Main Subject - Business

It happens all the time.

Successful leaders- people with great business acumen, great teams and great vision- are moving along, growing their companies when, all of a sudden, they fall flat on their faces.

Their businesses

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

start hemorrhaging money. Their best people start jumping ship. Their families start falling apart.

And they sit at their desks with their heads in their hands wondering, "How did this happen?"

I'll tell you how it happened

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

Examples of combination products may in

. They were blown up by a problem they never saw coming.

I call these problems "leadership landmines" because unless you're consciously looking for them, they're nearly impossible to spot. They're buried in the grind of dail

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

y life, quietly waiting to injure and perhaps even destroy the next unsuspecting leader who steps on them.

Before I go on, I need to tell you that what I'm writing is based on personal experience. At one time or another in m

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

y career, I've stepped on landmines like the ones I'm about to describe. In some cases, I even have the scars to prove it.

If you're moving and active, you're bound to have a painful encounter with a landmine every now and t

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

Combination pro

en. It's just the nature of leadership. But there are certain landmines that will absolutely wipe you out if you're not careful, and those are the ones that really deserve our attention.

A friend once told me, "If I could ki

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

ck the person most responsible for most of my problems, I would not be able to sit down for a week." From my own life and the lives of the leaders I've observed over the years, I have found that to be absolutely right. Most l

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

eaders I watch don't need to worry about the competition beating them. Instead, they need to be concerned about doing something stupid in the race and disqualifying themselves.

Leadership landmines come in many forms. Spendi

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

ng too much time basking in today's success without looking towards the future will sabotage your leadership. So will failing to make tough calls, advancing in position but not personal growth, and betraying the trust of your

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

people.

You may never have thought of some of these things as being that bad, but believe me, they are. And none of them are caused by other people, including your competitors. If these problems affect your life, the blame

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

ies squarely on your shoulders. So if you want to maintain your integrity as a leader, it's critical that you recognize them as leadership landmines and take steps to avoid them. Click here to learn more about Sandi...

Anot

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

Following aspects would a

her deadly landmine that many leaders step on is the propensity to lose touch with the people they're leading. When leaders become isolated- due to success, failure or even extreme busyness- they become ineffective.

It's the

dd to the challenges in developing combination products:

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

natural human response to withdraw during such times, but if you want to avoid this landmine, you can't do that. Get down off the mountain. Walk slowly through the crowd. Listen to your people and actually hear what they're

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

saying. Sense what they're feeling. Hang out with them.

Taking these actions will definitely enable you stay in touch with your people. The following steps also will help.

Value people.

They're the only appreciable

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

assets that you have, so don't go around thinking that they're replaceable or not necessary. You can't do your job without other people.

Avoid positional thinking.

Leadership has nothing to do with your position o

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

title; it has everything to do with your influence. If you want to keep from losing touch with your people, you have to adopt the mindset that the folks around you work with you, not for you. Titles and positions don't matte

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

Professional from academic institutions, pharmaceutical industries, health care indust

r. If you're good at what you do, you don't need them, and if you're not so good, they won't help. So stop thinking of yourself in terms of your position or title.

Love the people you lead.

This is something I've s

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

aid for many years: People really do not care how much you know until they know how much you care.

Understand that you're in the people business.

You might think you're in banking, real estate, manufacturing or pub

.

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

lishing. But, as my friend Ken Blanchard is fond of saying, no matter what you do, you're actually in the people business. Your clients are people, your suppliers are people, and your employees are people. Make no mistake- yo

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

Companies that provide selfless information through particip

u are in the people business.

Understand the "Law of Significance."

This law says, "One is too small of a number to achieve greatness." If you can achieve your dream by yourself, you don't have much of a dream.

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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