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 and sell their stolen ideas.

NDA’s, as mentioned above, are of course…[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 to the doctor’s salary is a good way to minimize any risk of bribery, or even the appearance…[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 am glad it didn’t. Those aspects are things that are covered by almost every other course…[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 of private trips offered by a doctor in Florida, in exchange for help in tax and Medicare fraud disputes.

A more…[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” is very common, and may the most effective way for that company to…[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 been shown many times to be effective. Although I have not ever been a corporate…[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 prefer to avoid because it cuts down on their authority and forces them to…[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 far as possible” is to determine what a reasonable investigator (or jury!) would consider being as such when determining whether a…[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 seems. First, it must be noted that these regulations are essential for patient safety and product success. Further,…[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 biomedical engineers enter into upon graduation is the QA department, where employees predict how customers…[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 met with a “customer” and advisors, both of whom helped shape our project into a successful product.

For…[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 cash flow issues, it is generally wiser to outsource a business segment. Despite outsourcing being more expensive, it requires…[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 checks, and a registration process that would begin in 2015. Pakistan’s…[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, of course, is an important component of this focus on…[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 previously, as is the case with all time management charts, flexibility is important, and should not be abandoned for the…[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 surprising when considering that India has long been plagued with medical treatments of poor (or…[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 estimates even a 90% chance of death if the alternative is (for example) a type of cancer with a 1% survival rate. Consent and…[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 funding ought to face different standards for payment than a corporation that succeeds in creating a viable,…[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 perform double-blind therapy. For example, at my lab, we administer real and placebo therapies to patients to study…[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 expectations (and especially so for first-time customers and newer companies). A certain level…[Read more]