Advice You - Business

All business managers have been warned against operating in an environment of crisis management. To be a more effective manager and leader, you’ll want to know that there are prevalent beliefs about crisis management that need to be understood and discounted. To allow

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

us to examine beliefs that have been assumed for many years, I’ve described these prevailing ideas as the myths of crisis management in the text that follows.

Management in the modern organization, of necessity, requires managers that are fleet-of-feet and able to man

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

Examples of combination products may in

ge ever-changing conditions. When the term “crisis management” was coined forty years ago, organizations were still rather staid and unchanging entities. Consequently, it was deemed an unfavorable sign if an organization of that time was regularly in a state of crisis

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

, or, change. And, the management of that organization was viewed as needing to exert more influence to obtain control of events at the firm. Crisis Management Myth #1, therefore, is that experiencing frequent change in organizations, (or “crises”) is a bad thing. On

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

the contrary, an organization in today’s business climate that is not in a constant state of fluctuation, change, and growth will not be able to survive. Organizations that understand the nature of change and its usefulness are those that do well. These organizations

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

Combination pro

know that: 1) change is inevitable, as nothing is certain, except change itself; 2) imminent changes that are faced with courage and confidence are readily managed; 3) change brings with it a certain amount of ambiguity and turbulence; and 4) the results of facing the c

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

allenges of change well will be a more cohesive company environment, aligned with its business community and its clients and customers.

The challenge for modern managers is to learn the agility and responsiveness required in an age of computerization and technological

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

interface. I’m frequently reminded of my research team’s early work with chaos theory and management. (Chaos Theory holds that if a butterfly flaps its wings in Tokyo this will result in a tornado in Texas.) Our essential findings from the chaos research were that ma

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

agers who tried to hold situations static in their organizations (or, “stable,” in their view) were most likely to wind up in a great deal of trouble. Why? Because in their struggle to keep things from “happening,” they ignored all of the early warning signs indicatin

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

g that trouble was brewing, and they refused to deal with these situations in a timely manner. And, why was that? Primarily, it was because their earlier management training had prescribed that they not engage in “crisis management.” What resulted, therefore, was the

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

severest form of chaos, often requiring months, and sometimes years, to disentangle and to make “right.”

Crisis Management Myth #2 – Inherent in the beliefs about crisis management and its consequences, is the assumption that managers should have full control over all

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

Following aspects would a

events in the organization. Fifty years ago, that might have been an accurate depiction of appropriate corporate management. Today, however, events are rarely “controlled,” but are, instead, managed, or orchestrated, for best effect. And, only in the rarest of organi

dd to the challenges in developing combination products:

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

ations will any one single individual have the ability to fully control all of the events and “goings-on” in the organization. I know of very few organizations where control of this sort is so complete. Most organizational management responsibilities in today’s orga

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

nizations are shared amongst several of the corporation’s leaders (for example, Presidents, CEOs, CFOs, COOs, and others), all working in orchestrated teams that lead organizational efforts. To fear engaging in change evidence, or “crises,” because full control over al

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

situations is preferred is at one and the same time both a delusion and an unattainable goal.

Crisis Management Myth #3 is a corollary to CM Myth #2: The “crisis manager” has no focus, because there is no control when managing in a state of crisis. The simple remedy

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

for lack of focus is to engage in a sound strategic planning process. The sole purpose of the strategic plan is to serve as the focus and the ballast for the organization when faced with serious questions and challenges. For an organization that has developed a solid

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

Professional from academic institutions, pharmaceutical industries, health care indust

strategic plan, there should be no question of straying from the central focus.

Crisis Management Myth #4 goes like this: When you’re dealing with crises, you’re not dealing with business. In today’s business world, crises (or, the everyday challenge of constant chan

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

ges) are business. There are many personality profiles among those who choose to join the management ranks. Included among them are individuals who do not relish change. In my executive coaching practice, I work with these “change-aversive” managers to help them unde

.

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

stand the importance that processes of change can bring to an organization. This work employs strategies that assist the manager in harnessing the better aspects of change and discounting some of the more unfavorable aspects.

Peter Drucker has said: “Unless it is seen

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

Companies that provide selfless information through particip

as the task of the organization to lead change, the organization . . . will not survive.” A change leader sees change as an opportunity, not in the negative sense, as a crisis. Crises, or situations of chaos, are simply opportunities that lead to change and to growth

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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Weighing scale has come up with different types of scale products to the users and business people. Bench scales is also one of the commonly and highly used weighing scales by the customers.

In 2005 we saw a paradigm shift in Starbucks Corporations retail strategy. A strategy from making customers at home in their “third place” to serving consumer rapidly at the drive thru.

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