Project manager faces many challenges in medical device industry compared to project manager involved in construction of a school or skyscraper. Project manager in medical device industry faces increased clinical and regulatory standards that are being FDA regulated. Project manager will have to keep up with FDA in regards to more clinical data and longer process time for 510K (PMA or IDE) approval. This results into higher expense to support R&D and clinical data. Project manager will also have to plan for the cost of innovation. Another challenge that we see in medical device industry is being innovative with the goal of saving life. Medical device has to constantly keep up with the upcoming opportunities and technology to evolve and continually help saving lives. Project manager involved in construction will have to plan and manage contractors, schedule, budget and risk but they don’t have to keep up with FDA regulations or innovation.

I see a lot of posts on here citing the FDA as a huge difference between a medical device project and a construction project. However, this is just one of many huge differences. The FDA makes life hard for BME's yes, but there is one huge elephant in the room when comparing projects... Medical devices are used to go inside someone. There are so many implications to that little statement that makes the projects whole different worlds. First off, the device has to be sealed. It doesn't need to support 1000 tons of steel it needs to be resistant to all the types of corrosion that different bodily fluids can do. It has to be inert to the human body as opposed to resisting high winds. It has to be modular, able to be used on everyone, regardless of individual anatomical differences, instead of housing plumbing and electrical wires. While it is arrogant and wrong to say one type of project is harder/more costly than the other, some differences in goals are clear. Buildings have to function as fully functional and equipped shelters. Medical devices have to function such that they accomplish a task while interacting with a human body and not have adverse effects on said human body.

The biggest difference, in my opinion, between a project manager for a medical device versus a that of a construction project is the customer, which in most cases, is a patient seeking medical aid. Along with making sure the device is "audit-ready" using GMP/GDP, there is also a concern of 'who' that device is going to. Questions asked by a project manager for a medical device should be: "Is this device going to improve the quality of life for the patient?", "Is it feasible/practical for the patient to obtain?", "How is project going to take?".

The project manager also has to make sure that whoever will be manufacturing these devices is fully qualified and/or has the proper training, especially if the device is something that will interact directly with the human body.
For example, I work with a newly developed cell/gene cancer therapy where we "re-engineer" t-cells, expand them, and re-infuse them into the patient. If this therapy is going to be successful, the project manager in charge would've had to make sure that the manufacturers have the proper experience and background knowledge. Also, because this would be going directly into a patient's blood stream, there needs to be some sort of sterility testing that is implemented prior to re-infusion. A project manager would also have to have contingency plans for instances where some aspects of the project may fail. For example, if sterility testing were to fail, is there still a chance the cells could be re-infused.

Of course, these problems will overlap with those of the construction project. However, with regards to project management in a medical device setting, there is usually people's lives on the line.

The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical device company . The Design Team should be comprised of multidisciplinary members with a strong knowledge of current workflow, recognition of the problem, and buy-in for improvement like nurses, physicians The project manager should have the skills needed to effectively listen to the client, clinical advisors, and end users, use that information, and develop a safe, effective, and meaningful solution. He has to learn new things fast, and use that information to make good decisions along the way. While for construction manager communication skills are important without it even the skilled workers are unable to work effectively . Construction project includes some additional problems so project manager needs to have strong problem solving skills. He should understand importance of team work.

The project manager for medical device company faces more challenges than the construction project manger .The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical device company . The Design Team should be comprised of multidisciplinary members with a strong knowledge of current workflow, recognition of the problem, and buy-in for improvement like nurses, physicians The project manager should have the skills needed to effectively listen to the client, clinical advisors, and end users, use that information, and develop a safe, effective, and meaningful solution. He has to learn new things fast, and use that information to make good decisions along the way. While for construction manager communication skills are important without it even the skilled workers are unable to work effectively . Construction project includes some additional problems so project manager needs to have strong problem solving skills. He should understand importance of team work.

They both have to follow a strict guidelines but I believe there are more challenges in doing project management for medical devices compared to project management for building a school or skyscraper. Schools and skyscrapers have limited risks that can be avoided such as how much force or weight the building can handle. There are more civil engineers, construction workers, and architecture while for medical devices, there are more biology and chemical engineers, material scientists, and researchers. Medical devices deal more with how the body works, the bodily functions, and how it could change instantaneously. These devices also have to account for the difference in people, how they can react to different people and how they can work for everyone. There are more obstacles to work around for medical devices.

Also, project management in schools and skyscrapers have more of an opportunity to build such projects because they occur very often. There are so many schools and skyscrapers already built that it becomes easier for these designs to be approved. For medical devices, the field is still expanding and since it deals with people in an internal and anatomical level, it is harder to have these projects and designs approved. You deal with muscles, cells, organs, different body parts, etc., while schools and skyscrapers are dealt with people on an external level because it surrounds people and gives them shelter.

Medical device projects also have many teams that all need to work together and consult one another to make sure the device actually works but when it comes to project management for buildings, one team designs the building, gives it to another team to approve it, and then eventually gives it to construction works to start building these buildings. FDA is also a huge difference between the two stated by many other people above. FDA will check in on you at any point in time to make sure you’re following procedures and regulations. They will be very strict and question everything to make sure every process is done correctly.

I don't believe that the challenges of project management are any different between different fields. The only difference would be in the root cause of the challenge but not in the challenge itself. The project manager still has to create a plan, allocate resources, manage, control, and execute the plan, and deliver the end product. The project manager still has to report to the stakeholders and manages the communication/reporting.

As I previously said the root cause to challenges may differ. In both medical device and construction projects, there are still critical paths that need to met or else the project will end up delayed. The root causes of these may differ. For medical devices, this could be due to regulatory delays or testing delays, such as FDA deficiencies whereas for construction, delays can be caused by inclement weather. The project manager still has to manage these tasks and try to prevent any further delays but the delays due to weather can not be controlled.

I believe there are a few more differences between building a building vs an implant for example. A building will have a timeline that is more necessary to follow. Buildings will usually have a shorter building timeline in comparison with a product. It is more critical to follow the timeline because permits and other things needed to construct a skyscraper in a metropolitan area is vastly different from making an implant in an R&D and manufacturing building. Buildings also have more variability in the timeline such as weather. Weather doesn't affect the timeline of an implant project. There are also more inspectors and government officials that check in on a building to make sure it's up to code, while an implant would see more intricate documentation via the FDA. An implant has probably one team while a building would have multiple teams working such as architects, electricians, plumbers, etc. all of whom can square the blame for a holdup while a BME team shoulders it alone. A implant project leader has no one to blame other than him or her self. There is a lot more failure when comparing projects that make implants compared to those building buildings like skyscrapers. They are quite literally "too big to fail" due to the time and money spent planning, so no matter what they have to make it work.

When considering the challenges between managing a project for a medical device and constructing a skyscraper, one must take into account the safety of both deliverables in the event of the worst case scenario, both of which can have dire consequences on human life. I personally believe that the safety of medical devices requires a lot more challenges to overcome simply because the field of medicine is far less developed than the field of construction. Building a skyscraper has already been done countless times and therefore has a lot more expertise that goes into it as a result of repetition, knowing material properties, and having a thorough design plan. A medical device however, lacks that knowledge and must therefore run clinical trials, but only after they have been proven safe and effective on animal models, which can only be accomplished by overcoming the FDA and ISO regulations implemented. The likelihood of completing the construction of a building is far greater than that of developing a novel medical device, simply because there are far more challenges and concerns facing something that has never been done before that interfaces with the human body. I currently work as a manufacturer at a cell-therapy company where we extract a patient's own white blood cells, prime them with additional surface receptors that make them more aggressive towards disease, expand them, then infuse them back into the patient. Since I am working with a blood-based product that is getting sent directly into a patient's own bloodstream, the amount of challenges my team faces in documentation, prevention of contamination, and communication across team members and clientele are tedious and burdensome, and one wrong move is all it takes to threaten a life.

Of course one main challenge that comes with project management for a medical device company would have to be adhering to FDA regulations. This, in turn, presents a multitude of challenges. For the most part, medical device companies involve several different teams to collaborate and provide the resources required to efficiently meet the milestones for a given project. This in itself already adds on to the existing challenge of adhering to FDA regulations because everyone involved must be familiar with and consider the specifications of the final product in order for it to be acceptable. The use of the wrong material or the production of an unacceptable geometry for a part, for instance, are factors that must be avoided in order to successfully finalize a project on time. With the restrictions that the FDA enforces, project managers must plan ahead and consider the unique resources and time it may take to drive the project down the right path. For instance, a colleague of mine is currently involved in a new project and due to the unique geometry of one of the parts, they are now required to order a new device to accurately measure certain aspects of the part in order to confirm that it was accurately produced. This device, unfortunately, costs a good amount of money and may take a number of weeks to arrive to their facility. This increase in cost and time was not entirely accounted for at the start and the team has been compressing in order to meet their deadlines. On top of the challenge of properly judging how long each milestone will take and the cost of the resources needed, there is also a challenge in gauging how many tests is sufficient to validate parts of a project, as well as how much room for error is acceptable. This is especially a challenge for medical device companies that produce class II and class III medical devices which have more stringent regulations.

All in all, these challenges can be overcome with experience, guidance, constant communication, and acknowledgement of nearly every aspect of the project and how they may adhere to FDA regulations.

I found the above replies interesting as most people mentioned that the Regulatory compliance (FDA approval, etc.) which must guarantee the medical product safety is the main challenge in the medical device industry compared to other industries and that would cost millions of dollars. Infiniti Research website stated on their website that the although FDA regulations and guidance is one of the main challenges for Medical Device manufacturing in recent years, there are many other challenges that could face any medical device manufacturer. This includes the Product quality which provides important advantages over other competitive products in the market, localization of medical devices (regional vs. multinational) which would affect the cost and the demand level of the product, and the product development cost. Product cost covers the prototyping, testing, all purchasing expenses. It may be hard for a medical devices company to trade off the product selling price and customer satisfaction. As it is well known, manufacturing a new product in the biomedical industry should take care of risk management part as it is paired with human health and any tiny mistake or carelessness would cost a lot (health-wise).

Professionalism and a well-trained project group would overcome these challenges by following smarter and shorter paths.

I think there is not much of a difference in how project management is structured and executed between the medical industry and any other industry. But one major difference or challenge for project management in the medical field is risk management. Although other industries have this as well, it's usually a static evaluation but for medical industries, risk management is a dynamic evaluation. Materials and devices are constantly evolving and changing once they set inside a body due to the body's function and reactions. Therefore, risks are to be evaluated in a much different and detained manner than say, building a bridge. Devices, furthermore react differently from patient to patient. Therefore, the project management cannot be a general work but a personalized work. This poses a much bigger challenge for project management in the medical industry.

The first challenge that comes to mind would be the FDA guidelines. But other challenges could be that each project has different specifications. Project managers for medical devices have to make sure the device works for every type of person that could be using that device. They have to make sure it is adjustable to every body type whereas a project manager for a building does not have to worry about it. Also a project manager for medical devices has to make sure the project that is being started is not a project that has been done already. Also when it comes to medical devices the project manager has to make sure it can actually be made and that it is practical. When making buildings that is not really a problem because there will always be a way to make a building.

I believe the main challenge for project management for medical devices is that there are more strict regulations with the FDA. If a project is not approved, it can set the schedule for compilation of a project back significantly, as you must identify the problem and potentially start from the beginning to solve the issue. Another issue may be underestimating the difficulty of the project and not planning accordingly for risks. Properly identifying the scope of the project in the beginning will allow for proper planning and management of risks. Since medical devices affect health and can be lethal if improperly manufactured, it is important to thoroughly plan for every step and to consider everything that could go wrong. 

@quanzi Yes, and "difficulty" of a medical device project has a number of facets to it.  There's financial difficulty, technological difficulty, clinical difficulty, and others.