The main solution to this would be either getting outside help using consultations or educating yourself on the topic. It is crucial to learn the biologics and drugs side of any medical component to ensure the overall success of the project so someone needs to navigate the challenges associated for this. Most of what engineering is learning and understanding challenges and different topics so they need to take initiative to learn about the secondary component. If it is a really complex component, maybe consultating an expert in the field is more feasible. They can provide valuable insights, guidance, and additional perspectives to enhance decision-making. But overall, it is a proactive step that anyone should take to ensure the success of the overall product. 

I agree with you regarding managing the secondary component of a combination product; it can be challenging, especially if the team and its manager lack experience in that area or they need more knowledge to develop part of the system. Therefore, it is crucial to adopt a strategic approach. One way to do this is by appointing subject matter experts (SMEs) who have extensive knowledge of the secondary component. These experts can offer valuable guidance and support throughout the development process. Another approach is to invest in team members' ongoing training and professional development to enhance their expertise in the secondary component. This investment will contribute to building a more capable and knowledgeable team.

I agree with the above posters in that consultants or SMEs would likely be the most cost-effective and efficient solution. However, if combination products are going to become more staple in the company, they might need to consider investing in a separate team (or multiple) to become familiar with the unique circumstances of combination products and their different processes. If the combination products become more frequent, then this team will likely gain more experience concerning the processes of CDER and CBER, which will benefit the company in the future. Hiring consultants and SMEs for smaller matters is beneficial, but if the FDA returns a RFD with an unexpected result, then the project will likely be dropped completely. If a special team is present to advise on these matters, then the project would be able to move forward. This team would only be beneficial if a company delves heavily in combination products. Otherwise, maintaining this team would likely take up a lot of resources without playing too much of a part in the regular work of each project.

For successful management of a project that the manager has little expertise in, there are multiple steps that the manager can take to ensure the success of the project. The first step could be to assemble a team of experts who are knowledgeable about the secondary component of the device. Additionally, it would be a good idea for the manager to become knowledgeable and get a basic understanding of the area related to the secondary component. As mentioned in the previous replies, it would also be beneficial to consult subject matter experts (SMEs) who know the field regarding the secondary component. Moreover, the project manager should also conduct a thorough risk assessment to identify and understand potential challenges or risks associated with the secondary component. Lastly, the manager should also conduct review and feedback sessions on the project's status from the project team members so that the manager can identify which areas (including the secondary component area) need more attention and overall help the success of the project. 

Combination products in the industry have additional forms and process steps that come with them as well. These of course vary from company to company how the overall project management process and documentation does. From the lectures, it was my understanding that the combination devices need to be identified as one specific regulated component based off the main function of the device, but they are still understood as combination devices serving multiple functions and the company would carry out the project management process and any required clinical research and focus in accordance. I have seen multiple job postings that specify design control work with combination products, I assume this would be because they have a different type of procedure associated with them. Therefore, I believe the secondary function would still be focused on as just as much as the primary function of the device, even if the process and research/documentation needs slight adjustments.  

I agree with the above posts by various members on educating oneself. It is essential to build a knowledgeable and multi talented team. This is possible when the project has been broken down sufficiently in steps to understand the various expertise needed to build the right team. It is also important to develop an open communication within the team with other members so update,ideas and challenges can be shared to brainstorm projects broader objectives and hurdles that are faced along the way. Collaborating with other experts in various secondary component device augmentation can allow building innovative solutions.