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 to overwhelm even seasoned engineers, and that is why some manufacturers and innovators turn to third-party medical device design firms. One of the biggest mistakes medical device engineers make, is jumping in too early and developing a prototype with cool technology without understanding the clinical problem. 3D printing is great, and rapid prototyping is fun- it really is a good time. However, if the goal is solving a clinical problem and providing a needed solution to the market, you must understand the problem you’re solving first.
The Global Center for Medical Innovation (GCMI) is the world’s leader in driving efficient medical product innovation, bringing together core members of the medical device community, including universities, research centers, clinicians, established device companies, investors and startups. GCMI exists to accelerate the design, development, clinical testing, and commercialization of innovative medical technology.
The first and only organization of its kind in the Southeast, GCMI launched in 2012 and teamed up with T3 Labs, leading preclinical CRO, in 2016 with the goal of helping new-product teams enhance their product development, shorten time to market, and potentially achieve significant cost savings throughout the process.
In a recent article by Senior Editor for Assembly Magazine, ‘How to Work With Medical Device Design Firms,’ GCMI and T3 Labs CEO Tiffany Wilson discusses the top needs for medtech innovators, and how the current state of the healthcare industry has influenced medical device design and innovation strategies.
You are going to need a multi-disciplinary team
“Creating a novel medical device is really a process that requires a multidisciplinary team,” says Wilson. “Many innovators and startup firms don’t realize that the developmental pathway they are entering into is highly regulated and ever-changing.”
“One huge piece of advice I have for physician innovators is to first secure the IP and then find a ‘GCMI.’ They offer direction and insights into the medtech landscape and marketplace to help determine whether or not your idea makes sense. Otherwise you are wasting time and money.” – Hunter Moyer, Founder and CEO of Vivid LED Technologies
“It is still possible for a small startup company to do all that on its own,” Wilson admits. “However, it’s likely to burn through valuable time, make mistakes and spend more capital to complete the concept-to-commercialization process.”
Engaging a firm that understands manufacturing and FDA requirements
“Now, more than ever, because of the Affordable Care Act and ongoing shifts in healthcare regulation, it is important to engage a firm that can help you design your device with manufacturing requirements in mind from the start,” claims Wilson. “Medical device firms should also possess the knowledge and resources that maximize the potential for FDA clearance, and understand what type of data payers will be looking for.”
“GCMI was instrumental in our early development including prototyping that led to a product candidate we could take into clinical trials. We used their space, cleanrooms, equipment and personnel to help develop and validate our product candidate and its value.” – Rafael Andino, Vice President of Engineering and Manufacturing for Clearside Biomedical, Inc
You can read the entire Assembly Magazine article about engaging third party medical device design firms here.
Are you seeking a partner to help navigate your novel medical device from concept to cure through preclinical and then commercialization? Contact GCMI today to learn more about the robust medical device ecosystem and the Southeast’s available resources for innovators.