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What happens when you plug too many plugs into an outlet? People tend to do that when the pressure is on, like at Christmas. We all know what happens … there’s a meltdown in the ci

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

rcuits and best case the lights dim and worst case your place burns down. We all know that but why do so many so-called leaders do that to their people?

If I had a dollar for ever

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

Examples of combination products may in

time I saw organizational leaders during times of change, through task after task on top of people with full time jobs and brazenly announce “they can do more”. Well, if I had tha

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

t dollar for every time I’d be a wealthy man. Of course we all know the leaders at the top have the dollars and the folks down on the project are dieing a slow death trying to keep

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

up with the overload.

Real change leaders; and real leaders as well, don’t do the task overload routine. They are leaders and aren’t afraid to make the tough calls and decide wher

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

Combination pro

e to utilize their resources without blindly adding task after task to already overloaded people. I hear the naysayer’s out there saying, “come on Ed, you have to challenge your pe

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

ple, you’re soft”. Well, I’m a former Marine sniper and it’s now about being soft, it’s about real leadership.

What’s happening today doesn’t need to happen if leaders just got it

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

– and understood what they’re doing. What they’re doing is ignoring what pilots know, and that is task saturation. Military pilots especially will tell you about task saturation.

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

hen the pilot gets overloaded with ‘tasks’ they will in fact go done. I think the figures are 80% of all aircraft accidents, at least in the military, happen because of from what t

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

hey call task saturation.

Most of you probably know, but pilots, amateur and professional, use checklists before and during flights and even have practiced them for various emerge

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

cies. The purpose of a checklist is to make the work they do into a routine task. It is organized and they are trained to use the checklist to make sure they do not suffer from tas

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

Following aspects would a

saturation. That means that the pilot doesn’t get ‘saturated’ or overcome with too many tasks and take the plane down.

Well the same thing happens on change projects. Presidents,

dd to the challenges in developing combination products:

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

Vice Presidents, all the senior leaders want to be macho and issue their edicts from on high, mandating the troops just need to give 110%. That of course implies that you don’t ha

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

e a full time job now, so just suck it up and do all the new things this year long project implementation is going to require, plus your full time job. Leaders like this are leadin

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

g from a position of power and not as a leader with personal power.

When they lead in this way they also imply, or sometimes say, that those who don’t agree are a problem, they ar

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

soft and don’t want to take a stand. In the past eight years I have worked seven or eight large change projects for organizations, and in all but one, maybe two cases did the lead

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

Professional from academic institutions, pharmaceutical industries, health care indust

ers not confuse a power trip with leadership. They demand people take on more and more because they don’t want to make the hard calls on the budget. They want their cake and eat it

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

too. It doesn’t work.

People in organizations all over this country and across the world suffer from task saturation. The plane the CEO is riding is going down, it’s happening eve

.

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

rywhere, and all the while the Emperor sits on high demanding more from the change leaders and wondering why they are failing. It doesn’t have to be that way, that is, if you are a

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

Companies that provide selfless information through particip

real leader. Make sure you don’t overload your organizational circuits. Make sure you are well aware of task saturation. You can challenge people and not kill them at the same time

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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With all the furor over Simon Cowell’s apparent abuse of the disillusioned, most of the press seems

In managing your own homebusiness, you should take into consideration the liquidity of your business.

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