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Executive recruiters and commercial lenders agree that it takes a different kind of leader to

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

run a $20 million company that it does to run a $2 million company. The same can be said abo

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

Examples of combination products may in

ut running $100 million and $1 billion companies. What makes the difference? What qualities d

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

oes a $100 million dollar leader possess that a $10 million dollar leader lacks? Is it educat

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

ion? Technical expertise? Charisma? Political cunning?

The crux of the question lies in the

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

Combination pro

word leader. Let's define leadership as: getting results through others and apply this concep

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

t to your organization.

* Have you been wanting to grow revenues to the next level yet neve

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

r manage to make it happen?

* Have you reached a plateau in either market share or revenue?

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

* Did you experience a sales spike only to fall back to your previous level?

* Do you ha

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

ve a strategy to grow to X level and then stop as additional business is foreseen as unmanage

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

able?

Which needs to grow first, the business or the leadership?

It's a chicken and egg rel

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

Following aspects would a

ationship. Executive recruiters and commercial lenders know that leadership is the egg while

dd to the challenges in developing combination products:

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

business growth is the chicken. Leadership growth drives and sustains business growth.

The s

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

kills and behaviors required for getting sustained results through others are not something w

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

e're born with. They can be developed. Leaders who continuously grow provide the fuel for con

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

tinuous growth of their organizations.

When I hear a business owner say we just can't seem t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o get the next level, I see an executive who has stopped improving the behaviors, attitudes a

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

nd skills needed for getting sustained results through others.

Have you encountered a revenu

.

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

e plateau? Is it possible your organization's leadership has plateau-ed?

What can you be doi

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

Companies that provide selfless information through particip

ng do to avoid these plateaus? Are you ready to explore new ways of moving to greater heights

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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