Digg It - Business

There are so many reasons why an individual decides to become a business owner. Here are just a few t

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

hat my clients have shared with me: to have schedule flexibility, increased income potential, laid of

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

Examples of combination products may in

f from employer, control of my destiny and the list continues with similarities and differences. Your

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

reason may be the same as the one mentioned above or it maybe totally different. However, we all have

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

a reason “why” we became entrepreneurs and a “purpose” for our business. Here’s another question: Wh

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

Combination pro

y does your business exist? Your why and purpose should be two separate answers.

T

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

e purpose of your business is your mission statement. A mission statement is a brief description of a

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

company or organization’s purpose. It can be stated in one sentence or less. The mission statement e

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

xplains what the organization provides to its clients; a reason for being.

Here is the mission state

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

ent for Google:

Organize the world’s information and make it universally accessible and useful.<

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

/em> Here is the mission statement for my business coaching services:

Empowering my cli

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

Following aspects would a

ents to see, create and get everything they want done using vision, goals, commitment & action.

dd to the challenges in developing combination products:

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

hat’s your business mission statement?

Having a business without a mission statement is like driving

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

a car with no destination. Doesn’t make sense!

It is important to keep your mission statement close

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

by to review when you are providing a service or developing a product for your clients/customers so

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

t can serve as a reminder of what your business is providing and your business principles and values.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Also the why & purpose of your business venture serves as a motivator when you nee

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

d encouragement during the challenges.

When developing your mission statement, it should answer one

.

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

mportant question:

What is the purpose of my business services? Once you’ve written your mission sta

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

Companies that provide selfless information through particip

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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