Expertise: Medical Device 39 results

Diagnostics

FDA’s Final Rule on LDTs and Its Impact on Clinical and Regulatory Professionals

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that was initially proposed in September 2023 concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. The FDA updated its regulations…

MedTech

Enhancing MedTech Patient Enrollment: The Value of a Recruitment Lead

As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and most importantly, for patients in need of life-changing therapies. Ironically, on examination, the causes for…

MedTech

Safety First: Special Considerations for Medical Device Trials

Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,…

Medical Device

5 Stages of Medical Device Development

Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which…