Throughline Biomedical partners with university biomedical engineering programs to integrate FDA regulatory science into the curriculum — giving graduates the framework to move their ideas and innovations from concept to patient impact.
The pathway from device concept to patient use runs through the FDA. Yet regulatory science remains almost entirely absent from undergraduate and graduate biomedical engineering education — creating a preventable gap between how engineers are trained and their ability to translate ideas and innovations into real outcomes for patients, regardless of where their careers take them.
Our services meet programs where they are — whether integrating regulatory content into existing courses or building faculty capacity to teach it independently.
An accessible entry point — topics tailored to course context and delivered by an active FDA Division Director with 13+ years of experience.
02Module-based regulatory science content designed to fit within existing BME courses — no separate course required.
03Expert-led workshops and resources to help faculty teach regulatory frameworks with confidence and accuracy.
04Real FDA regulatory scenarios — classification, benefit-risk, design controls — built for student engagement and grounded in actual FDA precedent.
We're currently partnering with a select group of university BME programs. Reach out to explore what's right for your curriculum.
Get in TouchThroughline Biomedical was founded by a biomedical engineer who completed her undergraduate and doctoral training in biomedical engineering with only a brief encounter with regulatory science — a single class across the full arc of her education. It was her 13 years as a Division Director at FDA's Center for Devices and Radiological Health that revealed the opportunity: an unmet need, sitting at the intersection of engineering education and patient impact, that no one was systematically addressing.
As Division Director for General Surgery Devices, she leads regulatory review of surgical technologies — evaluating submissions, guiding policy, and working to ensure that new innovations reach patients safely and efficiently. Across that work, a consistent pattern emerged: talented engineers arriving without a framework for how their work connects to the patients it is meant to help.
The name Throughline is intentional. A regulatory throughline — woven through BME training from foundational coursework through capstone — gives anyone working toward better outcomes for patients a framework for how innovative ideas actually get to them. That path runs through regulatory science, whether a graduate enters industry, research, clinical translation, or academic innovation. Throughline Biomedical exists to make that connection explicit, early, and durable.
The founder holds a Ph.D. in Biomedical Engineering from Brown University and brings 13 years of FDA experience across device classification, premarket pathways, benefit-risk analysis, and quality systems. She is currently working with programs at Brown, Tufts, and Fairfield University to understand what curriculum integration looks like in practice — and to shape services that work for real programs with real constraints.
"Every biomedical engineering graduate working toward better outcomes for patients deserves a foundational understanding of the regulatory pathway that connects their work to the people it's meant to help."
— Founder, Throughline BiomedicalWe're accepting a limited number of university partnerships. Let's talk about what your program needs.
Get in TouchThroughline Biomedical works with university biomedical engineering programs to make FDA regulatory science a meaningful part of how students are prepared to contribute to innovations that reach patients — wherever their careers take them. Our engagements are shaped around each program's existing structure, faculty capacity, and student population.
A low-commitment starting point for programs exploring regulatory science education
For programs that want to introduce students to FDA regulatory science without a larger curriculum commitment, a guest lecture or seminar is a natural first step. Delivered by an active FDA Division Director with 13+ years of experience, these sessions bring a level of credibility and practical depth that is difficult to replicate from within most BME programs.
Topics are tailored to the course context and student level — whether an undergraduate capstone, a graduate device design course, or a standalone seminar. Sessions can stand alone or serve as an entry point to deeper curriculum engagement.
Currently active with Brown University, Tufts University, and Fairfield University
Most BME programs lack the internal expertise to teach FDA regulatory science with accuracy and depth. Throughline Biomedical fills that gap by working directly with programs to embed regulatory content into existing courses — without requiring a new standalone course or significant faculty retraining.
These three core knowledge domains represent the foundation of how any engineer — in industry, research, or academia — engages with the process of bringing a device to the people it was designed to help:
Designed for programs where faculty want to teach regulatory content independently
Faculty in BME programs are trained as engineers and researchers — not regulatory scientists. Asking them to teach FDA frameworks without preparation leads to content that is either oversimplified or inaccurate.
Throughline Biomedical offers targeted faculty development to build the working knowledge needed to teach regulatory science with confidence. Engagements are designed to be practical and efficient, respecting the demands on faculty time while ensuring the content delivered to students is substantively correct.
Real regulatory scenarios built for student engagement
Regulatory science is learned most effectively through application. Throughline Biomedical develops case-based learning materials drawn from real FDA regulatory scenarios — giving students the opportunity to work through the same kinds of decisions that shape whether an innovation reaches the patients it was designed to help.
Cases are designed to be modular, adaptable to different course contexts, and grounded in actual FDA precedent rather than hypothetical examples. They can be used as standalone exercises, integrated into existing assignments, or structured as capstone components.
Every program is different. Reach out and we'll identify the right entry point for yours.
Get in TouchThroughline Biomedical is currently accepting a limited number of university partnerships. If you're a faculty member, department chair, or curriculum director interested in giving your students a clearer path from engineering training to patient impact, we'd welcome the conversation.
Thank you for reaching out. We'll be in touch within 2 business days.