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All the talk today is about managing change in organizations. Leaders talk about it like it is really something one can ‘manage’. Everywhere I go I see consulting practices with change leaders and much of

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

what comes out the other end, is only slightly better than the snake oil salesmen of time gone by. So what is up with managing change?

The first thing to realize is that you cannot manage change you can

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

Examples of combination products may in

only preferably lead or manage people. There is no such thing as organizational change, there is only people change. Organizations are large groups of people, yes organized in a particular way to accompli

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

sh a particular task, but they are still people. Right here is where most organizations, especially large ones, stumble when it comes to change.

Imagine with me you are looking straight at an iceberg, a

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

uge iceberg. If you could look straight at it you’d see a small tip on top, above the water and a huge bottom, probably at least three to four times the size of what is floating above the water. Imagine t

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

Combination pro

is is your organization, it look a little like an org chart doesn’t it? What if we laid an organization chart over top of what you see of the iceberg?

If you did you’d see the CEO at the top sticking out

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

of the water and his Lieutenants, the senior team as they say, sitting right out there with him. Under them around water level is where you start dropping in to middle management, according to the expert

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

, the scourge of change management. Stick with me now and keep looking at the iceberg with the org chart overlay. Under the water level is everyone else in the organization.

The problem in today’s organi

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

ations is the gap that exists between the CEO and the work taking place down at the bottom of the iceberg. The gap has never been greater. Most CEO’s, while personally bright, articulate and politically s

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

avvy, don’t have a clue what is happening at the bottom of the iceberg. Not a single clue. And what’s worse is they don’t care. Herein is the issue of managing change, the incredible gap today between wor

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

er and boss man at the top.

There of course is the old adage of managing things and leading people and while it sounds trite there is truth to it. When you have a CEO come in like the one did at Home Dep

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

Following aspects would a

t and wreak havoc on the organization, destroy all semblance of customer service and leave with over $250 million you see the problem. He said all along he was managing change. He wasn’t managing change h

dd to the challenges in developing combination products:

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

e was changing people to his way of doing business or else. Worked for him, he left an even richer man than when he came. And the gap, the organizational iceberg as I call it, has never been greater.

You

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

see using the iceberg again, there is a way the organization says it does things, and then there is the way they really do things. The way they say they do things is above the line and the way they really

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

do things is below the line. In well run organizations the gap between how you say you do it and how you really do it is small because the leaders, those above the water line, communicate, that means list

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

en as well as talk, with those below the line. In most organizations the leaders make up change plans and simply expect their ‘orders’ to be followed. That is not going to happen in today’s world. To man

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

Professional from academic institutions, pharmaceutical industries, health care indust

ge change effectively leaders must be in tune with their organizations and not look upon their people as things, which in most organizations today, that is how they see them. Oh they have their policy man

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

als that say otherwise, but those manuals are high and dry, well out of the water and the bottom of the iceberg.

If you want to manage change in your organization you’re going to have to get off the top

.

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

of your iceberg and get your feet wet and understand the work being done at the customer level everyday. You’re going to have to insure that your ‘senior team’ does the same. You must insure you know what

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

Companies that provide selfless information through particip

is going on, really going on in your organization and that you aren’t just getting the fine treatment from your so called team.

To manage change you’ll have to lead, perhaps for the first time.

Ed Kugle

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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