Case studies

Work that maps to how devices actually ship

Engagement patterns across FDA strategy, engineering, quality, digital health, and executive operating systems—written at the level a CEO or search committee expects.

FDA & Regulatory Strategy

Choosing the right FDA path before the first PCB spins

Classification, predicate strategy, and design controls timed to engineering—not bolted on after freeze.

Hardware–Software Integration

From detector physics to a product someone can operate

Sensor, readout, FPGA/DAQ, pipelines, and application UX as one vertical—not a pile of vendor PDFs.

QMS, V&V & Quality

Design controls that engineers will use, not ignore

ISO 13485-aligned process, verification protocols, and traceability without turning the company into a paper mill.

Digital Health & Telehealth

Device-adjacent software that clinicians and patients will actually open

Telehealth workflows, remote auscultation paths, and RPM-style product surfaces grounded in operations.

Ambient Sensing & Aging-in-Place

Privacy-first ambient awareness without camera theater

mmWave + UWB fusion for check-in and fall-risk context—dignity first, non-diagnostic by design.

Federal R&D & SBIR

Using federal R&D to buy down product risk—not to hide forever

SBIR/STTR and agency teaming as a deliberate path from technical risk to a commercial product.

Executive Leadership

An operating cadence for medical device companies that ship

Portfolio choices, engineering gates, and commercial milestones in one rhythm—fit for CEO/CTO desks.

Strategy framework Discuss a mandate