Elizabeth Ham

Hi, I’m Elizabeth, a seasoned consultant with over 5 years of experience in the medical device industry. I specialize in SiMD and SaMD, providing early-stage startups with the support they need to create technical documentation and plan business strategy.

About

I love working on new medical technology, especially if it relates to my mission of using comprehensive data to prevent and treat chronic disease. My work has involved at-home health monitoring, screening and diagnostic devices, radiographic imaging, and wearable devices. Curious about my credentials? I have a BSc in Biomedical Engineering from Georgia Tech, I've supported FDA submissions that have gotten clearance, and I have over 500 hours of consulting experience.I write regulatory, technical, and marketing documentation. I've helped clients plan clinical research, define product requirements, and analyze competitor markets. My goal is to ensure you have the tools, systems, and documentation you need to move forward with your device, whether that's raising a funding round or starting a clinical trial.Because I love working with startups, I can wear a lot of hats- my focus is in the SiMD and SaMD sector more than it is the deliverable. As a former founder, I know what it's like to juggle responsibilities and competencies.Let’s work together to bring your medical device to life.

Service Offerings

My services include (but are by no means limited to!) the following:

  • Clinical Research Documentation I can help your company write IRB submissions, clinical protocols, case report forms, and much more.

  • FDA Submissions From engineering requirements to V&V test protocols to describing your equivalence to a predicate device, I can help your company prepare 510ks and other FDA submissions.

  • Pitch Decks If you need to communicate your dense, technical medical info to investors in a compelling way, I'd love to help write a deck.

  • Competitor Analysis Curious about what your competition is up to? My competitor analyses focus on the clinical research pipeline.

Don't see what you're looking for? Shoot me an email and we'll have a conversation to see if I can meet your needs. If not, I might be able to connect you with an experienced colleague.

Publications

Mitigating Patient-to-Patient Variation in EEG Seizure Detection using Meta Transfer Learning, IEEE BIBE 2020
My team and I developed an automatic seizure detection pipeline for EEG data.

Get in touch

Ready to get started? Reach out via email or Twitter to schedule a consultation or just to chat!