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All companies face the challenges of continuity, succession, and profitability, but those issues generally create unique planning and management problems--as well as opportuni

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

ties--for family owned businesses.

When relatives go into in business together, their individual aims, goals and life visions can impede otherwise sound business planning and

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

Examples of combination products may in

decision-making. Absent sound advance business planning, for example, managing day-to-day operations can create problems among some owners. For others, attrition rates among

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

non-family member employees is difficult, while for still others too much success too soon can cause problems if some owners are reluctant to reinvest profits back into the bu

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

siness.

Prudent business owners and professional practitioners wouldn’t open their doors without insuring against the risks of fire, theft or liability. Yet, the death, disab

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

Combination pro

ility or retirement of a business owner or key employee can put the business at even greater risk. With careful preparation, however, businesses that are so hard to build will

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

continue when the owner or key employee is no longer able to continue working.

Though essential, business succession planning—and the estate planning of which it is also a p

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

art--is often delayed by any number of other priorities. The trouble is, as with the purchase of personal life insurance, lack of effective succession plans can doom a busines

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

s.

Business succession issues are complex and emotional for all involved, especially, as is often the case, when conflicts exist among family members. Not surprisingly, when

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

relatives work closely together, emotions and greed often interfere with business decisions, and each succeeding generation will have its own ideas about taking the company fo

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

ward -- if indeed, it wants to keep the business operational at all. In the end, however, few things are more satisfying for family owned business owners than knowing they hav

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

Following aspects would a

e workable succession plan!

Another increasingly prevalent factor for family businesses is the number of daughters and granddaughters taking over these firms. By 2004, accord

dd to the challenges in developing combination products:

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

ing to a study conducted by MassMutual Financial Group and the Raymond Institute American Family Business Survey, woman-owned family businesses had jumped by 37% in the last f

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

ive years. What’s more, while successful transition has always been key to the ongoing success of family-owned businesses, as Baby Boomers begin retiring, the number of compan

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

ies facing business succession and personal estate planning crises will likewise increase: ready or not!

Affinity Groups

Family owned business should consider the value of a

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

ffinity groups whose members are a select team of key employees with ownership or other long-term interests in their firms’ on-going success. Affinity groups can review the op

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

Professional from academic institutions, pharmaceutical industries, health care indust

tions enjoyed by family businesses, and encourage management to pursue business succession and other types of planning with the firm’s financial adviser and an independent att

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

orney specializing in this field.

Business Succession Planning Options typically include:

* Buy-Sell Planning

* Key Person Insurance

* Business Overhead Expens

.

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

e Insurance

* Personal Life & Disability Insurance

* Estate Planning

Intergenerational succession planning is critical to the continuation of family owned businesse

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

Companies that provide selfless information through particip

s. As indicated earlier, the key to intergenerational planning involves a careful family assessment and a thorough management transition strategy before estate planning begins

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 idea of the Balance Scorecard (BSC) is to create feasible measurements that will give you a complete view of your company and that are linked to your general objectives as a company.

There are several national groups that provide support for unemployed workers. They have been quite successful in mitigating the emotional toll of layoff as well as having beneficial effects on job search. Forty Plus and local VA groups are among the best. If none are available, start your own!

Why You Need a USP and How To Create One For Your Business. A USP is an ultimate statement of benefit. It is free, easy to duplicate and communicate, and above all, tells your prospects what's in it for them if they do business with you. Be sure to take the time to properly develop a USP that will work for you, your business and your target market.

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