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Sooner or later, most business owners need to look for outside financing. Whether it’s a line of credit with a bank to handle predictable cash crunches or a

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

significant capital investment to improve plant and equipment, virtually every business will need access to additional funds at some point in its life.

But

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

Examples of combination products may in

the time to start thinking about how to make the best impression with bankers and private investors ideally begins long before you schedule an appointment 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.

o discuss your financing needs. In fact, the best preparation you can undertake to get the financing your business requires is the very same work that you s

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

hould be doing to ensure that your business is financially sound in the first place. Business owners that can consistently demonstrate their ability to effe

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

Combination pro

ctively plan the future of their company will stand out in the crowd of more haphazard entrepreneurs.

Here are several things that you can do now to ensure

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

that your search for outside financing will be successful:

Determine Realistic Rates Of Growth: Unless you’re the next Amazon or eBay, “pie-in-the-sky” pro

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

jections about how quickly your revenues will grow will usually be seen as so much wishful thinking. Effective financial planning requires you to develop yo

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

ur business around realistic growth rates. Otherwise, you’ll wind up in the hole before you even begin.

Develop Pro-Forma P&L’s, Cash Flow Reports: Once y

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

ou have estimated what your revenue picture will look like, you can more accurately predict what your financing requirements will be. Put together projected

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

profit and loss statements and cash flow estimates so that you know exactly how much financing you’ll need and when you’ll need it.

Write Your Business Plan

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

Following aspects would a

: Contrary to popular opinion, written business plans are not just for those who are looking for venture money. A well-written business plan can be an effe

dd to the challenges in developing combination products:

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

ctive planning and management tool for every business. Often, the very act of writing about your business forces you to think through complex strategic issu

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

es, reevaluate your critical business assumptions and identify other areas where careful analysis will strengthen your chances of success.

Revise, Revise, R

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

evise: Take a look at your plan and your projections at least once a year, and revise them according to actual results. If your performance falls short of

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

your expectations, analyze why you failed, implement the necessary changes in your business strategy and adjust your projections to more realistically foreca

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

Professional from academic institutions, pharmaceutical industries, health care indust

st future results. Likewise, if you were too conservative in your projections, don’t be afraid to scale up your targets.

Keep Your Finance Contacts In The

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

Loop: A good relationship with a banker or outside investor should be developed over time, not simply when you have the need. Keep your financing contacts

.

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

up-to-date with what’s going on in your business by providing regular financial reports and by meeting with them periodically to apprise them of how things a

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

Companies that provide selfless information through particip

re going. The more knowledgeable they are about your business, the more comfortable they’ll be in providing you with the help that you need when you need it

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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