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You have a head spinning with business ideas but you encounter difficulties in financing? Or you have recently started your great potential business but are not yet turning profit? A fundame

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

ntal aspect for your business, financing is usually the most frequent obstacle in starting a business. You have the option of resorting to a business incubator on condition that your busines

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

Examples of combination products may in

s idea seems viable and promising. Now if you wonder how they are going to find out whether your idea is worth investing, the answer is a very sensible (and predictable) one: by analyzing yo

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

ur business plan.

What are business incubators? How many types are there?

A business incubator is a system offering support for start-up businesses or recently

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

founded ones. The facilities it offers go from financing, inexpensive office space, various business services (such as secretarial assistance) to management advice and support. Their role i

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

Combination pro

s to produce viable, standalone companies at the end of the program they are included in. Also, the selection they perform works like a measurement unit for the viability of the applicant bu

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

siness and gives entrepreneurs a chance to re-think their business strategy. The success rate of businesses created by incubators is of around 85%.

There are two categories of incubator spo

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

nsors: profit and non-profit.

* Non-profit entities are supported by the state or a local government directly, through a college or university, or in conjunction with a chamber of commerce.

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

Such incubators have been used to achieve social and economical objectives as decreasing the unemployment rate, increasing the enterprise formation rate, social assistance for disadvantaged

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

groups - youth, minorities, enhancing regional economy etc.

* Private companies are generally looking to make a profit. Applying for a program of such incubators should be highly questiona

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

ble and a matter for thorough analysis, as it may involve long-term hindering agreements, or sharing a percentage of 20 to 80 of the company ownership and it just may not be worth it.

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

Following aspects would a

ig>Who may apply and what are the conditions?

Any entrepreneur may apply for entering an incubator program on condition that his business project is viable or his busin

dd to the challenges in developing combination products:

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

ess has great potential. An necessary condition is that the applicant must have a business plan containing relevant information.

There are also specific conditions and requirements for admi

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

ssion into such programs that vary from case to case, usually referring to the business industry, business location, the for-profit/non-profit strategy of businesses or financing means.

Pro

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

grams usually last up to three years.

Advantages and disadvantages of resorting to a business incubator

On one hand, business incubators provide:

* financing,

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

without requiring
* customized professional assistance
* entrepreneurial training
* economical access to facilities
* inexpensive business services
* opportunities

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

Professional from academic institutions, pharmaceutical industries, health care indust

for entrepreneurs to connect with people who can promote business growth and profits
* a forum for exchange of ideas among entrepreneurs

On the other hand, there may be some inconvenie

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

nces too with business incubators. For instance, with incubators that have the goal of gaining a profit, the necessary agreement to be reached upon can be most of the times a very cumbersome

.

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

one for most firms.

Also, with non-profit incubators sponsored by governments there is the tendency to favor high tech startups that plan for rapid growth (as thus they will create more jo

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

Companies that provide selfless information through particip

bs) rather than more traditional businesses.

However, business incubators may be a very helpful opportunity to start your business; they can constitute a real boost for a beginner business.

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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