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An entrepreneur is not just any type of person. It takes guts, for both men and women to turn a startup into a prosperous business.

First, The Business
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
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There are always two parties in any business, two sides of the counter: “You”, the provider and “them”, the consumers. It might not be easy to digest, but th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
e way to get the best results is to identify an unsatisfied need in “them”, the public. Then, “you” create or choose a product to satisfy that need.

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

target market will be already located and all you need is to go to them and offer exactly what they need. An even better result is to offer customers what they
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
WANT, rather than what they NEED. Many sales are done through emotions and can provoke an instant decision, like the kid who sees something and immediately says
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
, “I want it!”

Beware Of Common Mistakes

Most people want to impose their product on the market. Sometimes it can be done, but you need to be very st
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
rong in order to create the need through advertising… and advertising money is not exactly your biggest asset in startup times.

What Has This Got To Do With
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
A Loan?

Everything in the world, that’s what! Can you imagine yourself asking for a loan without knowing where you stand in your intended business? Know
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ledge is like money in the bank, and is much respected by people who are in the money market, because they’ll immediately see the development of their business
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
through yours.

And What Do You Know?

The more you know about your business and about your target market, the better. It gives you a better chance of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
survival out there in the jungle. Look into statistics, general response of the public, a little about marketing and advertising.

And Now, Go For The Loan
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

Make your presentation as neat and clear as possible. Act as if you were the CEO of your Corporation, even before startup. Write out the text of your pres
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
entation and learn it upside down and back to front. Print out notes, graphs, pie-charts and anything that can make your points even clearer as to what your int
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ention is.

Offer The Lender A Business

The worst thing to do is literally “ask for help”. That little word is a no-do. Offer a partnership. It may ha
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e the format of a loan, when you get down to the paperwork, but in essence
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
, it is a partnership. Keep the greater portion of the stakes for yourself. The decision-making must be all yours. The capital can come from anywhere, but the b
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
usiness is YOURS.

You have the know-how and you have to show it, demonstrate it to the capitalist, that is, the lender. The more you know about the trade, the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
etter it will be for you, the easier it will be for you to get the loan and the better your chances will be of surviving.

Be Tempting, Sell Yourself Well <
.

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
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Offer a good deal, but always keep a couple of aces up your sleeve, to keep your negotiating capacity on the run. If you don’t need to offer them in the en
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
d, then don’t. All the better for you. Remember, it’s always the survival of the fittest. Now go for the loan you want. Customize it yourself and offer the deal

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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