Medical Device — Continuous Glucose Monitoring · Medical Device Validation Study · Dexcom
Medical Device Validation Study Project Manager Simulation — Dexcom
Coordinate Dexcom's pivotal accuracy validation study for the G7 continuous glucose monitor under FDA IDE oversight — a $1.5M, 14-week study enrolling 120 adults with type 1 diabetes across four endocrinology sites. Run the in-clinic comparator testing and agreement-rate analysis so the study's endpoints map cleanly into the PMA submission — while a tightening FDA interpretation and one lagging site test your rigor. Gain hands-on project management experience over 27 days of real decisions, stakeholders, and PMO deliverables — no prior experience required.
The scenario
Dexcom is the category leader in continuous glucose monitoring (CGM) — wearable sensors that read interstitial glucose every few minutes and stream it to a phone, replacing most of the fingersticks people with diabetes once relied on. The next-generation G7 sensor is built and the engineering work is done. What stands between it and the people who need it is evidence: the U.S. Food and Drug Administration will not clear the G7 for sale until a controlled study proves the sensor reads accurately enough to be trusted for treatment decisions. That study is yours to run. It is a $1.5M pivotal accuracy validation enrolling 120 adults with type 1 diabetes across four endocrinology sites. Over a 14-week window, participants wear the G7 while clinic staff draw frequent venous samples and run them on a YSI 2300 STAT Plus reference analyzer — the laboratory 'truth' the sensor's readings are measured against. The headline number is MARD (Mean Absolute Relative Difference) and a set of agreement rates that the FDA's reviewers will read line by line. Every reading has to flow cleanly into REDCap and survive the analysis intact. You are the coordinating Project Manager. You do not design the sensor and you do not run the statistics yourself — you sit in the room with the people who do, and you make sure the study that comes out the other end is one a regulator can sign off on. The protocol is locked, the FDA has already weighed in once with written pre-submission feedback, and a prior-generation sensor cleared on a similar design — which is exactly why the team assumes this one will too. Your job is to make sure the evidence is clean enough that the submission survives the reviewer who is paid to find the gap.
What you'll do as the project manager
- →Enroll and retain 120 adults with type 1 diabetes across four endocrinology sites within the 14-week study window
- →Generate a clean paired-glucose dataset — CGM readings matched to YSI reference values — sufficient to characterize G7 accuracy (MARD + agreement rates) across the full glucose range
- →Run the IDE study in conformance with the locked protocol and FDA pre-submission commitments, with deviations documented and reported on cadence
- →Demonstrate accuracy that meets the FDA iCGM special-controls thresholds, with particular rigor in the hypoglycemic range
- →Assemble the accuracy-study module of the PMA submission package, analysis-ready, by the close of the study
Project management skills you'll build
The challenges you'll navigate
- •Low-glucose accuracy reporting — the FDA's interpretation of how hypoglycemic-range agreement must be characterized has tightened since the prior-generation submission, and the team's instinct is to report it the way that cleared last time
- •Enrollment pacing across four sites — a single site lagging on activation or recruitment compresses the comparator-session schedule and the downstream analysis window
- •Comparator-session integrity — paired CGM/YSI readings only count if timing, sample handling, and analyzer calibration are consistent across all four sites
- •Protocol-amendment pressure — a request to add a cohort, a site, or an extra measurement looks small but can reopen the IDE and the FDA conversation
- •Submission-calendar dependency — the accuracy module feeds a fixed PMA filing date; slip in the study slips the submission
Technology & stakeholders
You'll manage 6 stakeholders, including Dr. Marisol Quintana (VP, Clinical Affairs), Gregory Holt (Sr. Director, Clinical Program Management), Dr. Pamela Reinholt (Principal Regulatory Consultant (IDE/PMA)), and more.
What you'll walk away with
A verified, shareable record of a completed enterprise project — plus the PMO deliverables you produced along the way (charter, project plan, SteerCo deck, closure document). It's real, demonstrable project management experience you can put on your resume and speak to in interviews.
Frequently asked questions
Do I need project management experience to start?
No. This simulation is built for aspiring and practicing project managers alike — you learn by doing. You make real decisions and get feedback, with no PMP or prior PM job required.
How long does this simulation take?
It runs over 27 days, roughly 23 minutes per day, covering the full project lifecycle from initiation to closure.
What will I learn?
You practice the core of project management — stakeholder management, budget and schedule control, risk, scope, and PMO governance — in the context of medical device validation study in medical device — continuous glucose monitoring.
Is this based on the real Dexcom?
It's a realistic scenario inspired by Dexcom and the Medical Device — Continuous Glucose Monitoring sector. Details and names are fictionalized for training — it's a simulation, not a record of any actual project.
What do I get at the end?
A verified project completion plus the PMO deliverables you produced (charter, plan, SteerCo deck, closure) — proof of hands-on experience you can show employers.
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