Project manager for a medical device company differs from that of a building/skyscraper due to FDA regulations. Project managers of medical device company have to follow design controls and regulations which abide to FDA guidelines. A project manager of a building or medical device both have to follow the phases of a project life cycle but will encounter different obstacles based on the needs of the project. A medical device project managers skill set that he/she can offer to the project team will focus on medical industry and research compared to construction and design of buildings. The project manager will have a team of specialist such as a researcher and biomedical engineer while a building manager will deal with civil engineers and architectures.

The difference between being a project manager for a medical device project compared to a building/construction project is that in the medical device industry, the project manager must see the project from the start to the end and also follow up afterwards for revisions and initiate risk management. On the other hand the building project manager has the similar life cycle of the project but has a twist, especially when it comes to following regulations and rules, these project managers it seems follows from the start to end of the project but ends at that. Medical device project managers have to follow FDA regulations and processes, if they are a manufacturer as well, they must follow ISO 9001 protocols. On the other hand building project managers have to work with OSHA and Directorate of Construction (DOC) to establish the saftey of the well being of the general public just how FDA protects the consumer's of such medical devices products. The U.S create these government based organizations branches to regulate and create a gold standard.

Some of the challenges for doing project management for medical devices compared to building a skyscraper are; the requirements of highly regulated medical device industry and the level of collaboration that need to be orchestrated across the project team.
There is a well known saying within the medical device industry "if it is not documented, it did not happen" that serves as reminder to the level of rigor and expectation of the FDA when it comes to documenting development of a product. Firms must establish procedures aligned with regulatory requirements and follow them in order to market a product successfully. This is a challenge to project management of medical device opposed to civil engineering industry which is not as highly regulated.
Collaboration is key during medical device development projects. Project teams are composed of many functions within their areas of expertise and a challenge of project management is to ensure that the work gets done through a collaborative approach, resolving conflicts without straining relationships between team members for a better outcome and engaged team members.

The challenges presented in project management for medical devices compared with project management for building a school or skyscraper, is that products or treatments need to be reviewed several times before being used or sold to people. This ends up taking a very long time for the product itself to be available. Because medical devices is designed for the well-being of people, safety and confidence in the product must be assured. If there happens to be something wrong with the product or treatment, they have to redesign it and go through the process all over again of checking for safety. I'd say that project management for medical devices requires a lot of patience because plenty of time is being involved.

The FDA regulations is the biggest challenge for any medical device project!,In general, some of those regulations: -Good manufacturing practices -Standards and Reporting Adverse Events to FDA registration,
-Labeling and classification. submission for 501k or PMA, and finally premarket approval.So any medical device project manager should know the FDA regulations and manage the team to reach the required project goals.

A project manager for medical device will face the following challenges during the lifetime of the project; increase competition; other medical device companies are also working on similar product and with intent to attract new customers. Selling into global markets and winning over strict food safety agencies by county that demand proof of compliance; Medical Device Listing, Premarket Notification 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies. In addition, short development time and time to release product to market, and documentation of every customer requests/complaints and managed. While a project manager for building a school or skyscraper faces less challenges. First, he/she would not have to worry about selling global, no real competition during the span of the project as competitors have been beaten for them to get awarded the school building project. Also, complaints documentation after project are less compare to after release of medical device.

Although the project managers for both medical devices and buildings seem to have the same challenges, they have completely different tasks and risks along the way. The project manager for a medical devices project has to deal with the medical team and the designing team; they both usually work together. Both teams have to think about the purpose this device has to achieve and the design that is going to be best fit for this purpose, that way I think it is easy for the project manager to communicate with both of them at once. However, the process is long and has to have a lot of reviews. The process usually consist of: the idea conception, product and market review, business development, design, testing and validation... all the way to product lifecycle management. The planning phase is tiring as well, it includes material testing, packaging design, quality design, as well as research and studies. Of course everything has to meet the FDA regulations, which makes this process more challenging. On the other hand, for a building project manager, he has to deal with architecture and civil engineers, that do not work together. Usually the architecture part cares only about the shape and the civil engineers care only about how strong the building is, so they don't work together most of the time. I think the process is easy since it is the same concept for every building, it is just a matter of weather challenges. However, they also have some regulations to follow, but they are not as strict as the FDA.

Apart from the abiding by the FDA rules and the medical device industry being highly regulated, the actual execution the project management cycle is very critical. If a company is building a skyscraper that it is not a novelty. The basics of architecture are already known and been applied many times over. The architect may be creative and slightly modify the shape of the building for the aesthetics. However, a medical device is almost always a novelty. Building a skyscraper is utilizing existing resources but building a medical device requires a lot of research and experimentation. The real obstacle comes in the execution phase where a certain experiment might not be producing promising results despite the research that has gone into it. The risk level is extremely high building a medical device. Even after a successful experimentation, the human genetic makeup is so diverse that it can still reject and the project can go into a huge loss.

The regulatory aspect of project management for medical devices is a very obvious difference. I think another big difference between project management for medical devices vs building construction involves the tighter and stricter deadlines. For medical devices, meeting deadlines is critical because it can potentially lead to discontinuation of product being sold. If the product is life or death, it adds more strain of trying to meet these deadlines as opposed to building a school or sky scrapper which doesn't have that same vital weight. Also, I can see project management for building construction more straight forward since, from my understanding, the blue print and execution for erecting a building hasn't changed as much over the last couple decades as opposed to medical devices which constantly have to meet updated regulations and execution of new product development.

Many of the posts above mention the regulatory aspect of project management as a greater challenge in the medical device industry. I do agree with this, but I would like to expand on what ao242 mentioned about globalization. Many companies develop medical devices to sell globally, and in that case, not only do they have to conform to FDA standards, but they also have to conform to the regulations of whatever country they plan to sell their product in, and they may need to do additional work in order to launch their product outside the US. I think this adds a level of complexity which a project manager for the construction of a new building would not have, since they would only have to abide by the building code regulations for the specific country that they are building in. I also agree that the competition in the medical device industry poses a significant challenge to managing a medical device project. Speed to market in this industry is absolutely critical to the success of a project, as product lifecycles are quite short. What this means is that any slip in the project timeline could ultimately lead to the cancellation of a project, and depending on the phase that the project was in this could be a huge loss for the company.

That is an excellent point. What happens many times is the project is broken up into sections. There's a general product development project, and then several separate regulatory projects hooked onto it, one for each country or region. You will often see a medical device come onto the market at different times in each country due to the differing requirements. Some countries, for example, would require more testing than others, so that takes extra time. We learn more about this next semester in Advanced Medical Device Development.

Project management for varying fields of work differ in the challenges they face and how they have to be tackled. When being a project manager for building a school or skyscraper, there are more mechanical regulations that need to be looked at. The building must be able to sustain and hold a certain weight limit and be built with certain criteria. While this also applies to medical devices to a certain extent, there are certain other aspects that need to be examined. Medical devices need to be tested at several levels. Initially, the medical device must undergo thorough animal trials, then clinical trials, and then after thorough examination it can be brought to the general population. It usually takes several years for this entire process to be completed. The medical device will be interacting with human beings and thus has an additional sense of pressure and area of management. Project management is difficult regardless of the task at hand, however, specific tasks will have specific challenges.

I think that there is minimal differences between a project manager within the biomedical engineering field and say a civil engineering project manager. Both projects follow a specific timeline at which the project has to be completed. Both projects may also use contractors from which different materials can be procured from. Furthermore, both projects are observed by their respective regulating bodies. For medical devices, the FDA monitors the companies that develop them and for public structures, there are different government sectors that monitor and make sure that the structures are up to code. It is also important to point out that both medical devices and buildings affect the lives of many people who are exposed or uses it. Due to this, the development and use of these things must be closely monitored. I think that one of the major differences between these areas is that field studied. But overall, in terms of project management, the timeline and procedure should be quite similar.

Project management for medical devices and building a school or skyscraper are very different projects which require different planning and execution phases. Medical devices should be planned in a way to ensure that the device will work and not cause harm to the consumer. It should be tested a lot in the execution phase to ensure a product that will be efficient in its use. However, the project management for building a school or skyscraper requires much more planning before it can be executed. Imagine having to build a building and it not being stable or usable. This would ruin a lot of time and money required to create the product. Thus, it is feasible that a lot of planning should go into drawings of the architecture.

Medical devices also have a different management style because it will not be as big as a school or a building. It is relatively small, even if it's something big like an MRI machine, compared to the size of a building. However, if the medical device is more expensive or complex, it might take a long time to create a usable product. Building designs have been around for some time, thus it can be used to create a new building design and take into measures the failures that could occur. These differences have to be taken into account to create a successful product.