One of the biggest challenges in medical device development is handling design change requests without causing delays, confusion, or regulatory issues. Design changes can come from new regulatory requirements, safety concerns, user feedback, or manufacturing improvements, and while they are necessary, they can also slow down development if not managed properly. A lack of clear processes for handling changes can lead to miscommunication, increased costs, and compliance risks if updates are not properly documented or verified. For example, consider a company developing a wearable glucose monitor. Midway through development, engineers discover that the adhesive used for the skin patch is causing skin irritation in some patients. A change in adhesive is needed, but this requires retesting for biocompatibility, updating specifications, and ensuring regulatory compliance. If the team does not have a structured design change process, the update could create delays, rework, or even force them to repeat previous testing phases.

In my opinion, the key to managing design changes effectively is to establish a structured, well-documented process that allows teams to evaluate impact, urgency, and compliance needs before implementing changes. Companies should have a Change Control Board (CCB) that reviews all design modifications to assess risks, verify regulatory requirements, and ensure smooth implementation. Additionally, using digital tracking systems can help maintain documentation and ensure all stakeholders are aligned, preventing unnecessary disruptions. A well-managed change process allows innovation to continue without derailing the project timeline or introducing compliance risks. How do you think companies can handle design change requests in a way that maintains both efficiency and compliance?