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“That will never happen to me!” is a clich? many of us apply to a number of topics in our lives, yet many of us subconsciously take precautions to protect ourselves from

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

unforeseen possibilities. We buy home insurance in case of theft or fire, we buy life insurance to protect our families in the event of our death and we buy car insuran

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

Examples of combination products may in

ce in case we are in a car accident. Some of us even buy business insurance to protect our company. The problem is many of us overlook the biggest “insurance” we should

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

be investing our time and money in from the beginning. The “insurance” provided by creating a thriving business. What does it mean to create a thriving business?

The fi

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

rst step to creating a thriving business is preparing an operational manual that will ensure that your business can survive any hurdle including business growth, owner a

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

Combination pro

bsenteeism and even owner death. Most business owners never stop to consider what might happen if they were injured, sick or worse. By taking a precautionary role in you

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

r business and considering things such as: “What if it happened to me?”; “What if my spouse, child or parent was sick tomorrow – could I dedicate the time to their recov

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

ery?”

These are all things we think we won’t have to worry about, but what if? Step back for a minute and think about how your business would change if you needed to ta

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

ke the time to dedicate to a personal problem. Perhaps in the short term it wouldn’t change much, but what about if you needed to step back for an extended period of tim

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

e? What would happen then?

The success of many of today’s small businesses hinges on the expertise and skills of the owner. What happens to the business though should t

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

he owner become ill or die? In many cases a family member steps in out of a feeling of obligation, but often they lack the skills necessary to allow the business to trul

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

Following aspects would a

y thrive. They don’t have the same dedication, determination or passion to see the business succeed as you did. In many cases, a promise to maintain a family business is

dd to the challenges in developing combination products:

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

made with the thought of “I won’t ever have to worry about that” in the back of the family member’s mind. After all, no one thinks it will ever happen to them.

By crea

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

ting an operational manual that outlines every faucet of your business operations including pertinent company information and a full description of how daily tasks are c

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

arried out, your business could easily continue uninterrupted without fear things were not being handled in the same manner you, as business owner, would expect. Family

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

members could easily hire someone to handle the business operations with your Operations Manual with the confidence of knowing things were being handled as you would han

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

Professional from academic institutions, pharmaceutical industries, health care indust

dle them.

Step back for a minute and think about what it means for you to truly create a thriving business. Just like plants need essential tools to survive, so does yo

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

ur business. The ingredients may be different but providing them is no less important. Plants need water, sun and dirt in order to grow vigorously and healthily. Your bu

.

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

siness needs a successful team leader, a needed product or service and a plan in order to be successful and profitable. Most businesses only have two of those important

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

Companies that provide selfless information through particip

ingredients and are missing the most important ingredient. If you leave instructions for watering your plants, shouldn’t you leave instructions for running your 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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Starting up your own business can be an extremely daunting task. Getting it up and running is a huge gamble as if the business fails the loss to you is often high in terms of lost investment of your time and money. Twenty per cent of businesses fail in their first year, and an additional thirty per cent will fold before they reach three years old. Make sure you know what the biggest pit falls are so you can avoid your own business becoming part of this statistic.

At the Federal Trade Commission we have seen attorneys who suffer from the vice of buggery get promoted to higher and more important international divisions. Now then, are these attorneys who have personal sexual problems and are breaking the laws of sodomy not wanted in the main group of Federal Trade Commission Employees?

Negotiating is small group management challenge. The group is dysfunctional at the start. Their are conflicting goals and objectives. You can establish an informal leadership role if you are able to establish a common goal for the collective group. This is not as hard as it sounds.

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