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Many people talk about business strategy but have a great failure to realise exactly what this is - is it surprising that a great deal of business people have a huge problem

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

discussing this when they do not exactly know what this is!

Questions that should be asked may include the determination of the fact that is there even a strategy in existence

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

Examples of combination products may in

or if so, is this the correct one? Additionally, how do we determine what a strategy is and how does one go about developing one?

It is important when developing strategy to look

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

at some of the issues and why a chosen path can go wrong-if one keeps doing the same thing, one will get the same results.

Many complaints about strategy range from the fact th

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

at it is difficult to determine, it gets messy and unfinished, and many people involved either do not contribute or attempt to dominate proceedings and a general feeling of the

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

Combination pro

uture and the failure of any future chosen path.

Broadly speaking, some schools of thought hold with notion that there are three main reasons for a failure of strategy.

Mana

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

gers often fail to realise what these differences are; business schools talk about corporate-centre strategy and business-unit strategy. Business-unit strategy is for controll

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

d organisations that may be part of conglomerates or single-business units whereas the other is for conglomerates planning growth through the use of single business units.

Anot

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

her is often no clarity of purpose; for example there is no point in using models that are simply intellectually attractive when the purpose of the task is to discover options

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

and directions and gather proof to support decisions about the future.

The business - unit level requires methods that are relatively straightforward and the only real obstacle

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

s are intimidation by "professionals" and their jargon. Most means of analysis are in excess of 35 years old but there is a general lack of understanding of them amongst busin

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

Following aspects would a

ess people and most of them do not know how to use them.

So how do we correct this anomaly? Initially, the ground rules need to be set so participants need to arrive with open,

dd to the challenges in developing combination products:

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

clear minds. Strategy may be likened to seeing everything around, from every angle available and even into the future and the following requirements must be met to be success

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

ful: Customers are paramount and form the basis of market understanding, practicality must take priority over theory, the business needs of now and the future need to be thoug

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

t about and the strategy needs to be measurable.

It is worth at this point to touch on the philosophy behind a strategy.

The best place to start is to take the old adage of be

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

gin with where you want to be and work backwards to where you are now.

If, on the other hand, one believes that strategy is an analytical process then start with where you ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

and work forwards. However there is a difficulty with this approach as straightforward arithmetical thinking stifles creativity. Perhaps, in the real world, a combination of bot

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

h methods is probably a necessity.

This is all, of course, driving towards growth of the business and that is largely down to marketing. So why are not all growing firms good m

.

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

rketers and why have not they developed a good strategy?

Very briefly, this begins with a failure to understand the difference between selling and marketing - marketing is ab

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

Companies that provide selfless information through particip

out developing products or services that customers will want where selling is about simply getting people to but the product.

The rest, for the moment, I leave you to ponder on

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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