Digg It - Business

"If we lived in a perfect world, there would not be a need for managers." - Bryce's Law

"Surround yourself with the best people you can find, delegate authority, and don't interfere." - Ronald Reagan (1986)

When the American colonies were forming a government in the 18th centu

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

ry, there was a fleeting notion that George Washington should become King with absolute power. Instead, our founding fathers opted for a democratic society where officials were elected by the people. The intent was to give the individual citizen a means to participate in the running of the gove

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

Examples of combination products may in

nment. This was a wise decision and has served America well for over 225 years. By being included in the process, people align their loyalties to the government and country, and are quick to come to its defense in times of national emergency. Involving the individual is a simple gesture that h

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

s had long range positive effects on our country.

It is an interesting dichotomy that whereas our country involves the individual, most of our other institutions do not. I have been fortunate to have traveled the world and have seen many different types of companies, from large to small, and in

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

just about every field of endeavor imaginable. Most are run top-down with a benevolent (or maybe not so benevolent) dictator at the helm. Assignments, estimates and schedules are pushed down the corporate chain with little regard for the individual employee.

Over the years there has been a lo

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

Combination pro

of discussion about Theories X, Y, and Z in management; whereas "X" is autocratic, "Y" is more of a "carrot and stick" mentality and "Z" promotes individual participation. Remarkably, despite the many years of promoting the rights of the worker, today we primarily live in a Theory X world. Emp

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

oyees are told what to do and when to do it, without any interest in their input. Today, this is commonly referred to as "micromanagement." Under this approach, although the work will eventually get done, there is no loyalty to the company by the employee, mistakes are made and quality suffers

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 productivity declines since there is no personal sense of urgency by the employee. In other words, the company works, but not like a well-oiled machine.

More recently, I have noticed this same phenomenon occurring in non-profit volunteer organizations, such as homeowner associations, clubs

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

school organizations, sports associations, even church groups. The people that run these groups may have the best intentions, but rarely do they know how to actually manage. Sadly, some people get involved with such organizations to satisfy a petty power trip they are on. Consequently, they h

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

ve little regard for organization and adherence to policies and rules. Instead, they try to micromanage everything. People, particularly volunteers, have a natural aversion to micromanagement and quickly lose interest in their work.

Let us always remember that the word "management" begins with

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

"man" for a purpose: it refers to how we interact with people and, as such, it is not a clerical or administrative function, but, rather, a people function; how to work with the human being, a very challenging task considering you are dealing with human beings who can be emotional, irrational, an

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

Following aspects would a

d just plain "thick." There is a countless number of books on the subject of "management" alone. But for our purposes, perhaps the best way to think of "management" is simply "getting people to do what you want, when you want it, and how you want it." If we lived in a perfect world, th

dd to the challenges in developing combination products:

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

re would not be a need for managers; people would know what to do, and projects would be executed on time and within cost. However, as we all know, we live in an imperfect world. People do make mistakes and problems arise, hence, the need for "managers", people charged with assigning and direct

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

ng the work of others. Managers are in the business of solving problems; people problems!

Some of the most productive organizations are those where management succeeded in getting the individual workers involved with the running of the company. Sure, management is still in control, but they ha

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

e stimulated employee interests by encouraging their participation and feedback. Management still has some top-down responsibilities, including:

1. Delegate - prioritize and assign tasks to qualified employees.

2. Control work environment - minimize staff interferences and provide a suitable

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

workplace to operate with the proper tools to perform the work.

3. Review progress - study employee reports and take corrective action where necessary.

Individual employees have bottom-up responsibilities to management:

1. Participate in the planning process - review work specifications and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ive feedback; estimate amount of time to perform an assignment, assist in the calculation of work schedules with management.

2. Perform work within time and costs constraints.

3. Report activities to management - including the use of time, interferences, and possible delays.

In this bottom-u

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

approach, employees are treated as professionals and are expected to act as such in return. This results in far less supervision as found in micromanagement. Employees are delegated responsibility, supervise their own activities, and report to management on progress. This approach will work

.

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

in any business, be it a corporation or non-profit volunteer organization. There is only one catch to this approach: some people resist assuming responsibility for their actions and prefer to have someone else tell them what to do; thereby when something goes awry, they can blame the other perso

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

Companies that provide selfless information through particip

for the snafu. This type of person is more suited for a dictator type of organization where they can continue to grouse about management, yet do nothing to help correct the problem. Aside from this, the benefits of the bottom-up approach far outweigh the negatives. It is simple and it works

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.diggit.org.ua/article/22718/diggit-Managing-from-the-BottomUp.html">Managing from the Bottom-Up</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/22718/diggit-Managing-from-the-BottomUp.html]Managing from the Bottom-Up[/url]

This literally can be the most profitable thing you'll ever do for your business and that is to understand exploiting the actual value of your customer. It's been called the Marginal Net Worth and th...

Winston Churchill’s Famous War Cry Is Fully Applicable for Today’s Entrepreneurs Arguably, the courage and moral leadership provided to the western world by Winston Churchill was the key instrument essential to keeping World War 2 from ending early, and ever so badly for the cause of freedom. The ability to use words as a tool for effecting an outcome was never so vividly displayed, before or since. A demoralized and near beaten people took heart, did not quit in the face of overwhelming losses and turned an imminent route into ultimate victory. This lesson is vital for entrepreneurs to apply to their struggle to gain traction and successfully compete in contemporary markets roiled with competition.

It's no coincidence that powerful people are very influential. One universal characteristic of influential people is that they don't struggle to get others to do things or to listen to their point of view - they just seem to make things happen. Influence is about changing the behavior of others; in other words, getting them to do what you want them to do in the absence of authority. To understand how to develop more influence, you must first become a bit of a student of human behavior, social science, and motivation.

Tags

Links

Digg It - Managing from the Bottom-Up

Related Articles: