In 2002 US Secretary of defense, Donald Rumsfeld drew attention to the danger of unknown unknowns when answering a journalist’s questions about the lack of evidence linking Iraq to terrorism and weapons of mass destruction. He said “Reports that say that something hasn’t happened are always interesting to me, because as we know, there are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns—the ones we don’t know we don’t know. And if one looks throughout the history of our country and other free countries, it is the latter category that tend to be the difficult ones.”
The danger of unknown unknowns is also important in many businesses including the regulated medical device and pharmaceutical industries. With the complications of medical applicati
ons, complex manufacturing processes and the regulated environment it can be challenging to know everything you need to know about your product, its application and its manufacturing process.
Unknown unknowns was not a new concept in 2002. The idea is often credited to psychologists Joseph Luft and Harrington Ingham who developed the Johari window in the 1950’s as part of psychological examination. Subjects are asked to list their character traits and so a
re people known to them. Traits that are mentioned by both are the known knowns, (called open or arena). Traits mentioned by other but not the subject are the unknown knowns, (blind spot). Traits that the person has but hides from others are known unknowns (hidden or façade). Traits the subject has that neither they nor others are aware of are the unknown unknowns (unknown).
The concept has been applied to many fields of endeavor such as investment banking and insurance, fields in which having as much relevant information as possible is important. And it also applies to regulated industry. In the matrix there are four quadrants. The first are the known knowns – issues related to our process and products that we know about and know how to deal with. This is the quadrant in which we want all issues to be. Early on in development many issues are in the other three quadrants.
The second quadrant are the known unknowns. These are the areas that we have already identified in our risk analyses as things that we need to know about but don’t know yet. This is the quadrant in which most of our present activity on the project is. Experiments and validations th
at we are carrying out on the product and process. It also includes discussions we are having with our regulatory advisors on the work we need to do to be ready for filing. It includes patent investigation and preparation work.
Quadrant three is least important in practice. In this quadrant are tasks that we do not know we need to do but can easily complete if the need arises. Perhaps it is providing known technical data to a regulator – you don’t know you need to, but when asked will know how to do it.
The fourth quadrant are the unknown unknowns. This is the area to which we need to pay a lot of attention, especially in the early stages of a process or product development process. These are the issues we don’t even know that we need to know about, and when we do find out we discover we have a major knowledge gap. The only way of reducing the size of the quadrant and to move subjects first to quadrant two and eventually to quadrant one is by investigating fully. You need to engage in brainstorming with a variety of experts to identify potential issues.
If you don’t have enough expertise in the subject area you should engage experienced consultants with great knowledge of the area to identify the issues. You may need to hire new people with relevant expertise. You should look for knowledge is all possible places. Discuss with friends and former colleagues who may know more about the subject area. Research online and in academi
c literature. But most of all, do not assume you know enough. Keep challenging yourself and your team to be sure that all relevant information has been identified. You do not need a major surprise like a potential patent infringement or regulatory obstacle to become apparent as you prepare to launch your new product.
Investigate actively until you can identify no more issues you need to know, and then investigate some more. It helps to be paranoid. Make sure you identify all possible unknown unknowns. Don’t get caught out by the things you don’t know but could have known if you had investigated more.