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Better neurodiagnostic operations, built quietly and well.

Kaizen Shark is a consulting practice for clinical operations leaders who want cleaner workflows, stronger quality programs, and a steady hand through change. Deep specialty experience in neurodiagnostics, with transferable expertise in quality systems, project leadership, and AI readiness across clinical settings.

Kaizen Shark is led by Sedalia Cole. Fifteen years in neurodiagnostics, seventeen in leadership roles, and a track record of turning messy clinical operations into programs that run on purpose instead of habit. Published in the Journal of Clinical Neurophysiology, presented internationally, and comfortable working with everyone from bedside technologists to epileptologists to executive teams. The deepest experience is in neurodiagnostics, but the work itself translates. Quality systems, KPIs, project leadership, and change management look similar whether the setting is an EEG lab, a clinical research site, a medical device company, or a digital health startup.

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What I do:

Clinical operations and quality

Quality management systems, SOPs, KPI design, audit readiness, and the kind of process work that holds up under regulatory scrutiny. Six Sigma where it helps, plain common sense where it doesn't.

Program and project leadership

Fractional leadership and project management for neurodiagnostic programs, software implementations, training build outs, and company wide initiatives. Remote friendly, outcome focused.

Specialty practice advisory

Building a remote monitoring program. Standing up an ambulatory EEG service. Growing an existing department without losing quality. This is the specialty work, informed by hands on experience across hospital, research, and industry settings.

AI and data readiness for clinical teams

Most clinical groups know AI is coming for parts of their workflow and aren't sure where to start. I help teams sort the useful from the hyped, pilot tools that actually fit the work, and build the data hygiene and KPI foundations that make any of it worth doing. Grounded in real clinical operations, not slideware.

A few things I've done:

Cut end to end client turnaround time by 13 percent using DMAIC
Improved training efficiency by 60 percent through a redesigned clinical QMS and LMS program
Reduced average recruitment turnaround by 67 percent
Defined KPIs that drove departmental productivity gains of 6 to 29 percent
Organized and led a solo neurodiagnostic training mission in Accra, Ghana, teaching 15 professionals across technologist, support, and physician roles
Published author and international speaker on EEG practices

Is this a fit?

Kaizen Shark is a good fit if you need a seasoned operator who can walk into a clinical program, see what's working, name what isn't, and help your team fix it without drama. Engagements are remote first, scoped honestly, and priced to the value of the work.

Most of my work has been in neurodiagnostics, but the underlying problems are universal in clinical operations. If you're in a related specialty or a healthcare company that needs a steady operator for a defined project, I'm happy to talk.

If that sounds like what you're looking for, send a note.

Sedalia Cole sedaliac@kaizenshark.com +1 425 306 1810