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Remember those drawings from science class of how a lever works?

The lever was a long bar that rested atop a triangularly shaped fulcrum. One end of the lever w

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

as underneath the object to be raised. The other end of the lever was where downward force was applied to raise the object at the other end. The keys to whether

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

Examples of combination products may in

r not the lever could raise the object were: 1) the distance of the fulcrum from the object to be raised, 2) the length of the lever, and 3) the force applied to

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

the fulcrum.

In short, the longer the lever and the more force applied, the easier and faster you can move the object.

When mapping this diagram to

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

he business of an independent professional, we find:

The professional is the fulcrum
The object to be moved is the business objective to

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

Combination pro

e achieved

The lever is the resource to be amplifed

The downward force can be a body of knowledge or expertise; external resources (suc

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

as mentors/coaches, training, experts, etc.); an investment of time or money; the use of skills, tools, or talents; and the use of systems, processes, procedure

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

s, and structures.

Here are 3 of the many ways in which you can employ leverage in your business:

Take your resources and repurpose or

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

euse them in new and innovative ways to add to your services, products, or resources. Hence, the body of knowledge represented by the original resource is

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

multiplied into several services/products/resources for your business. For example, I could take this article and use it both in my ezine and on my web site. I c

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

uld also make it into an eclass by expanding it with calls to action on the part of the reader. Once it is expanded into an eclass, it's just another step into m

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

Following aspects would a

king it a web-based class. From there I could take it into being a multi-session teleclass or an on-site seminar.

Can you see that without much additional effor

dd to the challenges in developing combination products:

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

you can take one resource and multiply it into 5 or 6 additional resources for your business?

Take a resource and percolate it through multiple b

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

sinesses for increased visibility.

For example, I could take this article and post it on several web sites that provided content for others to put in their

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

ezines or on their web sites. I could also directly contact the webmasters at several of the bigger web sites that service my same target market of independent p

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

ofessionals and offer them the use of the article on their web site. Bingo! One article, multiple places of exposure.

Tap into other forces to ach

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

Professional from academic institutions, pharmaceutical industries, health care indust

eve a desired objective.

For example, if you want to short-circuit the learning process on a particular business subject, you can hire a mentor or coach, a

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

tend a workshop or seminar, or buy a book or tape training series. In this way you are using the power of other people's knowledge and experience to speed your l

.

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

arning. And speed of learning is just another type of leverage.

The ultimate purpose of applying leverage in your business is to achieve your desire

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

Companies that provide selfless information through particip

objectives with more speed and less effort. Where are you missing opportunities to apply the power of leverage in your business?

Copyright 2004, Rose Hill, In

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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