I have also found it interesting that the meaning of "stakeholders" has a much more extensive meaning than I had originally thought. Stakeholders exist outside of the traditional roles we associate stakeholders with and are essentially classified a any individual with an interest in a particular business, whether it be monetary or not. One non-traditional example of a stakeholder is us as students. 

In most cases, students financially invest into a college or university through paying tuition, fees, and/or room and board. Evidently, through our financially contribution to NJIT, we have shown an interest in the services the university offers and how we can ultimately benefit from them. Additionally, as students of NJIT, our experiences and level of satisfaction with the university can be expressed through providing feedback, which is ultimately considered by the school, who makes decisions to change or improve aspects of their services based on our concerns. Therefore, as students of NJIT, we are ultimately playing a role as stakeholders in the context of our school. 

Employees can also be stakeholders in various contexts. Beyond their roles as workers, employees are stakeholders in their organizations. They have a vested interest in job security, workplace culture, opportunities for advancement, and fair compensation. Their engagement and satisfaction directly impact productivity, innovation, and overall organizational performance. Their skills, expertise, and dedication can directly influence the quality of products and services, operational efficiency, and competitive advantage. As stakeholders, employees have a vested interest in the organization's success and longevity so it directly impacts their livelihoods, career development, and job satisfaction.

A major stakeholder in medical devices is the healthcare professional who will be using the device. That’s why as part of design controls, a key initial step is gathering customer needs since they are a main stakeholder in the device. 

A stakeholder is anyone, group, or entity that has an interest or investment in a project, organization, or system. Stakeholders can be involved in or not involved in the project or organization.

External stakeholders receive the products or services that come from the project or organization. Internal stakeholders are the ones who work on the project or in the organization. They are responsible for the success of the organization. Executives, managers, and leaders are in charge of the project or organization and make decisions. Owners and investors have a monetary interest in the project or organization.

The last group of stakeholders are the providers of goods, services, and resources for the project or organization. Individuals or groups with potential impacts from project or organization activities. Similar organizations competing in the same market or industry. Collaborative entities working with the project or organization to achieve common objectives. Individuals or organizations responsible for reporting or communicating information about the project or organization to the public.

Like what the previous responders have mentioned, stakeholders are not just the board of directors and those with a financial stake in the company. It can be defined as almost anyone who is employed by the company, as well as its consumers! Company related stakeholders can be any type of employee who may benefit from the success of the company, such as engineers who work on a particular product that is about to be introduced to the market. The engineer in this case has a stake in the product since a positive and significant market release would indicate great success and efficient use of time, and permit improved benefits, positioning, and pay at the company to continue developing and maintaining this and future project.

The consumer would be a stakeholder beyond holding stocks because in the medical industry, the better the medical device/drug/etc., the better the impact it would have on the consumer's life when utilizing the product. This would make the patient's life more tolerable or even better depending on the type of product and how much improvements or negated symptoms there are. 

Going beyond the conventional definition of a stakeholder exposes a variety of parties that are involved. Stakeholders are individuals in the community who may be impacted by the project site. Suppliers supply essential resources, competitors shape market dynamics, and regulatory agencies monitor compliance. Public opinion and media coverage influence how people view a project. Long-term initiatives have an impact on future generations, and academic institutions research the results. Employees and contractors are directly involved, and investors and shareholders have financial stakes. Understanding this wide range enables improved impact prediction, risk reduction, and project success in general.

Any person, entity, or organization with an interest or concern in a project is considered a stakeholder. Stakeholders may be found inside or outside of the project or organization, and their levels of involvement and influence may differ. They may include: project sponsor that might be an  individual or group that provides resources, funding, or support for the project. Furthermore, stakeholders may include  project team members, customers, patients, shareholders and investors. Stakeholders must be identified, their requirements and expectations must be comprehended, and they must be actively included in decision-making processes at every stage of the project's lifespan.

I believe that a stake holder would be anyone that would be affected by the success or failure of the project, whether is it financial or career wise. For example, a project I am currently working on in the medical device industry has stake holders that are at the director level of the company, that don't see into the technical aspects of the project at all. Because I represent the R&D team in the project, I am not a part of the stakeholder meetings and I used to be confused as to why these directors were so called stakeholders if they don't have any money or time invested into the project. After the lectures, I udnerstood that the project is a critical level project in the company and the directors of R&D would be directly affected if the project succeeded in quick time or if it failed. Thus, these stakeholders were able to have a huge say in the direction and timeline of the project, because the responsibility of project success was directly correlated to them. Even though it was not necessarily a financial compensation that they would gain, the success of the project would directly affect their responsibilities as higher level executives within the company.  

I can definitely relate to having my definition of a stakeholder changed. What changed for me the most was that a stakeholder technically does not even have to be a person. I always thought of a stakeholder as a single person in a project, but never considered a larger picture. In simpler cases, a stakeholder can be another company that is either contracting another company or is simply affected by the project. However, some stakeholders I never considered before are regulatory agencies themselves or even the local community. I know I have certainly broadened my definition of some stakeholders, and it has continued to change a include different people/groups that some other people are mentioning as well. What other uncommon stakeholders do you think you might see in some medical device projects?

This new definition of a stakeholder is reasonable, particularly in the realm of medical device development, where the scope of the project's influence far exceeds the boundaries of those who have provided the funding. It becomes clear that a stakeholder is anyone who is affected by the outcome, has influence over it, or experiences consequences from its success or failure. Financial contribution is only one form of interest. Operational, legal, professional, and personal interests also create a legitimate stake in the project.

In medical device projects, several less obvious stakeholders deserve attention. Maintenance and service technicians, for instance, must repair and calibrate devices after they enter the field. Design decisions directly affect how safely and efficiently they can perform that work. Similarly, insurance companies have a significant level of influence on the project, as the level of insurance that covers the device will have a direct impact on the overall adoption of the device. Risk management groups within hospitals also have a significant stake in the project, as they are charged with tracking adverse events and liability related to medical technology.

The caregivers and family members may use the device or monitor the device, and therefore the usability issues will impact their lives. Regulatory reviewers and auditors can also be viewed as stakeholders since their professional credibility is connected to the approval of safe and compliant products. Even future patients represent a stakeholder group because early design decisions shape long-term safety and usability outcomes.

The concept of thinking in terms of stakeholders is similar to the construction of a bridge. A bridge architect may design the bridge for cars, but the bridge also affects pedestrians, the people living near it, those responsible for maintenance, city inspectors, and businesses that depend on foot or car traffic․ A similar ripple effect is present in the development of medical devices. If the team asks the question of who would be impacted if the device fails or is modified, they may identify another group of stakeholders who were not considered initially. What structured approaches could teams use at the start of development to capture these ripple effects before design decisions become fixed?

The fact that the definition of a stakeholder is very broad is also something that caught my attention. While they may not be considered a stakeholder per se, there are a lot of other additional stakeholders who may be considered, aside from the obvious ones such as the investors, the project manager, and the patients. Regulatory organizations may be considered as a stakeholder because they are the ones who ensure the safety and compliance of the device. Their job and responsibility will be negatively impacted if the project does not meet the proper standards. Since the project may impact the work schedule and income of the regulatory organization, their suppliers and manufacturers may also be considered as stakeholders because they are further affected. Healthcare professionals such as physicians and nurses may be considered a stakeholder in the medical device industry because they are the ones who will be using and recommending the device. The performance of the product may impact the productivity of their practice/ office. Since the cost and performance of the device may impact the earnings of the health insurance company, they are also possible stakeholders. Further stakeholders include a hospital or community system where the device is used especially if it has impacted budget and patient flow. Overall, this more comprehensive definition shows that the definition of a stakeholder is not limited to individuals who contribute to a project's financial resources but also includes all individuals who are affected by the project's outcome, whether positively or negatively. It seems to be like a domino effect and everything/ everyone is connected in one way or another. 

One category that's easy to miss is regulatory bodies and compliance officers. Even though they're not directly funding or benefiting from your medical device, they have enormous influence over whether your project can move forward. The FDA, notified bodies in Europe, or internal quality assurance teams all have a stake in ensuring the device meets safety and regulatory standards. Ignoring their perspectives early on can lead to costly redesigns or approval delays later.

Another overlooked group is maintenance and service personnel who will eventually have to repair, calibrate, or troubleshoot the device after it's in use. If you design something that's incredibly difficult to service, those technicians become frustrated stakeholders whose complaints can damage your product's reputation or lead to higher lifetime costs for hospitals. Similarly, disposal and environmental compliance staff have a stake if your device creates hazardous waste or has specific end-of-life requirements.

An interesting perspective that can be overlooked is how individuals who never interact with the project can still be a stakeholder since they are integral to being affected as a general byproduct of the project. For instance, when it comes to medical device projects, public health systems or even taxpayers can be considered stakeholders. If there is a device that improves the outcomes of a treatment, it may reduce the long-term healthcare expenses and hospital readmissions. If there is a reduction of these factors, then there will be an improvement in resources and public funding. Although the individuals who allocate funds never see the device or contribute directly to the development of the product, they will experience the downstream aftereffects through the product's failure or success. Through this perspective, it can also reveal that stakeholders can function at a societal level, not just within the company or individually.
Considering the stakeholders in a broader perspective can also raise the question as to who hold most responsibility in the product development process. If decisions made during a design phase can influence healthcare cost and accessibility, should PM's consider a wider societal stakeholder when making their designs and decisions? How would a team realistically take into account these indirect groups of individuals when planning for a project.

The tendency in most PM frameworks is to define stakeholders in fairly transactional terms: the people who fund the project, the people who approve it, and the people who use it. Expanding that definition to include anyone who experiences the downstream consequences of a products success or failure reframes the entire responsibility structure in a meaningful way. The medical device space is actually one of the better industries to illustrate this point because the ripple effects are so tangible. A device that reduces post surgical complications doesn't just benefit the patient in the recovery room, it reduces readmission rates, which creates several downstream effects, such as leaving a greater number of hospital beds, which in turn reduces strain on clinical staff, and reduces financial strain on both hospitals and patients themselves. 

Then Aby, to your point about where the responsibility sits is the one that I think needs to be further examined. PMs already operate under enormous pressure from the stakeholders they can see, sponsors pushing for faster timelines, regulatory bodies requiring documentation and customers asking for certain requirements all at the same time. Asking a PM to also hold space for a diffuse class of societal stakeholders is a genuine challenge that needlessly increases practical risk, as they may try to justify shortcuts because any harm feels more abstract and distributed rather than concrete and localized.