How does our design verification and validation phase of medtech development ‘translate’ to preclinical studies?
How does medtech design verification and validation “translate” to preclinical testing? GCMI’s Director of Scientific Affairs explains.
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…
Webcast Oct 21., 12pm: Building a foundation for growth: How Georgia Tech “born” Jackson Medical used Phase Zero to try to end “never events” in the operating room.
Overheating lighting instruments coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to these as “never events” so they should never happen, right? But, data suggests that they occur more than twice a day. This was a red flag for Jackson Medical co-founders James Rains and…
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…
Medtech IP legalese 101: What is a patent landscape review, what is a patent, what is freedom to operate?
All types of innovators need to carefully protect their intellectual property (IP) from those who may infringe on their ideas and products, and themselves from inadvertently infringing on others’. Medtech innovation is no exception and the landscape is rife with pitfalls. Smith, Gambrell and Russell’s Matthew Warenzak shares his insights on patent landscape reviews, patents…
Commercialization During the COVID-19 Crisis: Lessons Learned in a 60 Minute Webcast.
The vast majority of novel ideas from academia never make it into clinical use. Together we can change that. 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,…