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I ran across an interesting article in Wired magazine this week that told the tale of Kolo Soro, an elementary school teacher in the tiny village of Tomono in the northern Ivory Coast of Africa. This is an are

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

a so remote and void of technology that for generations communication between villages has been done by tying notes to rocks and having passing trucks toss them out the window at pre-described locations.

Kolo S

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

Examples of combination products may in

ro changed all that when he purchased a cellphone during a visit to a larger city and found that if he held the phone seven feet off the floor in a corner of his bedroom he could get a decent signal. Being an e

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

terprising young man he hung the phone on the wall, hooked up an earbud, and started charging his fellow villagers 80 cents per minute to make calls. He earned $200 the first month.

Being a smart entrepreneur K

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

lo plowed those profits back into his business. He bought a PlayStation 2 game console and connected it to a 13-inch color TV and charged 10 to 20 cents to play games. He made $20 in the first three days.

Now

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

Combination pro

I’ve worked with some pretty sharp entrepreneurs over the years, but in my mind Kolo Soro leaves them all in the dirt. He lives in a tiny African village where the average income is probably no more than a few

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

dollars a month, yet he has founded a thriving enterprise that continues to grow. Kolo’s next purchase will be a computer, which he plans to connect to the Internet using the cellphone signal.

You have to wond

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 how Kolo’s tactics would go over here in the good old US of A. He’d probably be fined for operating an unlicensed telco and arrested for contributing to the delinquency of minors. Or some superstore would mo

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

e in next door, slash prices, and drive poor Kolo out of business. I guess there are some advantages to starting a business in a region of the world not as advanced and competitive as our own.

What entreprene

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

urial lessons might you learn from Kolo Soro? The first lesson is as old as the rocks Tomono villagers used to communicate with: think outside the box. I’m pretty sure people used to say that even before ther

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

were boxes, that’s how creativity works. In fact, give the box to the kids and let them think with it. You never know what those little buggers might come up with that can make you a fortune.

Next, know y

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

Following aspects would a

ur market well. Kolo knew his fellow villagers well. He knew what was lacking in their lives. He identified a critical need and when he filled it, people literally beat a path to his door.

Find out wh

dd to the challenges in developing combination products:

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

t the customer wants and give it to them. Boy that was an MBA moment, huh. Kolo knew communication with the outside world was a crapshoot and the moment he discovered that cellphone signal he knew he could

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

make money from it. There is no more basic tenet of business than to find out what people will pay you for and sell it to them. Make waves, then sell boats.

Reinvest your profits back in the business.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
It speaks highly of Kolo’s entrepreneurial acumen that he saved up all the money from his first venture and plowed it right back into the business. I’m sure it would have been very easy to take that $420 and
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
pend it on food, clothing, and shelter, but Kolo’s vision was much bigger than that. I’ve seen entrepreneurs kill their businesses by spending the profits on themselves. Kolo brilliantly avoided that mistake a
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
d so should you.

Diversify to build revenue. I’m sure Kolo realized that to grow his business he would need to diversify his offering. After all, there’s only so much you can make from a single cellph
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
one hanging on the wall. With the addition of the gaming business he unplugged a second revenue stream that complimented his initial offering instead of competing with it. It was win/win for Kolo and his fello
.

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
villagers who were hungry for some kind of recreation other than kick the rock.

The final lesson is this: never say, "It can’t be done." If you think that you don’t have the brains or the money or the time o
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
the resources to start your own business, think of Kolo’s thriving enterprise in that tiny African village and remember this: those who don’t know things can’t be done are usually the ones who end up doing them

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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