Medical technology innovators learn quickly that there is little, if any, flexibility in the FDA approval process. NFANT Labs knew they needed multidisciplinary partners able to build flexibility into an inflexible process, designing and developing their product with a constant eye on efficiency and the FDA approval prize. In the United States, up to 70%…
We wish to extend a huge congratulations to our sponsor ALung Technologies! Just last week, it was announced that ALung has received IDE approval to conduct a VENT-AVOID trial of the Hemolung RAS for the US Market. The device, which achieved its CE mark in 2013, permitting sales throughout the EU, is the world’s first…
“Children aren’t little adults, yet we expect our physicians to retrofit adult devices to fit a pediatric patient,” says Sherry Farrugia, Chief Operating and Strategy Officer of the Pediatric Technology Center, and Director of Children’s Healthcare of Atlanta Partnership. “When adult devices are used it can often cause safety concerns in surgery, orthopedics – really…
The MedTech Conference, AdvaMed’s flagship event, is the leading medtech industry conference in North America. September 25 – 27 in San Jose will find thousands of medtech industry leaders gathered together in a multifaceted environment for business development, capital formation, technology showcasing, world-class educational opportunities and networking at AdvaMed 2017. Tiffany Wilson, CEO of GCMI…
The Medtech Women at SEMDA (MW@S) Advisory Board has announced the finalists for the inaugural class of the Top 10 Women in Southeast Medtech.
GCMI’s Director of Product Development, Mike Fisher, recently spoke about the ins and outs of successful medical device development as a guest on Greenlight Guru’s Global Medical Device Podcast. “A good rule of thumb for innovators is that your product, your prototype, or your idea should lead the conversation but right behind it needs to…
Who better to address unmet clinical needs and life-changing improvements to medical devices of all types than clinicians themselves? Piedmont Healthcare and T3 Labs’ a subsidiary of GCMI, embark on a journey to create a self-sustaining innovation enterprise: concept to commercialization. All I.J. was trying to do was celebrate a friend’s wedding at the beach.…
Tiffany Wilson Named one of the 110 medtech women leaders to know by Becker’s Hospital Review There is quite a network of women leading the medical technology industry- such an impressive network that Becker’s Hospital Review recently published a list of 110 medtech women executives and leaders to know. Each woman on the list…
Connect with GCMI & T3 Labs during MD&M East- Booth #963! MD&M East is one of the largest medtech events on the east coast, connecting thousands of engineers, executives, as well as hundreds of leading vendors. Not only is MD&M a great opportunity to reconnect with long time partners, innovators and colleagues while meeting new…
The Society of Quality Assurance is dedicated to promoting quality in the regulated research community, including clinical settings, laboratories, and manufacturing facilities. This year the annual meeting, held March 26-31, boasted attendance of over 800. Located in National Harbor, Maryland, the conference was in close proximity to Washington DC, posing a unique opportunity for more…