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Regulatory & Translational Strategy

Clear regulatory guidance and validation pathways aligned with FDA requirements and product reality.

Clinical & Medical Affairs

Clinical trial strategy, KOL engagement, partnerships and publication planning to generate readiness and credibility.

Market & Commercial Approach

Unmet-need and use case assessment, market positioning, and value narratives that support adoption and growth in various industries.

Jennifer L. Corso

Founder and Principal Advisor

With nearly a decade of success leading strategy in emerging life science companies, Jennifer provides senior and executive-level advisement to early-stage biotech and medical device organizations. Her background spans formal training as a physiologist in metabolics, chronic disease and cardiovascular science, leadership as a US Army officer including special operations, and the development of novel biochemical, diagnostic and biosensing technologies in photonics and optics. This multidisciplinary foundation enables her to guide biomedical innovation across commercial and defense sectors with clarity, rigor, and strategic focus.

From Insight to Outcome

Services
  • Advise executive and technical teams on clinical evidence strategy, technical validation, regulatory pathways (FDA Q-Sub, 510(k), De Novo), short- and long-term commercialization planning for 0→1 technologies.
  • Lead KOL engagement, scientific advisory board formation, institutional partnerships and external credibility.
  • Develop unmet-need assessments, market analyses, and opportunity forecasting for product development.
  • Develop and support publication strategy, medical communications, including manuscripts, abstracts, and conference strategy, in collaboration with clinical and academic partners.
  • Provide physiology and biomarker expertise for wearable and optical sensing platforms spanning clinical, preventative, and performance health applications.
  • Contribute to investor and partner diligence through technical positioning, evidence narratives, and translational strategy.
Experience

  • Clinical, regulatory, and product development leadership for optical and photonic technologies, including non-invasive and wearable NIRS platforms, photonic integrated circuits (PICs), and short-wave infrared (SWIR) spectroscopy.
  • Applied development of biomedical and performance technologies across remote patient monitoring, diagnostics, rehabilitation, and human performance, spanning commercial and defense contexts.
  • Deep technical and translational expertise across non-invasive glucose monitoring, hydration metrology, cuffless blood pressure, kidney disease and dialysis monitoring, muscle oxygen kinetics, and nitric-oxide–related sensing.
  • Senior product, clinical, and commercialization strategy for 0→1 technologies, including device strategy definition, clinical evidence planning, FDA regulatory pathways, and cross-functional translation across semiconductor, medical device, wellness, and defense industries.
  • Development of technical, clinical, and regulatory diligence materials to support engagement with existing and prospective investors, venture capital groups, and banking partners.
  • End-to-end organizational and market support, including use-case definition, market analysis, short- and long-term revenue forecasting, QMS development, product lifecycle management, cross-functional team leadership, KOL and institutional partnerships, medical affairs and technical communications, and intellectual property development.
  • Defense and government partnership leadership, including establishment of DoD funding and collaboration pathways (USSOCOM, DTRA, and AFRL), supported by prior service as a U.S. Army Officer with TS/SCI clearance.
  • Formal academic and industry research foundation in fuel metabolism and kinetics, cardiovascular signaling and health, neuroscience and electrophysiology, exercise and chronic disease, biopharmaceutical pharmacokinetics, and analytical chemistry.
Results

Track record is denoted by a 75% success rate in durable or monetizable outcomes, and a 100% success rate in reaching critical de-risking milestones.

  • Executed business and clinical strategy for NIRS-based biosensing platforms in cardiovascular rehabilitation and movement disorders.
  • Led product validation, FDA regulatory strategy, and clinical trial design for novel continuous-wave NIRS and broadband optical sensors targeting tissue oxygenation, non-invasive glucose monitoring, and hydration metrology.
  • Advanced regulatory readiness, including FDA pre-submission planning and evidence alignment to support downstream clearance pathways.
  • Established and represented strategic partnerships with premier medical institutions and universities to support clinical evidence generation and technology credibility.
  • Delivered formal unmet-need assessments, market analysis, and revenue forecasting for optical sensing platforms positioned as crossover medical–consumer products.
  • Formed scientific advisory boards and led KOL engagement across NIRS and medical coatings domains, enabling expansion into cardiovascular and orthopedic applications.
  • Developed publication and conference strategy, including technical authorship supporting device verification and validation, clinical study outcomes, and external credibility through press releases, white papers, and peer-reviewed manuscripts.
  • Prepared dual-use positioning and government engagement strategies for biosensing technologies spanning commercial and defense applications.
  • Supported investor and partner diligence and capital fundraising, delivering technical positioning, evidence and commercial narratives.

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