Unveiling the Extraordinary: The Tape Lab’s Role in Developing a Bio Wearable from Concept to FDA Approval
Introduction: Welcome to The Tape Lab blog, where we explore the remarkable stories surrounding adhesive tape and its influence on diverse industries. In this article, we delve into the captivating insights shared by our adhesive expert, Jason Zajac, during PTSC’s Tape Week 2023. Join us as we delve into the extraordinary journey of a biotech company and The Tape Lab, collaborating to revolutionize the healthcare landscape.
The Biotech Breakthrough: In a world propelled by data scientists and electrical engineers, a visionary biotech company emerges with an algorithmic software and device set to redefine healthcare. However, this groundbreaking innovation faces a unique challenge – it must securely attach to the human body.
Discovering The Tape Lab: With limited knowledge about tape, the biotech company turns to Google to find an adhesive solution, which directs them to The Tape Lab. The consulting expertise and deep understanding of medical tape captivates their attention, prompting the biotech company to forge a collaboration with The Tape Lab.
Unleashing the Magic of Tape: Through meticulous inquiry, The Tape Lab works to identify the ideal adhesive solution for the innovative device. Beyond proposing design modifications, they dive into short and long-term prototyping strategies, ensuring scalability for production. In strict adherence to the rigorous Biocomp 10993 standards encompassing cytotoxicity, sensitization, and irritability, The Tape Lab prioritizes the device’s safety and compliance.
Prototypes and Partnerships: The Tape Lab works to craft prototypes that incorporate the envisioned materials and designs. Multiple iterations throughout the development process allow for continuous refinement. Recognizing the crucial role of specialized manufacturers, The Tape Lab strategically recommends partnerships with Medical Converters, leveraging their expertise in complex multi-layer die-cut parts and layout considerations.
Navigating Biocomp Testing: To ensure both compliance and longevity of the device, The Tape Lab works closely with the biotech company to develop meticulous testing protocols. These protocols encompass not only the device’s requirements but also the adhesive tape that adheres to it. By sourcing reputable testing facilities to evaluate the device-tape combination, The Tape Lab fine-tunes designs, adhesives, and liners based on rigorous testing outcomes, ensuring optimal performance, and mitigating potential production hindrances.
Towards FDA Approval: The Tape Lab meticulously assembles all the necessary documentation (for the adhesive) for FDA submission, including comprehensive Biocomp data for materials in contact with the skin. Leveraging prior use cases involving similar materials, The Tape Lab aids the biotech company in preparing their 510K paperwork. The FDA submission initiates an intricate waiting game, featuring several meetings where the biotech company defends the merits of their device, with The Tape Lab providing invaluable input on adhesive properties and Biocomp testing protocols.
The Final Stages: The journey continues as the biotech company progresses through the FDA validation phase. During this crucial stage, The Tape Lab collaborates closely, assisting in establishing converter setups, developing packaging, specifying tooling, and outlining the conversion, assembly, and pack-out processes for the devices. Ensuring adherence to stringent requirements such as First Article inspections and IQ/OQ/PQ processes for tooling and machines, The Tape Lab guarantees that the adhesive portion of the parts meets the highest standards.
The Triumph: Finally, upon FDA approval of the biotech company’s 510K submission, the converter is ready to commence production.
Conclusion: The extraordinary journey of biotech companies and The Tape Lab serves as a testament to the power of adhesive tape in revolutionizing healthcare. Through unwavering dedication, meticulous testing, and strategic partnerships, they skillfully navigate the complexities of FDA approval, paving the way for a groundbreaking device that will shape the future of healthcare as we know it.