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Managers are facing an increasingly knowledge based business environment. This is true not only for the High Tec ones, but also to “traditional” industries. The mature and sometimes saturated markets served by these industries lead to tigh

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

t and aggressive competition, where knowledge and the ability to act fast can be the only factors separating the winners from the losers.

How can a manager make every day decisions, with high success rate? Well, nothing can substitute for

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

Examples of combination products may in

good intuition, experience and guts feeling, but these should be complemented by knowledge of the market, the clients, the competition and the manager’s own enterprise resources and policy. To add to the challenge, decisions need to be ma

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

de fast – with short reaction lag, as to allow for a high-speed implementation of the decision by the enterprise.

In their continuous seek for sound and unbiased decisions managers are relying on the real time flow of information, produce

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

d and processed by the Enterprise information systems. ERP, CRM and financial management applications are producing endless reports and insight, market research and intelligence are capturing fast changing trends and developments in the ma

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

Combination pro

rket arena. Yet, one source of knowledge and insight, highly relevant and important to manager’s decisions, is seldom ignored – the knowledge of employees, and those in field duties in particular.

Anyone familiar with sales and distributi

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

on of consumer goods is aware to the sophistication of the Hand Held Terminals (HHT’s) used by thousands of field employees in the sales and merchandising teams of companies such as Pepsi Cola, P&G and many others. Using HHT’s field employ

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

ees can collect enormous data related to shelf performance of their own and competing products. But these sophisticated information systems do not provide an answer to the simple task of collecting and processing the views and knowledge of

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

field employees – the front line troops of any marketing organization.

Enterprise information systems are providing quantitative measures – sales, inventory, orders, HR, cash, receivables and much more. These numbers provide a clear and

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

updated answer to the “How much” question, yet they cannot provide any information that is not quantifiable. They are not designed to provide insight to the “Why” question, in situations were human feeling, and personal knowledge intuition

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

and analysis are needed.

An example may clarify this claim: a marketing company is facing declining sales in a specific market segment. ERP indicators such as orders, sales and inventories are capturing and measuring this deviation in re

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

Following aspects would a

al time, however management cannot understand the causes and reasons for this event. Why is it that sales are showing decline in one specific region, while keeping the normal path in others? What should management learn from this event, an

dd to the challenges in developing combination products:

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

d what should it decide to do in order to reverse the negative trend? In many cases, the explanation to the problem is known to field persons, engaged in continuous communication with the “market” – retailers, consumers and competitors. It

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

can be the result of specific promotion activity by competitors, negative PR in local newspapers, weather, supply chain failures and other reasons. A simple interactive surveying of the filed force will highlight the most relevant cause o

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

r causes.

It should be emphasized at this stage we are not preaching here for democracy in management systems. It is simply a process of gathering and analyzing relevant information, bridging the knowledge gap between headquarters managem

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

ent and the front line field employees.

Like with many other management tools, the rapid progress in technology and communication is facilitating the practical implementation of ideas that were too difficult and costly in the past. The fa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ct is that almost all corporate employees, all around the glob, are using a cellular phone. Text messaging (SMS) technology is providing the cellular handset qualities that resemble those of the two-way pager – low cost and efficient means

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

for communication with mobile persons. With this in mind, what is needed is a software application and a central communication platform that enable managers to deliver right from their desktop questions and queries to populations of field

.

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

persons, receiving a full management report of the replies in real time, and anytime.

Any organization can start using this information facility immediatly, without any need for investment in hardware. In addition to the major benefit of

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

Companies that provide selfless information through particip

improving the knowledge base used by decision makers, it has a second favorable effect – preventing field persons from complaining about “those managers in their air-conditioned offices, who knows nothing about what happens in the field….

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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