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GCMI Design & Development has moved to gcmiatl.org
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols. Why choose GCMI for your preclinical testing needs? We are collaborative and accountable. We are committed to meeting your needs on your timeline and on your budget. …
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not…
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…
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…
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. …
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…