Preclinical testing’s role in the medical device design and development phase

In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase (called “Phase 1” at GCMI). At the completion of project planning, innovators have determined what work is required to take the technology from prototype to product. The Design and Development…

Under pressure: cadaveric testing yields initial human organ validation for GT Capstone Expo winners’ minimally invasive treatment for cardiac arrest

There are approximately 292,000 cases of in-hospital cardiac arrest every year for which the survival rate is less than 24 percent. Resuscitative efforts and supporting technologies are ineffective, slow, fatiguing, traumatic and expensive.   As their Fall 2020 Capstone Project, a group of students from the Georgia Tech Schools of Biomedical, Electrical and Mechanical Engineering…

Testing beyond the bench: how GCMI supported GT Capstone’s “Incisionizers” with early stage validation testing for its novel retraction device.

Georgia Tech recently completed its Fall 2020 (virtual) Capstone Design Expo. From the project’s website, “The Capstone Design Expo showcases Georgia Tech’s graduating seniors as they present their innovative projects designed and built during the Capstone Design Course. Students work in teams to solve either an industry problem, develop innovative tools to assist researchers, or…

News: Georgia Tech Names Raghupathy Sivakumar Inaugural Interim Chief Commercialization Officer

Last month, Georgia Tech named Raghupathy “Siva” Sivakumar inaugural Interim Chief Commercialization Officer. From Georgia Tech Research Horizons:   “Sivakumar will bring together commercialization and technology transfer activities from across campus with a goal of moving more intellectual property out into the marketplace to help expand Georgia Tech’s impact on the world. Attaining that goal…

How does our verification and validation phase of medtech development ‘translate’ to preclinical studies?

In section 21 CFR 820.3 of the federal code, FDA defines design verification as “the process of confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Design validation is defined as “the process of establishing by objective evidence that product specifications conform with user needs and intended use(s).”  Medical product…

How do you know you are ready for preclinical work? Join us for a free webinar on January 14.

Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions.  But this type of work is also expensive. The most effective product development strategies use preclinical studies wisely. The most expensive preclinical study is the one you have to repeat.   How…

Medtech Innovators and Investors: Are You Wasting Cash In Design & Development?

Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash unnecessarily.    Too many promising medtech innovations and early stage companies fail unnecessarily because they run out of funding before achieving milestones required for next-round investments.    It is possible to know earlier in the…

Learn more about: PreClinical CRO, Med Device Design, Development, Prototyping and More with GCMI.

Medtech and life science innovation is a complex, costly endeavor. How do you know you are on the right regulatory track? What activities need to happen in which order to achieve key milestones efficiently?   Preclinical work is expensive and the most expensive study is the one you have to do twice.   GCMI helps…

Recording & Takeaways: Lessons Learned from Rapid Commercialization and Collaboration in Response to PPE Shortages

Innovative medical technologies start with a great idea, novel science and an identified unmet clinical need. The process by which these technologies enter clinical care is as complicated as the science behind it. On October 7th, Georgia Tech Associate Professor of Engineering Christopher Saldana and the team at GCMI shared the impetus, idea, regulatory requirements…