With GCMI’s Help, Micron’s Microarray Needle Technology Nearer To Forever Changing the World for the Better Medical device and biotech or medtech innovation doesn’t work like consumer electronics or software. It works more like aerospace. Because lives are literally at stake it needs more than a place for people to work, high speed internet, brilliant…
Opportunities and implications for ISO 9001 certified entities to access the lucrative medical device market through ISO 13485 certification. Researchers estimate the total size of the U.S. medical device market somewhere between $170 billion and $240 billion in 2023. KPMG reports, “The medical device industry is poised for steady growth, with global annual sales…
Thursday, Oct 3, 2024 Georgia Tech Advanced Manufacturing Pilot Facility 575 14th Street Northwest Atlanta, GA 30318 5:30 – 7:30 p.m. Medical device innovation and manufacturing is unique in its rigors, challenges and impact potential. It is easy to squander scarce resources wasting time with too many prototypes instead of verifying and validating the…
Insights from a deep dive into medical device innovation and production with GCMI’s Saylan Lukas and GaMEP’s Dean Hettenbach Given the patient safety requirements codified in the United States Code of Federal Regulations overseen and enforced by the Food and Drug Administration, medical device innovation is a challenging enterprise to say the least. …
A materials scientist and six GT students take aim at Civil War technology still ubiquitous in clinical care and its implication in 30,000 deaths every year. The technology that has become Hub Hygiene’s easySCRUB started as a challenge issued to material scientist Jud Ready, PhD, in 2015 by a friend’s spouse, a North Carolina…
Three key considerations and solutions related to the challenges of manufacturing at scale; but the Golden Rule here is design for manufacturability from day one.
A webinar with GCMI and the Georgia Manufacturing Extension Partnership, June 25, 2024 at 10:30 a.m. EDST When – at long last – it comes time to build your new medical device, be that for verification and validation testing, show and tell or educational examples, clinical trials or “full scale,” you will always wish you…
By: Marty Jacobson with Paul Snyder Because clinicians have such an intimate knowledge of unmet clinical needs, hospitals are fertile ground for medtech innovations that improve value and outcomes. But bringing a technology or device to bear in clinical use, especially at any scale, works in much different, much more rigorous ways and paths…
Prologue – Eliminating a Surgical Never Event that Should not Exist Surgical instruments that emit high-intensity light coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to incidents like these as “never events” so they should never happen, right? But, survey results published in the Joint…
GCMI recently welcomed Georgia Tech President Angel Cabrera for an inside look at our work and its impact. Almost immediately after Angel Cabrera was named President of Georgia Tech in 2019, he led “more than 5,700 members of the Georgia Tech community [who] contributed to a new 10-year strategic plan that launched in November 2020.…