Main Subject - Business

When you’re setting about to launch a major change effort in your organization there are many things you must do but none are bigger than the one key ingredient to drivi

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

ng change in any organization of any size. What is it you say? Let me tell you a brief story.

One time awhile back I was having dinner with the CEO of a $500 million te

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

Examples of combination products may in

h company. We were discussing the changes he was trying to drive and how I might help. He went in to great detail all the things he was doing and how if he could sustain

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

the efforts it would change the company. Then he turned and asked, “People just don’t get behind it. What is the key to driving these changes?”

We all know that is the

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

uestion of the century. I turned and said, “You!”

He was puzzled as all leaders are when confronted with the reality that what they want to happened and what does happe

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

Combination pro

are too often two very different things. As you can imagine the CEO was shocked and more than intrigued. I told him the one key fundamental truth of change. If the high

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

st ranking person, the one over all the parts of the organization impacted by the changes, blinks during the change effort it will fail.

What I explained to him was tha

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

his Lieutenants, his direct reports, were smiling to his face and going out preaching change to anyone but their own organizations. His sales VP was the worst. Everyone

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

else needed to change but by gummy his organization ‘always delivered’ and didn’t need all this stuff. Oh he told the CEO, his buddy by the way, that he was playing the

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

hange game but his actions proved different.

I told the CEO that when driving change you have to follow a simple process. If you are the Big Kahuna in charge of the are

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

s of the organization being changed then you need to follow these steps …

1. Get real about what you want to accomplish with the change.

2. Count the cost both financi

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

Following aspects would a

lly and with your people and only then decide to make the changes. Once you know the cost then you apply the nomoreBS philosophy and look in the mirror and seriously dec

dd to the challenges in developing combination products:

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

de whether you are willing to pay the price. If you are then commission the work.

3. Commission the work after deciding the hard part, number two above.

In the case of

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

this CEO he had already embarked on his change journey. His VP of Sales was a major roadblock to the change effort. I told him that if he was serious about the changes t

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

en he’d have to confront his sales guy and friend. Ideally you would make this decision ahead of time, before investing millions in change.

You see the decision you hav

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

to make if you are the key leader of change is what to do if my key people resist. You have to decide, that after all due diligence, if my best person stands in the way

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

Professional from academic institutions, pharmaceutical industries, health care indust

will I terminate them? If you are unwilling to do that then don’t embark on this change effort. You will fail guaranteed. More change projects fail, not from middle mana

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

ement dragging their feet, but from the senior team being duplicitous and lying to the big guy. It happens all over the place and we see it everyday.

When you decide to

.

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

launch your next big change effort, make sure you have considered the cost … not just he financial cost but the people cost. If you are unwilling to pay it then save you

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

Companies that provide selfless information through particip

money, the aggravation and stay like you are today. You’ll be far better off. Sometimes the valor of your decisions is found in what you don’t do as much as what you do

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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Maybe the reason you're not reaching your audience is because you know too much about your subject! Find a sympathetic ignoramus, or hire one, to ask the dumb questions that you forget about, but that are foremost in the minds of your prospects, customers, and employees. Preaching to the choir is fun and easy, but learning how to talk to those who are ignorant about your products and services is a much more powerful approach.

The culture of a company affects how employees will accept the Six Sigma methodology. This article goes into detail to help you make the implementation go smoothly.

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