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 with particularly valuable intellectual property to move to a different country…   Read more»

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 debated, a compensation that is insignificant in comparison…   Read more»

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 process of medical device development. 3 months later, I…   Read more»

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 was accused of taking advantage…   Read more»

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 small companies, a flat hierarchical structure where “everyone does everything”…   Read more»

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 convenience, but rather the fact that matrix organizations have…   Read more»

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 multiple-boss structure is, of course, something that most bosses would…   Read more»

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 considered “as…   Read more»

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 a downside as it initially…   Read more»

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 this reason, an introductory job quite a few…   Read more»

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 feasible and developing well. Every week, we…   Read more»

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 focus on. When facing a…   Read more»

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 2012, legislation was passed that called for quality assessments, conformity…   Read more»

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 only incredibly important, but is a cornerstone of this industry. Minutes,…   Read more»

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 project. However, as mentioned…   Read more»

As Rashed mentioned, no medical device regulations whatsoever existed in India before 2005. It’s pretty stunning to consider that such a large market (over 1.3 billion) could have such lax regulatory affairs in such a critical field. However, it’s less…   Read more»

As Dave mentioned above, one essential aspect of allowing risky clinical trials is letting patients who are using them as a last resort go through with them. A patient should be free to engage in a trial where a research…   Read more»

We all agree that consent is incredibly important. However, when it comes to being paid for research, I think it is essential to consider the money involved in it. To clarify, I believe that a university publishing research using government…   Read more»

The biggest determining factor in performing a single or double-blind study is the feasibility of doing so. While a single-blind study is almost always possible to perform, there are a number of reasons why it may not be feasible to…   Read more»

This comedy sketch illustrates a couple fundamental problems faced by many businesses, including those in the medical device development industry. First is that customers often sometimes need to be “taught” what to buy, as they may come in with distorted…   Read more»