John David (J.D.) Mccullough Email & Phone Number

Chicago, Il, Us

Strategic consulting and fractional executive services for healthcare technology companies and investors across commercial, reimbursement, market access, operational, and regulatory aspects of healthcare AI. Includes medical device manufacturers, digital therapeutics (DTx), remote patient monitoring (RPM), AI/ML diagnostics and prognostics. Example scopes: • Commercial strategy and reimbursement lead consultant for AI algorithm division of global diagnostics company• Led commercial & operational functions as fractional CXO to Series A SaMD company, signing $2M ACV in biopharma and provider network deals• Led market entry and access as fractional exec at Series A SaMD company, engaging regulators (e.g., FDA, EU notified body, TGA) and payors for current and pipeline products.• US GTM planning for SaMD company, including patient volume mapping (payor, provider, and setting segmentation), reimbursement and evidence planning, early customer engagement, and business unit budgeting.

Bethesda, Md, Us

New York, Us

Commercialization-focused partner, tasked with AI business building and acquisition through Ascertain:• Led business planning for healthcare AI company investment and acquisition, including diligence, redesigning regulatory and R&D strategy, FDA and payor engagement, early customer engagement and partnerships.•Served as Aegis SaMD & MedTech subject matter expert (SME)

Oxford, Gb

(Now Arcturis Data) Sensyne used real world patient data and AI to optimize drug trial design and create healthcare products that reduce cost and improve outcomes. Responsible for US market partnerships, strategy, and business growth.• Led US market entry for new COVID testing product and achieved first US sales.• Negotiated clinical data licensing deals covering 7M+ patients with no upfront cost.• Led health system co-design, development, launch, and BD for the company’s first US healthcare products, keeping the EHR-based predictive analytics products outside FDA oversight.• Grew clinical data provider network by 42M patient records in less than 1 yr. Served as health system and biopharma lead for trial optimization and post-market monitoring deals.

Coralville, Iowa, Us

(Formerly known as IDx) Digital Diagnostics was the first company to have an FDA-cleared autonomous AI diagnostic. Led development, regulatory, clinical trial, GTM for 4 AI medical devices (FDA Class II & III), including strategic partnerships, development, data licensing, FDA engagement, clinical trials, KOL network building, international research.

Coralville, Iowa, Us

(Formerly known as IDx) Responsible for developing and validating OCT platform AI diagnostic opportunities, including biopharma licensing and partnerships, global data licensing, hardware development partnerships, FDA engagement, study design and management.

Coralville, Iowa, Us

(Formerly known as IDx) Led regulated med device software development and delivery, reducing release time 10x by transitioning to agile development, testing, and documentation while maintaining ISO 13485 and GMP compliance.

Online tool for booster clubs to streamline membership process and accept donations. • Founded and grew company through product launches, venture investment, and initial market success.• Apple and Google Play app store launches with thousands of active users.