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…

How do you know you are ready for preclinical work? Insights and recording from our latest webinar.

How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg joined Renovo Biomedical’s Anna Fallon on January 14, 2021 to answer that question.

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…

Critical questions to answer that determine if your idea has commercial potential in healthcare

From our colleagues at the Children’s Healthcare of Atlanta Pediatric Technology Center – “We knew that we had an innovative concept, but [we] needed to ensure that we were taking the correct steps that would help us reach commercialization in a timely and cost-efficient manner.” Professor James Rains and Georgia Tech Alumnus Mr. Kamil Mahknejia…

GCMI’s Design and Development Process Phase 5: Transfer to Production

At the end of verification and validation, a medical product is ready for regulatory submission or marketing, depending on the product’s regulatory classification. The manufacturing transfer phase typically follows, ensuring that high quality products can be made at sufficient product volumes.    Note: Industry uses “manufacturing transfer” and “transfer to production” interchangeably as you may…