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Stakeholders in Medical Device development

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(@ks629)
Posts: 38
Eminent Member
Topic starter
 

Chapter 2 of the PMBOK discusses stakeholders. Identifying stakeholders is a process that occurs throughout the entire project lifecycle and the project manager is expected to manage these stakeholders. In Medical Device Development what are some stakeholders and unique challenges to managing them in the industry?

For example, most projects in any industry have similar internal stakeholder. These include project sponsor, project manager, and project team members. In medical device development we also have the regulatory agencies and a unique set of customers. Customers or end users are often considered to be both the doctor and the patient and even the hospital. I have found that we spend a lot of time gathering feedback from doctors in medical device development, but very little time gathering input from patients.

 
Posted : 01/02/2018 5:23 am
(@as934)
Posts: 78
Trusted Member
 

In addition to the project team, stakeholders within the company also include people who are not working directly on the project but who will be affected by the outcome of the project. For example, rather than being tasked with coming up with a new device, a project team could be tasked with finding a way to improve an existing device in order to stay relevant on the market. If a competitor comes up with a better device, the your company would need to find a way to retain their market share. Perhaps they could achieve this by finding a way to make the device at a lower cost to the company, or by improving the design. In this scenario, the stakeholders in the company would be the project team, production (they will be building it), marketing and sales (they will be selling it), and any other people that will be involved in the project or who will have a change after the completion of the project. Regarding your comment about gathering feedback from doctors more than patients, I think it is because they are the ones using the product on patients. A doctor who has done countless knee replacements on patients can provide more substantial feedback because he can provide details from every case that he used the device and from his or her follow-up with the patient afterwards. In the project scenario that I mentioned earlier, we would want to have feedback about why they our using our product over a competitor's or the competitor's over ours. While the hospital, doctor, and patient are all stakeholders, who do you think is most important from the company's perspective?

 
Posted : 01/02/2018 4:09 pm
(@krp67)
Posts: 76
Trusted Member
 

I agree with as934 and additional to both voices, I want to examine the internal and external stakeholders briefly. We know employees can be considered stakeholders in a company. The first thought I had was laying off employees. Think of the self-checkout services that companies have adopted in past 4-5 years. I assume the project managers of this technology realized they will make a huge profit because companies will lay-off employees since they now, in the long term this will save the company in cost for production, which is critical. The companies managers now have to take into consideration the stalk holders i.e (employees). From a business point of view, this is great, from a employee view its terrible. Therefore, interpersonal skills need to be shown through out this process, because if you do not take care of your workers the company’s reputation will be tarnished. So what can be done? A program such as a severance package can be proposed. Which is done throughout many companies.

 
Posted : 02/02/2018 9:18 am
(@pdp47)
Posts: 54
Trusted Member
 

During my undergraduate I did an internship over the summer at a medical device company that developed knee and hip replacements. The company's customers were mainly doctors. I remember we use to get feedback from surgeons around the country on what they thought about the knee and hip replacement products. It seems medical device companies main target market is doctors and not really the patients. Currently I am working for a medical device company and our target market are hospitals around the world. I don’t really see medical device companies going out to sell products to the patients. Their biggest buyers are usually hospitals. At my current job we refer the the “customers” as people who work at the hospital.

 
Posted : 03/02/2018 10:31 am
(@ak977)
Posts: 41
Eminent Member
 

It makes sense that the customers for medical device companies would be hospitals/doctors and not actual patients. Companies need to sell their products in bulk and that isn't really a possibility when it comes to single patients (just how many hip replacements does a person really get in one lifetime?). Therefore, it really doesn't make sense to care too much about each individual patient. In addition, patients speak directly with their doctors and any relevant feedback is directly relayed by the doctors to the companies, making the process a lot faster and singular, versus medical device companies having to deal with thousands of individuals.

 
Posted : 04/02/2018 10:35 am
(@alexandrabuga)
Posts: 149
Estimable Member
 

In contrast to industry stakeholders, I work at a non-profit Sloan Kettering and when a clinician or nurse comes up with an invention-a new car-T cell therapy, or robotic surgical instrument they disclose their invention to our office (Office of Technology Development) and we work to protect the intellectual property (IP) and develop the inventions that are commercially viable and license them to larger device companies or create a start-up. The stakeholders of a the development of a Sloan Kettering medical device include: inventor(s) (we call them PIs for principal investigators), VP of Technology Development, the President of the department, Research and Technology Management, patients (end customer) and for start-ups and large value technologies, investors, our board members and CEO and President, Craig Thompson. Overall there are a lot of key stakeholders for developing a commercially viable medical device at Sloan.

 
Posted : 04/02/2018 11:18 am
(@srg36)
Posts: 117
Estimable Member
 

In medical device projects that I have worked on and am working on, one of our most important external stakeholders are our suppliers. We do not do any in house manufacturing, so we rely on vendors to manufacture all of our product. Since they are such an important stakeholder, it is critical to set expectations with your suppliers and maintain a good relationship with them throughout the project. Similar to how transparency is critical to the internal project team, it is also important to maintain transparency with your suppliers, although it can be a little more difficult because you do have to be careful how much you share with your suppliers, as they are often manufacturing products for your competitors as well.

 
Posted : 07/02/2018 9:07 am
(@msc52njit-edu)
Posts: 78
Trusted Member
 

Throughout the medical device field there are a lot of potential candidates who can be classified as stakeholders. A major stakeholder would personal investors in the company and the people who work for the company. Every individual who works for the company has invested their time and resources into ideas and projects that the company is planning to follow through on. Bad or good projects can affect all of the individuals in the company who need it to succeed in order to still have their position and income. The investors who put money into the company are also major contributors as they are a source of funding for the development and production of these medical devices and their stake also relies on the company succeeding. At my summer internship I learned that a major stakeholder in the medical device company are the sales representatives who are selling the medical devices to hospitals and separate privately owned practices. These representatives need good, reliable products to sell to these users and they need the company to thrive and be innovative so they can sell more products. When it comes to managing stakeholders, each individual should have a certain influence on the company and should be able to have a say, but this should be proportional to how much stake they have in the company. A person who owns half of the company should have more say than an individual worker. However, stakeholders need some limit in their power as they should not be making engineering or business decisions in areas in which they do not have expertise in.

 
Posted : 10/02/2018 12:54 pm
(@sahitya-sadineni)
Posts: 69
Trusted Member
 

The past summer, I did an internship with Prosidyan. They are a medical device company which create and produce bone graft substitutes. The company’s customers were mainly doctors/surgeons at hospitals. We would send the material to the hospitals around the country and the some other countries also to use the bone graft substitute for spinal surgeries. Based on some of the research I have done, it seems thats medical devices companies are trying to focus on doctors and hospitals as its customers and not so much the patients themselves. The customers are the hospitals.

 
Posted : 11/02/2018 3:42 pm
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