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So, you have chosen to be an entrepreneur and you have done your homework to choose the line of business in which you have your core competency. Now comes the investmen

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

t part in the line up of activities. The key question is how much capital is required, how you will you raise it, and how difficult or easy it is to come up with your p

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

Examples of combination products may in

art of the contribution.

Investing in a new, small venture will be relatively easier if you have savings that can be spared. You can infuse this partly into the ventur

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

. New grads, just out of college, with no experience and no capital will face an uphill climb.

Small Business Administration and Business Loans

All loans including SB

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

A loans are debt investments. The United States Small Business Administration guarantees various small business loans to selected entrepreneurs passing the normal busin

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

Combination pro

ss criteria. Business loans, like any other loan types, require a clean credit history and good credit score. But deciding on the type of loan that fits your needs may

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

not be easy. Most small businesses are operated from home, so capital equipment or real estate lease or purchases are not needed and thus do not require investment.

Th

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

re are loans specific to different investments such as equipment purchase, inventory build-up, real estate property purchase or construction etc. Real estate and equipm

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

ent loans provide longer terms than working capital and inventory loans/credits.

Working capital loans are mostly disbursed in the form of a line of credit which accum

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

lates interest only for the amount and the time of which it is drawn.

Working capital requirement arises when you have your business up and running. But making arrange

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

ments from the beginning, when the projected amount due for a six-month period exceeds your projected receivables is safer.

Loans and credit from friends and relatives

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

Following aspects would a

can give you flexibility, as there probably won’t be an interest component. Another big advantage of this is that it not only reduces the principle amount from institu

dd to the challenges in developing combination products:

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

ional lenders, but can also help slash the interest on it.

Aren’t There Down Sides To Debt Investment?

Qualifying for the loan, which can be an uphill battle, can als

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

o have other negatives. Monthly repayments and bills may be fixed but not your receivables, at least until your business gains stability. Missing a few payments can bri

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

g you to the threshold of a credit crisis.

Equity Investments

Starting a business entirely with your own resources is every entrepreneur’s dream. You would be the sol

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

e owner with no liabilities or loans of any kind. But this can’t always be the case, especially when your capital needs cross your limits. When this happens, getting fr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ends and relatives to invest with you is your best option. The partners in your venture share both profit and loss in the same proportion as this is an equity investmen

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

t. Venture capitalists and angel investors may be other options, albeit at an advanced stage.

The same risks, as in the case of debt investment, exist here too, but wi

.

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

h a distinct difference. For capital losses, you alone are not responsible and your liability is limited to your part of the investment.

Government grants such as mino

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

Companies that provide selfless information through particip

rity grants, grants for women entrepreneurs, and disaster funding can be considered. They are some of the more flexible and less expensive options that you can exercise

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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