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Business Owner Burnout (BOB) is the most common reason for business owners to consider selling their businesses. Most owners do not have their businesses ready to sell when b

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

urnout has finally taken its toll. And business owners who do succumb to BOB usually take a significant financial loss.

How can you learn to protect yourself from the ravage

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

Examples of combination products may in

s of “BOB” Syndrome? The first step is to begin looking at your business in a completely different light. Your business is like a wheelbarrow: If you want it to go somewhere

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

you have to pick it up and push. But it takes energy to push a business. Physical, emotional and economic energy may be in short supply when they are needed most. What can b

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

e done to ensure an adequate supply of these essentials when they are most needed?

The secret may be found when we ask ourselves important questions about our own businesses

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

Combination pro

--long before we reach the burnout stage. For example:

• Is my business fiscally fit?
• Do I want to get more out of my business?
• Am I happy with what I earn fro

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

my business?
• Is there anything I can do to improve the performance of my business?
• Am I satisfied with my position in the business?
• Would anyone REALLY

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

be willing to BUY my business?
• If I needed to sell my business immediately, would I get what I want (or need) from its sale?

But what is the most important question y

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

ou should ask yourself? Asking tough questions about your own business is always hard. That’s because often we are afraid of the answers! Do you know what really the tough

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

st question is to ask? “Do I know HOW I am going to exit my business when the time comes?”

This is probably the most important question a business owner can ask of one’s se

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

lf. Why? Nobody knows exactly “when the time might come” for exiting their business. In a perfect world, you might get to choose the time of your exit. But in the real wo

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

Following aspects would a

rld, a large percentage of business owners experience a life changing event that will cause them to attempt to sell their business at a time NOT of their own choosing. In my

dd to the challenges in developing combination products:

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

rofession, I see this happen all too often. Have you thought about how you will exit your business? Here are a few of your exit choices:

1) Die at the business, and they c

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

arry you out feet first (or wheel you out in that wheelbarrow)
2) Close the doors and walk away with nothing
3) Begin gifting interests in the business to family o

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

r management
4) Recapitalize by bringing in new capital and personnel
5) Sell to the employees
6) An outright sale of the business

Hopefully, you won't choose

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

numbers 1 and 2.

So the question remains: Do you have a PLAN to successfully exit your business? If not, you should. In fact, YOUR business might be one of the most valuable

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

Professional from academic institutions, pharmaceutical industries, health care indust

assets you own. Have you documented the value of your business? Do you know the value of your business? If you were to sell today--would you get what you want--or need in or

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

der to carry on with your life?

If you are like most business owners, your business is not prepared for sale. That means that your business is not as valuable as it should b

.

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

. In fact, you could probably be earning 10% to 20% more from operating your business if you just knew how....

I have worked with business owners for more than 30 years. Aft

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

Companies that provide selfless information through particip

er observing what many business owners have done right, and what they have done wrong, I have written and accumulated many articles that you will find to be extremely helpful

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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