Drug delivery device designs have become more complex because consumer demand for better functionality and user interface quality requires designs with added components, increased connectivity and software integration.
Complex products increase manufacturing and supply chain risks
The road to market for a Drug Device Combination Product is a long one that has significant investment and high consequence decision making. Manufacturing defects, out-of-specification component parts, validation failures and poor supplier performance are linked to a reported 126 percent increase in the recall rate for drug delivery devices in the first quarter of 2018, according to Stericycle.
In addition to recalls, pharmaceutical and medical product manufacturers lose billions of dollars because of supply chain problems such as drug shortages, security breaches, counterfeiting and safety issues.
Supply chain risk prevention starts at the beginning
A seamless launch of a drug delivery device requires a careful supply chain design that proactively mitigates predicted risks from the start. A globalized supply chain introduces different complexities, especially when relying on multiple suppliers. When engineering teams implement risk management strategies to address business or supplier constraints prior to the testing and approval process, there’s less impact and significant improvement to agility.