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This title is some how misleading, but on the other hand figuratively explain just the main point. The question is about int

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

egration. When you buy a mutual fund you are free from integration problems – those are handled by your fund provider.

If y

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

Examples of combination products may in

ou prefer to select (the best) stocks your self, you will have to do the integration on your own. Figuratively speaking, be

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

ause the real one minute assessment is about business management; how to integrate different solutions...and, what is your p

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

referred approach?

Integration problems arise when you are to solve different problems within the organization with differe

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

Combination pro

nt solutions.

For example in the Sales area. There are areas like:

e-Mail management – e-mail responding systems<

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

li>

Campaign management – sending e-mail campaigns. And or common mailings

Customer management

Serv

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

ice management

etc...

For all these areas your organization may choose a best-of-breed kind of solution

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

or a one-size-fits-all. In the first case the solution (system) will provide the best features for a specific area. The be

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

t e-mail responder, the best campaign management tool, etc. At the other end your organization may prefer a one-size-fits-al

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

l approach; a broad functional coverage of the system and its features, but for any specific area not the best choice.

In t

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

Following aspects would a

he first case your organization ought to manage the integrations problems by itself. In the last case the provider of the sy

dd to the challenges in developing combination products:

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

tem will handle many (but never all) of the integration issues.

This resembles financial management. It is fun to invest in

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

individual stock, building up a portfolio of what you think are the best stocks on the market. But are you sure whether thi

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

s self catered portfolio will outperform the market? Rather you might consider buying a mutual fund; it solves you many hea

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

aches. On the other hand, its less fun.

There is one difference; where in the financial situation you could choose to do bo

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

Professional from academic institutions, pharmaceutical industries, health care indust

th; dedicate a part of you portfolio to self selecting stocks and the other half with a mutual fund. This serves as a benchm

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

ark in the same time; which part performs better?

In business there is no such a choice; it is either left -- best of breed

.

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

or right (maybe wrong) –- one-size-fits-all. There are not many other options.

Check for yourself what option you would co

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

Companies that provide selfless information through particip

nsider first. This influences much of the contribution to this integration discussion in your organization.

© 2006 Hans Boo

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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Leadership is an abstract concept. It permeates society in so many different ways that it cannot be conventionally or neatly defined. Contexts change: every situation presents a different set of needs that alter what embodies the perfect leader for a person or organization. General definitions fail to capture these intricacies, and detailed definitions fail to capture the entire scope of this skill set. What is an aspiring leader to do?

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