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So you’ve decided you want to invent or produce a new product. Product crea

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

tion has become much easier thanks to the internet. Here are 8 key ways to

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

Examples of combination products may in

making more profit with product creation.

Key 1: The Idea Step
Make s

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

ure it’s an idea that will work Listen to others about things that would ma

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

ke their lives easier, then make those things.

Key 2: Ask Questions
P

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

Combination pro

roduct creation is more than making things--it’s making things that people

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

want. Talk to them to see if they would use the product before you sink tim

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

e and money into it.

Key 3: Research
You will need to find out first

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

if it has been done yet. Don’t do something someone else has already done

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

well.

Key 4: More Research
Before you manufacture it, you will need t

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

o make a prototype. This comes in several steps of creation, testing, fixin

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

Following aspects would a

g, recreation, testing, etc.

Key 5: Get People to Try It
Once you hav

dd to the challenges in developing combination products:

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

e the prototype done, get friends and relatives to try it out. If you have

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

the money, use a focus group.

Key 6: Make Changes
If there were any o

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

bjections to your product creation, make the necessary changes and make a n

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

ew prototype.

Key 7: Retest
Recreate and retest until you have a per

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

Professional from academic institutions, pharmaceutical industries, health care indust

fect model for manufacturing. This will save you an enormous amount of mone

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

y on failed production.

Key 8: Create It and Market
Marketing is goin

.

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

g to be your most important key once the product creation is done and it’s

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

Companies that provide selfless information through particip

being manufactured. Hire pros if you need to, but get this stage done right

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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Right about the time the infomercials were really starting to dominate late-night television, I was attending underground theatre. It was a multimedia presentation that showed actors living their lives and gigantic screen overheads with Stepford-like hosts jamming infomercials at both the characters and the audience.

If you are thinking of starting a new business, or if you are just about to take the plunge, you will know that there is a lot that you have to do. But where do you start? It is a good idea to get some of the groundwork done before you start, possibly this will often mean things that you hadn’t thought about, things that most people do as a reaction to circumstances rather than as a planned activity. However, in practice you will almost certainly find that it is easier to set things up right at the beginning, so that systems grow with the business, rather than find yourself “firefighting” later on.

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