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Many small businesses successes today are the result of the actions of the previous generation. Yet, many second generation businesses owners fail to capitalize on the efforts of their

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

ancestors. According to the US Small Business Administration, small business failure for family owned businesses is two out of three.

From my experiences as a business coach and an

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

Examples of combination products may in

mployee of a first generation business owner, this failure is probably much more about people failure than knowledge failure. These 7 mistakes may help you avoid the failure that many

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

econd business owners experience and achieve the business success that you desire.

Ivory Tower Mentality – Knowledge Failure

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

s had the ability to send the next generation to college to learn improved business skills. Unfortunately, many of these professors in business schools never worked in the real world,

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

Combination pro

but rather pontificated what they believe should be instead of what is is.

External Customers Relationships transfer – People Failure

First generation business owners knew 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

at their businesses needed loyal customers and took the time to develop these relationships. Second generation business owners believe that the relationships their fathers or mothers

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

had would automatically transfer to them.

Source of Employee Loyalty – People Failure

The loyalty of many employees within family businesses began with the first management

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

eam and not necessarily with the company. When the second generation came in, they believe that the employees loyalty was to the company.

No Plan – Knowledge and People Failure

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

i>

The success of many small businesses came from the entrepreneurial spirit and not necessarily from having a plan. With no plan to hand over, the next generation continues to conduc

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

business without a solid written business plan. In today's market place any business that does not have both a strategic pl

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

Following aspects would a

an for establishing a new vision and a strategic action plan will have great difficulty in surviving less along thriving.

Performance Savvy – People Failure

Since busine

dd to the challenges in developing combination products:

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

ses are comprised of people, managing people takes an understanding of what motivates people to do their very best. For example, when the current management team cries poverty and can

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

t afford raises for the employees, but then purchases brand new expensive cars, their actions have a negative impact on the employees. Employees don’t mind new cars, but do mind luxury

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

cars.

Assumptions – Knowledge and People Failure

Today’s second and third generation business owners carry numerous assumptions that were true for their parents or grandpar

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

nts, but not necessarily true today. Assumptions include:

Market place
What motivates employees
How much time the business demands
Owner entit

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

Professional from academic institutions, pharmaceutical industries, health care indust

ements

Values – People Failure

Many first generation business owners operated by core values where a man was as good as his or her word. Handshakes instead of f

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

ormal contracts had much greater value. Today’s business owners appear not to have the same deep seated values of their ancestors. The result of the lack of values can be summed up in

.

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

ne word – greed.

So if you truly want the efforts of the previous generation to be sustainable, then look to see if you as a second generation business owner are making any of

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

Companies that provide selfless information through particip

hese mistakes. Your small business success depends on the actions you take right now so that you are not 2 of those 3 family owned businesses that experience complete business failure

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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Memphis, Tennessee, is a major manufacturing center of auto and truck parts, textiles, and heating equipment and is the home of several Fortune 500 companies. It has been acknowledged as one of the 50 best metros to start and grow businesses.

Lawyers always get so angry when they hear someone is getting legal advice from anyone other than a lawyer. And one would guess that stands to reason because many get upwards of $150 to $300 for giving people advice.

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