, as we continually adapt to the particular needs of the implant environment, device geometry and materials, and desired claims for the device.
Lupine Medical is well versed in, and frequently updating our knowledge of the requirements to commercialize antimicrobial technologies. In addition to performing drug elution studies in house, we partner with several microbiology test facilities throughout the world to deliver targeted testing, specific to the device location, contact type, and implant duration. Let us put our extensive experience with antimicrobial test method development behind your technology, ultimately saving time, cost, and ensuring the fastest path to market.
With advanced science and research degrees, and years of experience with combination devices, the team at Lupine stands in your corner when it comes to designing and performing the testing that ensures you can launch your game-changing device.
Lupine Medical Founder and CEO Matt Trebella brings more than 13 years’ experience in the medical device industry. Inventor on several patents related to delivery of antimicrobial agents from medical devices, Matt has personally developed a technology from the bench-top of a start-up laboratory all the way to commercialization of that technology on a permanently implanted device of a Fortune 500 medical device manufacturer. After that successful launch, he has overseen the development and commercialization of other technologies aimed at reducing device complications.
Matt has consulted for industry leading medical device manufacturers, startups and growth stage clients ranging from two to more than ten thousand employees. The devices these companies make range from short-term skin-contacting devices to permanent implants that are contracting in the bloodstream. He has intimate knowledge of what it takes to design and develop a novel medical device, to test under GLP and FDA guidelines, and to navigate the FDA regulatory process.
Focusing on antimicrobial and anti-thrombogenic technology development and testing, Matt and his team expedite the development process saving you precious time and delivering your device to patients.
Experience and Accomplishments
With a successful history and track record of guiding advanced medical device creators through the highly regulated FDA approval process, you can count on the team at Lupine. Here are just some of the accomplishments and expert knowledge you’ll add to your team when you partner with us.
- Developed and patented antimicrobial technology.
- Successfully brought patented antimicrobial technology to market.
- Extensive experience with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Experts in antimicrobial assays for medical devices.
- Test method development for urinary, vascular, skin, and subcutaneous pocket environments.
- Partnerships with microbiology test laboratories around the world to leverage expertise in specific assays.
- Assay validation for analytical and microbial test methods.
- In-house test development and validation of anti-thrombogenic assays.
- Understand submission of data and reports to FDA.
Lupine Medical is based in Bozeman, Montana. While Montana may not seem like the ideal location for a company focused on consulting and testing for the medical device industry, Bozeman offers much when it comes to expertise in the industry. Bozeman is home to Montana State University and the Center for Biofilm Engineering, which puts us in regular contact with experts in the field of microbiology and biofilms. The university offers access to instrumentation and a highly educated work-force in the cultural hub of Montana. Bozeman is also just a short drive to Yellowstone National Park and some of the best skiing, biking, fishing, and outdoor activities in the world, which is why many experts in their fields have decided to call Bozeman home simply for the quality of life it offers.