Southeast Life Sciences’ approach to innovation is embodied in continuous networking, education and funding opportunities that encourage the life science industry to grow.

Our colleagues at the Global Center for Medical Innovation (GCMI) help direct the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. They are also regular publishers of insights intended to keep the ecosystem abreast of the latest in the life science design, development and commercialization landscape.

GCMI Medical Director Dr. Emily Blum and Director of Research and Development Engineering Saylan Lukas recently shared their insights on “State of Medtech Design and Development” including the hot technologies, high demand services, regulatory evolution and common hiccups for innovators to avoid.

  • What’s critical for new technologies currently in development that lean on AI, is to ensure collection of clean, correct, and unbiased data, and then storing and processing it properly.”

  • “More frequent, routine feedback from the FDA’s experts will always limit expenditures and risks a project might take heading down the wrong pathway.”

  • “Even the most basic “ back of the napkin” drawings for a novel medical device contribute to a robust design history file and can be of value to regulators in understanding a device’s origins and intentions. Rule of thumb: if it’s not documented, it doesn’t count.”

We invite you to take a deeper dive into the current state of the medtech design and development ecosystem in the detailed post on the GCMI news and blog.