I believe the biggest way to avoid this situation is not necessarily to treat “meets dimensions” as the same thing as “meets specifications.” In the ouch simulation, the CamTech pouch physically fit the device, but the odor and toluene issue…   Read more»

For me, my biggest motivator is my family. I thrive on having a comfortable family home for her and I that we can be proud of, while also going to travel to other countries and experience what we can together….   Read more»

From looking at the results listed, they don’t surprise me honestly. I think when someone thinks of their ideal or “dream” job, the reason is that it is both excited and challenging for them to do for most of their…   Read more»

I agree with your point, especially about how the outsourcing is not just about smaller companies lacking resources, but also about access to expertise and efficiency. Even if a company has the ability to run trials in house, I think…   Read more»

I think this is honestly a tough situation because at first you would be really motivated just from the excitement and passion of the project itself, but over time that lack of long term growth would start to catch up….   Read more»

I agree honestly that job satisfaction matters the most, but I don’t think it works entirely by itself. An employee could enjoy the actual work they do, but still leave if they feel underpaid, unsupported or even disrespected by their…   Read more»

From a project management perspective, I think it is important to at least give teams a basic understanding of what everyone else is doing, even if deadlines are rather tight. It may seem like skipping that step saves time, but…   Read more»

An effective way to evaluate on how to develop a project team is to tie development directly to the project performance gaps. Instead of automatically trying to plan big team buildings events or expensive training sessions, one can look at…   Read more»

I think one of the first steps to this is to quickly analyze and identify whether the missing task is on the critical path, because that could determine how urgent the situation really is. If it is, then the priority…   Read more»

Some of the main reasons project cost increases are due to the following: scope creep, failed testing, supplier delays, and poor planning that can occur from the beginning of the project. In medical device development especially, one failed test in…   Read more»

I agree that the budgeting and clinical studies are some of the hardest parts of a project, especially in medical device development where one failed study can have a delay on everything. Additionally, some of the most difficult parts is…   Read more»

A major factor that could affect schedule variance in a medical device project is the failure happening during verification, validation OR regulatory review. As an example: if a prototype fails biocompatibility testing or required documentation is incomplete, the team may…   Read more»

Delays or increased costs do not automatically mean that a project was unsuccessful, as others have mentioned. Many projects could encounter challenges or delays like supply chain issues, testing complications or changes in requirements that are outside of a team’s…   Read more»

Identifying the root cause of discrepancy between both internal and contracted verification and validation testing is something I agree with as the most important FIRST step. Additionally, reviewing the testing protocols and equipment utilized by both parties, companies would most…   Read more»

I agree that communication between the design and manufacturing teams is truly important during the transfer of design, especially when production demands begin to INCREASE. Additionally, it is an important aspect to consider that ensuring all manufacturing documentation is complete…   Read more»

I think another important aspect during design transfer is making sure the manufacturing team really understands the product and how it is supposed to be built. During development the engineers usually assemble the prototypes themselves and they know the device…   Read more»

If this were to happen in the middle of validation, I think the first step would be to immediately document and record the defects and contact the vendor in order to start a root cause investigation into the matter. Since…   Read more»

A lot of points listed here I agree with, especially with increasing project risk just to shorten the schedule could be a dangerous path, especially in medical device development. In the miniSim example, reducing the animal study timeline significantly from…   Read more»

While I think transparency is important, one practical reason finances might not necessarily be fully disclosed to a PM is that the budgets are often tied to a larger portfolio of projects and upper management might want flexibility to shift…   Read more»

I believe early stage risk assessments should be prioritized because they help identify major hazards before significant time and resources are invested into development. I hear my self mimicking this sort of idea frequently as it is important not only…   Read more»