I learned that the There are 'Non-essential Design Change', 'Design Change Number' and 'Engineering Change Order' in types of changes. I am wondering how the scale, the time required or the procedure of changes differs according to each change type in the actual field.
In practice, the scale, time required, and procedures differ considerably among Non-essential Design Changes, Design Change Numbers, and Engineering Change Orders (ECOs). Non-essential Design Changes usually involve minor adjustments that don’t significantly impact performance or regulatory compliance. These can often be implemented quickly with minimal documentation and limited review. In contrast, assigning a Design Change Number is more about tracking and documenting modifications in a systematic manner, ensuring traceability throughout the project lifecycle.
ECOs, however, are reserved for more substantial modifications that may affect device functionality, safety, or compliance. This process is more formal, typically requiring detailed documentation, cross-functional reviews, stakeholder approvals, and sometimes revalidation or additional testing. As a result, ECOs can extend the project timeline significantly. Adopting a tiered approach like this allows teams to balance the need for agility with regulatory and quality assurance requirements. How would you/ the team/the company ensure efficient change management while meeting strict compliance standards?
@sn64 Hey! The first step would be to establish a framework, defining a clear tiered approach to classify the changes. Then I would ensure that there is a clear documentation and tracking system in place to ensure proper documentation and traceability of the change taking place. I would also implement an electronic system with electronic approvals and signatures as well as automated workflows. This would help ensure everything is up to the standards of any regulatory board and ensure the change goes quickly and smoothly. Next, I would streamline the ECO process using templates and workflows and construct a change review board. This would help ensure the efficiency of the ECO and prioritize changes taking place. I would also have routine impact assessments, risk assessments, and input from regulatory experts at every stage throughout the ECO, which would help streamline the whole process and keep everything on track as well. Of course, this all relies on the workers themselves and is only possible through them, so it is also important to ensure they are all well informed on the status of the ECO and current tasks at hand as well as up to date on trainings related to documentation, compliance, and any necessary skills.
Efficient change management while meeting strict compliance standards can be achieved by implementing a structured framework that categorizes changes based on their impact and complexity. Establishing a clear documentation and tracking system ensures traceability and compliance. Utilizing electronic systems with automated workflows and electronic approvals can streamline the process, making it more efficient. Additionally, creating a change review board and conducting routine impact and risk assessments with input from regulatory experts can help prioritize and manage changes effectively. Continuous training and communication with the team are essential to keep everyone informed and compliant. How do you think regular training and communication can enhance the effectiveness of change management in a highly regulated industry?
One consideration when it comes to the length of times associated with change orders is the regulatory body a project manager is dealing with. The FDA and the EUMDR have different processes when it comes to fulfilling a ECO. In the US, a design change on a medical device can trigger the need for a 510k submission to the FDA. My knowledge on EU regulations are not great, but it can be assumed they have a comparable process to the FDA during certain situations. By being required to wait for regulatory bodies to process changes in the design of a medical device, it can lead to delays in a project. Additionally, design changes can be avoided by analyzing potential risks a medical device design can have. By understanding risks and using risk-based decision making, a project manager and their team and gauge the severity of potential failure points on either a practicality or regulatory basis. Having a firm understanding of where a project can expect design changes is a proactive step project managers can take in order to prioritize critical design changes while expediting changes that may not be essential.
Modifications are expected in the development of medical devices, albeit the extent and procedure for these modifications vary with respect to the impact on design, adherence to regulations, and project deadlines. These changes can be classified as minimal, such as changing the supplier for a certain component, to more drastic shifts like adjusting the functionality of the device or changing the regulatory pathway.
Minimal changes like replacing materials or upgrading software can be done with less review. For these minor changes, internal approvals are considered to be sufficient. These changes do not require new submissions to be made for regulatory approvals, but submissions for design history files do need to be made.
Changes of greater significance such as modifying the device’s intended use or the performance parameters are more involved. These changes require risk assessments, new verification testing, and often regulatory re-submissions, such as an FDA 510(k) amendment or PMA supplement. Those who opt to not redevelop and reassess all newly introduced components leave themselves open to compliance risks, recalls, and substantial delays.
In your opinion, how should teams approach different magnitudes of changes in terms of balancing compliance and integration. Is there room for softer approaches which encourage flexible methods of handling changes, or is a harder focus approach required to prevent project delays?
