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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…
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…
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…
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,…
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…