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If you own a personal watercraft you know that they can be exhilarating and fun and yet you a

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

re probably fully aware of how dangerous they can be. This is why personal water craft insura

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

Examples of combination products may in

ce is a must. The kind of insurance available varies from company to company and the kind of

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

nsurance you will most likely need varies from state to state.

There are some good recommend

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

tions on the American Watercraft Association website to bring you up to speed on the issues c

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

Combination pro

oncerning water craft and these can give you a pretty good idea of the types of coverages you

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

should be seeking.

Going skinny on coverage could prove to be disastrous in the case of a hu

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

e lawsuit due to an injury involving you or your watercraft it is deemed to have been partial

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

y your responsibility. The liability of such a judgment going against you could bankrupt your

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

family and there are some horror stories to prove that.

If you bought your watercraft on ti

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

e and borrowed money most likely you were required to buy the basic coverage. Nevertheless, t

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

Following aspects would a

is might not be enough that therefore you should be checking into extended coverages, even su

dd to the challenges in developing combination products:

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

h things as trivial as theft and emergency towing need to be considered seriously.

I was con

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

cerned about injuries to riders or water skiers I tow and once I had someone bump me in their

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

boat and damage my watercraft, they didn't have insurance and the derelict (opinion) was basi

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

ally broke. This really upset me and prompted me to do what I should have done in the first p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ace. I should have called an expert on insurance to help me.

Do not make that mistake, call

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

an expert to explain to you what you need and why. I certainly hope this article is of intere

.

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

t and that is has propelled thought. The goal is simple; to help you in your quest to be the

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

Companies that provide selfless information through particip

est in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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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This TQM article is written about a Baldrige Style Assessment in Strategic Planning Category 2 guided by Baldrige Approach. Included are some common assessment findings derived from companies being assessed by a group of trained and experience senior assessors. Reader may benchmark it for their improvement.

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