Digg It - Business

Some companies have a set of keywords they focus on when organizing activities. CLIENT, could be such a keyword, m

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

eaning to always focus on the client. RESULT and SOLUTION are two other examples. They seem clear, but carry a lot

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

Examples of combination products may in

of difficulties with them.

Result is meant to be tangible and measurable. A project that is finished on time mee

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

s that criterion. A solution is like an answer to a question; It is an answer to a problem or set of problems. W

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

hat problems are there? Lets have a look at a few:

There is a (relative) decline in the demand for produc

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

Combination pro

Management information is not sufficient. It is not clear what the effect of a marketing campaign is

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>

Current systems can not handle cooperative actions with third parties

Etc, etc...

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

, to solve this, you need a solution:

Hire an extra sales force
Build or maintain a system th

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

at solves the information leak and run more campaigns

Invest in new infrastructure that makes cooperatio

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

with third parties possible

Etc, etc…

The first solution is rather simple. It is a temporary

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

demand on resources, which is manageable. The second one is already more challenging. Here you have many options.

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

Following aspects would a

The third solution requires a familiar amount of attention.

If you stress "Result" more than (the type) of "Solu

dd to the challenges in developing combination products:

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

ion" you may end up with a very short term solution that will benefit for only a limited period of time. Besides y

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

ou may overlook long term effects (compare with overexposure of sun and long term effects) New or different probl

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

ms will occur and you have to redo the same actions. You can have a rapid solution. If you reserve too much time 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

or figuring out a (perfect)solution you finally might come up with one, but that took too long. You cannot foresee

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

Professional from academic institutions, pharmaceutical industries, health care indust

all market movements and changes.

Result orientation is externally focused. It is measured by the sales of goods

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

and services. By clients. Finding solutions is an internal focused activity. Within the different periods both sho

.

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

ld level themselves out. The best thing is to constantly level them as a constant point on the agenda; What kind o

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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This is the fourth and final part of a series of articles providing advice to companies who are considering putting their cleaning out for tender by contract cleaning firms.

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