Discussion Topic: Project Management in a medical device setting

Home Forums Medical Device Development Intro to Project Management Discussion Topic: Project Management in a medical device setting

This topic contains 29 replies, has 29 voices, and was last updated by  dh239 10 months ago.

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  • #883

    Course Facilitator

    What do you think the challenges are in doing project management for medical devices, as opposed to, let’s say, being a project manager for building a school or skyscraper?

    • This topic was modified 1 year, 8 months ago by  Josh.
  • #3490


    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.

  • #3497


    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.

  • #3502


    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.

  • #3503


    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.

  • #3507


    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.

  • #3510


    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.

  • #3515

    mark abdelshahed

    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.

  • #3523


    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.

  • #3530


    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.

  • #3534


    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.

  • #3535

    Course Facilitator

    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.

  • #3536


    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.

  • #3538


    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.

  • #3545


    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.

  • #3546


    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.

  • #3558


    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.

  • #3572


    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.

  • #3579


    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

  • #3588


    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.

  • #3599


    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.

  • #3600


    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.

  • #3633


    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.

  • #3661


    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.

  • #3665


    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.

  • #3668


    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.

  • #3671


    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.

  • #3677


    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.

  • #3679


    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.

  • #3683


    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.

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