Advice You - Business

As much as I can get! This would be the answer readily shouted out by most entrepreneurs. The fact is though, both over and underestima

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

ting the amount of capital needed to fund a business can have serious negative consequences.

Underestimating what you need can cause pro

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

Examples of combination products may in

blems ranging from having to go through the whole time consuming fund raising process again, to having to shut down the company because f

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

nds have run dry. Having to go back to the original investors and ask for more money often undermines the entrepreneur's credibility wit

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

h the investors and can cause a significant dilution in the founder's ownership.

Obtaining more than enough capital may seem like a bles

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

Combination pro

ing at first, but it can breed a lax attitude toward expense control. "If you have it, spend it," is not an advisable motto for a new co

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

mpany. If the investment takes the form of equity, raising too much money means that the founder's share of the business was reduced mor

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

than was necessary--and this violates one of the maxims of entrepreneurship: hold on to those equity points!

Typical advice given to e

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

ntrepreneurs is to do a cash flow projection, or cash budget, and then add 10%, 20% or even 50% to this amount, for "contingencies." The

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

e contingencies are all the things that can go wrong in a start-up venture, all the unfavorable events that can negatively affect results

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

.

Contingency planning is a skill that does not come easily to all entrepreneurs--even those with a finance background. How do you get

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

Following aspects would a

the cockeyed optimist (what you absolutely must be to even conceive of the idea of the starting a company), who expects the best, to pla

dd to the challenges in developing combination products:

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

for the worst?

To stimulate contingency planning, it helps to look at the reasons why entrepreneurs so consistently run out of money; a

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

mong these are:

Not realizing how expensive it is to introduce a new product, especially consumer products, on a national basis.

Not re

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

lizing how long it takes to introduce a new product, or for the market to truly accept the product.

Delays in regulatory approval, munic

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

ipal zoning, or patent approval.

Assuming that a small start-up company will get the same forbearance on payments and favorable terms th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t a large one will.

An entrepreneur with an early stage company must be prepared for one or more of these situations to occur. Continge

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

ncy planning doesn't mean simply adding a percentage or dollar "cushion' to the amount of capital being sought from investor or lenders.

.

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

It is a way of thinking--a recognition that the entrepreneurial road is always rocky. Envisioning what might go wrong does not equate to

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

Companies that provide selfless information through particip

entrepreneurs losing faith in their product or their company; it means they accept these difficulties as steps on the path to prosperity

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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Stickers are one of the things that can be used as an advertising medium. A sticker by definition is a paper having a backing which can be removed leaving a sticky side. In a populated place, you can see them anywhere from streets and walls. This can be one of the easy ways to promote and reach your customers.

Why Branding is a disservice to the buying public. It's like having a lamp and hiding it under your bed. The light doesn't help you. The light doesn't help your family members and friends. What's better than branding?

Business news, without it, no business can compete today, nor succeed. It has become the oxygen to the business system. You can’t seem to get enough of it. A few years ago business news was ruled by the magazines, and one often had two or three professional journals, subscriptions to daily business newspapers and magazines. The internet changed all that.

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