Logging the work that you do is extremely important.

An example of this is a recent event at my current workplace. The telemetry system had gone down and I was called in to repair it. This just so happened to occur on an observed holiday. I logged everything that was done that day, as well as the fix to the issue. This is important for different…[Read more]

Overcommunication, to me, mirrors micromanaging. Being consistently on top of someone to the point of pestering them.

Establish a communication protocol at the first team meeting. Communication is the most important aspect of teamwork, in my opinion. Being fair and appropriate to everyone’s preferred method of communication while having clearly defined consequences is key to effective communication. Whenever there is an issue, you can reference the communication…[Read more]

This would depend on the timeline as a whole. How much time has been allocated to this segment in the project? Were there any milestones missed prior to this that have already delayed the project? The Project Manager may have already buffered this segment of the project in case of delays. You should also check to see how much time you have between…[Read more]

What I would recommend is falling back on policies and procedures. At my current job, there is a policy surrounding PTO(Paid Time Off). We have to submit a request a minimum 2 weeks prior to the date we are requesting off. This gives everyone notice of the absence and allows for proper planning in the individual’s absence. If there is not a policy…[Read more]

The first problem that came to mind is communication. A PM has to communicate effectively to their team, investors and clients (to name a few). They should set up a reliable communication system for each group and update them periodically. A PM needs to be mindful of overcommunication, however. Overcommunication can cause people to become annoyed,…[Read more]

Missing a Milestone is bad, however, should not be deadly to a project. A well-designed project will have some wiggle room in case of tasks not going as expected. A missed milestone may also set you back budget-wise, but effective budgeting can account for it. Overall, missing a milestone is bad yet it also provides a learning experience.…[Read more]

It may seem straightforward to you, however, there are cases where companies are not following regulations. A recent example would be Philips Healthcare. They were forced to cease operations at both their Massachusetts and Washington facilities pending corrective actions due to CGMP violations. So obviously there are some things that Philips…[Read more]

The classes defined by the FDA are Class I, II & III. Each company may label them however they want internally. Companies tend to give the projects pseudo/ temporary names while the product is still in development.

There are different ways to get funding for a project depending on the size of the company. It also depends on if the company is privately owned or public. Overall, I would more so look at the risk for potential reward. If the risk to reward is worth it, I would recommend taking the leap in the potential project.

Design Verification and Validation should, on some level, be implemented throughout the entire life cycle of a medical device. You should verify that you can make each component of the device consistently within tolerance. You should also validate that you are including aspects in the device that the customer, or intended user, wants/needs.

I don’t see global regulation happening. When filling out the different applications with the FDA, there are application fees. If everything becomes global the application fee will change as well which I do not think will happen. Also, the level of comfort with devices and drugs are not the same globally. A great example would be the thalidomide fiasco.

Anthony,

The premise of the device is interesting and can provide needed support with suggested treatment. The reason for the disclaimer, in my opinion, is because electronics can fail. If they state that this can happen 100 % of the time, they are opening themselves up to hard backlash. If the sensor is damaged, or if the patch isn’t placed…[Read more]

The FDA definition for a medical device captures a broad spectrum of products that one may not initially consider a medical device. An example of this would be a bedpan. Although a band-aid is not used to treat a disease, it is used to prevent infectious diseases.

For the full definition of a medical device, please take a look at the following…[Read more]

Picking the proper project team is an essential component of a project. Each project will have multiple moving parts and having a diverse project team will be beneficial. It is important to have a well-rounded team where everyone’s weaknesses and combated by someone else’s strength. For example, it will not be beneficial in having a team of 5…[Read more]