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 for unmet clinical needs. At GCMI and T3 Labs we work to streamline the process and expedite product development by partnering with innovators: asking them important questions, providing guidance and enlisting multidisciplinary team resources wherever they may be in the process.
GCMI makes the medtech development process more transparent and predictable, decreasing the time required for a new device to get to market and attracting more investment. GCMI is positioned in the heart of the Southeast where our strategic partnerships with surrounding organizations continue to ignite and support medtech innovation.
GCMI and T3 Labs CEO Tiffany Wilson recently spoke with Sam Brusco, Associate Editor of Medical Product Outsourcing, to provide insight on how GCMI assists medical device developers and physician innovators in getting their novel technology to market. Here is a snapshot of what she had to say about the current landscape affecting medical device development, the mission and know-how of GCMI, and how innovators can better equip themselves to navigate the medtech approval pathway.
“The main challenge we see is that university innovators do not always appreciate the complexity of taking an invention or an initial prototype and turning that into a regulated product,” says Wilson. “There is usually a lot of education and discussion around that process. We also see university innovations developed in a vacuum vs. based on customer-based feedback and specifications—i.e., technology looking for a problem to solve rather than addressing true unmet clinical needs. Finally, the technology transfer process and finding the right business partner can be tricky.”
“The earlier [we are involved in the development of a new medical product] the better—but we can get involved as early as an idea or an unmet clinical need that needs to be addressed, or as late as a product on the market that needs to be re-designed. Our goal is to help accelerate the development and commercialization of new medical technologies so patients can benefit and the medtech startup industry can thrive, so we jump in where we can to help make that happen.”
Her advice to startups and physician innovators looking to bring your novel idea from concept to cure to commercialization?
“Start thinking about design controls and your quality system. Now. Understand your customer(s) and keep them in the loop throughout. Plan. Hit the pause button for a moment to do your homework, understand what milestones investors are going to want to see, what data FDA and CMS need to see, and what specifications are critical for customers to see.”
You can read the full article here.
Are you a physician innovator or engineer with an innovative medtech idea seeking a quality partner to help guide you through the process from concept to cure to commercialization? Are you not certain of your idea’s clinical and market feasibility or commercialization pathway? GCMI can help.
Contact firstname.lastname@example.org or call (404) 385-5191.