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Digg It - Tales from the Corporate Frontlines: The Organizational Structure of Our Growing Business
This article relates to the organizational structure competency, commonly evaluated in employee satisfaction surveys. It shows how structural concerns can affec
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
t the typical employee workday, as well as feelings towards your organization's management hierarchy and reporting structure. A healthy organizational structure
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
is one that arranges the activities of the enterprise in such a way that they contribute to the goals of the organization. Specifically, this competency looks t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
see if your employees clearly understand who they report to, as well as measure their sense of accountability to the organization. Evaluating this competency c
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
an be especially useful if your organization has recently experienced an organizational restructuring or might be considering one in the future.
This short sto
This short sto
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y, The Organizational Structure of our Growing Business, is part of AlphaMeasure's compilation, Tales From the Corporate Frontlines. It illustrates how business
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
growth affects every employee in the organization and lists some signals that a review and revision of organizational structure is necessary.
Anonymous Subm
Anonymous Subm
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
ission
My brother and I own and operate a mid sized manufacturing business that was passed down to us by our elderly uncles. Over the years, the business h
My brother and I own and operate a mid sized manufacturing business that was passed down to us by our elderly uncles. Over the years, the business h
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s experienced significant growth. The workforce alone has doubled since we added four new production lines just a few years ago.
At that time, we hired a group
At that time, we hired a group
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
of consultants to help us analyze and optimize the flow of work through the facility. The new processes and employees were integrated quite easily, and the prod
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ction areas of the plant ran smoothly.
Looking back, we see now that more attention should have been focused on the fulfillment and shipping areas of the busin
Looking back, we see now that more attention should have been focused on the fulfillment and shipping areas of the busin
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ess, as well as the HR and office functions. Several signs have appeared over the past year or so to tell us that we need to seriously consider rearranging our
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rganizational structure:
* Morale in the above areas has deteriorated measurably.
* Paperwork, reporting, forms and correspondence are often late and inco
* Morale in the above areas has deteriorated measurably.
* Paperwork, reporting, forms and correspondence are often late and inco
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
plete.
* Turnover rates in the affected departments are rising.
* Certain areas are often severely understaffed, especially during popular vacation an
* Turnover rates in the affected departments are rising.
* Certain areas are often severely understaffed, especially during popular vacation an
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d holiday periods.
* The reporting structures in these areas have become confusing, some employees express concern about vague accountability.
Although pr
* The reporting structures in these areas have become confusing, some employees express concern about vague accountability.
Although pr
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 combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ductivity in our shop area remains high, it does appear to be limited by the dysfunctions occurring in other integral areas of the business. We decided that now
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
is the time to conduct a thorough evaluation of our organizational structure and develop a plan to adapt and change it to more closely fit the needs of our grow
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ing business.
If we need outside help, we'll engage it. But the time has definitely come to address the effects of expansion on our entire organization and act
If we need outside help, we'll engage it. But the time has definitely come to address the effects of expansion on our entire organization and act
.
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
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
accordingly to preserve and grow the business we've inherited. It's more than just a business to us---it's a family tradition.
© 2005 AlphaMeasure, Inc.
© 2005 AlphaMeasure, Inc.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
- All Rights Reserved
This article may be reprinted, provided it is published in its entirety, includes the author bio information, and all links remain active
This article may be reprinted, provided it is published in its entirety, includes the author bio information, and all links remain active
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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