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As a change leader, if you’re worth your salt, you’ll have the big picture. Usually change leaders focus too much on the big picture at the expense of the business o

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

f their organizations. The ‘big picture’ I am talking about is you know why you’re changing what you are, you know how, what, when and everything there is to know ab

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

Examples of combination products may in

out the work at hand.

Now that we’ve established you’re in the ‘know’ as they say, it’s important that you keep everything you’re doing in perspective, top to botto

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

m. Now you say, “Ed, what does that mean?” It’s pretty simple really, it means you keep your feet on the ground and don’t get like one lady I knew who was leading 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

large change project, and the implementation of SAP in a new company established based on several mergers.

In her case, when I questioned her as to how much involve

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

Combination pro

ent she had with the field folks in designing the future, as she called it, she proudly told me none, “Ed, we are designing the future, the past doesn’t matter.” Wel

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

l, that may be true but you better know just how big the leap from yesterday to today is before you step off that cliff of change.

The primary thing you the change

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

leader must keep in perspective are that from your vantage point in that higher helicopter you’re riding is very different than the one of your grunt walking down on

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

the ground. What looks like a small change to you may be a giant change when you’re down there climbing the mountain of daily activity, just trying to stay current

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

with your job as it is today.

Try to visualize a gearbox in a big Caterpillar tractor. Imagine you are looking at it from the side and it is a pyramid shape, with b

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

g gears on top and descending to the bottom they become smaller and there are more of them. Now imagine that you are that big gear on top and the workers in your org

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

Following aspects would a

anization are those tiny gears at the bottom.

When you move your gear a little bit it’s no big deal, small movement, small change. But if you are that guy on the bo

dd to the challenges in developing combination products:

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

ttom, that row of tiny gears, you are spinning around like a top your kid just sent spinning. What appears to be a little change to you is a big change down at the b

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

ottom of your organization. To not be aware of or worst, to ignore that perspective will be fatal to your change efforts. It’s a pretty simple matter.

And this simp

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

le matter doesn’t come naturally. Even when you ‘get it’ you’re going to have trouble getting the other ‘big gears’ to get on board. There is a propensity to confuse

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

‘dictating expected behavior’ with real leadership. Many so called leaders like to say, “Oh, they can do it, it’s not that much additional work.” The problem is that

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

Professional from academic institutions, pharmaceutical industries, health care indust

if they don’t work to get the right perspective and know the real work of their organization, top to bottom, they just overload the people and results suffer.

When

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

results suffer who do they blame? They blame the people when it all started with them anyway. You don’t want to be that kind of change leader, you want to have the

.

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

right perspective and deliver the right results, to do that you need perspective. You need to insure that as the big gear at the top you realize when you make a chan

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

Companies that provide selfless information through particip

ge the little gears at the bottom are sent spinning. Be in tune and be a real change leader and the people will follow you as no one else. It’s all about perspective

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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