Main Subject - Business

It can be thought of as managing the “pattern or plan that integrates an organization’s major goals

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

, policies, and action sequences into a cohesive whole.’ These strategies can be either the generic

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

Examples of combination products may in

approach to competing or the specific adjustments and actions taken to deal with a particular situ

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

ation.

First, business organizations engage in generic strategies that often fit into some strateg

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

c type. One example is “cost, differentiation, or focus.” Another is “defender, analyzer, prospecto

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

Combination pro

r, or reactor.” These generic strategy types describe the consistent way the company attempts to po

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

sition itself relative to competitors.

The second aspect of strategic management is the process of

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

developing strategies for achieving the company’s goals in light of its current environment. Busine

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

ss organizations make choices about such things as how to scare off competitors, how to keep compet

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

itors weaker, how to react to and influence pending legislation, how to deal with various stakehold

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

rs and special-interest groups, how to lower production costs, how to raise revenues, what technolo

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

Following aspects would a

gy to implement, and how many and what types of people to employ. Each of these decisions may prese

dd to the challenges in developing combination products:

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

nt competitive challenges that have to be considered.

Thus, strategic management is more than a co

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

llection of strategic types. It is a process for analyzing a company’s competitive situation, devel

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

ping the company’s strategic goals, and devising a plan of action and allocation of resources (huma

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

n, organizational, and physical) that will increase the likelihood of achieving those goals. This k

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

Professional from academic institutions, pharmaceutical industries, health care indust

ind of strategic approach should be emphasized in human resources management. Thus, HR managers sho

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

ld be trained to identify the competitive issues the company faces with regard to human resources a

.

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

nd think strategically about how to respond.

Components of the Strategic Management Process
S

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

Companies that provide selfless information through particip

trategy Formulation
Strategy Implementation

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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Main Subject - Strategic Management

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