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?
Project management for medical devices would require a more in depth system of checks and balances. When managing a project in this sector, one would need effective coordination between those involved in compliance, risk management, engineers, manufacturers, scientists, clinicians and quality assurance. Adequate functioning between these groups are essential in order to maintain and achieve all of the FDA regulations checkpoints and clinical trials. Because medical devices are created, tested, approved, marketed, and then released to the public there are more sections in which there could be errors or defaults that could delay the devices development. In contrast, many project managers for building schools or skyscrapers follow a typical pattern of development. Project managers for this kind of project usually involves keeping within a budget, timeline and managing those employed on the project. Typically, the process of each project doesn't vary much. Building schools and skyscrapers follow a somewhat standard of development in contrast to medical devices that are newly engineered and designed.
Project management for medical devices is slightly more complex than that of a school building or skyscraper in that there are regulatory requirements. An entity or individual looking to gain FDA approval for a medical device encounters several tedious steps to gain approval. This can include but is not limited to clinical trials, registering for class types, etc. Even though the process is rigorous and requires focused attention to each detail, there is still a chance the FDA can decline approval. There are also complexities involved with the type of medical device, which requires more tedium in the way of regulations.
@daryllynnn Great compilation of info. The statement regarding structures such as schools or skyscraper following a specific pattern as opposed to medical devices being newly engineered tools paints a picture of the compounding factors involved with creating a medical device. Not to mention, the medical devices can directly and potentially adversely impact the lives of those who use them if not properly manufactured and utilized.
In my opinion, the main challenge in project management for medical devices is the process leading up to and including obtaining FDA approval. During this process, the medical device goes through a series of clinical trials and experiments to test performance, biocompatibility, and safety. Depending on the complexity of the medical device, there are a number of things that may present challenges for project managers and teams. Also, ensuring that the device is within FDA regulations and compliance is crucial in the success of medical device development. Making sure that there's proper documentation and the device meets requirements is another challenge that may be another setback in the development process. While I'm sure project management for building a school or a skyscraper may be just as time consuming and well thought-out, the invasiveness of preclinical research required during the developmental stages and the unknown decision of the FDA poses major challenges on the completion of the development of a medical device.
Managing a project for a medical device industry is more complex then developing products in any other industry due to FDA regulations. From the initiation phase to closing of the project the quality control need to be assured. Again after development the products goes through number of clinical trails for ensuring the quality. And after the whole process there could be chance of decline by FDA. The regulatory authorities of companies usually try to make sure that the developing device can make through FDA approval. Overcoming the challenges poses by FDA is most critical for medical device projects and that's the major difference with any other industry.
There are not many differences in project management between the two industries. Project managers still need to initiate, plan, execute, and close the project. However, in terms of the intricacies of the role, the medical device industry may present different obstacles/issues than a construction project. In terms of a medical device, the device needs to be constructed, tested for safety, tested for efficacy through clinical trials, and approved by the FDA. In all of these steps, many issues can be encountered. What if a safety issue is discovered? What if the device does not produce favorable results in a clinical setting? What if the FDA is making it difficult to get approval? Because of the many obstacles being faced, project managers have to be more creative and open-minded
On the other hand, the major concerns are about structural stability and safety. However, if a high-quality blueprint is produced and the construction is performed as laid out in the blueprint, structural/safety issues should not arise too often. For construction projects, a project manager's focus is more likely on making sure the blueprint is properly executed rather than facing many unpredictable obstacles.
The challenges presented by doing project management for medical devices rather than for construction stem from the fact that the medical device industry is one of the most highly regulated industries in the world. As a result, it is critical that the device meets the standards of different organizations such as the FDA, ISO, and other country/continent-specific organizations if the device is being sold across the world. Additionally, medical devices are naturally more complex as not only does the device have to function, but biocompatibility is critical in ensuring that it is safe for the patient. As a result, these projects could take long to complete and require a larger budget. Additionally, most medical devices require different vendors to supply different components of the device. Therefore, as a project manager, it is their responsibility to ensure that the project is being built with the patient in mind, resulting in a tough balance between planning the device and ensuring that the timeline is met and that the spending does not exceed the budget.
