Harnessing Cloud PLM and AI for Enhanced Productivity

Galvanize Logo

About the Company

Headquartered in Redwood City, California, Galvanize Therapeutics, Inc. is a leading developer of energy-based medical technology that treats a range of diseases, including solid tumors and chronic bronchitis. The company’s proprietary Aliya® PEF Energy platform utilizes short duration, high voltage, electrical pulses that destabilize cells through multiple biochemical processes. Unlike traditional thermal ablation techniques, Aliya PEF can be safely delivered to the target without damaging surrounding tissues.

AT A GLANCE

SYSTEM USED

Arena PLM and QMS

Best Thing About Arena

Seamlessly integrates with custom apps and AI platforms to further streamline product development and ensure compliance

Bottom-Line Impact

Saves Galvanize significant time in performing routine tasks so they can stay focused on product innovation

Key Benefits

  • Centralizes product and quality information in a single digitized system

  • Significantly reduces engineering change order (ECO) cycle times

  • Includes industry-standard RESTful APIs for seamless integration with custom apps and enterprise AI solutions like Botable.ai

  • Streamlines audits for medical device regulations including FDA, ISO 13485, and EU MDR

  • Reduces the time spent searching for information and performing repetitive tasks from hours to just seconds

  • Provides dedicated customer support from expert team of solution consultants and success coaches

BUSINESS CHALLENGES

During its early startup phase, Galvanize maintained product and quality documentation via paper. Implementing product changes was an arduous, time-consuming process, since engineering change orders (ECOs) had to be routed sequentially to each stakeholder for review and approval.

As the company grew, their product documentation and quality processes became more extensive. Because records were stored in file cabinets and other physical locations, employees had difficulty finding documents and identifying the latest revision. Consequently, compiling documentation during regulatory audits took considerable time. “In today’s regulatory environment, auditors expect a fast turnaround time. Failure to quickly retrieve records could result in a nonconformance,” noted Penny Dalton, Associate Director of Configuration Management and Document Control at Galvanize Therapeutics.

“Our reliance on paper made it challenging to maintain bills of materials (BOMs). What’s more, it created a regulatory burden. We needed to ensure information integrity as we implemented changes and released BOMs to our contract manufacturers (CMs). Our primary concern was avoiding product recall issues,” stated Deborah Sheffield, SVP of Regulatory and Quality at Galvanize Therapeutics.

“The hours spent sifting through piles of paper, searching for information, or recreating lost records detracted from our innovation initiatives. We needed a robust digital system to enhance efficiencies while ensuring accuracy and compliance,” added Dalton.

To address these challenges, the organization decided to invest in an all-in-one product lifecycle management (PLM) and quality management system (QMS) solution. They eventually selected Arena.

Image-Engineer reading product documents in a manufacturing facility

Blue quote mark

Having used Arena at my previous company, I knew that we would achieve significant cost savings and operational efficiencies with a cloud-native platform as opposed to paper or an on-premises solution like Agile. Also, the customer support and resources offered by Arena surpass those of other vendors we’ve used in the past. The Arena team is committed to our success!”

—Penny Dalton, Associate Director of Configuration Management and Document Control, Galvanize Therapeutics

THE SOLUTION

Connected PLM and QMS

Arena brings together the entire product record and associated quality processes in a single digitized system. Engineering changes link directly to the product BOM, ensuring that Galvanize’s teams always access accurate and current information. Arena’s automated change review and approval routings significantly reduce ECO cycle times, enabling the company to release products faster.

By connecting corrective and preventive actions (CAPAs), complaints, inspections, and other quality processes to the product record, Arena provides Galvanize complete visibility and traceability to ensure closed-loop quality and drive continuous improvement. Additionally, the ability to easily search and retrieve up-to-date QMS documentation in Arena helps Galvanize demonstrate compliance and expedite their audits.

Arena’s secure and well-documented application programming interfaces (APIs) enable Galvanize to seamlessly connect all the critical PLM and QMS information with other enterprise systems to accomplish their unique business processes.

Illustration-RheOx® system for the treatment of the symptoms of chronic bronchitis
Illustration-INUMI™ Flex Needle for Endoscopic Ablation

Blue quote mark

Arena’s flexible APIs enable us to continually explore new apps and integrations that further reduce our workload and help us meet our product commercialization goals.”

—Penny Dalton, Associate Director of Configuration Management and Document Control, Galvanize Therapeutics

RESULTS

Galvanize has moved away from paper-based processes and embraced digital through Arena’s advanced capabilities including BOM management, engineering change management, supplier items, training management, analytics, and quality management (i.e., complaints, CAPAs, DHRs).

Arena Integration With Botable.ai Enhances Employee Engagement

Using Arena’s RESTful APIs, Galvanize connects their PLM and QMS information with both commercial and custom-built AI applications to further streamline product development and quality processes.

Galvanize initiated an integration between Arena and Botable, an AI chatbot that instantly delivers answers to employees’ pressing questions. By leveraging this integration, non-R&D employees who do not routinely engage with Arena (e.g., sales, finance, executives) can ask questions in natural language and get immediate summarized answers with access to the controlled source documents in Arena—all from their Teams workspace. Additionally, employees receive alerts in their messaging app with links to training assignments in Arena and the scheduled due dates, ensuring that people get these critical notifications where they are every day.

“With the Arena API and Botable.ai, our employees can now perform simple searches and quickly find answers to their questions instead of constantly reaching out to the quality team. We’re also able to retrieve records much faster during our regulatory audits,” stated Sheffield.

Arena Integration With Custom App FIDO Automates Technical File Reviews

Galvanize must review all item part and item document numbers within the product’s technical file to ensure that referenced items are active prior to release. To expedite the review process, they developed an app named FIDO that automatically scans and extracts all the item numbers from each document. By integrating FIDO with Arena, the app can compare item numbers against the existing product lifecycle and revision in Arena and quickly verify their status.

“It would normally take us 13 hours to review a 100-page document. Thanks to the Arena API and FIDO app, it only takes us 67 seconds,” stated Dalton.

Extending the Value of PLM and QMS Through Future Integrations

Looking ahead, Galvanize plans to integrate Arena with their enterprise resource planning (ERP) system to help streamline the handoff to production. To do this, the company will leverage packaged connections to ERP available in Arena’s Marketplace, ensuring a low-lift, durable integration between two critical enterprise systems.

Illustration-Bronchial Rheoplasty Procedure using the RheOx System