Subjects - Business

Everybody thinks that being successful in developing and running their own business is all about hav

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

ing enough start-up and working capital, or the proper image that fits your market, or the right emp

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

Examples of combination products may in

oyees.

Yup, being successful in running your own show does require a significant dose of all of tho

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

e things.

But, what I see missing most of all – and it just jumps out at me when I see people, eith

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

r in their own businesses or as employees – is a willingness by that person to be themselves, and t

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

Combination pro

trust their own instincts.

I fight with this constantly in my own businesses, and indirectly with

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

my own employees.

They want themselves – and our company, by extension – to be something else.

And

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

this just absolutely drives me nuts-o.

We have whatever success we do by being who we are, not by

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

rying to be something or someone else.

I have one employee, Brad (real guy, name changed), who’s al

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

ays trying to portray us as bigger – much bigger – than we are. “Well, Michael,” he’ll tell me, “I

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

ust want to make sure that the customer takes us seriously.”

Hey, Brads of the world. The customer

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

Following aspects would a

already does take us seriously – they buy products and services from us. They do that because they

dd to the challenges in developing combination products:

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

ike who we are, how we act, and how we look.

We are who we are and, if we’re any good – and in the

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

ase of the real-world Brad I’m talking about, we’re damned good; been in business over 23 years, lot

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

of growth spurts, plenty of industry innovations along the way – we don’t need to make up anything

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

bout ourselves. They like us, they really do like us.

The corollary to this is a feeling by lots o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f people that “well, we better do it that way because that’s how Microsoft [substitute your own name

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

here] does it.”

Well, poop. We’re not Microsoft, we don’t wanna be Microsoft (really), and if we we

.

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 really trying to be more like Microsoft, they’d eat our lunch before we even got past breakfast.

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

Companies that provide selfless information through particip

e yourself, trust your gut. After all, what in the hell are you doing here if you can’t be yourself

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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The Internet is a very useful tool for job seekers as it is a great source of information. Also, taking into account of a more wired world, getting online has never been easier. People can cost-effe...

When entrepreneurs and business owners think of the tasks associated with selling, they may not realize that there is more ot it than merely entertaining prospects and clients on a golf course or over expensive dinners. This article points out the other aspects of selling activities that do not get as much attention.

In Chapter Five of Sun Zi Art of War, Sun Zi said that the adept at warfare exploit battle circumstances and use his soldiers like logs and boulders rolling down the mountain. Its destructive effect can be seen. Read on to find out how to apply this into business.

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