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Corporate Culture is one of the ingredients every corporation must have, says the book and sure enough our corporations are relentlessly working on it. But with all due respect, do the people in charge truly know the

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

crucial importance of it? Do they know what this really means? Corporate Culture is a top priority in any corporation and should not be delegated!

Many corporations are spending a lot of money to come up with a st

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

Examples of combination products may in

atement about their Corporate Culture, which then of course is valid for and must be lived up by each and every employee! This approach contains already failure and here is why:

• Do you know whether your idea of yo

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

r Corporate Culture is in alignment with your employees’ feelings and beliefs?
• Did you talk to your employees about it and did you ask for their opinion?
• Does your corporation have a dream, a vision whe

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

re everybody can buy in?
• Do you truly believe in your Corporate Culture or is it just PR for you?
• Does your Leadership Team believe it?

And those are only a few questions you should ask.

Many corp

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

Combination pro

orations not understanding Corporate Culture have literally a “Success-Cancellation-System” in place and they don’t even realize it! If your Corporate Culture is in total misalignment with your employees your company

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

is doomed to fail in the long run.

During my career I saw thousands of employed people living in fear of their bosses, trying to hide and do business as usual. In such a climate success cannot grow and tons of money

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

are wasted and lost. Yet, and this is especially true for large organizations, all these little profit leaks are just overlooked, because nobody in Management pays attention! “I am too busy for it!” was the response

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

I very often got when asking managers in charge.

How could this be changed for the better? I am sure that true leaders will certainly pursue every opportunity for growth and I am sure also that these leaders do hav

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

a dream! And this is how it starts, with a dream everybody in your corporation is inspired by!

Now if you are poised to change things around in your corporation for the better here is what you must do:

You start p

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

erforming a “state-of-the-company” – review since you need a solid base to start from. Look especially for the personal values of your employees. What are they and why do they keep them high? What kind of culture wou

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

Following aspects would a

ld they like to have? If you ask them for their personal dreams they might not recall, but I assure you they have personal dreams deep down in their sub-consciousness, waiting to be released. They need to be invited

dd to the challenges in developing combination products:

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

o share their dreams and hopes!

Invite all of your employees to participate in this process showing them your appreciation and your trust in their abilities. Each of them has so much to contribute to the common goal

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

, imagine where your corporation could be in ten years from now, when everybody shares the same values, shares the same culture and is living it every minute!

Even if you are still skeptic just keep on reading, beca

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

use there is such a power in human beings. Do you understand that integrating them into this crucial process of defining a Corporate Culture will have the effect of providing them with Personal Growth? And do you und

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

rstand the fact that all of us including you can only grow our success in the real world to the degree we grow personally?

Integration of all your employees in your Corporate Culture is so important that I cannot st

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

Professional from academic institutions, pharmaceutical industries, health care indust

ress it enough. But you must also integrate the different aspects of human beings and their development. I am talking about body, mind and spirit and I am talking about an integral structure with Truthfulness (like S

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

incerity, Integrity, Trustworthiness…), Reality (like Facts, Structure, Correspondence…), Justness (like Cultural Fit, Mutual Understanding, Rightness…), and Functional Fit (like Systems, Processes, Social Mesh…) as

.

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

ts quadrants.

If you are willing and ready to shape the “Corporation of Tomorrow” taking advantage of the Human Dimension and its power right at your hands, you will soon reach the critical mass to grow your corpora

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

Companies that provide selfless information through particip

tion beyond your current imagination!

I have to tell you however that you might need the help of somebody who fully understands the matter and you trust.

Walter H. Groth
Institute for Life and Career Transitio

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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