Case Study: Boston Scientific achieves 78% faster processes and $4.4M ROI with DocuSign

Boston Scientific brings products to market faster with DocuSign eSignature

Boston Scientific, a global medical‑device company with $8.4B in sales, 27,000+ employees and 13,000+ products, was hamstrung by paper‑based, manual processes across manufacturing, distribution, clinical trials and regulatory assessments. These workflows caused delays, high error rates and posed a risk of non‑compliance with FDA 21 CFR Part 11, so the team sought a secure, Part 11–compliant digital solution.

DocuSign’s Part 11 Module centralized and automated workflows—consolidating multiple forms into a single online chain‑of‑custody form, digitizing clinical consent, and replacing a 23‑page regulatory form with smart questionnaires using conditional logic. The transformation cut active‑release stages from 36 to 6, eliminated GDP errors, sped processes by 78% on average, and delivered a $4.4M ROI with significant savings across distribution, clinical trial and regulatory administration.

Boston Scientific

Kevin Clark

Manger of Global Clinical Operations