Built for Translational Clarity
Sigma Biotech is a translational strategy firm integrating science, regulation, quality, and clinical execution into one coherent development framework.
Sigma Biotech is a translational strategy firm integrating science, regulation, quality, and clinical execution into one coherent development framework.
Biotechnology most often fails not because of poor science, but because of misalignment across development functions.
Sigma exists to eliminate silos — aligning translational intent, regulatory reality, and clinical execution from the outset.
What ∑ Represents
Strategy anchored in regulatory pathways, clinical impact, and real-world use — not isolated milestones.
Regulatory, quality, clinical, and scientific leadership working as one unified team.
Alignment maintained from early strategy through post-market evidence generation.
CEO & Principal
Rachel brings 20+ years of translational research experience across medical device R&D, regulatory strategy, and clinical operations. She has guided programs from prototype through approval while balancing rigor, speed, and resource constraints.
Her focus is ensuring development decisions are approvable, executable, and aligned with patient impact.
Principal & Advisors
Sigma’s leadership includes senior translational scientists and clinicians with decades of experience across orthopedic, neurological, and interventional technologies.
Our principals have authored hundreds of peer-reviewed publications and supported regulatory interactions globally.
A multidisciplinary team of translational scientists, clinicians, and regulatory experts aligned around one mission: bringing better technologies to patients faster.
CEO & Principal
20+ years of translational research experience spanning medical device R&D, regulatory strategy, and clinical operations.
Scientific Principal
35+ years of translational research leadership with extensive clinical, orthopedic, and neurosurgical expertise.
Founding Inspiration
A respected clinician and scientist whose commitment to rigor, compassion, and patient-centered innovation continues to guide Sigma’s mission.
Sigma Biotech was established in memory of Dr. Felix Vega, whose dedication to scientific rigor and patient-centered innovation continues to guide our work.
Evidence-driven translational research that supports defensible decision-making.
Human-centered development from study design through real-world use.
A portion of profits will be dedicated to honoring Dr. Vega’s legacy through future initiatives.
If you are building complex biomedical technologies and need translational clarity across the development lifecycle, we should talk.