Digg It - Business

This article relates to the Senior/Top Level management of an organization, and how a huge vision of directional change translates into the day-to-day operation of the company. AlphaMe

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

asure defines senior management as the team of individuals at the highest level who have the day-to-day responsibilities of operating the organization. For many employees, this compete

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

Examples of combination products may in

ncy will target the managers occupying positions above their immediate supervisors. This competency covers topics such as strategic leadership, corporate vision, and corporate directio

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

n. Evaluating this competency can be especially useful in understanding how much your workforce favors the present direction of the organization.

This short story, Senior Management 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

d Directional Change, is part of AlphaMeasure's compilation, Tales from the Corporate Frontlines. It illustrates how undertaking a drastic directional change within a company requires

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

Combination pro

planning, engagement, and honest evaluation by the top levels of management, those who are ultimately responsible for the implementation of the changes.

Anonymous Submission

W

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

hen a company decides to change direction in a major way to increase profits and change with the prevailing business climate, change often begins at the top. Our company decided to cha

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

nge its marketing strategy significantly, nearly two years ago. Our main product was extremely service oriented, so it made sense to focus marketing efforts on the Internet, rather tha

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

the time-honored methods of TV ads and heavy direct mail.

This meant strategic restructuring- nothing drastic at the worker level, or even at middle management. But at the top level,

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

there was a definite lack of expertise in the area of Internet marketing. Some on the executive team who were most responsible for day- to -day marketing operations not only disagreed

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

with the decision to change strategy; they were also extremely vocal about their reservations.

We waited patiently to see how the parent company executive team would handle the situa

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

Following aspects would a

tion. It was no surprise when the objectors were asked to leave. After their departure, responsibilities were restructured to give those in charge of the change maximum resources with

dd to the challenges in developing combination products:

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

hich to accomplish the task. As the work proceeded, streamlining eliminated various positions, and certain workers were given responsibility for projects quite unlike anything they'd w

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

orked on before. Some training was offered, but apparently not enough. After a few years, it became obvious that the vision for change in marketing strategy was unsuccessful.

A team w

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

as assembled to investigate why the effort had failed. It was determined that top level management simply did not have the in depth knowledge and expertise in Internet marketing that w

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

as required. The company had removed the workers that were deemed non-essential to the plan, but this was not enough. Top management had not pressed hard enough to properly train those

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

Professional from academic institutions, pharmaceutical industries, health care indust

left to handle the transition. Expecting middle management and below to know and handle what the top level did not had deeply wounded the entire transition effort. Our investigation te

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

am determined that there was a genuine lack of experience and recommended intense training and education efforts as well as the hiring of highly experienced personnel in key areas. 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

se recommendations were followed, but not before our company learned a tough lesson about top management's role in turning a broad vision for change into day to day reality.

© 2005

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

Companies that provide selfless information through particip

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/24229/diggit-Tales-from-the-Corporate-Frontlines-Senior-Management-and-Directional-Change.html">Tales from the Corporate Frontlines: Senior Management and Directional Change</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/24229/diggit-Tales-from-the-Corporate-Frontlines-Senior-Management-and-Directional-Change.html]Tales from the Corporate Frontlines: Senior Management and Directional Change[/url]

Can brown paper be used to protect the outside of a box for shipping via UPS or the Post Office? See why brown paper should never be used on the outside of a shipping box.

There are a number of great ways to promote your online business offline. Combining offline advertising with your online presence will create momentum and increase your profits. There are a number of ways to promote your business offline.

Many feel that once an entrepreneur has gotten a business up and going, they are bored by operating the business and ready to move on to their next startup challenge. In fact, the proof of the entrepreneur's mettle is in demonstrating that the plan for the business was sound, and that the strategy was executable.

Tags

Links

Digg It - Tales from the Corporate Frontlines: Senior Management and Directional Change

Related Articles: