Bio Break: Target Product Profile

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Bio Break: Target Product Profile

Whether you’re in the early stages of a new project or refining a product concept, this episode of Bio Break delves into the foundational importance of a well-defined Target Product Profile (TPP) in medical device development. It’s packed with practical advice and expert insights to set you on the path to success.

A Target Product Profile, originally introduced by the FDA for pharmaceuticals, has become an indispensable tool in the medical device industry. Nick, with over 20 years of product development experience, highlights how a robust TPP can streamline processes, enhance team focus, and save valuable time during the product development lifecycle.

Key takeaways from the episode include:

  • Product Definition: Establishing the core purpose of the device and understanding its primary function.
  • Performance Metrics: Identifying and prioritizing the key performance and safety characteristics essential for success.
  • Market Differentiation: Highlighting what sets the product apart from competitors and defining its unique value proposition.

Nick explains how a well-thought-out TPP can prevent teams from wasting time on unnecessary tasks and misaligned objectives. By addressing essential questions—such as the target market, intended use, performance requirements, and competitive landscape—a TPP ensures alignment between stakeholders and sets clear goals for the development team.

Through relatable examples, including the challenges of developing COVID-19 diagnostics, this episode underscores how focusing on the critical details early can significantly improve outcomes. A strong TPP provides clarity, reduces risk, and increases the likelihood of regulatory approval and market success.

With a concise yet comprehensive overview, this episode is a must-watch for innovators, engineers, and executives seeking to maximize their product development potential. Discover how a strong Target Product Profile can make all the difference.

Target Product Profile

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A gloved hand holds a COVID-19 lateral flow test in front of a white bathroom sink and tiled wall. Overlay text reads: ‘From ELISA to DIY?’ in bold white font on a black background.

Nick Allan and Nigel Syrotuck reflect on recent ADLM diagnostics innovation and how it has shaped the future of clinical testing.

loved hand holding a blood vial in front of blurred Chicago skyline. Overlay text says ‘From vial… To Chicago?’ in bold white font on black background.

Each summer, the laboratory diagnostics showcase hosted by the Association for Diagnostics & Laboratory Medicine (ADLM) draws industry leaders to Chicago.

Thumbnail showing a vial of clear contrast agent on the left, with a red dotted arrow pointing to an X-ray image of a skull displayed on a tablet held by a person in a white coat. Overlay text reads “Not approved here?” in bold black and white text.

Nigel and Nick explore how contrast agents in imaging support medical device trials and diagnostics. While bones appear clearly in standard X-rays, soft tissues like those in the nasal cavity often require contrast agents to become visible.

A disposable medical syringe is pointed toward a small pile of pennies, with a red dotted arrow connecting them. The text overlay reads, “So cheap. So complex.”

Despite costing just pennies, syringes pack an extraordinary amount of design and manufacturing complexity. From precision-molded barrels to breathably sealed packaging, these tools are more than meets the eye.