E-Folder - Business

Every leader and business owner should have a dream for their business -- a dream that they want

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

to turn into reality. How do we make those dreams come true? We begin with the establishment 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

a stated purpose for our business and the development of a vision of what we want this business t

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

become in the future. We should be able to answer the following questions: "Why does my business

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

exist?" and "What do I want my business to be like in the future?" Once we have answered these q

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

Combination pro

estions, we are ready to move to the next step - organizing for success.

There are four steps to

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

success:

Plan - Execute - Track - Analyze

Many people think Henry

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

Ford invented the automobile. He did not - it was invented in 1769 and powered by steam. The fi

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

st gas powered car was built 18 years before Ford sold his first car. Henry Ford's dream was for

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

every family in America to own a car. This was considered an impossible dream in the early 20th

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

entury, yet Ford achieved his dream by turning it into a clear plan of action

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

Following aspects would a

/u>. He did that by turning:

1. His dream into specific goals

2. His

dd to the challenges in developing combination products:

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

oals into specific activities

3. His activities into specific daily and weekly

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

ctions

4. He assigned a specific time to complete each action

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

ote>

All he had to do was follow that plan, step by step, action by action, and his dream would

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

e achieved. There were about 250 other car manufacturers when Ford built his Model T assembly pl

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt in 1908, however, he built more cars in one day than most of his rivals could build in one mon

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

h. By 1914, he was building more cars in one day than most competitors could build in one year.

.

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

Even the most possible dreams need a plan. Think about what you want to accomplish with your bus

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

Companies that provide selfless information through particip

ness; begin now to dream the most possible dream for your business. Turn your dream 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

Tags

Links

E-Folder - Turning Dreams Into Reality

Related Articles: