Main Subject - Business

Several decades ago, a passenger jet approached a Florida airport with the pilot and co-pilot struggling to fix what they thought was a malfunctioning landing gear. The landing-gear light was on, signaling that the gear was de

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

ployed; but both men did not hear it actually deploy.

As the men sought to understand whether they had a defective landing-gear light or a defective landing gear -- the co-pilot actually taking up a hatch and getting down into

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

Examples of combination products may in

the wheel well -- the aircraft kept losing altitude. Too late, a warning alarm sounded and the plane crash, killing all aboard.

Quite possibly that tragedy has subsequently saved many lives. For the pilot and co-pilot's actio

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

ns have been used in flight simulation training programs to demonstrate how NOT to troubleshoot problems in the cockpit.

The incident has become known as the Landing-gear Fix, a diligent attempt to solve the wrong problem. Of

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

course, they had a landing-gear problem on their hands. But unbeknownst to them, they faced a far more serious problem, a pending crash.

The Landing-gear Fix is a leadership lesson. In the quest to get results, many leaders

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

Combination pro

often focus on Landing-gear Fixes -- putting their time, resources and talents into solving wrong problems. In fact, it's been my experience working with thousands of leaders during the past 20 years that most leaders are eith

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

r working on the wrong problems or working on the right problems in the wrong ways.

In this issue, I'll give you a tool to avoid getting involved in a leadership Landing-gear Fix. It's a tool that will help you avoid wrong pr

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

oblems and focus on the right ones. It's called the 20/60/20 rule. And it will save you aggravation and help you avoid wasting time.

When you are leading a group of people of whatever size to get results, understand that rou

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

hly about 20 percent of the people are intractable; they won't do -- or at least won't want to do -- what is required. Another 20 percent will be your ardent cause leaders in getting it done. And 40 percent will be on the fen

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

ce.

How does this rule help you focus you on the right problem? For one thing, it gives you a template of where to put your time and resources.

I wish I had known about the 20/60/20 rule early in my leadership endeavors. In

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

he military and later in other venues, I often gave inordinate amount of attention to people at the intractable end. That people were upset with me and my leadership and the direction I wanted to take organizations upset me –

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

Following aspects would a

more than it should have.

I did not know that if you are not getting a portion of the people upset with you, you are not challenging them enough as a leader. I did not know that the anger of the people you lead is the door pr

dd to the challenges in developing combination products:

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

ze of leadership.

Apply the 20/60/20 rule to a project you undertook in the past. (Remember, those are not exact percentages but approximations.) Which category did you focus your time, attention, and resources on? Was it th

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

e right category to do so? What would you do differently? How might you have moved people from the intractable end to the highly motivated end? How did you deal with the people in the middle, the 60 percent? What category d

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

manded your best resources and efforts? What could you have done differently to improve your results?

What are the lessons you learned in applying the rule to a past project? List at least three specific ones.

Now apply the

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

20/60/20 rule to a present leadership effort. This rule is about saving you time, money, and resources and getting you more results to boot. There are several ways to use it. First, as a straight up template.

How might the

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

Professional from academic institutions, pharmaceutical industries, health care indust

essons you learned in applying the Rule to a past project now help you apply it to this present one?

Focus on one of the three categories. How will you expend your time and resources? It does not matter which category you fo

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

cus on. The importance of the rule is that you have the option. Without this rule, most leaders scatter their focus.

Don't get caught applying diligent solutions to the wrong problems. Apply the 20/60/20 Rule, and you'll fo

.

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

us on getting the right results in the right way at the right time.

2005 © The Filson Leadership Group, Inc. All rights reserved.

PERMISSION TO REPUBLISH: This article may be republished in newsletters and on web sites prov

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

Companies that provide selfless information through particip

ided attribution is provided to the author, and it appears with the included copyright, resource box and live web site link. Email notice of intent to publish is appreciated but not required: mail to: brent@actionleadership.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/24341/mainsubjects-The-206020-Rule-Of-Leadership-Dont-Go-Solving-The-Wrong-Problems.html">The 20/60/20 Rule Of Leadership. Don't Go Solving The Wrong Problems</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/24341/mainsubjects-The-206020-Rule-Of-Leadership-Dont-Go-Solving-The-Wrong-Problems.html]The 20/60/20 Rule Of Leadership. Don't Go Solving The Wrong Problems[/url]

Many believe that print advertising is giving way to online advertising and marketing. Danskin ponders this subject straight from his experience and intuition.

Too many women find themselves unprepared and incapable of supporting a family or themelves alone.

Delegation is seen as the key to being a good manager. You see yourself as getting work done through others if you delegate a lot. But this only applies to tasks. Much of today's work is mental: solving problems, thinking creatively. To get this type of work done through others you need to be a facilitator, someone who asks lots of questions.

Tags

Links

Main Subject - The 20/60/20 Rule Of Leadership. Don't Go Solving The Wrong Problems

Related Articles: