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.

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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.