Advice You - Business

Think about this for a moment - Thousands and thousands of business decisions are made every day.

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

Many of those business decisions can be and are deadly! And think how very difficult it is to av

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

Examples of combination products may in

id making some of those deadly decisions. Here are five examples of some of the most common deadl

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

business decisions.

Deadly decision #1: One large customer or client Your business receives mor

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

e that 50% of its gross revenues from just one client or customer.

How to avoid: Set a policy th

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

Combination pro

t no single client or customer will represent more than 10 to 15% of your cash flow. Diversify yo

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

r client base to help your company prosper in the long term.

Deadly decision #2: No Market Resea

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

rch You create and launch a new product or service without adequate market research and testing f

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

rst.

How to avoid: Do your market research and testing “up front” before anything else whenever

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 launch a new product or service.

Deadly decision #3: Insufficient capital Your business is si

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

nificantly undercapitalized.

How to avoid: Use conservative projections and be sure to have as m

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

Following aspects would a

uch capital as needed to get you through a sales cycle or another planned funding source.

Deadly

dd to the challenges in developing combination products:

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

decision #4: No strategic focus for the company Your business has no strategic plan and therefore

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

no strategic focus. You pursue every opportunity for business instead of focusing your efforts in

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

a strategic manner.

How to avoid: Engage in strategic thinking and planning. Develop a strategi

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

plan and implement a strategic action plan.

Deadly decision #5: Create a business with equal pa

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

Professional from academic institutions, pharmaceutical industries, health care indust

tners Your business has equal partners (50/50; 33.33/33.33/33.33; 25/25/25/25, or some other spli

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

t). This is almost a guarantee that there is a business disaster waiting to happen. Every one is

.

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

n charge, so no one is in charge. No one has a final say. Decisions are made by consensus.

How t

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

Companies that provide selfless information through particip

avoid: Someone must be in charge. Put someone in charge so they have the largest ownership share

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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It turns out that you don't have to take many risks in business if you don't want to. Nor do you have to sell. Or be desperate to earn a fortune. In fact, in my experience the secret is to adopt an 'if at first you don’t succeed, try, try, try again' approach. If one thing isn’t a rip roaring success, switch to something else. As to making money? Do what you enjoy, have a vision, look after your customers and the money will follow.

This is the final installment on medical billing of electronic claims, focusing on the FA0 record. In this article, we review fields 56 through 66.

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