From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020. While many in the industry are working in overdrive to keep projects on track, the regulatory landscape can shift day-today, making it challenging to keep up with best practices for gaining or maintaining regulatory approval. To avoid setbacks with compliance, medical device manufacturers should strive to anticipate potential challenges and institute proactive measures.
Companies can begin to identify where a device may face risks by first looking into the sources that can cause complications and delays. Changes to device design, the manufacturing process, or the supply chain can present challenges when seeking regulatory approval. To achieve the highest level of quality assurance, companies should dedicate time to identifying each obstacle and develop precautions to stay ahead of any increases in risk.
Managing Material Needs
Backlogged supply deliveries in the past year have led to a widespread desire to move to onshore sourcing. From decreased capacity to transportation slowdowns, the limited availability of certain materials has made it difficult to maintain adequate supplies for production. These challenges, paired with the increasing scrutiny of materials with the publication of ISO 10993-18:2020, can create obstacles for device manufacturers trying to protect the quality, performance, and safety of their products during development and beyond.
Before material needs escalate, companies should consider a proactive approach to maintaining production. They can start by evaluating the risks of adding more safety stock compared to the likelihood of future shortages. If expanding safety stock presents fewer risks and is actionable financially, this should be a manufacturer's primary step to managing future material needs. This is an especially important step for small to mid-sized manufacturers that might face increased challenges in purchasing due to their comparative lack of scale.
If safety stock doesn't resolve issues with material sourcing, companies can brainstorm creative uses for work-in-progress materials. Utilizing what is available in unique ways could yield additional time to investigate future solutions more thoroughly. For example, if the same material is used across multiple products, discontinuing the manufacturing of a less profitable or in-demand product can allow for materials to be used for more critical devices.
Additionally, working with materials that have an established history in the device's production process can reduce new variables of risk. In general, companies should encourage the use of proven materials...