At Phase Zero, 6 things innovators need to know about the FDA approval process.
In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many new projects.
Supporting the development of new Point of Care (POC) technologies with IEEE and NIH
Michael Fisher, Director of Product Development for GCMI, shares his insights from the IEEE-NIH Healthcare Innovations and Point of Care Technology conference. Recently, GCMI attended and spearheaded a presentation during the IEEE-NIH Healthcare Innovations and Point of Care Technology conference which focuses on innovation and technologies for precision health and their clinical translation, to address…
Engaging a flexible third party medical product development firm to help you tackle an inflexible process
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%…
An Evening of Medical Device Development: The FDA and Pediatric Medical Devices
“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…
How process excellence leads to product excellence
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…
Talking bioskills training and medical device development with Georgia’s top surgeons
Connect with GCMI and T3 Labs at GSACS 2017! The Georgia Society of the American College of Surgeons (GSACS) promotes elevation in standards of surgical care. Each year, the society meets for an annual meeting aimed at further educating surgeons for the benefit of the healthcare system. GCMI and its subsidiary T3 Labs is…
Fostering Medical Innovation in the Clinical Setting: Piedmont Innovations & GCMI
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.…
Innovation: From concept to commercialization: Our SEMDA 2017 takeaways
The 2017 edition of the Southeastern Medical Device Association (SEMDA) annual conference has come and gone, and this year was better than ever- affirming why GCMI and T3 Labs continues to invest in the conference year after year. Here are just a few of the highlights from this year’s conference titled “Innovation: From concept to…
How GCMI is supporting the medtech development pathway for Micro C as they revolutionize medical fluoroscopy and imaging
Micro C raises additional $700K in seed round to complete several planned initiatives and bring their novel medical device to market. Micro C is the company behind a novel medical device of the same name that is going to change the imaging game for healthcare providers. Micro C Co-Founder and Chief Medical Officer Dr.…
The importance of innovators working with third party design firms to get novel medical technologies to market
GCMI and T3 Labs CEO Tiffany Wilson shares insights with Assembly Magazine on what it takes to bring a medical device from concept to commercialization. Developing a new medical technology is not for the faint of heart. It is a daunting, expensive, arduous process, but nevertheless, it is highly rewarding. The developmental pathway is enough…