Organizational structures will affect project management in the way the project is conducted and how much power the project manager, functional lead, or executive head will have. A functional organization will place a lot of power in the chief executive’s…   Read more»

In my personal experience I have only experienced a “Weak Matrix” organization, so I can only speak to that scenario from experience, but I can assume how it might work in a “Strong Matrix” organization.From my own experience, I was…   Read more»

ISO 13485 is functionally the same as ISO 14971, however there is an additional requirement on following EU MDR (European Union Medical Device Regulations). EU MDR does have some significant differences from the regulations dictated by the FDA. One important…   Read more»

I have interned with a risk management team of a medical device whiles they were dealing with a pretty big non-conformance in their processes, so I have had experience in the CAPA process. CAPA stands for corrective and preventative action,…   Read more»

Risk management happens throughout the lifecycle of the device, so it is absolutely looked at to determine the rewards and profits that the device could bring. However, it is often not the primary reason the project will continue or cease….   Read more»

I think the most important steps about a project proposal is having realistic expectations of the project. Being specific and having clear expectations for the device and the processes going into making it is ideal. Being able to fully and…   Read more»

A heart monitor is a device that adheres to a patient’s chest for a specified amount of time and records their heartbeat in that duration. A functional requirement is that it must be able to accurately obtain data on the…   Read more»

There will always be some form of change control as long as these documents are not in a “draft” state. If the document has a revision associated with it, any and all changes will go through change control, no matter…   Read more»

I have worked in a medical device company as a quality engineer and although I did not directly work with design controls on new products, I did get a chance to learn about the processes quite a bit. The first…   Read more»

Validation during design controls is meant to provide evidence that the device inputs address the customer needs. This is vaguely captured by the following four facets of validation: planning, review, methods, and documentation. Planning essentially details all the features of…   Read more»

Design controls are crucial to risk mitigation, especially in a medical device company. Design controls are a series of steps taken to ensure that the inputs of the device is matched by the output of the device and that it…   Read more»

Industry in general is a subject not really talked about in university classes often. There is never a lot of insight being provided into medical device companies, how they operate, and what kind of roles you may be given in…   Read more»

I also have experience in quality, specifically the risk management side of medical devices. However, rather than being a Clinical Quality Auditor, I think I would be more suited for being a Monitor. Monitors are responsible for verifying that the…   Read more»

Although I am not interested in pursuing a career that involves clinical studies specifically, I think it would be really interesting to do a retrospective study on the same treatment in different countries (specifically between first and third world countries)….   Read more»

In this scenario, a small division of a big medical device company will start developing stents. The company primarily focuses on orthopedics and is starting to develop smaller divisions to branch out into different areas in the medical device world…   Read more»

I’ll talk about two positive changes to the internal and external environment (strengths and opportunities). An orthopedic implant company is selling a titanium hip stem in the United States. During a business acquisition, the company acquired a Metal Injection Molding…   Read more»

Something interesting that some medical device companies are doing is marketing directly to the patient. While most sales and marketing efforts are done towards clinicians, surgeons, and hospitals, speaking directly to the patient is a different matter entirely. Patients are…   Read more»

There are a couple of key differences between nonprofit organizations and not-for-profit organizations; I am not sure which one the original poster is referring to, so I will write mainly on not-for-profits.The explicit reason that nonprofits are created are to…   Read more»

In my opinion, basic business literacy would be a great class to take and essential if one plans on going into industry. I agree wholeheartedly that the engineering management course was very surface level and I worry about going into…   Read more»

There are a lot of factors to consider when thinking about the morality of the “Corporate Veil.” The importance of the corporate veil is that it separates the business’ assets from the assets of the owners or shareholders. The corporate…   Read more»