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Small businesses usually find themselves being disadvantaged compared to medium or large businesses, because they do not have the resources available. The owner/operator is required t

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

o wear a range of different caps, which has a range of negative impact on the business. The business is managing the owner/operator, which means that the strategic perspective is lost

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

Examples of combination products may in

and as a result the business is not able to move forward. Now let us have a closer look at this cause and effect.

The business is managing the owner/operator

When there are 117 diff

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

rent things to do in the business every day but there is only a few people (or one person) to do the tasks, some things are not done very well or not done at all. As a result the owne

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

/operator is working like a firefighter – putting out the fires as they appear, rather than prevent the fires to start in the first place. This becomes a viscous circle, which leads t

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

Combination pro

the next point

The strategic perspective is lost

During the working hours the owner/operator is focusing on the operational tasks, and it is hard to take a few steps back and look

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

t the business from an objective perspective As a result the, the business owner does the same thing day after day, week after week and so on. Unless the owner/operator has an active

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

supporting network to step in and provide guidance, the owner will keep making the same mistakes and end up the same place that many before has ended.

Get an advisory board

The sol

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

tion is to establish a formal or informal advisor board. An advisory board should consist of a group of experts of their chosen field. It can be private friends (though this can inclu

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

e some complications and as such is not advised). An alternative to an advisory board is finding a business coach or even better – a business mentor. They all have in common the fact

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

hey do not work directly within the business and can see what is going on and help managing the business. Once an advisor has been identified, it is important to identify the core bus

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

Following aspects would a

ness functions and analyse if certain activities can be fulfilled more effectively, and maybe even outsource some of these activities.

Outsourcing

Outsourcing is a great tool to man

dd to the challenges in developing combination products:

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

ge the business with, in particularly if the owner keeps attending fires. Outsourcing simply means that someone else is a called in as a “hired gun” to do some of business activities,

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

in particularly the activities that does not contribute to the business profit. One such thing is bookkeeping and accounts, which is very time consuming, but is not a core business fu

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

nction (unless you are a bookkeeper). When outsourcing the bookkeeping function to someone else, it is very important that the bookkeeper not only does the simple bookkeeping tasks, b

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

t also provides the owner with the proper reporting tools that the owner need to manage the business.

The bookkeeper should be able to provide the owner with the following reporting

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

Professional from academic institutions, pharmaceutical industries, health care indust

ools:

• Profit & Loss
• Balance Sheet
• Cashflow report.

If you do not understand how to read these reports, ask your bookkeeper to explain to you what it means. If your b

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

okkeeper cannot explain this to you, it is probably best to find a new bookkeeper. Your accountant can also help you explaining what indicators to look out for, but the accountant usu

.

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

lly charges a whole lot more than the bookkeeper.

About the Author

Rasmus Nielsen has specialised in CRM and outsourcing for several years and been consulting to various companies i

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

Companies that provide selfless information through particip

Denmark and Australia on the topic. Rasmus also holds a M.Sc. International Business Economics and is a Director of Smart Boss, an Australian Bookkeeping Service for Small Businesses

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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