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Ever try to be something for everyone and find no one wants it? Do you have trouble finding the time to focus on your business? Do you do so much for so many that you find it's difficult to make any financial progres

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

s in your business; much less make an indelible mark in the mind of your potential customers? I found myself on that road so many times, that I could be a tour guide for Please-want-me-ville.

Where did this come fro

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

Examples of combination products may in

m and how can you get it to stop?

It starts publicly when we're very young... at school. A moment emblazoned in my mind was in Mrs. Moon's kindergarten class. I had just discovered a squirreled stash of my favorite

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

food, Pepperidge Farms Goldfish Crackers, in the front pocket of my patchwork dress. I squealed with delight and proudly started munching on them in the middle of "two plus three". My delight turned to horror when I

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

eard, "Miss Castle, I hope you have enough for everyone or you will stand in the front of the class with your face in the corner!"

Out of nowhere, large beads of sweat developed on my forehead as I desperately sea

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

Combination pro

rched every inch of my two-inch square pocket for enough goldfish to feed the entire class. Even though we were only on "addition", somehow I knew that four fishes and a tail wouldn't cut it. With my face in the corn

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

er for those very long twenty minutes, I vowed that I would always have enough to make everyone happy. In business, these fish have come back to bite me over and over again; until I started teaching people how to b

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

rand. Now they can 'gold-fish' for themselves.

As a teenager, I developed 'I don't have enough friends' syndrome. Not being one of the 'cool-n-popular' types, I had to buy my friends (I hope I'm not the only one who

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

did this). And since I wasn't the brain, I couldn't find my value in helping friends get "A's. I did everything else: the grunt work, the labor, the runs to the store, the 'kill- the messenger' calls, the kind of stuf

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

f that took me away from most of the 'friend' action. I did so much that I had no time to develop the relationships that I wanted in the first place. I was spread so thin... I was transparent! No wonder for the first

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

few years of my business, I worked unbelievably hard but had nothing (no money, no value) to show for it. It wasn't until I turned my focus inward that I really started to build something of value that customers w

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

Following aspects would a

anted.

A few dictionary definitions of focus:

1. concentrated effort or attention on a particular thing

2. a concentrated and unified quality

3. the quality of being sharply defined with clear edges and contrast

A f

dd to the challenges in developing combination products:

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

w dictionary definitions of inward:

1. situated within something

2. relating to or existing in the mind or spirit

3. toward the inside or center of something

Your business can never be developed as a brand until you

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

first:

a) suspend the need to be something for everyone, and

b) sharply define with clear edges from your inside or center

The challenge to our business success grows when we compound these learned behaviors with th

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

e entrepreneurial fear that we need to be attractive to e-v-e-r-y- o-n-e in order to survive. Especially because we don't know when and from where the next customer will come. I've done that dance too. (You know, the

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

one when you get off the phone with a new client closing a "new tiny project that feels huge because it's the only one you have 'dance').

If you identify at all with this, how's it working for you?

For me it didn't

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

Professional from academic institutions, pharmaceutical industries, health care indust

Nothing did until I:

1) deeply connected to what I offered, found my uniqueness in it and built on the internal power of it (the first part of the BrandU™ process), and

2) communicated it consistently with precision

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

and quality (the second part of the BrandU™ process known as CLICsm).

The points of effort that you are sending out in every direction - squandering your focus externally, trying to be something for everyone, doing

.

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

so much that results so little - all start from somewhere. That somewhere is a place that you control. The seeds of your brand are planted there. Don't be affected by your programming, program your success. I prom

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

Companies that provide selfless information through particip

ise you that if plant it there and tend it, it will grow, and grow, and... grow! And you will be filled with joy and financial success, and the freedom to enjoy it.

© 2003 Castle Montone, Limited All Rights Reserved

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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