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If something disastrous were to happen to you tomorrow, what plans do you have in place to make sure your business continues to operate? The motto “Be Prepared” may be used

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

by the Boy Scouts, but it is just as important in our daily lives as it is in our businesses. Should a disaster occur, by creating contingency plans for your business, you e

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

Examples of combination products may in

liminate the worry and stress caused by trying to come up with a solution in the thick of the situation.

Before a business owner can truly figure out how they would handle

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

an obstacle thrown in their path, it is important to take a step back and think about what possible disasters could occur. This is a very unsettling task for many business o

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

wners, but for those who have taken the time to map out how an emergency would be handled; the success rate of overcoming that emergency relatively unscathed is much higher.

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

Combination pro

The biggest hurdle for most in writing contingency plans is determining which areas are most important. Perhaps rather than trying to look at the whole picture and trying 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

o think about every conceivable “what if”, the best way to handle this almost impossible task may be to break it down into 4 main considerations – political, economical, soc

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

iological and technological.

Consideration #1 – Political Considerations

Political considerations include such things as legislation and how these changes might affect you

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

r business. For example, what impact would an increase in sales tax have on your business? If you are relying on government funding and tomorrow the government decided that

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

they had run out of funding for that particular program, where would you find the monies to replace the lost revenue? Other political considerations might include employment

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

laws, trade restrictions and trade agreements. By determining the impact each possible change might have in your business you can take precautions to plan for these changes

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

Following aspects would a

.

Consideration #2 – Economical Considerations

The economy plays a large role in business. Changes in the economy affect consumer confidence which in turn affects business

dd to the challenges in developing combination products:

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

. Another consideration is global events, it is important to stay on top of what is going around in not only your community, but also the country and the world and what poss

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

ible affect that might have on your business.

Consideration #3 – Sociological Considerations

Today’s marketplace is affected just as much by our political and economic cul

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

ture as it is by fads. Ensuring a thriving business is only possible by staying ahead of current fads and making sure your product or service will not be affected as society

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

ages, changes and grows.

Consideration #4 – Technological Considerations

Staying on the “cutting edge” in today’s society can sometimes be a tricky proposition. Technolog

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

Professional from academic institutions, pharmaceutical industries, health care indust

y always seems to be advancing faster than we can keep up. Just when we learn how to master a new product, program or skill, there is a newer, faster and more efficient mode

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

l to take its place. Staying on top of those changes and advancements will play a huge factor in whether your business will thrive or not.

Of course the ultimate contingenc

.

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

y plan includes a plan to ensure your business continues to thrive upon your death. By establishing a Procedure Manual for your business now, you will position your business

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

Companies that provide selfless information through particip

to overcome the greatest obstacle of all. All other obstacles can be faced head on with the knowledge you have worked diligently towards creating your own thriving business

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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Is your lead generation tool kit well stocked or almost empty? Or are your lead generation tools rusty and no longer work? What lead generation tools are you using? And are the tools you are using producing results? It has been my experience that the more lead generation tools you use, the more leads, clients and revenue you will generate. But, you must use productive and proven lead generation tools that give you a good ROI (return on investment). Reflecting on what have been successful tools for me in the past, your Strategic Thinking Business Coach identified thirteen (13) proven lead generation tools to apply to your service business. And here they are in no priority order.

Mobile carwash businesses must cluster their customers close together due to the high cost of fuel. When a mobile carwash business is driving around it is not making money however, when it is parked in a parking lot washing lots of cars in a row it is making the maximum and most efficient use of its resources and therefore creating profits for the company.

More than 500 managers and executives in the electronics hardware and design sector, many from electronics contract manufacturers and technology original design manufacturers (ODM), were recently polled in an online survey which presented numerous questions and various business perspectives and scenarios for commentary and ranking.

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