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Those founding or running businesses have a great deal more to consider than the bottom line, the profit margin, or the availability of products or employees. The public has lost its confidence in America’s businesses, and that trust will be very difficult for many

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

companies to reestablish. Every day the papers’ headline the latest example of graft, greed, dishonesty, and out-and-out corruption and point the finger at another of the companies – many of whom are names that people have previously respected or even revered. Unf

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

Examples of combination products may in

ortunately, those who caused the problem for their companies and their customers at the same time caused problems for all of America’s businesses and customers.

Then when we add on the other problems that people have identified – unanswered phones, phone calls that

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

are not returned, promises that are not honored, warranties that have no value, guarantees that aren’t honored, quality and service that is minimal or non-existent, business owners face still another problem. These problems may well be the reasons why people turn to

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

the net to buy, sell, and interact. It is, at least, one of the contributing factors in the rapid growth of eCommerce and the eroding faith in America’s corporate world.

A corporation’s core values are defined as those beliefs that are the foundation of the compan

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

Combination pro

y. They are the principles and standards upon which the organization intends to build and be known. Values such as honesty, fairness and respect for all individuals are intended to shape the behavior of every person involved in the organization, and these standards a

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

re intended to apply along the entire spectrum of the company from the top of the corporate ladder to the least paid member of the staff. When such is not the case, we find cases such as those that made headlines in 2003 and 2004 – executives using corporate funds f

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

or their own personal use, huge sums being paid to executives in the guise of varied benefit packages, and the out-and-out theft of company funds or the transfer of funds into accounts for which they were not earmarked.

Core values should not be confused with rules

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

or employment policies, nor are they the regulations which are often found in the employee handbook. Those are the do’s and don’ts which everyone is supposed to follow, but those are not the values by which they are to operate. Besides, most employee handbooks ar

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 not only cumbersome, they are confusing. They try to cover every situation and every operational policy, and the result is that most of the employees don’t even bother to read the entire handbook much less learn its content even in those areas where it is legally i

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

llogical not to do so (e.g., harassment). However, there are always those who do devour each word in an attempt to find ways to “beat the system.” Whatever the situation, few will turn to the company’s handbook as a means of identifying the values by which the orga

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

Following aspects would a

nization wishes to operate so that they can tailor their own behaviors accordingly.

In addition to the functional “turnoff” of the manual itself is the fact that, in many instances, the excessive rules and regulations are paralyzing to managers and supervisors who q

dd to the challenges in developing combination products:

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

uickly learn that problems can result when one tries to make sound and logical decisions about conduct, customer service complaints, responsibilities and regulations while adhering to the data in the employee handbook. Does that mean that there is no place for such

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

handbooks? Not at all, but it is important to realize that they are a means of laying out operational procedures and regulations which in many instances are necessary if the company is to stay within legal boundaries. Rules and regulations are not the foundation up

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

on which a company is built. To think so would be as ridiculous as confusing the role of the Constitution with the laws that legislators have drafted over the years. Strict adherence to those rule books often limits or paralyzes any attempt to hold effective discus

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

sions between managers and employees regarding needed and desirable behaviors and/or conduct. Yet, such discussions could be used to determine the most effective and sound resolutions to noted problems. However, if the corporation’s core values were used as the bas

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

Professional from academic institutions, pharmaceutical industries, health care indust

is for an interactive analysis of those same factors, the result would quite likely be a unique solution that would stand up well in relation to those core values.

It would be a good idea for those in business to read Jim Collin’s book, From Good to Great, since it

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

lays out a clear road map to greatness if companies will take the time and effort to follow the road to success. A company’s core values can be used to establish an organization's general attitude and approach to business ethics and morality. They go far beyond ope

.

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

rational rules, and there are no simple interpretations that can be orchestrated by a referee. Instead, companies must be able to solve the problems that are encountered by using the framework of those values to establish the corporate foundation. If this concept i

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

Companies that provide selfless information through particip

s put in place, the problems being faced now – lack of trust, jail time for corporate executives who breach those values, whistle blowers, and a breakdown in both communication and credibility – will disappear or at least be minimized.

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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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