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The three cultures inside every organization are analogous to the story of the three blind mice and the elephant. The perspective of each mouse is framed by the part of the elephant it touches. It was almost a decade ago when Schein (1996) wrote about the

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

three cultures of management. He asserts that there are three communities in organizational setting— executives, engineers, and operators—and they do not fully understand each other. In Shein’s view, when the three communities are not aligned, their acti

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ons limit organizational learning.

Schein defines the management culture as a set of basic tacit assumptions shared by a group of people. These assumptions color the way they perceive, think, feel, and behave. His tripartite conception of this culture is

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

similar to Stephen Covey’s (1991) discussion of how individuals’ value judgments affect interpersonal relationships. The first way is when people interact at the deep value-based level that forms the core of the group. The second is when the group tries

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

to convey a public image. The third involves the way the group actually operates on a day-to-day basis, which consists of making compromises about their values to achieve immediate goals.

We Can’t Judge a Book by its Cover

Shein states that observing a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

group or an individual’s overt behavior does not always help one understand a group’s culture. Underlying values and assumptions drive an individual’s behavior and the way the person perceives and thinks about the world. These values can be viewed as ideo

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

logies, which remind this author of the observation that a theory is driven by value, space, and time. Books on theories advise that a researcher can understand and replicate theories with the space and time assumptions, but it is very difficult or imposs

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ible to manipulate the value variable.

It is these values or ideologies that lead to the three groups within an organization. The executives’ values can be viewed as primarily political (i.e., focused on the bottom line or the return on investment to ple

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ase the share holders). The executive culture consists of the chief executive officer and his/her subordinates, who use the global occupational community as their point of reference (Schein, 1996). Most of their decisions are colored by political objectiv

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

es. The engineer culture consists of designers and technocrats who use their professional association as their point of reference. Their decisions are motivated primarily, by bureaucratic ideologies. They carry out the mandates of the executives, for exam

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ple: improve the bottom line. This may involve the design and automation of the processes without any concern for the number of employees that may be displaced. The operator culture is driven by their rational ideologies and past successes. They collabora

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

te to meet production schedules, yet in many instances, they cannot understand the actions of the engineers and the executives. It is imperative to understand the contributions of each of the three factors to decision making.

Those who lead organizations

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

should reflect on Schein’s observation--whether society is missing the point by primarily focusing on how engineers and executives learn. He claims that such a view is counterintuitive, given that the most appropriate way for the three cultures to unders

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tand one another is by understanding each other’s values. These values determine their behaviors. Fulmer and Wagner (1999) support this view in their discussion on leadership lessons—learning from the best.

Where to go from here?

Organizational leaders

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

in the US should realize that it is counterproductive to espouse teamwork and cooperation but reward only best-performing individuals. In this author’s view, this is a fundamental difference between the Japanese and American systems. The Japanese promote

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

teamwork and reward the team.

Schein describes other paradoxes in organizations. For example, while information technology specialists see networking as a way of removing hierarchy, executives view hierarchy as a tool for enforcing control and coordinati

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

on. Schein’s final suggestion is that organizational participants need to understand the inherent values upon which assumptions are based, understand one another, and address organizational problems from the same point of view for the sake of the organiza

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

tion’s survival. Recognizing that three cultural mind maps, mindsets, values, cultures and/or viewpoints exist within every organization is critical to resolving organizational issues and providing satisficing solutions. The ability of the three cultures

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

to recognize and work with each other’s value-laden viewpoints can improve interpersonal communications, lift employee morale; improve productivity, and increase retention rate.

Covey, S. R. (1991). The 7 Habits of Highly Effective People. Simon & Schust

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

er, New York, NY. Fulmer, R. M., & Wagner, S. (1999). Leadership: Lessons from the best. Training and Development, 53(3), 28-34 Schein, E. H. (1996). Three cultures of management: The key to organizational learning. Sloan Management Review, 38(1), 9-20.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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From Monday the 21st of August 2006, Royal Mail changed the rates for the postage of letters. Previously, the cost of postage depended purely on the weight of the letter. But now it has been decided that the price should depend on the size of the letter as well as the weight of the letter. This means that a single sheet of paper sent in a small envelope would cost just 30p for first class postage. Whilst the same sheet of paper sent in an A4 envelope would cost 42p.

Robotic welding has come of age in the past few years. In advances in computer technology and robotics, simple, repetitive tasks in manufacturing are often performed by robotic welding devices, with a resulting savings in labor and an improvement in safety, since there is less human interaction and less chance for human error.

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