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It is fundamental to all businesses that understanding your markets and customers allows for the development of effective strategies. Strategies that, when implemented wi

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

ll enable you to develop your competitive advantage. Simply put your competitive advantage is built upon your ability to exploit what it is that you do better then anyone

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

Examples of combination products may in

else.

A Companies BASE STRATEGY forms the basic foundation upon which you plan and build your Competitive Advantage. Your Base Strategy represents your broad game plan an

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

d how you intend to succeed in your current business environment; how you plan to leverage your strengths vs. the competition, it also serves as a guideline for decision-m

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

king, resource allocation as well as new product and service development. Understanding what external and internal factors drive your Base Strategy will enable you to cre

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

Combination pro

te your unique Strategy for success.

To this end I have outlined several basic strategies which will help you better understand where you and your company fit, thereby en

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

abling you to re evaluate your present base strategy and to more effectively understand your competitive advantage.

Commodity-Driven Base Strategy

Should be considered w

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

en your product or service is essentially the same as others on the market. To differentiate your product or service you could choose either pricing or value as a differen

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

tiating factor. This strategy requires close attention to cutting & controlling costs which maintaining high productivity.

Technology-Driven Base Strategy

This strategy

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

laces the emphasis on your ability to gain a temporary monopoly on a market thru the development of a technology or to compete in a market where superior technology provid

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

s a competitive advantage. Success of this strategy often is dependent upon the coordination of emerging technologies with breakthrough thinking.

Quality-Driven Base Str

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

Following aspects would a

ategy

This strategy focuses upon the assumption that your product or service is superior in quality to those of your competitors. Success with this strategy is dependent

dd to the challenges in developing combination products:

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

in part upon the ability to have systems in place to assure that your product or service continues to maintain superiority. This essentially means continuous improvement;

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

constant and consistent monitoring, or production, development and execution.

Service-Driven Base Strategy

This strategy should be considered if you find yourself in a p

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

sition of being unable to differentiate your products and services in terms of price, technology or quality. Your focus will be on the “value-add” benefits of doing busine

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

s with you, with an emphasis on service, delivery, follow-up etc.,

Customer-Driven Base Strategy

This strategy places a premium on going beyond meeting customer expectat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ions; always exceeding customer expectations. It requires that you have an on-going effort to improve quality and service. This goal and success of this strategy lies in y

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

ur willingness to exceed your customer’s expectations.

Review these strategies; select a strategy that will enable you to effectively position your strengths and availabl

.

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

e resources in the best possible light. Your Base Strategy along with your vision and your willingness and desire to pursue that vision will lead to the success that you

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

Companies that provide selfless information through particip

esire. Persistence pays! Remember the important thing is that you know where you’re going; that you have a vision; and that you know what you ultimately want to accomplish

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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