This topic may be more for those who have industry experience. For those who have experienced the design process and have seen a project go from charter to verification or launch, what has happened when verification testing has failed? How has your team investigated into finding the root cause and how much of a delay did it strain the project?
I know from my experience that delays can often go from one month to one year, dependent on project issues and lead times. Many of the issues that occur are less from proper verification, but from design transfer from the prototype to the final design where tolerances and manufacturer miscommunication have caused failure in some parts during mechanical testing.
Hi,
I'm a biomedical engineer with about 4+ years of medical device development experience. It's not a lot, but it's enough to have experienced something like this. When I graduated college, I began working for a laparoscopic surgical device company. I worked on two projects that essentially failed design verification or some portion of it. The first project ended up being abandoned due to poor component selection within the design that was ultimately exposed during design verification testing.
The second project didn't really fail design verification testing, but the product launch was delayed significantly because we wanted to make sure we met design verification completion deadlines.
The delay was due to the use of components that initially failed our incoming inspections. We tried to make it work by essentially "machining" the flaw away (quite literally, I designed some of the mills and fixtures used to eliminate the flaw). This got us past verifications but stalled us afterward because we couldn't scale the "machined" modifications up high enough for the quantities we desired.
The delay ended up resulting in a total redesign. Partly influenced by new data we came across from competitors in the market and from animal trials with surgeons.
In a way the failure lead us to a better design in a round-a-bout way
