A company’s success is not dependent on whether or not it is publiclt traded. In fact the decision to go public is usually made based on how the owner(s) is/are seeking to profit. Many business owners make their fortune by selling some part of their company. Before a company is sold or goes public, it is evaluated as a multiple of its 10 year…[Read more]

If you are looking to continue to build your company privately, an LLC is a good option. Because LLCs are passed through entities they are only taxed only once. Also with an LLC you get the Liability protection of a corporation without the same formalities or expenses. This is especially important as medical device companies are capital…[Read more]

While it may be true that some “current intervention practices de-incentive quality”, FDA regulations are intended to prevent harm to the device user, not to ensure quality. It is up to the discretion of the company to produce a product that Is not only safe and in compliance with regulation, but also one of good quality.

It is important to not…[Read more]

I agree with dbonanno1 and dag56 on the integration of R&D and quality. by having R&D Engineers work in conjunction with Quality during the design process, delays can be minimized as procedures can be done properly the first time. it should be the goal of every department to maintain compliance as it is necessary for the existence of the…[Read more]

For everyday tasks, “its too much work” is never a good reason not to do a particular task. the same applies to QA/QC systems. while these systems can be quite onerous to maintain, I think most people would rather good quality over expedited delivery or lowered cost. From a business standpoint, especially a startup, low cost and quality are…[Read more]

Its not just Dietary supplements that the FDA needs more regulation on. some prescription drugs get to market unapproved. when the FDA finally gets around to getting these drugs off the market, the companies are given a long period of time to stop making and distributing them. “FDA officials expect companies that have listed products with the…[Read more]

although the FDA will potentially have more money in the long run, the delay in negotiation for a new deal will cause “substantial layoffs at the [FDA]” as the article Alexandra posted stated. this will definitely slow down review time for devices. I also agree with akashranpura that there will be a monopolizing effect. However if the smaller c…[Read more]

In agreement with what Ibraheem stated above, Precision and Accuracy are most at risk with aging devices as use brings wear and fatigue. Part 21 CFR 820.72 of the FDA Medical Device regulations defines the rubric for calibration standards. proper calibration is not just dependent on the upkeep of the device, it must be considered during the…[Read more]

I personally would like to work in the industry, and I would also like to work on products that will reach the market in my lifetime. However I agree with krp76 that academic research does not only means long term research. The timeline of any study depends on the specific topic being researched. While many drugs and devices are developed in…[Read more]

assuming the university to which the study was outsourced to is competent to properly complete the task, as alexandrabuga stated, explicit instructions are vital for proper execution of the animal study. as bb254 stated, because of the distance of the university time delays are imminent, but can be mediated. to minimize delays, frequent phone or…[Read more]

Many instances of Research in industry is approached with only the final goal in mind. because of the confidentiality required in business, any discoveries are not reported on publicly further delaying gratification from the work done. In academia, however, researchers are often submitting publications throughout the investigation. this…[Read more]

Although I have yet to work in industry, I would like to work as a design engineer. I can see how familiarity with FDA regulations can be a great asset/necessity for Design/R&D Engineers when designing as things such as material selection for a device or implant have mandates. However, I am looking forward to discovering and discussing further…[Read more]

As I enter my second Year I must agree with kak33 and a few others about receiving proper preparation for industry. however i believe it depends on what part of the industry you are interested in and whether your focus is on the functionality/structural design or material/drug synthesis side of BME. If your interested in an area such as QA,…[Read more]

Networking and co-op/internships play are important. as per my experience, as a MS student coming from a BS in bio, taking a diverse courseload can be very useful in narrowing your list of potential careers in BME. Because my undergraduate background was not in engineering I was strongly encouraged to take graduate level materials and…[Read more]