This is an interesting question. I think inspections are always stressful for the quality department. Even if Regulatory has put forth current procedures and regulations of certain products, it is ultimate upon Quality ‘s responsibility to ensure that adherence to those regulations was properly met. The perspective of failing regulations and being…[Read more]

It is an absolute necessity to improve the relationship of QC with other company departments. It is in fact in those other departments best interest to ensure a healthy relationship with their QC. The quality department usually runs deep within the structure of the organization. There should be a great emphasis on the integration of various…[Read more]

I don’t believe companies intentionally want to fail to adhere to the rules. With the analogy of the speed ticket, for instance, let say you are rushing to get somewhere and unfortunately get pulled over and get a ticket. I don’t think your goal was to get one; perhaps you were hoping you might go unnoticed. We are all flawed in that way;…[Read more]

When the De Novo process was first initiated, sponsors needed to submit the premarket notification (510(k)), to which the FDA would issue final 510(k) decision of “not substantially equivalent” due to no predicate. The sponsor would then need to submit A De Novo request and the FDA would decide whether to classify device from Class III to Cla…[Read more]

An example of FDA approved wireless medical devices is the wireless electrocardiogram. It consists of the ECG monitoring circuit, microcontroller circuit, and an Android mobile phone. The phone has a function that detects if the wearer has fallen down and hasn’t moved for a while, and can call for help. The microcontroller interfaces to Android m…[Read more]

Combination product: metered dose inhalers, MDIs

An MDI is made up of a pressurized canister containing a drug substance and possibly excipients formulated with a propellant. The formulation is aerosolized through a valve fitted with an actuator (mouthpiece). Per FDA regulation, MDIs are considered drug-device combination products. The primary…[Read more]

While I find it interesting that the standard for labeling is inverted between Sweeden and the US, I am not a bit surprised that the US opted to have the genetically modified goods be ” standard”. I think it works in correlation with the US Capitalist system. The US tends to prioritize customers attraction over product quality. For instance, the…[Read more]

Although I believe animal testing is clearly unethical, I do find the efficacy of their results extremely valuable. Animal testing has been the most accurate and reliable strategy for checking new drugs, with few limitations or side effects due to animals and humans. Alternative models, computer simulation, have emerged as a mean to both…[Read more]

As others students stated, referencing the Toxicity Table from ISO 10993 should give a general idea of tests needed prior to clinical trial phase. Ultimately the test needed will depend on the expected functionality of the medical devices. For instance, in the case of orthopedic implants, it is important to measure maximal load and stress level…[Read more]

Research is always important no matter if it is in Industry or Academia. As Dr. Simon mentioned research in Industry is usually to create a solution to a problem while Academia researches tend to focus on understanding the problem, study various aspects of approaches to investigate the problems and perhaps solve the problem or at least provide…[Read more]

Before considering if Industry research is ” successful” , we need to define what ” success” actually is. What parameters are we using to measure success? is it in term of achieving an end result within the expected timeframe, or within the expected budget? Is the product effective to perform its expected function delineated in the design? Is…[Read more]

I think all these three features of a project are all intertwined. Although the achievable seems to stand as the most important one, in reality, it will be greatly undermined if the other two characteristics are not fully met. For instance, let say, you have a project be achieved within a timeframe, but the people working on it don’t have a clear…[Read more]

Besides having a solid technical background that most people are suggesting, I believe a manager should have excellent communication and people skills. We can’t really coordinate a project if you don’t relate or assimilate with the people actually doing the project. In planning the project, the manager should also set his/her deadlines way prior…[Read more]

I think no single phase is more important the others because the end project results in the efficiency of all the phase combined. However, I think the initiation phase should be given ample consideration as it set the tone for the rest of the project. Once the initiating phase is perfectly elaborated, everything else falls in place. This step is…[Read more]

One project in which I encountered crucial setbacks was my capstone project assigned to a group of five. We had a year to submit and present our findings. Although we did have an elaborate planning, almost nobody followed through. Communication became extremely difficult as no one reported the progress of their work. On our mid-project meeting, we…[Read more]

I strongly believe that, prior to execution of any projects, several rounds of planning and review of milestone should be conducted. The project manager should take into consideration possible delays and set back which are out his/her control and plan according. He should have this mindset commonly used in the military: ” if you are on time, your…[Read more]

I would suggest getting an internship/co-op to have an exposure to the Industry environment. However, even this is very competitive with company recruiting like 2-3 students in the pool of 100 people. If lucks aren’t in your shoes, perhaps try to look for a mentor, but make sure it is someone who shares the same interest as you. Attend various…[Read more]

I think the pursuit of either Academia or Industry ultimately depends on individual personality. For people who like being surrounded in a social content and aren’t mortified by deadlines, Industry might be a good choice for them. However, other people, myself included, who enjoy teaching, conducting experimental investigations and discovering…[Read more]

I am neither in the medical industry right now nor do I plan to be. I am oriented toward the academic lifestyle. However, from what I heard talking with various engineers working in industry, each aspiring industry-driven BME student should strive toward a graduate degree. The reason being that having a Bachelor degree is considered a standard…[Read more]

I wouldn’t completely disregard the benefit of the versatility of the BME field. Considering my case, for instance, I did my undergrad in Biology, with a concentration in the Neuro-endocrine system. Prior to my becoming a grad student, I was confident of my solid knowledge of that system, however, my deficiency in other courses such as…[Read more]