Main Subject - Business

It has long been said that knowledge is power. Actually it is 'potential' power, but that is a subject fo

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 another article. Let's just say it is the basis of power. This knowledge, or 'knowing' comes from two s

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

Examples of combination products may in

ources. It can come from within, as with intuition which can be confirmed by experiences. Or, from outside yourself, from

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

others, also confirmed through experience.

If you wish rapid advancement and success, you will need to draw on both sourc

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

es. Do you need convincing? Take a look back at history. There is no need to look back very far. When left to their own de

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

Combination pro

vices, or surrounded and influenced only by families or small communities most individuals coped and survived. They learne

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

d from their inner feelings and drew from a relatively shallow knowledge pool.

However, when communication methods and tr

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

vel methods improved people gained an opportunity to learn from a broader range of people. As educational material became

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

more widely available, the knowledge pool deepened. Today, that pool is a massive ocean containing, colleges, books, live

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

seminars and of course, the internet. It contains the knowledge along with the experiences of countless individuals, exper

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

ts and teachers who can spare you from wasting years on trail and error.

The Barrier: It's true that the

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

Following aspects would a

re is a multitude of varying opinions and experiences contained in courses and books. This creates a barrier for some peop

dd to the challenges in developing combination products:

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

le. They are unsure how to discern which ones are right or which are wrong. Therefore, they feel incapable of making the b

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

est selection to meet their needs. Consequently, they take no action and fail to gain the new knowledge that can propel th

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

m forward.

The Solution: Approach this diverse knowledge from a different point of view than from our tr

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

aditional judgmental position. Rather than trying to decide if some information is 'right or wrong', try

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

Professional from academic institutions, pharmaceutical industries, health care indust

to determine if it will "work or not work' for you. Because in the end, that's all that will matter.

If

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

you adopt this position, you can experiment with this wealth of information and experience. You will benefit greatly by ac

.

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

cepting that knowledge which resonates deeply within you. Therefore, find an excuse to take a course or read a book rather

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

Companies that provide selfless information through particip

than finding an excuse to avoid doing so. You will be amazed as your witness your career accelerating by leaps and bounds

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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It is said that variety is the spice of life. In most businesses, including healthcare, standardization of common processes produces the best results. Mr. Bryant discusses why you should standardize, gives you some expamples, and tells how to measure it.

Be prepared to field questions that the audience will ask and want to know. Brainstorm ahead of time for possible questions, scenarios, and answers. There will always be someone who asks the tough questions. If you are the expert, you are expected to know the answers. Obviously, if you don't know the answer, you should not make one up. If the question is way out of line, you can say you don't know the answer. But what do you do when your audience expects you to know the answer and you don't? How do you save yourself from losing credibility?

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