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Many people that speak to me seem to have a problem. A business problem that is - not a personal one. And they're speaking to me because they want to do something about it. They want things to be

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

better - more sales, new customers, new markets.

"What should I do?" they ask me.

Then comes the tough part. Doctors have to do it. Auto mechanics do it. It even happens at your local computer

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

Examples of combination products may in

repair shop. It is…

diagnosis n. "A thorough analysis of facts or problems in order to gain understanding."

Most business problems are difficult to solve without an understanding of the cause.

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

Identifying the cause, not just working on the symptom, is a critical step in creating an effective marketing process.

Often the cause of the problem can be overlooked because of:

Initial enth

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

siasm - and thinking that "we can't go wrong" when a project commences, which often leads to critical data being overlooked.

A narrow focus - thinking that certain issues don't need to be consid

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

Combination pro

red, such as competitor activity, the value being offered, usage of the product/service, and trends in the business or customer environment.

A misunderstanding of what marketing is - people are

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

sensitive about high-pressure sales tactics and over-hyped advertising, but they're examples of poor marketing practices and are rarely suitable.

And yes, sometimes it's hard to address the impo

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

tant issues. It's especially difficult when a project is already underway and there are factors to consider such as:

Vested interests and personal ego's.

Money already spent on research and pro

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

uct design.

Stakeholders already advised.

Potential loss of credibility, either personally or for the company.

To really focus on the underlying challenges facing a business it is important to

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

approach the sales and marketing function from a neutral viewpoint (as much as is possible).

Many people find sales and marketing issues to be 'soft', with few guidelines on what/how/when parti

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

ular activities should be done. In reality, many of these decisions are reliant upon the particular circumstances of the business, and a degree of subjective evaluation (sometimes called 'experti

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

Following aspects would a

e') is required.

But remember that good marketing practices transcend industry boundaries, and the activities implemented may vary tremendously from one industry to another, and from one busines

dd to the challenges in developing combination products:

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

s to another within the same industry. So you need to know what is best for you.

To solve marketing 'challenges' I like the four-stage approach to problem solving advocated by 19th century Frenc

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

mathematician, Jules-Henri Poincar? (altered ever so slightly here for business use):

1. Preparation - immersing ourselves in the issues, collecting and organising a diversity of data and relev

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

nt information.

2. Gestation - developing ideas in the mind, brainstorming, analysing.

3. Revelation - new facts are disclosed, a breakthrough insight occurs.

4. Action - following through wit

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

h plans, persisting to overcome difficulties.

Don't forget...the objective is to find out what you really need to do to improve your sales and marketing activities. Poincar?'s process itself is

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

Professional from academic institutions, pharmaceutical industries, health care indust

ot the answer, but it is a path that leads to better results.

Depending upon your situation, one or more of these stages may be quite short. But the learning that occurs through the process is i

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

valuable. And in the hands of a skilled marketer this new 'information' can be used to refine (or re-define) the uniqueness of your business and highlight the real value for your customers.

It i

.

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

s not unusual for clients to be quite surprised with the outcomes of this process. The clarity of purpose that results, and the new perspective they get on their marketing opportunities really gi

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

Companies that provide selfless information through particip

es their confidence a boost.

So if you think you have a problem with your marketing, make sure you accurately diagnose the 'real' cause before you prescribe a remedy - your success depends on it

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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