Advice You - Business

Great leaders surround themselves with great and skillful people. Jim Collins, author of Good to Great, and his team researched what it takes for organizations to achieve greatness. He identified

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

great companies and found that they all had the same kind of leadership. These leaders were usually humble, yet passionate about the business they were in. Unlike many of the celebrity CEO's of to

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

Examples of combination products may in

day, they were ambitious for their organization to succeed, rather than ambitious for themselves.

They focused their organizations on a combination of what they were passionate about doing, what

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

they were good at doing, and what would drive their economic engine (sustain and/or make profitable).

Collins states that one of the first things these leaders do is to surround themselves with t

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

e right people. Instead of spending time and money on motivational incentives, they find people who are already motivated. In other words, they recognize that true motivation comes from within.

I

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

Combination pro

have met many leaders who feel "stuck" with individuals who are not motivated to deliver the value that is needed. Most leaders do not have the luxury of bringing in new people. Quite often, you

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

have to work with who you have. If people aren't performing, you usually have to give them a chance. If over time, they do not improve, you may be able to let them go. Yet, it does not serve you o

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

your organization to focus your energy on "How do I get rid of this person?"

Leadership is about helping others to find their own internal motivation. The question is not: "How do we get this pe

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

rson to do the work?" The questions are: "What can this person be passionate about? What are his best talents and how can those talents be used best in this organization?" As leaders, we should wa

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

nt for every person in our care to be excited about getting up in the morning and coming to work. If we can help them find this, we won't have to motivate them.

People are motivated by meaning. L

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

aders create meaning where none seems apparent. At the very least, someone benefits from whatever work you are doing. That is cause for meaning. Enjoying your work is cause for meaning. Being skil

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

Following aspects would a

lful at what you do is cause for meaning. Honest, caring relationships are cause for meaning. Promoting growth and improvement through ongoing feedback, high expectations, and reasonable learning

dd to the challenges in developing combination products:

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

curves creates meaning.

It is easy to focus our attention on where people fall short, and on what's wrong. This focus on things going wrong reinforces problems. Great leaders are able to spot and

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

develop talent. They see what someone can do and they believe in it. They believe in it so strongly that the person is inspired to believe in himself. Having a strong belief in one's self is mean

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

ngful.

Another effective question to ask is: "What barriers have been created that stifle the passion and skill of these people?" Often there are rules and ways of doing things that get in the wa

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

y of the full expression of talents. For example, an employee knows how to solve problems for customers, but she must ask permission from a manager each time an incident occurs. Trusting her to fu

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

Professional from academic institutions, pharmaceutical industries, health care indust

nction as a responsible adult would give more meaning to her in her job and better service to customers.

The "right" person is inside of everyone. It is the responsibility of a leader to help peo

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

le find that person within themselves. If they can't find that internal motivation where they presently are, then you help them go somewhere else where they can.

Creating a self motivated group o

.

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

f people takes time and patience. It takes self reflection on the part of leaders, and the willingness to discipline one's thinking and behavior. Great leaders are passionate about their business

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

Companies that provide selfless information through particip

and skillful at producing their products or services. Today's leader must also be passionate about bringing forth meaning and self motivation in each and every person who works in the organization

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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