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Most people especially entrepreneurs or small business owners are so busy dealing with yesterday and today,

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

they fail to plan for tomorrow. Being able to envision your future is the first step and one that is often

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

Examples of combination products may in

b>overlooked and undervalued. The future vision for your business is necessary and essential to

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

chieve not only small business success in building your business, but balance both personally and professionally.

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

he act of visioning is not easy. Wallace D. Wattles recognized the tremendous effort of this action when he

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

Combination pro

wrote:

"There is no labor from which most people shrink as they do from that of sustained and consecutive thoug

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

t; it is the hardest work in the world."

Keeping sustained and consecutive thought is one of the greate

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

t ongoing challenges especially when working through a disciplined nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

d=236356">strategic planning process.

Thoreau also perceived why we need to stop our own personal definitions

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

of insanity and crystallize the vision for our lives when he penned these often quoted words:

"If one advances

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

onfidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with

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

Following aspects would a

success unexpected in common hours."

Vision is also necessary from a leadership perspective. In the book,

dd to the challenges in developing combination products:

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

ail-Safe Leadership: Straight Talk About Correcting the Leadership Challenges In Your Organization by Linda Mar

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

tin and Dr. David G. Mutchler, the authors from their years of working with organizations from small businesses to

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

ortune 500 firms believed that Vision is part of Level III alignment. The Vision is the first step in securing buy-

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 from everyone within the organization beginning at the Executive Level.

If the Executive Level Team doesn't know

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

Professional from academic institutions, pharmaceutical industries, health care indust

where it's going, how can the rest of the organization follow?

So take the time to crystallize YOUR vision for

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

YOUR company. Again, this may change in a few years depending upon your industry and your business.

As the le

.

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

der of your business whether you are a one person business, 10 person or 100 to 1,000 plus person company, remember

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

Companies that provide selfless information through particip

your role as the Leader, according to Warren G. Bennis, is:

capacity to translate vision into reality

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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E-Folder - Strategic Planning: The Act of Visioning in Business Building Demonstrates Great Leadership

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