The biggest disadvantage of NDA's, I believe, is jurisdiction. While multilateral patent agreements exist across many first-world countries, such is not the case for NDA's. This allows NDA signers wit...

A small reimbursement of $100, I believe, is a good reimbursement for a doctor's time that compensates the doctor without creating a meaningful conflict of interest. While the exact amount can be deba...

Like many of the students have stated previously, I expected this course to include a thorough technical look at different industry roles associated with Biomedical Engineering, as well as the general...

While not directly related to the kind of kickbacks we are interested in (and wary of) as medical device developers, it is interesting to take note of the trial of Senator Robert Menendez (D-NJ). He w...

Choosing an appropriate organizational type brings with its tradeoffs. Every type has advantages and disadvantages, and these can vary depending on the size and culture of an organization. In very sma...

A large number of companies nowadays use matrix-style organizational structures. Organizational structure has a huge impact on the performance of a company, so choosing this style is not a matter of c...

A project manager ideally wants to work in a functional, project-based organization where he or she has complete control over the team. Although matrix organizations are highly popular nowadays, the m...

Often times, it is best to determine what the worst case scenario is when making a decision. When making a decision for the safety margins in a medical device, one way to think of what ought to be con...

On one hand, it is easy to see how the burdensome costs of regulatory controls may deter businesses from pursuing medical device development. But there are reasons to believe that this is not as large...

While it is essential for the entire team to identify risks during development, it falls primarily to the Quality Assurance team to ensure that risks are properly identified and accounted for. For thi...

During my capstone project, I engaged in regular project design review meetings. These were incredibly essential to making sure that our project was a) turning out to meet customer needs and b) was fe...

There a number of general financial reasons why a company may choose to outsource a portion of a business. Generally, these tend to depend on cash flow and the growth avenues a company chooses to focu...

Much like India, Pakistan has only recently implemented a detailed regulatory environment. Until 2015, the Medical Device landscape was an almost fully rule-free environment, just as seen in India. In...

As students learning about the various good practices and regulations of the Medical Device Industry, we encounter the importance of proper documentation again and again. Strong documentation is not o...

Gantt charts provide a number of useful characteristics - they save time, allow for a manager to always be aware of where a team is compared to their proposed schedule, and provide a roadmap for a pro...