Emotional Intelligence is a combination of self-awareness, self-regulation, motivation, empathy, and social skills. Employees with great emotional intelligence are generally more personable and have great interpersonal skills. EI is extremely beneficial and important to marketing employees. The ability to know…   Read more»

Brand coloring is one of the simplest facets of marketing. The integration of color in marketing material is often a subconscious, psychological factor that affects the viewer. The most common colors that I see are blue and white. These colors…   Read more»

Choosing the correct partner is certainly a great risk when starting a company. Having a partner instead of a sole proprietorship can reduce liability, but divides the ownership between the partners. I would definitely consider doing a partnership in the…   Read more»

Yes. Someone should absolutely consider the type of business when accepting a job. The type of company could have a huge effect on, work-environment, stock options, retirement plans, job opportunities, networking opportunities, and much more. However, I don’t think someone…   Read more»

The ownership of a sole proprietor business cannot be directly passed on. The sons would have to start a new business, either with sole proprietorship (one of them owns and runs it), or a Limited Liability Partnership (both of them…   Read more»

I have experienced a solution to this quality and r&d integration problem. A separate department called “Advanced Operations” assists the R&D team to formulate manufacturing & testing plans that minimize the risks associated with quality. This provides a clear plan…   Read more»

Technology such as AI can be helpful in developing semi or fully automated quality inspections processes. I think it’s important to note that these new technologies also have to get validated themselves. Any new technology added to improve quality control…   Read more»

Quality Assurance is the methods used to ensure a product is suitable for the market. The methods include all of the systems, structures, reviews and evaluations used to meet product requirements. Quality Control is more focused on if the product…   Read more»

I agree that many new medical devices have no business being compared to 40-year-old devices. One of the primary benefits of a 510k is to bypass long and expensive clinical trials. So truly “new” developmental technology has no business being…   Read more»

A physician would likely have a hard time developing their own medical device. The design, development, verification, and validation phases can prove to be very expensive. Depending on the completixity of the device, extra personnel would likely have to be…   Read more»

The FDA’s strict regulations are often based on incidents where the lax of regulations caused harm to the public. The 1902 Biologic Act was instituted after a diphtheria antitoxin caused a Tetanus outbreak. Many regulations are instituted as a reaction…   Read more»

My first consideration would be how the device interfaces with the human body. A prolong-use device like an implant would have to satisfy far more regulations than the surgical instruments used to the implant it.  There is a wide knowledge…   Read more»

Industry research often has the benefit of short term results. With the goal of bringing a product or device to market, research is sought to be completed quickly. Long-term research can also be seen as an investment for the company….   Read more»

Research in Industry is generally completed faster due to strict deadlines. The time management risks of an industry research project should be accounted for in the planning phase. In Industry, the whole point of research is to ultimately develop a…   Read more»

From my own experience and from most of the replies on this thread, Microsoft Project seems to be the most popular software. During my undergrad, and even working in the industry, I have found the software hard to come by,…   Read more»

Multiple project managers could be a good idea depending on the scope and hierarchy of the project. In a large scale project, large or complicated tasks could be delegated to other managers. It is important that the hierarchy and accountability…   Read more»

Missing a milestone for a project should definitely be considered a failure. Failure to complete tasks on-time stems from poor estimation during the planning phase. Inexperienced project managers might place unrealistic timelines on certain tasks, which can significantly delay the…   Read more»

Perhaps I can share my thoughts as a Mechanical Engineering student. When starting my degree, I always had intentions of working in the medical device industry. The fact that BME is a “broad degree” is true, and even more true…   Read more»

My experience working in the industry is that the projects are goal-oriented. The project team works together to complete these goals and meet the desired specifications. I think the most rewarding benefit of working in industry is getting to view…   Read more»

Speeding up the approval of medical devices certainly has its benefits. The COVID-19 pandemic has created a dire need for devices such as vaccines and respirators. The dilemma of COVID-19 devices taking precedent over other “direly needed” devices is quite…   Read more»