Useful Advices - Business

Technology provides often a source for change. But also, technology is responsible for the fact that changes do not happen as

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

swiftly as possible. And one main ingredient in this dilemma is that existing technology is still suitable. Like the pair of

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

Examples of combination products may in

shoes that are still valuable to use, they are only out of fashion.

When thinking about introducing a change and when elabo

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

rating a vision about one, you are facing a similar dilemma that is to do with the first step you have to take. Basically the

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

re are two options: one is where you bridge from a current situation to a new one, the other is where you do not take the cur

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

Combination pro

rent technology is a starting point. The first option is focused on what you have now and reusability, the second option is f

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

ocused on a new technology and where the bridge to current usability will be thought of later.

Internet telephony is a clear

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

example that is struggling with this dilemma. There are many solutions but most of these come done at the same dilemma; do w

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

e start from what we have or do we momentarily discard current technology and elaborate on a new platform.

When concentratin

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

g on two movements in this area and focusing only on the physical phone (and not the underlying infrastructure) than the next

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

two options are clear example for either strategy.

Skype for example elaborated a strategy in which a new platform (the hea

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

Following aspects would a

dset, or skype internet phone) is taken as the core vehicle or device to manage the change. In this strategy the current phon

dd to the challenges in developing combination products:

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

e is left as it is, and both devices could grow to a new standard later on. A similar development is happening with digital t

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

elevision; new televisions all have TDT incorporated.

The Jajah strategy -- or other look-a-likes – started with the current

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

(mobile) phone in mind. You do not need a headset, you do need a computer or a mobile to establish the connection.

It is ha

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

rd to tell and not the focus of this article where both strategies will meet nor which one will be more likely to dominate.

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

Professional from academic institutions, pharmaceutical industries, health care indust

However, from a change viewpoint, the last mile is often the most difficult and that is where you need to reconnect to curren

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

t technology or people who will not change. If you know that this is the highest risk for managing a change, than you should

.

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

start bridging such a risk. In the current example this favors the Jajah solution.

But do not forget that this example is on

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

Companies that provide selfless information through particip

ly focusing on a single device in a complex environment and on a single dilemma. There is much more to it.

© 2007 Hans Bool

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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If you are looking for a job, you need to know how to negotiate salary. This article will show you how to effectively negotiate a higher salary to protect your best interests and come out on the winning end!

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