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A feasibility study way before laying down the foundation of a business, especially a small one, is a must. This is because a sm

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

all business owner cannot afford to make mistakes. A small folly can cost him a fortune, setting the business in doldrums even b

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

Examples of combination products may in

fore it sets off.

To begin with, think what you want to gain from the business. If you intend to manufacture products of a part

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

cular category, you may wish to market it efficiently, so that the business generates profits. To market the products well, you

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

eed to position them in the right market. Remember just talking to a few people in the industry would not be enough. You may hav

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

Combination pro

to talk to thousands of people and obtain expert advice on whether your business plans will work.

After studying, the market y

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

u will have to set prices for your different product categories carefully. You cannot price your products more than what the buy

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

ng power of the public in the particular area that you have targeted. So, fix a price that the masses will be willing to pay. Al

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

these details must be a part of your feasibility report. Let us find out what a feasibility study is and how to go about it.

W

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

at is a Feasibility Study?

Feasibility study refers to the research that determines the viability of one’s business plan. It is

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

market report comprising various details on the preferences of the consumers, consumer habits and their buying power, and the co

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

Following aspects would a

petition that the new business is likely to face in the targeted area.

Make a feasibility Report:

You can hire the services of

dd to the challenges in developing combination products:

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

a consultant who can make a feasibility report for you. These companies use various methods like – Internet, surveys, industrial

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

seminars and conference, and much literature is available on the subject to create the perfect feasibility report for you. If t

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

e industry you intend to get into is well defined such as toy manufacturing, you can use ready reports conducted by the national

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

professional organization. If not, you may also seek professional services of the consultants who can give you relevant advice o

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

Professional from academic institutions, pharmaceutical industries, health care indust

necessary business tactics after studying the market trends.

Importance of Feasibility Study:

It determines the potential of

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

he market where a product is set to sell. A feasibility study gives a business planner insight into whether the product is requi

.

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

ed in the market, and if yes, then will the consumers afford to buy it at the price determined. This survey can prove significan

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

Companies that provide selfless information through particip

ly important in formulating price strategies for a company’s products or services, which is a determinant of a business’ success

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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