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At a business conference recently I got a powerful message about the power of authenticity. Paul Ray, coauthor of the best-selling book, The Cultural Creat

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

ives: How 50 Million People Are Changing the World, gave a compelling presentation about how small business can leverage their authenticity to achieve grea

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

Examples of combination products may in

er success.

Ray shared that if you own or work in a small, socially responsible business, you have a big advantage over the "big guys," the Fortune 500-ty

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

pe corporations. While not every big business is "bad" and not every small business is "good," the public does not, in general, place much trust in the big

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

guys. Enron, WorldCom, and Tyco are just a few examples of big companies that lost the trust of their employees, customers and communities.

I always feel

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

Combination pro

bit sad when a favorite company, like Ben & Jerry's or Celestial Seasonings, gets bought by the big guys. I believe the product and company culture will p

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

robably change.

When we're smaller, it's easier in our marketing with both customers and prospective customers to share who we really are. We can share ab

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

ut our staff, our processes, our materials and why we operate the way we do.

Authenticity, Ray said, is not so much about our actual products or services,

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

but rather it is mostly about the claims we make and the evidence that proves those claims. So be transparent, tell stories about how you treat your custo

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

ers and your employees. Share about what you do in your community and how you minimize the environmental footprint of your business. Your web site is a gre

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

t place to do this for almost no cost, because you can easily add pages.

You want to establish that you and your company are, in fact, good people to deal

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

Following aspects would a

with. We all want to be treated honestly and fairly. And we'll do repeat business with businesses that walk their talk, whose performance matches their cl

dd to the challenges in developing combination products:

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

ims.

For example, I interviewed Joseph Cincotta, of LineSync Architecture for my Be Real Revolution community. On his web site at http://www.linesync.com/

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

web/linesync1.html (Studio Profile - History) Cincotta tells us how his firm treats employees: "Employees enjoy setting their own hours, mid-week ski passe

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

, and a congenial working environment." That sounds like a lot better working conditions than at the huge architecture firms in New York.

Or take the exam

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

le of a client of mine who has staff profiles on his web site that share not only what each employee's duties are in the business, but some personal inform

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation about their families and hobbies. We learn that the office manager also is a mother, grandmother and huskie dog lover and the doctor's assistant is a

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

native of Western North Carolina (a rarity in this land of transplants!) who enjoys traveling, gardening, reading, and re-decorating houses. They become mo

.

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

re real (i.e. authentic) people to us.

With all the advertising hype of claims that don't pan out, it's refreshing to realize that being real can actually

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

Companies that provide selfless information through particip

help your business thrive. So go ahead and take one step today to be more authentic in your business or career. I think you'll be pleased with the response

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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