Validation is the process that guarantees the product quality that the end user expects.  The design must provide that expectation with a process that can be consistent with that expectation as well.  The regulatory environment must use its systems to…   Read more»

Medical devices must be safe and reliable.  With data from the FDA that states that “44% of voluntary recalls from October 1983 through September 1989 may have been prevented by adequatedesign controls,” and “The most frequent causes for recalls are…   Read more»

As with many things in medicine and healthcare it looks good on paper.  In action is where the ethical dilemmas present themselves.  On one side there is a huge opportunity to advance medicine in real time.  On the other end…   Read more»

Experience is always valuable.  That is even more important in clinical research.  There is huge liabilities that are present when conducting research on human subjects.  I can understand why experience is so important.  My mom recently retired as a clinical…   Read more»

I live in a country where many people believe that we should have the right to choose.  Choose to own a gun, choose to say what we want, choose to vote; the quote life, liberty, and the pursuit of happiness. …   Read more»

I taught an entrepreneurship class for a summer camp we did for our students.  In that class we watched a video on how Coca Cola was started.  At the time there was differentiation in branding among colas.  Coca Cola became…   Read more»

@jafar The fact that the fate of the business is not connected to any individual owner upon there death is extremely important.  The flexibility with ownership makes comfort in longevity a lot easier.  I would love to do further research…   Read more»

At this time I would start an LLC.  I would start an LLC because it is cheaper and easier to start.  An LLC will still provide the legal protection that I would need when operating a business.  I would hope…   Read more»

I have not worked in a regulatory project but I have worked in government inspections and enforcement.  My first experience in the field was in zoning code enforcement.  I was responsible for enforcing the Denver Zoning Code and portions of…   Read more»

QA/QC in relation to ethics can present interesting dynamics.  I can go back to my college job as a cashier at Home Depot.  We were asked to meet performance measures of timeliness, accuracy, sales, and service.  Specific examples of ethical…   Read more»

If I was to simplify the difference between quality control and quality assurance, I would say that QA puts systems in place that supports the creation of a quality good or service.  QC refers to working the system to make…   Read more»

@llefevre This is a very interesting topic.  Companies can’t be innovators and pioneers if they have not mastered the other needs outlined in the pyramid.  It makes me think if that is true.  If we look at many of the…   Read more»

I have not personally signed a non-compete agreement.  It seems as though in biotech that it would almost be a necessity.  With the success of biotech organizations directly related to innovation, it is absolutely necessary to protect themselves.  Without an…   Read more»

The type of organization that works best is the one that maximizes management effectiveness.  My preference is a matrix organization.  The matrix organization has a lot of benefits.  I believe it provides a strong team environment where people take on…   Read more»

  If I were involved with a medical device development project, biomaterial selection would be important.  Choosing the right biomaterial is important for project success.  Biomaterial selection involves a number of tests to ensure safety for the end users.  Depending…   Read more»

I am on the fence with this topic.  On one hand, animal studies have contributed greatly to the medical innovation.  That innovation has been accomplished in medical device development and novel treatments.  It seems as though the life of humans…   Read more»

As I am choosing my career path in Biotechnology, project management is definitely in consideration.  I have also never seen any project manager positions that do not require experience.  The scope of project management is not something that can be…   Read more»

@ssbufford Thank you for highlighting the impact the new normal is having inside our hospitals.  As a classroom teacher I feel the impact of the pandemic on my job every day.  Desk shields, masks, disinfectant wipes are part of my…   Read more»

COVID-19 has impacted nearly every aspect of life.  It was a global problem that presented problems for most industries.  The medical device industry was impacted greatly.  The pandemic especially highlighted the failures of the medical device supply chain to operate…   Read more»

This course is extremely beneficial.  Not only does this course directly translate to all sectors within biotechnology, but it also has immense value across many industries as well.  The knowledge we are receiving are valuable to seemingly any organization.  To…   Read more»