Overview
Client: Galvanize Therapeutics
Consultant: Teresa Nelson, Phazes Project Management, LLC
Project: Aliya System Development & Confidential B2B PEF System Collaboration
Galvanize Therapeutics, a leader in the medical device space, partnered with Teresa Nelson of Phazes Project Management, LLC to manage two critical projects focused on pulsed field ablation (PEF) technology. The first project involved the Aliya System, a groundbreaking device FDA 510(k) cleared for the surgical ablation of soft tissue. The second, a confidential business-to-business collaboration, centered around developing a PEF system for a new indication for clinical trial use.
Teresa served as the program manager for both initiatives, bringing her vast experience in project management, technical leadership, and regulatory compliance to guide these highly complex projects. Her involvement was key in coordinating cross-functional teams, managing timelines, and ensuring regulatory adherence.
Challenge
The Aliya System, a PEF medical device, was in development to provide an innovative method for the surgical ablation of soft tissue. The project required precise coordination across multiple teams to ensure the product met all regulatory requirements and could be successfully launched in the U.S. market.
Teresa's Role
As the program manager, Teresa played a central role in the Aliya System's development and launch. She worked closely with the project team to plan and execute each phase of the project, from initial development through the U.S. market release. Her responsibilities included overseeing project timelines, collaborating with engineers, quality, regulatory and contract manufactures to ensure the product’s adherence to FDA regulations.
In addition to her project management duties, Teresa was the technical lead for UDI (Unique Device Identification). This role required her to develop UDI strategies to meet FDA requirements and to ensure the UDI system was effectively integrated into Galvanize's internal processes.
Key Outcomes
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Successful U.S. Market Launch: Teresa’s leadership ensured that the Aliya System met all key product development milestones to comply with regulatory requirements, culminating in a successful launch in the U.S. market.
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Regulatory Compliance: Her attention to detail in managing UDI ensured that the product complied with FDA guidelines, streamlining the approval process.
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Cross-Functional Team Collaboration: Teresa’s ability to coordinate and collaborate with cross-functional teams and contract manufacturers allowed for seamless communication and efficient project progression.
Conclusion
Teresa Nelson’s work with Galvanize Therapeutics highlights her exceptional program management skills, particularly in the highly regulated and complex medical device industry. Her ability to lead teams, navigate challenges, and ensure timely delivery was pivotal in both the Aliya System’s successful launch and the progress of the confidential collaboration project.
Her leadership not only facilitated the U.S. launch of the Aliya System, but also positioned Galvanize Therapeutics for future success in developing groundbreaking medical devices. Teresa’s contributions were invaluable to advancing innovative healthcare technologies, reinforcing her reputation as a top-tier program management consultant in the MedTech industry.
Case Study: Galvanize Therapeutics - Leading Program Management for Groundbreaking Medical Devices
Project 1: The Aliya System
Project 2: Confidential B2B PEF System Collaboration
Teresa's Role
As the program manager, Teresa led the development team to ensure that all technical, regulatory, and verification and validation testing requirements were met.
Additionally, she took on key technical lead responsibilities such as:
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Managing ethylene oxide (EtO) sterilization validation to ensure the device met stringent medical safety requirements.
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Overseeing biocompatibility validation to guarantee that all materials used in the device were safe for clinical use.
Though the project has been temporarily put on hold, Teresa's leadership ensured the project was positioned for success upon reactivation.
Challenge
In addition to the Aliya System, Teresa managed a confidential business-to-business collaboration project focused on developing a PEF system for a new clinical indication. This highly sensitive project required meticulous planning to meet an aggressive product development schedule. The project was put on hold, with details remaining confidential until market release.
Key Outcomes
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Cross-Functional Collaboration: Her leadership in coordinating a diverse team across multiple departments and organizations ensured that project milestones were met.
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Robust Validation: Teresa’s management of the overall project and the sterilization and biocompatibility validation testing was crucial for ensuring the device was positioned to move forward with clinical trials.