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At its core, leadership is about people. Fundamental to this is that leaders take care of their people. But this concept also uncovers one of the biggest clich?s in American business; people are our

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

most important asset. Countless organizations, and the leaders in those organizations, say this but the reality of their actions is far different. The message they often send is that the people don

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

Examples of combination products may in

t really matter – it is all about the bottom-line. The leader who sends the message that people don’t really matter will generally not be as successful in the long-run as the leader who is genuinely

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

serious about taking care of his people.

Even today, perhaps more so today, in a society where individuality is lauded and autonomy is cherished, people want to know they will be taken care of. Par

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

of this is instinct, stemming from our nature as tribal beings who need to associate. Part of it stems from the social contract that emerged in our society, and still persists somewhat, that says t

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

Combination pro

e firm will take care of us in return for a hard days work and a full career. And part of it stems from the hierarchical nature of our institutions that says those at the top look out for those at t

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

e bottom; parents care for children, teachers educate and care for students, and employers take care of employees. Leaders then are viewed as having the responsibility for taking care of those they

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

lead. This responsibility extends to three areas; at work, at home, and for life. We will only look at work in this article.

At work

Beyond the expectation and responsibility that the leader will

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

ake care of the led, when a leader takes care of his people he sends a clear message; I care about you, I respect you and I want you to be OK. In response leaders gain increased loyalty from followe

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

s based on mutual respect. Ultimately this results in better performance of the group. The thought process for the follower goes like this, “If I know you care about me, I will care about you and wh

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

t you want done. However, if you don’t care about me then I will not care about you and I certainly will not care about what you are trying to accomplish nor will I work very hard to help you accomp

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

Following aspects would a

ish it.” So much of what we are talking about here are respect issues. With respect people will go out of their way for you. Without respect they will make sure that your important package always

dd to the challenges in developing combination products:

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

ends up at the bottom of the stack.

Do not lower your standards. No where in here did I say it was acceptable to encourage poor performance. In fact the leader who overlooks poor performance is com

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

romising their integrity. Unfortunately many people view “taking care of people” as “coddling” them. They go on to say, why should I coddle them if they are getting a paycheck. Let’s be clear, we sh

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

ould not coddle them. We should treat people as adults and expect the best from them. We should work to give them the best working environment we can and we should implement timely and proper correc

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

ive action when necessary. We want to take care of them so they will want to take care of us. This extends to understanding what they are facing at work and at home.

Taking care of people is one of

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

Professional from academic institutions, pharmaceutical industries, health care indust

the fundamental responsibilities of leadership. It requires deliberate and intentional effort and sometimes the efforts of the leader will be rebuffed. That is not a reason to stop doing it. The ret

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

rn on investment of time and money in taking care of people is very high. Some of this return is quantifiable, as in the cost of turnover and higher production. Some of it is not quantifiable as in

.

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 case of positive PR.

Taking care of people is about setting a standard and helping them achieve it. This is not coddling nor is it a sign of weakness from the leader. It is quite easy to dismiss

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

Companies that provide selfless information through particip

people but it far too difficult to replace them. Far better to create an environment where they want to stay and they want to make a positive contribution.

© 2006 FireStarter Speaking and Consultin

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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Managers have their eye on cost in product development and HR issue. But these can only reduce at one point. They hardly see at waste of not doing anything of their workforce and machines. Read how these factors affect the bottomline of any business.

You've had years of sowing. Isn't it time for the reaping to begin? There's money to be made from your accumulated wisdom... and people will pay you for it!

A good manager knows how to ask good questions. In fact, knowing how to ask good questions is a key to success. This article will teach you how to analyze any issue and get the answers you need for effective decision making, saving you time and money.

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