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The turbulence that welcomed in the new millennium caused tangible paradigm shifts in corporate America with relation to security, economics and ethics. And while m

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

any companies were purging thousands of employees in order to balance their books in an instantly depressed economy, others were being exposed for other, more egreg

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

Examples of combination products may in

ious acts of greed, dishonesty and criminality. This was a dark time for corporate America.

But, with all tragedy and chaos comes renewal, and even opportunity. Co

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

rporations who are brave, willing and able-minded to lead from the ashes can take up a prized position in the ranks of the trustworthy, and benefit from the spoils,

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

counted in new revenue.

Where do you start? If your company is really good at what they do already, then it will be a relatively simple process. If you have a no

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

Combination pro

t-so-glowing reputation in your industry (you know who you are), then the journey will take a bit more effort and time – look at it this way, you have even more to

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

gain. I strongly encourage you to work extra hard to clean up that reputation. No time is better than the present. Furthermore, the marketing initiatives related to

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

corporate culture marketing can be initiated the moment you begin that process.

Areas of Focus The first step is to document your current position. Hopefully, you

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

’ve already completed this step. This entails identifying your baseline in several areas of excellence, such as:

A. delivery of goods and services

B. quality rati

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

ngs

C. accuracy of orders or services

D. customer service ratings

E. employee satisfaction

F. institutional values (i.e., excellence, quality, integrity, honest

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

y, corporate citizenship, etc.)

Then, identify external recognitions of your company for similar measures of excellence. This includes awards, nominations for awar

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

Following aspects would a

ds, and individual awards (usually C-level recognition). Also, make a list of all charitable work that is sponsored by your organization, then a list of charitable

dd to the challenges in developing combination products:

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

activities in which you’re interested.

Gap Analysis We also recommend that you conduct a gap analysis related to these 6 areas of focus. This is done by surveying

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

a mix of key managers (see E and F below) with questions such as “How do customers perceive our ability to deliver goods/services” on a 1-10 scale, or very poor to

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

excellent. Then, simply survey the target customers directly (anonymously) on the same questions. For “E,” you’ll want to survey all employees and collect their res

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

ponse by business unit, division or group. For “F,” you’ll want to get internal and external surveys, including employees, partners, vendors, and customers. Insert

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

Professional from academic institutions, pharmaceutical industries, health care indust

the data into graphs that will allow you to see where significant gaps exist. The information this exercise presents is priceless, and should stimulate initiatives

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

to rectify the situation…fill the gaps.

Once you’ve completed these tasks, you will have sufficient information on which to establish and grow an “excellence” prog

.

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

ram.

I recommend you also read my article entitled Gain Competitive Advantage Through Corporate Culture Marketing, which will outline the steps involved in buildin

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

Companies that provide selfless information through particip

g your Corporate Culture Marketing Program.

If you are interested in initiating a CCM program immediately, please contact us at Danskin Creative Communication, Inc

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 greatest benefits of them all is that you finally can take charge of your life. This means that you can do whatever you want to do, whenever you want do it, and you don't have to worry about anyone dictating what do!

Ever wonder if Six Sigma has had positive impact on your employees? This article will show you how to find the answer by conducting a step-by-step employee assessment!

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