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A sure-fire way to start the success of your business strategic planning process is to identify the

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

foundation upon which your business was built. Lacking a well defined mission statement and equall

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

Examples of combination products may in

y communicated vision statement identifying your desired future will make the job a great deal more

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

ifficult. Rather like threading a needle and thread without tying a knot at its end, an undefined b

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

usiness floats its intended outcome with little to anchor its goals and strategic activities. “Your

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

Combination pro

ission and vision statements should be used to help focus your business in terms of direction, lead

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

ership, and goal-setting ; mission and vision statements are the basis for your organization’s strat

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

gic planning”, said Don Midgett, author of Mission and Vision Statements: Your Path to a Success

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

ful Business Future.

“Visionary businesses excel because they set goals that relate directly t

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

their mission and vision statements. They communicate their vision statement and vision-based goal

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

s to both customers and employees. They come up with strategic activities and daily/weekly/monthly a

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

Following aspects would a

ctions to reach their goals and, over some period of time, achieve their vision. It is in this way

dd to the challenges in developing combination products:

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

hat a business can control its own destiny, rather than let outside forces determine a business dire

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

ction.” A periodic review by management of your strategic planning actions will let you know if you

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

ave chosen the right strategic activities for your business. Additionally you can also make sure th

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

at the strategic planning activities you have chosen to do are all supportive of your mission and vi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion statements. Use your mission and vision statements to chart and stay the course.

Need help wit

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

h this? Go to www.missionvisionstatement.com and obtain Mission and Vision Statements: Your Pat

.

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

to a Successful Business Future – you will get well constructed exercises and examples to help

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

Companies that provide selfless information through particip

you develop meaningful and useful mission and vision statements for your strategic planning process

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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