I personally do not have a direct experience to link a product failure but there are some common reasons for the failure to occur. The device can experience some form of contamination whether it is from a chemical attack or foreign substance. Poor molding of the device is another reason that can lead to a deform before the device reaches final assembly and it is the usually cause for device failure. Next, the manufacturing/ assembly QC and poor product design creating difficulty re-creating the device based on the documentation and expectations from the design phase and having that be pushed into the manufacturing floor. Also, Overstress or stress overload to the device created a stress crack that pushed the device into the failure zone. Lastly, the incorrect material selection is a critical issue that can make or break the device. With the material, it is important to keep in mind the various environments need to be taken into account because it can be a factor to alter the ideal properties for the device to function properly.
http://www.qmed.com/mpmn/article/five-common-causes-medical-device-failure

I don't have experience with dealing with a launched product that failed, but the most recent example of a product having to be pulled from the market are the Samsung Note 7s. This massive recall was due to the fact that when the batteries were charging they would overheat, explode and catch fire. The initiative Samsung put out on recalling these phones was Note 7 Refund and Exchange Program, where those who have a Galaxy Note 7 device can exchange their phone for another Samsung smartphone, or receive a refund. In terms of Medical Devices that had to be recalled, the FDA has a list of devices and creates a published notice of the reason the device was pulled from the market. For example, the Greatbatch Medical's Standard Offset Cup Impactor used for hip joint replacement was recalled on 16-DEC-2016 due to inadequate sterilization. It was identified as a Class I recall, which is the most serious type of recall because the use of this device may cause serious injuries, infections, or even death.

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm480134.htm

As Viraj and Luisa gave examples of recalling of products. I will add that companies face a lot of financial troubles when the device is being recalled. As any industry has competitors, it gives your competitors a chance to copy your idea and make it more secure. Not only this, but it creates a hype in the public and the shares or investors start to back out of the company because no one wants to take a risk with their money. A lot of these companies in the medical field are extra careful with who they bring on board and products that will bring millions of dollars worth of profit are vetted multiple times because launching. Hence, if the product fails and is off the market, the steak holders who invested their money into your company and products will back out. This is one of the reasons I feel can destroy a project manager or a team member or the company itself's career. This is also a serious issue for project managers, they need to have the experience working as a member before becoming the manager. As Dr.Simon mentioned in a lot of his lectures, that it is impossible to get a job as a project manager right out of school. This is one of reasons because one needs to be familiar with the market, product, engineering, and networking before this individual can make acquire the skill set and mind needed to execute a successful product on the market.

I haven’t had no experience in product failures but I can figure out ideas that how a product can fail. I believe that having a poor budgeting could make a product fail, sometime teams look at different ideas, or plan almost everything, and forget that a major part is expenses, also sometimes not all the expenses are taken into account and projects are stopped because expenses don’t fit the budget so due to that the product fails. Another way that I believe a product would fail in having bad team working on a project that everyone is giving to much input that everyone could get confuse and end up blaming each other and the project could not be done in the proper timing.

I personally never had experience dealing with recalls, but I assume that are some costly side effects from a recalls such as tainting of the company brand to potential litigation if the recall is based on causing harm to individuals. I think all possible "Risks" should be considered before releasing products. Especially if the products can come into contact with children.

Chris

I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of product. The lot was inadvertently labeled as a different model number that looks similar. The root cause investigation for this recall indicated that the packaging material for both models were not controlled in storage and there was no clear identification in the SOP to instruct the operator of which packaging material is to use with different models. The second recall I worked on was a product that was not packaged properly, which have led the company to believe that the integrity of the product may have been compromized. Therefore, the organization decided to recall these products to ensure patient safety.

I have also had the experience of a product batch recall. A customer had complained about metal shavings being in his rx bottle. The company right away had recalled all bottles from that batch, adjusted the packaging line, to have a magnet to sift through any shaving particulates that would result from the tablet press. I don't recall the exact costs, but it was expensive, but was best route to reduce chances of lawsuits and user harm.

Hi All,

I have not had personal experience with a product recall; however one I remember quite well is the Toyota recall of many of its cars. The pedals had the tendency to stick, causing many accidents. Over 4.1 million cars needed to be recalled, causing Toyota millions and harming their name and sales. This really shows the great cost that the recall itself can cause, but also their name was badly damaged.

-Andrew Nashed

https://www.theguardian.com/business/2010/feb/02/faulty-cars-recalled-toyota-reputation

Hey all,
thanks for sharing your experience or even things that were in the news.Pfizer also had a recall on three of their drugs in 2014 once it was reported that a container of one drug had some capsules that belonged to a different drug! How scary is that? They recalled lot numbers of all three drugs as they were both produced on the same line.

As you mentioned, recalls may be detrimental to the reputation of a company. Particularly the possibility of litigation. Below I attached a link to an article about a lawsuit that is currently happening with Merck.

http://www.investopedia.com/news/mercks-zostavax-drug-hit-lawsuits-mrk-gsk/

Hi jnm22 thats very interesting anf very scary, because it could affect many of their customers and maybethe company might get sue to some tragic, so do you know how they were able to fix or how they found out about this problem and how long they tool to fix this issue?

Product failure can be described in two categories; product risk & business risk. Product failure is not a fun thing to deal with and a lot of companies deal with it in different ways. Some companies have a non-conformance tracking system where quality notifications are initiated when a non-conformance occurs. Sometimes it can be parts that were received from a vendor with incorrect dimensions. In this case a risk assessment is done to figure if the part is accepted or not. If yes, a deviation must be recorded. If not, all parts of the same batch/lot number must be returned to vendor or scrapped based on the agreement that was made.

From my experience, there are a lot of ways things can go wrong. It all depends on the quality management and how they categorize the different levels of risk.

From work experience, I have not encountered a product failure in the current company that I am apart of, but I have participated in a root cause analysis based on a problem identified from our engineering team, a problem which was identified to causing interference. Once the problem was identified and verified, the SOPs for this process was changed via a change order form and the beta testing units were then recalled in order to make the nessesary changes. We believe that having a controlled testing team is important in identifying such problems prior to it being released to the general public, which would help us save money and also the integrity of the company.

Like many have said I have also been involved in root cause analysis to examine the reasoning behind something failing. In many cases, most of the root cause analysis I have done involves a lot for a product failing. From my experience, the investigation usually involves QC rejecting the lot after in process manufacturing inspection. Many times QC either does a 100% inspection or an AQL and during that inspection something fails. Most of the lot failures that I have encountered have occurred due to foreign matter being on the product. At the end of the day, if the lot can't be reworked it ends up being completely scrapped and I consider that a failure.

In another situation, we had a cranial stabilization device that was used to hold patients heads during neurosurgery. We were getting complaints in the field that the product was breaking due to stress on the screws holding the knob handles in place and as a result the product would break or collapse. We had to do an investigation and open a huge initiative to essentially change the material of the screws.