MedtechtoMarket is a contract design, development, and manufacturing company that takes products all the way from translational biomarkers all the way through to commercial launch. Matt Pearce, Director at MedtechtoMarket, discussed the productization strategy that his company deploys. He commented that great science does not necessarily equate to a marketable product. The presentation discussed the “ingredients” needed to make a diagnostic and the process of bringing them all together.
Within product development, there are usually between three and five essential ISO standards that scientists must comply with in order to manage risk, ensure usability engineering evaluations, and labelling. These standards must be met to become a legal manufacturer and submit a technical file. Pearce explained that the intended use statement should not be overlooked because it is critical to driving product design, validation, and regulatory submission for diagnostics.
Furthermore, early establishment of design specifications and ongoing risk assessments are essential for regulatory approval and product safety. Pearce added that design intent and traceability are important to regulators. The risk management aspect must be closely followed throughout the project to classify the severity of the product. Pearce also insisted that every time one does a design change, the risk assessment should be revisited to guarantee that no new risks have been identified or generated.
Meanwhile, manufacturing validation should occur before clinical and analytical validation to ensure that the product tested is the one that customers will receive. The manufacturing validation requires setting up various procedures like SQC processes, risk assessments, and a master validation plan. Next, scientists move onto clinical and analytical validation and verification, which involves stability studies, limits of detection, linearity, and precision. Furthermore, this stage points to the intended use setting of whether the instrument in question can be reused on multiple patients.
Overall, clinical studies vary by product type, with method comparison and diagnostic performance studies needed, often requiring thousands of tests for technical file submission. Successfully productising a diagnostic requires a clear intended use statement, robust quality management, and early attention to design inputs and risk management.
By following the structured process outlined by Pearce, researchers can ensure their product meets regulatory standards and is ready for market. Ultimately, careful planning and adherence to best practices are essential for turning scientific innovation into a reliable, marketable diagnostic solution.
