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If you are a business plan writer planning how to start a new business, you have to make some assumptions. For those assumptions to have some credibility, you shou

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

ld be aware of industry metrics. Unless the business you are starting is truly the first of its kind on the planet, you should be able to find some metrics based on

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

Examples of combination products may in

what is typical for the type of business you are planning.

As an example, fast service restaurants likely have developed correlations between traffic and sales. Th

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

ere is a reason why these types of restaurants are located on busy streets. A certain amount of the cars that are passing will stop and each car that stops will mak

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

an average purchase. These three numbers - the traffic count, the percentage of those cars that will pull in and the average purchase per car – should give you an

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

Combination pro

average sales figure to benchmark your own projections against. If you plan on stopping more cars than average or sell more to each car than average, you should ha

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

e an explanation of these projections in your business plan.

Another example can be found in retail. One key in retail is to turn over inventory as often as possib

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

le. The dollar amount of inventory in your store, which may be limited by the size of your store, and the number of times that the inventory turns over, provides a

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

reasonable projection for annual sales. Find out what the average amount of inventory per square foot is for the type of store you are planning and the number of ti

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

mes others in your type of business turn over their inventory. Like the previous example, if you are planning sales higher or lower than the industry averages, incl

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

de an explanation of why you are planning for that difference in your business plan.

Whatever the industry, whether you are feeding beef cattle, unloading containe

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

Following aspects would a

s off ships or selling ebooks online, there are likely a few key metrics that can be used as benchmarks and probably a lot of research is being done by somebody som

dd to the challenges in developing combination products:

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

ewhere on how to improve results of those equations. Of course, if someone is spending a lot of money doing that type of research, they are likely going to keep th

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

ir findings confidential. So how does the average small business owner access these numbers?

There are a few ways inexpensive research can be done. Obviously, chec

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

k a search engine first and see what you can find out on the Internet. Industry associations may have the numbers you are looking for and be willing to share them.

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

imilar business resources can be found through organizations like the Chamber of Commerce. Depending on the business, it may be as simple as asking someone else in

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

Professional from academic institutions, pharmaceutical industries, health care indust

the business. Go ask a couple of people who are managing the type of business you are entering and find out from them what the numbers are. They may not divulge the

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

stats for their specific business, but they may share industry standards. If you are able to attend a trade show or convention in that field, you may be able to tal

.

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

k to several people in the industry in a short period of time.

If you include your research into industry metrics in your business plan and explain why your assump

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

Companies that provide selfless information through particip

ions are the same as, or deviate from, those metrics, it will give your assumptions and your business plan a lot more credibility than your assumptions on their own

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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