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E-Folder - The Development Of Organisations - Part 1
One of the main factors which affects the performance of individuals at all levels within an organisation is the way in which the organisation itself develops and changes in time. Such changes are often closely related to a company’s growth but not necessarily; developments can clearly take place in an organisation which is not increasing in size as such.
From analysis of the way in which many organisations have m
From analysis of the way in which many organisations have m
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
ade growth over the years, it is possible to build up a picture of a number of principles of development, which the normal organisation will follow as it develops.
These principles cannot be rigidly applied: every organisation is different, and different functions or areas of one company can be at different stages of development at one point in time. However, applied with flexibility, the principles are of value i
These principles cannot be rigidly applied: every organisation is different, and different functions or areas of one company can be at different stages of development at one point in time. However, applied with flexibility, the principles are of value i
; 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
n interpreting company problems and planning future policy.
Outline of Principles:
From its inception, an organisation ‘develops’ by way of several distinct ‘phases’. At a particular stage of development, its management style, internal structure and processes will follow a pattern, which will change as the company develops. The move from one phase to another is a natural but challenging process. As the company de
Outline of Principles:
From its inception, an organisation ‘develops’ by way of several distinct ‘phases’. At a particular stage of development, its management style, internal structure and processes will follow a pattern, which will change as the company develops. The move from one phase to another is a natural but challenging process. As the company de
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
velops, its original approach no longer copes effectively with the changing demands made upon it; the resulting problems in turn force the company eventually to alter its approach and thus move into the next phase of development.
Three main phases of development can be identified:-
o The Pioneering Phase (Phase 1)
o The Scientific Management Phase (Phase 2)
o The Integration Phase (Phase 3)
The Pioneering Phas
Three main phases of development can be identified:-
o The Pioneering Phase (Phase 1)
o The Scientific Management Phase (Phase 2)
o The Integration Phase (Phase 3)
The Pioneering Phas
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
:
Organisations are typically created by one or two people with an idea. They will identify a need for which they feel they can supply a solution (i.e. a new product or a service). They believe there are sufficient markets for the product to make a financial profit and that they have the capacity to create the product.
From this sometimes vague origin, the organisation begins. At its outset, all revolves around t
Organisations are typically created by one or two people with an idea. They will identify a need for which they feel they can supply a solution (i.e. a new product or a service). They believe there are sufficient markets for the product to make a financial profit and that they have the capacity to create the product.
From this sometimes vague origin, the organisation begins. At its outset, all revolves around t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
he individual or individuals with the original idea (the pioneers). They raise the necessary finance from personal resources; relations etc. create the initial market through friends and contacts and provide themselves with the technical and practical expertise necessary to put their idea into production.
As the idea takes hold, the pioneer(s) need to bring others into their organisation to share the load, initial
As the idea takes hold, the pioneer(s) need to bring others into their organisation to share the load, initial
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
ly on the production and clerical sides. The new entrant to the company is often given only a general picture of the duties; to a large extent they create their own role within an informal and flexible structure.
At its height, the following characteristics typify an organisation in the pioneering phase:-
Leadership from the Top:
All decisions are taken by the pioneer(s), who have the overall picture of the co
At its height, the following characteristics typify an organisation in the pioneering phase:-
Leadership from the Top:
All decisions are taken by the pioneer(s), who have the overall picture of the co
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
mpany. The leadership is autocratic (other employees are
expected to do what they are told) but respected and followed as the
expert on every aspect of the business. Everyone in the organisation as
a result knows what is expected of them.
Clear Organisation Goals:
The organisation is geared directly to the needs of its customers; being normally of small size, it can change quickly and easily cope with changes
Clear Organisation Goals:
The organisation is geared directly to the needs of its customers; being normally of small size, it can change quickly and easily cope with changes
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n demand. It is easy for employees to see what the company is trying to do.
Informal Organisation:
There are no formal or rigidly defined lines of responsibility and communication. Most information is passed verbally - little paperwork is used. Everyone in the organisation knows, and comes frequently into contact with, most of their colleagues.
Dynamic And Informal Operation:
Few procedures or methods are stand
Informal Organisation:
There are no formal or rigidly defined lines of responsibility and communication. Most information is passed verbally - little paperwork is used. Everyone in the organisation knows, and comes frequently into contact with, most of their colleagues.
Dynamic And Informal Operation:
Few procedures or methods are stand
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
ardised, nor are standards rigidly defined. Forward planning is minimal. Products are tailor-made and the work process is moulded to suit customer needs.
In summary, the pioneer runs the business much like a family; loyalty is rewarded and strict paternalistic discipline imposed. For this approach to be successful, the pioneer needs to have a complete and detailed picture of every aspect of company operation and t
In summary, the pioneer runs the business much like a family; loyalty is rewarded and strict paternalistic discipline imposed. For this approach to be successful, the pioneer needs to have a complete and detailed picture of every aspect of company operation and t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
heir subordinates must be willing to accept dependency and autocratic leadership. (The latter requirement sometimes leads to the selection of managers who find difficulty in coping when the organisation moves into the next development phase)
Crisis Of Phase 1:
The duration of the pioneer phase in a particular organisation is extremely variable and is often closely geared to the personality of the pioneers themsel
Crisis Of Phase 1:
The duration of the pioneer phase in a particular organisation is extremely variable and is often closely geared to the personality of the pioneers themsel
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
ves. This style of organisation depends on the pioneer’s ability to ‘oversee’ the company’s detailed operation. The phase may end with the retirement or departure of the pioneer when their successor, in the person normally of their son (or another family member) lacks the original pioneer’s depth of knowledge of the company and technical expertise and, therefore, has to adopt a different style. In other cases, othe
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
problems gradually develop which may force the pioneer themselves to modify their approach, if they are able to do so.
Typical events which may cause an organisation to move into the next stage of development are:-
Growth In Size:
Increasing numbers of employees, size of market and production facilities cause the informality of pioneering management to become inadequate. The top manager can no longer directly c
Typical events which may cause an organisation to move into the next stage of development are:-
Growth In Size:
Increasing numbers of employees, size of market and production facilities cause the informality of pioneering management to become inadequate. The top manager can no longer directly c
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
ontrol the detailed running of the company.
Specialist Techniques:
The increasing complicated nature of the business demands the application of more ‘professional’ techniques if control is to be kept. (i.e. production planning, cost control and work study). This necessitates a more defined structure of management to avoid confusion between specialists and line management.
Succession To The Pioneer:
As already i
Specialist Techniques:
The increasing complicated nature of the business demands the application of more ‘professional’ techniques if control is to be kept. (i.e. production planning, cost control and work study). This necessitates a more defined structure of management to avoid confusion between specialists and line management.
Succession To The Pioneer:
As already i
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
ndicated, the successor to the pioneer may not be sufficiently versed in the ways of the company to take as strong a role as leader.
Lack Of Capital:
When the pioneer can no longer supply the necessary capital funds for growth, outsiders may be called upon to provide the necessary resources and, in turn, will require a say in how the business is run. The pioneer is no longer free to operate as they personally wou
Lack Of Capital:
When the pioneer can no longer supply the necessary capital funds for growth, outsiders may be called upon to provide the necessary resources and, in turn, will require a say in how the business is run. The pioneer is no longer free to operate as they personally wou
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
ld like.
Better Planning Needed:
The informality and flexibility of day-to-day planning can no longer guarantee to support the increased resources of the company. Planning of all aspects of the company (production, marketing, investment, etc.) needs to be more systematic and longer term.
Professional Management:
Experienced managers are introduced from outside the company who are not prepared to function wi
Better Planning Needed:
The informality and flexibility of day-to-day planning can no longer guarantee to support the increased resources of the company. Planning of all aspects of the company (production, marketing, investment, etc.) needs to be more systematic and longer term.
Professional Management:
Experienced managers are introduced from outside the company who are not prepared to function wi
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
hin the paternalistic, autocratic style of pioneering management
Where a company can be identified as predominantly in Phase 1 of development, the adequacy of this situation can be judged by considering whether any problems exist in the following areas:-
Communication:
o Are instructions failing to reach their destination?
o Does middle management find themselves bypassed by communications between the top manag
Where a company can be identified as predominantly in Phase 1 of development, the adequacy of this situation can be judged by considering whether any problems exist in the following areas:-
Communication:
o Are instructions failing to reach their destination?
o Does middle management find themselves bypassed by communications between the top manag
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ers and the shop floor?
o Do managers and supervisors complain that they are never told anything, or are always the last to hear?
o Are there clashes between line managers and specialists?
Job Performance:
o Do some things never get done?
o Does everyone disclaim responsibility?
o Do some things get done several times by different people?
o Do senior management complain that supervisors will not accept respo
o Do managers and supervisors complain that they are never told anything, or are always the last to hear?
o Are there clashes between line managers and specialists?
Job Performance:
o Do some things never get done?
o Does everyone disclaim responsibility?
o Do some things get done several times by different people?
o Do senior management complain that supervisors will not accept respo
.
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
nsibility and do not act as part of management?
o Does lower management complain that senior management will not delegate?
o Are there regular arguments between departments?
Co-ordination And Planning:
o Are decisions proving to be wrong or not getting made at all?
o Is the company losing production or sales through failing to plan ahead?
o Are standards of quality and quantity of work varyin
o Does lower management complain that senior management will not delegate?
o Are there regular arguments between departments?
Co-ordination And Planning:
o Are decisions proving to be wrong or not getting made at all?
o Is the company losing production or sales through failing to plan ahead?
o Are standards of quality and quantity of work varyin
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
g from person to person? Are customer complaints going up?
o Does the company desperately need increased production at reduced unit cost?
If the answer is ‘yes’ to a signification number of these and similar questions, the company would benefit from some of the procedures normally adopted in the second ‘Scientific Management’ phase development.(See Part 2)
Copyright © 2006 Jonathan Farrington. All rights reserve
o Does the company desperately need increased production at reduced unit cost?
If the answer is ‘yes’ to a signification number of these and similar questions, the company would benefit from some of the procedures normally adopted in the second ‘Scientific Management’ phase development.(See Part 2)
Copyright © 2006 Jonathan Farrington. All rights reserve
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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