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Communication is faster and access to information is more readily available today than it has ever been. Ease of communication will increase. The ability to obtain th

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

e information you need will improve. On the other hand, the amount of time you have to make a decision that will benefit or harm the success of your endeavor will dec

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

Examples of combination products may in

rease.

If you have something good to offer, you must let the people who need it know about it. The step you take or choose not to take today will have ramifications

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

for your business tomorrow.

Will your potential customer learn of, be contacted by, or worse yet, buy from your competitor who has a product or service that is infer

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

or to what you offer?

What if this happens because you had an idea, or were given a suggestion, that you needed to think about; wanted to give additional considerati

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

Combination pro

on; took more time to further contemplate; had to have another look at, and/or felt you needed to seek out advice from just one more person before making the decision

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

?

What if in the meantime, your competitor had the same idea or was given the same suggestion. Your competitor, unlike you, makes a yes, "go forward", or a no, "move

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

on", decision.

If the decision was correct or incorrect, a decision was made as to the action that would be taken. The person will either benefit from or deal with

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

he ramifications resulting from their decision. Whichever the case may be, the impact on your company will result from internal action.

Overthinking, delaying or hav

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

ing difficulty pulling the trigger can all significant effect the productivity of your decision. Any of these factors can put you in a position where the impact on yo

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

ur company is determined by the actions of someone else. Do you want YOUR business to be put in that position?

A yes or no decision, over time, will be determined to

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

Following aspects would a

have been right or wrong. There are many variables that impact situations; we all know only hindsight is 20/20. There is no way, though, to avoid the fact that a dec

dd to the challenges in developing combination products:

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

sion today effects tomorrow one way or another to a lesser or greater degree.

Results of a single decision can extend through the life of your business. A single dec

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

ision can lead to your endeavor thriving. Or your great idea, your groundbreaking solution, your better way of doing things can wither and die on the vine.

The abili

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

ty to put ego aside, to be open to new ideas, to have the willingness to accept advice are all matters one must consider in relation to their decision making process.

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

The most common problem that causes companies to either not be as successful as possible or to fail is easily identifiable. A person enters the business world posse

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

Professional from academic institutions, pharmaceutical industries, health care indust

sing a core competency in their given field of endeavor. Problems arise when that person extends beyond their area of expertise to become personally involved in other

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

areas that would be better handled by people hired to do those jobs.

Delegating, trusting the people to whom you assign tasks and having the willingness to roll the

.

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

dice with their work product are all critical factors. These considerations directly impact the ability to make good decisions in an expedient fashion and execute ta

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

Companies that provide selfless information through particip

sks that make your company more successful.

In conclusion, "The price of consulting is less expensive than the cost of paying for your own mistakes." - Anthony McCun

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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The cost of employee dissatisfaction can be remarkable, and many companies try to prevent the loss of employees by throwing money at them. While it may work for a little while, the undermining factors will go unnoticed, resulting in throwing more money at the problem.

Communication failures are common in industry and government. In many cases the poor communication stems from a lack of knowledge by managers, supervisors and team leaders in how communication works in the human brain. A result of this poor understanding is lower levels of productivity than is otherwise possible.

Franchisors prior to the sale of a franchise collect information from franchisees to qualify them in the Sales Process to see if they can afford the franchise. Even more importantly by asking for this information the Franchisor can insure that the Franchisee has the necessary cash flow to float the franchised outlet and the franchisees salary until a point of profit or approaching to ROI

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