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If you are just starting a business or buying an established one, you are prone to commit certain funding mistakes. After all, to err

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

is human. It’s possible, however, that these mistakes can cause all your efforts to go to waste. It’s better to know about such common

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

Examples of combination products may in

mistakes and rectify them quickly, or better yet, not make them at all.

Common Funding Mistakes:

Here are few mistakes that are comm

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

itted almost by every business owner. Underestimating the capital amount required: A capital intensive business cannot buy necessary

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

expensive equipment and cannot meet fixed and variable costs unless it has sufficient capital to do so. Most business owners, however,

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

Combination pro

underestimate the appropriate amount and thus face problems later on.

Mortgaging everything: To borrow a large sum of money, busines

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

owners use all their savings and put up all their assets as collateral.

Getting a loan from friends: Many entrepreneurs choose frie

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

nds and relatives as the first option to get a loan for their new venture. If the debt is not paid back on time, relations can get spo

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

led.

Inaccuracy in financial records: Most business owners don’t keep complete and accurate records of their funds and business tran

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

sactions.

How to Avoid Such Funding Mistakes?

It is not difficult to avoid funding mistakes. All you need do is to be is careful abo

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

t certain things, like: Make Quick Decisions: Time is precious. Don’t waste time on a deal that you don’t find suitable after proper

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

Following aspects would a

verification.

Analyze Non-Financial Aspects: Apart from financial accounts, also look at the non-technical and non-financial factors

dd to the challenges in developing combination products:

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

hat play major roles in the business’ growth. Analyze employee relations, customer relations, shareholders relations, etc.

Look at th

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

e Cash Flow: Try to prepare a cash flow forecast at least for two years. Make proper provisions for increases in salaries, insurance,

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

epreciation, debt repayment, etc.

Do the Competitive Analysis: You must know what your competitors are doing, what their future plan

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

s are and in what projects they are investing. Also, know your USP and analyze it for your profit.

Look at the Weaknesses: You must

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

Professional from academic institutions, pharmaceutical industries, health care indust

now what your weaknesses are and how they can be overcome. Also, try to assess the risks involved and make separate arrangements for c

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

ontingencies.

A business owner should do a typical SWOT analysis to know the strengths (S) and weaknesses (W) of the business and wha

.

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

kind of opportunities (O) and threats (T) are involved with it. Such analysis can help make rational decisions and avoid irreparable

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

Companies that provide selfless information through particip

mistakes.

Websites and consultancies also offer special services to help business owners analyze any situation and make the best 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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