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GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards for our medtech and life science customers. …
Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols…
Medical product design verification and validation activities (called “Phase 3” and “Phase 4” at GCMI) typically come after a design phase (called “Phase 2” at GCMI). At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this…
Design and Development for medtech: digging in to complete design tasks, achieving design freeze and ensuring readiness for manufacturing.
The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not the only study that a reviewer might be working on. How do you make the report detailed, yet easy to read? What elements must be present? What common mistakes should you be certain to avoid?…
Where does Medtech Project Planning fit in with Product Development and why is it important? Let’s review the basic steps for successful Project Planning. What is Project Planning? Project planning, also referred to as “Phase 1” at GCMI, follows directly after the feasibility phase, “Phase Zero.” Phase 1 is the beginning of the formal…
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…
Here are some of the most common cost types you should consider when planning your preclinical study to give your product the best chance of getting to market as swiftly and efficiently as possible focusing on what matters most – clearance from regulatory bodies like the FDA.
When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already surmounted significant obstacles. They are nearer to realizing the possibility that their product will enter the market and patient care than ever before. Quality preclinical research begins with a robust preclinical study…