I completely agree with the information you have included here about efficiently managing design change requests. I would expect that design changes are quite common in medical device development, so it is critical for companies to consider how they will handle them before even beginning a project. One aspect of your post that especially resonates with me is the need for sufficient documentation. As you mentioned, digitizing this system is a great way to improve documentation. This way, you could link multiple documents together, review previous versions of documents, identify where/why changes are occurring, etc. Another way companies could improve documentation is by using standardized templates and protocols for changes. This way, the process would be streamlined, consistent, and familiar. 

Design change requests in medical device development are definitely a challenge I agree. An idea on how a company can handle these change requests is finding primary and back up options for the parts/materials they will be using for the product. That way, if a change needs to be made either out of necessity or just preference, the development team can do so in an efficient way. The counter argument of this can be that it will take extra time for the development team to source all of these backup options from vendors. I think this can be a valid argument up to a certain point. My response to this is the development team will already be in the stage of finding the proper materials and parts. This should not add on too much time and I think it mitigates a great deal of risk in the project. The transition to a new part or material would be almost a seamless procedure. This should also be effectively known between the development team and production team so they are both on the same page what back up options work. 

Effectively managing design change requests in medical device development requires a structured process to evaluate their impact on safety, compliance, and functionality. Clear communication between engineering, regulatory, and quality teams ensures that changes are assessed and implemented without disrupting the development timeline. Prioritizing and documenting changes systematically helps maintain traceability and regulatory compliance while minimizing risks. Utilizing version control and change management software streamlines approvals and prevents unintended design deviations. By integrating a well-defined change control process, companies can enhance innovation while ensuring product quality and development efficiency.

I would like to expand on risk assessment during the change control process. Changes, by nature, can introduce new risks. This comes either via product performance, production capabilities, or regulatory compliance. These risks may not be obvious out of the gate. Conducting an FMEA (Failure Modes and Effects Analysis) can help teams proactively identify and reduce risks before implementing a change. I would also like to emphasize that stakeholder alignment is incredibly important. Design changes can have downstream effects on a multitude of departments, be it from supply chain to manufacturing, to even marketing. It is important to meet cross-functionally to address all impacted teams and ensure that all risks are accounted for organization-wide. This approach can minimize delays and prevent costly surprises down the road. 

Unfortunately, design change requests will cause some delays, but this can be mitigated by having separate teams work on separate parts of the project. This would allow the team that focuses on the adhesion to troubleshoot this problem early without holding the project up as it would have if there was only focus at one portion at a time. Aside from that, the best thing a project team can do is discuss any changes together to find out a solution that won't drastically impact the project management timeline. This would also allow those working on documentation to know about any changes before they're made.

Design changes can occur due to wanteding to improve the medical device or wanting to fix any issues it may have. In wach case, it is good to have a list of risks to be proactive on as mentioned in the previous posts. Some ways to make the continuous improvement process more compliant is to keep everyone updated on the new standards and regulations so that if any new risk arise, everyone is prepared.

Additionally, having a streamlined plan for the risks outlined can make the change process more efficient. It is crucial to maintain proper communication thorughout any and all changes. For this, I would suggest a living document that has all the tasks and the responsible team/person for that action item. A living document with revisions would also be helpful.

Design change requests (DCRs) are bound to happen in the development of a medical device either through user suggestions or feedback, risk analysis, adherence to regulations, or incorporation of new technologies. Nevertheless, unmanaged changes that are made later in the process can lead to budget overruns as well as developmental and scheduling issues, all of which, if uncontrolled, could result in dire consequences regarding the timeline of the project.

The challenge with DCRs lies primarily in understanding the impact that proposed modifications have on compliance to regulations and how it will affect overall project scope. An example would be what may look like a trivial engineering design change to a Class II device in terms of materials may actually lead to costly additional regulatory submission changes along with updated biocompatibility analysis. Uncontrolled design revisions can lead to bottlenecks that were not expected.

Design changes also have the potential to impede the work process, which is why it's essential to apply a Change Control Process (CCP) that allows for effective prevention of such issues by integrating documentation, impact assessments, traceability, and gatekeeping oversight. Other advanced methods include freezing designs at predetermined critical milestones and phases. Such an approach minimizes changes that need to be applied after reaching the latter windows of submission and validation. Some changes after these points do have room, but in order to prevent delays, cost overflowing, and rework within devices, they should be tightly controlled.

What alterations do you believe are necessary in order to strike a balance between the volatility caused by design innovation and project stability? Do you think stricter change control policies should be induced, or, is flexibility more favorable in the long run?

I believe the best way to handle Design Change Requests is to plan for them in the first place. Obviously no one wants to plan for something to go wrong, but good project management will always plan for setbacks and revisiting steps to provide a realistic and efficient timeline for the project. Ideally, each portion of the project will have its own feedback loop where each step is verified and completed to satisfaction. In the case of the proposed situation, there would be a team dedicated to developing and testing this adhesive. The team may follow a plan where they first investigate different adhesives and perform various benchtop testing to determine the desirable adhesive for the sensor. This research may last three months. Then, they can move to live trials where the adhesive is applied to animals or possibly humans to verify its adhesiveness and biocompatibility. If these trials are expected to last a month, this total allocated time is four months. However, a good project manager would not plan this stage for four months, they may plan the stage for six months in the case that their original pick for the adhesive is not as adhesive or biocompatible as presumed and they need to select a "runner-up" of human trials, or new adhesive all together. Good project managing will always plan for undesirable outcomes and have an active plan in place for when doing so is necessary.