Ensure Supply Chain Flexibility

Creating a plan for supply chain resilience requires additional considerations even after the design freeze. Buffering inventory and looking for alternative parts and more suitable suppliers can provide the flexibility needed to mitigate possible risks and react to future constrained markets. Additionally, consider long-term partnerships with suppliers who have the desire to grow with you. When changing components in the healthcare industry, it’s particularly important to meet US and international regulations and ISO standards. Change becomes more challenging downstream in the design cycle after investing effort into verification testing and regulatory approval. Having well-established design failure modes and effects analyses can help manufacturers weigh the risks against the effort. Some components are easier to qualify and replace. Critical parts such as ones contributing to the primary function or a differentiating feature of the product need to be identified and de-risked early, backed by a robust supply chain. “For those critical items, you’re probably going to write a letter to file with the FDA, with some verification evidence that says, ‘This is a like-for-like replacement,’” says Celestica’s Kevin McFarlin. “Most design iterations take about three months to turn through the system and test. For greater efficiency, it is better to build those up in a bulk change.”