Advice You - Business

Many small business owners do not regularly measure the results of their business. I have heard many small business owners say that they wait until their accountant c

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

omes in to tell them how their doing. Or perhaps they look at revenue and payroll each month then place the report in the drawer. As long as there is money in the che

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

Examples of combination products may in

cking account or available credit on their credit line, they are content to continue doing business in the same way they always have. While there are many lucrative b

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

usinesses that enjoy the luxury of not having to worry about making more money, most of us want to obtain the maximum financial benefit possible from our hard work.

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

Imagine you are at a baseball game and the scoreboard is not working. Imagine further that neither of the managers is keeping track of balls and strikes, or outs, or

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

Combination pro

runs. How would the manager decide when to bunt, swing away or steal? How would the players know which base to throw to? Further, if no records are kept, how would th

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

ey know who their best hitters are? How does each hitter do against right or left handed pitching? I don’t think either of the managers of these teams would be in a p

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

osition to devise an effective strategy for winning the game. If the talent of each team is roughly equal, strategy will determine the outcome of the game. In fact, t

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

he weaker the talent of any team is, the more important strategy becomes.

Of course, this does not happen in the real baseball world. But it certainly happens in 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

small business world.

Accounting is nothing more than keeping score. It is a virtual certainty that the failure to measure results in a timely manner will result bu

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

siness owners discovering what has happened after it’s too late to do anything about it.

Keep in mind that measuring results goes well beyond basic accounting activi

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

Following aspects would a

ties. For instance your company may be quite profitable and successful and the owner may enjoy a flexible entrepreneurial work schedule. The company spends a signific

dd to the challenges in developing combination products:

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

ant amount of money on advertising but there is no method in place to measure the amount of business derived from each type of advertisement. As long as the company k

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

eeps making money no one is concerned. However, there may be money being wasted on advertisements that are ineffective or do not generate enough business to justify t

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

he cost. If, at some future date, it becomes necessary to reduce advertising expenditures, how will the owner know which campaigns to eliminate? It’s too late to obta

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

in the information necessary to evaluate the alternatives.

There are many easy to use software products available that require no accounting knowledge. They will all

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

Professional from academic institutions, pharmaceutical industries, health care indust

ow you to know what has happened in the past, what is happening now and, if used effectively, will allow you to know what will happen next.

Start keeping score today

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

. If you are too busy, get someone else to do it. Discipline yourself to spend time each month looking at results. Compare activity to last year. Do a budget for your

.

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

business and compare results to budget. I am certain you will find things that are not working the way you want. Change them! Fix them! Learn to maximize your compan

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

Companies that provide selfless information through particip

y’s potential. Don’t be one of those business owners that know their favorite team’s win/loss record but can’t tell you how much money their business made last month.

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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