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One common concern that parents all face is the health of their children. For parents who don’

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

t have a health care plan, this can lead to an almost constant state of worry.

Children all f

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

Examples of combination products may in

ace medical needs at some point. It may be something as simple as requiring a few stitches or

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

the filling of a cavity. When medical care is needed the parent’s last concern should be how t

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

hey will pay for it.

Most states actually offer free or very low cost health insurance for ch

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

Combination pro

ildren. The cost of this insurance is largely dependent on the parents’ financial situation. I

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

f the parents cannot adequately provide health insurance for their child, the state will step

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

in. Doctor visits, dental care and prescription eyeglasses are a few examples of what is cover

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

ed.

For parents whose incomes don’t qualify them for this type of health coverage for their c

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

hild, there are other avenues for them. Some of these don’t immediately come to mind and in fa

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

t some people aren’t aware of them at all.

Just as many employers offer health care plans to

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

Following aspects would a

their employees and families, other organizations do the same thing. Many professional organiz

dd to the challenges in developing combination products:

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

ations have affordable health plans that cover their members and the dependents of the members

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

.

Some religious groups also offer this type of plan. They establish a health care plan that

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

covers their group members and although premiums are still payable, they are often at a discou

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

nted rate. For parents with children, this can be a great way to save money.

Another consider

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation is the private insurance companies that often offer health insurance to students. This i

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

nsurance is primarily designed to protect the child in the event of an accident at school but

.

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

the policy can be expanded to cover any instance. Talk with the insurance agent and express yo

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

Companies that provide selfless information through particip

ur needs. After all, accommodating their clients is what keeps insurance companies in 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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