Useful Advices - Business

A product consists roughly of two main elements. The function of the product – what it does or is capab

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

le of doing and the usability of the same: how it does it.

Product developments starts often focusing

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

Examples of combination products may in

n the first element. Compare for example the evolution of the windows operating system. When the first

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

indows (95) arrived we were all amazed (may I say so) with the amount of possibilities we (not Mac or N

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

xtstep users, etc) couldn’t imagine. If you look at the latest release of windows (called vista) the am

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

Combination pro

unt of (functional) features is not extensive. Yet the user interface has been improved a great deal.

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

When comparing the four main releases (95, 98 XP and Vista) of the operating systems you could say that

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

in the beginning the increase in functional features dominate where as in the end the non-functional an

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

usability elements dominate in the improvements of the products.

This is a normal development cycle.

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

nless there would be a new revolutionary operating system -- which is not in line of expectations -- th

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

functionality of the current operating systems seem to have matured a great deal. Or, seen from the o

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

Following aspects would a

her side, this could mean that before the introduction of new and revolutionary products previous versi

dd to the challenges in developing combination products:

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

ns needs to enter a dead-end street.

More or less the same is happening -- in a lagging parallel -- wi

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

h the mobile phones. The first mobile phone really changed the world. Now, most important features get

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

tandardized and “only” the usability of the product improves.

Until there is a new mayor next step.

F

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

r operating systems a next step could be the light computer (Sun’s network computer) where most functio

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

Professional from academic institutions, pharmaceutical industries, health care indust

al features are found on the web (instead of MS Office, you will use Google’s Office).

For mobile phon

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

s there is a similar revolution possible from the standard mobile to a new device. But this might take

.

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

uite a while because the innovation rate in the mobile industry has been almost too impressive. We prob

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

Companies that provide selfless information through particip

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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Credit card processing costs can add up but cannot directly be passed on or down to customers. While business owners should include the cost to process credit cards when determining fees, they cannot surcharge customers for using credit cards -- at least in most scenarios.

Brainstorming is not a free for all without rules and regulations. It requires a great deal of discipline and structure to have a good brainstorming meeting. If the do's and don'ts for brainstorming are not followed a meeting can be ruined in a heartbeat.

Are you a Bakersfield resident who just recently learned that you have a mold problem? If you are, you will want to get it taken care of. Not only can some molds be dangerous to your health, but they can also be dangerous to your home.

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Useful Advices - A Normal Product Life Cycle - Some Examples

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