How many times have you hear people in your organization ask third party providers (vendors, consultants, CROs) the question “Tell me what industry standard is”?  This question is posed to any number of topics, be they procedural activities, technology adoption, data standards, or even corporate structure.  Whenever I get this question from a client I get a bit of a cold shiver down my spine and have to find a way to politely respond in a way that gets them closer to the answer to the question they should really be asking “what should we be doing to improve”?

You see, the problem is not the idea of finding out how your competition at other companies are operating.  It is fine to seek out what others are doing and then determine if that way of doing business will fit within your corporate construct.  The problem lies in modelling yourselves after other companies just because they do something a particular way.  Admittedly there are a number of practices that are common within the industry but these are more general in nature, as they should be.  For example, if someone asks me how they should be capturing data in the year 2018 I would say you should be using EDC.  This example, as with a few others, is more of a general practice within the industry and is one of necessity as oppose to preference.   So yes, there are general practices that one can point to in the industry which almost everyone is doing, but these are well known to the point of being self-evident.   The typical “Industry Standard” question is directed at more granular topics which are far more complicated.

The reason why the term “industry standard” does not fit well in BioPharma is because our very diverse organizations do not and should not in fact do things the same way.  Even so, we continue to try and apply homogeneous methods and procedures across our diverse organizations with mediocre results.  The following examples may seem familiar to you:

• A new consulting firm comes in and applies an almost identical “templated” approach to your problem that they used with their previous client.
• A new initiative is implemented that borrows efficiency modeling and practices from manufacturing (or another industry entirely) and attempts to apply them to your (non-manufacturing) organization.
• A new set of executives enters your company and begins to alter the operational aspects to more closely resemble the company they just left.

All of these examples and others like them usually have limited success as they fail to take into account two crucial characteristics of the Biopharma industry:

• People are not constants like parts in a manufacturing process, so it is unlikely that people will react the exact same way to a given stimuli.
• Culture, both social and corporate, plays a significant role in the operational facets of a company.

When we boil it down to its simplest parts, yes we are all doing the same type of work in a regulated environment, but the similarities end at that macro level.  How we go about completing this work can, and should, differ based on the culture of your organization.  A certain methodology widely accepted at one company may not be palatable at another company. Yet many third-party providers (CROs, consultants, vendors) will force a particular process or product on you because it has been successful elsewhere. Worse yet, it may be labeled a “best practice.”And worse still, you may embrace it only because of this industry standard/best practice label.

Why does this happen so often? Usually out of understandable frustration for our under-performing organizations and the resulting mistrust of current staff and opinions, followed by the eager embrace of the attractively branded unknown. Keep in mind that you are often getting this information third-hand and may not be aware of any pitfalls and issues these other companies are experiencing.  As the old saying goes “If you do what everyone else does, you get what everyone else gets”. It is better to follow the Rolling Stones: don’t get what you want, get what you need.

So, the next time you overhear someone asking “what is industry standard?,” consider exploring the purpose of that question.  If your colleagues are hoping to simply mimic other companies, then try and steer them instead in the direction of analyzing what it is your company needs first. Perhaps you may identify practices from other companies that fit with your culture, or indeed, it may be better to develop your own tailored solution – your own “best practice.”  Instead of asking what other companies do, begin with answering where you would like to be, and identifying what is keeping you from getting there.

Contact shevel@waife.com for more…