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Do you run a small business? Is your business insured? If not you could be risking your and your business’ future.

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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

insurance, and see why its today’s business lifeboat.

Expensive if You Don’t Use It – Cheap if You Do

The cost of doing business toda

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

Examples of combination products may in

y is rising all the time, its true. Salaries and worker’s benefits are taking a bigger chunk of your profits.

Taxes are always a key co

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

nsideration, and material costs are rising as well. Add to this insurance, and you have a real significant number on your cost of doing

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

usiness column (on your profit and loss statement).

When looking at insurance you will be amazed as the amount of risks you are obliged

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

Combination pro

to cover.

There are the obvious accidents or acts of nature risks, worker’s compensation, health and retirement plans, but then there

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

are a host of other risks that can, and many should be insured.

It’s a maximum that all insurance is expensive if you don’t use it, but

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

very cheap if you do.

The “Got To Have” Business Insurance Risks

Here is a list of basic insurance risks that every business should co

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

ver;

• Fire, Theft, Water Damage, and Malicious Damage to your business location

• All required worker insurance obligations, and for

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

good worker relations, some perk insurance for employees, like some group private health plan, and retirement fund.

• Product liability

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

if you are producing a product

• Transportation insurance for all your vehicles (full Casco advised)

• Fidelity insurance if your empl

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

Following aspects would a

oyees handle money. This may be a really indispensable pre-paid asset to your business.

The “Nice to Have” Business Insurance Risks

•

dd to the challenges in developing combination products:

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

Business interruption insurance

• 3rd Party Liability if you are producing a product for wide distribution

• Litigation insurance

• D

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

amage due to civil disobedience and terrorist activity

• Business specific items

Buying Insurance

The choice of buying insurance is b

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

coming a tiresome activity with so many options and prices (and insurance terms), that finding and using a good broker may be your best

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

bet

The insurance broker has some advantages over using one company exclusively.

The broker can shop around, negotiate directly with u

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

Professional from academic institutions, pharmaceutical industries, health care indust

nderwriters (which you cannot do), and tailor make some policies for you.

The cost of using a broker may be easily absorbed by the lowe

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

cost of the insurance he provides you and your business.

You must make very sure of the broker’s qualifications, and demand a list of

.

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

companies and underwriters he deals with.

Ask for a client list, and his inclusion in professional insurance societies. A search on the

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

Companies that provide selfless information through particip

internet is also helpful. When you are satisfied, start using the broker to plan your business insurance risk profile and coverage plan

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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