The medical device design services and product development team at GCMI facilitates medical product development through all phases – from initial concept generation through transfer to production manufacturing. We guide and execute along a strategic pathway, focusing on both product excellence and regulatory compliance. Our team works with a variety of innovators: individual physicians, researchers and engineers, start-up companies and publicly traded industry leaders.
When an innovator has identified a medical problem, taking an efficient approach to identify the viability of potential solutions is key. Our Phase 0 focuses on evaluating critical product elements early, with limited cost and effort.
Key Questions:
At the completion of Phase 0, an innovator will have data-based support for the value in launching a full development program for the product including needed medical device design services.
In our experience, careful planning streamlines medical device design services needs and the product development process, lowering costs and providing greater market predictability.
Key Questions:
At the completion of Phase 1, the project team will have a clear vision for the path to generating the product.
Iterations from medical device design services, refinement and evaluation allow for product evolution from the prototype stage to manufacturable assembly.
Key Questions:
At the completion of Phase 2, the project team will have the specifications and initial supporting test data for a functional product.
Thorough engineering evaluations of the product demonstrate whether the output of medical device design services and efforts have met all of the product requirements.
Key Questions:
At the completion of Phase 3, a project team will have statistically significant evidence of the product’s functionality and safety.
Thorough system and user testing demonstrate whether the design has sufficiently addressed the customer’s clinical need.
Key Questions:
At the completion of Phase 4, a project team will have documented evidence as to whether the product is usable and solves the stated clinical need.
In order to scale production to quantities needed for sale, manufacturing processes must be shown to repeatedly and reliably generate the commercialized product. For many medical products, regulatory approval must also be granted prior to market introduction.
Key Questions:
At the completion of Phase 5, the product will be ready for routine production and sale.
Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to see early investment in de-risking medical innovations. There is simply too much potential for failure in the pathway to commercialization, plus financial risk related to market forces and competitive products.
Too many medtech development projects are unsuccessful because innovators discover major roadblocks too late in the process. Here are some of the top ways to give your medtech innovation a better chance for successful commercialization.
We have completed another revision of our design files for those wishing to produce face shields for healthcare providers
Click here to learn more and access the updated design files.
Prototyping is an exciting and important part of the medical product innovation process. Prototypes can give you something tangible to touch and feel – a physical representation of your ideas coming to life.
Because prototyping is such a fun and exciting part of the development lifecycle, it is very easy to burn time and money unnecessarily.
We offer some of the top items to consider when deciding if a prototype is needed.
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing COVID-19 pandemic. Read.
It’s crucial to maintain a capital efficient, yet flexible, process for medical device design services and product development process in order to have the greatest likelihood of arriving at your intended destination in the least amount of time.
Designing for manufacturability is a critical task. The effort to develop a component manufacturing process and an assembly process is just as critical. Making these two paths overlap as much as possible allows a development team time to improve on manufacturing methods prior to any pilot builds.
From our colleagues at Greenlight Guru:
“The goal for most creators of new medical devices is to be able to get them to market as quickly as possible, right? So, what commonly puts roadblocks in the way?
Compliance issues. What are the common issues and what happens with these non-compliances?”
Greenlight Guru founder and VP of QA/QR shares his insights. We thank Greenlight Guru for including GCMI on its “Ulimate List of Medical Device Incubators and Accelerators”.
IEEE 11073-20701™-2018 defines an architecture that binds the participant and communication model to the Web services data transport model defined in previous IEEE 11073™ standards.
PISCATAWAY, NJ, 14 Feb. 2019 – IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Standards Association (IEEE SA), today announced the publishing and availability of IEEE 11073-20701-2018 – IEEE Approved Draft Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding.
In mid-March 2020, the shortage of personal protective equipment for healthcare providers responding to the COVID-19 outbreak had become a national emergency. By March 13 Christopher Saldana, Ph.D., associate professor of manufacturing at Georgia Tech and his mechanical engineering students and colleagues were already working on challenges and solutions for desperately needed protective personal equipment (PPE) for frontline healthcare workers.
Read more about how this collaboration produced and delivered more than 250,000 PPE face shields by April 7.
From the Delta News Hub: April 2, 2020: Delta Flight Products, the airline’s wholly owned subsidiary, is collaborating with Global Center for Medical Innovation (GCMI), a non-profit affiliate of the Georgia Institute of Technology, to manufacture face shields to protect hospital workers during the COVID-19 pandemic.
Using materials and designs provided by GCMI, Delta Flight Products is leveraging its best-in-class manufacturing facilities to quickly deliver an initial order of 2,000 shields to aid workers in New York by Friday, and an additional 4,000 for Atlanta-area hospitals in the following days.
Read more from the Delta News Hub.
When an innovator has identified a medical problem, taking an efficient approach to minimize risk and identify the viability of potential solutions is key. Our Phase Zero focuses on evaluating critical product elements early, minimizing risk, cost and effort.
Key questions:
Answering these questions validates the project direction and anticipates your resource requirements, timeline and team needs. What, then, should medical technology innovators with a ‘napkin sketch’ or research idea expect to get out of GCMI’s Phase Zero service offering?
GCMI, in partnership with Children’s Healthcare of Atlanta and the Georgia Tech Pediatric Technology Center, has completed our first design files for those wishing to prototype Face Shields for healthcare providers, the first in what we hope will be a series of designs for badly needed PPE items.
“GCMI is unique in that we were able to choose the services that we needed precisely at the time we needed them. The way GCMI engages with their customers is unlike any other firm.” – Lou Malice, nFant CEO
“We would be quite naive about what’s next if not for GCMI. It’s a bootcamp on medical technology commercialization for academic researchers.” – Darren Roblyer, Ph.D., Boston University
The design and development process can make or break a medical device’s commercial potential. It is dependent on careful consideration…
Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to…
As the global COVID-19 pandemic continues to force all of us to find safe paths forward, GCMI continues to remain…
In mid-March 2020, the shortage of personal protective equipment for healthcare providers responding to the COVID-19 outbreak had become a…
Aflac Incorporated, a leader in supplemental insurance at U.S. worksites, today announced it has contributed $5 million to two organizations that are…
In one week, a team of students in a joint biotech medical lab with Georgia Tech and Emory students started…
From the Delta News Hub: April 2, 2020: Delta Flight Products, the airline’s wholly owned subsidiary, is collaborating with Global…
“In response to the unprecedented challenges from the COVID-19 pandemic, ExxonMobil is applying its deep knowledge and experience with polymer-based…
To our GCMI clients, experts, and friends – From the beginning of the COVID-19 crisis, my team and I have…
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE…
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA –…
Image credit: GT Research Horizons GCMI, in partnership with Children’s Healthcare of Atlanta and the Georgia Tech Pediatric Technology…
We are pleased to partner with Dr. Joanna Newton, along with a skilled and motivated team at Georgia Tech and…
Fast track answers to critical questions that de-risk medtech innovations When an innovator has identified a medical problem, taking…
Prototyping is an exciting and important part of the medical product innovation process. Prototypes can give you something tangible to…
Photo courtesy of http://studyclerk.com/ For most medical device innovators, prototyping is one of the most exciting times in product development.…
GCMI’s Sarah Cohen and Mike Fisher provided substantial insights for Assembly Magazine’s Austin Weber in a recent article, “Best Practices…
As the year comes to a close and many of us look forward to a holiday respite, I find myself…
GCMI’s foremost goal as an affiliate of the Georgia Institute of Technology is to partner with Georgia Tech faculty and…
At GCMI, medtech and medical device innovation are at the core of our efforts including our work within our industry…
GCMI’s 2018 year end review and 2019 look ahead Thanks to our staff, customers, sponsors and fellow industry, academic and philanthropic visionaries, GCMI has tangibly advanced our mission of accelerating the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. 2018 Highlights Leading…
So you have an idea for a new medical device. Now what? Coming up with a concept for a new medical device is an exciting moment. The possibility of solving a real unmet clinical need can seem so promising that you may overlook the myriad process challenges that go along with bringing this idea to…
In GCMI’s experience, the decision to commit to a design and development plan for a new medical product should not be understated in its significance. Prior to making this commitment of time, money, energy and focus, an innovator must truly understand the tasks ahead of them, what the finish line looks like, how long it…
In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many…
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…
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%…
“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…
Mike Fisher, Director of Product Development of GCMI 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…
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…
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.…
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…
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.…
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…
Having a facility like T3 to test novel and breakthrough applications’ ability to save lives is crucial for battling diseases and disorders. Dr. Matheny and the original team of T3 recognized the need and saw to it that it was met. Dr. Robert Matheny, MD, Chief Scientific Officer of CorMatrix Cardiovascular Inc. The change in…
GCMI and T3 Labs CEO Tiffany Wilson shares medtech development pathway insights in Medical Product Outsourcing. Bringing a new medical device from concept to cure to commercialization is an intimidating, complex and expensive process which often stifles innovation instead of encouraging it. Yet there remains a tremendous need and viable markets for medtech innovation…
The Masters of Biomedical Innovation and Development program (BioID program) is a collaborative academic experience in Biomedical technology and a hands-on clinical experience built upon the extraordinary resources and reputation of the Wallace H. Coulter Department of Biomedical Engineering: a joint department of the Georgia Tech College of Engineering and the Emory University School of Medicine.…
Dr. Steven Goudy, MD, is an associate professor and Director of Pediatric Otolaryngology for the Emory School of Medicine. He recently took the time to sit down with our CEO Tiffany Wilson during a webinar highlighting how physician innovators should approach the medtech development and approval pathway to increase the odds of successfully completing the…
John O’Shaughnessy, Founder & CEO of Matrix Surgical USA Innovators seeking to enter the world of medtech face a daunting path from concept to commercialization. Design, engineering, prototyping and preclinical testing to prepare a single FDA regulatory submission are just a few examples of the many hurdles medtech innovators must successfully clear before event attempting…
Now more than ever, physician innovators are entering into a highly regulated and cost constrained environment. “This industry is not for the faint of heart,” says Rafael Andino, Vice President of Engineering and Manufacturing for Clearside Biomedical, Inc. Andino is part of a team of innovators that built a biopharmaceutical company from concept to clinical…
Read how GCMI and T3 worked together to help John Erbey at Strataca develop a new way to manage Acute…
At T3 Labs, we take great pride in our scientific acumen. Afterall, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA. Our preclinical testing and training program leaders are trained scientists themselves, interested in understanding and participating in the science and methods behind innovations…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…