The Covid vaccine was shown to be good, cheap, and fast due to several reasons. Under normal circumstances, it would be nearly impossible to fulfill all three. During the pandemic, the government passed an emergency use authorization which took a…   Read more»

In the case of a recall, Medical Device Manufacturers should take the following steps on what to do. First, a letter should be sent to clinics, doctors, patients, and all stakeholders of the recalled device describing the reason for recall,…   Read more»

After landing a job that I’m passionate about, I’d be very excited to begin by journey learning from new experiences, and continue growing my skills. In the situation where there’s no long term growth or opportunities in the company, I’d…   Read more»

To motivate my team, I would reward small improvements while also providing helpful feedback on how to improve their performance. Overall, each member should be taking on roles and tasks that challenge them technically and interpersonally. I would also find…   Read more»

I think that a proper assessment should be made to find the root cause of the delay. Several things can be done to prevent these situations, such as communicating deadlines, and providing feedback on schedules. Another way would be to…   Read more»

I would want to begin as an Engineer, and then move up to a manager role. As an Engineer, I’d begin to gain experience working with others on a team to complete a project. After gaining experience and project management…   Read more»

One factor to take into consideration would be the risk associated with losing your only supplier. If you opt to more suppliers, you reduce the risk associated with procurement, but increase the risk of effectiveness complaints. Therefore, having fewer suppliers…   Read more»

It’s never truly safe to use any method that causes an increase to risk or cost. After completing a risk analysis, duration compression should only be used if there’s no safer option. In the case of an emergency authorization from…   Read more»

In order to prevent scope creep from happening, the scope process should begin as soon as possible. During initiation, all information of project history should be compiled when determining what the product can or can’t do. The Work Breakdown Structure…   Read more»

I have experience as a Quality Engineer. One of my tasks was to manage the equipment maintenance schedule and order calibration services. During production of the devices, my team and I would catch equipment or other processes being done out…   Read more»

I think in order create an innovative design that passes all regulatory compliance, it should have an effective Validation Plan. The validation method is required to test the device’s safety and effectiveness, and the results to prove its safety and…   Read more»

Although I worked for a company before with a Team, I don’t have experience Initiating and Managing a Project. I think that as an Engineer becomes more experienced with managing many projects in their career, every process in the project…   Read more»

In order to reduce the time and money needed for a project while also increasing the chance for a successful product is to gather up all previous meeting minutes, schedules, and procedures for previous successful projects. Those can be used…   Read more»

Hi everyone. My name is Brandon Klavansky, and I’m a BME MS student at NJIT. I’m looking forward to connecting.
 
http://www.linkedin.com/in/brandon-klavansky-b66479208

I think that email communication is used for official information that includes meeting invites, task delegations, and announcements from the manager. Most companies will use a VPN with a private email server in order to protect sensitive information.  Microsoft Teams…   Read more»

I think it depends on what you mean by Slack Time. Unexpected delays can happen and extra time should be given for cases such as failure in Validation or Verification phases. Although it’s initially costly, the time given is valuable…   Read more»

I agree that feasibility studies will improve the chances of success in the Design Control process and help a project lifetime. Innovative projects are often higher in risk, an can result in the scenario described above, where they discovered a…   Read more»

Using ES, EF, LS, and LF is very helpful for planning for any contingencies. Many factors can cause delay in a schedule such as not thoroughly examining Project or Design Inputs. A device may have required more feasibility data, and…   Read more»

I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either…   Read more»

Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can’t change the testing parameters. The bottles’ labels must be able to stay adhered to the bottle at 37C. In this case, we’d…   Read more»