Failure to Understand and Sufficiently Appreciate

W.L. Gore and Associates (Gore) is a company that develops medical devices. In reality, Gore is a materials development company (think Teflon, their most famous product), but one division is dedicated to developing applications of these materials to medical devices.

In the early 2000's, the medical device division developed a product aimed at treating aortic aneurisms. This device was a simple long tube of teflon material, with rings to hold the teflon open, like a Chinese finger trap. Along the length of the tube ran a long, thin connecting bar used during the "deployment" of the device into the aorta (these are the really cool devices that are inserted into the heart and blood vessels through a vessel in the leg - in the picture above, the Gore device is on the left and a competing device is on the right).

Because a very similar Gore device was already in use for aneurisms in the abdomen, early clinical testing of the new device didn't include pulse-fatigue testing, where the device is repeatedly bent back-and-forth. Over time, it was discovered that the long connecting bar would break because of the much harsher and more active environment near the heart.

Failure to do the pulse-fatigue testing was a result of a lack of understanding by the engineers on the project of the anatomy and how that area of the body moved. At the same time, the clinical physicians on the project likely knew about the anatomical issues, but had an under-appreciation for them in terms of engineering problems. A related issue leading to the failure of the device may have been complacency on behalf of the project manager and other team members. Because a similar device had been implemented effectively in other areas of the body, it was assumed the new device would work well in the aorta near the heart.

Gore has taken steps to reduce this type of failure by implementing more complex and advanced a priori modeling. In addition, they require project managers to be very well schooled in all aspects of the development process. If the project manager on this particular project had been able to make the connection between the physicians' knowledge and the engineers' knowledge, the failure might have been avoided altogether.

The FDA determined that the breakage of the connecting bar in Gore's device was not "life-threatening." However, Gore has a very conservative policy on all its devices and voluntarily chose to remove the product from the market because they deemed the risk of damage from the broken bar too high. They felt it was possible for the broken bar to gouge or even penetrate surrounding tissues, including the aorta. While legally they could have continued to produce and market the device, they chose to go back and re-design it in order to meet their own standards of safety and to avoid simply producing a "good-enough" product.

This decision, a direct result of failure during initial project management, not only cost Gore a lot of money, it became an emotional struggle for the project members as well. After the product was removed from the market, almost daily a doctor or two would call the company requesting the product be put back on the market ("it's FDA approved") because, they would say, "you're killing my patients by not letting me have your device."

Failure to understand and sufficiently appreciate key aspects of a project often leads to failure to produce or to produce well. Sometimes, as in the case above, it can lead heavy consequences indeed.