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Crash!

Aaarrrgh!

The scream of a manager scurrying to cope with yet another organizational, technological, competitive, market, industry, s

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

ocio-political or other kind of momentous change.

Yep. Managing in today's world is a bit like walking through a field of land-mines -- any

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

Examples of combination products may in

oment now another big change is going to erupt and irrevocably alter the landscape.

And you never quite know when or where it's going to exp

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

ode... or what it's going to do to the environment.

Let's face it...

Whatever tools you're using today... next year they'll be different.

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

hatever your customers want today... next year they'll want something different.

Whoever your major competitors are today... next year they'

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

Combination pro

l be different.

Okay, maybe the year after next year.

Or maybe before the year is out!

Whether you like it or not, you will confront chang

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.

But since history shows that those who resist change get left behind, I suggest you start liking it!

You see, although I've painted a ne

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

ative picture of change -- as a field of land mines -- I really shouldn't have.

Change is good. It's great! If it wasn't for change, we woul

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

n't enjoy the high living standards we have today, would we?

So why do we sometimes tremble at the thought of change? Fear? Inertia?

It's p

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

obably a natural human instinct. But if you do find yourself resisting an impending change -- whether it's a technological advance, new marke

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

trend, a corporate restructure, new people to manage, or anything else -- I suggest you identify what's driving your resistance and make an

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

Following aspects would a

effort to overcome it as soon as possible.

In fact, I urge you to seek out change before it really begins to affect you, your team or your c

dd to the challenges in developing combination products:

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

mpany. That way, you won't be caught off guard... and, in fact, you'll be ahead of the game.

Now, you'll need to use your judgment about whi

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

h change is worth preparing for -- which technologies are likely to impact on you, which market forces are for real (rather than temporary fa

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

s), and which corporate maneuverings will likely affect you and your team.

And you'll need to think carefully about how to respond -- should

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

you rush to seize an opportunity... or move more slowly, to see what unfolds. (It may pay to move slowly. For example, in the mid to late 199

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

Professional from academic institutions, pharmaceutical industries, health care indust

0s, many companies, large and small, lost a lot of money in the rush to reinvent themselves for the Internet.)

As a manager, you'll also nee

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

to guide your team to accept and embrace change. Whether it's getting them to use a new software program, to brainstorm solutions to new p

.

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

oblems, or to work with new people.

At the end of the day, coping with change is really about how you think about change.

If you focus on w

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

Companies that provide selfless information through particip

at you can gain from the change, rather than what you may lose, you'll see it in a far more positive light and be better able to deal with it

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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