Useful Advices - Business

Consultants tend to be expensive. A coach instead, may charge the same price per hour, but coaches neve

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

r dedicate all their time to a single job. In fact you could think of the same construction hiring a co

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

Examples of combination products may in

nsultant. A flexible consultant would be able to deliver according to your requirements. Two to three d

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

ays a month would be possible. The question remains; what will be delivered?

Before continue reading t

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

his article it might be interesting to take one minute of your time for a simple assessment; the title

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

Combination pro

gives away most of the idea:

One Minute Assessment: Cost & Revenue

Another way ther

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

efore, is not (only) to focus on costs. But on revenues.

You could adapt the pricing mechanism for the

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

consulting vacancy you are contemplating. One way would select a fixed price per hour or a fixed fee fo

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

r a period of time, but on a (much) lower level, for example 60% of the normal price or fee. complement

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

ary, a variable part as a pay for performance. This could vary from 40% to 60% of the normal fee. In ca

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

se the target is reached you will have to pay the consultant 20% more than average, in case the target

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

Following aspects would a

is not met you pay the lower level of 60%.

In the last case however, you are still not satisfied, nor

dd to the challenges in developing combination products:

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

with the result, nor with the fact that you paid, although less. Because of the problem that is not sol

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

ved. Another step would be to focus completely on the result – no cure no pay. The inconvenience with

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

his option – for large and complex projects – is the way to determine the impact of the individual cons

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

ultant on the overall results. But even more important is the way you want this consultant to match yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur requirements. Different challenges require different consulting roles. If you do agree a variable ta

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

rget, the consultant might be seduced to propose the most expensive solution.

Maybe some common sense

.

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

would do to define the best answer to each specific situation. If you think a consultant is expensive,

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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Section 127 plans allow employers to pay employee education costs and get a tax benefit, all the while allowing the employee to exclude the amounts from their taxable income - a win-win proposition.

Learn about an up and coming way to finance a growing medical practice. And no, it does not require a bank loan

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Useful Advices - What to Consider When You Face an Expensive Consultant

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