You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives.
Topics: Medical Device Innovation, FDA Approvals, Scott Gottlieb
No matter the therapeutic area, device companies agree: Creating cutting-edge products is expensive. From the R&D costs to the pricy FDA fees, the expense for innovation adds up quickly. As products become more technologically advanced, the cost for designing new devices has increased. At the same time, device companies are being hit with fees that are wiping out their R&D budgets, such as the new 2.3% medical device tax, which reportedly requires companies to collectively pay an estimated $194 million per month. How do the companies overcome this expense?
Topics: Research & Development, Medical Device Innovation, FDA
I ran across an article in MDDI on virtual prototyping that could have an impact on clinical trials. There is mixed opinion on the value of clinical trials. Advocates claim they are necessary to ensure patient safety, while many in the device industry argue trials are only necessary for complex medical devices.
Topics: Virtual Prototyping, Medical Device Innovation, Clinical Research