Advice You - Business

Here's a comical story to illustrate an important point you will need to understand if you want to build a viable business.

One Christmas, sev

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

eral years ago, my family and I decided to pull names. We wrote down three items we wanted ranging in preference on small pieces of paper. The

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

Examples of combination products may in

paper was then folded and placed in a box. We each took turns pulling a piece of paper from the box. Each of us would be responsible for buy

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

ing one really nice gift for one individual.

Christmas Day rolled around and I eagerly looked forward to receiving one of my choices. I watc

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

ed everyone unwrap their gifts: perfume, a 14K gold chain, wool tams.

Then it was my turn. I hurriedly unwrapped the gift placed in my hand.

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

Combination pro

My stomach dropped. It was a 2-lb box of chocolate candy and a knick knack! I needed a box of candy like I needed a hole in my head so needl

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

ss to say this wasn't one of my choices. I was extremely disappointed.

I ate one or two pieces of the candy and ended up taking the rest to w

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

ork. The knick knack? I don't remember what happened to it.

Now, I know what you're thinking. It's the thought that counts. I agree to a c

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

rtain point. There is some appreciation I should have felt. After all, I could have ended up with nothing. (Thank goodness for my grandmoth

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

er. She gave all her granddaughters beautiful blankets that year [the boys got blankets the next year] which made me feel much better.. But a

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

ter thinking about what happened I made a decision. I would not longer wait for someone else to make Christmas special. Each year, I treat m

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

Following aspects would a

self to something meaningful.

Now, you're probably wondering what all this has to do with building a business. Everything. Why? There are m

dd to the challenges in developing combination products:

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

any people who have the same attitude towards making money online I had all those years ago. They are waiting for someone to drop something in

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

their lap that will cause the money to come pouring in. That's like waiting for Santa Claus to come down the chimney with all your heart's des

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

ire.

Do you fit this category? If you do you already know Santa Claus is not coming. The truth is you're going to have to invest time and mo

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

ey in your business even during periods when nothing is happening.

If you already have a venture underway and are looking for better results,

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

Professional from academic institutions, pharmaceutical industries, health care indust

you're going to have to adopt new marketing techniques...maybe even some you're doubtful of.

The relative who pulled my name back then didn't

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

ealize he taught me an important lesson. And, that lesson is "if it's going to happen it's up to me." Since then I've tried to apply this tru

.

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

th to many aspects of my life. Even though the results are not perfect, I have the opportunity to learn from the experience which helps me d

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

Companies that provide selfless information through particip

better the next time.

So, don't wait for Santa Claus. Start implementing your ideas and begin using the marketing information you've learned

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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