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Management is different from leadership but just as important. To understand the nature of management, we need to be clear how it differs from leadership. The first step in answering the question: “What is management?” is to understa

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

nd the basic tasks of all organizations. Like any other species, an organization needs to take care of its immediate business of survival but it also has to evolve to ensure its fitness to cope with changes in the environment and the

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

Examples of combination products may in

actions of competing species.

Management is the function that organizes the execution of today’s business. Leadership is the evolutionary mechanism that changes organizations to prosper in tomorrow’s world. Whenever a species or ind

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

vidual animal runs into obstacles, variations occur and new forms are selected from those variations. Leadership is a risk taking type of action that explores new frontiers and promotes new ways of behaving. It follows that, in a sta

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

le environment, good management is all that is needed to prosper; leadership in this context isn’t required.

This portrayal is not the popular one where leadership means being the top dog in a group regardless of what’s going on in

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

Combination pro

he environment. Also, management has been cast on the rubbish heap since the late 1970’s following the initial wave of Japanese commercial success in the West. We wanted a scapegoat for our failure to compete with the Japanese, and m

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

nagement was fingered for this role. Jack Welsh, Tom Peters and other gurus called for more leadership and an end to management, which they saw as stifling innovation. The reality was that a lack of competition created a complacent a

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

titude AND lackluster management. It was the way management was practiced that was the problem, not anything to do with management as a function. We simply needed to upgrade management for a new reality.

Being hierarchical by nature

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

and inclined to worship heroes, we tend to regard the person in charge of our group as a leader. But complexity demands specialization and executives need to perform multiple roles that depend on the unique demands of their situation

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

If their main function is to maintain quality, low cost and good customer service while motivating employees to perform to their potential, then they are performing the management function, not showing leadership.

Management is lik

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

investment. Managers have resources to invest – their own time and talent as well as human and financial resources. The goal or function of management is to get the best return on those resources by getting things done efficiently.

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

Following aspects would a

his doesn’t entail being mechanical. The manager’s style is a contextual issue. With highly skilled and self-motivated knowledge workers, the manager can be very empowering. Where the workforce is less skilled or motivated, the manag

dd to the challenges in developing combination products:

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

r may need to monitor output more closely. By saying that management is a function, not a type of person or role, we better account for self-managed work teams where no one is in charge. Managemenet simply makes the best use of all

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

esources even when we manage ourselves. Hence management does not necessarily entail a dictatorial, controlling overseer. Skilled managers know how to coach and motivate diverse employees. Getting things done through people is what t

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

ey do.

The aim of management is to deliver results cost effectively in line with customer expectations and profitably, in the case of commercial organizations. It is not only leaders who can be inspiring. Inspiring leaders move us t

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

change direction while inspiring managers motivate us to work harder.

Management is a vital function thanks to the complexity of modern organizational life. The need to coordinate the input of so many diverse stakeholders, experts

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd customers requires enormous patience and highly developed facilitative skills. Excellent managers know how to bring the right people together and, by asking the right questions, draw the best solutions out of them. To facilitate w

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

ll requires managers to work very closely with all relevant stakeholders.

By contrast, the leader can be a bit of an outsider. Like Martin Luther King, Jr. promoting desegregation on buses to the U.S. government from the sidelines,

.

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

he leader can induce people to change even with no direct involvement or authority over the people who are needed to take the hoped for action.

Managers don’t just keep ongoing operations ticking over. They also manage complex proje

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

Companies that provide selfless information through particip

ts like making a modern movie or putting the first man on the moon. Leadership is only required to sell the tickets for the journey or to resell it periodically if resistance develops, but management drives the bus to the destination

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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Article discusses some great business ventures. Owing your own franchise is a great business move because the name has already been established. A few of the more recently lucrative franchises industries are discussed within the article.

Have you ever noticed how long it takes to get your car washed at a carwash? Have you ever thought to yourself they could surely get you out quicker. Why does it take so long to WASH A CAR? Some of the washes I use take 30-40 minutes.

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