Boston Scientific Brings Products to Market Faster with DocuSign eSignature

Every 1.3 seconds, somewhere in the world, a patient is treated with a Boston Scientific product. With $8.4 billion in sales and 27,000+ employees, the company has a vast footprint and plays a massive role in human health. The company doesn’t just manufacture medical technology—it gives medical professionals the tools to change people’s lives.

But managing the design, production, and distribution of over 13,000+ products is a tremendous task—and manual product development and distribution processes were slowing down operations. There were simply too many versions of different forms, each requiring signatures from numerous stakeholders. 

“We needed a better solution,” Kevin Clark, Manager of Global Clinical Operations, said. “And not just any solution, but one that complied with FDA 21 CFR Part 11, the regulation governing electronic signatures in medical records.” As a result, when Clark discovered DocuSign's Life Sciences Modules for 21 CFR Part 11, he knew it could be game changing.

As required by the regulation, DocuSign's Life Sciences Module for 21 CFR Part 11 is designed as an open system with controls that ensure the authenticity, integrity, and confidentiality of electronic records. Secure, compliant, and digital, DocuSign eSignature modernized Boston Scientific’s distribution process by automating form completion resulting in a $4.4 million ROI on the company’s DocuSign investment.

Digitizing the product distribution process

Boston Scientific’s process for moving products from manufacturing sites to distribution centers required the completion of multiple forms, which were scattered and often hard for users to find on the company’s site. The workflow was outdated, slow, and complex.

“We had three forms, multiple people reviewing, multiple people signing, and no automation, so products weren’t getting to market quickly enough,” Clark said. With DocuSign eSignature, Boston Scientific centralized and automated the process. Not only did the tool enable Boston Scientific to create reusable templates to standardize forms, but it also provided consistent signature status visibility and ensured that forms automatically kept moving along the “chain of custody,” Clark explained. 

“We couldn’t eliminate stakeholders,” Clark said, “but we did condense all those forms into one and bring it online.” Thanks to DocuSign, Boston Scientific reduced the stages required to complete forms from 36 down to six—an 83% improvement. And, as a result, the company cut costs associated with distribution and product controls by 48%.

Improved clinical trial experiences for patients and physicians

Boston Scientific was able to eliminate paper processes and improve user experience for physicians and patients in clinical trials too. For example, when bringing patients into clinical trials, Boston Scientific struggled with a workflow that required too many manual steps. 

“Someone on our team would have to email each form to physicians. They’d have to print it out, get signatures from patients, scan it, and email it back,” Clark said. Delays were putting the success of the trials—and ultimately the development of new products—at risk. With DocuSign eSignature, patients can sign forms digitally, providing consent quickly and securely.

“In the clinical group, DocuSign adoption spread like wildfire,” Clark said. Boston Scientific saved 41% in clinical trial costs.

Reducing errors to ensure compliance

DocuSign eSignature also improved Boston Scientific’s regulatory assessment process (DRA). This manual process, which ensures that the company adheres to medical regulations, was long, manual and put Boston Scientific at risk of non-compliance.

“This was a 23-page form. Over 150 questions. Zero logic. No drop-downs,” Clark said. The error rate was high at 48%.

But Boston Scientific transformed the workflow using DocuSign smart questionnaires with conditional logic and advanced formulas, which digitized preparation and submission, and added automation to make completion faster and more straightforward. Now, the compliance team can instantly determine which questions are required because they’re highlighted in the form, saving them time. And, because the forms now offer version control, errors have dropped dramatically, from 48% down to 0%. 

From smart automated forms and signature workflows, to more reliable compliance processes, Boston Scientific is completing forms 78% faster than it did before DocuSign eSignature and bringing products to market faster. “When we talk about work flow, DocuSign is the epitome of how to streamline and gain efficiencies,” Clark said.