Useful Advices - Business

The market may change and make things difficult and you could be left with the bitter taste in your mouth of not having taken the decision at the rig

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

ht moment. Business is not only about buying and selling. It’s about taking the right decisions at the right moment.

Don’t Let Others Beat You 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

It

If you have detected a niche in the market that you can fill in, go for it. Don’t waste time watching to see what happens, whether it is t

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

e right moment or not. Waiting gives your precious time to others. Rushing to do things without a proper planning isn’t good either. You have all the

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

ideas in your head, so just write them down, on paper or on your computer and make a checklist of everything you need to open your business.

Ni

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

Combination pro

he Marketing

Your first attempt should consider every nail and every sheet of paper needed to get your business going. There will always be tim

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

e to cut down on unnecessary things later on. I talked about a “niche” above, because niche marketing is very interesting. Once you detect the niche

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

and the needs it has, you tailor a product or service for that niche and you already have a market, without having to spend precious cash on random a

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

vertising. What little advertising you will have to carry out, will be specifically directed to your niche.

You will have time later on to expand an

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

d add products to your line, innovate and improve, to widen your scope, a little at a time, so as to grow steadily and firmly and surpass the critica

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

moment. It is said that 80% of new businesses do not make it through the first year.

Start Closing The Circle

Once you have your business

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

Following aspects would a

plan ready, you can start to think of a business loan. Considering what is mentioned in the previous paragraph, every lender knows the risks that a

dd to the challenges in developing combination products:

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

new business implies. So, this risk will have to be shared, in the form of the provision of some asset of yours, whether private or dedicated to the

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

usiness, to show confidence in your own project.

Very few loans will be granted on the business plan alone, however brilliant it may appear, so bear

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

this in mind and place your car, truck, a piece of land, whatever it may be, as collateral from the very beginning. Don’t wait for the lender to ask

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

for it.

Some Additional Considerations

When you start to fill in the numbers in your business plan, consider the loan payment in advance.

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

Professional from academic institutions, pharmaceutical industries, health care indust

If you take the trouble to calculate how much you need and how you will repay it, making it participate in the general cash flow, it will give the lo

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

an officer a good impression. For this, you will need to shop around and get free quotes, no

.

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

to be confused with applications.

The interest rate will vary slightly from lender to lender and depending on the amount and collateral you offer,

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

Companies that provide selfless information through particip

but in general there is no great difference. The main difference in these matters is your decision and how you prepare your way for your new activity

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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