Overview
Client: Blaze Bioscience
Consultant: Teresa Nelson, Phazes Project Management, LLC
Project: Ongoing (currently in development)
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Blaze Bioscience, a cutting-edge biotechnology firm developing a medical device for use during brain surgery, engaged Teresa Nelson of Phazes Project Management, LLC as a project management consultant. The focus of the partnership was to develop an innovative medical device designed to visualize tumor fluorescence during brain surgery. This device provides real-time, high-resolution visualization of cancer cells during surgery and is planned for clinical trial use.
Teresa’s extensive experience in project management and her specialized knowledge in the medical device industry were critical in managing the complex development process of this innovative technology. This case study highlights her expertise in driving the project forward, ensuring compliance, and meeting key milestones in a regulated, high-stakes environment.
Challenge
The development of a medical device that uses fluorescence imaging posed several challenges:
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Complex Product Development: Managing the technical intricacies of designing a device that integrates seamlessly into neurosurgical procedures required close coordination with multiple teams, including engineers, software developers, and contract manufacturers.
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Regulatory Compliance: Given the nature of the device and its application in brain surgery, compliance with stringent medical device regulations was critical, necessitating meticulous attention to detail in design controls and documentation.
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Coordination with Contract Manufacturers: Ensuring the alignment of external contract manufacturers with the project’s goals, timeline, and quality standards was vital to the development process.
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Labeling and UDI Strategy: Developing labeling and UDI (Unique Device Identification) requirements and labeling designs to comply with FDA regulations and recognized standards to ensure the device is ready for commercial launch upon completion of clinical trials.
Teresa's Role
To address these challenges, Teresa implemented a comprehensive project management strategy, leveraging her expertise and industry knowledge:
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Collaborative Development Process: Teresa took a proactive role in managing the product development lifecycle. She led the device team, ensuring that all key stakeholders, including engineers, software developers, and contract manufacturers, were aligned and working towards common goals. By facilitating communication and collaboration between these diverse groups, she maintained a unified vision for the project and minimized potential bottlenecks.
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Regulatory Expertise and Documentation: Teresa’s technical acumen and familiarity with regulatory requirements were instrumental in ensuring compliance at every stage of development. She authored critical design control documents, protocols, and other essential paperwork, to support clinical trial readiness. Her attention to detail in design control documentation ensured the device met all necessary requirements and standards, allowing for a smoother transition to clinical testing.
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Coordination with Contract Manufacturers: One of Teresa's key responsibilities was managing the relationship with contract manufacturers responsible for the device’s development. She oversaw the project schedule and ensured that all manufacturing partners adhered to timelines and quality standards. Her ability to build strong relationships and clear communication channels with these partners was crucial in maintaining the project’s momentum and ensuring on-time delivery of components.
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Technical Lead for Labeling and UDI: As the technical lead for labeling and Unique Device Identification (UDI), Teresa developed a labeling strategy that complied with regulatory standards while ensuring clarity and usability. Her work in this area included label design, determining UDI requirements for each component, and authoring labeling requirements and protocols which contributed to regulatory submission readiness. By taking ownership of these technical aspects, she ensured that the device’s identification and tracking systems were both compliant and efficient.
Key Outcomes
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Streamlined Development Process: Teresa’s management style fostered a collaborative and efficient development environment, allowing for the timely completion of design control deliverables and project milestones.
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Regulatory Compliance: Teresa’s comprehensive approach to design control documentation ensured the device is well positioned for regulatory body review.
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Effective Contract Manufacturer Coordination: Her proactive management of external partners helped maintain the project timeline and ensured the production of high-quality components.
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Labeling and UDI Compliance: Teresa’s development of a robust labeling and UDI strategy minimized risks and prepared the device for commercialization upon completion of clinical testing and regulatory clearance.
Case Study: Blaze Bioscience - Innovating Brain Surgery with Fluorescence Imaging Technology
Conclusion
Teresa Nelson’s work with Blaze Bioscience exemplifies her exceptional project management skills and expertise in the medical device industry. By overseeing and coordinating every aspect of the development process, she played a critical role in advancing this groundbreaking technology towards clinical trial readiness. Her ability to manage complex projects, align diverse teams, and navigate regulatory challenges highlights her value as a consultant and industry expert.