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Who cares about your product or service? I am not saying that to be rude, I

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

am truly asking you, who cares?

If you don’t have an answer to this questio

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

Examples of combination products may in

then it’s time for you to stop and re-evaluate what you are doing.

Many bu

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

iness owners fail to create a thorough plan. They think that because they ha

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

e a product or service to sell that someone will want to buy it. Sometimes t

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

Combination pro

at’s true and sometimes it isn’t but the question shouldn’t be “will someone

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 to buy this?” the question should be “who has a need for this?”

New bu

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

siness owners have the tendency to want to cater to everyone because they do

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

’t want to miss out on business. This isn’t always the best thing to do. Aft

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

r all, if you are having a baby do you go to the dentist? They are both doct

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

rs right?

Let’s say you want to sell coffee online. That’s great but with 9

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

Following aspects would a

3,000,000 results for coffee on Google, you need to have a plan that’s more

dd to the challenges in developing combination products:

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

olid than “I will put up a website and advertise.”

You should consider what

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

kind of people need to buy coffee online. Where do these people live? Why is

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

buying online a better option than going to the store? What age group is 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

t likely to want to buy coffee online? Are there certain occupations or indu

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

Professional from academic institutions, pharmaceutical industries, health care indust

tries that would benefit from this service?

These are all things you must c

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

nsider.

If you start a business and you try to sell to anyone who will buy

.

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

ot only will you waste a lot of time but you’ll also miss out on increasing

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

Companies that provide selfless information through particip

our revenue.

So I’ll ask you again, who cares about your product or service

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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