All preclinical study estimates are not created equal: they may or may not include line items that can widely influence the total fee. We know preclinical studies are expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but is not always…
Tiffany Wilson, CEO of The Global Center for Medical Innovation (GCMI), and Frank Tighe, Lead Entrepreneur in Residence at The Advanced Technology Development Center (ATDC), discussed the medical product development process for early stage innovators. Learn from their experiences by watching. Too many promising medtech innovations and early stage companies fail unnecessarily…
The design and development process can make or break a medical device’s commercial potential. It is dependent on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. 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. Medical device…
Preclinical work, especially GLP studies, are costly and critical to the product’s successful regulatory submission. Efficiency and quality in preclinical work begins with a robust preclinical study protocol. Preclinical protocols are the foundation on which reports required by regulatory bodies are built. What elements in a preclinical study protocol give the study the best…
Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time to attend a webinar! The team at GCMI is excited to announce that we will be hosting a series of webinars starting next week. Our first webinar focuses on good laboratory practice (GLP) preclinical…
What we learned during an open dialogue with GCMI, Piedmont Healthcare, Children’s Healthcare of Atlanta, and West Tennessee Health on pulling new medtech ideas out of the clinical mindspace and into development. Hospitals are hotbeds for innovative, value-based clinical medtech solutions. Identifying unmet clinical needs in hospital settings, along with the guidance and resources to…
Dr. Steven Goudy, MD, is an associate professor and Director of Pediatric Otolaryngology for the Emory School of Medicine. He recently took the time to sit down with our CEO Tiffany Wilson during a webinar highlighting how physician innovators should approach the medtech development and approval pathway to increase the odds of successfully completing the…
Now more than ever, physician innovators entering into the medical device ecosystem are experiencing a highly regulated and cost constrained environment. Maneuvering through this world is not for the faint of heart and takes more than sheer will: it takes a multidisciplinary team. Navigating the journey from concept to commercialization for novel new products and…