We specialize in providing comprehensive preclinical and R&D support to medical device companies. Our expertise spans surgical and interventional procedural support, engineering team interactions, and the science and design of studies.
Mike is a medical device leader with a 20+ year proven track record of assisting companies with their multifunctional development and commercialization needs as well as over 15,000 hours of surgical and
interventional procedural experience in animal, human cadaveric, and bench models. He has served as a Subject Matter Expert for US and OUS industry presentations & panels, as well as for clients during regulatory body meetings. He is a co-author on multiple publications, abstracts, and posters.
Mike has worked with and for academic CROs, private CROs, and industry—providing a unique perspective on product development design and planning. Mike founded Osiris Med Dev in December 2018 to more closely collaborate with client core teams (e,g, R&D, regulatory, clinical, and quality experts) in the development and implementation of efficient plans for successful global regulatory clearance as well as sales force and end user training for market adoption. That partnership with clients allows him and his colleagues to support them all throughout the product development cycle.
Mike graduated from the University of Minnesota with a BA in Contemporary American History along with completing both the pre-med and pre-pharm tracks.
Mike holds Surgical Research Specialist (SRS) certification through the Academy of Surgical Research (ASR) and is a member of the Society of Interventional Oncology & Society of Interventional Radiology. A native Minnesotan, Mike lives in the Twin Cities with his wife, Alicia, sons Jack & Nolan, and goldendoodle Ripley.
Mike and his family enjoy golfing, fishing, hockey, lacrosse—and are very experienced at sitting in ice cold hockey rinks.
Haydee graduated from the University of Massachusetts Amherst with a BS in Public Health Sciences in 2016, moving on to complete a MS in Environmental Health Sciences with a concentration in Developmental Toxicology in 2018.
After graduate school, Haydee spent several years working in a preclinical CRO based in the Twin Cities. During her time in the industry, Haydee rose from a technical role in managing the pre- and post-operative care of animal test subjects to scientific project management support, data collection and interpretation, and eventual Study Directing of projects ranging from non-GLP discovery to complex, large-scale GLP studies.
She honed her skills in protocol development, meticulous study oversight, and report writing, managing projects across a wide array of different device specialties before moving on to join Osiris Med Dev in June of 2021. Stepping into a consulting role allowed her to expand her skills in the “before” and “after” of her clients’ preclinical programs, developing rigorous testing strategy and study design on the front end, and assisting in the regulatory submission and response phase on the back end, permitting her to see the lifecycle of a product from the bench to the clinic.
She continues to contract as a Study Director at several preclinical CROs and enjoys using her scientific background and regulatory knowledge to help structure the studies she directs to yield well-rounded and comprehensive data.
A native of the beautiful state of Maine, Haydee now lives in the Twin Cities with her husband Ben, and two cats, Elvis and Lucy. Haydee and Ben enjoy spending as much time outside as the Minnesota climate
allows, from backpacking on the Superior Hiking Trail to canoe trips down the many rivers in northern Minnesota and Wisconsin.
Growing up as the daughter of a research veterinarian and preclinical entrepreneur, Madie was essentially raised by the industry and eventually entered by joining a CRO in 2022 where she took on both technical and administrative roles, from pre- and post-operative animal management to invoicing.
After a short period, Madie accepted a position as an intern with Osiris Med Dev in May of 2023 to further explore her interests within the industry. A quick and enthusiastic learner, she was brought on full time a month later to take a more active role in preclinical strategy, where she has since gained experience in study design and development, project management, and data analysis. Under the mentorship of her Osiris teammates, Madie has rapidly developed her skills and has since implemented
them by working with clients to build strategic preclinical programs.
She has come to truly appreciate how amazing the preclinical industry is and the impact we have on our clients’ success. In her free time, Madie is an avid hockey fan, player, and coach. Off the ice, she enjoys seeking out new
local coffee shops in the Twin Cities and spending time with her former nanny kiddos. She is also an avid fan of the theatre arts and frequently visits NYC and other cities to see shows & her friends’ performances.
Olivia graduated from Iowa State University with a BS in Animal Science. After graduation, she moved back to Minnesota and started her career in the preclinical industry as a large animal care technician at a local CRO. After gaining experience in the field, she moved up quickly to a Study Coordinator role, where she developed skills in data collection and analysis, report writing, client relations, data review and tabulation, and GLP regulatory compliance.
After 4 years, Olivia was transitioning into a Study Directing role, gaining further experience in protocol development and project management, when she was approached by her former coworker, Haydee, with a great opportunity. Olivia officially joined the Osiris team shortly after in November of 2022. Through Osiris, Olivia is able to apply her expertise in the preclinical project phase to provide client support from the initial product idea and benchtop testing through regulatory submission and response.
Her experience includes project management, non-GLP and GLP study directing including protocol development, data organization and analysis, and study reporting, non-GLP quality assurance review, submission supportive document writing, and regulatory feedback interpretation and response.
Olivia and her fiancé, Michael, live in St Louis Park, MN with their two cats, Luna and Jinx, and three hermit crabs, Kahuna, Ruby and Jeff. In her free time, she enjoys trying new restaurants around the Twin
Cities, hiking in the many Minnesota parks, watercolor painting and reading.
