We are delighted to introduce you to Michaela Hoffmeyer, Senior Science Advisor at MRIGlobal. Michaela supports teams in in vitro diagnostic product development for government and commercial clients. She partners with clients to provide expert guidance on regulatory approval processes, including Emergency Use Authorizations for COVID-19 tests.
Michaela support includes all aspects of the diagnostic product development pipeline from R&D through clinical validation, and all regulatory elements including FDA pre-submissions, 510(k) and de novo submissions, home-use through high complexity CLIA tests, and dual CLIA waiver submissions. Her specialties include: in vitro diagnostic development; design control; regulated products and RUO; clinical trials and testing, and laboratory quality management system support. She holds a master’s degree in molecular biology from the University of Texas.
GETTING TO KNOW MICHAELA HOFFMEYER
When did you know you wanted to be a scientist?
I sort of always knew. I would dissect my dad’s flowers to see what was inside of them, and I was the kid that would rather watch nature shows on TV than Saturday morning cartoons. I loved high school biology class so much I decided to major in it, but I think it really hit me I could make a career out of science when I was working on my undergraduate degree. I used to think if you liked biology then you had to become a physician, because I mistakenly thought the only option for someone with a biology undergrad degree was go to medical school. But after being exposed to all the other career options available to me with a degree in biology, I knew I was bound for grad school and not med school.
What was your pathway to becoming a scientist?
My graduate work was more translational than most of the other projects of my peers, it was closer to the clinic. When I finished grad school I knew I wanted to be closer to the clinic, and that lead me to my first job at an in vitro diagnostics (IVD) company. It was a perfect fit for me and I felt that the tests I was helping to develop were directly impacting people’s lives. I feel that way even more so now with all the work we do to support SARS-CoV-2 (COVID-19) diagnostics.
What is your role at MRIGlobal?
I am a senior advisor for clinical diagnostic programs. I serve as a subject matter expert on the development of in vitro diagnostics, meaning I help our government and commercial clients understand the requirements of the Food and Drug Administration (FDA) and other regulatory agencies if they want to bring an IVD to market. I help our clients navigate the design control process, create design verification and clinical trial testing programs in alignment with FDA requirements, clinical laboratory standards and guidance. I prepare packages for submission to the FDA or other regulatory agencies (USDA, CE, etc.) and lead discussions with these agencies regarding the performance. A lot of our clinical validations require testing in our CLIA labs, so I am also involved in overseeing CLIA lab testing projects, standing up or bringing in new CLIA lab menus to support our clients.
What excites you about working at MRIGlobal?
The work we do makes a real difference. We are all seeing the power of diagnostics right now with the COVID-19 pandemic. It’s not a solution, but widespread testing is another tool in the toolbox to confront the pandemic. Many people probably didn’t realize how important diagnostic tests are until faced with the situation we are in now, globally. The work we do with our clients helps bring these testing solutions to the people that need it, whether that’s high throughput automated solutions, or simple tests you can buy at your local drug store. Our work with commercial IVD development has expanded exponentially since the start of the pandemic, especially guidance on obtaining Emergency Use Authorizations.
I also love that I get to work on assays using the very cutting edge of diagnostic technology, sometimes on technologies that have never before been cleared by the FDA.
What are your interests outside of work?
I am a mother, so that’s another full time job. I also grow orchids. I love botany, and almost decided to go to graduate school in paleobotany instead of molecular biology, but I was concerned about my long term career prospects. I am also an accomplished knitter and love to sew, especially costumes for my daughter.