In addition to competition against similar products, there is also a challenge of continuous improvement of the device itself. Medical Device companies almost always want smaller products with “cutting edge technology” and that means increased complexity and increased sophistication of the design. If it is a long term design project such as new product launch, this can lead in budgeting conflicts as R&D expenditures may increase or even time line conflicts.
One of the biggest challenges of doing project management for a medical device as opposed to building a building is having to assure that the device in question is meeting vigorous FDA regulations and that all other documents such as human testing applications and such are in order. The project manager is to assure that any documents such as technical requirements and test plans are in order in order to proceed in a project; however, the extra hurdle with medical devices are the regulations and those have a slew of documents on their own. This can also hinder scheduling for a project manager since getting these documents approved on time is not up to the project manager, but the third parties which can request even more documentation that may or may not exist. This is why drugs often go through years of pre-clinical and clinical trials before entering the market; these strict regulations on medical devices could affect the flow of the project depending on what level medical device is being developed.
The challenges of doing project management are always present. These includes providing adequate information and communication avenues for the team members as well as the ability to track deadlines and progress. The project manager oversees all actions and activities being done. Project management within Medical Devices differ from various industries. One main reason I can think of is the regulations. Project Managers must be conscious of FDA regulations at all times of the project to ensure the device is made to be safe and effective. Also, all progress must be documented appropriately to ensure traceability. Project Managers within this industry also have to manage the expertise of several different backgrounds and decipher the languages of different team members. The project manager is the composer while the team members are the players. They must conduct well and provide not only the right cues but facilitate the right environment to allow for effective and efficient work to be done.
I think the challenges are different for other industries as opposed to medical device. These differences are in the regulations involved on a project of respective industries such as building a school. For instance, projects in the medical device industries need to take into consideration the FDA regulations, such as 510(K) clearance. While construction site has to fulfill safety and health regulation established by Occupational Safety and Health Administration (OSHA).
However on the other hand, general process of project management is similar for most of the industries. The challenges that comes in the project are somewhat similar across all the industries
I think there are many challenges to doing project management for medical devices vs other projects. One of the main challenges would be that there might not be a medical device to base your work off of. Other projects have history and its easy to modify something that you know has a history of working and is documented. Medical devices are relatively new compared to say building a multi-story building. This makes is easy for the project to become prey to scope creep due to you not having a very good previous model of the project. Another challenge that would go hand in hand with the main challenge stated is just advice in general not being available. In project management when initiating a project, you talk to people who are really doing the work but if they don't have experience, you cant really find out what you didn't know.
In my opinion, most of the challenge for project management of medical devices comes from the process (aka Design Controls). Developing medical devices requires a lot of detailed traceable documentation that must been done in a certain way. All of the hundreds / thousands of documents that are generated as a result of the development of medical device bust be maintained and managed in a DHF (Design History File). This file must be very well organized and include all of the proper documentation, since it can be audited (and mostly likely will be) be the FDA at any time. If the DHF is not maintained / created properly throughout the medical device project life cycle this could become a huge problem during or after the product has been released. If the FDA was to audit a DHF and the proper Design Control documentation does not exist, they can choose to take action based on the severity of the missing paperwork which could lead to pulling a product from the market if it has already been released. Being a project manager for medical device development means staying on top of all of the necessary Design Control documentation and DHF, on top of the regular project management that is needed for any other type of project in a different field.
Challenges that project managers for medical devices face differ from those that construction project managers face in a few ways. Construction project managers and medical device mangers both have to ensure the project is on track and according to plan. They both manage the project so it is completed on time and within budget. For construction project managers Other functions may include specifying scope, budget, and schedules, selecting subcontractors and workers, developing communication strategy for resolving conflicts, etc. For devices stringent medical development regulations exist. These include regulatory requirements such as 21 CFR Part 820, the FDA’s guidelines for the regulation of quality systems related to the methods used in facilities and controls used for design, purchasing, manufacturing, packaging labeling, storing, installing, and servicing. For a building, an architect hands you a blue print, you know where everything goes and the materials are readily available. It’s like Legos, the pieces exist, and all you have to do is know how to put the pieces together. For medical devices, the material has to be biocompatible, it has to survive in vivo, and the duration of the material, when in vivo, has a time constraint due to the body’s immune system attacking the foreign material. The human immune system recognizes the foreign material as soon as it’s placed in the body and initiates an immune response. Even if the body accepts the material, at some point, one may have to operate in the near future either to replace it or remove debris from the implant. Updating a building is easily done whereas updating an implanted medical device involves tampering with one’s health. To develop an implantable device, Good Manufacturing Practice must be used. You can build a cement block anywhere, try building a hip joint outside on your lawn and see the response you receive from the FDA.
Project manager is both jobs has its own rules and regulations. For example, in medical devices the person has to make sure that the product is safe and able to pass all the FDA regulations. While in construction, they have to make sure that buildings are safe in general as well as during earthquake, fire hazard etc. This also depends on where the construction is held. In cities like lisbon, earthquake is most important. While in california fire hazard etc. So in short, there are challenges in both jobs, the only difference is that they are bit different from each other.
The challenge in manufacturing medical devices as opposed to a sky scraper or a bridge is the process of making it compatible with the body. These medical devices will be used in, on, or around the body and must be engineered as such. The involvement with the FDA makes this process all the more complex. The FDA has a very specific set of regulations and that are put in place for the safety and well-being of potential recipients. The individualized set of possible risks must be generalized and addressed by the FDA. In the case of a skyscraper, the safety concern is overall risk of structural failure. This is something that, once the building is open for the public, it is not really something that can be a further concern. However, with a medical device that is replicated for many recipients, an individual may encounter an adverse effect after the product is on the market. The whole line may have to be recalled in this case. With a building it cannot be recalled just because one person in the building does not like the way the windows face. In the case of project management for a medical device, there is a cyclic way of the project in the way that it may have to come back to square one in the case of a complaint.
I think that any project management position in any field is going to come with a lot of work, time dedication, and planning on the project managers part. The main difference between a project manager for a construction company and project manager for a medical device company are the industries that they work for. Both the construction/building development and medical device industry have their own regulations set forth by the government, company, and any 3rd parties that may be involved. In the medical device industry, I believe there are more regulations that the project manager has to overcome because this industry involves developing devices that come into contact with humans and need to be safe. A construction project manager also must follow safety regulations but not as many. Another main responsibility that can be seen between these 2 project managers is that they are working on their assigned project from start to finish. They both also have a project cycle they need to plan out and follow that matches the requirement of their specific industry. In conclusion, being a project manager in any industry is a tone of responsibility and work—and unfortunately for project managers in the BME industry they get to work with the FDA regulations which is a pain.
Being a project manager for a medical device company is more challenging than a project manager for skyscraper building company. Medical devices should pass the FDA regulations which is more complicated than the regulations followed by a skyscraper building company. Medical device should pass regulations like good manufacturing process (GMPs), good labelling process (GLPs), 510K process, device classification into class 1, 2 or 3 based on the risk possessed by the device on the patients. If the device needs to be tested on humans, then IRB approval has to be obtained before doing clinical trials. Apart from these challenges the other processess almost remain the same for both.
Like many have mentioned- I believe the main difference of being a project manager for a medical device company is that it is a highly regulated field and different countries have different regulations. Some have mentioned the novelty and uncertainty when it comes to devices and FDA regulations, but if there is a similar existing medical device on the market with FDA approval, then its easier to plan just as if there was a similar already existing skyscraper that passed regulations. If it is a novel device then there needs to be more work upfront, and even considering aspects like IP. If filed on the medical device you want to make sure you are focused and can obtain regulatory approval so you have enough time to bring the device to market and actually make money before the patent expires.
As Bhargav mentioned, there will always be regulations and challenges to consider and Project Managers will encounter similar challenges across industries.
The primary difference between project management for medical devices and other non-medical companies is the adherence to regulations set forth by the FDA. Due to the fact that medical devices are ultimately intended for human use, there are much tighter regulations placed on safety. As someone who works in such an environment, safety and efficacy are at the very forefront of every endeavor my company undertakes. In addition, all the equipment we use must be qualified and validated before any sort of clinical work can begin. This again is to satisfy FDA regulations in order to protect patients, users, and trial participants. The primary phases of project management are probably largely similar, but the detail and attention devoted to safety and protection are paramount in medical devices.
I think that the main challenge project management for medical devices face is the lengthy time of certain projects. This is mainly due to the rigorous protocols and strict regulations enforced by the FDA or other regulatory agencies alike. Since medical devices are in direct contact with humans, testing can be quite a challenge where specific protocols have to be followed to ensure the validity of the results. Also, since its a system that can be incorporated into a human, testing can yield variable results due to the dynamics of the various organ systems present in humans; where these results can greatly influence the parameters initially set for the device. Add to that the strict regulations enforced by the FDA, due to human subjects; your timeline can be drastically lengthened.
The regulations enforced by the FDA are definitely a large and unique consideration that sets medical device development apart from other projects. This, coupled with the demands of global regulatory bodies, makes medical device development particularly complicated. However, there are also the considerations of quality of life and ethics that come into the picture when dealing with human health. While a device may be novel and abide by all regulations, it could be inaccessible to the patients that need them. Cost of treatment and impact on lifestyle are major considerations that need to be made when developing new devices. Also, variations between person to person always makes the exact function of a device uncertain, which is a problem not seen in projects that deal with static environments.
