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As a business and technology consultant there is one significant error I continue to see in modern business practice. Too often, management treats t

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

heir payroll expense as a fixed cost of doing business. This is caused by the accounting practice of lumping payroll as a operating expense line ite

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

Examples of combination products may in

. While this is an acceptable accounting practice, a good manager must accept the reality that the work output of the employee should be directly pr

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

portional to the salary.

Too often I have heard managers state something to the effect of "Well, we are paying him anyway so he might as well work

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

n that project." This is shortsighted and just plain dumb. Logically, a good employee works on what is assigned to him or her. It is the job of a go

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

Combination pro

d manager to ensure that the work performed is delivering positive value to the corporate enterprise. This is why you don't pay a Chief Financial Of

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

icer to empty the trash cans; it is a poor use of resources.

For example, XYZ Corporation sells widgets. Joe, an employee who designs new widgets,

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

pends an average of three months developing a new product. Those three months of Joe's time absolutely should be included in the overall pricing str

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

tegy for the new widget or the company will show a new loss on that specific product. Too many businesses don't want to do the necessary analysis to

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

determine the viability of a new product based on the overall labor cost (i.e. Joe's salary) associated with the development. Instead, Joe's salary

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

s rolled into the operating expenses of the Research and Development department.

This scenario causes a wide array of problems since you never real

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

Following aspects would a

y know if you are making a profit on the new widget. A decade ago this was less of a problem since, most likely, Joe's newly designed widget would h

dd to the challenges in developing combination products:

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

ve been available on the market for a few years and would have sold several million units, thereby offsetting the accrued labor cost of development.

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

However, in the modern era of "just in time" manufacturing and global outsourcing, a new product will be hot for just a few months. This is why Appl

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

Computer has continued developing new variation of their iPod series of products. By continually improving on the original concept, they amortize e

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

rly R&D costs over the life of the product. If Apple had frozen development of the iPod and never released a new version, chances are, the iPod woul

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

Professional from academic institutions, pharmaceutical industries, health care indust

have been replaced with something else from another competitor by now.

The global marketplace requires innovation if you wish to remain on top. Bu

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

innovation comes at the price of your R&D budgets. A good manager will always work off of sales projections for a new product prior to committing r

.

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

sources and manpower to the development of this new product. If the projected sales figures look high enough to cover all the costs of development t

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

Companies that provide selfless information through particip

en you should commit the necessary resources. Besides, if the product fails, you can always blame the sales department for giving you faulty figures

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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Is it truly possible to transition from Employee to Business Owner without risking everything? Learn why Self-Employment may not be your best option.

Many medical billing companies take for granted the software that they get to do their jobs. This review will give you a good idea of how much work is involved in making your software.

Are you the type to sing in your car? Play air guitar or air drums? I am, mostly to lost classic hair bands on my satellite radio. Having fun in what you do is critically important to the overall success of your business. If you are not having fun doing what you are currently doing, why are you doing it?

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