Manigen Consulting

Clinical Diagnostic Blind Spots

Most clinical diagnostic providers are missing key pieces of information to provide efficient and effective care. Often data trends go unnoticed and providers are unaware that there is a cheaper and easier solution to providing top of the line patient care.

Case Study 1: Startup Lab Compliance

A biotech startup was struggling to prepare for its first CLIA inspection, fearing that a failed audit could halt operations. Manigen stepped in as an external Lab Director, creating a compliance roadmap, training the staff, and optimizing QC processes with practical alternatives to CLSI guidelines. As a result, the lab passed its inspection on the first attempt, and the improved QC processes boosted operational efficiency by 20%.

Case Study 2: IVD Lot Verification

A diagnostics manufacturer faced inconsistencies across product lots, threatening the reliability of their assays and making traditional lot verification methods expensive and time-consuming. Manigen implemented a tailored verification strategy using hypothesis-based QC beyond 2SD to meet regulatory tolerances efficiently. This solution reduced verification time by 30% and saved the company over $50,000 annually in testing costs.

Case Study 3: International Trial Support

A medical device company needed to run a field trial in Europe but lacked connections with suitable clinical sites and principal investigators. Manigen identified VUMC as an ideal partner, facilitated collaboration between the hospital and the company, and managed investigator recruitment. The trial was completed on schedule, generating key data that accelerated regulatory approval by six months.

Case Study 4: ED Workflow Optimization

A large hospital system wanted to analyze workflows in their Emergency Department (ED) to reduce patient wait times and improve outcomes. Manigen integrated AI-driven analytics tools with the hospital’s EPIC EMR system, delivering real-time insights into the activities of nurses and doctors. This solution cut average wait times by 15%, significantly improving patient satisfaction scores.