Malcolm Dell

About Malcolm Dell

Product & development executive who builds and scales complex regulated systems by owning product strategy, risk positioning, and cross-functional execution from concept through regulatory action and commercialization readiness.I specialize in drug–device combination platforms — integrating product value, regulatory constraints, quality systems, and manufacturing readiness into single, executable strategies that drive outcomes. My work sits at the intersection of product strategy, regulatory pathway definition, organizational alignment, and capital efficiency.At MedicaSafe, I own product and development strategy for a prescription drug–device platform, including:Regulatory and product strategy for a 505(b)(2) NDA — shaping submission architecture, sequencing evidence, and managing FDA engagement across CDER and CDRH.CRL recovery leadership — defining remediation scope, prioritizing technical risks, directing cross-functional teams, and integrating external advisors into a coherent resubmission plan.Risk and trade-off decision authority across engineering, quality, compliance, and commercialization constraints.Securing a $1.5M FDA user-fee waiver, materially extending operational runway.Setting CMC, Module 3, and GMP readiness strategy for a regulated system aligned to FDA expectations and inspection readiness.Earlier in my career, I translated technical innovation into repeatable production by helping establish in-house prototyping and manufacturing capability, and was trained by senior leaders from Teva, Takeda, Kimberly-Clark, Paragon, and Google Health.I’m passionate about building product strategy that stands up to regulatory scrutiny, reduces execution ambiguity, and unlocks capital inflection points.Core expertise: Product Strategy • Regulated Systems • FDA/CDER/CDRH Strategy • CMC/Quality/GMP Leadership • Cross-Functional Decision Ownership • Risk Prioritization • Execution Integration

Experience

1. Vice President of Product and Operations

   Medicasafe, Inc

   Jul 2024 — Present · New York, NY, US

Education

• The Cooper Union for the Advancement of Science and Art

  Master's Degree, Mechanical Engineering

  2014 — 2017

• The Cooper Union for the Advancement of Science and Art

  Bachelor's Degree, Mechanical Engineering

  2010 — 2014