Five primary client categories.
Most engagements fall into one of five categories: (i) medical-device companies commercializing biosensor, microfluidic, or electrochemical-analysis technologies and needing senior technical guidance on materials selection, device architecture, calibration, validation, FDA pathway, and ISO 13485 quality systems; (ii) semiconductor and photonics groups seeking thin-film, heterostructure-device, or process-integration expertise; (iii) investors and acquirers conducting technical due diligence on deep-tech assets; (iv) federal program officers and grant applicants needing senior review of SBIR/STTR, NIH R-series, NIAAA CRP, ARPA-H, or BARDA proposals; and (v) law firms and patent counsel requiring expert review of claim construction, invalidity, freedom-to-operate, or trade-secret disputes.
Three ways to engage.
Monthly Retainer
For companies that need senior scientific guidance available on an ongoing basis. Typical scope: standing advisory role, regular review of internal technical work, occasional written opinion memos, and an agreed monthly time commitment. Suited to early- and mid-stage medical-device or semiconductor companies between formal board meetings.
Fixed-Scope Project
For a clearly defined deliverable: a technical due-diligence report, a regulatory-pathway strategy memo, a manuscript or grant-proposal review, a patent claim chart, a freedom-to-operate opinion, or a design-of-experiment plan for a calibration or clinical-validation study. Fixed scope, fixed timeline, fixed fee.
Hourly Expert
For shorter engagements, expert-witness work, single-question opinion calls, peer review of a specific deliverable, or as-needed advice. Billed hourly with a transparent minimum and conflict-of-interest screening up front. Typical use: pre-investment calls, single-document reviews, or short technical-advisory sessions.
What a typical engagement looks like.
Technical Due Diligence
For investors evaluating a medical-device, biosensor, or semiconductor target. Includes review of the company's underlying physics, materials and process choices, claimed performance versus data, IP position, FTO exposure, regulatory pathway realism, and key personnel scientific track record. Delivered as a written memo with red flags, green flags, and prioritized questions.
FDA Pathway & Regulatory Strategy
Pathway selection between 510(k), De Novo, and PMA for novel non-invasive monitoring devices; predicate-device analysis; design-control architecture; risk-management approach to ISO 14971; clinical-evaluation report scope; and audit-readiness preparation, coordinated with the firm's regulatory consulting partners where appropriate.
Grant Strategy & Review
NIH SBIR/STTR, NIAAA, ARPA-H, BARDA, and NSF proposal development and senior review. Includes specific aims sharpening, innovation framing, approach critique, milestone realism, commercialization-plan strengthening, and biosketch preparation in NIH SF424 format. Personal experience as PI on Phase I and Phase II SBIR awards totaling more than $1.7M.
Patent & FTO Opinion
Coordination with patent counsel on claim construction, invalidity defenses, continuation and CIP strategy, PCT national-phase entry, and freedom-to-operate analysis. Specific experience with FTO benchmarking against Biolinq, Abbott FreeStyle Libre, Dexcom G-series, SCRAM Systems, Satio, Trividia, and emerging NIR-based alcohol-sensing technologies.
Design-of-Experiment & Validation
Calibration model design, statistical validation planning, accuracy and precision study protocols, interference and selectivity testing, stability and shelf-life study design, and human-subject pilot design for biosensors and continuous-monitoring devices. Coordination with biostatistics and clinical partners.
Expert Witness & Litigation Support
Written opinions and trial testimony on biosensor architecture, electrochemical analysis, thin-film semiconductor device physics, MEMS fabrication, and related topics. Specific experience with claim construction, validity, infringement, and trade-secret matters in deep-tech.
A short conflict screen, then a scoping call.
The simplest way to start is to send an inquiry with one or two sentences describing the question or company, the desired outcome, and any deadlines. I will respond with a brief conflict-of-interest screen and, if there is no conflict, schedule a no-charge 30-minute scoping call to determine whether the engagement is the right fit. If it is, I will follow up with a written engagement letter specifying scope, deliverables, timeline, fee, and confidentiality terms before any chargeable work begins.