What a great and insightful question! I can tell you from experience, that the forecasting and management of costs spent is an extremely important aspect of any company, let alone a medical company. In a medical or big pharma company, cost projections and inventory management for various materials and products (both expirables and not) play a major role in the manufacturing and production side that allows them to continually meet demand of the market.

If there was an improper estimation of costs for a product, the impact would depend on the type of improper usage. If it is an overshoot, it is generally considered okay to a margin because there should be some slight over-ordering to account for unexpected increased shifts in demand or emergency situations that might require additional inventory to cover. However, undershooting the estimation of costs can leave a company immobilized to meet demand and take action on those aforementioned shifts in market demand or emergencies, which could force the company to spend more money than intended if in terms of economies of scale.

Nonetheless, it is important to have cost forecasts and projections to be accurately reflective of the market demand, material cost, and other unexpectancies, BUT it is generally better to have more than less of cost projections.

Well, this question is interesting. I experience this during my research work. During one of my research works, I miscalculated costs and resources. Therefore, the project timeline increased significantly. I had to change my whole plan. I needed more money. I had to contact more collaborators. It was very hard to arrange a collaborator in the middle of the project. Moreover, I also miscalculated my resources. my teammates could not work as much as I expected. In the lecture, Dr. Simon mentioned that teammates may also work on some other projects. We have to consider it during project planning. I missed it during my research project planning. Therefore, project time also suffers significantly. 

At the onset of my senior capstone course, each team was required to make budget that is composed of both the product budget (accounts for all of the materials the final device is composed of) and the developmental budget (accounts for all of the materials used in the developmental phases of the product). As we were instructed to create this budget at the beginning of the course, it was somewhat difficult, as we were not sure exactly what problems we could run into throughout our project that could incur additional costs. We estimated the costs as much as possible for both product and developmental materials, but this is not entirely possible to do without knowing what will and won't go wrong. At this point in the course, we have just began the construction phase of our device and are experiencing issues with what we thought would be an effective method of assembling our product. We will likely have to spontaneously budget for a different means of assembling our device (a special adhesive that we hope will be compatible with the material of our device). However, if we are not satisfied with the results of this adhesive, we will likely have to order and budget for multiple adhesives in a trial-and-error series of testing. As of right now, we have a little over a month to manage this budget before our final device must be completed, so we are currently on schedule, however, throughout the construction of our device, we will likely encounter more issues that could impact our project schedule. Hopefully, we will be able to meet the deadline for our complete product and not encounter too detrimental of issues that break our budget tremendously. 

I have had experiences where projects have been dropped because of improper funding or lack of resources especially after a lot of work have been put into it. This hurts the company a lot in the short-term because all the resources, tools, equipment, and documents that came out of that project needed to be destroyed or disposed of in a proper manner. The worst part is when teams have dedicated a lot of time and effort researching, planning, and executing a project that have taken months or even years to complete when all of the sudden the company decides to stop the program. It can hurts both the team and the stake holders of that company so every medical device company should prioritize rigorous feasibility studies, risk assessments, and resource allocation strategies. 

While I have not managed projects myself within academics or medical device development, in terms of improper estimation of costs I have also seen an extension within the project time-line. If the budget for certain projects is not enough, the project itself will likely be paused, with a focus falling instead to other projects occurring. In pausing the project, teams are capable of seeking additional sources of funding, such as grants within the academic sphere, to continue the project. Another option moving forward is to also divide the main project into smaller sub-projects, and prioritize what aspects are necessary and which are not. In the course of this action, the budget available can prove to be enough to create the final deliverables needed. However, time and resources are spent with replanning the time-line, working out what new tools, equipment, and other such materials are needed with changes that have occurred, and in communication and approval of said changes. 

For my senior project during undergrad, my team and I had experienced the pitfalls of costs and resources. The academic project served as a way to allow biomedical engineering students to understand what it takes to develop and design a medical device and how easy or how difficult it is in the real medical device world. For the academic project, each team member was given $125, which totals the budget to be $500, there being four members. With that budget, that is used to order parts needed for the device to be developed. It was quite difficult to be within the budget and order all of the essential components for the prototype with the mechanical parts, electrical parts, and materials for a clean, finished product. The overall cost of the project was about $420, but the prototype had to be redesigned due to the cost of multiple materials. From my project, the electrical component was the most expensive due to pressure sensors, wirings, LCD display, and microcontrollers involved. The mechanical component had to be readjusted in terms of the amount of air bladders and the change of air compressors due to the pricing and it not fitting the specifications of sound. The team had thought about building the air bladders from scratch, but due to the budget constraints and time, that was irrational. Since the building of the prototype was to be done within two semesters, it was quite difficult to adjust the design and have it pass verification and validation testing at the same time. The testing was delayed and took much longer with the redesign. It was not perfect as it was done, but it was not the ideal prototype nor did a lot of the specifications and design inputs pass. We were in a rush to finish testing, the finished product, and presenting everything to the faculty panel. Overall, I was not satisfied with the prototype with how messy things got with the materials and how the finished product was not what we had in mind. Due to this being an academic project, it was a huge learning lesson and experience, but in the real world, that would not fly and you could be fired due to miscalculating costs, multiple redesigns, delays in testing, and not finishing on time.

Another crucial pitfall was the resources. As said before, there were four team members, but one of our team members sort of disappeared. They were working with us in the previous year which was junior year with brainstorming and pitching the prototype to a faculty panel. Once the senior year and building started, they were nowhere to be found nor seen. Not even the faculty advisor knew about their whereabouts, thus we had to continue as a team of three. Luckily, our budget was not cut, but we had to split their responsibilities within the three of us which was doable. 

An organization running multiple projects will have many tasks that should ideally be organized, and there are different methods for planning them. Depending on the organization's level of project management sophistication, the task breakdown can range from using pen and paper to automated workflow software. Regardless of the method, planning is considered the most important phase, as it eases the execution and closing processes. Not planning at all, or not enough, is a red flag and sets the project up for failure. Realistically, formal project planning may not be fully embraced across organizations, and they will rely on intuition, increasing the risk of cost overruns. I have seen setbacks due to improper estimation caused by a lack of task planning. The budget was spent when it was not needed because resources already available were not known. Additionally, the required resources were expensive and had long delivery times, which prolonged the schedule. Another common occurrence was the lack of communication between senior management and the project manager & team. Decisions to withhold information led to inaccurate estimates of how much could be spent and who could do which tasks. Ideally, tasks for inventory and purchasing should have been planned ahead. 

My time in the medical device field has been fairly limited, but as opposed to resource management the pitfall my team faced was more oriented on time restrictions. We were working on a longitudinal study for an experimental device and needed 60 participants within 3 years to complete the study. I joined the team shortly after they finished their first year with the study, and we had only just begun working on subject 15. The timing restrictions were heavy since the sponsoring company needed their results by the given deadline or they would cut the grant leased to us for the project. As such the PM on my team decided rather than to worry about costs as much, he hired new hands like myself to contribute to the study to help increase the speed at which we could overturn patients. While my experience may not be as expansive as some of the others here, I have noticed that the limiting factor when it comes to the verification process of a device is not the cost, but the amount of time it takes to complete. This time only goes up with the complexity of a given device. Trying to finish a project within the marked deadline can prove difficult even for experienced teams; that lesson comes across clearly in this wees lecture discussing lead times, slack, and start and finish order for given projects. 

An example that came to mind regarding this topic would be an academic project that I participated in with a group to create a medical device from scratch. The basic budget that we were given was $200 and the group decided to come up with a newly made bioreactor from electronics and 3D printed materials in the timespan of an academic semester. The group encountered a myriad of pitfalls from of this timespan mainly because of how big the aspirations of the group were compared to more realistic expectations on where to big the project. The more plans that the group had devised to create this bioreactor, the less and less time the group had to actually achieve these because of how non tangible the product was up until the end of the semester. The project was completed and was even admired for it craftsmanship while being handmade, but the true potential of the project was mostly sidelined due to timing and lack of focus. The pitfall of lack of resources are what plagued the project the most because it was become almost every week where a team member would theorize and suggest a new idea to the project such as a LED screen, a button configuration or even a new gear design that never truly saw the end of it's potential due to lack of resources. The group essentially acted as four project mangers working together but no one had the forethought to take major consideration how to allocate time and resources into the project for it to fully prosper, which is what highlights to me what is truly important for a project manager to run especially a medical device project. 

Time and resource estimates can either make or break a project. Therefore, I think this is a really good and interesting topic. I have seen how an entire schedule can change in an instant if the time taken for certain tasks is underestimated. I believe it is better to over estimate than under estimate because finishing a project early is better than finishing it late and rushing through it. This not only happens in industry but in academic related activities and everyday life. For example, most times I think my assignments and research may not take too long and end up scheduling myself for too many assignments in a small time slot. However, problems may arise, I can get distracted and in the end, not as many assignments as I anticipated end up being completed. This delays the schedule for the rest of the day or even rest of the week. This situation is much more complex in the medical field. For example, certain processes may take a very long time to be completed and get delayed such as all the documentation, testing, FDA regulations, marketing, legal work, etc; the project ends up getting pushed back with all these delays. I work at a startup company and the CEO always underestimates how long it will take us to construct cartridges we are outsourcing for a different company. He always gives the other company a time frame and if they are not complete in that time frame, the other company gets irritated because they are running out of resources and they were given a false date. This then causes tension with both companies. This is why, in my opinion, it is important to overestimate time rather than underestimate. Not many people can buy themselves time especially if there are other people and businesses at risk or involved. I would like to hear if anyone else has encountered similar delays in projects or even day to day life.