Biomedical manufacturing traceability means that the flow of material and information within a biomedical product value chain can be followed from raw materials to patient outcomes. Biomedical traceability is an important concept because better traceability has the potential to help improve patient outcomes via innovation and optimize biomedical manufacturing to improve safety and quality while minimizing waste. Recent research by Gregory Theyel, Ph.D., Director of the Biomedical Manufacturing Network, offers insight on the adoption of biomedical traceability activities and their relationship to companies’ product and process innovation. His research shows the early stage of development to trace the flow of material and information within biomedical product value chains and also reports the nature and extent of adoption of traceability activities and their relationship to companies’ innovation performance.

Biomedical companies that are part of Dr. Theyel’s research are engaged in traceability within their value chains, but their efforts usually end after the manufacturing of their drugs or medical devices. What is missing is tracking the prescription of drugs and medical devices and the health outcomes of patients using these products. This is an important finding because companies are likely to be missing out on opportunities for innovation via the use of traceability. The essence of product design and improvement is insight on how customers are using a product and the outcomes from the use of a product. This insight can help a company improve how a product is used (in this case how a product is prescribed) and improve the product if the outcomes are not meeting customers’ expectations. Dr. Theyel’s research supports the link between traceability throughout the biomedical value chain and product innovation. Companies leading in new product introduction are also leaders in traceability of raw materials and tracking the health outcomes of patients using its products. An important finding of this research is that traceability is related to product innovation for biomedical companies.

Biomedical traceability can be the key to innovation. Being able to assess patient outcomes as a dependent variable can enable the assessment of the other aspects of a traceability system facilitating an understanding of the weakest links and opportunities for enhancement. For example, if a particular source of raw material or more targeted prescription lead to better patient outcomes, then this insight can help companies improve their products and processes. Insight on how customers are using a drug or medical device and what are the outcomes from the use of a product can offer critical insight for product and process improvement.

Gregory Theyel, Ph.D., is the Director of Biomedical Manufacturing Network, which offers biomedical manufacturing business assistance, technology transfer and education to grow the biomedical industry cluster. Learn more about the Biomedical Manufacturing Network at

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