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While Americans and Australians may appear similar in language and culture, the two nations are actually quite different. Understanding these idiosyncrasies will ensure Au

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

stralian businesses are better equipped to negotiate deals and develop long-term business relationships. Below are some primary aspects to consider:

For Australian busine

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

Examples of combination products may in

ses, it often seems that Americans are more likely to build personal relationships through business deals, rather than build business deals through personal relationships.

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

This means Australian businessmen and women, need to focus on getting the details of the deal right first, with the idea that a relationship might develop later.

In a som

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

what related them, active selling in the US is expected, often to a degree that may be regarded as over-the-top or overly agressive in Australia. You cannot be shy or timi

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

Combination pro

in the US, be clear of your advantage and be prepared to "sell it" strongly.

In addition, time is money, so you must not waste time. Be well preapred with samples, packa

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

ing, sales sheets, ROI calculations or sales forecasts and be able to answer detailed questions on pricing, marketing and logistics.

Be prepared to be direct, its seen as

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

a virtue. Ask for what you want, say what you mean and do what you say. Americans seldom take offence to a well-phrased, direct question because they always reserve the ri

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

ht to say "No". Likewise, they expect you not to take offence if they cleraly outline their reservatiosn with your proposal or simply say "no".

Be positive. The Australia

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

tendancy to be self-effacing or to downplay achievements so as not to be seen to be "boasting" can clash with American's can-do attitude. However, it is also important to

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

watch the use of Australian humour that can often be inappropriate in the US. In general, business conduct in the US is conservative, polite and succinct - keep the Austra

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

Following aspects would a

ian sense-of-humour in check until you know your contact very well.

Be persistent, effective follow-up is essential. In Australia you would most probably be considered as

dd to the challenges in developing combination products:

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

someone who is extremely annoying after 2 - 3 follow-up attempts. In the US there is so much "noise" and competitive activity in the marketplace that your target contact m

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

y not have had time to hear and absorb your message. Be persistent - 10 - 12 attempts to make contact can be very normal in the US.

Lastly, be very, very clear on your co

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

petitive advantage and be able to articluate that advantage in a brief marketing message - often called the 30 second elevator pitch. Americans were the inventors of the 3

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

second elevator pitch and whether you like or loathe the idea, you need to have one. What problem does your product or service solve, what benefit does it deliver, who a

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

Professional from academic institutions, pharmaceutical industries, health care indust

e you better than and how can you prove it.

America is an amazing country of opportunity and innovation. It is Australia's largest trade and investment partner and the re

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

ent Free Trade Agreement (AUSFTA) ensures our two countries continue to strengthen their economic and political ties. Within this broader context however, its important fo

.

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

both sides to realise that while some of our cultural differences might be subtle, mis-understandings can easily occur. Hopefully, some of the practical advice provided h

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

Companies that provide selfless information through particip

re and in the Australian Trade Commisison's free guide - "Doing Business in the United States" can help businesses on both sides of the ocean to avoid unnecessary faux pas

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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Destroy your business records, or else! Identity theft is bad enough without businesses making it easy for the thieves. If common sense isn't enough motivation for you you to properly dispose of customer information, then maybe a federal law will help.

If you do medical billing, most likely you use computers. So what happens when the power goes out? This article takes a look at some backup plans that are good to have.

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