Overview
Client: DUSA Pharmaceuticals
Consultant: Teresa Nelson, Full-Time Project Engineer
Project: Levulan Kerastick and BLU-U Light Therapy Medical Device
DUSA Pharmaceuticals, a leading dermatology-focused company, developed the Levulan Kerastick and BLU-U light therapy system, a combination product used for the treatment of actinic keratoses. This innovative therapy consisted of a drug (Levulan Kerastick) and a light therapy medical device (BLU-U). Teresa Nelson, as a Project Engineer, played a crucial role in the design, development, validation, and procurement of components for this FDA-cleared combination product. Her work supported both the existing product line and the development of new products.
Challenge
The development of a combination product like Levulan Kerastick and BLU-U involved several complex challenges:
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Regulatory Compliance: Ensuring that next-generation products and product changes met stringent FDA regulations for both the drug and the device was critical.
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Cross-Functional Collaboration: Coordination across multiple departments, including R&D, manufacturing, quality, regulatory affairs, and procurement, was necessary to streamline the design and development process.
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Component Design and Validation: Developing next-generation components for both the drug and the light therapy device required precise validation to ensure they worked in harmony for optimal patient outcomes.
Teresa's Role
As a Project Engineer, Teresa took on the following key responsibilities:
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Design and Development: Teresa led the cross-functional team through the design and development of improvements to the Levulan Kerastick and the BLU-U light therapy system. She worked closely with industrial designers, quality, regulatory affairs, production, and contract manufacturers to ensure the drug and device components were in compliance with FDA regulations.
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Validation of Components: Ensuring that new components and changes were properly validated was a key part of Teresa’s role. She oversaw the rigorous validation processes for new packaging and drug delivery components. This required detailed analysis and documentation to meet FDA design control requirements.
Key Outcomes
Teresa Nelson’s leadership as a Project Engineer led to several key outcomes:
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Successful FDA Clearance: Teresa’s meticulous attention to detail in design, development, and validation played a crucial role in achieving FDA 510(k) clearance for the next-gen BLU-U.
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Innovative Product Development: Teresa’s ability to manage the design and procurement of components for both existing and new products allowed DUSA Pharmaceuticals to continue innovating in the field of dermatology.
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Cross-Functional Collaboration: Her leadership in coordinating a diverse team across multiple departments ensured that all project milestones were met on time and within regulatory standards.
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Component Validation: Teresa’s focus on rigorous component validation ensured product improvements complied with regulatory standards and contributed to the overall success of the Levulan Kerastick and BLU-U system in the market.
Conclusion
Teresa Nelson’s work as a Project Engineer at DUSA Pharmaceuticals exemplifies her expertise in managing complex, cross-functional projects in a highly regulated industry. Her ability to lead a team through the design, development, and validation of a combination product resulted in the successful FDA clearance of next generation dermatological products. Teresa’s attention to detail, leadership, and focus on quality were instrumental in bringing this innovative product to market, further solidifying DUSA Pharmaceuticals' reputation as a leader in dermatology.