Advancing Healthcare with Medical Devices Requires a Winning Regulatory and Clinical Trial Strategy
Time to market is essential to stay ahead of competitors, maximize revenue generation, and increase the lifecycle a new medical device.
Lucent Clinical Consulting helps medical device and healthcare companies accelerate the global commercial launch of new medical devices, adapt to regulatory standard changes and protect core markets.
Recent Client Wins
- Empowered a client in achieving product development and on-time regulatory approval of a therapeutic dose monitoring diagnostic assay for a novel cardiovascular drug. Justified broad regulatory claims for IVDD CE mark, saving the client $570K in development costs and 6 months of effort.
- Delivered regulatory and clinical trial guidance which enabled a client to complete development of a novel AI/ML cardiac rhythm detection algorithm with FDA Breakthrough Device Designation, negotiate with the U.S. Food and Drug Administration, and achieve De Novo approval within 1 calendar year.
- Mentored a client on risk-based clinical trial monitoring methods for a diagnostic device, reducing the trial lifetime cost for trial monitoring by >$1M.
- Supported a client in creating standardized regulatory tools and a departmental project portfolio with metrics that quantified the business value of the function.